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

  • The FDA Regulatory Landscape for Covid-19 Treatments and Vaccine (Updated) April 7, 2020 Update: FDA announced on March 31, 2020 that it has created the Coronavirus Treatment Acceleration Program (CTAP), a special emergency program to expedite the development of safe and effective treatments for Covid-19.  Under CTAP, FDA has redeployed medical, operations, policy, and regulatory staff to triage and rapidly respond to inquiries, requests, and... 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
  • Federal Circuit Clarifies Limits of Safe Harbor Defense in Amgen v. Hospira Recently, in Amgen Inc. v. Hospira, Inc.,[1] the Federal Circuit clarified the limits of the Safe Harbor defense in cases involving patented manufacturing methods. In a case brought in the District of Delaware, Amgen alleged that Hospira infringed several patent claims over methods of manufacturing erythropoietin (EPO), a biologic drug used to treat anemia.  Following... More
  • Mylan and Biocon Launch Herceptin (trasuzumab) Biosimilar Ogivri™ in U.S. Last week, Mylan and Biocon announced the U.S. launch of Ogivri™ (trasuzumab-dkst), a biosimilar to Herceptin® (trasuzumab).  Genentech’s Herceptin, which was first approved in 1998, is a monoclonal antibody used to treat breast cancer and metastatic stomach cancer.  Genentech and its parent company Roche had previously tried to block Ogivri™ from the U.S. market by... More
  • 2019 Year-End Biosimilar Litigation Roundup As 2019 draws to a close, a handful of actions regarding biologics are pending in the federal courts.  The current cases are listed below, in order from most-recently-filed to oldest: Amgen v. Tanvex (19-cv-1374, S.D. Cal.) In July 2019, Amgen brought claims against Tanvex BioPharma USA, Inc. and two related entities in connection with Tanvex’s... More
  • PTAB Denies Sigma-Aldrich’s Petition for Patent Interference on CRISPR-Cas9 On September 23, 2019, the Patent Trial and Appeal Board (“PTAB”) issued a decision dismissing Sigma-Aldrich’s interference petition related to the revolutionary CRISPR-Cas9 biotechnology.  The claims at issue in Sigma-Aldrich’s petition were directed to methods of genetically modifying a eukaryotic cell using a CRISPR-Cas9 system.  The petition was unusual because it sought an interference although none of... More
  • In Mayo, Federal Circuit Seeks to Head Off Disputes Over When Claims Are “Deemed Allowable” by Counting Continued Examination Time Until Notice of Allowance Earlier this week, the Federal Circuit declined to further extend the patent term of an antibody patent held by the Mayo Foundation.  In Mayo Foundation v. Iancu,[1] the court held that the time spent on a request for continued examination (“RCE”) following a declaration of interference did not count toward the three-year application pendency period... More
  • Federal Circuit Walks Back Its “Exceptional” Stance on the Doctrine of Equivalents in the Latest Amgen v. Sandoz Decision In Amgen’s long-running dispute with biosimilar-maker Sandoz over biosimilar versions of Amgen’s filgrastim (Neupogen®) and pegfilgrastim (Neulasta®) biologics, the Federal Circuit earlier this year affirmed summary judgment of no literal infringement and no infringement under the doctrine of equivalents.  Amgen Inc. v. Sandoz Inc., 923 F.3d 1023 (Fed. Cir. May 8, 2019).  In so holding,... More
  • Federal Circuit Rebuffs Fifth Amendment Challenge to IPR Proceedings In Oil States Energy Services, LLC v. Greene’s Energy Group, LLC,[1] the Supreme Court suggested that whether inter partes reviews (“IPRs”) apply to pre-AIA patents is an open constitutional question.[2]  But following the Federal Circuit’s recent decision in Celgene Corp. v. Peter,[3] it appears that retroactive IPRs are here to stay, at least for now.... More