Association for Molecular Pathology v. United States Patent & Trademark Office
689 F.3d 1303
| Fed. Cir. | 2012Background
- Plaintiffs sought a declaratory judgment that fifteen claims from seven Myriad patents cover non-patentable subject matter under §101.
- District court held Plaintiffs had standing under MedImmune and granted summary judgment that all challenged claims were §101 ineligible; later remanded after Mayo decision.
- Remand addressed jurisdiction and merits: (a) whether Ostrer has standing to sue, and (b) whether Myriad’s composition and method claims are patent-eligible.
- Isolated BRCA DNA (genes BRCA1/BRCA2) and cDNA claims were challenged; some method claims claimed to analyze or compare BRCA sequences; claim 20 of the '282 patent covered screening potential therapeutics via transformed cells.
- Court held Ostrer has standing to challenge validity; other Plaintiffs lacked standing to the same degree.
- On merits, composition claims to isolated DNA (including cDNA) may be patent-eligible; method claims to analyzing/comparing sequences are not; method claim 20 involving transformed cells is patent-eligible.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Do Plaintiffs have standing to sue under MedImmune? | Ostrer has injury; others rely on implied risk of suit. | No affirmative acts against all Plaintiffs; claims are stale. | One Plaintiff (Ostrer) has standing. |
| Are Myriad's isolated DNA and cDNA claims patent-eligible under §101? | Isolated DNAs are products of nature; not markedly different. | Isolated DNAs are man-made with distinct structure; not products of nature. | Isolated DNAs (including cDNA) are patent-eligible; cDNA claims clearly patent-eligible; full-gene claims depend on structure, with cDNA strongly supporting eligibility. |
| Are Myriad's method claims to analyzing or comparing BRCA sequences patent-eligible? | Methods provide transformative processing of sequence data; not mere mental steps. | Claims are abstract mental steps; not patent-eligible. | Claims to analyzing/comparing sequences are not patent-eligible; they are abstract ideas. |
| Is claim 20 of the '282 patent, a method for screening potential cancer therapeutics via transformed cells, patent-eligible? | Transformative steps render it patent-eligible; not just abstract. | Prometheus-like reasoning may render it ineligible if no inventive concept. | Claim 20 is patent-eligible due to transformation of cells; it is not merely an abstract principle. |
Key Cases Cited
- MedImmune, Inc. v. Genentech, Inc., 549 U.S. 118 (U.S. 2007) (all-the-circumstances standing test for declaratory judgment; injuries need not be concrete at all times)
- Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S. Ct. 1289 (U.S. 2012) (limitations on patent eligibility for natural laws; guidance on transformative steps)
- Chakrabarty, 447 U.S. 303 (U.S. 1980) (man-made invention with markedly different characteristics may be patentable)
- Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (U.S. 1948) (laws of nature vs. mixtures; invention must show utility difference)
- Parke-Davis & Co. v. H.K. Mulford Co., 189 F.95 (C.C.S.D.N.Y.1911) (purification does not automatically yield patentable subject matter)
- In re Merz, 97 F.2d 599 (4th Cir. 1938) (purified natural products; distinction between purification and new invention)
- Chakrabarty (duplicate for emphasis), 447 U.S. 310 (U.S. 1980) (markedly different characteristics; invention with utility)