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I wasn't aware that the S.Ct. gave a petitioner the option to file a reply to an answer to a pertition for cert. Here is a link:
http://articles.law360.s3.amazonaws.com/0447000/447558/Momenta%20v.%20Amphastar%20cert%20reply.pdf
An effective response, IMO.
Still, one must be very cautious in any face-off with Ms. Millett:
http://www.bisnow.com/dc-legal/nominee-pattie-millett-black-belt/?utm_campaign=legal_060513.htm&utm_medium=email&utm_source=Eloqua
Latest addition to MNTA docket:
May 24 2013 Brief of respondents Amphastar Pharmaceuticals, Inc., et al. in opposition filed.
Jun 4 2013 DISTRIBUTED for Conference of June 20, 2013.
She is Amphastar's lead lawyer at the appellate level. MNTA should make substantial campaign contributions to the members of the Senate Judiciary Committee to expedite her approval as an appellate judge and get her off the case ASAP. Once she was brought in for the Federal Circuit proceedings (I don't think she participated at the district court level), she completely outwitted MNTA's lawyers.
NVO has already initiated a P1 trial in what a recent NVO investor presentation describes as "LAI287, a novel insulin analogue potentially enabling a once-weekly treatment paradigm".
A later slide calls it an ultra long-acting basal insulin.
Both the ANTB and NVO insulins are delivered subQ, ANTB using PEG tech and NVO some kind of cartridge.
Here's the link to the NVO trial:
http://clinicaltrials.gov/show/NCT01730014
The Amphastar brief in its first footnote cites the SCt. case (Merck) and footnote that I was recalling. The SCt's footnote in Merck referred to the infringement of patents on "research tools", not "testing methods" as I had thought, in reserving judgment about the applicability of the HW safe harbor. I do not see much difference between the 2 types of patents, especially when the patent holder is not the product originator but a 3rd party that can obtain no benefit from any HW patent term extension. However, the Amphastar brief makes a good argument about ripeness, substantially reducing IMO the chances that cert will be granted at this point. This case could drag on endlessly, which I suspect is a major goal of Amphastar's legal team.
Link to Amphastar reply brief:
http://articles.law360.s3.amazonaws.com/0445000/445660/Amphastar%20Brief.pdf
My first reaction based on a quick read of the brief is that Amphastar has a very competent set of attorneys on its side.
One hopeful note, assuming my recollection is correct, is that the brief refers to the patent as a "testing, not manufacturing method, patent." I recall a footnote in one of the earlier SCt. cases on the scope of the Hatch-Waxman safe harbor, stating that the Court was reserving judgment on whether it extended to testing patents, but I will need to look up the case to make sure of this.
MNTA - an example of the wheels of justice grinding slowly
Latest entry on the SCt. docket:
Apr 2 2013 Response Requested . (Due May 2, 2013)
Apr 29 2013 Order extending time to file response to petition to and including May 24, 2013.
ASCO 2013 abstracts
You can search for abstract titles,authors and presentation times by keyword through this link:
http://iplanner.asco.org/am2013/am2013.aspx
So much for Amphastar's strategy of waiving its response right:
No. 12-1033
Title: Momenta Pharmaceuticals, Inc., et al., Petitioners
v.
Amphastar Pharmaceuticals, Inc., et al.
Docketed: February 21, 2013
Lower Ct: United States Court of Appeals for the Federal Circuit
Case Nos.: (2012-1062, 2012-1103, 2012-1104)
Decision Date: August 3, 2012
Rehearing Denied: November 20, 2012
~~~Date~~~ ~~~~~~~Proceedings and Orders~~~~~~~~~~~~~~~~~~~~~
Feb 15 2013 Petition for a writ of certiorari filed. (Response due March 25, 2013)
Mar 21 2013 Waiver of right of respondents Amphastar Pharmaceuticals, Inc., et al. to respond filed.
Mar 27 2013 DISTRIBUTED for Conference of April 12, 2013.
