News & Analysis as of

Genus Biotechnology

Procopio, Cory, Hargreaves & Savitch LLP

USPTO Provides Guidance in Light of Amgen v. Sanofi

The U.S. Supreme Court’s May 2023 decision in Amgen, Inc. v. Sanofi (Amgen) sent shock waves through the patent world, particularly in the chemical and biotech segments, due to its invalidation of Amgen patents based on a...more

Proskauer - Life Sciences

The Supreme Court Kept the Door Open to Genus Claims

The U.S. Supreme Court on May 18, 2023 delivered its decision on the scope of the patent enablement requirement, set forth in 35 U.S.C. § 112, in the antibody dispute Amgen, Inc. v. Sanofi. While the parties obtained...more

Procopio, Cory, Hargreaves & Savitch LLP

5 Takeaways from the U.S. Supreme Court Decision in Amgen v. Sanofi

The U.S. Supreme Court’s unanimous decision in Amgen Inc. v. Sanofi (referred to as the Amgen decision) likely makes it more difficult for life sciences companies to obtain broad patents claiming an entire genus of antibodies...more

Procopio, Cory, Hargreaves & Savitch LLP

Pharma-Related Patent Enablement Reaches the Highest Court

The U.S. Supreme Court has agreed to hear a case that is extremely significant for companies that operate in the biotechnology, pharmaceutical, and chemical sectors. At issue in Amgen v. Sanofi is a determination of the...more

MoFo Life Sciences

Traversing Higher Hurdles For Functional Limitations Under Section 112

MoFo Life Sciences on

Genus claims have long been an important component of patent strategy, extending coverage around a lead compound to stop would-be competitors. Recent decisions from the Federal Circuit, however, highlight a tightening...more

Hogan Lovells

FDA seeks comments on how to transition approved drug products to device status under Genus - Major regulatory changes for imaging...

Hogan Lovells on

On August 9, the U.S. Food and Drug Administration (FDA) published a notice announcing its implementation of the U.S. Court of Appeals for the D.C. Circuit’s April 2021 decision in Genus Medical Technologies LLC v. U.S. Food...more

Kilpatrick

The Federal Circuit Continues to Invalidate Genus Claims Defined by Function

Kilpatrick on

In our earlier post, we questioned whether the Federal Circuit would continue to invalidate genus claims directed to biologics, and the answer is yes. Not surprisingly, the Federal Circuit panel in Amgen v. Sanofi affirmed...more

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