As a firm responsible for managing global portfolios for pharmaceutical companies, we closely follow and seek to stay abreast of developments regarding patentability in various jurisdictions. We recently reviewed the Unified Patent Court (UPC) first decision – invalidating EP Patent No. 3,666,797 B1 – and provided a summary of that case. This analysis will focus
Supreme Court
Solicitor General Urges the Supreme Court to Reverse the Federal Circuit’s Teva v. GSK Decision
After the Supreme Court invited the Solicitor General to file a brief expressing the views of the United States regarding Teva Pharms USA, Inc. v. GlaxoSmithKline LLC, et al., the Solicitor General filed its brief amicus curiae on March 29, 2023. The Solicitor General urged the Supreme Court to grant Teva’s petition for a…
Amgen v. Sanofi Case on Enablement of Antibody Genus Claims Will be Heard at the Supreme Court; Cert Denied in Juno v. Kite
The Supreme Court agreed on Friday, November 4, 2022, to review the standard for enablement of genus claims after the Federal Circuit’s decision in Amgen, Inc. v. Sanofi. We have previously covered Amgen’s petition for a writ of certiorari and the multiple amicus curiae briefs submitted in the case. As detailed below, the Supreme…
Will the Supreme Court Take the Bait? CVSG Issued and Other Updates in the Amgen v. Sanofi Case
On April 18, 2022, the Supreme Court invited the Solicitor General to file a brief expressing the views of the United States in the Amgen, Inc. v. Sanofi, Inc. case, which involves important questions of enablement for genus claims. We have previously covered the Federal Circuit’s decision, Amgen’s petition for a writ of certiorari…
Enablement Ruling Extinguishes Broad Antibody Claims, What Comes Next?
Last week, a federal court in Delaware unsealed an opinion supporting its grant of summary judgment that U.S. Patent No. 7,033,590 (“the ’590 Patent”) is invalid for lack of enablement.[1] The ’590 Patent is owned by Baxalta Inc. (“Baxalta”), a subsidiary of Takeda Pharmaceutical Co. Ltd (“Takeda”).
As we previously discussed,…
Not Backing Down Now – Multiple Amicus Curiae Briefs Filed for Amgen v. Sanofi
At the end of last month, three amicus curiae briefs were filed following the petition for a writ of certiorari in the Amgen, Inc. v. Sanofi, Inc. case. We previously discussed the petition for a writ of certiorari in detail here.
The first amicus brief was submitted by the Association of University of Technology…
A Potential Pivot in Patent Procedure – Will the Supreme Court Hear Amgen’s Challenge to the Standard of Review for Enablement?
As we have previously discussed, on February 11, 2021, the Federal Circuit decided Amgen Inc. et al. v. Sanofi, Aventisub LLC, et al. The Federal Circuit affirmed the district court’s grant of JMOL that Amgen’s Repatha® patents (U.S. Patent Nos. 8,829,165 and 8,859,741) were invalid for lack of enablement. The claims at issue…
A Heightened Bar: Federal Circuit Leaves Functional Antibody Claims on Thin Ice
In a precedential opinion in Amgen Inc. et al. v. Sanofi, Aventisub LLC, et al., No. 20-1074 (Fed. Cir. 2021) issued on February 11, 2021, the Federal Circuit affirmed the decision of the United States District Court for the District of Delaware granting JMOL that Amgen’s Repatha® patents (U.S. Patent Nos. 8,829,165 and 8,859,741)…
Jury Finds Amgen Antibody Patents Not Invalid
Over four years ago, in October 2014, Amgen initiated a patent infringement suit against Sanofi and Regeneron regarding biologics for treatment of high cholesterol.[1] The case reached an important milestone recently as a jury entered a verdict largely upholding the validity of Amgen’s asserted patents, to the disappointment of Sanofi and Regeneron. A similar…
PTAB Institutes a Second IPR on Rituxan®-related ’821 Patent
The PTAB recently instituted a second IPR of US Patent 9,296,821 (“the ’821 patent”), which covers certain uses of Rituxan® (rituximab), a monoclonal antibody marketed by Genentech and Biogen Pharmaceuticals. The ‘821 patent claims methods of treating low grade or follicular non-Hodgkin’s lymphoma (NHL) by administering rituximab during a chemotherapeutic regimen of cyclophosphamide, vincristine, and…