Earlier this month, FDA issued final guidance on the labeling of biosimilar products. The final guidance continues the approach adopted in FDA’s March 2016 draft guidance. That approach largely treats biosimilars like generic drugs for purposes of labeling, even though biosimilars, unlike generic drugs, are not exact copies of innovator products.
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Biologics Blog is a source of insights, information and analysis related to biologics, including the legal developments, trends and changing regulation that impact the biotechnology industry. Patterson Belknap represents biotechnology, pharmaceutical and healthcare companies in a broad range of patent litigation matters, including patent infringement cases, PTO trial proceedings, patent licensing and other contractual disputes. Our team includes highly experienced trial attorneys with extensive technical knowledge, many of whom have advanced scientific degrees and industry experience in fields such as molecular biology, biochemistry, chemistry, statistics and nuclear engineering.
On July 18, FDA released its long-awaited Biosimilars Action Plan (“BAP”). In prepared remarks to the Brookings Institution the same day, FDA Commissioner Scott Gottlieb described the BAP as “enabling a path to competition for biologics from biosimilars” in order to “reduc[e] costs and to facilitat[e] more innovation.” While the BAP is straightforward, the Commissioner’s remarks included unexpected jabs at innovator drug makers for what FDA believes is anticompetitive conduct. The speech was likely driven by the Trump Administration’s American Patients First plan, which sets as a top FDA priority the reduction of prescription drug prices, including by reducing “gaming” of regulatory requirements, but what the speech achieves given the role of FDA remains unclear.
Allergan’s attempt to shield its Restasis patents from inter partes review by assigning the patents to the Saint Regis Mohawk Tribe was rejected last week by a unanimous Federal Circuit panel. The Federal Circuit affirmed the PTAB’s February 2018 decision holding that tribal sovereign immunity does not bar IPRs.
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. Justice Thomas wrote the opinion for a seven-justice majority while Justice Gorsuch wrote a dissent joined by Justice Breyer.
Analytical studies to demonstrate that a biosimilar is highly similar to its reference product are central to the biosimilar development and approval process. For this reason, there have been calls from industry for more guidance from FDA on its expectations for evaluating and demonstrating analytical similarity.
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.
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.
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, 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.
Fourth Circuit Rules that Maryland’s Anti-Price Gouging Act for Off-Patent or Generic Drugs is Unconstitutional
The U.S. Court of Appeals for the Fourth Circuit last month handed manufacturers and wholesalers of off-patent drugs a victory by ruling that Maryland’s anti-price gouging act violates the U.S. Constitution’s dormant commerce clause. The legislation, like many others, was enacted in the wake of the Martin Shkreli case, where the former Turing Pharmaceutical CEO raised the price of a vital and old prescription drug by 5,000 percent. Although the Circuit sympathized with consumers affected by this type of conduct, it held, in a majority opinion written by Judge Stephanie Thacker, that Maryland overstepped its constitutional limits in seeking to compel manufacturers of off-patent or generic drugs to act in accordance with Maryland law outside of Maryland.
Yesterday, Pfizer announced that FDA had approved Retacrit® (epoetin alfa-epbx), a biosimilar of Amgen’s Epogen® and Johnson & Johnson’s Procrit® (epoetin alfa). Epoetin alfa (EPO) is a blockbuster treatment for anemia. Retacrit is the first EPO biosimilar approved in the United States. EPO biosimilars have been marketed in the EU for over a decade. Hospira (now a Pfizer company) initially filed an application for approval of its EPO biosimilar in 2014. FDA rejected that application in a complete response later and Hospira later resubmitted it after addressing FDA's concerns. While Retacrit received a favorable FDA advisory committee recommendation in May 2017, it was rejected again in a second complete response letter due to concerns with the proposed manufacturing site for the biosimilar. Nearly a year later, FDA approved Retacrit. Pfizer plans to launch Retacrit this year.
Last week, the Supreme Court upheld the constitutionality of inter partes review (IPR), as expected by most observers. However, it was the Court’s decision in a second IPR-related case that will have an immediate impact on patent practitioners. In SAS Institute Inc. v. Iancu, the Supreme Court, in a 5-4 decision, held that the PTO’s practice of “partial review”—instituting an IPR on some but not all claims challenged in a petition for IPR—is inconsistent with the text of the AIA. The decision will lead to immediate consequences, not the least of which is a major increase in the number of claims tried before the PTAB.
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.
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. Four key takeaways from the oral argument are discussed below.
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.
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.
On March 6, 2018, the U.S. Food and Drug Administration (“FDA”) authorized, with special controls, the first direct-to-consumer test to detect the presence of genetic mutations in the BRCA1 and BRCA2 genes (“BRCA genes”). The test, offered by the personal genomics company 23andMe, analyzes DNA from a consumer’s self-collected saliva sample for three mutations in the BRCA genes. Mutations in the BRCA genes are associated with an increased risk of developing breast and ovarian cancer in women, and breast and prostate cancer in men. However, the test only detects a small fraction of the more than 1,000 known mutations in the BRCA genes. The three mutations that the test does identify are most prevalent in people of Ashkenazi Jewish descent and are rarely present in individuals of other ethnic groups.
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.
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.
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.
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.
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.
On December 19, 2017, FDA approved Spark Therapeutics’ gene therapy Luxturna (voretigene neparvovec-rzyl), the United States’ first gene therapy approved to treat an inherited genetic disease. This approval follows that of Novartis’ Kymriah (tisagenlecleucel) and Gilead Sciences’ Yescarta (axicabtagene ciloleucel), both gene therapies approved earlier this year to treat certain forms of cancer. Gene therapy has arrived, and although the genetic material central to these new treatments is not expressly listed in the statutory definition of “biological product,” FDA is regulating these products as biologics, giving them twelve-year non-patent exclusivity.
2017 has been a record-setting year for biosimilar approvals in Europe. Although the first biosimilars to the European market were approved in 2006 and 2007, the number of approved biosimilars has doubled in the past two years. These approvals have expanded the market into new therapeutic areas and new classes of biologics.
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.
To continue reading Irena Royzman and Andrew Cohen's article from Law360, 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 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.
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.
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.”
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