Apr 2 2013 Response Requested . (Due May 2, 2013)
Conquering the complexities of biologics to get to biosimilars - FiercePharma Manufacturing
http://www.fiercepharmamanufacturing.com/special-report/conquering-complexities-biologics-get-biosimilars?page=full
Worth a read; includes commentary from MNTA execs.
Below is a link to MNTA's full pettion for cert. I did not realize, but should have probably guessed, that the petition would be longer than a few paragraphs or pages. There are 33 pages of analysis, plus appendices containing the lower court opinions. The petition addressed the Soliciter General's recommendation to deny cert in Classen as follows:
Thanks, it appears the FDA blog author extracted the key portions of the petition, which I have reproduced below for convenient reference:
MNTA petition for cert filed:
(I have been reviewing the SCt website for the filing on a daily basis for the past week, and this is the first time I have seen this posted. I assume that a copy of the petition will be widely available in the near future. I am curious whether the petition will take the position that the Fed. Cir.'s majority interpretation of the Hatch-Waxman safe harbor results in a violation of the 5th amendment takings clause. Also surprised MNTA has not issued a PR by now; note the 2/15 filing date).
No. 12-1033
Title: Momenta Pharmaceuticals, Inc., et al., Petitioners
v.
Amphastar Pharmaceuticals, Inc., et al.
Docketed: February 21, 2013
Lower Ct: United States Court of Appeals for the Federal Circuit
Case Nos.: (2012-1062, 2012-1103, 2012-1104)
Decision Date: August 3, 2012
Rehearing Denied: November 20, 2012
~~~Date~~~ ~~~~~~~Proceedings and Orders~~~~~~~~~~~~~~~~~~~~~
Feb 15 2013 Petition for a writ of certiorari filed. (Response due March 25, 2013)
--------------------------------------------------------------------------------
Mouton, thanks for posting the SG brief. After reveiwing it this evening, I consider the chances that the SCt. will grant cert. in Classen to be close to nil. It will be interesting to see whether the Court asks the SG for its views after MNTA files its petition for cert. The SG left open the question of whether Amphastar's continuing use of MNTA's process patents to ensure batch-to-batch consistency is permitted under the HW exemption. But it is not clear, as imnot6 noted, what the answer is. Regardless of the SG's views, the SCt. might grant cert in any event because of the profound negative effect the Fed. Cir.'s opinion could have on manufacturing patents. I need to spend some more time (which is in short supply with some major year-end deadlines to meet)to go back over the Fed. Cir.'s and DC decisions in MNTA and the SCt.'s prior opinions on the HW exemption.
If it will help anyone, I did take a stab at formatting the portion of the SG's brief I consider key to MNTA's case to make it more readable, which I am reproducing below:
Extract from SG brief for Classen
The FDA may also require post-approval studies and clinical trials to determine whether, in light of new safety-related information, existing drugs should be withdrawn from the market or should carry different or more prominent warnings. See 21 U.S.C. 355(e) (authorizing Secretary to withdraw approval based on “new evidence” that drug is not safe for use); 21 U.S.C. 355(o)(4)(A) and (E) (Supp. V 2011) (authorizing Secretary to require “a labeling change as the Secretary deems appropriate to address” new safety information). Manufacturers have both business and legal incentives to respond voluntarily to reports of unexpected safety problems with their products. Those that undertake studies and clinical trials to investigate safety-related issues must file periodic reports with the FDA describing their investigations. 21 U.S.C. 355(o)(3)(E)(ii) (Supp. V 2011). But if the FDA becomes aware of new safety information indicating that a drug poses a serious risk to human *14 health, it may require the manufacturer to undertake post-approval studies and clinical trials if the manufacturer fails to do so voluntarily. 21 U.S.C. 355(o)(3)(A) (Supp. V2011); see 42 U.S.C. 262(a)(2)(D) (Supp. V 2011).
