Amgen Inc. | MedPath

Federal Circuit Ruling Opens New Patent Challenge Avenue for Life Sciences Companies

3 days ago

• The U.S. Court of Appeals for the Federal Circuit's decision in Xencor Inc. case provides drugmakers with a new strategy to challenge patents by focusing on inadequate written descriptions in Jepson claims. • The ruling establishes that Jepson claim preambles are limiting and require sufficient written description support, particularly important for complex biological inventions like antibodies. • Following the 2023 Supreme Court Amgen v. Sanofi decision, this ruling creates a higher bar for patent protection of biologic products, requiring detailed descriptions and practical applications beyond theoretical utility.

UPC Issues Landmark Ruling on Second Medical Use Patents in Cholesterol Drug Dispute

7 days ago

• The Unified Patent Court's Düsseldorf Local Division has issued its first-ever ruling on second medical use patent infringement in a dispute between Sanofi/Regeneron and Amgen over PCSK9 inhibitor drugs. • The court established a two-part test for infringement: the product must be marketed in a way that leads to the patented use, and the alleged infringer must know or should have known about such use. • While upholding the validity of Sanofi/Regeneron's patent for using PCSK9 inhibitors to reduce lipoprotein(a) levels, the court ruled Amgen's Repatha did not infringe as there was insufficient evidence of it being prescribed for this purpose.

UPC Sets Precedent in First Second Medical Use Patent Ruling: Sanofi and Regeneron Lose Against Amgen

7 days ago

• The Unified Patent Court (UPC) issued its first ruling on second medical use pharmaceutical patent claims, upholding Sanofi and Regeneron's patent as valid but finding no infringement by Amgen's cholesterol drug Repatha. • The landmark decision establishes that proving infringement requires evidence of actual or likely off-label use of a drug for the patented indication, plus the alleged infringer's awareness of such use. • The Düsseldorf Local Division adopted a "foreseeability" test for infringement, determining that rights holders must demonstrate the generic manufacturer "knows or reasonably should have known" about off-label prescriptions.

Sonoma Biotherapeutics Strengthens Leadership Team with Appointment of Rajesh Krishnan as Chief Technical Officer

9 days ago

• Sonoma Biotherapeutics has appointed Rajesh Krishnan, Ph.D., as Chief Technical Officer to advance their engineered regulatory T cell (Treg) therapies for autoimmune and inflammatory diseases. • Dr. Krishnan brings over 25 years of industry experience in process development and manufacturing, most recently serving as CTO and CSO at Oncternal Therapeutics with previous leadership roles at Dynavax, Gilead, Merck, Amgen, and Pfizer. • The strategic appointment comes at a crucial time for the clinical-stage biotech company as they continue developing novel treatments aimed at restoring immune system balance through proprietary Treg cell therapy platforms.