On August 19, 2024, the Association for Molecular Pathology (AMP) sued the FDA to challenge a new rule that allows the FDA to regulate laboratory developed tests (LDTs). The rule, which became effective on July 5, 2024, explicitly categorizes in vitro LDTs intended for clinical use as medical devices, placing such LDTs within the purview of the FDA. The complaint was filed in the Southern District of Texas. AMP’s suit follows another suit filed by a trade association, the American Clinical Laboratory Association, targeting the same rule.
The U.S. Advanced Research Projects Agency for Health (ARPA-H) announced new funding for a “program to help AI-enabled medical tools maintain peak performance.” The new funding is through the Performance and Reliability Evaluation for Continuous Modifications and Usability of Artificial Intelligence (PRECISE-AI) program.
Medical device companies are often well versed in prosecuting multiple patents within a single “family.” Indeed, such families are often of significant value to early stage (and later stage) medical device companies. But a Federal Circuit decision from last year raised the possibility that the continued prosecution of patents within a family could invalidate those early, valuable patents. In a clarifying decision, the Federal Circuit recently explained that “a first-filed, first-issued, later-expiring claim (e.g., in a Parent Patent) cannot be invalidated (under the doctrine of obviousness-type double patenting – “ODP”) by a later-filed, later-issued, earlier-expiring reference claim (e.g., in a child patent) having a common priority date.” This may sound complicated, but it can be good news for patent owners who own a family of patents because it is now less likely that a later prosecution will invalidate an earlier issued patent.
Judge Andrews of the District of Delaware recently denied Novartis’s request for a preliminary injunction against MSN Pharmaceuticals. Novartis Pharm. Corp. v. MSN Pharm. Inc., Civil Action No. 20-md-2930-RGA, Dkt. No. 1456 (D. Del. Aug. 12, 2024). Novartis had requested a preliminary injunction to block MSN Pharmaceuticals from launching a generic version of Novartis’s top-selling oral heart failure drug Entresto®.
On July 10, the Senate unanimously passed the Affordable Prescriptions for Patients Act of 2023 (S.150), which seeks to increase competition and lower drug prices by imposing limits on patent litigation related to biological products. The bill attempts to target “patent thickets” or the large patent portfolios companies create with significantly overlapping patent rights seen by lawmakers as obstacles to competitors entering the market.
On August 13, 2024, the Federal Circuit issued its decision in Allergan USA, Inc. v. MSN Laboratories Private Ltd., No. 24-1061, which limits the scope of obviousness-type double patenting for patents in the same family. The Federal Circuit held that a first-filed, first-issued, later-expiring patent claim cannot be invalidated for obvious-type double patenting based on a later-filed, later-issued, earlier-expiring child patent when the patents share a common priority date.
REALTIME ADAPTIVE STREAMING LLC v. SLING TV, LLC
Before Moore, Lourie, and Albright. Appeal from the United States District Court for the District of Colorado.
Summary: Awarding attorneys’ fees may be an abuse of discretion if the court relies on factors that should be given no weight in the exceptional-case analysis.
WISCONSIN ALUMNI RESEARCH FOUNDATION v. APPLE INC
Before Prost, Taranto, and Chen. Appeal from the United States District Court for the Western District of Wisconsin.
Summary: Literal infringement and infringement under the doctrine of equivalents are treated as the same issue for issue preclusion.
The June 2024 issue of Vanity Fair included the provocative headline: “Why Counterfeit Ozempic Is a Global-Growth Industry.” Novo Nordisk’s patented drug Ozempic® (semaglutide injection) was first approved by the FDA in 2017 for the treatment of type 2 diabetes. A few years later, clinical trials demonstrated that Ozempic® could also be used for weight loss in individuals without diabetes who had previously struggled to lose weight. News of the “miraculous weight loss” achieved with Ozempic® (and its sister drug Wegovy®) led to widespread demand for the drug and global shortages.
PLATINUM OPTICS TECHNOLOGY INC., v. VIAVI SOLUTIONS INC.
Before Moore. Appeal from the Patent Trial and Appeal Board.
Summary: Standing based on potential infringement liability requires concrete plans for future activity which will create a substantial risk of future infringement or will likely lead to a patentee claiming infringement.