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ryman, I addressed that in my previous post. If other CEO's purchase shares of their company in the open market, it means they are not in possession of anything material - at the time of their purchase.
Comparing other CEO's of other companies to any other CEO is really tough to do and I don't think on the surface, it's a fair or apples to apples comparison. What are they working on if anything? How active are they in their company? Are they just a figure head or are they rain makers? Do they engage in direct talks with partners, the FDA, are they talking to other companies about new or existing deals, are they working on agreements, etc.
From what I know about Wotton and Apple, they are very active and engaged. I don't know about the particulars of other CEO's or insiders.
No. If those insiders could buy shares, it would mean they are not in possession of material non-public information. Gonella has a ton of shares, he may be overweighted in his ATRS investment.
As far as Wotton and Apple, these two are very active in the business and therefore unable to buy. I asked Jack once this directly: "if Wotton and Apple could buy shares during an open window period, could they buy?" He said yes. "Then how come we don't see any purchases?" He said, "they can't because they are in possession of material information." He then added, we are so busy at this point, I don't know if they will get an opportunity to buy, then he further added, "look at it this way, if they do buy, it means not much is going on with the company and what they are working on."
Sometimes, with all the gnashing of teeth about wanting to see insider buys (just do it kind of mentality), and if those insiders tried to get in some buys to appease the public trading entity, they could very well have the SEC breathing down their necks with possible violation of 'insider trading.' Then what would happen to the stock price if we saw a PR release about the SEC investigating some Antares insiders trades?
Antares website says this:
CODE OF BUSINESS CONDUCT AND ETHICS
Insider Trading. Company Personnel are prohibited from trading in securities
while in possession of material inside information. Among other things, trading
while in possession of material inside information can subject such Company
Personnel to criminal or civil penalties. Any insider trading policy adopted by the
Company from time to time is incorporated by reference into this Code of Conduct.
1-PH/2786018.3 5
CORPORATE GOVERNANCE GUIDELINES
Share Ownership by Directors and Executive Officers. The Board believes
that the number of shares of the Company’s capital stock owned by each
director and executive officer is a personal decision, but encourages stock
ownership.
Howarth bought 18,600 shares today and now has a total of 568,916 shares....fyi.
they'll only go to the EU with a partner and to just eat into Medac's share of the SQ pie and along with just because. LOL.
Great prior post / answer tdp!
tdp:
It does seem obvious to us at this point. Ultimately, as you know, what we think doesn't mean squat. But I'm confident that Antares legal team will and is working on the legal means and methods of which we can only be take the spectator role, watch and wait, and do some quarterbacking from the sidelines.
Exactly! Prior art exists. Medac is claiming Antares infringes on with 3 of their higher concentrations - because of Medac's patent.
Solutions containing concentrations greater than 25 mg/ml were commercially available for medical use prior to the Medac '231 patent.
Example 1:
Name and address
Hospira NZ Limited
23 Haining Street
Te Aro
Wellington
New Zealand
Date of preparation
1 January 2008
Package quantities
Methotrexate Injection
Strength Pack
5 mg/2 mL 5 x 2 mL vials
50 mg/2 mL 5 x 2 mL vials
100 mg/4 mL 5 x 4 mL vials
500 mg/20 mL 1 x 20 mL vials
1 g/10 mL 1 x 10 mL vials
1 g/10 mL 1 x 10 mL ONCO-VIAL®
Nothing new (as shown) on that particular docket report (as far as anything from Antares legal counsel) just yet.
This is one of the few files available as all the exhibits (21 total) are "Sealed".
First, the docket report:
U.S. District Court
District of Delaware (Wilmington)
CIVIL DOCKET FOR CASE #: 1:14-cv-00270-SLR
Antares Pharma Inc. v. Medac Pharma Inc. et al
Assigned to: Judge Sue L. Robinson
Cause: 35:145 Patent Infringement
Date Filed: 02/28/2014
Jury Demand: None
Nature of Suit: 830 Patent
Jurisdiction: Federal Question
Plaintiff
Antares Pharma Inc. represented by John C. Phillips , Jr.
Phillips, Goldman & Spence, P.A.
1200 North Broom Street
Wilmington, DE 19806
(302) 655-4200
Email: jcp@pgslaw.com
LEAD ATTORNEY
ATTORNEY TO BE NOTICED
Megan C. Haney
Phillips, Goldman & Spence, P.A.
1200 North Broom Street
Wilmington, DE 19806
302- 655-4200
Email: mch@pgslaw.com
ATTORNEY TO BE NOTICED
V.
Defendant
Medac Pharma Inc. represented by Jack B. Blumenfeld
Morris, Nichols, Arsht & Tunnell LLP
1201 North Market Street
P.O. Box 1347
Wilmington, DE 19899
(302) 658-9200
Email: jbbefiling@mnat.com
LEAD ATTORNEY
ATTORNEY TO BE NOTICED
Defendant
Medac GmbH
Date Filed # Docket Text
02/28/2014 1
COMPLAINT - filed against Medac GmbH, Medac Pharma Inc. - Magistrate Consent Notice to Pltf. ( Filing fee $ 400.00, receipt number 0311-1470947.) - filed by Antares Pharma Inc. (Attachments: # 1 Exhibit A, # 2 Exhibit B, # 3 Exhibit C, # 4 Civil Cover Sheet)(rwc) (Entered: 03/04/2014)
02/28/2014 2
Notice, Consent and Referral forms re: U.S. Magistrate Judge jurisdiction. (rwc) (Entered: 03/04/2014)
02/28/2014 3
Report to the Commissioner of Patents and Trademarks for Patent/Trademark Number(s) 8,480,631; 6,565,553. (rwc) (Entered: 03/04/2014)
02/28/2014 4
Disclosure Statement pursuant to Rule 7.1: No Parents or Affiliates Listed filed by Antares Pharma Inc. (rwc) (Entered: 03/04/2014)
02/28/2014 Summons Issued with Magistrate Consent Notice attached as to Medac Pharma Inc. on 2/28/2014. (rwc) (Entered: 03/04/2014)
03/04/2014 5
SUMMONS Returned Executed by Antares Pharma Inc.. Medac Pharma Inc. served on 2/28/2014, answer due 3/21/2014. (Haney, Megan) (Entered: 03/04/2014)
03/05/2014 Case Assigned to Judge Sue L. Robinson. Please include the initials of the Judge (SLR) after the case number on all documents filed. (rjb) (Entered: 03/05/2014)
03/14/2014 6
MOTION for Preliminary Injunction - filed by Antares Pharma Inc.. (Attachments: # 1 Text of Proposed Order)(Phillips, John) (Entered: 03/14/2014)
03/14/2014 7
[SEALED] OPENING BRIEF in Support re 6 MOTION for Preliminary Injunction filed by Antares Pharma Inc..Answering Brief/Response due date per Local Rules is 3/31/2014. (Attachments: # 1 Exhibit A, # 2 Exhibit B, # 3 Exhibit C, # 4 Exhibit D, # 5 Exhibit E, # 6 Exhibit F, # 7 Exhibit G, # 8 Exhibit H, # 9 Exhibit I, # 10 Exhibit J, # 11 Exhibit K, # 12Exhibit L, # 13 Exhibit M, # 14 Exhibit N, # 15 Exhibit O, # 16 Exhibit P, # 17 Exhibit Q, # 18 Exhibit R, # 19 Exhibit S, # 20 Exhibit T, # 21 Exhibit U)(Phillips, John) (Entered: 03/14/2014)
03/14/2014 8
[SEALED] DECLARATION re 7 Opening Brief in Support,, Declaration of Charles Schneider in Support of Antares Motion for Preliminary Injunction by Antares Pharma Inc.. (Phillips, John) (Entered: 03/14/2014)
03/14/2014 9
[SEALED] DECLARATION re 7 Opening Brief in Support,, Declaration of Anthony R. DiSanto, Ph. D. in Support of Antares' Motion for Preliminary Injunction by Antares Pharma Inc.. (Phillips, John) (Entered: 03/14/2014)
03/14/2014 10
[SEALED] DECLARATION re 7 Opening Brief in Support,, Declaration of Robert Apple in Support of Antares' Motion for Preliminary Injunction by Antares Pharma Inc.. (Phillips, John) (Entered: 03/14/2014)
03/14/2014 11
DECLARATION re 7 Opening Brief in Support,, Declaration of Mark Fisher, M.S. In Support of Antares' Motion for Preliminary Injunction by Antares Pharma Inc.. (Phillips, John) (Entered: 03/14/2014)
03/14/2014 12
CERTIFICATE OF SERVICE of (1) Antares' Motion for Preliminary Injunction and Proposed Order; (2) Antares' Opening Brief In Support of its Motion for Preliminary Injunction; (3) Declaration of Charles Schneider in Support of Antares' Motion for Preliminary Injunction; (4) Declaration of Robert Apple in Support of Antares' Motion for Preliminary Injunction; (5) Declaration of Anthony R. DiSanto, Ph. D. in Support of Antares' Motion for Preliminary Injunction; and (6) Declaration of Mark Fisher, M.S. In Support of Antares' Motion for Preliminary Injunction by Antares Pharma Inc. re 9 Declaration, 8 Declaration, 11 Declaration, 6 MOTION for Preliminary Injunction , 7 Opening Brief in Support,, 10Declaration (Phillips, John) (Entered: 03/14/2014)
03/18/2014 13
STIPULATION TO EXTEND TIME for Medac Pharma, Inc. to move, answer, or otherwise respond to the Complaint to April 21, 2014 - filed by Medac Pharma Inc.. (Blumenfeld, Jack) (Entered: 03/18/2014)
Below is testimony pertaining to the 'motion to dismiss'.
IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF DELAWARE
ANTARES PHARMA, INC.
Plaintiff,
v.
MEDAC PHARMA, INC. and
MEDAC GmbH,
Defendants.
Civil Action No. 1:14-cv-00270-SLR
DECLARATION OF MARK FISHER, M.S. IN SUPPORT OF
ANTARES’ MOTION FOR PRELIMINARY INJUNCTION
Of Counsel:
Imron T. Aly
Kevin E. Warner
Joel M. Wallace
WINSTON & STRAWN LLP
35 West Wacker Drive
Chicago, IL 60601
Tel: (312) 558-5600
Fax: (312) 558-5700
ialy@winston.com
kwarner@winston.com
jwallace@winston.com
Ahmed M.T. Riaz
Legal Affairs Counsel
ANTARES PHARMA, INC.
100 Princeton South Corporate Center
Suite 300
Ewing, NJ 08628
(609) 359-3020 (telephone)
(609) 359-3015 (facsimile)
ariaz@antarespharma.com
John C. Phillips, Jr. (#110)
Megan C. Haney (#5016)
PHILLIPS, GOLDMAN & SPENCE, P.A.
1200 North Broom St.
Wilmington, DE 19806
Tele: (302) 655-4200
Fax: (302) 655-4210
JCP@pgslaw.com
mch@pgslaw.com
Dated: March 14, 2014 Attorneys for Plaintiff, Antares Pharma, Inc.
Case 1:14-cv-00270-SLR Document 11 Filed 03/14/14 Page 1 of 32 PageID #: 425
1
IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF DELAWARE
ANTARES PHARMA, INC.
Plaintiff,
v.
MEDAC PHARMA, INC. and
MEDAC GmbH,
Defendants.
