Previewing Generic's Skinny Label: Supreme Court To Rule On Teva's Certiorari Petition

• Jurisdiction: United States,Federal
• Law Firm: Foley Hoag LLP
• Subject Matter: Intellectual Property, Litigation, Mediation & Arbitration, Food, Drugs, Healthcare, Life Sciences, Patent, Trials & Appeals & Compensation, Food and Drugs Law
• Author: Jeffrey I.D. Lewis, Sarah Burg and Mital Patel
• Published date: 23 May 2023

Key Takeaways:

• Supreme Court set to consider cert. petition on generic drug use of "skinny labels" to avoid infringing method of use patents.
• Court expected to consider cert. petition during court conference on May 11, 2023.
• Whatever decision the Supreme Court makes regarding Teva's petition against GSK may send ripples throughout the drug industry If the petition is denied, that may signal to many the end of the skinny label safe harbor. If it is granted, it could lead to greater clarity.

The Supreme Court is expected to consider Teva's pending petition for certiorari in the highly anticipated GlaxoSmithKline LLC v. Teva Pharms. USA, Inc. on May 11, 2023, a case that could carry enormous implications for the pharmaceutical industry and patent litigation. It concerns the practice known as "skinny labeling," a practice authorized by the Hatch-Waxman Act and used by generic drug makers to avoid infringing patents that cover methods of use.

The case centers on GSK's branded drug product, Coreg', which uses carvedilol (a type of beta blocker) to treat high blood pressure and heart failure, and Teva's generic version of that product. Despite Teva's use of a skinny label, a jury found that Teva had induced infringement of GSK's method of use patent. The trial judge then set that verdict aside, a split Federal Circuit panel reversed siding with the jury, and the full circuit court denied en banc review over vigorous dissents. Teva's certiorari petition argues that the Federal Circuit's decision could sow "competition-killing uncertainty," contrary to the Hatch-Waxman Act, which the U.S. healthcare system "cannot sustain." While we await the Supreme Court's decision on certiorari, this client alert provides an overview of the case, the legal issues at stake, and the potential impact of the Supreme Court's ruling on the industry.

Why Monitor Teva's Cert Petition?

Teva's petition raises important questions concerning how the Hatch-Waxman Act will be interpreted for both branded and generic manufacturers and may affect the scope of generic liability for years to come. The actual facts of the case, as we discuss below, are convoluted and case-specific'and perhaps a reason to deny certiorari'but Teva and amici have brought larger issues to the Court's attention.

The Hatch-Waxman Act provides three options for an abbreviated new drug application (ANDA) applicant to address unexpired patents listed in the FDA's Orange Book (officially called the Approved Drug...