Association for Molecular Pathology v. United States Patent & Trademark Office
653 F.3d 1329
| Fed. Cir. | 2011Background
- plaintiffs challenge patent eligibility of fifteen claims across seven patents related to BRCA genes; Myriad asserted patents cover isolated BRCA1/BRCA2 DNA and related diagnostic/method claims; district court held plaintiffs lacked standing except Dr. Ostrer and granted summary judgment that all challenged claims were ineligible under §101; district court relied on MedImmune all-circumstances test and found affirmative acts and readiness to infringe; Myriad asserted standing arguments based on communications and enforcement actions against others; the court distinguished standing from mere belief in invalidity or fear of suit; on merits, the court held isolated DNAs are products of nature and that method claims are abstract mental steps under the machine-or-transformation/Prometheus framework; the court declined to strike Myriad’s broader isolated DNA claims, and Myriad appealed.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Declaratory judgment jurisdiction for standing | Ostrer alleges immediate, concrete injury | Myriad argues no current affirmative act toward Ostrer; only stale communications | Ostrer has standing; others lack standing |
| Isolated DNA composition claims patent-eligible | Isolated DNAs are products of nature; not markedly different | Isolated DNAs are man-made with distinctive structure and utility | Isolated DNAs deemed patent-eligible subject matter |
| BRCA sequence analysis claims patent-eligible | Claims cover abstract mental process of comparing sequences | Transformations exist in sequencing; not just abstract | Claims to comparing/analyzing sequences not patent-eligible |
| Method claim for screening cancer therapeutics patent-eligible | Transformation steps render it patent-eligible | Transformations and purpose do not save it from abstract idea | Claim 20 is patent-eligible under §101 |
Key Cases Cited
- Diamond v. Chakrabarty, 447 U.S. 303 (U.S. 1980) (led to 'markedly different' standard; living invention patentable when markedly different)
- Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (U.S. 1948) (laws of nature exception; no patent for naturally occurring combinations unless markedly different)
- Prometheus Labs., Inc. v. Mayo Collaborative Servs., 628 F.3d 1347 (Fed. Cir. 2010) (transformation central to patent eligibility in Prometheus)
- Bilski v. Kappos, 130 S. Ct. 3218 (U.S. 2010) (machine-or-transformation test; abstract ideas exception remains)
- Chakrabarty, 447 U.S. 303 (U.S. 1980) (pivotal for doctrine distinguishing natural products vs. man-made invention)
- Lujan v. Defenders of Wildlife, 504 U.S. 555 (U.S. 1992) (standing requirements; injury, causation, redressability)
- MedImmune, Inc. v. Genentech, Inc., 549 U.S. 118 (U.S. 2007) (all-the-circumstances test for declaratory judgments in patent context)
- SanDisk Corp. v. STMicroelectronics, Inc., 480 F.3d 1372 (Fed. Cir. 2007) (standing requires affirmative acts and readiness to infringe)