Since 2008, the FDA has used this authority to require 249 post-approval safety studies or clinical trials, based on new information or other reasons. See FDA, Post-market Requirements and Commitments, http://www.accessdata.fda.gov/scripts/cder/pmc/index.cf m (database last updated Nov. 2, 2012). Drug manufacturers voluntarily conduct post-approval scientific studies or clinical trials in other circumstances as well. For example, manufacturers conduct such studies in order to prepare “supplemental” new drug applications - applications for the FDA's approval to change the formulation, manufacturing method, or labeling of a drug. See 21 C.F.R. 314.70(b). Such applications are used when a manufacturer seeks the FDA's approval of a new indication of an already approved drug. The FDA evaluates such applications under the same standards that apply to a completely new drug. Thus, drug makers must justify the proposed label change by submitting data from clinical trials supporting the safety and effectiveness of the drug for the new indication. 21 U.S.C. 355(a) and (d); 21 C.F.R. 314.70(b)(3)(iv)-(v).
At any given time, a drug maker therefore may be conducting clinical trials for a drug and submitting the resulting information to the FDA, even though the FDA has previously approved the same drug to be marketed for a different medical indication. The FDCA thus unambiguously contemplates that drug manufacturers will conduct post-approval scientific studies or clinical trials for the purpose of developing*15 and submitting information about their products to the FDA. Such post-approval studies serve the same essential function in the federal regulatory process - ensuring the safety and effectiveness of the drugs consumed by the American public - as the pre-approval activities that the court of appeals recognized are shielded by Section 271(e)(1). When the post-approval development and submission of information to the FDA requires the use of a patented invention, Section 271(e)(1) insulates that research from liability for patent infringement.
b. The court of appeals identified nothing in the statutory text that would justify the court's categorical ruling to the contrary. Instead, it rested its interpretation principally on the legislative history of Section 271(e)(1). The court emphasized that the history is “replete with statements that the legislation concerns premarketing approval of generic drugs.” Pet. App. 27a; see id. at 27a-28a. That observation is true but is unsurprising. As this Court recognized in Eli Lilly, a principal object of the Hatch-Waxman Act was to eliminate “distortions” caused by the interaction of the patent laws with the requirement of FDA pre-marketing approval for generic drugs. 496 U.S. at 669. The legislative history of Section 271(e)(1) therefore focuses on the safe harbor's expected role in facilitating market entry by generic drug manufacturers. See, e.g., H.R. Rep. No. 857, 98th Cong., 2d Sess. 15 (1984). In addition, the purpose of the safe harbor is to immunize conduct that would otherwise constitute patent infringement. The practical value of Section 271(e)(1) therefore is likely to be greatest in the context of efforts by generic drug manufacturers to obtain FDA approval for generic *16 versions of other companies' patented drugs.
By contrast, because a brand-name manufacturer's performance of additional studies on its own approved drug is less likely to spawn allegations of patent infringement, the question whether such conduct falls within the safe harbor may have less practical significance. As this Court also recognized in Eli Lilly, however, “It is not the law that a statute can have no effects which are not explicitly mentioned in its legislative history.” 496 U.S. at 669 n.2 (citation omitted). Indeed, as the dissent below observed, “[n]one of the legislative history cited by the majority *** speak[s] to the question at issue here - whether the statute as enacted also covers post-approval activities.” Pet. App. 55a. On that question, “[t]he language Congress chose to enact and that was signed into law by the President is plain on its face. There is no ‘pre-approval’ limitation.” Ibid. And “it is ultimately the provisions of our laws rather than the principal concerns of our legislators by which we are governed.” Oncale v. Sundowner Offshore Servs., Inc., 523 U.S. 75, 79 (1998).
