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.

In the last several years, independent pharmacies have faced escalating pressure from Pharmacy Benefit Managers (PBMs) over how they procure diabetic testing supplies...

On May 5, President Trump issued an Executive Order (EO) titled "Regulatory Relief to Promote Domestic Production of Critical Medicines," with the stated purpose...

The U.S. Attorney's Office for the Southern District of New York last week announced the resolution of two significant False Claims Act (FCA) cases...

Bass, Berry & Sims hosted its inaugural Healthcare Regulatory & Compliance Summit in-person on April 24 with a virtual broadcast of the content the following week.

On April 8, the U.S. Department of Justice's (DOJ) Final Rule, codified at 28 CFR Part 202, (Final Rule), implementing President Biden's Executive Order 14117 "Preventing Access to U.S. Sensitive Personal Data...

Late last year, the Los Angeles City Council considered an amendment to the Hotel Minimum Wage Ordinance. On March 7, 2025, the Los Angeles city attorney (City Attorney) submitted a draft ordinance to the City Council...

There has been increased enforcement against medical device companies that engage in the pervasive practice of paying third party sales agents based on their volume of sales.

In a judgment on 1 May 2025, the Court of Appeal increased the FRAND licence fee payable by Apple to Optis (a so-called "non-practicing entity" who monetise IP rights) relating to the 4G standard...

In this episode, hosts Amy Mudge and Daniel Kaufman discuss various health-related cases involving medical devices and FTC rulings. They delve into notable cases such as the QRay bracelet, which claimed pain relief through ionization, and the ViaTek mosquito shield band, which purported to repel mosquitoes.