Head of Life Sciences Irena Royzman and associate Daniel Williams co-authored a Law360 article titled “Supreme Court Amgen Ruling's Major Effect On Enablement,” which was published on Jan. 16, 2024. The article examines the impact of the Supreme Court's decision on the direction of the law. Read the article here ..read more

On Sept. 14, 2023, the U.S. District Court for the District of Delaware denied defendant Parse Biosciences Inc.’s (Parse) motion to dismiss a complaint filed by plaintiffs 10x Genomics Inc. (10x) and the Board of Trustees of Leland Stanford Junior University (Stanford) asserting willful infringement of six patents covering technologies in the field of genomics. 10x is based in Pleasanton, CA, and asserts that it has invested more than $1 billion in research and development to invent its genomic analysis products, including instruments, reagent kits and analysis software, which are used to disc ..read more

Head of Life Sciences Irena Royzman authored a Law 360 article titled “High Court Amgen Patent Ruling Promotes Medical Innovation” on May 22, 2023. The article discusses the impact of the U.S. Supreme Court's interpretation of the patent enablement requirement in Amgen Inc. v. Sanofi on medical innovation, patent litigation, licensing and preparation of patents.  Read the full article here ..read more

Head of Life Sciences Irena Royzman authored an article in the National Law Journal titled “Why the Supreme Court Should Reject Attempts to Monopolize a Therapeutic Target” on March 24, 2023. The article explains that broad functional patent claims hurt innovation, hurt the investment community and hurt patients when we need real solutions and new therapies. Read the full article here ..read more

For decades, antiviral drugs have been used to combat viral infections, including HIV/AIDS and influenza. Now they are a source of hope in the fight against the COVID-19 pandemic. While there is a global effort to develop and test new drugs to fight SARS-CoV-2, the virus that causes COVID-19, that process takes time, during which the disease is rapidly spreading and taking thousands of lives. There is a faster option being pursued simultaneously: testing already-existing drugs to see whether they are effective in treating this new disease. Drug repurposing is being aggressively pursued by the ..read more

The 10th anniversary of the U.S. biosimilar pathway the Biologics Price Competition and Innovation Act of 2009 (BPCIA) is quickly approaching and marks an expansion of the U.S. biosimilar market.  The BPCIA, signed into law on March 23, 2010, was slow to get going.  The FDA did not approve the first biosimilar product, Sandoz's Zarxio (Neupogen), until the spring of 2015, and Zarxio was first launched in September of that year.  In the past year, the U.S. biosimilar market has greatly expanded.  Sixteen biosimilar products are now marketed in the U.S.  Ten of the 16 we ..read more

In December 2020, the U.S. District Court for the District of Columbia issued a decision in Teva v. FDA, reviewing FDA’s definition of “protein” in connection with the agency’s determination that Teva’s Copaxone®, a medication for treating multiple sclerosis, is a “drug” rather than a “biological product.” Biologic products are regulated under the Biologics Price Competition and Innovation Act (BPCIA), which has more arduous requirements for approval of follow-on biosimilar or interchangeable products than those for generic drugs. Following several failed efforts to have FDA reclassify Copaxon ..read more

Over the past decade, the “printed matter doctrine” has rarely been invoked in life sciences cases, but recently on Nov. 10, the Federal Circuit issued a decision in C R Bard Inc. et al. v. Angiodynamics, Inc., No. 2019-1756, 2019-1934, 2020 WL 6573331 (Fed. Cir. Nov. 10, 2020), where it reviewed the applicability of the printed matter doctrine in the context of patent eligibility under 35 U.S.C. §101 and anticipation under 35 U.S.C. §102. In CR Bard, the Federal Circuit found the asserted patent claims eligible as they were not solely directed to printed matter, and remanded other issues to t ..read more

Last week, the U.S. Supreme Court declined to review the constitutionality of inter partes review proceedings (IPRs) challenging patents issued before the Leahy-Smith America Invents Act (AIA). The AIA, enacted in September 2011, introduced IPRs and other post-grant review proceedings enabling third parties to challenge the validity of issued patents before the Patent Office under a lower standard of proof than in district court. Since then, thousands of pre-AIA patents have been the subject of these proceedings. The Court’s two recent denials of petitions for certiorari in Celgene Corp. v. Pe ..read more

It has been nearly 10 years since the U.S. Biosimilars Pathway (the Biologics Price Competition and Innovation Act) was enacted. The first biosimilar product in U.S. history was approved and launched in 2015. Ten biosimilars were approved in 2019. The Food and Drug Administration (FDA) has now approved 26 biosimilars in total, including biosimilars of nine of the world’s most important biologic medicines: Avastin (2), Epogen (1), Enbrel (2), Herceptin (5), Humira (5), Neupogen (2), Neulasta (3), Remicade (4) and Rituxan (2). The Supreme Court and Federal Circuit have interpreted provision ..read more