Civil Action No. 1:14-cv-00270-SLR
DECLARATION OF MARK FISHER, M.S. IN SUPPORT OF
ANTARES’ MOTION FOR PRELIMINARY INJUNCTION
I, MARK FISHER, DECLARE AS FOLLOWS:
I. INTRODUCTION
1. I have been retained by counsel for Antares Pharma, Inc. (“Antares”) to provide
opinions concerning U.S. Patent Nos. 6,565,553 (“the ’553 patent”) and 8,480,631 (“the ’631
patent”) (together, “the patents-in-suit”). My opinions and their bases are provided in this
declaration, although the analysis is preliminary since I have been informed that discovery has
not begun in the case. If requested, I expect to provide testimony concerning my opinions at any
hearing or trial for this matter.
2. I have been informed that Medac Pharma, Inc.’s parent company is medac GmbH, and
that medac GmbH sells an autoinjector containing methotrexate in Europe under the trade name
Metex Pen. I have reviewed a press release by Medac Pharma, Inc. dated January 27, 2014,
attached as Exhibit F, which reports that it filed an application with the FDA to sell an automated
injector containing methotrexate, for subcutaneous use. It is my understanding that the
application to the FDA filed by Medac Pharma, Inc. seeks approval for a device that is the same
or substantially similar to the Metex Pen injector sold in Europe.
Case 1:14-cv-00270-SLR Document 11 Filed 03/14/14 Page 2 of 32 PageID #: 426
2
3. I have been asked to provide my opinions regarding whether the Metex Pen, if made or
sold in the United States, would infringe claim 18 of the ‘553 patent or certain limitations recited
in claim 1 of the ‘631 patent. I have also been asked to consider certain dependent claims—that
depend on claim 18 of the ‘553 patent or claim 1 of the ‘631 patent—as discussed further below.
4. I am providing this declaration to summarize my opinions, which I formed after review
and analysis of the ‘553 and ’631 patents, their prosecution histories, and my study of a Metex
Pen methotrexate injector. In forming my opinions and preparing this report, I have relied upon
my knowledge and experience in the field and have also reviewed and considered other
information, documents and things. The complete list of documents and things that I have
considered in forming the opinions expressed in this report is attached as Exhibit D.
5. I reserve the right to supplement this report as a consequence of any opinions that
Medac’s witnesses may provide, discovery that may be provided during the case, and further
information about Medac’s proposed methotrexate injector that becomes available. I expect that
additional information will further support my opinions. I also reserve the right to modify or
supplement my opinions based on any claim construction ruling regarding the patents-in-suit.
II. QUALIFICATIONS AND EXPERIENCE
6. I am a mechanical engineer by training and have over 30 years of experience in the
field of product design and development in the areas of health care, consumer goods, industrial
products and aerospace components. Throughout my career I have advised clients on complex
engineering projects involving a wide range of mechanical devices, including medical devices
and injection products. These industrial and commercial products include an insulin injector,
hydraulic cylinders and pumps, dental equipment, surgical equipment, and diagnostic testing
equipment.
Case 1:14-cv-00270-SLR Document 11 Filed 03/14/14 Page 3 of 32 PageID #: 427
3
7. In the last 15 years I have focused on the engineering of medical devices. In addition to
the above mentioned technical techniques and skills, this requires the routine use of and attention
to matters of function, safety and reliability, as well as knowledge of the process by which
medical devices are regulated and approved for use by medical professionals and consumers.
8. In 1983 I received a bachelor’s degree in mechanical engineering from the Milwaukee
School of Engineering. I then obtained a master’s degree in mechanical engineering from the
University of Illinois at Urbana-Champaign. My graduate studies focused on materials,
tribology and design. I also received professional training in subjects such as product design,
project management, and engineering of medical devices.
9. I am currently employed by Northwestern Global Health Foundation as the Director of
Engineering. Northwestern Global Health Foundation is an organization with a mission to
improve access to life-saving medical technologies to resource-limited populations, by creating
and developing technologies and products for the developing world. For example, I was
involved with the design and creation of a diagnostic test for infants who may be infected with
HIV. This test, in addition to others in development, are targeted for limited resource settings
such as Sub-Saharan Africa.
10. From 1996 to 2010, I worked at the product design firm IDEO. IDEO is regarded as
the world’s largest and premier product development consultancy firm. IDEO is widely credited
with inventing the modern profession of product design, which is a cultural and professional
approach to designing products in a manner which integrates the influences of engineering,
industrial design, human factors engineering, manufacturing, and business factors. IDEO is
renowned for the creation of thousands of successful products across a wide range of industries,
and has consistently received top awards and citations for design quality and commercial
Case 1:14-cv-00270-SLR Document 11 Filed 03/14/14 Page 4 of 32 PageID #: 428
4
success. IDEO has executed successful programs for hundreds of companies such as Apple
Computer, Proctor & Gamble, Novartis, Ford Motor Company, Polaroid, and Hewlett Packard,
among others. IDEO’s method, culture and accomplishments have been the topic of books,
lectures, college curricula, and major news coverage.
11. As an engineer and project manager at IDEO, I was responsible for overseeing and
leading technical teams in the development of medical device related projects for companies
such as Eli Lilly & Co., Smith & Nephew, Medtronic, and others. Eventually I was promoted to
the Health Practice Lead for the Chicago office, where I oversaw all healthcare related products,
including the design and development of drug delivery devices.
12. While at IDEO, my work included the following projects that relate to the technology at
issue in this case:
? Multi-dose injector
? Multi-use, fixed dose injector
? Multi-dose pen jet injector
? Surgical equipment for general surgery, orthopedic surgery, image-guided surgery
? Transdermal drug delivery materials
? A number of medical diagnostic products
13. Even as I became an engineering manager, I remain engaged in the detailed aspects of
engineering projects to this day. Furthermore, the above examples of my work have a common
thread in that they involved fluid mechanics and pressure systems.
14. I have received multiple design awards for my work in various industries. I have been
recognized by the Industrial Designers Society of America with the IDEA award in 1999 for the
Dentsply Air Abrasion System. These awards are presented annually to designers who have
Case 1:14-cv-00270-SLR Document 11 Filed 03/14/14 Page 5 of 32 PageID #: 429
5
shown excellence in the field of international product design. The awards are presented to
designers of certain categories of products, and the designers are chosen from hundreds of
nominations submitted by a panel of peers and academicians. These awards are considered the
highest peer commendations within the product design community and are rarely given to
engineers.
15. I have also received multiple Medical Design Excellence Awards which recognize
significant advances in medical product design and engineering that improve the quality of
healthcare delivery and accessibility. I was awarded MDEA for the Dentsply AirTouch Air
Abrasion System in 1999, the Eli Lilly Humatrope Reconstitution System in 2005, and the Bayer
Contour USB blood glucose meter in 2010.
16. From 1990 to 1996 I worked at Enerpac as Senior Project Lead and Manager of OEM
Engineering. Enerpac is a global market leader in high pressure hydraulic tools and products.
My primary focus was work on the design of high pressure hydraulics. This involves mastery of
concepts of fluid mechanics and fluid systems.
17. From 1983 to 1989 I worked as a Senior Mechanical Engineer at Sundstrand
Corporation. Sundstrand was a leading designer and manufacturer of aerospace and industrial
products. At Sundstrand, my work focused on pumps and fluid systems.
18. Based on my work throughout my career I have more than 20 patents issued or pending
before the PTO and European Patent Office. I have been issued patents in the areas of health
care related products, including adjustable dose injectors, injectors, and transdermal pororator
and patch systems. I have also been granted patents for hydraulic systems and consumer
products.
19. A full copy of my curriculum vitae is attached as Exhibit C.
Case 1:14-cv-00270-SLR Document 11 Filed 03/14/14 Page 6 of 32 PageID #: 430
6
III. PRIOR TESTIMONY AND COMPENSATION
20. I have not testified as an expert witness, at trial or deposition in the last four years.
21. I am being compensated at a rate of $200 per hour for my services. My compensation
is not contingent on the content of my testimony or the outcome of this litigation.
IV. TECHNOLOGICAL BACKGROUND FOR PATENTS-IN-SUIT
22. The patents-in-suit relate to automated injectors. The ’553 patent describes a particular
injector design as shown in the claims, and the ’631 patent describes a particular injector design
that is specifically for use with hazardous medicaments, including methotrexate.
23. The traditional form of injecting drugs is using a manual, hand powered, syringe. The
syringe is either prefilled with medication by a manufacturer or the user must insert the syringe
into a vial containing the drug and draw the proper amount. The user was traditionally a doctor
or nurse, but increasingly patients are self-injecting or asking to self-inject to avoid office visits.
After the medication is drawn into the syringe, the user manually inserts the needle into the skin.
Next, the user presses down on the plunger to push the drug out through the needle.
24. There are several routes of injections depending on the depth and area where the
injection is given. Two routes used for injectable drug administration are subcutaneous and
intramuscular injections. Attached as Exhibits H and I are Guidelines published by Becton
Dickenson, a syringe and injector manufacturer, illustrating these two types of injections.
25. An intramuscular injection is used when it is desirable to inject the medicine deeply
into the tissue of a patient either because of the type of medicine being injected or because,
generally speaking, muscle tissue contains more blood vessels therefore drugs injected
intramuscularly act more quickly. Because the injection is intended to reach the muscle,
intramuscular injections use longer needles, normally 1 inch (or 25.4 mm) or more for adults.
Ex. H (IM Guidelines). These injections are given into major muscle groups such as the upper
Case 1:14-cv-00270-SLR Document 11 Filed 03/14/14 Page 7 of 32 PageID #: 431
7
arm (deltoid muscle), buttocks (ventrogluteal or dorsogluteal site), or mid-thigh (vastus lateralis
site). Id.
26. In contrast, subcutaneous injections are intended to deposit the drug in the layer
between the skin (dermis) and muscle. Ex. I (SC Guidelines). This layer is mostly filled with
adipose and fatty tissue. Because there are fewer blood vessels, drugs injected subcutaneously
often are released into the body more slowly than intramuscular injections. Needles used for
subcutaneous injections are shorter than those used for intramuscular injections, traditionally
about 1/2 inch (12.7 mm) or less. The shorter needle is used for subcutaneous injections because
insertion of the needle into the muscle is not desired. The skin layer in humans is about 2 to 3
mm over the entire body, so these injections are given in sites where there is skin over a thicker
layer of fatty tissue such as the outer aspect of the upper thigh, the abdomen, or the upper
buttocks. Id.
27. There are several problems with hand-powered syringes. The manipulation of a syringe
with a needle can be unpleasant or cause unease for a patient or caregiver and such apprehension
can cause mistakes and accidents such as dropping the syringe or inadvertent needle sticks.
Filling the syringe with the proper dose can be difficult for some patients particularly those with
poor vision or arthritis (rhuematoid and osteo arthrisis). Administration of the dose requires
needle insertion and then depression of the plunger to inject the medicine while the needle is
inserted, both potentially challenging activities. Also, if patients are self-administering the drug,
then the needle insertion and subsequent injection can lead to perceived or real pain.
28. Recognizing the problems with hand-powered syringes, inventors at Antares developed
needle-assisted automated jet injectors that improved drug delivery and reliability. I have been
Case 1:14-cv-00270-SLR Document 11 Filed 03/14/14 Page 8 of 32 PageID #: 432
8
asked to consider two Antares patents for further assessment, the ‘553 patent and the ‘631 patent,
and compare them to the proposed Medac device.
V. THE ’553 PATENT
29. The ’553 patent is entitled “Needle Assisted Jet Injector.” The inventors are Peter L.
Sadowski, David M. DeBoer, Claude L. Berman, and Paul R. Lesch, Jr. The patent is assigned
to Antares Pharma, Inc. The ’553 patent issued May 20, 2003, and stemmed from Application
No. 10/062,652. Ex. A, front page.