c. Although the court of appeals grounded its holding in the legislative history rather than in the statutory text, respondent focuses (Br. in Opp. 9-10) on the statutory term “solely” in defending the court of appeals' limitation of the safe harbor provision to pre-approval activities. In respondent's view, once a drug maker has obtained the FDA's approval to market a drug, any post-approval scientific study concerning that drug cannot be “solely” for purposes related to the development and submission of information to the FDA because the drug maker is also engaged in the ordinary commercial distribution of the drug. That *17 argument rests on a misinterpretation of the safe harbor provision. Section 271(e)(1) states that “t shall not be an act of infringement to make, use, offer to sell, or sell *** a patented invention *** solely for uses reasonably related to the development and submission of information” under federal laws regulating drugs. 35 U.S.C. 271(e)(1). The word “solely” indicates that, in applying the safe harbor, the court should focus on the particular “use[]” that is alleged to be an “act of infringement.” A particular “use[]” may be “reasonably related to the development and submission of information,” and therefore may fall within the safe harbor, even if it serves other purposes as well. Thus, 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. See Abtox, Inc. v. Exitron Corp., 122 F.3d 1019, 1030 (Fed. Cir. 1997).
By contrast, if a defendant makes multiple “uses” of a patented invention (e.g., by selling a patented drug commercially while simultaneously administering it to research subjects during a controlled study), one “use []” may provide a basis for infringement liability even though the other falls within the safe harbor. See p. 18, infra. 2012 WL 6206566 (U.S.). In the pre-approval context, determining whether a defendant's use of a patented invention in drug development research was “solely for uses reasonably related to the development and submission of information” to the FDA will normally be a straightforward inquiry.
In the post-approval context, that inquiry*18 may be substantially more difficult because the drug maker simultaneously may be engaged in the ordinary commercial manufacture and sale of the product in question. In such circumstances, a more nuanced analysis is required. A drug maker's use of a patented invention in routine commercial activity is not immune from infringement liability merely because, for example, the company may periodically report adverse reactions to the FDA. See 21 C.F.R. 314.80 and 600.80. That is because the ordinary commercial exploitation of a patented invention is not “reasonably related to the development and submission of information” for the FDA, even if such exploitation sometimes generates information useful to the FDA. That conclusion is reinforced by the ordinary meaning of the statutory term “development,” which implies more than merely the collection of information incidental to commercial transactions.
In some cases, however, post-approval research activities will fall squarely within the ambit of Section 271(e)(1). If the FDA has approved a drug for acne, for example, and its manufacturer separately conducts a clinical trial of the same drug as a treatment for melanoma, the clinical trial (but not the routine sales of the drug for acne treatment) will be protected under the plain terms of the statute. Likewise, if the FDA directs a manufacturer to conduct a clinical trial of a blood pressure drug to determine whether a different dosing regimen would mitigate dangerous side effects of which the agency recently became aware, see 21 U.S.C. 355(o)(3)(A) (Supp. V 2011), that research will be protected from infringement claims by Section 271(e)(1). *19 3.
Although the court of appeals erred in its interpretation of Section 271(e)(1), this Court's review is not warranted. The Federal Circuit has subsequently interpreted the opinion below narrowly in a manner that will cabin the adverse impact of that decision. It is unclear, moreover, whether Section 271(e)(1) applies to patented research methods like those at issue here. Finally, notwithstanding its cramped understanding of the safe harbor, the court of appeals reached the correct result in this case.
a. Although the decision below appeared seriously to misconstrue Section 271(e)(1), the Federal Circuit has since clarified that its ruling in this case does not limit application of the safe harbor provision to pre-approval activities relating to the marketing of generic drugs. After the Court invited the Solicitor General to express the views of the United States in this case, the court of appeals recognized that “the plain language of [Section 271(e)(1)] is not restricted to pre-approval activities.” Momenta, 686 F.3d at 1358-1359; see id. at 1359 (“[P]ost-approval studies that are ‘reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs' fall within the scope of the [Section] 271(e)(1) safe harbor.”).
