In a recent precedential opinion[1], the Federal Circuit rejected arguments by Amgen that a single step purification process used by Sandoz for its G-CSF biosimilar infringed claims of Amgen’s patent describing a multistep purification procedure for proteins expressed in a non-mammalian system.

In this case, the Federal Circuit explained that the doctrine of

Recently, in Adello Biologics LLC v. Amgen Inc., Case PGR2019-00001 (Paper No. 13) (PTAB Apr. 19, 2019), the PTAB instituted post-grant review of claims 1-30 of U.S. Patent No. 9,856,287 (“the ’287 patent”).  The ’287 patent is the patent at issue in a pending litigation between Amgen and Apotex under the Biologics Price Competition

On February 14, 2019, the PTAB issued final written decisions in two separate IPRs filed by Sanofi-Aventis, Genzyme Corp., and Regeneron Pharmaceuticals (collectively “Sanofi”) against U.S. Patent No. 8,679,487 (“the ʼ487 patent”) assigned to Immunex Corporation (“Immunex”). Claim 1 of the ʼ487 patent is the only independent claim, and it is directed to “an isolated

The PTAB recently denied institution of two IPRs filed by CSL Behring LLC, CSL Behring GMBH, and CSL Behring Recombinant Facility AG (collectively “CSL”) targeting U.S. Patent No. 9,623,091 (“the ʼ091 patent”) owned by Bioverativ Therapetutics, Inc. (“Bioverativ”).   More specifically, on January 6, 2019, the PTAB denied institution of IPR2018-01313 (“the ʼ313 IPR”), and on

The Biologics Price Competition and Innovation Act (“BPCIA”) requires applications to market a biological product be submitted for review by the FDA under § 351 of the Public Health Service Act (“PHS Act”). However, it carved out a limited exception for biological products that are in a product class that had already been approved under

Last month, the FDA released four new guidance documents providing insight on the FDA’s interpretation of provisions of the Biologics Price Competition and Innovation Act (“BPCIA”), as it amends the Public Health Service Act (“PHS Act”) and the Patient Protection and Affordable Care Act (“ACA”), among other statutes. Two of the documents relate to the

The FDA recently proposed an amendment to its regulations defining the term “biological product.”  The proposed amendment incorporates changes made by the Biologics Price Competition and Innovation Act (BPCIA) into the FDA’s regulations, and provides the FDA’s interpretation of the statutory terms “protein” and “chemically synthesized polypeptide.”  The proposed definitions of the statutory terms are

Prior to 1994, the term of a U.S. patent was 17 years from the date of issuance.  When the Uruguay Round Agreements Act (“URAA”) changed the term to 20 years from the earliest nonprovisional priority date, it appeared that unpatentability due to obviousness type double patenting (“ODP”) would no longer be relevant since the patent