Rhett D. Ramsey

IRVINE, Calif., September 10, 2025 – A trial team from Knobbe Martens secured a significant success on behalf of innovator Sigray, Inc. in an IP dispute involving groundbreaking x-ray technologies....

On July 27, 2025, the U.S. and EU reached a trade agreement. As part of the agreement, the U.S. will impose a 15 percent tariff “on the vast majority of...

Congress authorized the FDA to determine whether a drug is “in shortage in the United States.” The FDA’s determination of a drug shortage triggers mechanisms designed to alleviate the shortage....

Judge Andrews of the District of Delaware recently denied Novartis’s request for a preliminary injunction against MSN Pharmaceuticals. Novartis Pharm. Corp. v. MSN Pharm. Inc., Civil Action No. 20-md-2930-RGA, Dkt. No. 1456 (D. Del. Aug. 12, 2024). Novartis had requested a preliminary injunction to block MSN Pharmaceuticals from launching a generic version of Novartis’s top-selling oral heart failure drug Entresto®.

JANSSEN PHARMACEUTICALS, INC. v. TEVA PHARMACEUTICALS USA, INC. Before Prost, Dyk, and Hughes. Appeal from the United States District Court for the District of New Jersey. Summary: District court erred by adding unclaimed limitations to the claims in analyzing obviousness. Janssen sued Teva for infringement of a patent claiming a dosing regimen for administering paliperidone to treat schizophrenia. Specifically, the patent claimed a long-acting dosing regimen, comprising a series of three intramuscular injections. Teva stipulated to infringement but challenged validity. After a bench trial, the district court found, among other things, that Teva had not proven that the claims were invalid as obvious.

On January 9, 2024, the USPTO published guidelines for its patent examiners when evaluating compliance with the enablement requirement in light of the U.S. Supreme Court’s recent decision in Amgen Inc. et al. v. Sanofi et al., 143 S. Ct. 1243 (2023). In Amgen, the Supreme Court unanimously held that claims drawn to a genus of monoclonal antibodies, which were functionally claimed, were invalid due to a lack of enablement. Notably, the Supreme Court did not expressly cite the Wands factors in analyzing whether the specification at issue in Amgen enabled the claims, but the recently published USPTO guidelines underscore that “USPTO personnel will continue to use the In re Wands factors to ascertain whether the amount of experimentation required to enable the full scope of the claimed invention is reasonable.”