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I just didn't think it was the FDAs place to do that one way or another...
But if so, would it be possible to surmise that the FDA is waiting for the final result from the case before approving?
Still a chance the SCOTUS takes it up, but certainly nothing to count on. In the end, it's not just MNTAs patent that will be in trouble because of the CAFC ruling...
I doubt he knew that the CAFC would overturn the (obvious) intentions of what safe harbor is.
Any news out? volume just picked up...
Blackrock increased it's holdings. Up to 4729666 or 9.15%. You'd think they could afford one more share :)
The implications of reporting Thursday before market opening or Friday before market opening is inconsequential at best.
It's been a slow board lately so I guess it's something to talk about :)
Not bad for a market cap of $280m or whatever it is. So Merck has now put $90m+ into THLD?
Is this the first time it's been on a Friday?
I don't own a position, but post CELG news, it doesn't seem especially expensive at $285m market cap and Merck running all the trials.
Makes sense. Either way, I would certainly say THLD is significantly more attractive today than it was yesterday
Indeed, and it is perfectly in line with what MNTA management has been saying about the enox market. Assuming no other entrants (which might be a stretch of an assumption since other companies can pretty much rip off MNTA at will now), does $85m represent a stabilization of the market?
under 2 months is certainly on the lower end of expectations so it gives THLD a shot. I think THLD has a better safety profile as well, no?
NVS will report earnings on 1/23
It seems the market has moved on from enox ever being more than a $5-8m a Q drug for MNTA.
It's also NVS's legal team and they really have nothing to do with this. The CAFC judges were hell bent on overturning what safe harbor means so don't even think Jonnie Cochran could have helped.
Yup. And Amphastar can go on using MNTA's patent(s) to market and sell its product. The courts have done a fine job on this one.
Solicitor General Recommends Cert Denial In Hatch-Waxman Safe Harbor Patent Case
Wednesday, January 9, 2013
from Patent, Trademark & Copyright Law Daily™
http://www.bna.com/solicitor-general-recommends-n17179871784/
Despite a “ misguided” decision by the U.S. Court of Appeals for the Federal Circuit, the U.S. Supreme Court should deny review of the scope of the Hatch-Waxman Act's safe harbor provision on patent infringement, according to a Dec. 13 government brief (GlaxoSmithKline v. Classen Immunotherapies Inc., U.S., No. 11-1078, gov't brief filed, 12/13/12).
The Office of the U.S. Solicitor General, responding to the high court's request for the government's views, said that the appeals court “cabin[ed] the adverse impact of that decision” through its later decision in Momenta Pharmaceuticals Inc. v. Amphastar Pharmaceuticals Inc., 686 F.3d 1348, 103 USPQ2d 1800 (Fed. Cir. 2012) (151 PTD, 8/7/12).
Further, the actions of the alleged infringer in the instant case could be outside the safe harbor even under the Momenta standard, the government said, so the petition for writ of certiorari should be denied.
The Supreme Court is scheduled to discuss the petition in its Jan. 11 conference.
Question Presented
The question presented in the cert petition is: Is the U.S. Court of Appeals for the Federal Circuit's interpretation that the safe harbor from patent-infringement liability provision of 35 U.S.C. §271(e)(1) is limited to activities conducted to obtain pre-marketing approval of generic counterparts faithful to the statutory text and decisions of the U.S. Supreme Court?
The provision provides an exception to infringement “solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs.”
Second Time at High Court
In the instant case, Classen Immunotherapies Inc. is assignee of patents (6,638,739; 6,420,139; and 5,723,283) on methods for determining an optimum immunization schedule for certain diseases.
Classen initially sued a number of vaccine suppliers, including Biogen IDEC and GlaxoSmithKline, for patent infringement based on their participation in immunization studies occurring after marketing approval for the vaccines was obtained from the U.S. Food and Drug Administration.
The case has already been the subject of controversy for conflicting rulings on patent eligibility under 35 U.S.C. §101, the second ruling coming after remand from the Supreme Court. Classen Immunotherapies Inc. v. Biogen Idec, 659 F.3d 1057, 100 U.S.P.Q.2d 1492 (Fed. Cir. 2011). In the remanded August 2011 decision, the court held that the asserted claims of the '739 and '139 patents were statutory subject matter under Section 101.
