On August 15, 2023, the Food and Drug Administration (FDA) issued its updated guidance on informed consent for clinical investigations. The FDA’s updated guidance is titled Informed Consent Guidance for IRBs, Clinical Investigators, and Sponsors. Informed consent enables prospective subjects to understand the relevant information concerning a clinical investigation while also providing them the opportunity to pose questions, deliberate on participation, and grant voluntary agreement.
Recent reports, including one by PitchBook, indicate that both venture capitalist funding for medtech companies and the variety of medtech companies receiving venture capitalist funding has increased since the first quarter of 2023.
IN RE CELLECT, LLC
Before Lourie, Dyk, and Reyna. Appeal from the Patent Trial and Appeal Board.
Summary: Obviousness-type double patenting analyses for patents with Patent Term Adjustments are based on the adjusted expiration date of the patent.
VOLVO PENTA OF THE AMERICAS, LLC, v. BRUNSWICK CORP.
Before Moore, Lourie, and Cunningham. Appeal from the Patent Trial and Appeal Board.
Summary: The Board must consider the combined weight of multiple objective indicia of non-obviousness and must provide an explanation for the weight attributed to each objective indicia proven by the patent owner.
INCEPT LLC v. PALETTE LIFE SCIENCES, INC.
Before Newman, Schall, and Taranto. Appeal from the Patent Trial and Appeal Board.
Summary: No teaching away when art does not disparage invention and free samples cannot count as commercial success.
Software is increasingly used as a medical device, transforming the healthcare industry with the goal of improving patient outcomes. However, developing software as a medical device involves navigating complex and evolving regulatory frameworks. Regulatory frameworks can complicate the already complex problem of innovation in software and can often run roughshod over the distinctions between software, artificial intelligence, machine learning, and deep learning. Development in each of these areas is known to progress in leaps and pauses and can occur at any point from data collection to testing, design, development, or deployment. Yet as human involvement leads to opportunities for technological improvements, human touchpoints can also lead to mistakes and biases.
Medical Device companies often need the U.S. Food and Drug Administration (FDA) to approve “indications for use” of their products–for use selling them in the U.S. Those same companies often seek U.S. patent protection so that they can profit from their inventions underlying those same products. In both cases, the companies seek to persuade federal government agencies to approve their requests.
AXONICS, INC. v. MEDTRONIC, INC.
Before Dyk, Lourie, and Taranto. Appeal from the Patent Trial and Appeal Board.
Summary: Where a patent owner in an IPR proposes a claim construction for the first time in a patent owner response, a petitioner must be given the opportunity in its reply to argue and present evidence of anticipation or obviousness under the new construction.
The U.S. Food and Drug Administration (FDA) recently released draft guidance regarding clinical considerations for studies of medical devices intended to treat opioid use disorder (OUD). According to the FDA’s press release, the draft guidance aligns with the FDA’s Overdoes Prevention Framework and aims to advance evidence-based treatment for individuals with substance use disorders.
The FDA has updated its Medical Device Shortages List to remove Specimen Collection, Laboratory Reagents and Testing Supplies, Transport Media Device, Saline Vascular Access Flush, and Certain Ventilation-Related Products. This comes as supply chain issues from the COVID-19 pandemic continues to improve, albeit at different speeds around the globe. Non-continuous ventilators had been in short supply since at least August of 2020, according to Medical Design & Outsourcing.
