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Category: Patent Litigation

Supreme Court Reverses Federal Circuit, Holds Patent Owners May Recover Lost Foreign Profits

On Friday, June 22, 2018, the Supreme Court issued its decision in WesternGeco LLC v. ION Geophysical Corporation, 585 U.S. ___, Slip. Op.  No. 16-1011 (June 22, 2018), reversing the Federal Circuit and holding that WesternGeco’s award for lost foreign profits was a permissible application of the damages provision of the Patent Act, 35 U.S.C. § 284.[1]  Justice Thomas wrote the opinion for a seven-justice majority while Justice Gorsuch wrote a dissent joined by Justice Breyer.

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Senator Hatch’s New Legislation Would Eliminate IPR Challenges by Generics and Biosimilar Makers

Generics and biosimilar makers have increasingly used inter partes reviews, proceedings made possible by the America Invents Act, to challenge patents protecting innovator small-molecule drugs and biologic medicines.  Senator Orrin Hatch, co-author of the Hatch-Waxman Act, has introduced an amendment that would require these manufacturers either to take advantage of the abbreviated regulatory approval pathways provided by the Hatch-Waxman Act and BPCIA and challenge innovator patents in district court or to challenge innovator patents in IPRs before the PTAB, but not both.  Senator Hatch explains that while he strongly supports IPRs and the America Invents Act and that IPRs are of particular importance to the tech community to fight “patent trolls,” they are also “producing unintended consequences in the Hatch-Waxman context” and “threaten[] to upend the careful Hatch-Waxman balance by enabling two separate paths to attack a brand patent.”  If enacted, generics and biosimilar makers that choose to take advantage of the abbreviated regulatory process will challenge innovator patents in court rather than in IPRs before the PTAB.

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First Decision on Label Carve-Outs for Biosimilars Expected in Enbrel Litigation

As biosimilar litigation between Amgen, the maker of Enbrel® (etanercept), and Sandoz, the maker of biosimilar ErelziTM (etanercept-szzs) heads toward trial before Judge Claire Cecchi in the District of New Jersey, Sandoz is seeking to stave off Amgen’s infringement claims for three of the patents in suit by pointing to its recent amendment to the Erelzi label, which “carves out” certain treatment indications listed on the Enbrel reference label and, Sandoz argues, moots any claim that Erelzi infringes Amgen’s patents covering the use of etanercept to treat those conditions.

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Federal Circuit Issues Two Decisions Impacting Standing to Challenge Validity of Pharma Patents

Two recent Federal Circuit decisions address when a party has standing to challenge the validity of a patent. Though the cases arose in different contexts, they both center on the question of what it means for a party to be facing an imminent and cognizable injury. In Altaire Pharmaceuticals, Inc. v. Paragon Bioteck, Inc., 17-1487, the Federal Circuit upheld a party’s standing to appeal from a post-grant review where it was at risk of an infringement suit. In AIDS Healthcare Foundation v. Gilead Sciences, Inc. et al., 16-2475,[1] however, the court reached the opposite conclusion and determined that the immediacy requirement to bring a declaratory judgment action was not met for a party that had an interest in purchasing generic drugs, but did not itself produce them.

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Supreme Court Holds IPRs Are Constitutional

In a highly anticipated ruling, the Supreme Court upheld the constitutionality of inter partes review proceedings.  Justice Thomas, writing for the seven-member majority in Oil States Energy Services, LLC v. Greene’s Energy Group, LLC, held that the Patent Trial and Appeal Board could reconsider and cancel patent claims through inter partes review without violating Article III or the Seventh Amendment of the Constitution.

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In WesternGeco v. ION Geophysical Corp., the Supreme Court Weighs the Availability of Foreign Damages for U.S. Patent Infringement

On Monday, April 16, 2018, the Supreme Court heard oral argument in WesternGeco LLC, v. ION Geophysical Corporation, No. 16-1011, a case with broad implications for patent holders that sell products abroad.  The case addresses whether lost profits accrued outside of the United States can be recovered for patent infringement occurring domestically.  In the decision below, 791 F.3d 1340 (Fed. Cir. 2015), the Federal Circuit adopted a per se bar to recovery of such foreign damages, even when domestic patent infringement is established and proximately caused.  Although WesternGeco involves infringement under 35 U.S.C.§ 271(f) – which prohibits the supply of components of a patented invention in the U.S. with the intent that they be combined abroad – in its argument in support of the petitioner, the Solicitor General framed the question more broadly as whether lost profits accrued outside of the United States can be recovered for any domestic act of patent infringement under § 271.[1]  Four key takeaways from the oral argument are discussed below.