The court of appeals explained that its decision in this case “did not turn” on any “artificial distinction” between pre- and post-approval activities. Id. at 1358. Instead, that decision held only that Section 271(e)(1)'s safe harbor “does not apply to information that may be routinely reported to the FDA, long after marketing approval has been obtained.” Id. at 1357-1358 (quoting Pet. App. 27a). *20 The Momenta court's interpretation of the opinion below is not the most natural reading. Nevertheless, the Federal Circuit has authoritatively construed its earlier decision and has held, as a matter of controlling circuit precedent, that Section 271(e)(1) is not limited to pre-approval activities for generic drugs. See Momenta, 686 F.3d at 1358-1359 (“[T]he plain language of the statute is not restricted to pre-approval activities.”); id. at 1355; see also 2012-1062 Docket entry No. 86 (Fed. Cir. Nov. 20, 2012) (denying petition for rehearing en banc). The court of appeals has thus correctly recognized that, if “the use of the patented invention is done to generate information that will be submitted pursuant to a relevant federal law, that use falls within the safe harbor.” Momenta, 686 F.3d at 1360.[FN4] Accordingly, no practical reason remains for this Court's intervention. FN4.
The Momenta court additionally held that, for purposes of Section 271(e)(1), information may be deemed “submitted” to FDA if it is preserved in records that FDA regulations require a drug manufacturer to make available for inspection by FDA on request. See 686 F.3d at 1357. We express no view on the correctness of that conclusion or of the court of appeals' ultimate disposition of Momenta.
According to the SCt.'s docket report, the SG filed its response to the SCt.'s "invitation" for the SG's views on Classen on 12/13. However, the response has not yet been posted on the SG's website. I have not been able to locate a copy of the response on the internet (such as PACER & a google search).
According to a poster on YMB, the SG recommmended against a grant of cert in Classen. The Fed. Cir.'s decision in Classen should be viewed as favorable to the MNTA position, so perhaps the SG believes that the adverse decision in MNTA is a better vehicle for SCt. consideration. But without seeing the SG's response (I would think the MNTA case would at least be cited), I am just guessing.
http://finance.yahoo.com/mbview/threadview/?&bn=141eb5e5-e7f7-3fca-b70f-35531014315a&tid=1355779968586-5cb9c766-5464-4fd2-bb0d-7d3e4fbc7854&tls=la%2Cd%2C0
From the docket:
Jun 25 2012 The Solicitor General is invited to file a brief in this case expressing the views of the United States.
Dec 13 2012 Brief amicus curiae of United States filed.
Surprise #7: FDA Approves Generic Copaxone
Probability: 17%
From Cowen's list of top 10 potential surprises for 2013.
Also includes a prediction of the impact on MNTA's stock price, FWIW.
http://www.fiercebiotech.com/press-releases/biotechnology-industry-outlook-top-10-potential-surprises-2013
A better surprise would be for the S.Ct. to reverse the Fed. Cir. in Amphastar, but I have yet to see the petition for cert. Presumably MNTA will issue a PR when it is filed.
NKTR
The PIII trial was recently posted on CT.gov and is scheduled to start next month:
http://clinicaltrials.gov/show/NCT01736475
Just posted the article on the MNTA website:
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=81699583
I have reproduced the article below (and it opened up on my computer without any prompting for a password so I think it should be an open-access article)..
My guesses as to the odds:
I agree with ifwal's >90% assessment that the S.Ct. will grant cert in both Classen and MNTA and both cases will be decided together. The fact that Fed. Cir. rendered inconsistent opinions in the 2 cases -- and the Fed. Cir. is the national appeals court for patent-related cases -- should suffice for S.Ct. review of both cases. The S.Ct.'s invitation to the Solictor General to present its views on Classen in June (before the MNTA panel decision in August) indicates that the some judges were interested in the issue. Until the MNTA decision, I knew little about the Solicitor General process, but it seems fairly rare that the SG is asked to chime in on cert petitions. After reviewing several "invitation" briefs on the SG website, the SG will likely provide a fairly comprehensive brief and express its opinion on how the cases should be decided. Of course, the SG opinion is not binding on the S.Ct., but it should have influence.