30. I have reviewed the claims, specification, figures, and prosecution history of the ’553
patent. Based on this review, I have determined that the claim terms would be understandable to
a person of ordinary skill in the art, and I have used the plain and ordinary meaning of each term.
I have included the plain and ordinary meaning, where necessary, in my analysis of each claim
element below.
31. Independent claim 18, reproduced below, is representative of the asserted claims of the
’553 patent:
18. A jet injection device, comprising:
a housing;
a nozzle assembly associated with the housing to define a distal
end, the nozzle assembly defining a fluid chamber configured for
containing a fluid, and the nozzle assembly comprising an
injection-assisting needle configured for penetrating an injection
point up to the distal end, the needle defining a discharge channel
in fluid communication with the fluid chamber and with a needle
orifice of the needle, wherein the needle orifice is disposed beyond
but less than about 5 mm from the distal end for delivering the
fluid;
a pressure wall associated with the fluid chamber for pressurizing
the fluid therein;
a trigger assembly operable by a user; and
Case 1:14-cv-00270-SLR Document 11 Filed 03/14/14 Page 9 of 32 PageID #: 433
9
a force generating source associated with the trigger assembly such
that the operation of the trigger assembly activates the force
generating source for providing a force of less than about 40 lbs on
the pressure wall to expel the fluid from the fluid chamber through
the discharge channel to an injection site that is substantially
remote from the orifice.
VI. THE ’631 PATENT
32. The ’631 patent is entitled “Hazardous Agent Injection System.” The inventors are
Paul Wotton, Peter L. Sadowski, and John William Hayes. The patent is assigned to Antares
Pharma, Inc. The ’631 patent issued July 9, 2013, and stemmed from Application No.
13/607,659. Ex. B, front page.
33. I have reviewed the claims, specification, figures, and prosecution history of the ’631
patent. Based on this review, I have determined that the claim terms would be understandable to
a person of ordinary skill in the art, and I have used the plain and ordinary meaning of each term.
I have included the plain and ordinary meaning, where necessary, in my analysis of each claim
element below.
34. Independent claim 1, reproduced below, is representative of the asserted claims of the
’631 patent:
1. A hazardous agent injection system, the hazardous agent
injection system comprising:
methotrexate in an amount of from about 0.02 ml to about 4.0 ml
and at a concentration of from about 7.5 mg/ml to about 150
mg/ml;
a needle-assisted jet injector, the needle-assisted jet injector
comprising:
a container configured to contain the methotrexate;
an injection outlet member associated with the container, the
injection outlet member including an injection-assisting needle
configured to pierce the skin of a patient and deliver a jet of
methotrexate to the patient subcutaneously;
Case 1:14-cv-00270-SLR Document 11 Filed 03/14/14 Page 10 of 32 PageID #: 434
10
a firing mechanism associated with the container and configured to
expel the methotrexate from the container through the outlet
member for injecting the methotrexate; an energy source
associated with the firing mechanism and configured to power the
firing mechanism and to jet inject the methotrexate from the
injection outlet member as a fluid jet; and
a trigger mechanism associated with the firing mechanism and
configured to activate the firing mechanism,
wherein the needle-assisted jet injector is configured to eject the
methotrexate from the injection outlet member such that one or
more of confidence intervals of (a) the maximum concentration of
methotrexate in blood plasma of a patient following administration
of a dose of the methotrexate to the patient (“Cmax”) with the
hazardous agent injection system, (b) the time to reach the
maximum concentration of methotrexate in blood plasma of a
patient following administration of a dose of the methotrexate to
the patient with the hazardous agent injection system (“Tmax”)
and (c) area under the curve of the concentration of methotrexate
in blood plasma of a patient following administration of a dose of
the methotrexate to the patient with the hazardous agent injection
system of the needle-assisted jet injected methotrexate (“AUC”}
falls between about 80% and about 125% of a corresponding
measured confidence interval of the same dose of methotrexate
delivered subcutaneously or intramuscularly by a hand-powered
syringe, and wherein the needle-assisted jet injector is configured
to subcutaneously inject the methotrexate in less than 5 seconds.
VII. LEGAL STANDARDS FOR PATENT INFRINGEMENT AND VALIDITY
35. I understand that an infringement analysis is a two-step process. I further understand
that the first step is to determine the proper meaning of the terms of the asserted claims as they
would be understood by a person of ordinary skill in the art at the time of the invention and that
the second step is to compare the properly construed claims to the accused device or method on a
limitation-by-limitation basis.
36. I understand that the comparison of the asserted claims to the accused device in an
infringement analysis requires a determination that each and every element of the asserted claims
or its equivalent is found in the accused device. I further understand that Antares has the burden
Case 1:14-cv-00270-SLR Document 11 Filed 03/14/14 Page 11 of 32 PageID #: 435
11
of proving that Medac’s methotrexate injector infringes an asserted claim of the ’553 and/or ’631
patent.
37. I understand that for a claim to be literally infringed, the accused product must contain
each and every limitation of the claim. I understand that if an accused product does not contain
each and every limitation of a claim, it may still infringe the missing element under the “doctrine
of equivalents.” A claim element may be infringed under the doctrine of equivalents when the
differences between an element in the accused product and the corresponding element in the
asserted claim are insubstantial. One way to show this is to demonstrate that the feature at issue
in the accused device and the corresponding limitation of the claim at issue perform substantially
the same function, in substantially the same way, to achieve substantially the same result.
38. I understand that the claims of an issued patent are presumed valid by statute. I also
understand that this presumption may be overcome and a claim may be found invalid with a
showing of clear and convincing evidence that the claim is anticipated or obvious by the prior
art. I understand that for a claim to be anticipated, every element of that claim must be present in
a single prior art reference. I also understand that if an element is not expressly disclosed, it may
be inherently disclosed if that element necessarily present in the prior art reference.
39. I understand that a patent claim may be considered obvious if multiple pieces of prior
art in combination would have made the invention of the claim obvious to a person of ordinary
skill in the art. I understand that a person of ordinary skill must be motivated by the art or
problem to be solved in the field to combine the prior art in the same way as the claim. I also
understand that for a combination to be obvious, a person of ordinary skill in the art must have a
reasonable expectation of success in combining the prior art to solve the identified problem.
Finally, I understand that when considering evidence of obviousness, one must also consider
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evidence of so-called objective indicia of nonobviousness. These include unexpected results,
fulfilling a long-felt need, and commercial success.
VIII. OPINIONS
40. In my opinion, the Medac methotrexate injector infringes at least claims 18 and 24 of
the ’553 patent. It is also my opinion that Medac’s methotrexate injector infringes claims 1, 6, 7,
10, 11, 12 and 13 of the ‘631 patent that relate to the injector. I understand that another expert is
addressing issues related to the final limitation describing the pharmacokinetic properties of the
claimed invention in the ’631 patent.
A. Definition of a Person of Ordinary Skill in the Art
41. I was asked to evaluate what credentials a person of ordinary skill in the art would have
for the inventions claimed in the ’553 and ’631 patents. I was informed that the level of skill is
determined as of the filing date of the patent. For the ’553 patent, the filing date is August 11,
1998. Ex. A, front page. The filing date for the ’631 patent is March 20, 2009. Ex. B, front
page.
42. In determining the level of skill of the POSA, I have relied on my years of experience
as a product designer and mechanical engineer. I have also been informed that the following
factors could be applicable in the analysis to determine the level of a person of ordinary skill in
the art: (1) the educational level of the inventor; (2) type of problems encountered in the art; (3)
prior art solutions to those problems; (4) rapidity with which innovations are made; (5)
sophistication of the technology; and (6) educational level of active workers in the field.
43. It is my opinion that the level of ordinary skill in the art for the ’553 and ’631 patents is
a medical device designer with an engineering or other technical degree, and could be a
bachelor’s degree with several years of experience in the medical device field, or an advanced
degree with fewer years of experience.
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B. Analysis of Medac’s Methotrexate Injector
44. My analysis of Medac’s methotrexate injector included a study of the device itself,
which I understand is commercially sold in Europe as the Metex Pen. See Ex. N (Medac Poster.)
I also reviewed the Patient Instructions for using a version of the Metex Pen, attached as Exhibit
G. These instructions describe the various doses available, background information about the
approved indications and drug, safety information, and instructions for how to use the injector.
45. Below is a picture of a sample of an unfired Medac injector.
Figure 1 (Medac Injector)
C. The ’553 Patent
46. Each and every element of claims 18 and 26 of the ’553 patent is present in Medac’s
methotrexate injector.
1. Claim 18: A jet injection device, comprising:
47. I understand that this portion of the claim is called a “preamble,” and is not a limitation.
It provides a label to the claim. Thus, it does not need to be separately addressed.
48. In case a court finds that this preamble is a limitation, Medac’s methotrexate injector is
a jet injection device, because it uses a jet to inject to the medicament into a patient to a depth
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beyond the tip of the needle. See Ex. A (’553 patent) 5:50–55. I have personally observed this
behavior in testing with the device, and it is consistent with my understanding of the high
pressure impact that is used with the Medac injector. As can be seen in the screen shot, attached
as Exhibit J, when Medac’s injector is fired into a block of ballistics gel, the force of the injector
causes the fluid to be expelled as a jet that penetrates to a deeper portion of the block. This is in
contrast to the lack of jet as shown in the screen shot of firing a manual syringe into the same
type of block. Ex. K. Ballistics gel is a useful model to show a side-by-side evaluation for
general behavior for an injection. See Ex. M (Schwritz Article at 40–41.)
2. a housing
49. Medac’s methotrexate injector contains a housing. Specifically, the injector has a twopart
housing made up of a front and rear assembly. The housing is what contains the parts
inside, so that there is a rigid structure surrounding the automation source and the needle.
Figure 2 (Front and Rear Housing)
3. a nozzle assembly associated with the housing to define a distal end
50. Medac’s methotrexate injector contains this element. The “nozzle assembly” is defined
later in claim 18 as the “injection-assisting needle,” which is surrounded by a cover or nozzle, so
Front
Housing
Rear
Housing
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that the needle is not exposed. Medac’s injector contains a needle associated with the end of the
housing that together defines the distal end of the injector. The needle is surrounded by a cover
or nozzle, a needle guard. The needle and needle guard define the distal end, as required by the
claim.
4. the nozzle assembly defining a fluid chamber configured for containing a fluid,
and the nozzle assembly comprising an injection-assisting needle configured for
penetrating an injection point up to the distal end, the needle defining a discharge
channel in fluid communication with the fluid chamber and with a needle orifice
of the needle
51. The nozzle assembly discussed above defines the front edge of the fluid chamber for
containing a fluid, as the fluid chamber includes the syringe, which is pressed against the front of
the Medac device and contains the drug fluid. As discussed above, Medac’s injector also
contains a needle intended to penetrate the injection point up to the distal end of the injector.
When inserted, the distal end of the injector is pressed against the injection point. Also, in
Medac’s injector, the needle is hollow to allow the fluid medicament to flow from the syringe,
through the needle, and into the injection site. The needle orifice refers to an open tip of the
needle, which is present in Medac’s injector. Medac’s methotrexate injector meets this
limitation.
5. wherein the needle orifice is disposed beyond but less than about 5 mm from the
distal end for delivering the fluid
52. The needle orifice of Medac’s methotrexate injector is about 5 mm from the distal end
of the injector when actuated, and will be used to deliver the fluid from the syringe into the
patient. The phrase “about 5 mm” in the context of the claims and the patent refers to a needle
that is intended to deliver medication subcutaneously. I am aware of subcutaneous needles that
are even up to 12 mm, so this claim limitation is focused upon shorter needles wherein the needle
is still used to deliver the drug past the end of the needle. I have observed the needle on Medac’s
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injector and its associated instructions, and it is designed for, and used for subcutaneous
injections. Thus, consistent with the principle of delivering drug beyond the end of the needle,
the Medac injector has an exposed needle length that is “less than about 5 mm” because it
delivers an injection past the needle opening but still within subcutaneous depth. See Ex. A (’553
patent), 5:47–57.
