Authored by Justice Kagan this week, the first SCOTUS case on generic drug entry under Hatch-Waxman: Caraco v. Novo Nordisk. Justice Kagan approached this detailed statute with humor and logic, and brought all 9 Justices along for the party. Since generic drugs have saved the US health care sector over $1 trillion from 1999 to 2010, this is an important topic.
Novo Nordisk’s molecular patent on the diabetes drug repaglinide (Prandin) expired in 2009, but Novo acquired a “use” patent on the combination of repaglinide with metformin (which is also generic). It was undisputed that Novo holds no patent on the two other FDA approved uses of repaglinide: repaglinide alone and in combination with thiazolidinediones. When Caraco filed its ANDA for generic approval of these two unpatented uses, Novo responded by amending its use code in the FDA Orange Book to cover all uses of repaglinide for human diabetes. The Court of Appeals for the Federal Circuit agreed with Novo, essentially extending full patent protection over all uses of repaglinide until 2018. The Supreme Court unanimously reversed.
If you want the statutory details, see The Orange Book Blog, SCOTUS blog, and FDA Law Blog.
1. Novo is still a big winner here. Their patent expired in 2009; it is April 2012 and there is still no generic repaglinide in the US. With annual US Prandin sales of about $230 million, this litigation has paid off for Novo. As Justice Sotomayor points out in her concurrence, unless the FDA acts to remedy use code abuse, similar litigation delays will abound.
2. The use patent at issue was for the combination of two drugs (repaglinide + metformin), both of which are generic.
3. Justice Kagan’s writing style is refreshingly clear, with healthy measures of logic and humor. Most importantly, she insists that the very specific provision at issue (the scope of a counterclaim under 21 U.S.C. § 355(j)(5)(C)(ii)(I)) must be interpreted in light of the overall goals of Congress in the Hatch-Waxman Act. That sends a clear message to the Federal Circuit that hypertechnical readings of this statute will not be tolerated if they are out of sync with congressional policy favoring generic entry. Good news for generic drug companies.