U.S. SUPREME COURT

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The Supreme Court’s decision to review Hikma Pharmaceuticals USA Inc. v. Amarin Pharma Inc. places renewed attention on a familiar but unsettled issue in pharmaceutical patent law: how the induced infringement doctrine applies when a generic drug launches with a concededly “skinny” label, but engages in broader marketing and communications outside the FDA-approved label.

Although the case arises under the Hatch-Waxman Act, it squarely implicates the scope and enforceability of method-of-use patents, particularly for later-developed indications that often represent substantial additional investment by brand-name manufacturers.

Patent eligibility under 35 U.S.C. § 101 remains one of the most hotly contested and unpredictable areas of U.S. patent law. In the years following the Supreme Court’s landmark decisions in Alice Corp. v. CLS Bank Int’l (2014) and Mayo Collaborative Services v. Prometheus Laboratories, Inc. (2012), lower courts, the USPTO, and the Federal Circuit have wrestled with the proper application of the two-step framework for determining whether an invention is directed to an abstract idea, law of nature, or natural phenomenon—and, if so, whether it includes an inventive concept sufficient to transform it into patent-eligible subject matter.

The U.S. Supreme Court on May 18, 2023 delivered its decision on the scope of the patent enablement requirement, set forth in 35 U.S.C. § 112, in the antibody dispute Amgen, Inc. v. Sanofi. While the parties obtained finality, many in the pharmaceutical and biotechnology industries received the opinion under a cloud of uncertainty and concern for exclusivity rights broad enough to both protect clinical candidates and deter competitors. While the patent bar may remain apprehensive, the Supreme Court kept the door open to genus claims.  The impact of the decision may not be as far-reaching as feared.

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.

Allele v. Pfizer – The Basics. On April 23, 2021, Pfizer, Inc., BioNTechSE, and BioNTech US, Inc. (“Pfizer and BioNTech”) filed a joint reply supporting of their previously filed motion to dismiss a patent infringement complaint filed by Allele Biotechnology and Pharmaceuticals, Inc. (“Allele”) in the Southern District of California. The patent at the center of the case is U.S. Pat. No. 10,221,221 (“the ’221 Patent”) which covers Allele’s mNeonGreen, a monomeric yellow-green fluorescent protein notable for its intense brightness. On May 4, 2021, the court denied the motion to dismiss, leaning heavily of the Federal Circuit’s 2008 decision Proveris Science Corp. v. Innovasystems, Inc. As this case continues to develop it could help shed light on an unsettled issue – are “research tools” categorically excluded from the 35 U.S.C. § 271(e)(1) Safe Harbor?

In the recent case of Amgen Inc. v. Sanofi, Aventisub LLC, the Federal Circuit affirmed the district court’s invalidation of certain of Amgen’s antibody patent claims, concluding that the claims were not “enable[d]” under 35 U.S.C. § 112. This decision establishes that it is more difficult to satisfy the enablement requirement for antibody claims that use functional language to describe the antibody. (The court granted Amgen’s motion to extend the deadline for filing a petition for panel rehearing and/or rehearing en banc until April 14, 2021. See id., Order (March 8, 2021).)