Food, Drugs, Healthcare, Life Sciences

In Otsuka Pharmaceutical Co. v. Sandoz, Inc., the Federal Circuit upheld the district court’s determination that the claims at issue were neither obvious nor invalid under the doctrine of obviousness-type double patenting based on a "lead compound" approach to the obviousness determinations.

After the Supreme Court decided that the personalized medicine method claims at issue in Mayo Collaborative Services v. Prometheus Laboratories, Inc. did not satisfy the patent eligibility requirements of 35 USC § 101.

GlaxoSmithKline and Genentech have settled a U.S. lawsuit related to Genentech's Cabilly II (US 6,331,415) and Cabilly III (US 7,923,221) patents.

The deadline has passed for the Trump Administration to appeal the district court decision vacating the HIPAA Privacy Rule to Support Reproductive Health Care that went into effect at the end of 2024.

The FTC has now withdrawn its appeal of the Ryan, LLC v. FTC decision.

In 2025, the U.S. federal government continues to prioritize healthcare fraud enforcement, with the False Claims Act (FCA), Anti-Kickback Statute (AKS)...

Bergeson & Campbell, P.C. (B&C®) and Chemical Watch are pleased to present FIFRA Fundamentals, a two-day course taught by professionals from B&C's renowned Federal Insecticide, Fungicide, and Rodenticide Act...

As US pharmaceutical manufacturers continue to lead biopharmaceutical research and development, they find themselves increasingly at odds with the nation's shifting regulatory landscape...

On 8 September 2025, the European Commission published a call for evidence on "the targeted revision of the EU rules for medical devices and in vitro diagnostics".

On September 9, 2025, the "Make America Healthy Again Commission," established pursuant to President Trump's February 13, 2025 Executive Order 14212 and chaired by HHS Secretary Robert F. Kennedy Jr....

Bergeson & Campbell, P.C. (B&C®) and Chemical Watch are pleased to present FIFRA Fundamentals, a two-day course taught by professionals from B&C's renowned Federal Insecticide, Fungicide, and Rodenticide Act...

In June 2024, the US Food and Drug Administration (FDA) and the Department of Justice (DOJ) announced a joint federal task force to curb the illegal importation, distribution and sale of illegal e-cigarettes.