Mayo Collaborative Services v. Prometheus Laboratories, Inc.
Mayo v. Prometheus, 566 U.S. 66 (2012), was a case decided by the Supreme Court of the United States that unanimously held that claims directed to a method of giving a drug to a patient, measuring metabolites of that drug, and with a known threshold for efficacy in mind, deciding whether to increase or decrease the dosage of the drug, were not patent-eligible subject matter.
| Mayo v. Prometheus | |
|---|---|
| Argued December 7, 2011 Decided March 20, 2012 | |
| Full case name | Mayo Collaborative Services, DBA Mayo Medical Laboratories, et al. v. Prometheus Laboratories, Inc. |
| Docket no. | 10-1150 |
| Citations | 566 U.S. 66 (more) 132 S. Ct. 1289; 182 L. Ed. 2d 321; 2012 U.S. LEXIS 2316 |
| Argument | Oral argument |
| Case history | |
| Prior | Patent held invalid, 2008 WL 878910 (S.D. Cal.); reversed, 581 F.3d 1336 (Fed. Cir. 2009); vacated and remanded in light of Bilski v. Kappos, 130 S.Ct. 3543 (2010); reversed anew, 628 F.3d 1347 (Fed. Cir. 2010); certiorari granted, 131 S.Ct. 3027 (2011) |
| Holding | |
| Patent claims directed to a diagnostic method, that is based on a newly discovered natural correlation and utilizes well-known routine methods of analysis, were not patent eligible subject matter, because such method did not add an "inventive concept to application of the natural laws". | |
| Court membership | |
| |
| Case opinion | |
| Majority | Breyer, joined by unanimous |
| Laws applied | |
| 35 U.S.C. § 101 | |
The basic idea behind the court's decision in Mayo is as follows: although a discovery of a new natural phenomenon (or a law of Nature) would satisfy the non-obviousness requirement, patent claims, that either wholly pre-empt the natural phenomenon or add no additional "inventive concept" to this discovery, do not meet patent-eligible subject matter criterion.
The decision was controversial, with proponents claiming it frees clinical pathologists to practice their medical discipline, and critics claiming that it destabilizes patent law and will stunt investment in the field of personalized medicine, preventing new products and services from emerging in that field. A 2017 study concluded, that the decision in Mayo promoted biotech businesses and non-profit institutions to "increase use of trade secrecy" rather than the more traditional patenting, with substantial detriment to the society.