Marketing approval for US biosimilars has taken off in 2017. FDA has approved five biosimilar products this year, increasing the number of approved biosimilars from four to nine. In addition to new biosimilars of AbbVie’s Humira and Janssen’s Remicade, FDA has approved the first two biosimilars for the treatment of cancer. All five of the products approved this year are biosimilars of complex blockbuster therapeutic antibodies.
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.
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).
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.
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.
On Oct. 5, the Federal Circuit issued a decision in Amgen Inc. v. Sanofi (No. 2017-1480), a closely watched case involving functional antibody claims, claims that define antibodies not by their sequence or structure but by their function, such as the ability to bind a biological target. The Federal Circuit held that although written description and enablement of such claims are assessed at the priority date, post-priority-date evidence is relevant to determining the breadth of the functional claims and whether antibodies representative of the claimed genus have been disclosed. The court also held that the disclosure of a new therapeutic target does not provide a written description of the antibodies that may bind and inhibit that target, even if it is routine to make such antibodies. These holdings have important ramifications for the biotech industry.
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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.
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.
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.
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Amgen filed patent infringement claims against Mylan over Mylan’s proposed Neulasta biosimilar. The suit is the latest in a number of litigations over the blockbuster drug.
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.
FDA announced Thursday that it has approved Mvasi (bevacizumab-awwb), Amgen and Allergan’s biosimilar of Genentech’s Avastin (bevacizumab), a monoclonal antibody used in the treatment of a number of different cancers. Mvasi is the seventh biosimilar approved in the United States under the BPCIA and the first biosimilar approved by FDA for cancer treatment. Mvasi was approved for all six indications of Avastin that are not protected by orphan drug exclusivities, with Avastin’s other indications protected by exclusivities expiring in 2021 and 2023.
On August 10, 2017, the Federal Circuit issued its decision in Amgen v. Hospira. It dismissed Amgen’s interlocutory appeal from a discovery order on jurisdictional grounds and denied a writ of mandamus ordering the district court to compel manufacturing discovery for patents that Amgen did not assert against Hospira’s biosimilar of Epogen. In denying Amgen’s request for mandamus, the Federal Circuit explained that Amgen did not establish an indisputable right to Hospira’s manufacturing information and therefore did not meet the requirement for mandamus. The decision has important implications for innovator companies that do not receive needed information under the Biologics Price Competition and Innovation Act of 2009 (BPCIA): innovators need to sue blind or risk not obtaining discovery for unasserted patents. The Federal Circuit also confirmed that Rule 11 is satisfied in such blind lawsuits due to an applicant’s withholding of information.
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”).
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.
On Thursday, July 13, 2017, FDA’s Oncological Drugs Advisory Committee (ODAC) unanimously recommended approval of biosimilars of two blockbuster cancer drugs. The first, Amgen and Allergan’s ABP-215, is a proposed biosimilar of Roche/Genentech’s Avastin (bevacizumab), a monoclonal antibody used in the treatment of a number of different cancers. The second, Mylan and Biocon’s MYL-1401O, is a proposed biosimilar of Roche/Genentech’s monoclonal antibody Herceptin (trastuzumab), a drug used in the treatment of HER2+ breast and gastric cancer. If, as expected, the drugs receive final FDA approval, each of these drugs will be the first U.S. biosimilar for its respective reference product.
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.
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.
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.
This post, Part III, of a three-part series (Part I and Part II) on FDA’s interchangeability draft guidance highlights a number of open issues that stakeholders have identified in their comments to FDA. These include the naming and labeling for interchangeable products as well as the relationship between multiple interchangeable products for the same reference product. Biosimilar makers also wanted FDA to make clear that physician-mediated switching is possible for non-interchangeable biosimilar products even if pharmacy-level substitution is not. A number of patient groups, by contrast, expressed concern that payers were in effect mandating pharmacy-level substitution for non-interchangeable biosimilars by taking innovator products off formularies.
