Skinny Labels Back In Focus After HHS Report On Addressing Drug Prices

• Published date: 13 October 2021
• Subject Matter: Intellectual Property, Food, Drugs, Healthcare, Life Sciences, Patent, Food and Drugs Law, Biotechnology & Nanotechnology
• Law Firm: Morrison & Foerster LLP
• Author: Mr Fitz B. Collings

Skinny labels are back in focus at the White House. On September 9, 2021, the U.S. Department of Health and Human Services submitted its much-anticipated report to the White House Competition Counsel regarding a "Comprehensive Plan for Addressing High Drug Prices." The HHS Report-issued in response to President Biden's Executive Order on Promoting Competition in the American Economy-contains a range of approaches for effecting reforms aimed at reducing the price of prescription drugs. Among these proposed reforms are administrative actions that will be undertaken by the Food and Drug Administration to "address potential barriers to biosimilar and generic drug development and market entry to spur competition so that consumers can access the medicines they need at affordable prices." HHS Report at 19.

For both the biosimilar and generic drug marketing pathways, HHS emphasized the importance of labeling carve-outs-so-called "skinny" labels-under 21 U.S.C ' 355(j)(2)(A)(viii) as a way to "decrease[] costs to patients and to the federal government, including reducing spending on Medicare and Medicaid." HHS Report at 21. HHS's emphasis appears driven in part by a recent case before the Federal Circuit, GlaxoSmithKline v. Teva Pharmaceuticals USA, Inc., addressing patent-infringement liability for generic drug manufacturers that employ skinny labeling practices. 976 F.3d 1347 (Fed. Cir. 2020), aff'd in part and vacated in part, 7 F.4th 1320 (Fed. Cir. 2021); HHS Report at 21 ("Recent litigation has raised some questions about the practice of carving out patent-protected indications for generic drugs, which may discourage the use of carve-outs and thus delay the approval of some generic drugs.").

The patent at issue in GlaxoSmithKline covered the use of Coreg^' (carvedilol) to treat congestive heart failure. Teva's label for its generic carvedilol product omitted this patented indication when FDA first approved it but retained indications for two other approved uses: treatment of post-MI LVD (left ventricular dysfunction following post-myocardial infarction) and hypertension. During this time, however, Teva also marketed carvedilol as therapeutically equivalent to Coreg^', and there was evidence that post-MI LVD patients were also being treated with carvedilol for congestive heart failure. Beginning in 2011, Teva maintained the carve-out but added language elsewhere in the carvedilol label stating that it could be used to treat congestive heart failure. The jury...