The Supreme Court’s 2011 term opened on October 3, 2011, with three notable cases on its docket related to patents. The three cases reflect the recent trend in Supreme Court jurisprudence granting certification on cases affecting rights related to patents. This e-alert highlights the three patent-related cases currently on the High Court’s docket.

Mayo Collaborative Services v. Prometheus Laboratories, Inc.

Like Biliske v. Kappos, the Supreme Court in this case will decide once again what is patentable under 35 U.S.C. § 101. The Court will decide specifically whether § 101 is satisfied by method claims that cover observed correlations between blood test results and patient health.

This case has a long history. The Supreme Court originally granted certiorari to hear the case seven years ago, but then dismissed the writ as improvidently granted in Laboratory Corp. of Am. Holdings v. Metabolit Labs., Inc., 548 U.S. 124, 135 (2006). Last year, the Court again granted certiorari, but subsequently vacated and remanded the case to allow the Federal Circuit to reconsider the question in light of Bilski v. Kappos.

The claims at issue cover methods that seek to optimize the therapeutic efficacy of thiopurine drugs in the treatment of gastrointestinal and non-gastrointestinal autoimmune diseases (e.g., Crohn’s disease and ulcerative colitis) while minimizing the drug’s toxic side effects. The claimed methods typically include one or two lettered steps: (a) administering a drug that provides 6-thioguanine (“6-TG”) (the active metabolite) to a person, and/or (b) determining the levels of the drug’s metabolites, 6-TG and/or 6-MMP, in the person. The measured metabolite levels are then compared to pre-determined metabolite levels, “wherein” the measured metabolite levels “indicate a need” to increase or decrease the level of drug to be administered so as to minimize toxicity and maximize treatment efficacy.

On remand, the Federal Circuit held that the asserted method claims are drawn to statutory subject matter under § 101. Specifically, the Federal Circuit found that Prometheus’s claims recite a patent-eligible application of naturally occurring correlations between metabolite levels and efficacy or toxicity, and thus do not wholly preempt all uses of the recited correlations. According to the Federal Circuit, the claims recite specific treatment steps, not just the correlations themselves. And the steps involve a particular application of the natural correlations – the treatment of a specific disease by administering specific drugs and measuring specific metabolites.

The Federal Circuit also found that the treatment methods claimed in Prometheus’s patents satisfy the transformation prong of the machine-or-transformation test. The Federal Circuit found two transformations – (1) transformation of the human body and of its components following the administration of a specific class of drugs, and (2) transformation of the various chemical and physical changes of the drugs’ metabolites that enable their concentrations to be determined.

On appeal to the Supreme Court, petitioner Mayo Collaborative Services has asked the high Court to decide whether 35 U.S.C. § 101 is satisfied by a patent claim that covers observed correlations between blood test results and patient health simply because well-known methods used to administer prescription drugs and test blood may involve “transformations” of body chemistry.

Oral argument is set for December 7, 2011.

Caraco Pharmaceutical Labs., Ltd. v. Novo Nordisk

In Caraco Pharmaceutical Labs., Ltd. v. Novo Nordisk, the Supreme Court will decide whether the Hatch-Waxman Act counterclaim provision (21 U.S.C. § 355(j)(5)(C)(ii)(I)) applies where (1) there is an approved method of using the drug that the patent does not claim, and (2) the branded manufacturer submits “patent information” to the FDA that misstates the patent’s scope, requiring correction.

The Hatch-Waxman Act enables a generic manufacturer in a Paragraph IV suit to assert a counterclaim challenging the accuracy of the patent information submitted to the FDA by the listed drug manufacturer:  

[The ANDA] applicant may assert a counterclaim seeking an order requiring the holder to correct or delete the patent information submitted

by the holder . . . on the ground that the patent does not claim either –  

(aa) the drug for which the application was approved; or

(bb) an approved method of using the drug.

21 U.S.C. § 355(j)(5)(C)(ii)(I). The interpretation of this counterclaim provision is the central issue in the case.

The Federal Circuit held that the Hatch-Waxman Act authorizes a counterclaim only if the listed patent does not claim any approved methods of using the listed drug. Moreover, according to the Court, the counterclaim provision does not authorize an order compelling a patent holder to change its use code narrative – rather, it only authorizes suits to correct or delete an erroneous patent number or expiration date.

Oral argument is set for December 5, 2011.

Kappos v. Hyatt

The Supreme Court in Kappos v. Hyatt will address evidentiary issues related to § 145 actions. Specifically, the Court will decide: (1) whether the plaintiff in a § 145 action may introduce new evidence that could have been presented to the agency in the first instance, and (2) whether, when new evidence is introduced under § 145, the district court may decide de novo the factual questions to which the evidence pertains, without giving deference to the prior decision of the United States Patent and Trademark Office.

The Federal Circuit considered the issues posed in Kappos v. Hyatt en banc. The Court characterized a § 145 action as a “hybrid” between an appeal and a de novo proceeding. It also held that issues that were not considered by the patent office cannot be raised with the district court in most circumstances. And if no new evidence is introduced, a district court should review the action on the administrative record, subject to the court/agency standard of review. However, once an applicant introduces new evidence on an issue, a district court should review the issue de novo.

The Federal Circuit further held that 35 U.S.C. § 145 imposes no limits on an applicant’s right to introduce new evidence before a district court, apart of course from the limitations for all civil actions contained in the Federal Rules of Evidence and Federal Rules of Civil Procedure. As with any evidence introduced in a civil action, the district court as fact-finder may give less weight to evidence introduced by an applicant in a § 145 action if the district court questions its credibility or reliability.

A date for oral argument in front of the Supreme Court has not yet been set.