53. In addition, I am aware of wide tolerances in needle lengths when manufacturing glass,
prefilled syringes. In addition, there are a number of parts in the assembly that also contribute to
the variation in the needle projection from the end of the device, for example the flange of the
syringe can vary in thickness from part to part. As an example of these tolerances, I have
attached a sample for a single type of syringe from Becton Dickinson as Exhibit L. While I do
not yet have direct access to the tolerances in the parts and assembly of the device, as those
would be internal documents in Medac’s possession, I would expect a tolerance range of
approximately plus or minus 2 mm. This would mean that a needle projection that is nominally
5 mm may vary from 3 mm to 7 mm within a manufacturing lot and between lots. Given the
number of products that Medac is likely to make and sell, if it is allowed to do so, the length of
exposed needle on at least some devices will be shorter than about 5 mm.
54. Also, there is also an additional tolerance for how firmly the needle guard has to be
pressed against the skin during use. There may be a distance where the needle guard is not fully
retracted because there is a needle guard spring biasing the needle guard forward. The tolerance
stacks combining the prefilled syringe and needle tolerances, the part tolerances, the assembly
tolerances and the needle guard retraction variation make it likely that at least some of Medac’s
devices will have a needle extension “less than about 5 mm” beyond the distal end.
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55. At a minimum, the Medac exposed needle length is equivalent to the claimed needle
length. That is because any difference is insubstantial, as the purpose of the needle length that
Medac selected is for subcutaneous injection while still expelling drug past the end of the needle
tip, which is also consistent with the purpose of the claimed invention.
6. a pressure wall associated with the fluid chamber for pressurizing the fluid
therein
56. The pressure wall in the ’553 patent refers to the plunger in the syringe. Medac’s
methotrexate injector contains a plunger in the syringe. It is aligned at the rear of the syringe
before firing. During activation, the ram contacts the plunger and pushes it within the syringe to
push the fluid medicament out through the needle. Thus, Medac’s device meets this limitation.
7. a trigger assembly operable by a user
57. The ’553 patent defines the trigger assembly as the part of the injector that activates and
triggers the energy source or energy generating means which forces medicament out of the
nozzle assembly. Ex. A, (’553 Patent), col. 4:9-11. In Medac’s injector, the trigger assembly is
made up of the activation button that is first armed by pressing the injector against the injection
site. Once armed, the user may press the triggering button to release the spring (force generating
source) to drive forward the ram and plunger. Thus, the Medac device has a trigger assembly for
the user to operate.
8. a force generating source associated with the trigger assembly
58. The force generating source can include a coil spring, gas spring, or gas propellant.
’531 Patent Col. 4:11-12. Medac’s injector uses a coil spring as the force generating source,
pictured below.
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Figure 3 (Main Spring)
There are two springs within the Medac injector, and the main spring provides the force to drive
the medicament out of the injector. The second spring is located within the needle cover and acts
to extend the needle cover after firing to engage the locking mechanism and cover the needle.
9. such that the operation of the trigger assembly activates the force generating
source for providing a force of less than about 40 lbs on the pressure wall to
expel the fluid from the fluid chamber through the discharge channel to an
injection site that is substantially remote from the orifice.
59. As described above, when activated the trigger assembly (Button) releases the Main
Spring, driving the Ram forward onto the plunger. The plunger then pushes the medicament out
through the needle. Based on my measurements, the main spring in the Medac device generates
approximately 4 lb at full compression, which of course is less than 40 lbs as required by the
claim.
Figure 4 (Button, Main Spring, and Ram)
Main Spring
Button Ram
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60. The Medac injector expels the medicament through the needle to an injection site that is
substantially remote from the orifice. In other words, pressure is used to get the leading edge of
injection depth past the end of the needle. See Ex. A (’553 Patent) Col. 2:60-65; 5:50-57. In
Medac’s device, the drug is expelled as a jet so that it pushes drug further into the subcutaneous
layer.
61. I have run a comparative experiment with a Metex Pen and a manual syringe. I tested
the Metex Pen because I understand this product is available in Europe and am informed that
Medac intends to sell a substantially similar device in the United States. In my experiment, I
observed that its discharge pattern ejects fluid substantially remote from the needle orifice. I first
used a manual syringe and injected it into ballistic gel. I then fired the Metex Pen into ballistic
gel, and compared results. Ex. J (Medac injection screen shot.) A ballistic gel test is useful to
compare side-by-side effects of various injectors to get a sense of how they operate and inject
fluid into tissue. See, e.g., Ex. M (Schwirtz) at 40–41; Ex. K (manual injection screen shot).
62. The Metex Pen creates a jet of fluid that penetrates deeper and therefore allows the drug
to disperse deeper beneath the surface. As can be seen in the screen shot, when Medac’s injector
is fired into a block of ballistics gel, the force of the injector causes the fluid to be expelled as a
jet that penetrates significantly deeper than the needle tip. Ex. J. In other words, the fluid
pressure creates a pit into which the drug can be deposited. Thus, this limitation is present in the
Medac methotrexate injector.
63. As all elements of claim 18 are present in Medac’s injector, the injector infringes claim
18.
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10. Claim 24: The device of claim 18, wherein the needle is configured for insertion
into the insertion point, which is on the epidermis layer of skin, with the injection
site being in the subcutaneous region.
64. As detailed above, all elements of claim 18 are present in Medac’s injector. The Patient
Instructions make clear that Medac’s injector is intended to be placed against the patient’s skin,
or epidermis layer. This is shown in the following steps:
8. With your free hand, build a skin fold by gently squeezing the
area of the cleaned skin at the injection site.
9. Position the uncapped transparent end of Metex Pen pre-filled
Pen perpendicular to the fold of skin.
10. Without pressing the button, push the Metex Pen pre-filled
Pen firmly onto your skin in order to unlock the button.
11. While holding the Metex Pen pre-filled Pen firmly against the
skin, now press the button with your thumb.
12. You will hear a click which indicates the start of the injection.
Keep holding the Pen against he raised skin until all of the
medicine is injected. This can take up to 5 seconds.
Ex. G. The Instructions also warn the user to not remove the injector from the skin before the
end of the injection. (Id.)
65. The injection site for methotrexate, when using Medac’s injector, is within the
subcutaneous region. The January 27, 2014 Press Release (Exhibit F) specifically states that the
product will be for subcutaneous administration of methotrexate. Also, the Medac injector states
that it is for “s.c.” injection, which is a common abbreviation for subcutaneous injection. In
addition, the Patient Instructions state the product is intended to deliver methotrexate
subcutaneously. Ex. G, (“Metex Pen is administered subcutaneously (under the skin) by or
under the supervision of a physician or healthcare staff as an injection once a week only.”).
Thus, the Medac device infringes claim 24.
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D. ’631 Patent
66. Each and every element of claims 1, 6, 7, 10, 11, 12 and 13 of the ’631 patent is present
in Medac’s methotrexate injector.
1. Claim 1: A hazardous agent injection system, the hazardous agent injection system
comprising:
67. I understand that this portion of the claim is called a “preamble,” and is not a limitation.
It provides a label to the claim. In case a court finds that this term is a limitation, Medac’s
methotrexate injector is a hazardous agent injection system, since the device is an injection
device that contains methotrexate. The ’631 patent identifies methotrexate as one “hazardous
agent.” Ex. B, Col. 2:15-4:30; 10:37-13:9. The Medac auto-injector is powered by a spring, so
it is a powered injector. Id. 14:52-56.
2. methotrexate in an amount of from about 0.02 ml to about 4.0 ml and at a
concentration of from about 7.5 mg/ml to about 150 mg/ml
68. I understand that the Metex Pen in Europe is available in several different volumes,
ranging from 0.15 ml to 0.6 ml of methotrexate solution, and that these have a drug
concentration of 50 mg/ml. Ex. G. All of these numbers fall within the claimed ranges. The
product I inspected and studied had a label stating that it contained 0.6 ml, and had a
concentration of 50 mg/ml, as shown below. It is very likely that each of Medac’s U.S. products
will use similar concentrations of 50 mg/ml, and similar volumes, which fall within the claimed
range.
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Figure 5 (Label)
3. a needle-assisted jet injector, the needle-assisted jet injector comprising
69. Medac’s injector is a needle-assisted jet injector. Medac’s device has a needle. And
Medac’s device is a jet injector because it uses an energy source to produce enough pressure to
eject the medicament at a fast speed and inject the medicament into a subject in less than about 5
seconds. Ex. B (’631 Patent), Col. 26:60-66. The energy source in Medac’s injector is the Main
Spring, which has a strength when compressed of approximately 4 lbs based on my
measurements. According to the Patient Instructions that accompany the Metex Pen, step 12 of
the “How to administer the injection” section states:
You will hear a click which indicates the start of the injection.
Keep holding the Pen against the raised skin until all the medicine
is injected. This can take up to 5 seconds.
Exhibit G. This indicates that the injection is completed before 5 seconds. I also have timed an
injection using a Medac injector. That injection was fully complete, administering 0.60 ml in
about 1.5 seconds.
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70. In the context of the ’631 patent, “jet” refers to using enough pressure to get the depth
of the injection beyond the end of the needle. See Ex. B (’631 patent), 27:11-18, 32:30-34. As
can be seen in the screen shot, attached as Exhibit J, when Medac’s injector is fired into a block
of ballistics gel, the force of the injector causes the fluid to be expelled as a jet that penetrates
significantly beyond the tip of the needle. Ex. J. This is in contrast to the lack of jet and
penetration shown in the screen shot of firing a manual syringe into the same type of block. Ex.
K.
4. a container configured to contain the methotrexate
71. As discussed above, Medac’s device contains methotrexate. Within the device, the
methotrexate is contained in a syringe, which is a container configured to contain the
medicament.
Figure 6 (Syringe in Injector)
Methotrexate
in Syringe
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5. an injection outlet member associated with the container, the injection outlet
member including an injection assisting needle configured to pierce the skin of a
patient and deliver a jet of methotrexate to the patient subcutaneously
72. Medac’s methotrexate injector contains an injection outlet member. As defined within
the claim, the injection outlet member is the needle that is attached to the syringe, and, when
used, pierces the skin of the patient. When activated, the methotrexate in Medac’s injector
travels from the syringe, through the needle, and is delivered subcutaneously. The Press Release
specifically states that the product will be for subcutaneous administration of methotrexate. Ex.
F. Also, the Medac injector states that it is for “s.c.” injection, which is a common abbreviation
for subcutaneous injection. Fig. 5. In addition, the Patient Instructions state the product is
supposed to deliver methotrexate subcutaneously. Ex. G.
73. Medac’s device meets the “deliver a jet of methotrexate” limitation. As discussed in
paragraphs 69 through 70 above, the medicament is ejected from the device as a jet, extending
beyond the end of the needle opening. Additionally, Medac’s injector delivers the entire
injection in less than 5 seconds, which is consistent with the use of a jet injector within the
context of the ‘631 patent. E.g., Ex. B (’631 Patent), Col. 19:1-4; 25:55-59; 37:45-53. For these
reasons, the Medac device infringes.
