Merck is planning to sell a subcutaneous version of its blockbuster Keytruda that can be injected rather than administered intravenously.  Yet, standing in the way of that is a growing portfolio of patents recently acquired by Halozyme Therapeutics.  In 2024, Halozyme was awarded numerous patents covering modified PH20 hyaluronidase polypeptides.  Merck immediately went to the Patent Office and filed petitions for the patents to be cancelled.  What is the likelihood Merck’s patent challenges will succeed?  Or Merck will be compelled to sign a license for Halozyme’s patents. 

In a precedential decision that issued on May 19, ESIP Series 2, LLC v. Puzhen Life USA, LLC, the Federal Circuit confirmed that the Supreme Court’s recent Click-to-Call decision precludes judicial review of decisions by the PTAB concerning real-parties-in-interest.  recent Click-to-Call decision precludes judicial review of decisions by the PTAB concerning real-parties-in-interest.

The American University Law Review recently published a very timely and compelling article on the intersection between the Hatch-Waxman Act and the BPCIA, on the one hand, and post-grant proceedings at the PATB, on the other.  The article, which is titled, Ships in the Night: Resolving Administrative Conflict Between FDA- and Patent-Related Legislation, American Univ. Law Review [Vol. 68:1111], (hereinafter, “Garcia & Stroud”), is authored by Carlos A. Garcia, Patent Counsel, Eli Lilly & Company, and Jonathan Stroud, Chief IP Counsel, Unified Patents Inc.  The article is a comprehensive and thorough overview of how petitions for inter partes review and other post-grant proceedings may be impacting efficient resolution of patent issues for generic drugs.