Safe Harbor Controversy Begins
The decision also addressed Biogen and GSK's argument that their participation in the studies complied with the FDA reporting requirements and thus were noninfringing under the Section 271(e)(1) safe harbor. The 2-1 court ruled that the safe harbor applies only to pre-approval activities.
Judge Pauline Newman wrote that the companies “are not required by law or regulation to perform … post-approval vaccinations in order to generate data. … The fact that GSK or Biogen would have to report to the FDA any adverse reaction after administering a vaccine does not mean the administration itself is noninfringing.”
The majority and dissent differed in their interpretations of a Supreme Court precedent on the issue, Merck K.G.a.A. v. Integra Lifesciences I Ltd., 545 U.S. 193, 74 USPQ2d 1801 (U.S. 2005).
The Integra court held that “[t]here is simply no room in the statute for excluding certain information from the exemption on the basis of the phase of research in which it is developed or the particular submission in which it could be included.”
The Classen appeals court majority--Chief Judge Randall R. Rader joined the opinion--ruled that the “phase of research” limitation applied only to “the types of information that are relevant to an IND [investigational new drug application] or NDA [new drug application].”
In dissent, Judge Kimberly A. Moore said, “While it is true that the Supreme Court decided Integra in the context of pre-approval activities, the Court repeatedly underscored the breadth of the statute's text. Accordingly, I conclude that the safe harbor extends to all uses that are reasonably related to submitting any information under the [Federal Food, Drug, and Cosmetic Act], including information regarding post-approval uses.”
GSK filed a petition for certiorari on Feb. 28.
Momenta Comes Out the Other Way
The Momenta case involved post-approval activities as well, but this time Moore was in the majority, joined by Judge Timothy B. Dyk, with Rader in dissent.
The Momenta court acknowledged that some activities could be outside the scope of the safe harbor, but it was not because they were post-approval.
Rader provided a detailed review of the legislative history, since he had been an active participant as a member of the staff of Sen. Orrin G. Hatch's (R-Utah) at the time the Hatch-Waxman Act was being approved. Rader said that the safe harbor should only apply to very specific acts and applied only to experimentation performed for pre-marketing approval and not for commercial activities.
Government Says Momenta Cabined Error
The high court called for the views of the solicitor general June 25.
“The court of appeals erred in stating that Section 271(e)(1)'s safe harbor encompasses only activities undertaken to obtain the FDA's pre-marketing approval of generic products,” according to the brief filed by Solicitor General Donald B. Verrilli Jr. “Congress not only contemplated that drug manufacturers would conduct post-approval scientific studies and clinical trials, but specifically authorized the FDA to require such studies in a variety of circumstances.”
“Nevertheless, there is no longer any practical need for this court's intervention in light of the Federal Circuit's subsequent decision in Momenta,” Verrilli said.
The brief acknowledged Rader's recap of the legislative history, but characterized as “true but unsurprising” his statement that the record was “replete with statements that the legislation concerns premarketing approval of generic drugs.”
The Hatch-Waxman debate was certainly focused on pre-marketing activities so as to facilitate generic drugs' market entry, Verrilli said, but that does not mean the safe harbor was strictly confined to those activities. Quoting from another case on Section 271(e), Eli Lilly & Co. v. Medtronic Inc., 496 U.S. 661, 669 n. 2, 15 U.S.P.Q.2d 1121 (1990), he said, “t is not the law that a statute can have no effects which are not explicitly mentioned in its legislative history.”
The brief then made some distinctions as to post-approval activity that would fall under the safe harbor. “[A] researcher's use of a patented invention in conducting an experiment reasonably related to the development and submission of information to the FDA is protected by Section 271(e)(1), even if that experiment also advances other commercial objectives, such as product development,” the government said.
But the alleged infringer could be simultaneously selling a drug commercially while participating in a controlled study, the brief noted, such that one activity would be infringing while the other would not.
