Orange Book Blog

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Orange Book Blog is published for informational purposes only; it contains no legal advice whatsoever. Publication of Orange Book Blog does not create an attorney-client relationship. Orange Book Blog is Aaron Barkoff's personal website and it is intended for other attorneys. Orange Book Blog is not edited by McAndrews, Held & Malloy, Ltd. ("MHM") or its clients. No part of Orange Book Blog--whether information, commentary, or other--may be attributed to MHM or its clients. MHM represents many companies in the pharmaceutical and biotechnology industries, and therefore Orange Book Blog may occasionally report on news that relates to MHM clients. Orange Book Blog will always strive to be unbiased. All information on Orange Book Blog should be double-checked for its accuracy and current applicability. -- © Aaron F. Barkoff 2006-2017 GlaxoSmithKline v. Teva, No. 14-878-LPS-CJB (D. Del.) by Aaron F. BarkoffIn an opinion last week, Judge Stark of the District of Delaware granted Teva s motion for judgment as a matter of law that GSK failed to present sufficient evidence to support a jury verdict that Teva induced infringement of U.S. Patent No. RE40,000. Judge Stark s decision effectively vacates a jury award of more than $200 million to GSK.Here is an abbreviated chronology of the relevant facts:May 1997: GSK obtains FDA approval of Coreg® (carvedilol) tablets for the treatment of congestive heart failure (CHF)June 1998: U.S. Patent No. 5,760,069 issues to GSK, claiming a method of treating CHF by administering carvedilolMarch 2002: Teva files an ANDA for carvedilol tablets with a para. III certification to U.S. Patent No. 4,503,067, which claims the carvedilol compound, and a para. IV certification to the 069 patentMarch 2007: the 067 patent expiresAugust 2007: Teva amends its para. IV certification against the 069 patent to a section viii statement, carving out the CHF indication from its label and leaving indications for hypertension and left ventricular dysfunctionSeptember 2007: FDA approves Teva s ANDA; Teva launches generic carvedilolJanuary 2008: the 069 patent reissues as the 000 patentApril 2011: Teva amends its label, adding back the CHF indication, making Teva s label essentially a copy of GSK s full labelJune 2015: the 000 patent expiresJudge Stark held a seven-day jury trial last year. The jury found that Teva willfully induced infringement of certain claims of the 000 patent during two time periods: (1) January 2008 to April 2011 (the skinny label period); and (2) May 2011 to June 2015 (the full label period). The jury awarded $234 million in lost profits and $1.4 million in reasonable royalty damages to GSK. The parties then filed post-trial motions.In granting Teva s motion for JMOL, the court summarized its conclusion as follows:The Court agrees with Teva that neither sufficient nor substantial evidence supports the jury s finding of inducement. GSK failed to prove by a preponderance of the evidence that Teva s alleged inducement, as opposed to other factors, actually caused the physicians [i.e., as a class or even at least one of them] to directly infringe, by prescribing generic carvedilol and to do so for the treatment of mild to severe CHF. Without proof of causation, which is an essential element of GSK s action, a finding of inducement cannot stand.The court s decision that no reasonable jury could have found that Teva induced infringement of the 000 patent during the skinny label period is not surprising. But the court s decision of no inducement during the full label period is unexpected.The court found that many factors--but not Teva s label or marketing materials--caused doctors to prescribe generic carvedilol. For instance, the court found:In addition to the knowledge and experience that ordinarily skilled cardiologists had acquired by July 2007 about the benefits of treatment with carvedilol, such doctors had access to American Heart Association and American College of Cardiology guidelines, carvedilol research studies published in the New England Journal of Medicine, The Lancet, and the British Heart Journal, GSK s own Coreg® label and product insert, and GSK s extensive promotional activity--totaling nearly $1 billion--which included sending doctors to hospitals, giving seminars, and detailing, marketing, and advertising Coreg®.Further, Teva showed that once generic carvedilol entered the market in September 2007, and continuing beyond 2007, doctors continued prescribing carvedilol (be it Coreg® or a generic) in the same manner as they had prior to the generics entrance, as they based their prescription decisions on the various factors addressed above without relying on Teva s--or any other generic manufacturers --label. GSK s expert, Dr. McCullough, testified that he had not read Teva s generic label before he started writing prescriptions for carvedilol. As GSK concedes, prior to the generics entrance into the market in 2007, physicians already knew how to use carvedilol for treating CHF. Three cardiologists testified at trial . . . and all three agreed that even in September 2007, when generic companies (including Teva) began selling carvedilol, doctors relied on guidelines and research, as well as their own experience, in addition to GSK marketing. None viewed generic labeling, including Teva s label, as impacting prescribing behavior.As Teva correctly notes, no direct evidence was presented at trial that any doctor was ever induced to infringe the 000 patent by Teva s label (either skinny or full). There was no direct evidence that Teva s label caused even a single doctor to prescribe generic carvedilol to a patient to