Amster Rothstein and Ebenstein, LLP - Intellectual Property Law

ARE Patent Litigation Alert:
US Supreme Court Grants Cert for the Second Time in Prometheus v. Mayo Case on Patent-Eligible Subject Matter

June 21, 2011
Author(s): Charles R. Macedo, Michael J. Kasdan

The U.S. Supreme Court has granted certiorari for the second time in Prometheus Labs., Inc. v. Mayo Collaborative Servs., 628 F.3d 1347 (Fed. Cir. 2010) ("Prometheus II"), cert. granted, No. 10-1150, 2011 U.S. LEXIS 4764 (U.S. June 20, 2011) to address the issue of whether and in what circumstances a patent claim should be held invalid for failure to claim patent-eligible subject matter under 35 U.S.C. § 101.  The patent claims at issue in Prometheus relate to the diagnosis and/or treatment of patients using the drugs AZT or 6-MP.   The challenged claims include “administering” and/or "determining" steps, which the Federal Circuit has twice confirmed are "transformative" under the so-called "machine-or-transformation" test.

In its original Prometheus decision, issued after the Federal Circuit decided In re Bilski, 545 F.3d 943 (Fed. Cir. 2008) (en banc) ("Bilski II"), aff'd sub nom. Bilski v. Kappos, 130 S. Ct. 3218 (2010) ("Bilski III"), the Federal Circuit found the claims at issue to be patent-eligible under the machine-or-transformation test.  Prometheus Labs., Inc. v. Mayo Collaborative Servs., 581 F.3d 1336 (Fed. Cir. 2009) ("Prometheus I"), cert. granted, judgment vacated, and remanded, 130 S. Ct. 3543 (2010) ("Prometheus II"); see Charles R. Macedo & Michael J. Kasdan, ARE Patent Law Alert: Prometheus Labs v. Mayo Clinic: Federal Circuit Applies Transformation Prong of In re Bilski Test and Finds Drug Usage Method Claim to be Patentable Subject Matter Under Section 101 (Sept. 17, 2009).

The day after the Supreme Court issued its 5-4 decision in Bilski III, the Supreme Court issued a "grant-vacate-remand" ("GVR") order, in which it granted certiorari, vacated the Federal Circuit's decision in Prometheus I, and remanded the case for further proceedings consistent with the Court's decision in Bilski IIISee Prometheus II.  At the same time, the Court also issued a separate GVR order in another case in which the Federal Circuit found a similar claim to be patent ineligible for failing to meet the machine or transformation test as described in Bilski IICf.  Classen Immunotherapies, Inc. v. Biogen IDEC, 304 Fed. Appx. 866 (Fed. Cir. 2008) ("Classen I"), cert. granted, judgment vacated, and remanded, 130 S. Ct. 3541 (2010) ("Classen II").

On remand, in Prometheus III, as in Prometheus II, the Federal Circuit "again h[e]ld that Prometheus's asserted method claims [we]re drawn to statutory subject matter, and [] again reverse[d] the district court's grant of summary judgment of invalidity under § 101." 628 F.3d at 1349; see Charles R. Macedo, ARE Patent Litigation Alert:  Federal Circuit Turns Its Attention to Natural Phenomena Under 35 U.S.C. § 101 (Dec. 17, 2010).

After discussing the Supreme Court's holdings in Bilski III, Prometheus III characterized the issue on remand as follows:

[W]hether Prometheus's asserted claims are drawn to a natural phenomenon, the patenting of which would entirely preempt its use as in Benson and Flook, or whether the claims are drawn only to a particular application of that phenomenon as in Diehr.



628 F.3d at 1353. Prometheus III concluded the claims at issue were drawn to the latter, and thus were patent-eligible.

Prometheus III confirmed that, despite the GVR order by the Supreme Court in Prometheus II, "the Court did not disavow the machine-or-transformation test." 628 F.3d at 1356. Rather, the fact that the claims met the machine-or-transformation test was a relevant factor upon which the Federal Circuit could again rely to conclude that the claims were indeed patent-eligible subject matter.

The latest petition for certiorari poses the following detailed question concerning patent-eligible subject matter:

Whether 35 U.S.C. § 101 is satisfied by a patent claim that covers observed correlations between blood test results and patient health, so that the claim effectively preempts all uses of the naturally occurring correlations, simply because well-known methods used to administer prescription drugs and test blood may involve "transformations" of body chemistry.



Petition for Writ of Certiorari, Mayo Collaborative Servs. v. Prometheus Labs., Inc., No. 10-1150, 2011 U.S. LEXIS 4764 (U.S. Mar. 17, 2011) (No. 10-1150).  We will continue to monitor this case and other patent-eligible subject matter cases.

For more information on these developments, please contact one of our attorneys.



*Charles R. Macedo is a partner and Michael J. Kasdan was a partner at Amster, Rothstein & Ebenstein LLP. Their practice specializes in intellectual property issues including litigating patent, trademark and other intellectual property disputes. Charles may be reached at cmacedo@arelaw.com.

Mr. Macedo is also the author of The Corporate Insider’s Guide to U.S. Patent Practice, published by Oxford University Press in 2009.




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