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Amgen v. Adello: A Blind Biosimilar Infringement Lawsuit

Last month, Amgen sued Adello for patent infringement under the Biologics Price Competition and Innovation Act of 2009 (BPCIA) in connection with Adello’s proposed biosimilar of Amgen’s Neupogen.  Adello elected to bypass the pre-suit procedures of the BPCIA and did not provide any information regarding its biosimilar or how it is manufactured to Amgen.  In its lawsuit, Amgen asserts 17 patents against Adello blind.  The lawsuit illustrates the consequences of the Supreme Court’s and Federal Circuit’s recent decisions holding that provisions of the BPCIA requiring production of information to the innovator company are not enforceable under federal or state law and that information needed to assess infringement can only be obtained by filing a patent infringement lawsuit.

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Win or Go Home? Standing to Appeal PTAB Decisions Upholding Patentability to the Federal Circuit Before Submitting a Biosimilar Marketing Application

Biosimilar developers have been aggressive in filing petitions for inter partes reviews (IPRs) of biologics patents before the Patent Trial and Appeal Board (PTAB), many of them preceding the filing of a marketing application.  Such early IPRs are attractive to biosimilar makers, because they provide a chance to challenge innovator patents years before the biosimilar maker files a marketing application with FDA.  Since a petitioner need not have Article III case-or-controversy standing to bring an IPR, the remoteness and uncertainty of future infringement in such circumstances does not preclude these early IPRs.  Under settled precedent, however, a biosimilar maker must have Article III standing to seek a Federal Circuit appeal if the PTAB issues a final decision upholding the challenged patent.  A decision expected from the Federal Circuit this quarter in Momenta Pharmaceuticals, Inc. v. Bristol-Myers Squibb Co., No. 17-1694 (Fed. Cir. argued Dec. 5, 2017) will address how and when a biosimilar maker can establish that standing.

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USPTO Adopts Amgen v. Sanofi, Excises “Newly Characterized Antigen” Test from its Written Description Guidance for Antibody Claims

Last month, the USPTO issued a memorandum to its patent examining corps clarifying its guidance concerning the written description requirement for claims drawn to antibodies.  In the memorandum, the USPTO adopts the Federal Circuit’s recent decision Amgen v. Sanofi, 872 F.3d 1367 (Fed. Cir. 2017). The Federal Circuit recently denied Amgen’s petition for rehearing and rehearing en banc in Amgen, confirming that Amgen is the law for written description for antibodies.

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PTAB Holds Indian Tribes Don’t Offer an Out from IPR

In a highly anticipated decision on the Saint Regis Mohawk Tribe’s motion to terminate inter partes review proceedings, the Patent Trial and Appeal Board rejected tribal sovereign immunity to IPRs.  The PTAB’s decision also raised doubts about the effectiveness of assignments even in cases where the sovereign assignee has immunity but the assignor effectively still owns the patent.  The portion of the decision broadly holding that tribal sovereign immunity does not apply to IPRs came as a surprise to some commentators, who observed that the PTAB could have reached the same result on narrower grounds.  Following on the heels of the PTAB’s December 2017 University of Minnesota decision holding that a sovereign waives immunity to IPRs when it asserts the patent at issue in district court, Saint Regis Mohawk Tribe deals another blow for patentees seeking to avoid IPRs with sovereign immunity.

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Hepatitis C Patent Falls for Non-Enablement, Wiping Out $2.5 Billion Infringement Verdict

In a hard-fought patent battle involving “groundbreaking” work by both parties, Chief Judge Stark of the U.S. District Court for the District of Delaware ruled that plaintiff Idenix’s patent for treating Hepatitis C virus (HCV) infection was invalid as a matter of law for lack of enablement.  The decision overturns a $2.5 billion award to Idenix, a Merck subsidiary.  The opinion provides valuable insight into the court’s thinking on enablement of method of treatment claims encompassing a large genus of therapeutic agents.

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U.S., European Biosimilar Approval Activity in 2017

2017 was a record-setting year for biosimilar approvals in the U.S. and Europe. In the U.S., five complex antibody products were approved, two of which are in new therapeutic areas for U.S. biosimilars. In Europe, 16 biosimilars were approved. The number of approved biosimilars in Europe has doubled in the past two years. These approvals have expanded European biosimilars into new therapeutic areas and new classes of biologics. In both markets, biosimilars of pegylated biologic products, such as pegfilgrastim, continue to pose challenges for biosimilar makers.

