Association for Molecular Pathology v. Myriad Genetics, Inc.
133 S. Ct. 2107
| SCOTUS | 2013Background
- Myriad identified the precise location and sequence of BRCA1 and BRCA2 genes, mutations of which raise breast/ovarian cancer risk.
- Myriad obtained patents claiming isolated DNA for BRCA1/BRCA2 and synthetic BRCA cDNA, asserting exclusive rights to testing and sequencing.
- Plaintiffs challenged the patents as invalid under 35 U.S.C. §101, arguing natural phenomena and products of nature are not patentable.
- District Court held claims on isolated DNA and cDNA were invalid as products of nature; Federal Circuit reversed on remand after Mayo guidance.
- On remand, the Federal Circuit split on isolated DNA but agreed cDNA claims were patent eligible; the Supreme Court granted certiorari.
- The Supreme Court held that naturally occurring DNA segments are not patent-eligible merely because they have been isolated, while cDNA is patent-eligible.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Isolated natural DNA patent eligibility | Association argues isolated DNA is a product of nature and not patentable. | Myriad contends isolation creates a nonnatural, patentable molecule. | Isolated DNA not patent-eligible |
| cDNA patent eligibility | cDNA is naturally occurring and thus not patentable. | cDNA is laboratory-created and not naturally occurring. | cDNA patent-eligible |
| PTO practice and deference to administrative rulings | PTO practice should be given deference in patent eligibility. | Congress has not endorsed PTO practice; deference not warranted. | PTO practice not controlling; deference rejected |
Key Cases Cited
- Diamond v. Chakrabarty, 447 U. S. 303 (U.S. 1980) (manufacture with markedly different characteristics is patentable)
- Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U. S. 127 (U.S. 1948) (discovery of natural principle not enough for patent)
- J. E. M. Ag Supply, Inc. v. Pioneer Hi-Bred Int’l, Inc., 534 U. S. 124 (U.S. 2001) (PTO practice not necessarily controlling patent eligibility)
- Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S. Ct. 1316 (S. Ct. 2012) (laws of nature and abstract ideas are not patentable; framework for §101)
- Association for Molecular Pathology v. United States Patent and Trademark Office, 689 F.3d 1303 (Fed. Cir. 2012) (Federal Circuit remand and distinction between isolated DNA and cDNA)