This post, Part II, of a three-part series (Part I) on FDA’s interchangeability draft guidance, highlights the key issues that were raised in the stakeholder comments provided to FDA. FDA received 52 comments in total from a variety of stakeholders, including patients, physicians, insurers, innovators and biosimilar makers. The stakeholders were divided in their views in a number of areas. Patient and physician groups and innovators urged FDA to adopt more stringent requirements for interchangeability assessments. Biosimilar makers and insurers, by contrast, generally pressed for a loosening of the guidance provided by FDA as well as clarification that interchangeable biosimilar products were not more similar to the innovator product than the non-interchangeable ones. The comments also raised a number of issues not addressed by the guidance, which will be discussed in the third post in this series.
The comment period for FDA’s draft guidance Considerations in Demonstrating Interchangeability With a Reference Product closed on Friday, May 19, 2017. Innovators, biosimilar makers, patients, healthcare providers and other stakeholders have weighed in on the long-awaited guidance. Interchangeable biosimilars, unlike other biosimilars, may be substituted for the innovator product without the intervention of the healthcare provider who prescribed the innovator product. FDA’s guidance for interchangeable biosimilars is thus particularly important to stakeholders. This post, Part I of a three-part series, provides an overview of the key provisions of the guidance. Parts II and III will focus on the comments from stakeholders and open issues.
Approvals of biosimilar products in Europe continue to outpace those in the United States. 28 biosimilars are currently approved in Europe and five in the U.S. In 2017, the European Medical Agency has approved six biosimilar applications, including applications for biosimilars to two of the best-selling complex biologics, Humira (adalimumab) and MabThera (rituximab). EMA is likely to approve seven more biosimilar applications in the coming months. The Food and Drug Administration in turn has approved one biosimilar this year, and has scheduled an advisory committee meeting for later this month for Pfizer’s proposed biosimilar of Amgen’s EPO (epoetin alfa), which the agency previously rejected. Proposed biosimilars of complex biologics in a number of new classes are pending before both agencies at the same time.
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.
President Donald J. Trump has now been in office for just over one hundred days. Observers have been quick to mark this milestone and assess the new administration’s performance, especially on headline-grabbing issues like immigration and foreign policy. Amidst the hubbub, however, few have commented on how President Trump’s opening moves could affect the multi-billion-dollar biologics industry. President Trump’s actions during his first hundred days on issues like trade, judges, and healthcare have the potential to shape the biologics industry for innovators and biosimilar makers alike for years to come.
In public debates over the Affordable Care Act (ACA), also known as Obamacare, biosimilars are rarely, if ever, mentioned. But the U.S. biosimilar statute, the Biologics Price Competition and Innovation Act (BPCIA), was in fact enacted as part of Obamacare — specifically, as Title VII to the ACA. Although the BPCIA is no longer politically controversial, it could, at least theoretically, be swept up in a blanket repeal of Obamacare, if a bill repealing the ACA did not contain an appropriate carve-out.
In a memorandum and order published last Friday in the Janssen v. Celltrion litigation pending in the federal district court in Massachusetts, Judge Mark L. Wolf provided “guidance” that the Biologics Price Competition and Innovation Act (BPCIA) does not limit an innovator’s remedy to a reasonable royalty unless a biosimilar applicant initiates and follows all steps of the “patent dance.”
Today, Judge Gregory Sleet of the U.S. District Court of Delaware orally dismissed Genentech’s lawsuit against Amgen alleging violations of the BPCIA. Judge Sleet did not issue a written opinion, but his order states that the case is dismissed without prejudice for lack of subject matter jurisdiction in light of Amgen v. Sandoz, 794 F.3d 1347 (Fed. Cir. 2015).
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.
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.
A number of biosimilar makers have tried to obtain approval for proposed biosimilar versions of Amgen’s Neulasta (pegfilgrastim), a long-acting version of Amgen’s Neupogen (filgrastim), but have encountered hurdles so far both in the U.S. and Europe.
Today, the Supreme Court granted Sandoz’s petition for certiorari and Amgen’s cross-petition for certiorari in Amgen v. Sandoz, case nos. 15-1039 and 15-1195. The two cases were consolidated, and an hour was allotted for oral argument. This case will be the Supreme Court’s first interpreting the Biologics Price Competition and Innovation Act (BPCIA).
Despite nearly universal opposition from both biosimilar makers and innovator companies, FDA has issued final guidance adopting its controversial August 2015 proposal for naming biologics. Under the guidance adopted by FDA, the nonproprietary name of a biologic will consist of the core nonproprietary name of the originator product plus a meaningless but distinguishable suffix of four lowercase letters unique to each product.
