On May 18, 2023, the Supreme Court of the United States issued its opinion in Amgen, Inc. v. Sanofi, clarifying the standard of satisfying the enablement requirement, in particular, for broad functional genus claims. The Court, in a unanimous decision affirming the Federal Circuit’s holding, focused on whether the specification enabled the full scope of the invention to be practiced.
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On April 22, 2021, the Supreme Court of the United States unanimously held that Section 13(b) of the Federal Trade Commission Act does not authorize the FTC to seek, or a court to award, equitable monetary relief. The decision is likely to have a significant impact on the FTC’s decision-making process in bringing future cases directly to federal district court, as opposed to going through the administrative process, and it will likely spur congressional debate and possibly lead to new legislation.
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The Supreme Court of the United States is to decide the fate of administrative patent judges of the Patent Trial and Appeal Board, namely whether the current appointment scheme violates the Appointments Clause of the U.S. Constitution. This case, which may have broad implications on post-grant proceeding process before the USPTO, is being watched by companies around the world.
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On May 20, 2019, the Supreme Court of the United States issued a rare unanimous decision in Merck Sharp & Dohme Corp. v. Albrecht, et al., holding that judges, not juries, must decide whether state law failure-to-warn claims against brand-name drug manufacturers are preempted by the FDA’s labeling regulations. In so holding, the Court further clarified the preemption standard set forth in an earlier decision, Wyeth v. Levine, concluding that such claims are preempted where a drug manufacturer can show “that it fully informed the FDA of the justifications for the warning required by state law and that the FDA, in turn, informed the drug manufacturer that the FDA would not approve changing the drug’s label to include that warning.”
The Supreme Court of the United States recently affirmed the decision of the U.S. Court of Appeals for the Federal Circuit in Helsinn Healthcare v. Teva Pharmaceuticals, 855 F.3d 1356 (2017), which invalidated a patent-in-suit under the post-AIA on-sale bar. The question presented, answered by the Court in the affirmative, was “[w]hether, under the Leahy-Smith America Invents Act [AIA], an inventor’s sale of an invention to a third party that is obligated to keep the invention confidential qualifies as prior art for purposes of determining the patentability of the invention.”
Justice Thomas, writing for the Court, concluded that the “on sale” provision in §102(a)(1) of the AIA was a re-enactment of the “on sale” bar provision in the pre-AIA patent statute that did not alter its meaning or interpretation, despite the inclusion of the phrase “or otherwise available to the public” in post-AIA §102(a)(1). Thus, based on the Federal Circuit’s “settled precedent,” and consistent with the Supreme Court’s decision in Pfaff v. Wells Electronics, 525 U.S. 55 (1998), the Court held that “a commercial sale to a third party who is required to keep the invention confidential may place the invention ‘on sale’ under [the AIA].” Details of the ruling and some takeaways for companies entering into licenses and supply agreements are discussed below.