treat mild to severe CHF. Hence, in order to uphold the verdict, the Court must find in the record substantial evidence to render it reasonable for the jury to have inferred that at least one doctor was so induced. GSK, as the verdict winner, is entitled to the benefit of all reasonable inferences that may be drawn from the evidence presented to the jury. The Court s determination, however, is that--given the dearth of evidence that doctors read and understand and are affected by labels, and given the vast amount of evidence that doctors decisions to prescribe carvedilol during the relevant periods were influenced by multiple non-Teva factors--such an inference was an unreasonable one for the jury to have drawn.The court distinguished more typical ANDA cases that involve a method-of-use patent, in which the patent owner alleges inducement of infringement before a generic launch and the court heavily relies on the proposed ANDA label when evaluating the inducement claim:For instance, GSK directs the Court to Sanofi v. Watson Laboratories Inc., 875 F.3d 636, for the proposition that the marketing of a generic drug with labeling that encourages infringement can be viewed as causing infringement despite the fact that the innovator company published the results of clinical studies and promoted the patented use. That case does not persuade the Court to reach a different conclusion than described above. Sanofi involved the ordinary Hatch-Waxman framework, where a claim of induced infringement is filed before the generic has launched its product, and necessarily, before the generic has even attempted to communicate with any direct infringer. In those cases, as this Court held during earlier portions of this case, the focus must be on intent, rather than actual inducement. Here, by contrast, GSK filed its case almost seven years after Defendants launched their generic carvedilol products into the market. Hence, GSK s inducement claims are not premised on a hypothetical, but instead must be supported by sufficient evidence as to what actually happened during the relevant time period. This Court has decided that reliance on a label and speculation about what may occur in the future cannot substitute for actual evidence about what has actually occurred in the past when, as in this case, there has been a period of actual, past conduct that is pertinent to infringement.This case is relatively unique--particularly because it involved an at-risk launch. It will be interesting to see how the case affects litigation strategies used in other ANDA cases involving method-of-use patents. And we will certainly be paying attention to the inevitable appeal. Hospira, Inc. v. Genentech, Inc., IPR2017-00731 (PTAB) by Aaron F. BarkoffApparently it is not impossible to change the PTAB s mind. In a rare decision last week, the Board granted Hospira s request for rehearing of its earlier decision denying institution, and instituted review of U.S. Patent No. 7,846,441. Genentech is expected to assert the 441 patent in BPCIA litigation over biosimilar versions of Herceptin (trastuzumab).The 441 patent, entitled Treatment with Anti-ErbB2 Antibodies, claims a method of treating a cancer characterized by overexpression of ErbB2 receptor, comprising administering a combination of an intact antibody which binds to epitope 4D5 within the ErbB2 extracellular domain sequence and a taxoid, in the absence of an antracycline derivative. In its Petition for IPR, Hospira argued that the prior art disclosed the claim limitation in the absence of an antracycline derivative because:(1) the cardiotoxicity of anthracycline derivatives was well known in the prior art; (2) both preclinical and clinicalstudies employed the combination of an anti-ErbB2 antibody with paclitaxel or anthracycline, not together; and (3) Baselga ʼ94 shows that the combination with paclitaxel was superior to the combination with doxorubicin, an anthracycline derivative.Genentech countered that Hospira did not show that an ordinary artisan would have avoided anthracyclines when pursuing the combination therapy of antiErbB2 antibody with a taxoid. The Board agreed, and therefore denied institution.In its decision on Hospira s petition for rehearing last week, the Board reversed its earlier decision, explaining:In its Request for Rehearing, Petitioner contends that we erred in interpreting the limitation in the absence of an anthracycline derivative as requiring avoidance of an anthracycline derivative. According to Petitioner, this term is a negative limitation that is satisfied by anti-ErbB2 antibody–paclitaxel combinations that do not include an [anthracycline] derivative. After reconsidering the current record, we find Petitioner s argument persuasive. In particular, because Baselga 94 suggests a therapeutic composition consisting of an anti-ErbB2 antibody and paclitaxel, and does not suggest that doxorubicin must necessarily be included as part of the same treatment regimen, we are persuaded that the reference satisfies the limitation in the absence of an anthracycline derivative. In support of its decision, the Board cited Upsher-Smith Labs., Inc. v. Pamlab, L.L.C., 412 F.3d 1319, 1322 (Fed. Cir. 2005) for its conclusion that a claim to a composition that is essentially free of antioxidants is anticipated when the prior art teaches optional inclusion of antioxidants, despite no express teaching to exclude the antioxidants. Although Hospira did not cite the Upsher-Smith case in its Petition (or propose a construction of the disputed claim limitation), it did so in its request for rehearing. CAFC holds that later-developed antibody species may be evidence that a claimed antibody genus is invalid