Europe’s biosimilar market continues to develop, with biosimilars in new classes approved and pending in applications before the European Medicines Agency (EMA). The EMA has approved four additional biosimilars in 2016, including three biosimilars in two new classes: a biosimilar of Amgen’s Enbrel (etanercept) and two biosimilars of Sanofi’s Clexane (enoxaparin sodium). In addition to the now 22 approved biosimilars, 16 additional biosimilar applications are under evaluation by the EMA with 12 of the 16 falling in four new product classes: biosimilars of Amgen’s Neulasta (pegfilgrastim), Genentech’s Herceptin (trastuzumab), Roche’s MabThera (rituximab) and AbbVie’s Humira (adalimumab). While Europe’s biosimilar pathway offers important lessons for the U.S., the Food and Drug Administration (FDA) is setting its own path. Two of the four biosimilars approved in the U.S., Sandoz’s biosimilar of Amgen’s Enbrel and Amgen’s biosimilar of AbbVie’s Humira, were approved in the U.S. without any prior approval in Europe. The FDA has also rejected applications for proposed biosimilars with authorization and marketing experience in Europe, making clear that approval in Europe will not necessarily result in approval in the U.S.
The America Invents Act established inter partes review proceedings within the U.S. Patent and Trademark Office for certain challenges to the validity of issued patents. More than 5,000 IPR petitions have been filed to date, and more often than not the PTO institutes review of the challenged claims. In over 80 percent of IPRs that have reached a final decision, the PTO has invalidated some or all of the instituted claims. IPR proceedings have impacted patents across technologies, including pharmaceutical and biotech patents.
Last week, the Solicitor General submitted its brief in Amgen v. Sandoz, arguing that the Supreme Court should review and decide in Sandoz’s favor both questions presented by the parties’ cross-petitions for certiorari. Two days later, however, the Supreme Court denied cert in Amgen v. Apotex, which raised similar issues.
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).
FDA Says BPCIA Poses No Fifth Amendment Taking for Innovator Biologics Submitted Prior to Its Enactment
On the same day that FDA approved the first biosimilar of Humira, the fourth biosimilar to be approved in the U.S., it also denied a citizen petition filed by Abbott Laboratories (now AbbVie) requesting that FDA not accept any filing or approve any application for a biosimilar version of Humira® (adalimumab), AbbVie’s best-selling biologic, or any other product for which a biologics license application (BLA) was submitted to FDA prior to March 23, 2010, the date on which the Biologics Price Competition and Innovation Act (BPCIA) was signed into law. AbbVie argued that to accept or approve any such biosimilar filing would constitute an unconstitutional taking under the Fifth Amendment. AbbVie filed its petition in April 2012, long before any biosimilar was approved in the U.S. and before Amgen filed its biosimilar application for Humira with FDA. All four of the U.S. biosimilars approved to date have relied on BLAs submitted to FDA prior to March 23, 2010.
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.
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.
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.
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.
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.
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.
Six years after the biosimilar pathway was enacted into law, FDA has approved three biosimilars for marketing in the US. Sandoz’s Zarxio, a biosimilar of Amgen’s Neupogen, was the first biosimilar to be approved. Zarxio, a relatively simple biologic, was approved in March 2015 under the Biologics Price Competition and Innovation Act of 2009 (BPCIA). This year, FDA approved two complex biologics, Celltrion and Pfizer’s Inflectra, a biosimilar of Janssen’s Remicade, and Sandoz’s Erelzi, a biosimilar of Amgen’s Enbrel. FDA staff and its arthritis advisory committee also recommended approval of Amgen’s proposed biosimilar of AbbVie’s Humira. On the other hand, Sandoz revealed in July that its biosimilar application for Amgen’s Neulasta, a long-acting version of Neupogen, had been rejected by FDA and Hospira did the same last year for its biosimilar application for Amgen’s EPO. Although the approvals (and rejections) provide significant insights as to FDA’s requirements, there are no simple lessons to be drawn.
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.
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.
Judge Chesler of the U.S. District Court for the District of New Jersey has dismissed one of Amgen’s pending lawsuits against Sandoz under the U.S. biosimilar statute, the Biologics Price Competition and Innovation Act (“BPCIA”).
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.
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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