Prometheus Laboratories, Inc. v. Mayo Collaborative Services
628 F.3d 1347
| Fed. Cir. | 2010Background
- Prometheus owns the ‘623 and ‘302 patents claiming methods to optimize thiopurine drug therapy by administering a drug and measuring metabolite levels to adjust dosage.
- Mayo produced and used Prometheus’s test but later planned to deploy its own test measuring the same metabolites with different toxicity thresholds.
- District court granted summary judgment invalidating the claims under §101 as drawn to natural phenomena and preemptive of basic correlations, relying on a narrow pre-Bilski test.
- On review, this court previously held the claims were patent-eligible under the machine-or-transformation test, but the Supreme Court later remanded for reconsideration in light of Bilski.
- On remand, we again hold the asserted method claims are drawn to patent-eligible subject matter and transform the body and samples as part of a treatment method.
- The court distinguishes these claims from purely data-gathering or abstract-idea claims and concludes the claims do not preempt all uses of the correlations between metabolite levels and drug efficacy/toxicity.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether Prometheus claims are patent-eligible under §101 after Bilski. | Prometheus: claims satisfy machine-or-transformation or are a practical application. | Mayo: claims preempt natural correlations and fail §101. | Prometheus claims are patent-eligible and not preemptive. |
| Whether the claims transform a bodily subject or sample. | Prometheus: administering and determining steps transform the body. | Mayo: steps are data gathering, not transformative. | Claims satisfy the transformation prong of the test. |
| Whether the final wherein clauses render the claims non-patentable as mere mental steps. | Final steps do not negate the transformative prior steps. | Mental steps negate patentability. | Mental steps do not destroy overall patentability. |
| Whether the claims preempt all uses of natural correlations. | Claims are specific to treatment methods and do not preempt all uses. | Claims preempt the correlations. | Claims do not wholly preempt natural correlations. |
Key Cases Cited
- Laboratory Corp. of America Holdings v. Metabolite Laboratories, Inc., 548 U.S. 124 (U.S. 2006) (preemption concerns and abstract ideas in patentable subject matter)
- In re Grams, 888 F.2d 835 (Fed. Cir. 1989) (algorithmic data-gathering vs. transformative steps in a medical process)
- Benson, 409 U.S. 63 (U.S. 1972) (laws of nature not patentable; transformation clue as to patentability)
- Flook, 437 U.S. 584 (U.S. 1978) (warning against relying on post-solution activity as patent-eligibility)
- Diehr, 450 U.S. 175 (U.S. 1981) (claims must be viewed as a whole; not patentable if only abstract ideas)
- In re Abele, 684 F.2d 902 (CCPA 1982) (production/detection/display steps can redeem patentable subject matter)
- Prometheus Labs., Inc. v. Mayo Collaborative Servs., 581 F.3d 1336 (Fed. Cir. 2009) (claims are patent-eligible as a transformative application of natural correlations)