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Patent dance remains on point

The Federal Circuit’s recent decision in Amgen v Sandoz provides a measure of clarity for innovator companies and biosimilar makers eyeing patent litigation. While the Supreme Court of the US held in June that initiating the pre-litigation information exchanges set out in the Biologics Price Competition and Innovation Act (BPCIA) – colloquially referred to as the “patent dance” – cannot be enforced under federal law, the Federal Circuit’s decision goes a step further. It holds that initiation of the exchanges cannot be enforced under state law, either. As a result, innovators seeking to compel disclosures from biosimilar makers have no recourse other than to sue for infringement. For a number of reasons, however, the decision might not prove as impactful in the long run as it may seem.

To continue reading Irena Royzman and Michael Fresco's article from Intellectual Property Magazine, please click here.

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Federal Circuit: BPCIA Preempts State Law In Biosimilar Litigation

The Federal Circuit ruled that Amgen’s state law unfair competition claims, which were premised on Sandoz’s failure to follow the patent dance, are preempted by the BPCIA.  The decision largely affirms the status quo, making clear that biosimilar applicants may opt out of the patent dance without incurring any consequences besides those specified in the statute.

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Mixed Results as IPR Petitions for Biosimilars Soar

Inter partes review proceedings for biosimilar products are soaring. Biosimilar makers are taking advantage of IPR proceedings to challenge patents protecting some of the world's most important biologic medicines due to the advantages that these proceedings offer: no standing requirement, no presumption of validity, a lower burden of proof and potentially broader claim construction. More than half of the IPR petitions challenging these patents were filed in fiscal 2017. But the results are mixed, with the Patent Trial and Appeal Board denying a high percentage of the petitions. Many of these patents are ultimately litigated in district court under the U.S. biosimilar statute, the Biologics Price Competition and Innovation Act of 2009 (BPCIA). 

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Federal Circuit Affirms Apotex Bench Trial Win in Neulasta Biosimilar Suit

On November 13, The Federal Circuit issued a decision affirming a district court judgment that Apotex did not infringe Amgen’s recombinant protein patent in its abbreviated Biologics License Applications referencing Amgen’s Neulasta and Neupogen.  Judge James Cohn of the Southern District of Florida ruled in Apotex’s favor in September 2016 after a bench trial.  On appeal, the Federal Circuit found sufficient evidence in the record to support the judgment of noninfringement.

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All-or-Nothing Damages Strategy Leaves Promega with Nothing

The Federal Circuit’s recent decision in Promega Corp. v. Life Technologies Corp. is a cautionary tale that failure to present evidence of damages closely tied to each alternative basis of liability may result in a hollow victory – infringement with no corresponding damages.  The Federal Circuit, on remand from the Supreme Court, affirmed the district court’s rulings in a patent suit against Life Technologies that both overturned the jury’s $52 million infringement verdict in favor of Promega, and denied Promega’s motion for a new trial on damages and infringement. The Federal Circuit held that Promega was not entitled to any damages under the narrow “all-or-nothing” damages strategy that Promega had pursued throughout the litigation, and that Promega had waived any alternative damages arguments.

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The Supreme Court’s interpretation of the biosimilars statute and the value of certainty

In Sandoz v. Amgen, the Supreme Court interpreted the U.S. biosimilars statute, the Biologics Price Competition and Innovation Act (BPCIA), for the first time. The Court held unanimously that provisions of the BPCIA requiring disclosure allowing innovator companies to assess whether their patents are infringed cannot be enforced under federal law. The ruling also allows biosimilar makers to provide notice of commercial marketing long before FDA approval of the biosimilar. The Court’s decision introduces uncertainty into provisions of the BPCIA that many viewed as necessary and enforceable. But, due to the value of certainty for both biosimilar makers and innovators alike in resolving patent disputes for blockbuster biologics, the impact of the Supreme Court’s decision may ultimately be modest.

To read the article by Irena Royzman and Nathan Monroe-Yavneh in Nature Biotechnology, please click here.

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Amgen and Genentech Break New Ground in Avastin Biosimilar Dispute

Amgen and Genentech have become embroiled in a novel procedural dispute relating to Mvasi, Amgen’s biosimilar of Genentech’s Avastin (bevacizumab).  On October 6, in a complaint filed in the Central District of California, Amgen brought an action seeking a declaratory judgment that 27 of Genentech’s patents are not infringed, invalid, and unenforceable.  Amgen’s suit appears to be the first post-approval declaratory judgment action brought by a biosimilar applicant under the young U.S. biosimilar statute, the Biologics Price Competition and Innovation Act (BPCIA). Shortly after Amgen filed its declaratory judgment action, Genentech filed its own suit in the District of Delaware, alleging that Amgen had failed to honor promises made during the pre-suit BPCIA process and infringed Genentech’s patents.  Amgen then promptly moved to transfer the Delaware case to California. Genentech then filed another complaint in the District of Delaware, followed by another Amgen motion to transfer.

