Merck v. Integra
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| Merck v. Integra<tr style="text-align: center;"><td colspan="2">Image:Seal of the United States Supreme Court.png Supreme Court of the United States</td></tr> | ||||||
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| Argued April 20, 2005 Decided June 13, 2005 | ||||||
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| Holding | ||||||
| The Court held that the use of patented compounds in preclinical studies is protected under §271(e)(1) at least as long as there is a reasonable basis to believe that the compound tested could be the subject of an FDA submission and the experiments will produce the types of information relevant to an IND or NDA. | ||||||
| Court membership | ||||||
| Chief Justice: William Rehnquist Associate Justices: John Paul Stevens, Sandra Day O'Connor, Antonin Scalia, Anthony Kennedy, David Souter, Clarence Thomas, Ruth Bader Ginsburg, Stephen Breyer | ||||||
| Case opinions | ||||||
| Majority by: Scalia Joined by: unanimous <tr style="text-align: center; background: #6699FF;"><th colspan="2">Laws applied</tr></th><td>U.S. Const.; </td> |
Merck KGaA, Petitioner v. Integra Lifesciences I, Ltd., et al., 545 U.S. 193 (2005), is a United States Supreme Court case with ramifications for patent law. The dispute dates to approximately 1996 and centers on a federal law known as the "FDA safe harbor".
[edit] See also
[edit] References
- Kintisch, E. (2005, April 8). Case probes what's fair game in the search for new drugs. In Science, 308, 174.
- Mamudi, Sam, Supreme Court broadens research exemption, Managing Intellectual Property, June 14, 2005
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