The Federal Circuit has issued a unanimous precedential decision holding that a patent whose term was extended through Patent Term Adjustment (“PTA”) can be invalidated for obviousness-type double patenting (“ODP”), affirming the PTAB’s Ex Parte Cellect decision that we discussed in a previous post. The Court agreed with the PTAB that ODP should be assessed after PTA is applied to a patent, meaning that PTA does not protect a patent from ODP.
Is the genus claim dead, or has its demise been greatly exaggerated? We may soon have the Supreme Court’s answer. On April 18, following eight years of patent infringement litigation between Amgen and Sanofi, including two trials and two Federal Circuit appeals, the Supreme Court called for the views of the Solicitor General (“SG”) on Amgen’s petition for a writ of certiorari after the Federal Circuit invalidated its asserted patent claims for failing to satisfy the enablement requirement. See Amgen Inc. v. Sanofi, 987 F. 3d 1080 (Fed. Cir. 2021). The subject patents are directed to a genus of antibodies defined not by their structure (e.g., amino acid sequence) but by their function—specifically, the ability of the antibodies to bind certain parts of the PCSK9 antigen. Although these antibodies are not per se immunotherapeutic—PCSK9 is a target for treating high cholesterol and does not implicate immune system modulation—the Supreme Court’s resolution of the enablement questions presented will certainly have consequences for patenting protein immunotherapies, particularly antibodies, where claims are frequently drawn to genus-type claims with limitations to binding of immunoregulatory antigen targets.
The issue for the Supreme Court’s review if certiorari is granted is the standard for assessing enablement for broadly drafted claims to a functionally defined genus covering potentially many thousands (if not millions) of compositions when only a relatively few working embodiments are disclosed in the specification. Amgen’s petition argues that …
Continue Reading Amgen Inc. v. Sanofi: Does the Supreme Court’s Call for the Solicitor General’s Views Signal an Intention to Resolve Important Enablement Questions for Genus Claims?
In a warning to patent owners, a patent whose term had been extended through Patent Term Adjustment (“PTA”) was recently found invalid for obviousness-type double patenting (“ODP”) by the U.S. Patent Trial and Appeal Board (“PTAB”). Ex Parte Cellect Patent Owner and Appellant, Appeal No. 2021-00503, 2021 WL 5755329 (PTAB, Dec. 1, 2021). This is particularly concerning for makers of biopharmaceuticals, especially immunotherapeutic proteins and other biologic drugs. The duration of the patents protecting these drugs is critical to their value, and the terms of these patents are often extended by PTA. Moreover, effective lifecycle management strategies for immunotherapeutics typically involve developing broad, independent patent portfolios (often covering new or extended medical indications), increasing the risk of generating potentially invalidating ODP art.
Previously, several district courts have split on whether a PTA-based extension of patent term is vulnerable to ODP. In 2021, two New Jersey district court decisions found …
Continue Reading Does the PTAB’s Recent Ex Parte Cellect Decision Signal Concern for the Valuable Patent Terms of Biopharmaceuticals?