The U.S. Court of Appeals for the Federal Circuit has ruled again on the appointments clause questions evolving from a patent dispute between Arthrex Inc. and Smith & Nephew Inc., this time in connection with a former acting director of the Patent and Trademark Office (PTO).
Medical devices and diagnostics are patent-dependent items, and companies may be able to avail themselves of extensions of their patents due to the time taken for FDA regulatory review. The U.S. Patent and Trademark Office announced March 8 that it had granted Neovasc Medical Ltd. a one-year extension of the term of two patents for the company’s flagship Reducer device, thus giving the company one additional year of market exclusivity to obtain the FDA’s approval for the device.
The U.S. Patent Trial and Appeal Board’s (PTAB) decision Feb. 28 that Broad Institute scientists were the first to invent the use of CRISPR/Cas9 genome editing in eukaryotic cells is just another chapter in the ongoing saga of who has patent rights to various elements of the CRISPR platform.
The existence of prior art isn’t always readily evident when companies in the device and diagnostic spaces file patent applications with the U.S. Patent and Trademark Office (PTO). As it turns out, literature describing that prior art need not be widely distributed to invalidate a patent as Quest Diagnostics Inc., of Secaucus, N.J., recently discovered, an object lesson for all in the med-tech space that research for prior art must be exhaustive if a patent is to hold up over time.
The U.S. Patent and Trademark Office (PTO) has been scrambling to adjust to recent developments in case law for patent subject matter eligibility, and the latest PTO response is a pilot program for new patent applications.
The U.S. Patent and Trademark Office (PTO) has been scrambling to adjust to recent developments in case law for patent subject matter eligibility, and the latest PTO response is a pilot program for new patent applications.
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 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.
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).
