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

  • Opposition to Rehearing Filed in Major Federal Circuit Case Narrowing Hatch-Waxman Venue Last week, Mylan filed a brief in opposition to Valeant’s petition for rehearing en banc in Valeant Pharms. N. Am. LLC v. Mylan Pharms. Inc., No. 2019-2402. In November, a Federal Circuit panel held that venue in Hatch-Waxman cases brought under 35 U.S.C. § 271(e)(2)(A) is proper “only in districts where actions related to the submission of... More
  • WTO to Discuss Member Proposal to Waive IP Rights for COVID-19 Technologies On October 2, 2020, India and South Africa urged the World Trade Organization (WTO) Trade-Related Aspects of Intellectual Property Rights (TRIPS) Council to temporarily waive the obligation of member states under the TRIPS Agreement to protect intellectual property rights for technologies related to the “prevention, containment or treatment” of COVID-19. Kenya, Eswatini, Pakistan, Mozambique, and Bolivia... More
  • Rehearing Requested in Major Federal Circuit Case Narrowing Venue in Hatch-Waxman Cases Earlier this month, Valeant Pharmaceuticals North America LLC (“Valeant”) filed a petition for rehearing en banc in Valeant Pharms. N. Am. LLC v. Mylan Pharms. Inc., No. 2019-2402, arguing that the Federal Circuit panel’s decision limiting venue in Hatch-Waxman cases conflicts with precedent regarding “what the act of infringement is” and “where the act of infringement... More
  • FDA’s Draft Guidance for Industry Seeks to Answer Questions on Biosimilar Interchangeability FDA has published new draft guidance for industry titled “Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act.”  The draft guidance supplements two prior documents concerning biosimilar interchangeability published in December 2018.[1]  This new guidance, in particular, has some useful information for prospective applicants who seek licensure of an “interchangeable” biosimilar... More
  • For the First Time Since TC Heartland, the Federal Circuit Addresses Venue in an ANDA Case – the Holding May Also Impact BPCIA Litigation On November 5, 2020, in Valeant Pharms. N. Am. LLC  v. Mylan Pharms. Inc., No. 2019-2402, the Federal Circuit held that venue in Hatch-Waxman cases brought under 35 U.S.C. § 271(e)(2)(A) is proper “only in districts where actions related to the submission of an Abbreviated New Drug Application (‘ANDA’) occur, not in all locations where... More
  • Future of Biosimilars at Issue in Latest Supreme Court Affordable Care Act Case On Tuesday, November 10, 2020, the Supreme Court heard oral argument in California v. Texas, a challenge to the Affordable Care Act (the “ACA”) brought by Republican Attorneys General and the Trump Administration.  The central issue in California v. Texas is whether the ACA’s individual mandate remains constitutional now that it is no longer backed... More
  • FDA Issues Updated Guidance on Emergency Use Authorization for COVID-19 Vaccines On October 6, FDA issued updated guidance for industry concerning “Emergency Use Authorization for Vaccines to Prevent COVID-19,” updating the previous guidance issued in June.  The updated guidance, which is being “implemented immediately” and “without prior public comment,” is intended “to provide sponsors of requests for Emergency Use Authorization (EUA) for COVID-19 vaccines with recommendations... More
  • 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