Biologics Blog

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.

Recent Blog Posts

  • PTO Announces Deferred Fees for COVID-19 Applications Under New Program The U.S. Patent and Trademark Office has announced that it will defer application fees for certain inventions relating to the fight against COVID-19.  In its September 16 announcement, the PTO acknowledged its role in "dissemination of important scientific information to the public to promote further innovation" and recognized that this "information flow is now more... More
  • The FDA Regulatory Landscape for Covid-19 Treatments and Vaccine (Updated) September 17, 2020 Update: The Trump administration is currently considering accelerating the approval of an experimental Covid-19 vaccine being developed by Oxford University and AstraZeneca.  In line with FDA’s June 2020 guidance on the development and licensure of Covid-19 vaccines, it appears that the administration is considering granting Emergency Use Authorization (EUA) for the vaccine. ... More
  • FDA Releases Industry Guidance on Development and Licensure of COVID-19 Vaccines The Food and Drug Administration (“FDA”) issued its Development and Licensure of Vaccines to Prevent COVID-19: Guidance for Industry on June 30, 2020.  This nonbinding guidance is intended to remain in effect for the duration of the COVID-19 public health emergency declared by the Secretary of Health and Human Services.  The guidance advises vaccine development... More
  • Federal Circuit Upholds Enbrel® Patents and Blocks Biosimilar Earlier this month, in Immunex Corp. v. Sandoz Inc., the Federal Circuit upheld two patents covering Enbrel’s active protein and a process used to manufacture the drug, effectively blocking Sandoz’s Enbrel® biosimilar Erelzi from the U.S. market until 2029 and providing a major victory for Amgen.[1]  Enbrel is the brand name for the molecule etanercept,... More
  • Federal Circuit Holds That Amendments to Biosimilar’s BLA Do Not Trigger Anew BPCIA’s Notice of Commercial Marketing Provision Under Section 262(l)(8)(A) of the BPCIA, a biosimilar maker must provide notice to the reference product sponsor 180 days before the date of first commercial marketing of the biosimilar.  In Sandoz v. Amgen, 137 S. Ct. 1664, 1678 (2017), the Supreme Court explained that the biosimilar maker does not need to wait until its abbreviated... More
  • No Antitrust Violations for Creating and Enforcing Humira Patent Thicket Last month, Judge Manish Shah of the United States District Court of the Northern District of Illinois dismissed an antitrust complaint brought by indirect purchasers of AbbVie’s blockbuster rheumatoid arthritis drug, Humira®.  The suit alleged antitrust violations under a novel “patent thicket” theory, citing § 2 of the Sherman Act, and “pay-for-delay” and “market allocation”... More
  • Q1 2020 Biosimilar IPR Update: Drop in New Filings At the end of 2017, inter partes review (IPR) proceedings for biosimilar products were on the rise.  This was followed by a dip in the number of new filings in FY 2018 and the first half of 2019.  Through Q1 2020, this downward trend has continued.  Specifically, there has been one new biosimilar IPR filing... More
  • Samsung Bioepis and Merck Launch Herceptin (trasuzumab) Biosimilar Ontruzant® in U.S. This week, Samsung Bioepis announced the U.S. launch of Ontruzant® (trastuzumab-dttb), a biosimilar of Genentech’s Herceptin (trasuzumab).  Ontruzant® will be marketed and distributed in the U.S. by Merck.  This launch represents Samsung Bioepis’s first oncology biosimilar in the U.S. market.  Genentech’s Herceptin is a monoclonal antibody used to treat breast cancer and metastatic stomach cancer,... More
  • FDA Finalizes New Definition of Biological Product Last week, the U.S. Food and Drug Administration (“FDA”) issued a final rule to amend its regulation that defines the term “biological product” in line with the definition set by the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”), as amended by the Further Consolidated Appropriations Act, 2020, enacted on December 20, 2019 (“FCA... More
  • Hospira Seeks En Banc Review of the Federal Circuit’s “Safe Harbor” Ruling in Amgen v. Hospira In December, in Amgen v. Hospira, 944 F.3d 1327 (Fed. Cir. 2019), a panel of the Federal Circuit issued the first decision applying the statutory Safe Harbor of 35 U.S.C. § 271(e)(1) to BPCIA patent litigation.  The Federal Circuit affirmed the jury’s finding that Hospira’s pre-approval manufacture of batches of its biosimilar was an act... More