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A New Strain Of Inequitable Conduct Litigation

In July, a split panel of the Federal Circuit upheld the district court’s use of an adverse inference from litigation misconduct to hold a patent unenforceable for inequitable conduct. The Federal Circuit’s decision in the case, Regeneron Pharmaceuticals Inc. v. Merus NV, raises interesting questions about the relationship between attorney misconduct during litigation (which is not supposed to affect the enforceability of a patent) and misconduct during prosecution of the patent (which can). Because the court’s opinion gives no clear answer to these questions, it opens new tactical opportunities for defendants asserting inequitable conduct defenses in patent cases and may incrementally expand the use of a doctrine that the Federal Circuit has famously referred to as a “plague” and repeatedly tried to rein in.

To continue reading Aron Fischer and Rachel Schwartz's article from Law360, please click here.

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Following Biosimilar Trial, Jury Awards Amgen $70 Million for Pfizer’s Pre-Approval Infringement of Now-Expired EPO Patent

In one of the first Biologics Price Competition and Innovation Act (BPCIA) litigations to reach trial, a jury on Friday awarded Amgen $70 million in damages for Pfizer’s infringement of one of Amgen’s expired patents protecting Epogen®.  The jury found that Pfizer’s subsidiary Hospira, in manufacturing its proposed biosimilar ahead of FDA approval, was not protected by the statutory safe harbor, 35 U.S.C. § 271(e)(1).  This action provides an important lesson in the potential value of expired or soon-to-expire patents in BPCIA litigation.  Because a biosimilar maker’s pre-approval activity may not be covered by the statutory safe harbor, patents that are expired at the time of approval may still have been infringed. 

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New Biosimilar Litigation Reflects Benefits of Complying with BPCIA

On August 2, AbbVie sued Boehringer in the District of Delaware, alleging infringement of multiple patents related to AbbVie’s blockbuster biologic Humira (adalimumab). Though AbbVie has “more than 100 issued United States patents” that protect Humira and says that Boehringer infringes 74 of them, AbbVie explains that it was only able to assert 8 of the patents against Boehringer in its complaint.  As AbbVie explains, Boehringer was able to limit the scope of litigation to 8 patents by complying with the procedures of the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”).

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Coherus Asks Court to Stay BPCIA Litigation After FDA Rejects its Neulasta Biosimilar

Many biosimilar makers have tried and failed to obtain approval for biosimilar versions of Amgen’s Neulasta (pegfilgrastim), a long-acting version of Amgen’s Neupogen (filgrastim).  Coherus BioSciences, Inc. is the latest biosimilar maker to encounter such hurdles.  FDA denied Coherus’s biosimilar application in June, pushing any approval of the proposed biosimilar back by at least a year.  Coherus was forced to lay off a third of its workforce after FDA’s rejection of the application.  On Tuesday, it asked a federal court to stay the BPCIA litigation recently brought against it by Amgen.  Coherus seeks to stay discovery until resolution of its pending motion to dismiss to allow it to conserve resources while preparing to resubmit its biosimilar application.

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The Travails of the First U.S. EPO Biosimilar

Pfizer’s proposed biosimilar of Amgen’s Epogen® and Johnson & Johnson’s Procrit® (epoetin alfa) is poised to be the first erythropoietin (EPO) biosimilar in the U.S.  FDA staff recommended approval of Pfizer’s product as a biosimilar for the four indications of Epogen/Procrit.  On May 25, 2017, FDA’s advisory committee agreed with that assessment, but FDA did not approve Pfizer’s product following the meeting.  Instead, in a first for biosimilar products, FDA issued a complete response letter in June rejecting Pfizer’s EPO biosimilar application for a second time.  Pfizer revealed that FDA did not approve the application after the advisory committee meeting due to FDA’s concerns with a manufacturing site for the EPO biosimilar.  Pfizer’s product may not be approved, much less launched, this year due to outstanding manufacturing issues.

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High Court Interprets The Biosimilars Statute — What Now?

On Monday, the U.S. Supreme Court issued its first interpretation of the biosimilars statute, the Biologics Price Competition and Innovation Act of 2009. The BPCIA, part of Obamacare, introduced an abbreviated pathway for regulatory approval of biosimilars, allowing biosimilars to piggyback on the regulatory data of innovator biologics for their approval.