As to how the S.Ct. will decide, I would assign a 60/40 probabilty that the court will affirm Classen and reverse MNTA. The legislative history as recounted by Chief Judge Rader strongly favors MNTA's position. But the statute can be literally read, as Judge Moore did in MNTA without resort to legislative history, to favor Amphastar. Scalia has long advocated disregarding legislative history if the statutory language is clear. I belive this is called the "textualist" view of statutory interpretation. Presumably Scalia could pull along a few colleagues if he considers the Hatch-Waxman language to be clear.
Here's a link to the SG website for anyone interested:
http://www.justice.gov/osg/briefs/index.html
Here's the text of the law360 blog article:
I need to run into a meeting, but the Solictor General's brief should be quite influential as to whether the SCt grants cert in Classen. I am sure the MNTA decision will be analyzed in the SG brief for Classen -- SG briefs are generally very thorough. It would not surprise me if the SG recommended that MNTA and Classen be consolidated.
MNTA can petition for Supreme Court review. Ordinarily the SC does not grant pertitions for cert. However, another case in which the Fed Cir reached a decision that could be viewed as at odds with MNTA, Classen, is before the SC on a petition for cert. The SC invited the US Justice Dept's Solicitor General to express its views on taking up the case. That was back in June. I just checked the Solicitor General's website, and so far the SG has not responded to the SC's "invitation". Today's rehearing denial may open the door for the SG to issue its views.
denial of rehearing in MNTA just posted on Fed Cir website:
PETITION FOR REHEARING EN BANC
2012-1062, MOMENTA PHARMACEUTICALS, INC., ET AL. v. AMPHASTAR
-1103, PHARMACEUTICALS, INC., ET AL.
-1104 Denied.
NVO: there were several articles in late May/early June about NVO's oral insulin efforts, which have been underway for 6 years. The Bloomberg piece linked below is as comprehensive as any of them. The NVO project head's view about the chances for success:
FWIW, I view from time to time both the Supreme Court's docket entries for Klassen and the Solicitor General's website for SG action on the SCT's invitation for the SG's views on Klassen. Thus far (and I just checked both), the SG has not responded to the invitation. It would not surprise me if the SG is awaiting the Fed Cir's action on the MNTA rehearing request before weighing in. But I have no idea what might happen procedurally at the SCt level if the Fed Cir grants the request. Perhaps someone more familiar with SCt/SG procedures could chime in.
This is the text of the last entry on the SCt's Klassen docket:
The company cited in the PR, Mirna Therapeutics, is not our old friend Marina Biotech (f/k/a NSTK). I can find no announcement on MRNA's website that it has received any additional funding.
Curiously enough, MRNA and Mirna did enter into a collaboration last year. From the PR:
Ariad -- ponatinib: favorable comments from Pazdur
Pazdur's Tale of Two Targeted Therapies
The Pink Sheet Daily. 2012 Sept 24, S Sutter
http://www.oncologystat.com/news/Pazdurs_Tale_of_Two_Targeted_Therapies.html
*****************
FWIW (and not surprisingly), the Fed. Cir. docket entries for 8/30 show that MNTA has brought in new counsel from Morrison & Foerster's DC office with Supreme Court credentials. Links to their bios:
http://www.mofo.com/Deanne-Maynard/
http://www.mofo.com/Natalie-Ram/
I did not see an entry for a petition for en banc rehearing.
FWIW, the invitation to the SG appears in the list of orders issued by the SCt on 6/25/12 and reads as follows:
Thanks for the explanation of the Fed. Cir.'s internal review guidelines. Indeed this is troubling for the reason you present.
Do you know whether the original assignment of this case to a panel that included the Chief Judge and Judge Moore simply happenstance, or was the fact that the 2 were on the Classen panel taken into consideration? TIA.
