Legal Opinion
Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/s
Supreme Court of the United States
Decided April 17, 2012No. 10-844PublishedCited by 209 opinions
1Opinion of the CourtJustice Kagan
When the Food and Drug Administration (FDA) evaluates an application to market a generic drug, it considers whether the proposed drug would infringe a patent held by the manufacturer of the brand-name version. To assess that matter, the FDA requires brand manufacturers to submit descriptions of the scope of their patents, known as use codes. The FDA does not attempt to determine if that information is accurate. Rather, the FDA assumes that it is so and decides whether to approve a generic drug on that basis. As a result, the breadth of the use code may make the difference between approval and…
2Cases cited14 opinions
- United States v. Ron Pair Enterprises, Inc.Supreme Court of the United States · 1989
- Robinson v. Shell Oil Co.Supreme Court of the United States · 1997
- Stern v. MarshallSupreme Court of the United States · 2011
- TRW Inc. v. AndrewsSupreme Court of the United States · 2001
- Ardestani v. Immigration & Naturalization ServiceSupreme Court of the United States · 1991
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3Cited by209 opinions
- F.T.C. v. Actavis, Inc.Supreme Court of the United States · 2013
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- Haddrick Byrd v. Robert ShannonCourt of Appeals for the Third Circuit · 2013
- Electronic Privacy Information Center v. United States Department of Homeland SecurityCourt of Appeals for the D.C. Circuit · 2015
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