But Alleged Infringers May Still Be Liable
The immunization studies in the instant case were conducted by the Centers for Disease Control and Prevention and the alleged infringers were invited to participate. However, the researchers were interested in receiving vaccination records and medical histories of children after the fact. That is, the companies had already delivered and health care professionals had already administered the vaccines.
The '283 patent claims that the Federal Court earlier held not to be patent eligible ended with a step of reviewing and comparing information on the effects of different immunization schedules. But the patent-eligible claims of the '739 and '139 patents, according to the solicitor general, could be infringed by the immunization of a patient.
Consequently, the government said, the companies' allegedly infringing acts were performed prior to their participation in the CDC study. Classen's allegation, according to the brief, “which asserts that petitioner infringed the patented methods in the routine conduct of its business, does not implicate Section 271(e)(1).”
The brief concluded, “This case therefore would not provide the court with the opportunity to interpret Section 271(e)(1) against the backdrop of a genuine claim of entitlement to the protection of the statutory safe harbor.”
Carter G. Phillips of Sidley Austin, Washington, D.C., represents GSK. Joseph J. Zito of Washington, D.C., represents Classen. Harry J. Roper of Jenner & Block, Chicago, filed an amicus brief on behalf of the Pharmaceutical Research and Manufacturers of America.
TEVA filed a CP on 12-31 requesting that FDA refrain from approving any new multiple sclerosis drugs prior to review by an advisory committee in light of the safety issues seen in Tysabri and Gilenya after each were approved and on the market.
Teva highlights Biogen's BG-12 and a potential kidney risk based on information that Biogen posted on a public website.
Follow-on biologics have 3 years to change the FDA culture (and that’s just fine)
January 7, 2013 2:25 pm by Chris Seper | 0 Comments
There’s been lots of good news for biologics lately. Among them: the leadership of the U.S. Food and Drug Administration isn’t leaving.
Even when a president wins a second term, there’s typically some turnover in federal offices. This hasn’t happened at the FDA this time around. Craig Wheeler, president and CEO of Momenta, thinks that the fact the FDA leadership won’t change much in President Obama’s second term is a great sign for his company and others preparing generic biologics.
“There are many positive things in the FDA right now,” Wheeler said Monday in an off-site meeting at the JP Morgan Healthcare Conference in San Francisco. “Elevating the (Office of Generic Drugs or OGD) to a super office. The co-location of OGD and (Office of New Drug Chemistry) so they get that interaction. Historically they’ve been very siloed.”
Wheeler said that while the FDA’s leaders are in favor of biologic generics, it will take time for that same attitude — and a comfort level of how to put biologics through a smoother approval process — to filter down through the rest of the agency.
So biologic companies like Momenta have about three years to change the culture at the FDA?
“That’s fair,” Wheeler responded. “But that’s plenty of time.
“The leadership — the general leadership — is biased toward the generic side,” Wheeler added. Now, he said, they need to “transplant that to the rest of the agency.”
Momenta’s biggest win in 2013, however, wouldn’t come through the FDA. It would come through the courts — where it’s had some pretty mixed results.
Wheeler said the big breakthrough this year would be approval to market their generic version of Teva’s multiple sclerosis treatment Copaxone. Teva is hoping to keep Momenta (and Mylan) from selling a generic version until as long as 2015. Momenta is appealing, and a ruling would open up a drug that has roughly 40 percent of U.S. market share and generates $4 billion in revenue for Teva.
“It would show we could not only work in sugars but also in peptides,” Wheeler said
http://medcitynews.com/2013/01/follow-on-biologics-have-3-years-to-change-the-fda-culture-and-thats-just-fine/#ixzz2HOfpAjs9
Is MNTA not at JPM conf this year?
WB Steve and happy new year! :)
Thanks IO. All the best these holidays and have a happy new year!
Meticulous and thought provoking as usual IO. Have a great holiday! :)
Ganesh exercised and held 7200 options today. Would be nice to see a bit more of that from MNTA management :)
http://ir.momentapharma.com/secfiling.cfm?filingid=1179110-12-18116
Wow. 4 people actually voted "yes"? This seriously puts into question the credibility of the advisory comittee
Well, they've made pretty good money on it so far!
