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.
Artificial intelligence (AI) and machine learning (ML) present regulators and payers alike with some interesting dilemmas, but that statement can be applied to patent offices and inventors as well. In this fifth installment in a series on AI in radiology, we’ll examine the hazards of acquiring and sustaining intellectual property protection for these algorithms, a much more complicated and complex undertaking than many developers might appreciate.
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 U.S. Court of Appeals for the Federal Circuit recently decided an appeal of a patent lawsuit involving Cardionet LLC, of Conshohocken, Pa., invalidating the Cardionet patent for lack of subject matter eligibility. While the patent offers a significant improvement in the functionality of any computer that uses the Cardionet algorithm, the Federal Circuit declared that the invention does nothing more than use the computer as a tool to express an abstract idea.
Patent subject matter eligibility often seems to overshadow the America Invents Act of 2011 of late despite the controversies over inter partes reviews, but patent attorney Robb Roby told BioWorld that the most important provision of the landmark patent reform legislation may be the provision for prioritized examination. In some instances, this fast-track program has led to a grant of patent in substantially less than a year, a feature Roby said provides a critical turn-around for small companies trying to sustain their appeal to venture capitalists.
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.
In a decision that seems to have yet again roiled the patent subject matter eligibility question, the U.S. Court of Appeals for the Federal Circuit determined that a district court had erred in determining the 7,941,207 patent held by Cardionet LLC, of Conshohocken, Pa., is not eligible for patent protection.
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.