for lack of written description, and casts doubt on the “antibody exception”Amgen Inc. v. Sanofi, No. 2017-1480 (Fed. Cir. October 5, 2017) by Christopher P. Singer, Ph.D.In a precedential opinion yesterday, the Federal Circuit refined the manner in which it applies the written description requirement to antibody claims. Specifically, the court clarified that “post-priority-date evidence of a particular species can reasonably bear on whether a patent” having claims to a genus fails the written description requirement of 35 U.S.C. § 112. In addition, the court cast further doubt on the “newly characterized antigen” test--also known as the “antibody exception” to written description.As brief background, Amgen sued Sanofi alleging that the cholesterol-lowering drug Praluent® (alirocumab) infringed U.S. Patents 8,829,165 and 8,859,741. The patents are directed to antibodies that bind PCSK9 and their use in methods of treating hypercholesterolemia. The court identified claim 1 of the ‘165 Patent as representative:1. An isolated monoclonal antibody, wherein, when bound to PCSK9, the monoclonal antibody binds to at least one of the following residues: S153, I154, P155, R194, D238, A239, I369, S372, D374, C375, T377, C378, F379, V380, or S381 of SEQ ID NO:3, and wherein the monoclonal antibody blocks binding of PCSK9 to LDLR.Sanofi conceded infringement of the claims but alleged the patents were invalid for lack of written description and enablement, and for obviousness.Post-priority-date evidenceDuring litigation, Sanofi offered evidence of later-developed antibodies, including alirocumab, in support of its argument that the patents were invalid for lack of enablement and written description. The district court excluded the post-priority-date evidence, reasoning that it failed to illuminate the state of the art at the time of filing and was irrelevant for any other purpose. The Federal Circuit ultimately reversed the district court on this issue and remanded for a new trial on both 112 issues.Citing to its 2010 en banc decision in Ariad v. Eli Lilly, the court reaffirmed that written description is determined based on the state of the art as of a patent’s priority date and that evidence which illuminates the state of the art only subsequent to the priority date is not relevant to written description. Nevertheless, it found that the circumstances of this case were distinguishable:Evidence showing that a claimed genus does not disclose a representative number of species may include evidence of species that fall within the claimed genus but are not disclosed by the patent, and evidence of such species is likely to postdate the priority date. If such evidence predated the priority date, it might well anticipate the claimed genus.Here, Appellants sought to introduce evidence not to illuminate the state of the art on the priority date but to show that the patent purportedly did not disclose a representative number of species. As a logical matter, such evidence is relevant to the representativeness question. Simply, post-priority-date evidence of a particular species can reasonably bear on whether a patent “fails to disclose a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can ‘visualize or recognize’ the members of the genus.” (slip opinion at 8-9, quoting Ariad).The court acknowledged that it had not ruled on this specific question to date, but justified its holding as following “the common-sense logic of admissibility” from recent cases including Abbott GmBH Co., KG v. Centocor Ortho Biotech, Inc., 971 F.3d 171 (D. Mass. 2013) and Abbvie Deutschland GmbH v. Janssen Biotech Inc., 759 F.3d 1285 (Fed. Cir. 2014). It also reasoned that this case was distinguishable from In re Hogan (559 F.2d 595 (CCPA 1977), clarifying that the decision only prohibits introduction of post-priority-date evidence to illuminate the state of the art, and is silent with regard to the use of such evidence to show that a patent fails to disclose a representative number of species.Newly characterized antigen testAnother issue on appeal related to whether the district court’s jury instruction concerning written description was improper for including the sentence:In the case of a claim to antibodies, the correlation between structure and function may also be satisfied by the disclosure of a newly characterized antigen by its structure, formula, chemical name, or physical properties if you find that the level of skill and knowledge in the art of antibodies at the time of filing was such that production of antibodies against such an antigen was conventional or routine. (slip opinion at 12).Finding for Sanofi, the court held the sentence to be improper, relying heavily on its decision in Centocor Ortho Biotech, Inc. v. Abbott Labs., 636 F.3d 1341 (Fed. Cir. 2011), and characterizing it as “the only case where we examined the ‘newly characterized antigen’ test in [ ] detail.” (slip opinion at 15). As one concern, the court indicated that the test may allow the enablement requirement (make and use) to subsume the written description requirement in clear violation of its holding in Ariad. In signaling what could be the death knell, the court stated that “the ‘newly characterized antigen’ test flouts basic legal principles of the written description requirement . . . [and] allows patentees to claim antibodies by describing something that is not the invention, i.e., the antigen” in contradiction of the quid pro quo regarding the disclosure of the invention. (slip opinion at 18). From a practitioner’s point of view, it will be interesting to follow this case on remand. Recent cases such as Abbvie Deutschland v. Janssen have highlighted the risk of relying on functional