<<Is this a reasonably quick process? The 3 Judges just present the case to the full circuit and they all vote? Or is another hearing? >>
I just looked at the procedural histories of the McKesson and Akamai cases you referred to, plus a 3d en banc case discussed in your Morgan Lewis link (Gilbert Hyatt), and agree that the process can be very drawn out. In fact, the Fed. Cir. took 4 months to grant rehearing en banc in Akamai and 6 months in the Hyatt case after the respective decision dates of each case. McKesson received a rapid grant -- 1-1/2 months after the decision -- but that occurred shortly after the en banc rehearing was ordered in Akamai. As you note, the identical issue is preent in both cases.
It's troubling to me that several months may elapse before the Fed. Cir. may act on the en banc request. There is an indication in the McKesson order granting en banc review that a party may be able to request accelerated review, but it was for the purpose of having the case considered jointly en banc with Akamai. Given that the MNTA district court trial is set for January, MNTA should have grounds for making such a request. However, I have little familiarity with Fed. Cir. practices and whether accelerated review is a realistic possibility if good reason exists.
FWIW, I think it highly likely that this will be taken up en banc for the reasons described in the post linked below.
I also agree with Dew that this may be addressed legislatively.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=78183767
The Chief Judge's statement in his dissent about his role in Hatch Waxman was far more muted than his statements made near the conclusion of oral argument (which I just listened to again).
From his dissent:
The Chief Judge in his dissent expressly invited Momenta to request reconsideration en banc:
"This decision (“post-approval studies”; “after ap-proval”; “not restricted to pre-approval activities”) cannot be genuinely reconciled with Classen (“pre-marketing approval”). Instead, the court in this decision uses the same language as the dissent in Classen (“post-approval”; “I conclude that the safe harbor extends to all uses that are reasonably related to submitting any information under the FDCA, including information regarding post-approval uses”). This decision should instead request the entire court to resolve the issue en banc."
FWIW, he seemed furious at the majority's decision (lots of bold text). He also observes (again as he did in oral argument) that he particiapted in the drafting of the Hatch-Waxman exception. I expect he will lobby hard for further en banc proceedings.
NKTR: >>Of course my biggest wish is he goes back and partners 102.<<
Maybe there is a chance this will happen before the results are in from the 102 PIII trial in mBC in 3 + years. As I am sure you know, it's possible that the data from the PII O/C extension trial in platinum resisant/refractory, Doxil-failure patients will lead to an AA. Robin and the CMO have inidcated that they will discuss the possibility of an AA with the FDA once the data are final. It seems to me that the interim RR data presented at the April R&D day -- 17% confirmed and 25% confirmed + unconfirmed RRs (RECIST) -- merit trying for an AA if the RRs hold up. There were still 21 patients being treated with 102 at the March interim cutoff time so the RRs might even improve. A firm timetable for trial completion has not been given, but it should be completed by year end, at which point they say they will meet with the FDA to review their options.
One risk to AA consideration is NKTR's early termination of extension trial recruitment because of the Doxil shortage, which reduced the patient pool. However, the 94 patients recruited seem close enough to the 110-patient target set when they met with the FDA in February 2011. A bigger potential hurdle is the PIII confirmatory trial requirement, which I understand must generally be underway before the FDA will grant an AA. Perhaps the FDA would defer action on an AA until the trial begins or simply accept NKTR's commitment to run the trial as promptly as possible. I recall that folotyn received an AA even though a confirmatory trial had not started at the time of the AA. 102 does have orphan status for this patient population.
My guess is that a deal for one or both of the opioid pain drugs (181 & 192) will not occur until the latter part of 2013. The PII for 181 is about to begin and will not be completed until the middle of next year. The PI for 192 also just began.
I have no idea why NKTR shot up as much as it did today. The news flow, including the 118 PIII results, still seem months away except, possibly, for the topline data from the 102 O/C trial.
Thanks, I have no problem reading this dropbox download (although whether I will read all 278 pages is questionable).
A pdf of J. Gorton's Markman decision has now been posted on the district court's website and is linked below (no Pacer fee to view). It's more legible than the dropbox version linked by mouton.
http://pacer.mad.uscourts.gov/dc/cgi-bin/recentops.pl?filename=gorton/pdf/momenta-teva%20markman%20mo.pdf