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Supreme Court Decides Amgen v. Sandoz: Patent Dance Cannot Be Enforced by Federal Injunction, Notice of Commercial Marketing Can Be Given at Any Time

On June 12, 2017, the Supreme Court decided Amgen v. Sandoz, the landmark case about the meaning of the Biologics Price Competition and Innovation Act (BPCIA). First, the Supreme Court held that no federal injunction is available to force biosimilar applicants to participate in the BPCIA’s patent dispute resolution procedures (a/k/a the patent dance); but it remanded to the Federal Circuit to address whether such an injunction is available under state law.  Second, the Court held that under the BPCIA, a biosimilar applicant may provide 180-day notice of commercial marketing before the biosimilar product is licensed, meaning that as a practical matter, the 180-day notice period need not affect the timing of the biosimilar product’s launch.   

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The Federal Circuit’s First Application of the AIA’s On-Sale Bar: Implications for Bio/Pharma

When a small pharmaceutical company discovers a new medicine, it’s not uncommon for the company – which may not itself have the resources or infrastructure to get that medicine to patients – to seek a distribution partner early in development.  If the partners make a deal – say the distributor pays for the right to sell the drug (if it gets approved) – and the partners publicize the existence of the deal (but not the full details of the medicine), does the deal bar a patent filed more than one year later?  In Helsinn Healthcare S.A v. Teva Pharms. USA, Inc. (May 1, 2017), a unanimous panel of the Federal Circuit ruled that the on-sale bar of the America Invents Act (AIA) precludes such a patent, just as the pre-AIA on-sale bar would.  But, in a decision with the potential to chill deals between small bio/pharma companies and potential commercialization partners, the court left unresolved some important questions about the meaning of the AIA’s on-sale bar.

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Supreme Court Reverses § 271(f)(1) Ruling in Biotech Case

In Life Technologies Corp. v. Promega, the Supreme Court reversed the Federal Circuit’s interpretation of 35 U.S.C. § 271(f)(1), and held that a single component does not constitute a “substantial portion of the components of a patented invention” under the statute. The Court, however, declined to address how many components are needed to trigger liability.

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PTAB Ruling on CRISPR: No Interference

On Wednesday, February 15, 2017, the Patent Trial and Appeal Board (“PTAB”) ruled in favor of the Broad Institute of MIT and Harvard in a closely watched patent fight with UC Berkeley over the breakthrough CRISPR genome-editing technology.  The PTAB concluded that the Broad Institute’s later-filed patents for using CRISPR in eukaryotic cells did not interfere with Berkeley’s earlier-filed patent application that disclosed the use of CRISPR technology in vitro and claimed the use of CRISPR technology in general.

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U.S. Biosimilars Pathway Under Trump

This week’s election of Donald Trump as the next President of the United States undoubtedly impacts many sectors of the American economy, and the bio/pharmaceutical industry is no exception.  Two of Trump’s stated policies might bear directly on how biologics will be protected and litigated in this country and abroad: the repeal of the Affordable Care Act of 2010 (ACA), also known as Obamacare, and the repudiation of the Trans-Pacific Partnership (TPP).

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Humira Biosimilar Approved As Litigation Gets Going

The FDA on Friday approved the first U.S. biosimilar of Humira (adalimumab), AbbVie’s best-selling biologic for treatment of inflammatory conditions.  The biosimilar, Amgen’s Amjevita (adalimumab-atto), received approval for all of the indications requested by Amgen:  in adults, moderately to severely active rheumatoid arthritis, active psoriatic arthritis, active ankylosing spondylitis, moderately to severely active Crohn’s disease, moderately to severely active ulcerative colitis, and moderate to severe plaque psoriasis, and in patients four years of age and older, moderately to severely active polyarticular juvenile idiopathic arthritis.  Amjevita is the fourth FDA-approved biosimilar in the U.S.  As noted by the FDA, Amjevita has been approved as a biosimilar of Humira, not an interchangeable product.  Amgen also submitted its Humira biosimilar for review by the European Medicines Agency in December 2015, but the EMA has yet to issue a decision.

