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The U.S. Food and Drug Administration (FDA) recently released draft guidance regarding clinical considerations for studies of medical devices intended to treat opioid use disorder (OUD).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.

The FDA implemented the breakthrough device program in 2015. The program was designed to expedite review of premarket approval (PMA), 510(k) clearance, and De Novo marketing authorizations. Applicants can seek a breakthrough device designation prior to requesting market approval regardless of the classification of the device. In order to qualify as a breakthrough device, the device must (1) provide for a more effective treatment or diagnosis of a life-threatening or irreversibly debilitating disease or condition and (2) meet at least one of: (a) represents a breakthrough technology; (b) no approved or cleared alternatives exist, (c) offers significant advantages over existing approved or cleared alternatives, or (d) device availability is in the best interest of patients.

Sacral neuromodulation stimulates nerves above the tailbone to treat fetal incontinence and related bowel and bladder control issues. After California-based Axonics Inc. (“Axonics”) entered the sacral neuromodulation market in late 2019, MedTronic sued for patent infringement. Axonics filed for inter partes review (IPR) of the asserted patents at the Patent Trial and Appeal Board (PTAB). Although MedTronic initially prevailed in the IPR, Axonics has now succeeded on appeal at the Federal Circuit.