North America: Food, Drugs, Healthcare, Life Sciences

On June 8, 2012, Genentech’s lawsuit seeking a declaration that US Patent No. 6,733,752 was invalid and not-infringed by Genentech’s trastuzumab product (HERCEPTIN).

Health Canada specifically contemplates certain proteins as SEBs in its Guidance, although Health Canada has not limited SEBs to only particular classes of drugs.

On May 23, 2012, the Federal Court held that Merck Frosst Canada Ltd. ("Merck") is liable to Apotex Inc. ("Apotex") for damages under section 8 of the Patented Medicines (Notice of Compliance) Regulations (the "Regulations"), but exercised its discretion to reduce the amount of compensation payable based on a defence of ex turpi causa.

Prescription drug costs have skyrocketed over the past decade, and employers are rightfully demanding answers (if not, they should).

In May 2024, FDA finalized a rule regarding LDTs, which purported to amend the 21 CFR 809.3(a) definition of "in vitro diagnostic products"...

On April 2, 2025, in a significant decision in FDA v. Wages and White Lion Investments, LLC, the Supreme Court unanimously upheld the Food and Drug Administration's (FDA) decision denying marketing authorization for certain e-cigarette products.

Prescription drug costs have skyrocketed over the past decade, and employers are rightfully demanding answers (if not, they should).

The members of BakerHostetler's Antitrust and Competition Team are pleased to present these brief updates from the conference sessions on Day 2 at this week's ABA Antitrust Spring Meeting...

On 4 April 2025, Washington became the first state to enact a broad, industry-agnostic merger control regime.

In May 2024, FDA finalized a rule regarding LDTs, which purported to amend the 21 CFR 809.3(a) definition of "in vitro diagnostic products"...

On April 22, 2025, the U.S. District Court for the Northern District of West Virginia entered a Stipulation and Order Vacating Permanent Injunction and Dismissing All Claims and Counterclaims with Prejudice...

The National Security Commission on Emerging Biotechnology (NSCEB) announced on April 8, 2025, the availability of its final report and action plan, "urging Congressional action...