6. a firing mechanism associated with the container and configured to expel the
methotrexate from the container through the outlet member for injecting the
methotrexate
74. The firing mechanism of the Medac injector is the Ram that is pushed by the Main
Spring, then interacts with the Plunger within the Syringe to push the medicament through the
Needle and into the patient.
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Figure 7 (Ram)
7. an energy source associated with the firing mechanism and configured to power
the firing mechanism and to jet inject the methotrexate from the injection outlet
member as a fluid jet; and
75. The Main Spring is the energy source that is released by the triggering mechanism and
powers the Ram to jet inject the medicament into the patient. See Fig. 3 (Main Spring), above.
As discussed above in paragraphs ##, the methotrexate of Medac’s injector is expelled as a jet.
8. a trigger mechanism associated with the firing mechanism and configured to
activate the firing mechanism
76. The trigger mechanism in the Medac injector is the button which, when depressed,
activates the firing mechanism. Specifically, when the distal end of the injector is pressed
against the skin, it activates the Interlock, which allows the device to be fired. When the Button
is pressed by the user, this releases the collets in the Rear Housing of the device which allows the
Main Spring to expand and push the Ram forward toward the distal end of the device.
9. wherein the needle-assisted jet injector is configured to eject the methotrexate
from the injection outlet member such that one or more of confidence intervals . . .
77. I am generally aware that companies use various techniques to test clinical efficacy.
For this last element of claim 1 of the ‘631 patent, however, I understand that another expert will
be opining about the specifics of these tests and requirements and whether Medac’s injector
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meets this limitation. I have been asked to assume that this limitation is present for purposes of
evaluating infringement.
10. and wherein the needle-assisted jet injector is configured to subcutaneously inject
the methotrexate in less than 5 seconds.
78. Medac’s injector meets this timing limitation. According to the Patient Instructions that
accompany the Metex Pen, step 12 of the “How to administer the injection” section states:
You will hear a click which indicates the start of the injection.
Keep holding the Pen against the raised skin until all the medicine
is injected. This can take up to 5 seconds.
Exhibit G. This indicates that the injection is completed before 5 seconds. This is also
consistent with my experiment of using the Metex Pen to inject methotrexate, which was
completed in fewer than 5 seconds.
79. Medac’s injector also meets the “configured to subcutaneously inject the methotrexate”
limitation. The Press Release specifically states that the product will be for subcutaneous
administration of methotrexate. In addition, the Patient Instructions state the product is intended
to deliver methotrexate subcutaneously. Ex. G. Also, the Medac injector states that it is for “s.c.”
injection, which in my experience is a common abbreviation for subcutaneous injection. See Fig.
5 (Label) above.
80. Based on the assumption that the last element of claim 1 of the ‘631 patent is met, and
my evaluation of all the other elements, Medac’s device infringes claim 1 of the ‘631 patent.
11. Claim 6: The hazardous agent injection system of claim 1, wherein the needleassisted
jet injector further comprises an outer housing member configured for
allowing a user to handle the injector.
81. All elements of claim 1 are present in Medac’s injector, as shown above. The Rear
Housing of the Medac injector is configured for allowing a user to handle the injector.
According to the Patient Instructions, the Metex Pen injector has a component referred to as the
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Handling area. The image on the instructions identifies this area as the Rear Housing. Further,
in the Instructions for Use, step 6 states:
6. Hold the Metex Pen pre-filled Pen with one hand in the
handling area.
Ex. G. Medac’s device infringes claim 6.
12. Claim 7: The hazardous agent injection system of claim 6, the needle-assisted jet
injector further comprises a safety member located at the proximal end of the
outer housing.
82. Claim 7 depends from claim 6. All elements of claim 6 are present in Medac’s injector,
as shown above. In Medac’s injector, the safety member is the Interlock and Button Fingers that
prevents the injector from firing unless the injector is firmly pressed against the skin of the
patient. The Button is located at the far proximal tip of the Rear Housing.
Figure 8 (Button)
Fingers of the Button extend from the proximal end of the Rear Housing to the Interlock.
Button
Fingers
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Figure 9 (Front Assembly)
If the Button is pressed before ready, the Button Fingers interact with the Interlock and prevents
the release of the Main Spring. When the injector is pressed against the skin, the Needle Guard
is pushed back, which disengages the Interlock. If the Button is pressed in this state, the Button
Fingers allow the release of the collet in the Rear Housing, thus releasing the Main Spring.
Medac’s device infringes claim 7.
13. Claim 10: The hazardous agent injection system of claim 1, wherein the
container and the injection outlet member associated with the container comprise
a syringe.
83. Medac’s injector meets all injector elements of Claim 1. As detailed above, the
container and injection outlet member are a syringe and needle. Medac’s device infringes claim
10.
14. Claim 11: The hazardous agent injection system of claim 10, wherein the needleassisted
injector further comprises a syringe sleeve, the syringe sleeve having
bore portion configured to abut the outside of the syringe wall so as to minimize
syringe movement resulting from of the firing mechanism action.
84. As detailed above, Medac’s injector meets all injector elements of Claim 10. In
Medac’s injector, the syringe is fit into a Syringe Collar. See Fig. 9. The Syringe Collar and
Interlock Needle Guard
Front
Housing
Syringe
Collar
Guard
Spring
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Needle Guard locates the syringe radially providing support to the syringe during the injection
process by preventing radial movement from the impact of the sudden firing of the ram during
activation. Medac’s device infringes claim 11.
15. Claim 12: A method of treating a patient having an autoimmune disease, the
method comprising administering methotrexate to the patient using the hazardous
agent injection system of claim 1.
85. Medac’s injector in combination with the Patient Instructions meet every limitation of
this claim. As described above, Medac’s injector is a hazardous agent injection system claimed
in Claim 1.
86. Statements by Medac make it clear that it is intended to treat an autoimmune disease.
The Patient Instructions for Metex Pen state that the injector contains methotrexate at various
doses. It states that the Metex Pen is indicated for, and intended to be used for the treatment of
active rheumatoid arthritis in adult patients, polyarthritic forms of severe juvenile idiopathic
arthritis, when the response to NSAIDs has been inadequate, severe recalcitrant disabling
psoriasis, which is not adequately responsive to other forms of therapy. Ex. G. The Medac Press
Release states that its NDA filed with the FDA contains the “proposed indications [of]
rheumatoid arthritis (RA), poly-articular-course juvenile RA and psoriasis.” The Press Release
also states that Medac concurrently has received a notice of allowance for an associated patent
that is “directed to a method for the treatment of inflammatory autoimmune diseases by
subcutaneously administering MTX.” The Press Release further states that, “Among the
multiple indications for which [its subcutaneous methotrexate product] is expected include RA,
an incurable, progressive, inflammatory, autoimmune disease.” Ex. F.
87. According to the Patient Instructions, when used according to the instruction, “Metex
Pen modifies and slows down the progression of the disease” indicated. These diseases include
autoimmune diseases. Ex. G. While I am not a doctor, I do have enough understanding to
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address this limitation given the express statements that Medac has made. Medac infringes claim
12.
16. Claim 13: The method of claim 12, wherein the autoimmune disease is selected
from the group consisting of rheumatoid arthritis, juvenile rheumatoid arthritis,
psoriatic arthritis, systemic lupus erthematosus, steroid-resistant polymyositis or
dermatomyositis, Wegener’s granulomatosis, polyarteritis nodosa, and vasculitis.
88. As discussed above regarding claim 12, Medac has made numerous statements in its
Press Release that it intends its methotrexate injector to be used for the treatment of Rheumatoid
Arthritis. Ex. F. Further, the Patient Instructions that accompany the Metex Pen provide
instructions how to use the methotrexate injector in the treatment of RA. Ex. G. Medac
infringes claim 13. Finally, the Pachon poster presentation describes the current use of the
Medac methotrexate autoinjector for the treatment of rheumatoid arthritis, and states that it has
been in use in Europe for over a year. Ex. N.
E. Validity Analysis of the Asserted Claims
89. As discussed above, it is my opinion that the Medac methotrexate injector infringes
claims 18 and 24 of the ’553 patent and claims 1, 6, 7, 10, 11, 12 and 13 of the ’631 patent. I
have been asked to evaluate whether these claims are likely valid.
90. I have read the prosecution history of the ’553 patent. After review, I agree with the
patent examiner that the prior art does not render claims 18 and 24 anticipated or obvious.
Additionally, I do not think a person of ordinary skill in the art would have had a reasonable
expectation of success to achieve the claimed combinations in claims 18 and 24 of the ’553
patent. This technology is complex and requires substantial research and development.
91. I also reviewed the prosecution history of the ’631 patent. After review, I agree that the
prior art does not render claims 1, 6, 7, 10, 11, 12, and 13 anticipated or obvious. Additionally, I
do not think a person of ordinary skill in the art would have had a reasonable expectation of
Case 1:14-cv-00270-SLR Document 11 Filed 03/14/14 Page 31 of 32 PageID #: 455
Case 1:14-cv-00270-SLR Document 11 Filed 03/14/14 Page 32 of 32 PageID #: 456
"631 was filed in 2009, 553 was filed in 2003, but does not in my opinion state about any use with methotrexate as the medicament."
Did you miss my previous post?
Antares '631 patent, claim 1 states:
What is claimed is:
1. A hazardous agent injection system, the hazardous agent injection system comprising:
methotrexate in an amount of from about 0.02 ml to about 4.0 ml and at a concentration of from about 7.5 mg/ml to about 150 mg/ml;
a needle-assisted jet injector, the needle-assisted jet injector comprising:
a container configured to contain the methotrexate;
"Claim 1 of the Antares Patent 8480631 states that the concentration of Methotrexate to be used will range between 7.5 and 150 mg/ml. To anyone skilled in the art would know that that to formulate the drug at the higher concentration the solution would require the pH of the solution be basic. Such information was available many years prior to the submission of any the patents ('631, '553 and '231). Any one of ordinary skill in the art would have realized this."
Meaning, Medac does not have a claim to formulation of mtx in solution and their claim of Antares infringing on the 3 doses above 10mg is baseless.
Antares '631 patent, claim 1 states:
What is claimed is:
1. A hazardous agent injection system, the hazardous agent injection system comprising:
methotrexate in an amount of from about 0.02 ml to about 4.0 ml and at a concentration of from about 7.5 mg/ml to about 150 mg/ml;
a needle-assisted jet injector, the needle-assisted jet injector comprising:
a container configured to contain the methotrexate;
Antares filed there lawsuit v Medac to protect the shareholders interest. Medac response was to file their own lawsuit (see definition of "patent trolls". Medac's filing, imo, will be dismissed.
Yes, Medac filed a 505(b)(2) NDA. Also, the lawsuit is asking the Court to enter an Order for the Medac NDA approval or effective date, to be a date not earlier than the expiration date of the two ('631 and '553) patents.
When an ANDA (or) a 505b2 is filed with a P IV certification, yes, the FDA is prohibited from approving for 30 month stay.
Example:
"A list of ANDA Paragraph IV drug challenges is maintained at FDA’s Office of Generic Drugs. There is no listing for 505(b)(2). Because of this, a sponsor of a 505(b)(2) needs to monitor court dockets for their proposed product.
Let’s look at an example 505(b)(2) Paragraph IV filing. Cipher Pharmaceuticals Limited developed a formulation of fenofibrate capsules that it believed did not infringe on the patents (there were two) held. Cipher developed a product that would not have the food effect that was characteristic of the RLD (TRICOR(R)). The RLD is a capsule containing micronized fenofibrate mixed with a surfactant. Cipher’s product dissolves fenofibrate in polyglyceride, HPMC and sodium starch glycollate.
