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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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.
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.
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.
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).
The biotechnology and life sciences industry has voiced strong support for Sequenom’s recent request that the Supreme Court review the Federal Circuit’s decision holding that Sequenom’s patent on prenatal diagnosis using fetal DNA was invalid under 35 U.S.C. § 101 for claiming ineligible natural phenomena. Twenty-two amici have filed briefs in support of Sequenom’s petition, representing a diverse contingent of stakeholders: biotech and life science companies, innovators in other technological fields, academics, international and domestic professional organizations, and IP licensors. Many elaborate on the arguments raised by Sequenom in its petition, including the potential for a Mayo-induced “crisis of patent law and medical innovation.”
Amgen’s Enbrel (etanercept), a blockbuster biologic treatment for a number of autoimmune diseases, including rheumatoid arthritis and psoriasis, has been an attractive target for biosimilar makers. Sandoz, the maker of Zarxio (filgrastim-sndz), the only biosimilar launched in the US to date, is also first in line with an Enbrel biosimilar in the US. Last October, Sandoz announced that FDA accepted its regulatory application for a proposed Enbrel biosimilar for review. Sandoz is seeking marketing approval for all of Enbrel’s medical indications. But Sandoz’s proposed Enbrel biosimilar brought litigation under the US biosimilars statute, the Biologics Price Competition and Innovation Act of 2009 (BPCIA).
On March 21, 2015, Sequenom filed a petition for writ of certiorari to the Supreme Court in Sequenom, Inc. v. Ariosa Diagnostics, et al. (No. 15-1182). Sequenom seeks Supreme Court review of a Federal Circuit decision holding Sequenom’s patent on a breakthrough non-invasive fetal DNA diagnostic method invalid as directed at patent-ineligible natural phenomena. In its petition, Sequenom calls its case the “ideal vehicle” for the Supreme Court to address mounting concern – acknowledged by the Federal Circuit below – that Mayo Collaborative Servs. v. Prometheus Labs. Inc., 132 S. Ct. 1289 (2012), has been interpreted too broadly, rendering otherwise meritorious inventions patent ineligible. Sequenom argues that the Federal Circuit’s interpretation of Mayo is incorrect and would have sweeping and devastating effects on innovation in biotechnology.
On November 19, 2015, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) gave a positive opinion, recommending marketing authorization of Samsung Bioepis’s Benepali, the first biosimilar of Enbrel (etanercept), in Europe. Enbrel is a blockbuster treatment for rheumatoid arthritis and a number of other autoimmune conditions associated with elevated levels of tumor necrosis factor alpha (TNF-alpha), a protein that plays an important role in promoting inflammation. The CHMP recommended approval of Benepali for these conditions. In the US, FDA recently accepted Sandoz’s regulatory application for its proposed biosimilar of Enbrel for review. Sandoz is seeking approval for all of Enbrel’s indications. FDA’s review of Sandoz’s proposed biosimilar will provide important information on the requirements for biosimilarity and extrapolation for complex biologic products.