The America Invents Act (AIA) is barely 10 years old, but a bipartisan pair of U.S. senators have proposed patent reform legislation that would amplify the use of the inter partes review (IPR) process to challenge an existing patent. There are several critical features of the new legislation, but Sens. Patrick Leahy (D-Vt.) and John Cornyn (R-Texas) said the legislation would relieve the problem of poor-quality drug patents that “drive up the costs of prescription drugs.”
The U.S. Federal Trade Commission (FTC) has taken a more assertive stance regarding enforcement of several considerations, most conspicuously about mergers and acquisitions. However, the agency’s push for less cumbersome processes has now been applied to a host of considerations pertinent to the life sciences, including bias found in artificial intelligence algorithms, abuse of drug patents, and repairs for medical equipment, a signal that more frequent and more rapid FTC enforcement is on the near horizon.
The question of whether an artificial intelligence (AI) algorithm can be an inventor has been making the rounds in the past couple of years, and the question came up again in the U.S. District Court for the Eastern District of Virginia. Stephen Thaler, who developed the Device for the Autonomous Bootstrapping of Unified Sentience (DABUS) algorithm that has been credited with two inventions, failed to persuade the court that an algorithm qualifies as an “individual,” and thus patents must still be assigned to humans, at least where the U.S. Patent and Trademark Office is concerned.
In a precedential opinion, the U.S. Court of Appeals for the Federal Circuit affirmed a lower court’s conclusion that Belcher Pharmaceuticals LLC’s chief science officer engaged in inequitable conduct by withholding material information from the U.S. Patent and Trademark Office during prosecution of Belcher’s 9,283,197 patent.
Kite Pharma Inc. is no longer on the hook for $1.2 billion in damages and royalties a jury awarded to Juno Therapeutics Inc. and the Sloan Kettering Institute for Cancer Research in a patent infringement suit involving Kite’s CAR T therapy Yescarta (axicabtagene ciloleucel).
As many lower and middle-income countries continue to scramble for COVID-19 vaccine doses, which are largely being manufactured in Europe and the U.S., their own regulatory rules may be getting in the way in some instances.
The U.S. Supreme Court’s decision in the case of U.S. v. Arthrex might be seen as having fully resolved the interaction between the Appointments Clause and the inter partes review (IPR) process, but there are other controversies brewing, nonetheless. Patent attorney James Lovsin, of McDonnell Boehnen Hulbert & Berghoff LLP (MBHB), said on an Aug. 17 webinar that because the current commissioner of patents is only an acting commissioner, his review of IPRs may also be a violation of the Appointments Clause, thus invoking the possibility that some patent cases will be subject to additional administrative delays.
The U.S. Court of Appeals for the Federal Circuit didn’t change a thing in a trio of rulings stemming from Eli Lilly and Co.’s inter partes review challenges of several patents protecting Teva Pharmaceutical Industries Ltd.’s migraine drug, Ajovy (fremanezumab).