On April 29, 2023, the FDA announced a final rule on regulation of laboratory developed tests (LDTs).[1] The rule explicitly categorizes in vitro diagnostic products (IVDs) intended for clinical use as medical devices, which are within the purview of the FDA.[2] The final rule will publish on May 6, 2024.[3] Until then, the unpublished version is available. [4]
Medical devices that contact the human body undergo biocompatibility safety assessments prior to market release, including tests for physiochemical properties. The Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) recently released a dataset to assist medical device firms in this process. The information addresses capabilities of third-party analytical chemistry labs.
Johnson & Johnson (J&J) reported on April 5, 2024, that it has entered an agreement to acquire Shockwave Medical, a company in the cardiovascular medical device sector, in a deal totaling a reported $13.1 billion. The deal would further expand J&J into the cardiovascular treatment market.
JANSSEN PHARMACEUTICALS, INC. v. TEVA PHARMACEUTICALS USA, INC.
Before Prost, Dyk, and Hughes. Appeal from the United States District Court for the District of New Jersey.
Summary: District court erred by adding unclaimed limitations to the claims in analyzing obviousness.
Janssen sued Teva for infringement of a patent claiming a dosing regimen for administering paliperidone to treat schizophrenia. Specifically, the patent claimed a long-acting dosing regimen, comprising a series of three intramuscular injections. Teva stipulated to infringement but challenged validity. After a bench trial, the district court found, among other things, that Teva had not proven that the claims were invalid as obvious.
SALIX PHARMACEUTICALS, LTD. v. NORWICH PHARMACEUTICALS., INC.
Before Lourie, Chen, and Cunningham. Appeal from the District of Delaware
Summary: The Federal Circuit ruled that an ANDA listing an infringing indication cannot be approved during the pendency of the infringed patent even if the ANDA also lists a non-infringing indication.
The Biden Administration’s Inflation Reduction Act (IRA)’s Medicare drug price negotiation program, which allows Medicare to directly negotiate prices with drugmakers, has faced several legal challenges.
Orthobond received on April 5th de novo approval for the company’s spinal fusion device with quaternary ammonium compound coating.
Orthobond’s antibacterial treatment, Ostaguard™, covalently bonds its antimicrobial, polycationic molecules to the surface of an implant before packaging and sterilization. Orthobond claims that its patented approach requires dunking a medical implant such as a screw or replacement part in a chemical bath and then heating the device.
Chewy, Inc. v. International Business Machines Corporation
Before Moore, Chief Judge, Stoll and Cunningham. Appeal from the United States District Court for the Southern District of New York.
Summary: A feature in the specification limits the claims if the patent uniformly describes it as an aspect of the invention as a whole. And a patentee cannot transform an abstract idea into a patent-eligible, specific implementation of that abstract idea merely by reciting conventional techniques.
PFIZER INC. v. SANOFI PASTEUR INC.
Before Lourie, Bryson, and Stark. Appeal from the Patent Trial and Appeal Board.
Summary: Evidence that a claimed parameter is recognized as a result-effective variable can overcome the lack of explicit disclosure of the exact parameter in the prior art.
3M recently completed the spinoff of its healthcare technology business as the new standalone public company, Solventum Corporation. Solventum has an IP portfolio with over 7,300 patents globally.
