patent eligibility

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Patent eligibility under 35 U.S.C. § 101 should be a straightforward threshold question: any “new and useful process, machine, manufacture, or composition of matter” is eligible for protection. Yet over time, this once-clear principle has become anything but.

Although the statute itself has remained unchanged for two centuries, its interpretation has evolved dramatically through judicial decisions. And it is this common law precedent that has shaped the approach to the determination of patent subject matter eligibility.

In a move that could reshape the U.S. patent landscape, Congress has reintroduced two major pieces of legislation: the Patent Eligibility Restoration Act (PERA) of 2025 and the Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL) Act. Both bills purport to restore clarity, strength and global competitiveness to the U.S. patent system—longstanding priorities for patent owners across industries.

Here we break down what each bill proposes and what it could mean for innovators if passed in its current form.

Over the last seven years there has been commotion in Obviousness-type Double Patenting (“ODP”) practice. One of the latest cases to spur a considerable amount of interest is Mitsubishi Tanabe Corp. v. Sandoz, Inc., which is currently on appeal to the Federal Circuit (“CAFC”). While a detailed review of this case is not the intent of this post, as a fair number of practitioners have provided insightful coverage, an historical overview is helpful for framing the decision and issues that need clarification from the CAFC.

Nearly seven years after the landmark Supreme Court decision in Alice Corp. v. CLS Bank Int’l, subject matter eligibility for patent claims under 35 U.S.C § 101 remains a moving target. In Alice, the Court found claims for a computerized escrow arrangement ineligible for patenting because they were directed to the abstract idea of “intermediated settlement” and did not recite an inventive concept that could impart eligibility under Section 101. While the Alice case focused on a software invention, a few recent lower court decisions suggest that, in certain circumstances, medical device patents may not be immune from similar patent eligibility challenges.