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Apotex Prevails in Neulasta Biosimilar Litigation, Files for Cert on 180-Day Issue

Among the first generation of biosimilar litigation under the Biologics Price Competition and Innovation Act (BPCIA) is a dispute between Amgen and Apotex over Apotex’s proposed biosimilar versions of Amgen’s Neupogen (filgrastim) and Neulasta (pegfilgrastim).  That dispute has resulted in the first final judgment in a BPCIA lawsuit.  Earlier this month, Judge James Cohn of the Southern District of Florida ruled after a consolidated bench trial addressing both products that Apotex’s biosimilar applications did not infringe Amgen’s sole remaining patent, U.S. Patent No. 8,952,138 (the ‘138 patent). Meanwhile, Apotex, which remains subject to an injunction prohibiting it from marketing its biosimilar products for 180 days after they are approved, has filed a petition for a writ of certiorari to the United States Supreme Court challenging that injunction.

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Four Years of IPRs: Lessons from Proceedings for the Cabilly II Patent

It has been four years since the first inter partes review proceedings were filed in the United States.  The first IPR petition, filed on September 16, 2012 (the first day IPRs became available), made it all the way to the Supreme Court, and the number of IPRs has greatly exceeded expectations, making the Patent Trial and Appeal Board one of the most important and busiest forums for patent validity litigation in the US.  IPRs were intended to help high-tech innovators besieged with suits from patent trolls to efficiently and cheaply invalidate dubious patents and focus on innovation.  But the impact of these proceedings goes far beyond electrical and computer fields as they have had a major impact on biotech and pharmaceutical patents as well.  The PTAB proceedings for U.S. Patent No. 6,331,415 (better known as the “Cabilly II patent”) – one of the most litigated biotech patents in the US – offer key insights into IPRs and why they are widely used across technologies. 

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Amgen’s Federal Circuit Appeal: the Importance of Manufacturing Information to Biosimilar Litigation

Amgen has filed its appeal brief in Amgen v. Hospira, following the Federal Circuit’s denial of Hospira’s motion to dismiss the appeal for lack of jurisdiction.  The appeal presents an important question for biosimilar litigation:  where biosimilar applicants fail to provide manufacturing information in the pre-litigation information exchanges of the Biologics Price Competition and Innovation Act (BPCIA), are they required to provide that information in litigation even if it is irrelevant to the asserted patents?  The question is particularly important because if the answer is no as the district court held, then innovator companies will be forced to assert manufacturing patents that they do not know to be infringed in order to be able to obtain discovery to evaluate their infringement.  Amgen also addresses whether the Federal Circuit has jurisdiction to hear the appeal under either the collateral order doctrine or the All Writs Act.

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CIMZIA Does Not Infringe Yeda’s Monoclonal Antibody Patent

In UCB, Inc. v. Yeda Research and Development Co., the Federal Circuit affirmed the determination by the District Court for the Eastern District of Virginia that UCB, Inc.’s  Cimzia® (certolizumab pegol), a humanized antibody fragment that treats inflammatory conditions such as rheumatoid arthritis and Crohn’s disease, does not infringe a monoclonal antibody patent owned by Yeda Research and Development Co., Ltd..  (Fed. Cir. No. 2015-1957, September 8, 2016).  Based on actions taken during prosecution, the Federal Circuit agreed that Yeda was “estopped from including chimeric and humanized antibodies within the scope of the monoclonal antibodies claimed” in its patent.  

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Amgen’s Federal Circuit Appeal to Address Important BPCIA Disclosure Issue

The Federal Circuit has now issued two decisions interpreting the Biologics Price Competition and Innovation Act of 2009 (BPCIA).  In Amgen v. Sandoz, the first decision to interpret the BPCIA, the majority held that biosimilar makers could opt out of the first step of the BPCIA’s pre-litigation disclosures, the provision requiring biosimilar makers to provide the innovator company with their abbreviated Biologics License Application (aBLA) and other manufacturing information describing the processes used to make the proposed biosimilar.  The court held that the innovator company could sue under the BPCIA in such circumstances and obtain the needed information in discovery.  In its second decision, Amgen v. Apotex, the court further buttressed its reasoning as to why the first step of the BPCIA’s pre-litigation provisions was optional.  Amgen now appeals a discovery ruling in its biosimilar litigation with Hospira holding that Amgen v. Sandoz does not require Hospira to produce manufacturing information for its proposed biosimilar of Amgen’s Epogen (epoetin alfa).   Hospira moved to dismiss the appeal as premature.  The Federal Circuit denied the motion and is allowing the appeal to proceed on the merits while at the same time requiring the parties to further address jurisdictional issues.  

