Ariosa Diagnostics, Inc. v. Sequenom, Inc.
19 F. Supp. 3d 938
N.D. Cal.2013Background
- Ariosa (plaintiff) seeks declaratory judgment that its non‑invasive Harmony prenatal test does not infringe Sequenom’s licensed U.S. Patent No. 6,258,540 (’540 patent), which claims methods of detecting paternally inherited cell‑free fetal DNA (cffDNA) in maternal serum or plasma.
- The ’540 patent's independent claims recite steps such as obtaining noncellular fraction, amplifying paternally‑inherited nucleic acid, and detecting it (including dependent claims adding PCR, probes, fractionation, Y‑chromosome or percentage limits).
- Parties agree cffDNA itself is a natural phenomenon; dispute centers on whether the claimed methods add an "inventive concept" sufficient for §101 patent eligibility or instead merely apply conventional techniques to a natural phenomenon.
- Ariosa presented evidence (specification, prosecution history, expert testimony) that sample prep, fractionation, amplification, and detection in plasma/serum were well‑understood, routine, and conventional by 1997. Sequenom conceded many claim steps are conventional but argues the claims are patentable applications of the natural phenomenon and do not preempt all uses of cffDNA.
- The court considered Supreme Court §101 precedent (Prometheus/Mayo, Myriad, Flook, Diehr, etc.) and found as a matter of law on summary judgment that the claims, viewed as a whole, add only conventional steps to the natural phenomenon and thus are not patent eligible. The court granted Ariosa summary judgment and denied Sequenom’s.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Patent eligibility under 35 U.S.C. §101 for claims that detect paternally inherited cffDNA | The claims are invalid: they claim a natural phenomenon (cffDNA) and add only well‑understood, routine, conventional laboratory steps (amplify/detect) — insufficient inventive concept | The claims are patentable applications of a natural phenomenon; they are novel uses and do not monopolize cffDNA or preempt all uses | Held invalid: claims are directed to a natural phenomenon plus conventional activity and thus not patent eligible under §101 |
| Whether applying conventional techniques to a newly discovered natural phenomenon suffices for eligibility | Such application is insufficient; discovery alone is not patentable | Use of the natural phenomenon is inventive and should be protectable if applied in a new context | Court: Supreme Court precedent requires more than applying routine techniques; discovery of cffDNA cannot be the inventive concept |
| Preemption risk (does claim preempt practical uses of cffDNA?) | Patent would preempt practical detection/use because conventional detection methods are the only commercially viable ways to access cffDNA | Patent does not preempt all uses; other methods exist | Court: substantial preemption risk — no evidence of practical, commercially viable alternative detection methods at time of invention; supports invalidity |
| Claim‑construction / claim‑as‑a‑whole vs dissecting claims | Focus on claims as whole but assess whether whole claim adds inventive concept beyond natural phenomenon | Warns against dissecting but must analyze whether combination is inventive | Court examined claims as whole and found the combination was routine and conventional; not saved by viewing steps together |
Key Cases Cited
- Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948) (discovery of natural phenomenon not patentable absent inventive application)
- Gottschalk v. Benson, 409 U.S. 63 (1972) (abstract algorithms are not patentable subject matter)
- Parker v. Flook, 437 U.S. 584 (1978) (mathematical formula plus conventional post‑solution steps is not patentable)
- Diamond v. Diehr, 450 U.S. 175 (1981) (application of a formula in a transformative/physical process can be patentable)
- Bilski v. Kappos, 561 U.S. 593 (2010) (claims attempting to patent abstract ideas are ineligible)
- Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66 (2012) (claims that recite laws of nature require additional inventive concept beyond routine steps)
- Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107 (2013) (naturally occurring DNA is not patentable simply because isolated; methods applying conventional techniques to a discovery are not necessarily patentable)