In preparing for their showdown before the U.S. Supreme Court March 27 on what it takes to enable broad genus claims, both Sanofi SA and Amgen Inc. are warning that future innovation will be at stake if the court accepts the other company’s position.
U.S. Supreme Court case law on patent subject matter eligibility has provoked several attempts by Congress to rewrite the statute, but there are lingering concerns about the latest proposal, the Patent Eligibility Restoration Act of 2022. Among these concerns is that the revised set of exceptions to subject matter eligibility might take time to work through both in terms of litigation and patent prosecution, but the bill has the support of a number of stakeholders, including two former commissioners of the U.S. Patent and Trademark Office (PTO).
It’s taken eight years of jury trials, court reversals and appeals for Amgen Inc. to get the nod to argue its case before the U.S. Supreme Court on what is needed to meet the enablement standard for functional patent claims that envelop a genus.
Teva Pharmaceuticals USA Inc.’s quest to get the U.S. Supreme Court to overturn the Federal Circuit and preserve label carveouts, or so-called skinny labels, continued Oct. 3 with the high court asking the solicitor general to weigh in.
If the U.S. Supreme Court agrees to hear Teva Pharmaceuticals USA Inc. vs. Glaxosmithkline LLC, it could be one of the biggest biopharma cases on the court’s calendar in the coming year. But that’s still an if. Whether the patent infringement case involving a so-called “skinny label” makes it to the high court’s docket depends on which interpretation of the underlying question the court accepts.
The doctrine of patent assignor estoppel is not found in the U.S. statute, but that omission has led to only limited litigation over the doctrine despite the notoriety of the case of Hologic v. Minerva. Nonetheless, the Federal Circuit reinforced the understanding that an assigned patent is still in force when the disputed claim is not seen has having been materially broadened by the time a patent has been granted in its final form, thus closing one of the principal contractual questions surrounding patents that are handed off from one device maker to another.
The question of whether an artificial intelligence (AI) algorithm should enjoy the status of an inventor has been making the rounds in various nations, but the U.S. Court of Appeals for the Federal Circuit has rejected the notion based on a plain reading of the statute. The court said that the statute is unambiguous in that only natural persons can claim inventorship, but the question will be appealed to the Supreme Court, which will have an opportunity to put this debate to rest.
Makers of biotech therapies and in vitro diagnostics may be understandably weary of hearing about patent subject matter eligibility under Section 101 of the Patent Act, but Sen. Thom Tillis (R-N.C.) is prepared to take another swipe at the problem. Tillis announced Aug. 3 that the Patent Eligibility Restoration Act of 2022 is intended to reverse some of the deleterious effects of U.S. Supreme Court jurisprudence on Section 101 questions, a proposal that may be the last, best chance to address what many believe is a fundamentally broken judicial understanding of subject matter eligibility.
The effects of U.S. Supreme Court case law on patents are well demonstrated, but the latest victims of patent jurisprudence are directed toward a critical need for desperately ill patients. The Court of Appeals for the Federal Circuit ruled that several claims found in three patents licensed to Caredx Inc., of Brisbane, Calif., are ineligible due to a purported lack of inventiveness under Section 101 of the Patent Act, an outcome that sustains what some believe is a trend in case law that is hostile toward diagnostic patents in the U.S.
Patent subject matter eligibility under Section 101 of the Patent Act has proven controversial for patents in the U.S. thanks in no small part to Supreme Court jurisprudence in cases such as Alice v. CLS Bank and Mayo v. Prometheus. In the latest development, the Court has declined to hear the American Axle case, which some see as presenting an exceptionally low bar for subject matter eligibility, leaving many observers despairing of any chance of restoring a decent patent system for makers of in vitro diagnostics and other items that are among the mainstays of the medical device industry.