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Enbrel Biosimilar Approved in US But Enjoined For Now

On August 30 FDA approved Sandoz Inc.’s biosimilar of Enbrel (etanercept), Amgen Inc.’s blockbuster biologic for treatment of moderate to severe rheumatoid arthritis and a number of other autoimmune conditions.  The biosimilar, Erelzi (etanercept-szzs), is the third biosimilar approved for marketing in the US under the Biologics Price Competition and Innovation Act of 2009 (BPCIA).  Erelzi has been approved for all of Enbrel’s indications and is the first U.S. biosimilar of etanercept. 

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The Ripple Effect of the Federal Circuit’s Decision in Amgen v. Apotex on Biosimilar Litigation

In July, the Federal Circuit decided Amgen v. Apotex, No. 2016-1308 (Fed, Cir. July 5, 2016), its second decision interpreting the U.S. biosimilar statute, the Biologics Price Competition and Innovation of Act of 2009 (BPCIA).  The Federal Circuit affirmed the district court’s preliminary injunction barring Apotex from selling its proposed biosimilar until 180 days after post-licensure notice of first commercial marketing.  The Federal Circuit held that 180 days’ notice was mandatory regardless of whether the biosimilar maker provided its regulatory application to the innovator as prescribed at the outset of the BPCIA procedures or not.  The decision has impacted other district court litigation, including the Janssen v. Celltrion/Hospira and Amgen v. Hospira cases, since the biosimilar makers in those cases also argued that they did not need to provide 180 days’ notice of commercial marketing after being licensed by FDA.

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Federal Circuit’s Application of Mayo Revives Biotech Patent

In Rapid Litig. Mgmt. Ltd v. CellzDirect, Inc., the Federal Circuit reversed a ruling of patent invalidity under Section 101, reviving a biotech patent to a method of preserving hepatocytes, liver cells, for medical use.  The Federal Circuit reversed the district court at both steps of the Supreme Court’s framework for patent eligibility set out in Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289 (2012).  In the wake of the Supreme Court’s recent denial of certiorari in Sequenom Inc., v. Ariosa Inc., where Sequenom sought guidance on the proper application of the Mayo two-step test, the Federal Circuit’s decision provides important guidance for how to determine patent eligibility for biotech inventions that build on natural discoveries.  It also may help stem what many, including several Federal Circuit judges, have described as a crisis in medical innovation due to how courts and the Patent Office have applied Mayo.  

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Amgen and Hospira Square Off Over BPCIA Private Right of Action After Amgen v. Apotex Ruling

Amgen and Hospira have fired off a dueling letters to the court in their litigation over Amgen's Epogen biosimilar, debating whether the U.S. biosimilar statute, the Biologics Price Competition and Innovation Act of 2009 (BPCIA), contains a private right of action.  The letters come in the wake of the Federal Circuit’s Amgen v. Apotex decision, which held that the BPCIA’s 180-day notice of commercial marketing provision is mandatory and enforceable by an injunction.  

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Federal Circuit Decides Amgen v. Apotex, Holds that 180-Day Notice of Commercial Marketing is Always Mandatory in Biosimilar Litigation

Today, the Federal Circuit decided Amgen v. Apotex, No. 2016-1308 (Fed. Cir. July 5, 2016), its second decision interpreting the U.S. biosimilar statute, the Biologics Price Competition and Innovation of Act of 2009 (BPCIA).  The Federal Circuit affirmed the district court’s preliminary injunction barring Apotex from selling its proposed biosimilar on the U.S. market during the 180-day post-approval notice of commercial marketing period.  Writing for a unanimous panel that also included Judges Wallach and Bryson, Judge Taranto held that “the commercial marketing provision is mandatory and enforceable by injunction even for an applicant in Apotex’s position.”

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Supreme Court Denies Sequenom’s Cert Petition, Leaving the Federal Circuit’s Interpretation of the Mayo/Alice Patent Eligibility Framework Intact For Now

The Supreme Court today denied Sequenom Inc.’s petition for writ of certiorari, in which Sequenom asked the Court to review a decision of the Federal Circuit invalidating its patent on a breakthrough prenatal diagnostic procedure.  In denying the petition, the Court has declined to revisit the patent eligibility framework it set out in Mayo Collaborative Servs. v. Prometheus Labs. Inc., 132 S. Ct. 1289 (2012) and reaffirmed in Alice Corp. Pty. Ltd. v. CLS Bank International, 134 S. Ct. 2347 (2014).

