Knobbe Martens

Judge Andrews of the District of Delaware recently denied Novartis’s request for a preliminary injunction against MSN Pharmaceuticals. Novartis...

On August 19, 2024, the Association for Molecular Pathology (AMP) sued the FDA to challenge a new rule that allows the FDA to regulate laboratory developed tests (LDTs). [1] The rule, which became effective on July 5, 2024, [2] explicitly categorizes in vitro LDTs intended for clinical use as medical devices, placing such LDTs within the purview of the FDA. [3] The complaint was filed in the Southern District of Texas. AMP’s suit follows another suit filed by a trade association, the American Clinical Laboratory Association, targeting the same rule. [4]

Today Representatives Kevin Kiley (R-CA) and Scott Peters (D-CA ) introduced the Patent Eligibility Restoration Act (PERA), bipartisan legislation mirroring a proposed law introduced last year by Senators Thom Tillis (R-NC) and Chris Coons (D-DE). The proposed law seeks to restore patent eligibility to inventions across many fields and affirms the basic principle that the patent system is central to promoting technology-based innovation.

Specify the Steps of Information Manipulation or Lose under § 101 - In Mobile Acuity Ltd. v. Blippar Ltd. Appeal No. 22-2216, the Federal Circuit held...

Before Dyk, Clevenger, and Stoll. Appeal from the United States District Court for the District of Delaware. Summary: An expert witness can testify...

Before Dyk, Reyna, and Stark. Appeal from the United States District Court for the Western District of Texas. Summary: When assessing patent...

Congratulations on successfully trademarking your product or brand! Now it’s crucial to protect that investment through diligent trademark oversight...

In a concerted effort to combat the illegal sale of delta-8 THC edibles packaged to look like popular snacks, the US Food and Drug Administration...

Before Reyna, Prost, and Schall. Appeal from the United States District Court for the Northern District of California. Summary: Claims are...

On August 14, 2024, the U.S. Food and Drug Administration (FDA) approved a colony stimulating factor-1 receptor (CSF-1R)-blocking antibody, NIKTIMVO...