language, rather than sequence features, to claim antibodies. Conversely, older cases that deal with written description, such as Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956 (Fed. Cir. 2002) and Noelle v. Lederman, 355 F.3d 1343 (Fed. Cir. 2004), provide a basis to argue that functional language, coupled with some amount of structure that correlates to the recited function, can satisfy the written description requirement.While Amgen’s claims do not include any sequence features common to the claimed antibody genus, such as a CDR, they include some amount of structural description of the epitope to which the antibody genus binds, which distinguishes them from the purely functional/activity-based limitations in the claims at issue in the Centocor and Abbvie Deutschland cases. The court will no doubt have its hands full in determining whether the description of the epitope structure recited in Amgen’s claims will be adequate to fulfill the written description requirement (retaining some part of the “newly characterized antigen” test), and whether the strength of the post-priority-date evidence will demonstrate that the claims lack written description support. Acorda Therapeutics v. Mylan Pharms., 2015-1456 (Fed. Cir. March 18, 2016)AstraZeneca v. Mylan Pharms, 2015-1460 (Fed. Cir. March 18, 2016) by Alex MenchacaWhere is an ANDA applicant subject to personal jurisdiction when the only act of infringement is artificial infringement under 35 U.S.C. § 271(e)(2)(A)? This question has generated a great deal of interest recently--especially since the Supreme Court s Daimler decision two years ago. In a precedential opinion on Friday, the Federal Circuit answered the question and determined that personal jurisdiction exists in any state where the ANDA applicant intends to market its product--essentially everywhere in the United States.Mylan filed ANDAs in connection with Ampyra® (dalfampridine), Onglyza® (saxagliptin), and Kombiglyze® (saxagliptin/metformin). Acorda markets Ampyra® for the treatment of multiple sclerosis while AstraZeneca markets Onglyza® and Kombiglyze® for the treatment of type 2 diabetes. Both Acorda and AstraZeneca sued Mylan in Delaware, and Mylan filed motions to dismiss for lack of personal jurisdiction in both cases.Both motions were denied. In the dalfampridine case, Judge Stark held that Mylan was subject to both general and specific personal jurisdiction. In the saxagliptin case, Judge Sleet held that Mylan was subject to specific personal jurisdiction, but not general personal jurisdiction. Mylan sought and obtained interlocutory review by the Federal Circuit of both of those orders. The appeal attracted six amicus filings, including briefs from GPhA, Teva, BIO, and PhRMA.The Federal Circuit majority opinion limited its analysis to specific personal jurisdiction. The court began with the rule from International Shoe: specific personal jurisdiction may be exercised over a defendant when the defendant has certain minimum contacts with the forum such that the maintenance of the suit does not offend traditional notions of fair play and substantial justice. Further, the minimum contacts requirement focuses on whether the defendant s suit-related conduct creates a substantial connection with the form State. In short, the Federal Circuit held that specific personal jurisdiction may be exercised over Mylan because the minimum-contacts standard is satisfied by the particular actions Mylan has already taken--its ANDA filings--for the purpose of engaging in that injury-causing and allegedly wrongful marketing conduct in Delaware. The fact that the infringement at issue in the cases was artificial infringement under 35 U.S.C. § 271(e)(2)(A) was used by the Federal Circuit to support its holding. The court explained that this statute is directed to the real-world consequence of marketing a generic in competition with the brand name drug: concrete, non-artificial acts of infringement. Having determined that infringement under section 271(e)(2)(A) carries real-world consequences (and is more than an artificial construct), the Federal Circuit analogized the lawsuits against Mylan for intended future actions to suits for retrospective relief based on past acts and noted that the Supreme Court has defined minimum contacts in those retrospective contexts:In a formulation worded to address suits for retrospective relief based on past acts, the Supreme Court has said that the minimum-contacts requirement is met when the defendant purposefully directed activities at the forum, and the litigation results from alleged injuries that arise out of or relate to those activities.The Federal Circuit explained that Mylan s ANDA filings constituted activities purposefully directed at Delaware and that the lawsuits resulted from injuries that the plaintiffs would sustain by Mylan s activity:Mylan s ANDA conduct is suit-related and has a substantial connection with Delaware because the ANDA filings are tightly tied, in purpose and planned effect, to the deliberate making of sales in Delaware (at least) and the suit is about whether that in-State activity will infringe valid patents. Thus, Mylan s ANDA filings constitute formal acts that reliably indicate plans to engage in marketing of the proposed generic drugs. Delaware is undisputedly a State where Mylan will engage in that marketing if the ANDAs are approved. And the marketing in Delaware that Mylan plans is suit-related: the suits over patent validity and coverage will directly affect when the ANDA can be approved to allow Mylan s Delaware marketing and when such marketing can lawfully take place.Although the majority opinion did not address the issue of general