From our private database of 34,000+ case briefs...
Caraco Pharmaceutical Labs, Ltd. v. Novo Nordisk A/S
United States Supreme Court
566 U.S. 399, 102 U.S.P.Q.2d 1345 (2012)
The United States Food and Drug Administration (FDA) reviewed Abbreviated New Drug Applications (ANDAs) to determine whether to grant approval to market new generic drugs. The ANDA process aimed to expedite the release of new generic medications. Because the FDA considered patent infringement in deciding whether to approve an ANDA, brand manufacturers were required to submit use codes describing the scope of their patents. As a policy, the FDA assumed use codes were accurate in deciding whether to approve ANDAs. Novo Nordisk A/S (Novo) (defendant) held a patent claiming the approved use of combining repaglinide with metformin, but the patent did not claim the approved uses of using repaglinide alone or in conjunction with thiazolidinediones. Caraco Pharmaceutical Labs, Ltd. (Caraco) (plaintiff) filed an ANDA seeking to market a generic version of repaglinide to use alone and with thiazolidinediones. Novo filed a patent-infringement claim in federal court against Caraco. While Caraco’s ANDA was pending, Novo amended its use code to state all three approved uses were covered under Novo’s patent. Caraco filed a counterclaim against Novo. The district court granted summary judgment in favor of Caraco, and the Federal Circuit reversed. Caraco appealed.
Rule of Law
Holding and Reasoning (Kagan, J.)
What to do next…
Unlock this case brief with a free (no-commitment) trial membership of Quimbee.
You’ll be in good company: Quimbee is one of the most widely used and trusted sites for law students, serving more than 607,000 law students since 2011. Some law schools—such as Yale, Berkeley, and Northwestern—even subscribe directly to Quimbee for all their law students.Unlock this case briefRead our student testimonials
Learn more about Quimbee’s unique (and proven) approach to achieving great grades at law school.
Quimbee is a company hell-bent on one thing: helping you get an “A” in every course you take in law school, so you can graduate at the top of your class and get a high-paying law job. We’re not just a study aid for law students; we’re the study aid for law students.Learn about our approachRead more about Quimbee
Here's why 607,000 law students have relied on our case briefs:
- Written by law professors and practitioners, not other law students. 34,000 briefs, keyed to 984 casebooks. Top-notch customer support.
- The right amount of information, includes the facts, issues, rule of law, holding and reasoning, and any concurrences and dissents.
- Access in your classes, works on your mobile and tablet. Massive library of related video lessons and high quality multiple-choice questions.
- Easy to use, uniform format for every case brief. Written in plain English, not in legalese. Our briefs summarize and simplify; they don’t just repeat the court’s language.