Patent Law

Prometheus Labs. v. Mayo Clinic (Fed. Cir. 2009)

In a unanimous panel opinion, the Federal Circuit has rejected Mayo's patentable subject matter challenge under 35 U.S.C. 101 - holding that the claimed methods for calibrating a drug dosage were properly the subject of patent protection. The lower court had found the claims invalid under Section 101.

In its decision, the Federal Circuit applied its recent Bilski precedent.

The proper inquiry under § 101 is whether these methods meet the Supreme Court?s machine or transformation test articulated in Benson and Diehr, and applied in Bilski, and, if so, whether the machine or the transformation is central to the purpose of the claims.

Of course, Bilski is now on appeal at the Supreme Court.

The claimed method is essentially an iterative testing mechanism where the treatment drug is injected in the patient and the patient's subsequent metabolic response is measured. The next dosage is then re-calibrated based upon the measured metabolic response.

Holding: Following Bilski, the Federal Circuit ruled that the required administration of a drug "transforms an article into a different state or thing" and that the transformation was an "integral" part of the calibration method. As such, the claims satisfy the patentable subject matter test of Bilski.

To be patentable, the claim must not wholly preempt the use of a natural process. Here, the court only weakly rebutted Mayo's argument:

The claims cover a particular application of natural processes to treat various diseases, but transformative steps utilizing natural processes are not unpatentable subject matter. Moreover, the claims do not preemptnatural processes; they utilize them in a series of specific steps.

Method of Diagnosis: The court was clear to distinguish the Prometheus claims from diagnosis claims that merely requiring data gathering and correlation rather than an injection of drugs.

The asserted claims are in effect claims to methods of treatment, which are always transformative when a defined group of drugs is administered to the body to ameliorate the effects of an undesired condition. . . .

The crucial error the district court made in reaching the opposite conclusion was failing to recognize that the first two steps of the asserted claims are not merely data-gathering steps. . . . [T]he administering and determining steps are part of a treatment protocol, and they are transformative.

Thus, this decision at least suggests that the asserted diagnosis claim in LabCorp v. Metabolite would not be patentable. That claim involved only two steps: (1) assaying a body fluid for its homocysteine level; and (2) correlating high homocysteine with a vitamin deficiency.

Despite the stated distinctions, this case could be seen as a muted challenge to the Supreme Court and especially to Justice Breyer's dissent from the Court's late dismissal of its grant of certiorari. In its one sentence reflection on Breyer's dissent, the Federal Circuit opinion merely indicates that opinion's lack of precedential value and that the claims are "different."

In reaching its conclusion, the district court relied heavily on the opinion of three justices dissenting from the dismissal of the grant of certiorari in Laboratory Corp. of America Holdings v. Metabolite Laboratories, Inc., 548 U.S. 124 (2006) (Breyer, J., dissenting). . . . That dissent is not controlling law and also involved different claims from the ones at issue here.

The court was clear the parties did not dispute other validity issues such as obviousness or novelty, but rather focused solely on the question of patentable subject matter.

Chances for Supreme Court Review: The setup of this case makes is a good candidate for Supreme Court review especially if the Court is not fully satisfied by its Bilski decision. The Supreme Court has regularly used case clustering in the past when considering patent issues: Nonobviousness (John Deere (1966), Adams (1966), & Anderson's-Black Rock (1969)); Patentable subject matter (Flook (1978), Charkabarty (1980), Diehr (1980)); Prosecution history estoppel (Warner-Jenkinson (1995) & Festo (2000)).

Notes: Judge Lourie drafted the opinion which was joined by Chief Judge Michel. District Court Judge Clark (E.D.Tex.) joined the panel sitting by designation.