Cipher filed their NDA in December 2002 and sent a notice on March 5, 2003. Abbott sued in April and October 2003 (messy because Abbott had a license from Laboratoires Fournier SA, so they both got involved). This suit triggered the 30-month stay until the matter was resolved. Cipher prevailed and was approved by FDA as Lipofen (TM) in January 2006."
That's all true for ANDA filings, like the case King v TEVA.
No "ANDA", Medac filed a New Drug Application is what I'm seeing.
We'll have to see where this goes. Medac has just been served the Summons and now has until 3/21/2014 to respond. Failure to respond will cause a judgement by default against Medac. I assume they will respond.
On the plus side, Antares Counsel is the same Counsel (Phillips, Goldman & Spence, P.A.) that TEVA used in their patent litigation: King et al v TEVA (epi-pen).
I believe no press release would be issued until Medac responds.
http://www.otrexup.com/self-administration-video.php
Thanks for the heads up on the video, Joe.
Regarding TEVA / Copaxone / generic....this is why I think one of the future pipeline products in Antares arsenal will be 'copaxone', delivered through their vibex device platform. Antares, imo, gets and understands the strategy: reformulation of existing drugs coupled with an unmet need plus, the value aspect proposition not only for Antares, but insync with managed care. Playing both sides to its advantage - win win.
biopete,
But that is that value proposition for Antares with Otrexup. As you know, there is no FDA approved SQ mtx protocol in the US - zip, zero, nada, none, except now with Otrexup. New ball game in the US for the middle space void with previously unavailable SQ adminstered mtx, via SQ methotrexate using Otrexup and at home. So and hopefully, Otrexup will be helping our health care system not to be so screwed up.
****Unofficial transcript****
LeRoux Jooste, Senior Vice President and General Manager
Pharmaceuticals, will present at the RBC Capital Markets’ Global
Healthcare Conference on Wednesday February 26, 2014. Hosted by
Randall Stanicky, RBC financial analyst.
RBC: Please give an idea of some early feedback into the Otrexup launch.
LeRoux: We are delighted with the progress, we look at leading indicators
of success and right now what I see are reps smiling and calling me with
positives about their experiences. Having done many launches and the
first leading indicator for me is a rep complaining or wanting more
information, more material or just telling you why they just can't reach their
target.
Right now with less than a month in - by the end of the week we should
have called on all of our target Rheumatologists, so we are getting out
there despite the weather to call on the Rheumatologists. We have made
tremendous progress on coverage - I've yet to hear of a product that has
equal coverage within a month after launch. We now have 62% coverage in
commercial plans of which 32% are auto (__?___). Most of the coverage is
on a Tier 3. 9% of commercial plans right now are not covered, which I
think is a low percentage and 28% are covered but not yet listed. So this
means they are still going through the process, who the formulary is, of
which Tier they’ll put it in but as prescriptions come in, they’ll process and
decide what to do, where to put Otrexup in. So early indicators for us are
very positive, getting good feedback from doctors with good feedback from
the plan and they understand the value proposition.
Clearly, the two big ones on the managed care side, United and they have a
policy to not get a new branded product on for the first six months, but
we’ve had discussions with them and they do get the value proposition and
we look forward to April when we can be successful with them. We’ve
taken them through a cost offset model and they understand the value. And
then Kaiser would be the next big one where we hope to have meaningful
discussions with them and it looks positive. So I would say all in all, less
than a month into the launch – looking good. Doesn’t mean we can’t tweak
things. We kicked off what we call our “plan do check at progress” where
we monitor and look at requests to follow up with interviews with
physicians to understand where we might improve the process, to ease
access so for instance, we’ll add more impetus and effort behind the
insurance verification process. We’ve now made available a service where
patients, doctors, nurses have a 1-800 number they can call to get the
information on the specific plans for insurance purposes. Just examples,
as we are continuously looking at things, TQM approach, for making sure
we are covering all the bases.
RBC: That’s great, that tells us this is the First approved subcutaneous
methotrexate (mtx), so as you think about, how do we think about the label
and the overall value proposition?
LeRoux: Well, this is a tremendous opportunity for us, because mtx is the
anchor drug for Rheumatoid Arthritis, the go to DMARD (disease modifying
anti-rheumatoid drug) of choice and all mtx has been the go to DMARD of
choice for the past 20 years or so and it will remain the go to DMARD. The
opportunity here is to move from oral mtx to SQ (subcutaneous) mtx -
through Otrexup - before you need to consider other options which could
include the more expensive biologics. So that’s were the value
propositions comes in. So for the Rheumatologists and the patients, they
can expand and enhance the benefits that their getting from go to first
choice DMARD’s – to keep the patient in low disease control. Now if for
some reason mtx, SQ mtx or Otrexup, after 3 months, 6 months, or 3 years
begins to show lack or inadequate response, then they can go to the other
options that they would normally consider earlier on. It’s at that point that
they still can have access to a biologic – in that sense we are not
competing with biologics. We are creating space in the middle that
enhances and expands the treatment with mtx.
RBC: And from a patient perspective, how is this priced and how do we
think about the co-pay. I know you mentioned Tier 3 but do you have a copay
strategy?
LeRoux: Absolutely, so right now we knew that most of the plans we’ve
got currently that have coverage, have put this in a tier 3 with a co-pay
between $40 and $70. The patients out of pocket would be, if it wasn’t for
the co-pay assistance we provide, $40 to $70. We make available to
patients a co-pay assistance card that automatically includes 12 refills that
then can be reactivated a year later when we would buy down up to $50.
So if your co-pay is $50, we’ll buy down $40 and you’ll pay $10. If your copay
is $70, we’ll buy down $50 and you’ll pay $20. If your co-pay is $30,
we’ll pay $20 and you’ll pay $10. So most patients will have a co-pay of
$10.
RBC: LeRoux, I think you’ve launched close to 30 products….
LeRoux: I wouldn’t say 30 products, I’ve been involved in 30 launches
with the most relevant launch I’ve been involved with personally, I headed
up the commercial collaboration between Wyeth and Immunex and
launched Enbrel.
RBC: How would you characterize the response so far? Are you
focusing, I believe, on 2500 reps…sorry 2500 docs….lets talk about your
targeting strategy and how you’re thinking of your greater reach. (6:26)
LeRoux: There’s about 4000 Rheumatologists in the US, maybe a little
more than that. 2500 or so of them are responsible for 80% of the mtx
scripts – these are the busy Rheumatologists that we will go in and see. So
we are actually, with 25 reps, we are quite adequately able to call on all
2500 Rheumatologists. We can certainly look at the decile filing by the
Rheumatologists. If the doctors are using mtx, we are going to be in there
and access their usage. And a good example of why we are doing this is,
there are some Rheumatologists who initiate some prescriptions using mtx
but then move on very quickly to a biologic. That doesn’t mean they’re not
a good potential physician/Rheumatologist for Otrexup, it just means that
they haven’t really had the opportunity to benefit from all mtx because of
their tolerability and plateau effect of when you get to 15 mg – the gut has
limitations. You can prescribe 20mg of oral mtx but you’ll only absorb
15mg. There are some physicians, especially younger physicians, who
graduated in the last decade or so that didn’t get much education in school
on mtx, maybe an hour at most and most of their education has been
through biologic companies. They’re 9 biologic companies with 1000’s of
sales reps – so there’s an opportunity for us to go in with a good product
that can provide good clinical outcomes for the physician and we find they
are very receptive to that. (8:09)
RBC: Is there a training aspect needed for Otrexup – in terms of using the
device?
LeRoux: Oh, the device is really simple. I mean, I could use it with one
hand. It’s good to remember Rheumatologist patients all ready have some
disability in their hand function and their grip strength is quite low. It’s a 3-
step process: simply remove the cap…for training I could show
you……..it’s really a simple process.
We have a device we make available at the doctors office so that the doctor
can show patients and the nurses can actually train patients on how to use
this device – and remove the cap, remove the safety and then you can
either on the belly or the thigh, with a light gentle pressure, count for 3
secs and your are done. (9:05). There’s nothing easier than that. It’s
actually easier than swallowing a pill or handful of pills because when
you’re taking oral mtx @ 2 ½ mg tablets and you’re on a 20 mg dose, your
swallowing 8 tablets and they don’t task that good either.
RBC: How do you think about the market opportunity, I think on a recent
call you talked about 10k patients being roughly 50 million in market
opportunity – how big can this product be?
LeRoux: We’ve said it’s $200 million plus – I’m going to talk about peak
sales, the unmet need. You know, you have about 4 million scripts for mtx
in the US written for RA. Currently, less than 5% of those are written for
parenteral mtx. You look at other countries, like Germany, Holland, Canada
– 30, 40, 50% of patients are on SQ mtx for obvious reasons.
RBC: About the rollout, still early in the launch (“very early” LeRoux
interjects) – how are you thinking about the roll out that we’ll watch and
think about the sales ramp for the rest of the year?
LeRoux: That’s a great question and one that analysts in particular need
to understand. This is not an acute crisis type of event – this is not like
somebody that has bronchitis and needs and antibody script now or
migraine and needs the prescription right now. These are patients that
have been sick for years and in many instances have all been on oral mtx.
The currently would see the Rheumatologist on average of once every 3
months, sometimes once every 4 or 5 months unless something happens
like a flare up or something, but most of the business is going to come
from that routine, every 3 months or so – the patient comes in, see’s the
Rheumatologist, they do their ‘Brooklyn act’, “how ya du’en” – “I’m a little
stiff and tender in the morning”, maybe some other joints acting up and as
the disease progresses there should be a treatment – then the dialogue
begins between the patient and the Rheumatologist because this is a life
long disease and every patient is looked at individually, then the
Rheumatologist and patients will start talking about something else, about
looking at adding something else for you. Maybe it’s adding a steroid and
then see you next month and see if that helped. But gradually, and even
with the biologics, its about a 2 – 6 week process for the doctor and the
patient to agree on a treatment and a treatment goal and what the options
are.
(11:42) Now Otrexup is going to get into the dialogue at that point. In some
cases, they’ll write the prescription right there and then if they know
insurance verification and they are comfortable that this patient is ready to
move on and these are the scripts you’ve seen in the first two weeks.
That’s not an immediate ramp up, so what happens is in most cases, this
dialogue as I said takes between 2 – 6 weeks and they’ll say, okay lets think
about this, get the insurance verification, think about what I told you, come
back in 2 weeks time and we’ll train you and put you on Otrexup.
(12:25) So I would say if you’re looking at a ramp up, the 1st 3 – 4 months
patients are going to come in and see their doc, doc looks at the patient to
see where they might benefit from Otrexup. They’re going to get them back
in, in another 4-6 weeks, go through the insurance verification and I would
say – if your really looking at ramp up, maybe in July – when we’ll really
see the scripts come in – yea, we’ll really see scripts come in. We do have
some indication; to me the weekly’s so far, what we are doing is working.
We know we can get the product through the distribution channel and into
the hands of the patient. We know that the insurance verification works.
We now the co-pay works, we know that the training part in the doctors
office works. So that the leading indicators and what we follow up and
understand of what’s working and what isn’t working, what can be
improved – to me, the early indicators from the weekly’s are telling us the
process is working.
Now, as the docs become more and more familiar – again, we’re Antares,
who’s Antares right? So a doc, Rheumatologist that sees Otrexup will be
excited but next week, it’s what was the product again? (13:35) So we
have to get back in there with frequency and regularity and build up a
recognition and awareness of Otrexup.
RBC: Relative to initial expectations and tracking are things in line with
what you would have thought?
LeRoux: (13.42) Absolutely.
RBC: You’ve talked about the LEO partnership, how did that come about?