personal jurisdiction, Judge O Malley s concurring opinion did. Judge O Malley wrote that a straightforward application of Supreme Court precedent also establishes general personal jurisdiction in these cases. It may be, however, that the question of general personal jurisdiction is now moot given the court s analysis of specific personal jurisdiction. Momenta and Sandoz v. Teva, No. 2014-1274 (Fed. Cir.)Momenta and Sandoz v. Amphastar, No. 2014-1276 (Fed. Cir.) by Aaron F. BarkoffIn a precedential opinion today, in companion cases concerning generic enoxaparin, the Federal Circuit reached two decisions that pharmaceutical companies should take note of:1. Teva s enoxaparin is not made by a patented process within the meaning of § 271(g) because the process is used merely to ensure that the intended product or substance has in fact been made. In other words, the process simply provides information regarding a substance that has already been made but does not transform it. 2. The safe harbor of § 271(e)(1) does not apply to Amphastar s routine quality control testing of each batch of generic enoxaparin as part of the post-approval, commercial production process. Momenta and Sandoz, which were the first to market a generic version of Sanofi s anticoagulant Lovenox (enoxaparin), asserted U.S. Patent No. 7,575,886 against Teva and Amphastar. The 886 patent claims methods for analyzing enoxaparin to determine whether it has the appropriate chemical structure. Momenta alleged that Teva s and Amphastar s enoxaparin manufacturing processes infringe the 886 patent.The Federal Circuit s decision concerning § 271(g) was a split decision, with Judges Wallach and Moore in the majority and Judge Dyk dissenting. According to the majority opinion, Momenta argued that its patented method is used [by Teva] to select and separate batches of intermediate drug substance that conform to USP requirements for enoxaparin from batches that do not, and that selected batches are then used to make the finished drug product. The majority concluded, Although Momenta s arguments are not without merit, it is more consonant with the language of the statute, as well as with this court s precedent, to limit § 271(g) to the actual ma[king] of a product, rather than extend its reach to methods of testing a final product or intermediate substance to ensure that the intended product or substance has in fact been made. Judge Dyk, in dissent, argued that the quality control testing method of the 886 patent is a necessary intermediate step in the manufacture of enoxaparin. He warned:Patents on purification methods or the quality control method at issue here, which may be integral to the regulatory or commercial viability of a product, but which do not create or transform a product, combine components, or confer new properties, could be freely infringed simply by outsourcing those processes abroad. Congress could not have intended to create this loophole when it sought to protect process patent owners from foreign competitors using U.S. manufacturing processes abroad.The Federal Circuit s decision concerning the 271(e)(1) safe harbor is especially interesting because the court previously reached the opposite conclusion during the preliminary injunction phase of the case (Momenta I). There, the court found that Amphastar s testing according to the patented method was protected by the safe harbor because it was necessary both to the continued approval of the ANDA and to the ability to market the generic drug. The majority in that case distinguished the facts from those in Classen, where the court held that § 271(e)(1) does not apply to information that may be routinely reported to the FDA, long after marketing approval has been obtained. In Momenta I, Judge Moore wrote the opinion for the majority, which included Judge Dyk, while Chief Judge Rader vigorously dissented.This time around, the panel (which again included Judges Dyk and Moore) unanimously held that § 271(e)(1) does not exempt Amphastar s testing. The court states, With the benefit of additional briefing in the current appeals, which reflects the full district court record developed by all parties after the preliminary injunction phase, we conclude Amphastar s submissions are appropriately characterized as routine. According to the court, The conclusion in Momenta I that Amphastar s commercial use of Momenta s patented method falls within the safe harbor of § 271(e)(1) would result in manifest injustice. Amphastar points to no case, until Momenta I, extending immunity under § 271(e)(1) to encompass activities related to ongoing commercial manufacture and sale. Thus, the court vacated the district court s grant of summary judgment to Amphastar and remanded the case. Amgen v. Sandoz, No. 15-1499 (Fed. Cir. May 5, 2015) by Aaron F. BarkoffIn a per curium Order today, the Federal Circuit granted Amgen s Emergency Motion for an Injunction Pending Appeal, stalling, at least temporarily, Sandoz s commercial launch of Zarxio, a biosimilar version of Amgen s Neupogen (filgrastim). Zarxio is the first biosimilar product approved by FDA under the Biologics Price Competition and Innovation Act of 2009 (BPCIA). FDA approved Zarxio on March 6, and Sandoz agreed not to commercially launch the product until May 11 or a Federal Circuit ruling in its favor.The primary issue in the case is whether the pre-litigation information-exchange provisions of the BPCIA are mandatory, as Amgen argues, or optional, as Sandoz contends. The BPCIA states that a biosimilar applicant shall provide a copy of its FDA application and manufacturing information to the Reference Product Sponsor (RPS)--here, Amgen. The statute further states that