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Apotex Drops Sham Litigation Counterclaims in Neupogen and Neulasta Biosimilar Litigation

In a consolidated litigation in the Southern District of Florida involving Apotex’s proposed biosimilars of Amgen’s Neupogen, an anti-infection drug for cancer patients, and of Amgen’s Neulasta, a long-acting version of Neupogen, Apotex participated in the pre-suit information exchanges of the BPCIA, agreed with Amgen as to what patents should be asserted in the BPCIA’s immediate litigation phase but then counterclaimed that Amgen engaged in sham litigation by bringing suit on one of the agreed patents.  With trial to begin in July, Apotex recently stipulated to dismissal of its sham litigation counterclaims, leaving for another case the question of whether a biosimilar maker can both agree as to which patents to litigate in the immediate litigation phase and sustain a claim of sham litigation against the innovator for asserting agreed patents.  

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Full Federal Circuit Denies En Banc Review of Jurisdictional Decision with Important Implications for BPCIA Litigation

On June 20, 2016, the full Federal Circuit declined to rehear Acorda Therapeutics Inc. v. Mylan Pharms. Inc., 817 F.3d 755 (Fed. Cir. 2016) en banc. Acorda affirmed two District of Delaware decisions finding specific jurisdiction over Mylan Pharms., an out-of-state ANDA filer, based on its plans to sell its proposed generic drugs in Delaware. After the Supreme Court’s decision in Daimler AG v. Bauman, 134 S.Ct. 746 (2014), Mylan has argued that it could only be sued in its home state of West Virginia in ANDA cases since future sales of its proposed generic drugs could not confer specific jurisdiction in Delaware.  The Federal Circuit disagreed.  Under Acorda, plaintiffs in ANDA cases as well as in cases brought under the Biologics Price Competition and Innovation Act (BPCIA) can bring suit in their forum of choice based on future sales of proposed generic or biosimilar products so long as considerations of fairness, such as efficiency or undue burden, do not render jurisdiction in the forum unreasonable.  

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Supreme Court Affirms Cuozzo – Leaving in Place BRI and Judicial Review Limitation for IPR Proceedings

In Cuozzo Speed Technologies, LLC v. Lee, No. 15-446, the Supreme Court affirmed the Federal Circuit’s holdings that an alleged defect in the PTO’s institution of an inter partes review (IPR) was not subject to judicial review even on appeal of a final decision, and that the PTO can apply the “broadest reasonable interpretation” claim construction standard in IPR proceedings.  Over 30 amicus briefs were filed in this case, with pharma/biotech innovators urging the Court to reverse the Federal Circuit.  

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Amgen Appeals Ruling on Requirement to Produce Manufacturing Information for a Biosimilar Product under Amgen v. Sandoz

Amgen has appealed a partial denial of its motion to compel in Amgen v. Hospira, which sought discovery of the formulation for the cell culture media that Hospira uses to manufacture its proposed biosimilar of Amgen’s Epogen. Judge Andrews of the District of Delaware granted Amgen’s motion to the extent it sought information relevant to infringement of an asserted patent, but did not agree with Amgen’s broader argument that disclosure of manufacturing information was required under the Federal Circuit’s decision in Amgen v. Sandoz, which held that an innovator company can commence suit when a biosimilar maker fails to provide required information under the statutory process set forth in the Biologics Price Competition and Innovation Act of 2009 (BPCIA) and “access the required information through discovery.”  Amgen’s discovery dispute with Hospira represents an important lesson in the aftermath of Amgen v. Sandoz.  Innovator companies that assert only a subset of their manufacturing patents, as Amgen did, may only be able to obtain discovery relevant to those patents.  As a result, innovator companies may choose to assert all of their manufacturing patents in order to obtain manufacturing information that biosimilar makers fail to provide under the BPCIA.

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Supreme Court Asks Solicitor General to Weigh In on Amgen v. Sandoz

Today, the Supreme Court deferred a decision on certiorari in Amgen v. Sandoz, inviting the Solicitor General to file a brief expressing the views of the United States. Sandoz petitioned for review of one aspect of the Federal Circuit’s 2015 decision, that court’s first and so far only interpretation of the Biologics Price Competition and Innovation Act of 2009 (BPCIA), and Amgen filed a conditional cross-petition asking for review of another aspect of the decision if Sandoz’s petition were granted.  The Supreme Court’s order asks the Solicitor General to comment on both petitions.

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Ariosa Files Opposition to Sequenom’s Cert Petition

Ariosa Diagnostics, Inc., Natera, Inc., and DNA Diagnostics Center, Inc. have filed briefs in opposition to Sequenom’s petition for writ of certiorari to the Supreme Court for review of the Federal Circuit’s decision holding Sequenom’s fetal DNA diagnostic patent ineligible under Section 101 and the test set out in Mayo Collaborative Servs. v. Prometheus Labs. Inc., 132 S. Ct. 1289 (2012).

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