LeRoux: Well, we’ve had dialogue and discussions with many potential
partners. We ultimately worked with LEO and felt they would be the most
suitable and desirable partner to work with because of their competence
and expertise in psoriasis – their established relationships with
dermatologists. It’s a little different situation in a dermatologists office –
(where actually the label for Otrexup is very favorable for psoriasis) but
dermatologists per se, are not currently using mtx as a go to first choice,
like Rheumatologists, so there’s more of a educational / informational
requirement and so a company that has an established rapport and
credibility with dermatology was important to us. And we also happen to
feel that the chemistry and management team gelled very quickly and like
minded knew and agreed on what needs to get done. So we think the
collaboration is off to a great start and they are launching with their reps
this week.
RBC: Your thoughts on that launch?
LeRoux: I certainly think it’s a tremendous upside opportunity. If we
think about patients with psoriasis in the US, probably about a million or so
have what is called severe psoriasis, defined by the body surface area and
the disability associated with that indication, so the number of patients is
as big as RA patients. But there are currently other options available to
them such as light therapy, topical, etc.., so with a different protocol I see a
significant opportunity.
RBC: How are they ruling that out with respect to their sales force?
LeRoux: So they will have their full derma sales organization to put this
product in first position, post launch and it fits very nicely with their
current portfolio, as does the label, where the label actually recommends
mtx. So that patients can get the response and then potentially they can go
back to the conventional therapy and of which the label actually says is
recommended, which is great.
RBC: With respect to your recent testosterone product, we had a recent
update there. Can you talk about that and the benefits of SQ overall?
(16:19)
LeRoux: The testosterone opportunity is growing tremendously. Scripts
today which are given once monthly or every 2 weeks in a doctor’s office.
It’s a deep tissue injection in the butt and it is a pain in the butt, a 20 gauge
needle and that’s because testosterone is a very viscous oily liquid and if
you were to try to give that subcutaneously through a 20 gauge needle,
first of all you’d have to be one of the strongest men in the world and able
to push down the plunger and expel the oil viscous liquid through a 20
gauge needle and even if you could, it would take about 35-40 seconds to
try to do that. So without a device with a very high powered energy source
behind that – being able to deliver a full does – subcutaneously only takes
less than 6 seconds. So again, same as this device, slightly easier process
– you gently push down, and as you push down, the needle is inserted.
Same as it is with this one. It’s not like other auto injectors, where the
activation of the device fires a needle into you like a dart. While gently
pressing, you don’t realize it because the cuff/needle guard creates sort of
a numbing effect, if you like, stretching the skin and before you know it the
needle is in. Patients would say, “Am I done?” And we have to show them
the red flag has actually gone down and they have injected themselves.
(17:41)
So with the testosterone injection, same thing would be once a week, self
administered at home, discretely, single use disposable device.
RBC: And I guess we’re still looking at the data, what’s the timing of the
pathway, I know we’re still somewhat early but how quickly?
LeRoux: Ah, it’s not that early. I can’t say things we haven’t disclosed
publicly yet but we had a press release a couple of weeks back on the
Phase 2 date which was very positive for us. We will meet with the FDA at
the end of the Ph 2 and we will begin the Ph 3 program and should have
that completed by the end of next year and we hope to file and get a
product on the market by late 2016.
RBC: That’s a huge market, what are you thinking about as far as a slice
of that market?
LeRoux: Well, the market is growing. The injectable market is growing
about 40% compounded annual growth rate. The gels are growing
tremendously, I think, don’t quote me on this but I would think that less
than 20% of the potential treatable male population is getting testosterone
treatment. Not that they would ever hit 100% but this market is going to
continue to grow. Some analysts have estimated this is a $5 billion plus
market. So we see again a huge opportunity in this specialty space
starting with urology and endocrinology, where we think this drug fits quite
nicely. The market research that we’ve done really tells us they really
would prefer to use an injectable testosterone but at the time we launch, we
likely would see a generic gel on the market and that has some inherent
issues associated with that. But hey, I’ll be happy with 15% market share
for instance….it’s going to be a huge product anyway.
So we certainly look at this as a specialty opportunity. Our plan would be
to retain the product, as we have done with Otrexup. That doesn’t mean we
wouldn’t consider talking to partners for collaboration of thought, whether
that be for a primary care or however you structure it.
RBC: How do you make that decision, when looking at Otrexup, that was
obviously a big platform endorsing approval, so how do you think about
the go-it alone strategy?
LeRoux: Well, now that we’ve validated the platform and we know that we
have more than just Otrexup and testosterone in the pipeline, we have at
least, which we haven’t disclosed, but behind that are 2 or 3 other products
which will be in the pipeline and when we make the decision on those, we
will announce them.
But this is a 505b2 model where we look at reformulating products. Putting
them in this device that now is validated and one of our selection criteria
would be – it’s not just a reformulation into an easy to use device. If we
can’t add clinical value such in the case of Otrexup where there is added
bioavailability above 15mg. In the case of testosterone, the very reliable
and shall we say efficient testosterone within the therapeutic window of
say 250-300 nanograms, 1100 nanograms without the huge peaks and
troughs that you see with intramuscular injection and somewhat flat and
low levels you see with a gel. There’s a real clinical value add on top of
making it easy to use, self administered by the patient. So for us, that
model has a lot of value, profitability and the return on investment is great.
As we grow and bring in more product into the pipeline, we can afford the
infrastructure to expand and build out and do what we need to do. With
Otrexup, by 2016, we think $200 million. By 2017, at that range, we could if
we needed to, afford a primary care sales organization of 250 reps which
would be more than adequate to reach 50% of the primary care physicians
that write 80% of the business. (21:53)
RBC: It’s a great point, if you think about the platform, obviously your
commercialization of Otrexup, now which is a big opportunity and you also
have a bunch of partnerships, you have platform technology – another one
of those is with TEVA and the Epi-pen. Is there an update you can provide
there? I know there’s an opportunity for you with your partner to get an AB
rated approval, is that still the plan?
LeRoux: Still the plan. Absolutely. Nothing has changed. Based on the
product we’ve already delivered to TEVA, that hasn’t changed.
RBC: And are you involved in discussions with the FDA or TEVA?
LeRoux: I personally am not involved.
RBC: But at this point, Antares still expects an AB ……..
LeRoux: Nothing has changed. I think we’ll have an update on our
quarterly call somewhere in the 2nd week of March.
RBC: We’re getting low on time, but as you think about the rest of the
year and obviously there is a lot going on, Otrexup is going to be ramping
and is something we can watch, testosterone moving forward, what are the
major data points that we should be thinking about relative to the broader
story about Antares?
LeRoux: Well, number one will be Otrexup performance in the 2nd half – a
slow steady buildup and as patients go back and see their Rheumatologist
and make their treatment decisions, 2nd half then we’ll really see some
ramp up and utilization. You want to see that and that’s what I expect and
to add value. Then beyond Otrexup, you have to look at QS-T. We have to
initiate the Ph 3 study. That would be the next big value adding milestone.
Announcements on potential products “M” and other products behind the
pipeline and looking then at partnerships. It’s becoming less, but still very
important for us, but less critical for us to depend on partnerships. TEVA’s
important to us and we want to continue to strengthen that relationship and
work at making that relationship successful for us. So we do whatever we
can to make sure the products in development, pursue the pens, the epipen
and the other products Pen 1 and Pen 2 that we haven’t disclosed yet,
are on track and we expect milestone announcements soon for the rest of
those products as well
Given the number of posts about the planned sales I thought I would post what the guidelines are:
Happy reading!
Title 17 - Commodity and Securities Exchanges
Volume: 3
Date: 2013-04-01
Original Date: 2013-04-01
Title: Section 240.10b5-1 - Trading âon the basis ofâ material nonpublic information in insider trading cases.
Context: Title 17 - Commodity and Securities Exchanges. CHAPTER II - SECURITIES AND EXCHANGE COMMISSION (CONTINUED). PART 240 - GENERAL RULES AND REGULATIONS, SECURITIES EXCHANGE ACT OF 1934.
Subpart A - Rules and Regulations Under the Securities Exchange Act of 1934. - Manipulative and Deceptive Devices and Contrivances.
§ 240.10b5-1Trading “on the basis of” material nonpublic information in insider trading cases. Preliminary Note to § 240.10b5-1:
This provision defines when a purchase or sale constitutes trading “on the basis of” material nonpublic information in insider trading cases brought under Section 10(b) of the Act and Rule 10b-5 thereunder. The law of insider trading is otherwise defined by judicial opinions construing Rule 10b-5, and Rule 10b5-1 does not modify the scope of insider trading law in any other respect.
(a) General. The “manipulative and deceptive devices” prohibited by Section 10(b) of the Act (15 U.S.C. 78j) and § 240.10b-5 thereunder include, among other things, the purchase or sale of a security of any issuer, on the basis of material nonpublic information about that security or issuer, in breach of a duty of trust or confidence that is owed directly, indirectly, or derivatively, to the issuer of that security or the shareholders of that issuer, or to any other person who is the source of the material nonpublic information.
(b) Definition of “on the basis of.” Subject to the affirmative defenses in paragraph (c) of this section, a purchase or sale of a security of an issuer is “on the basis of” material nonpublic information about that security or issuer if the person making the purchase or sale was aware of the material nonpublic information when the person made the purchase or sale.
(c) Affirmative defenses. (1)(i) Subject to paragraph (c)(1)(ii) of this section, a person's purchase or sale is not “on the basis of” material nonpublic information if the person making the purchase or sale demonstrates that:
(A) Before becoming aware of the information, the person had:
(1) Entered into a binding contract to purchase or sell the security,
(2) Instructed another person to purchase or sell the security for the instructing person's account, or
(3) Adopted a written plan for trading securities;
(B) The contract, instruction, or plan described in paragraph (c)(1)(i)(A) of this Section:
(1) Specified the amount of securities to be purchased or sold and the price at which and the date on which the securities were to be purchased or sold;
(2) Included a written formula or algorithm, or computer program, for determining the amount of securities to be purchased or sold and the price at which and the date on which the securities were to be purchased or sold; or
(3) Did not permit the person to exercise any subsequent influence over how, when, or whether to effect purchases or sales; provided, in addition, that any other person who, pursuant to the contract, instruction, or plan, did exercise such influence must not have been aware of the material nonpublic information when doing so; and
(C) The purchase or sale that occurred was pursuant to the contract, instruction, or plan. A purchase or sale is not “pursuant to a contract, instruction, or plan” if, among other things, the person who entered into the contract, instruction, or plan altered or deviated from the contract, instruction, or plan to purchase or sell securities (whether by changing the amount, price, or timing of the purchase or sale), or entered into or altered a corresponding or hedging transaction or position with respect to those securities.
(ii) Paragraph (c)(1)(i) of this section is applicable only when the contract, instruction, or plan to purchase or sell securities was given or entered into in good faith and not as part of a plan or scheme to evade the prohibitions of this section.
(iii) This paragraph (c)(1)(iii) defines certain terms as used in paragraph (c) of this Section.
(A) Amount. “Amount” means either a specified number of shares or other securities or a specified dollar value of securities.
(B) Price. “Price” means the market price on a particular date or a limit price, or a particular dollar price.
(C) Date. “Date” means, in the case of a market order, the specific day of the year on which the order is to be executed (or as soon thereafter as is practicable under ordinary principles of best execution). “Date” means, in the case of a limit order, a day of the year on which the limit order is in force.