in the event that a biosimilar applicant fails to provide its application and manufacturing information, the RPS may file a declaratory judgment action against the applicant. Sandoz argues that a biosimilar applicant therefore has a choice: either provide a copy of its application and manufacturing information to the RPS and proceed to the subsequent information-exchange provisions of the BPCIA (including the exchange of patent lists, invalidity and non-infringement contentions, etc.), or accept the consequence of a declaratory judgment action filed against it.Amgen filed suit against Sandoz last October, alleging state-law claims of unfair competition and conversion based on Sandoz s alleged failure to comply with the BPCIA, as well as patent infringement. With Sandoz s biosimilar application proceeding quickly toward FDA approval, Amgen filed a motion for preliminary injunction against Sandoz in February. On March 19, the district court denied Amgen s motion, ruling that the information-exchange provisions of the BPCIA are optional and that Sandoz fully complied with the law.Amgen immediately appealed to the Federal Circuit, and, two days after the district court denied Amgen s motion for injunction pending appeal, filed the emergency motion that the court granted today. Amgen s appeal attracted the support of three amicus filings, by BIO, AbbVie, and Janssen, while GPhA, Celltrion, and Hospira filed amicus briefs in support of Sandoz.Amgen and Sandoz requested an expedited appeal schedule, which the Federal Circuit granted. Briefing is complete, and the court scheduled oral argument for June 3rd. The standard for granting a motion for injunction pending appeal is high-- whether the movant has made a strong showing of likelihood of success on the merits. It therefore appears likely that that Federal Circuit will ultimately reverse the district court and rule that the pre-litigation information-exchange provisions of the BPCIA are mandatory. McAndrews Shareholder Sandra Frantzen will be one of the featured speakers at American Conference Institute s Summit on U.S. Biosimilars conference in Munich, Germany, April 20-21. Ms. Frantzen will be speaking on Incorporating Inter-Partes Review and New USPTO Procedures into Branded and Biosimilar Litigation Strategies. Other speakers include in-house counsel and executives from AbbVie, Boehringer Ingelheim, IPM Biotech, PAREXEL, Sandoz, and Sanofi, as well as outside counsel from U.S. and European firms.The complete agenda is as follows: Diving into the Science of Biologics and Biosimilars: What Counsel Needs to Know to Formulate a Regulatory and Patent Strategy Understanding the Structure of the USFDA and Its Role in Approving and Regulating Biosimilars Delving into the Mechanics of the USFDA Biosimilars Approval Process and Section 351(k) Applications Under the Pathway Mastering the Essentials of New USPTO Post-Grant Proceedings for Effective Use in the Biosimilars Space Obtaining Adequate Patent Protection in the U.S.: Factoring Key Cases into Your Biosimilars Patent Strategy U.S. Federal Trade Commission and State Law Updates: Understanding the Controversy Surrounding Competition, Substitution, and Naming in the Biosimilars Arena Minimizing the Uncertainty Surrounding the Pathway: Insights Into USFDA s Current Initiatives Regarding the First Wave of Biosimilars Applications Evaluating the Risk and Commercial Opportunity in the Emerging U.S. Biosimilars Landscape In-House Keynote Address by Julia Pike, Head Global IP Litigation for Sandoz Timing is Everything: A Cheat Sheet for Managing the Logistics of the BPCIA Exchange Process Biosimilars Litigation Spotlight: Immediate Action Plans for Innovators and Biosimilars to Prepare for the Battles to Come Incorporating Inter-Partes Review and New USPTO Procedures Into Branded and Biosimilar Litigation Strategies Open Floor Session: Lessons Learned So Far: Comparing and Contrasting the U.S. and E.U. Biosimilars Experience Orange Book Blog readers can save €100 with discount code OBB100. For more information or to register, please visit the conference website. Apotex Inc. v. Daiichi Sankyo, Inc., Nos. 2014-1282, 2014-1291 (Fed. Cir. Mar. 31, 2015) by Dunstan H. BarnesApotex, Inc. sued Daiichi Sankyo Co., Ltd. and Daiichi Sankyo, Inc. in the United States District Court for the Northern District of Illinois for a declaratory judgment of non-infringement of a Daiichi-owned, but Daiichi-disclaimed, patent, if Apotex were to manufacture or sell a generic drug bioequivalent of Daiichi’s Benicar®. On March 31, 2015, a three-judge Federal Circuit panel unanimously reversed the district court’s dismissal for lack of case of controversy. The Federal Circuit found that Apotex has a concrete, potentially high-value stake in obtaining a declaratory judgment, and that both Daiichi and generic manufacturer Mylan Pharmaceuticals, Inc. have a concrete, potentially high-value stake in denying Apotex that judgment and thereby delaying Apotex’s market entry.The factual background is key to understanding the debate. Daiichi listed two patents covering Benicar® in the Orange Book. The first, U.S. Patent No. 5,616,599, covers the active ingredient of the drug, and expires on April 25, 2016. Because Daiichi provided the FDA with pediatric test results, the FDA must wait a further six months, until October 25, 2016, to approve a generic version of the drug. The second, U.S. Patent No. 6,878,703, covers methods of treatment, and expires on November 19, 2021.In April 2006, Mylan filed an ANDA with a paragraph IV certification that both the ’599 and ’703 patents were invalid or not infringed by Mylan’s proposed generic drug. In July 2006, for reasons that