Also, I thought I had never heard of Visium before, but clearly I have, since I made that Feb 2011 post. Lol
13G filed. Visium reporting 3.6m owned (7%) Looks like a new holder??
Sounds like the SCOTUS should express a view then :)
Vin, perhaps he meant next Friday. Or more specifically, if the stock is trading between 10.94 and 10.98 on Friday at 2:11PM, then a "Monkey Alarm Doji/Hillybilly Slam" pattern has formed, a bullish/bearish pattern that means the stock could be headed down, or even up.
Have a good weekend everyone!
District court question. Will they wait to see if the supreme court gets involved, or can they go ahead close the case per the CAFC recommendation?
Oops no wonder the stock went up a bit today. You updated the readmefirst :P
Close over 11. Does that mean we're going to 50 now?
Pretty curious volume today (eom)...
Since the FDA has never issued a tentative approval before your post makes a lot of sense :)
Amarin Announces $100 Million Non-Equity Financing and Vascepa Sales Force Hiring While Continuing to Assess Strategic Alternatives
Steps Are Consistent With Amarin's Continuation of Its Strategy to Parallel Process Three Strategic Options
Conference Call Scheduled for Today, December 6th at 4:30 p.m. ET
BEDMINSTER, N.J., and DUBLIN, Ireland, Dec. 6, 2012 (GLOBE NEWSWIRE) -- Amarin Corporation plc (Nasdaq:AMRN), a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, announced today a $100 million non-equity financing with an investment fund managed by Pharmakon Advisors and that Amarin is continuing its preparations to commercialize Vascepa® (icosapent ethyl) capsules with the hiring of a sales force in the United States. Payments by Amarin under this hybrid debt-like instrument are expected to be made over a 3.5-year period commencing in November 2013 and to continue through early 2017.
As previously announced, the initial commercial launch of Vascepa is planned for early in the first quarter of 2013. The company is hiring 250-300 specialty sales professionals for the launch of Vascepa for its initial indication, the MARINE indication, which is approved by the U.S. Food and Drug Administration (FDA). Amarin's goal is for every sales representative hired to have, at a minimum, three to five year existing relationships with the identical physician groups Amarin will be calling on and educating about Vascepa.
In addition to hiring a sales force, Amarin has been focused on continued commercial preparations for Vascepa which, as previously disclosed, has included, but has not been limited to, finalizing the introduction of Vascepa to managed care plans to gain formulary access, building up inventory levels, hiring key personnel (e.g., managed care, marketing, sales infrastructure, pricing), developing direct-to-consumer advertising and speaker training and coordinating other pre-launch marketing activities.
Amarin's hiring of a sales force is part of a continuing strategy to evaluate three potential paths to Vascepa commercialization: an acquisition of Amarin, a strategic collaboration, and self-commercialization, the latter of which could include third-party support.
"This transaction provides Amarin with non-dilutive capital that will ensure our ability to fully execute on the Vascepa product launch while continuing our strategic partnership discussions," stated Joseph Zakrzewski, Chairman and CEO of Amarin. "This innovative transaction allows maximum flexibility for Amarin."
Vascepa's next indication, for the patient population studied in the ANCHOR Phase 3 trial, remains on target for a Supplemental New Drug Application (sNDA) submission to the FDA by the end of February 2013 resulting in an anticipated PDUFA action date for the ANCHOR sNDA before the end of 2013.
Conference call for investors
Amarin will host a conference call and webcast for investors, today at 4:30 p.m. ET to discuss the above topics. The conference call will be webcast live and a link to the webcast may be accessed from the "Events & Presentations" page on the Amarin corporate website at www.amarincorp.com.
To listen to the live call on the telephone, dial 1-877-407-8033 (United States and Canada) or 1-201-689-8033 (International). The conference call ID number is 405508. A replay of the call will be available for 30 days by dialing 1-877-660-6853 (United States and Canada) or 1-201-612-7415 (International), conference ID 405508.