For companies in the life sciences, patent subject matter eligibility has acquired a bad reputation, but the U.S. Patent and Trademark Office (PTO) has attempted to provide administrative workarounds to the problem. PTO director Kathi Vidal said recently, however, that the agency intends to revisit its guidance, just one of several steps the PTO is taking to eliminate some of the drag on patent applications in the U.S.
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.
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.
Makers of vitro diagnostics (IVDs) are facing several significant challenges in the next few years, thanks to existing and impending revisions to a number of regulatory frameworks. There are other considerations that are adding to the headwinds, such as a poor patent protection environment in the U.S., the net effect of which is to make life unusually miserable for developers of these tests.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA seeks nominations for blood products advisory panel; Massachusetts hospital hit for HIPAA access non-compliance; No reports recorded for Medtronic recall; Tillis, Cotton eye patent examiner practice for Section 101 problem.
The problem of patent subject matter eligibility is still a nightmare for companies in the diagnostics space, but patent attorney Michael Borella said this is still an issue for software as well. Borella said there are three characteristics that should be considered while drafting patent claims – specificity, technical character and novelty – to arrive at a reasonable assurance that that the key claims in a patent application will survive a challenge in hazardous legal environs, such as the Court of Appeals for the Federal Circuit.
The patent subject matter eligibility problem has rattled the world of diagnostics for several years, but the U.S. Senate has been silent about legislation in recent months. Patent attorney Michael Borella, of McDonnell Boehnen Hulbert & Berghoff LLP (MBHB), said he does not expect Congress to provide any legislative fix to the problem any time soon.
The U.S. Supreme Court has declined to hear the case of Athena v. Mayo, which many hoped would ease the patent subject matter eligibility problem. This outcome leaves Congress and the Court of Appeals for the Federal Circuit as the only likely sources of resolution for the problem, but there is skepticism as to whether either of these parties is both willing and able to overcome the impasse.