(2) A person other than a natural person also may demonstrate that a purchase or sale of securities is not “on the basis of” material nonpublic information if the person demonstrates that:
(i) The individual making the investment decision on behalf of the person to purchase or sell the securities was not aware of the information; and
(ii) The person had implemented reasonable policies and procedures, taking into consideration the nature of the person's business, to ensure that individuals making investment decisions would not violate the laws prohibiting trading on the basis of material nonpublic information. These policies and procedures may include those that restrict any purchase, sale, and causing any purchase or sale of any security as to which the person has material nonpublic information, or those that prevent such individuals from becoming aware of such information.
[65 FR 51737, Aug. 24, 2000]
Happy New Year to all !
This graph represents why I have been a long term investor in Antares. The graph's trend from 2008 through 2013 is clear. Year over year, if one was a patient investor that believed and understood the business plan, this is the result. A friend of mine put it simply this way, "This is now the 5th year in a row that investors made money by simply holding." Pretty simple.
All the best!
bsav my friend, many thanks for your due diligence with this investment ! All the best to you and your family this Holiday!!
Actually, I don't need to look at the chart to see its headed higher. Chart reading can help state the case, but I prefer the solid fundamentals as in a solid business plan that is working its way through to fruition. Just a matter of time for a sound business plan to take effect (and I've signed up for the long haul) and this one will.
So, whogo, I'm not clear on that message on yahoo about your recent stock pick. No go?
How does Loko know the innovation is a new safety cap? I didn't hear that mentioned but maybe I missed the reference. I wouldn't think, like you perhaps are also, that the "improvement and innovation" would simply be a cap. Maybe they are going to add audio and visual feedback mechanisms.
(P.S. Sometime ago, I decided to put loko on permanent ignore and was and will be my last interaction with him on the dysfunctional yahoo board. Speaking of boards, he should actually post on this board, he could post links till the cows come home! But I don't read his posts anymore. Just grew tired of his constant mentioning of me this, me that, tappy this, tappy that, etc., and how me and others control the board. So I figured, okay, heck, I don't need the hassle, I'll put him on ignore along with a host of others, won't respond to him so he doesn't get upset, etc. Is he still bashing me?? LOL no need to answer)
silvrmoon, I assume that the improvements and innovation comment refers to the existing pen. I'd have to go back and check the litigation documents for the exact wording, but I recall during talks before District Court Judge Sleet between both sides of legal counsel, something was mentioned about pending revision or another version. In fact, it led me at one point to think that Antares had two pens in the mix. It leads me to believe that after FDA approval and the green light from the DOJ, that they will be "tweaking" the existing pen as opposed to a brand new pen from someone else or TEVA's own in-house shop.
bio-pete, let's argue that TEVA tries to shake off Antares and go with a "new" pen design - wouldn't that trigger another submittal to the FDA - start from scratch again? From that pdf they used during the recent presentation, it looks like they are trying to portray themselves in a more entrepreneurial fashion - more nimble - but if they are going to go after markets like Antares currently is, I believe Antares is ahead of the game. But who knows what it all means. Maybe they are grooming themselves for the grooming of Antares.
My two cents for this bone chilling day!
Well, time will tell silvmoon if it means anything. But as we know, Antares has been fulfilling it's contractual obligation to date with the pre-orders for the epi-pen pre launch, but it sounded like they are working on improvements or as the TEVA rep said, "innovations" to perhaps a next generation epi-pen which I suspect would be another version provided by Antares. But that is in the future as in lets get the first one into the mix! Thx! Also got the message from ryman and will send you a private email from mine soon.
Yo, bsav (and other AIS/ATRS posters). I'm just now starting to look into this stock. Don't have much else to say at this point but just wanted to give a shout out to my good friend bsav!
O/T - nice little pick up today with Antares pps.
Later gents!
Fyi: Teva presented today. At the very end of the Q&A, an analyst from Morgan Stanley asked about the epi-pen status. Elizabeth with TEVA answered, 'we plan to launch a generic epi-pen in 2015 and then we are looking into further improvements and innovation of the epi-pen but I will not comment further on that." hmmm.
Also, take a look at the "Supporting Materials" Teva R&D in Focus - New Therapeutic Entities pdf that comes with the presentation. Take a look at page 21, "Class of 2013" emerged following evaluation of >150 ideas slide. Does this remind anyone of someones else's slide??
http://ir.tevapharm.com/phoenix.zhtml?c=73925&p=irol-EventDetails&EventId=5036013
Hi Ryman, the link is an abstract / hypothesis connecting insider selling to class action litigation and gives a general overview of litigation - driven class actions. But I don't see the relevance to these Antares programmed sales. If, as this articles talks about, there is a "crash" in the stock price, then someone, some class, will file a lawsuit and such is life in this litigious society.
From your article: " Hence, it is important to distinguish between “abnormal” or “strategic” insider selling and routine insider selling for predicting shareholder litigation. Insiders often sell for diversification or liquidity reasons and rebalance their portfolios.
Since these types of insider sales are not motivated by adverse (private) information, we would not expect such sales to result in stock price declines that trigger lawsuits. footnote 11"
And why would current fund managers/buyers of Antares, vote to approve the vehicle that provides insiders with performance based options?? I think if a fund manager looking into buying Antares takes a more holistic overview and weighs all aspects. I think the BOD of Antares wants to keep the current regime at Antares and they want to keep them happy and if the insiders want to tap into what if offered to them as a reward for their work, I have no problem with that.
I also think what would hurt the price the most, would be for deals to become unraveled - for Antares to not execute their business plan. Come to think of it, whether we all like or not, agree with it or not, part of the Antares business plan is the availability of cashing in the options. Is Wotton doing so, because he knows the stock is going to crash and burn? I don't think so.
That's it for me for awhile - back to family activities, Thanksgiving with relatives (for the first time minus the family Patriarch), travel, all that good stuff!!
Hey ryman, I've finally got a little time to catch up on things. Don't the options available to Wotton have expiry until 2018? Meaning, he can change the planned sale(s) along the way and capture the price that the price will be next year and so on? I see a difference in a CEO dumping shares on the open market to capture whatever price he can get and a scheduled SEC planned sale to capture his options granted to him along the way. Looking at that action with a purist point of view, then you don't want to see anyone sell, for whatever reason. But in this example, a purist point of view is not the correct point of view, imo. Just as PR's of other companies get reported about insiders buying company stock, when in fact, the buys are company sponsored and not purchased by the reporting person.
I believe I have seen posts from you prior that stated when he sells, it doesn't impact the pps in the least and I haven't seen a negative pps impact that would compare to the hand wringing from posters when the sales happen. I think the market perception of these sales are fleeting. Yes, there is a negative overhang from message board peeps, but that is also irrelevant in the grand scheme of things. There seems to be a lot of grey area involved with this subject, but ultimately, I think it's bottom line irrelevant to any claim of cause and effect for the performance of a stocks performance. And given the overwhelming proxy votes in favor of the Performance Compensation Plan that includes the awarding of options for the insiders, the planned sales are not a concern of even the institutions who had the power to approve or vote down the same.
On the flip side of the coin, one could argue like you, that Wotton "should wait". But to our chagrin, CEO Wotton decided not to wait. That begs the question for each individual shareholder to ask, why? My own answer is that he decided not to hold off on planned sales because in this opinion (or his ego as you have offered) he earned it. So, I guess my point is, each shareholder has to comes his or her own terms with these planned sales.
Happy Thanksgiving!!
Hi Ryman, on the flip side of the coin, VVUS, since earlier this year (May/June high of $15.65)has lost almost half its value. Plus from the SEC filing footnote # "5. Dr. Denner disclaims beneficial ownership of the shares being reported on this Form 4 except to the extent of his pecuniary interest therein."
http://www.sec.gov/Archives/edgar/data/1361754/000110465913083704/xslF345X03/a4.xml
The purchases were from an off-shore company.
Also a decent read about Insider sales and buys:
"They might need the cash for a big personal purchase such as a new house or yacht, or they might need the cash to fund a charity. Sometimes they sell as part of a planned selling program that they have put in place for diversification purposes, which allows them to sell stock in stages instead of selling all at one price.
Other times they sell because they think their stock is overvalued and the risk/reward is no longer attractive. Some even dump their own stock because they have inside knowledge that a competitor is eating their lunch and stealing market share.
But insiders usually buy their own shares for one reason: They think the stock is a bargain and has tremendous upside.
The key word in that last statement is "think." Just because a corporate insider thinks his or her stock is going to trade higher, that doesn't mean it will play out that way. Insiders can have all the conviction in the world that their stock is a buy, but if the market doesn't agree with them, the stock could end up going nowhere. Also, I say "usually" because sometimes insiders are loaned money by the company to buy their own stock. Those loans are often sweetheart deals and shouldn't be viewed as organic insider buying.
At the end of the day, its large institutional money managers running big mutual funds and hedge funds that drive stock prices, not insiders. That said, many of these savvy stock operators will follow insider buying activity when they agree with the insider that the stock is undervalued and has upside potential. This is why it's so important to always be monitoring insider activity, but it's twice as important to make sure the trend of the stock coincides with the insider buying.
Hi ryman,
So, where's OrbiMed and Deerfield stand? I don't see them listed.
So Tev-Tropin was taken off the Aetna Preferred list BUT added to the Step Therapy first list.
If CVS takes off a certain drug, don't patients then find it somewhere else, like Walgreens? I can recall directly, this happened to my mother-in-law when one of her drugs was no longer available through CVS but was at Walgreens......
Tappy, LloydDC linked this article earlier today and yes, it is a terrific read!
I tried earlier today to respond to LloydDC's post, but there were apparently for a period of time, technical glitches in this web site and my post did not take.
So thanks for the repost and thanks to LloydDC!
and here's the link LloydDC refers to:
http://www.otrexup.com/
and under the Registration box it states:
"Stay tuned for exciting updates! Otrexup will be available to you in January 2014."
scubasteve: from Antares investor presentation, a big YES to your question. The only question will be how soon will they seal a deal now that the approval is in hand. I'm guessing they have been 'talking' with potential partners but now with FDA approval Antares has greater leverage in talks with others.
Priority Goals for Next 12-18 Months
• OTREXUP™ approval and launch
• VIBEX™ QS T (testosterone) to complete clinical studies
• VIBEX™ QS M to begin clinical studies
• Teva programs advance including both multi-dose pen
products filed
• TevTropin® 10 mg approval and launch
• International OTREXUP™ partnership
• OTREXUP™ partnership - Psoriasis
Granted that I tend to look at things with simplicity and in this case I see this political science major / bio tech investor / advisor as putting out his latest report (when he's no longer invested in ATRS) as more of him feeling a need to 'save face.'
What do you think the real purpose was behind Adams' tweet about Antares FDA approval? To placate his followers who bought and sold on his advice only to now miss out on more gains. So his crystal ball now says to his followers, don't worry investors, Otrexup (even with approval) on the follow through is smoke and mirrors. He is irrelevant as an Antares investor.
What do you think the real purpose was behind Adams' tweet about Antares FDA approval? To placate his followers who bought and sold on his advice only to now miss out on more gains. So his crystal ball now says to his followers, don't worry investors, Otrexup (even with approval) on the follow through is smoke and mirrors. He is irrelevant as an Antares investor.
Sweet, very sweet!
........“We expect the commercial launch of OTREXUP™ in early 2014 will make a meaningful difference in the lives of people living with RA, pJIA and psoriasis and we believe also introduces the potential for a cost effective treatment option for physicians,” said LeRoux Jooste, Senior Vice President Sales & Marketing. “I have been fortunate in my career to lead and play a major role in several successful product launches and I am excited to introduce OTREXUP™ with an experienced team of sales and marketing professionals.”
and now that I think about it, who paid for the signs that are on the gate????