Antares Pharma, Inc. (ATRS)

[jab91252]

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
[phone]
Email: [e-mail]
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: [e-mail]
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
[phone]
Email: [e-mail]
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: [phone]
Fax: [phone]
[e-mail]
[e-mail]
[e-mail]
Ahmed M.T. Riaz
Legal Affairs Counsel
ANTARES PHARMA, INC.
100 Princeton South Corporate Center
Suite 300
Ewing, NJ 08628
[phone] (telephone)
[phone] (facsimile)
[e-mail]
John C. Phillips, Jr. (#110)
Megan C. Haney (#5016)
PHILLIPS, GOLDMAN & SPENCE, P.A.
1200 North Broom St.
Wilmington, DE 19806
Tele: [phone]
Fax: [phone]
[e-mail]
[e-mail]
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

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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.

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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.

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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

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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

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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.

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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

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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

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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
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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;

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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

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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

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