remain unexplained, Daiichi disclaimed all claims of the ’703 patent, as permitted under 35 U.S.C. § 253. Daiichi then sued Mylan for infringing the ’599 patent. Only validity was disputed in the case, and after trial, the court upheld the validity of the ’599 patent and entered judgment of infringement against Mylan. With the validity of the ’599 patent intact, Mylan’s earliest date for market entry is October 26, 2016, six months after the ’599 patent expires. Note that as a result of the court’s decision, Mylan did not have a lawfully-maintained paragraph IV certification with respect to the ’599 patent.In June 2012, Apotex filed its own ANDA with a paragraph III certification stating that the ’599 patent is valid and a paragraph IV certification that Apotex would not infringe the now-disclaimed ’703 patent. Essentially, Apotex sought approval to enter the market for generic versions of Benicar® at the same time as Mylan—on October 26, 2016.The wrinkle is that Daiichi did not sue Apotex for infringing the disclaimed ’703 patent, and the FDA has not removed the ’703 patent from the Orange Book. Under § 355(j)(5)(B)(iv), because Mylan was the first ANDA filer and Mylan has lawfully maintained a paragraph IV certification regarding the ’703 patent, Mylan is presumptively entitled to 180 days’ exclusivity before facing competition from another generic manufacturer. Thus, if Mylan were to enter the market for generic version of Benicar® on October 26, 2016, it would presumptively be entitled to exclusivity until April 23, 2017.By filing its declaratory judgment action, Apotex sought to enforce a provision provided in § 355(j)(5)(D)(i)(I)(bb)(AA) for forfeiture of Mylan’s 180-day exclusivity period if Mylan has not marketed its generic drug 75 days after a court has entered a final decision from which no appeal (certiorari aside) has been or can be taken that the ’703 patent is invalid or not infringed.The parties did not dispute that allowing Apotex to enter the market earlier would likely transfer sales from Daiichi and Mylan to Apotex. But Daiichi maintained that there was no case or controversy because it could not assert its disclaimed ’703 patent against Apotex, and Mylan additionally argued that Apotex lacks a “tentative approval” from the FDA for its ANDA and thus any delayed-market-entry injury is unduly speculative.The Federal Circuit found, in contrast to the district court, that a case or controversy did exist, because the drug sales over a potential six-month period of exclusivity are concrete and substantial. The court contrasted the present parties’ substantial, concrete stakes in a judgment of non-infringement with cases in which a case or controversy was missing because the plaintiffs had generalized or bystander interest in others’ compliance with law.The Federal Circuit also provided a common sense reasoning regarding the fact that the now-disclaimed ’703 patent is the only barrier to Apotex entering the market at the same time as Mylan. Had Daiichi never listed the ’703 patent in the Orange Book, Mylan would not be eligible for an exclusivity period. Thus, Apotex seeks through its declaratory judgment action to eliminate the entry barrier created by Daiichi’s listing of the ’703 patent that Daiichi subsequently disclaimed. ACI s Paragraph IV Disputes Master Symposium returns to Chicago next week, September 30 to October 1. According to ACI, this is an advanced forum for brand name and generic counsel on the intricacies of Hatch-Waxman litigation. The agenda includes the following presentations:Review of Key Supreme Court Cases that May Alter the Course of Paragraph IV LitigationIdentifying New Due Diligence Concerns Relative to ANDA Drug Targets and Anticipating New Paragraph IV ChallengesIt s All About Timing: Exploring the Surge in Premature Paragraph IV Notice Filings and Its ConsequencesTeva v. Sandoz--A Debate on the Standard of Review for Claim Construction: De Novo vs. DeferentialExploring the Use of Reissue Applications to Amend Invalidity Findings in the District CourtsAnalyzing the Evolving Utilization of IPR and Other PTO Proceedings in Paragraph IV LitigationUnderstanding the Importance of Abiding by Local Rules: A Magistrate s PerspectiveA View from the Bench: The Judges SpeakExploring New Developments in Double-Patenting Type Obviousness and Federal Circuit and PTO Discord on ObviousnessExperts, Problems of Proof, Dispositive Motions and Markman Hearings: Addressing Common Dilemmas Encountered in a Paragraph IV TrialUnderstanding How the Supreme Court s Decision in Limelight v. Akamai Will Impact ANDA Litigation Involving Method of Treatment PatentsFTC Keynote: Reverse Payment Settlements and Other Antitrust Concerns Impacting Paragraph IV Litigation in the Wake of ActavisThe Ever Shifting Boundaries of the Safe Harbor: Determining the Scope of 271(e)(1) Protections Relative to Paragraph IV Litigation After Classen and MomentaNew Exclusivity Challenges for Brand Names and Generics: Exploring Their Implications for Paragraph IV ChallengesThe Uncertain Future of At-Risk Launches: A Study of Injunctive Relief, Damages, and the Impact of the Protonix CaseEthical Considerations for Paragraph IV Matters Before the PTO and District CourtsACI is also offering two pre-conference workshops on Monday, September 29: PTO Procedures Practice Boot Camp for Paragraph IV Litigators and A Judge s Perspective on Effectively and Ethically Communicating with the Court in Paragraph IV Matters, which will feature four former federal judges.Mention discount code OBB200 to save $200 on registration. For more information, please visit the conference website. Tyco Healthcare et al. v. Mutual Pharm. et al., No. 2013-1386 (Fed. Cir.) by Aaron F. BarkoffIn 2006, Mutual filed an ANDA for a generic version of Restoril (temazepam), including a paragraph IV certification to Tyco s U.S. Patent No. 5,211,954. Tyco filed suit against Mutual under 35 USC 271(e)(2), Mutual responded with antitrust counterclaims (which the court temporarily stayed pending resolution of the case), and the case proceeded to judgment.The district court found in 2009 that Mutual did not infringe the 954 patent under section 271(e)(2) because Mutual s product, when manufactured to the ANDA s specification (i.e., where temazepam has a specific surface area of at least 2.2 m2/g), could not infringe the patent (which claims temazepam having a specific surface area of 0.65-1.1 m2/g).On August 5, 2009, the day after the district court entered its judgment of noninfringement, Tyco filed a citizen petition urging the FDA to change the criteria for evaluating the bioequivalence of generic temazepam products in order to help ensure therapeutic equivalence. On September 8, 2009, while the citizen petition was still pending, the FDA approved Mutual s ANDA. The FDA denied Tyco s citizen petition in its entirety five months later.After the Federal Circuit affirmed the district court s later decision that the 954 patent was invalid for obviousness, the district court lifted the stay of Mutual s antitrust counterclaims. In an opinion on January 18, 2013, the district court granted summary judgment to Tyco on Mutual s counterclaims, which, according to the Federal Circuit, were based on four arguments:That Tyco s section 271(e)(2) infringement claim constituted sham litigation that subjected Tyco to antitrust liability for using illegitimate means to keep Mutual s product off the market.That no reasonable litigant could have expected Tyco s patent to withstand a validity challenge.That Tyco s citizen petition was a sham.That Tyco s infringement suit was the product of fraud under Walker Process.In a 2-1 decision last week (over Judge Newman s dissent), the Federal Circuit affirmed two aspects of the district court decision and vacated two others. The court affirmed the summary judgment against Mutual s claim that no reasonable litigant could have expected Tyco s patent to be upheld as valid and affirmed the summary judgment against Mutual s Walker Process fraud claim. The court vacated the summary judgment that Tyco s infringement claim under 271(e)(2) was not sham and that Tyco s citizen petition to the FDA was not a sham.The premise of Mutual s argument that Tyco s 271(e)(2) infringement claim was a sham was that Mutual s ANDA specified that the temazepam in Mutual s ANDA product would have a specific surface area outside of the range claimed in the 954 patent. The Federal Circuit stated that it is not unreasonable for a patent owner to allege infringement under section 271(e)(2)(A) if the patent owner has evidence that the as-marketed commercial ANDA product will infringe, even though the hypothetical product specified in the ANDA could not infringe. But the court found that there was conflicting evidence concerning the specific surface area of the temazepam in Mutual s ANDA product, and remanded for the district court to determine whether Mutual has shown that the subjective element of the sham-litigation test has been satisfied. Similarly, the Federal Circuit found that there were disputed issues of fact precluding summary judgment with respect to whether Tyco s citizen petition was a sham. The court stated:Particularly probative of whether the citizen petition was reasonable is the FDA s response, which denied the petition in terms indicating that, in the FDA s view, it was wholly without merit. The FDA found that Tyco had provided no evidence from clinical trials, pharmacokinetic studies, bioequivalence testing, or any other source . . . . Instead the petition relies entirely on uncorroborated generalities and theoretical speculation to support its critical point. The court also noted that Mutual s expert reviewed the citizen petition and concluded that Tyco did not have a scientific basis to conclude that Mutual s production would not be bioequivalent to Restoril. The court concluded, The testimony of Mutual s expert and the FDA s response to the citizen petition are sufficient evidence from which a reasonable finder of fact could conclude that Tyco s citizen petition was objectively baseless. With regard to the subjective prong of the test, the Federal Circuit found it significant that Tyco filed the citizen petition just one day after the district court granted summary judgment of noninfringement. Mutual argued that filing the citizen petition at that late date caused the FDA to delay the approval of Mutual s ANDA, and thus resulted in a further period of market exclusivity for Tyco. Mutual also pointed to an email from Tyco s R D group stating that a temazepam formulation that was bioequivalent to Restoril could be made from temazepam having a different specific surface area. The court concluded, The timing of the citizen petition and the email are sufficient evidence from which a reasonable finder of fact could determine that Mutual had satisfied the subjective element necessary to show that Tyco s citizen petition was a sham. The Federal Circuit found, however, that there was an open issue as to whether the filing of the citizen petition caused any antitrust injury to Mutual. Thus, the court remanded the case with instructions for the district court to determine whether Mutual suffered an anticompetitive harm in the form of a delay in the approval of its ANDA due to the filing of Tyco s citizen petition with the FDA.

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