Tag: prometheus

USPTO Preliminary Guidelines Spread Mayo on Patent-Eligibility

The National Law Review recently published an article by Christopher L. Drymalla, Jeffrey B. Swartz, Jeffrey S. Whittle and Michael R. Samardzija, Ph.D. of Bracewell & Giuliani LLP regarding Patent-Eligibilty:

A day after the United States Supreme Court delivered its decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc.,1 the United States Patent and Trademark Office issued preliminary guidance2 instructing examiners to reject process claims that invoke laws of nature and only add steps which constitute “well-understood, routine, conventional activity” that is described in the most general of terms regardless of whether there is a transformation involved.

According to the Patent Office, although the “machine or transformation test” remains an “important and useful clue,” it is not to be considered “the sole or a determinative test” for eligibility as it does not “trump the ‘law of nature’ exclusion.” Moreover, the Mayo decision reinforces the need for a patent applicant whose claims include a law of nature, a natural phenomenon, or an abstract idea to ensure the “claimed product or process amounts to significantly more than a law of nature, a natural phenomenon, or an abstract idea with conventional steps specified at a high level of generality appended thereto.” (emphasis in original). Although the guidelines put special importance on process claims as were at stake in Mayo, the guidelines appear to indicate this analysis may apply to all claims related to laws of nature, natural phenomena, or abstract ideas.

Neither the guidelines nor Mayo provide specific guidance for what would make a product or process significantly more than a law of nature, a natural phenomenon, or an abstract idea. Nevertheless, the Patent Office sees the claim at issue inMayo as a prime example of one which merely includes a highly general and conventional step of which patent examiners are expected to be more cautious.  As explained in the guidelines, the claims in Mayo emphasize the “law of nature” correlation between the concentration of the drug and its threshold limits for therapeutic effects and harmful side effects.

Simply adding the well-understood, routine, conventional actions of administering the drug and checking its blood concentration in the most general of terms, however, does not confer patent eligibility as the claims themselves are “effectively directed to the [law of nature] exception itself.” Based on the new guidelines, an examiner confronting a similar claim set is directed to reject the claim as non-statutory subject matter under 35 U.S.C. § 101 (utility or patent-eligibility requirement section). The guidelines do specifically note that the applicant in such a case will then have the opportunity to defend the claim and show why it is not drawn to the patentability exception itself. The applicant will have to rely on other claim limitations to support the argument.

The Patent Office’s guidelines suggest that the Mayo decision should be viewed as a cautionary tale for applicants who intend to direct claims to inventions which arguably incorporate the use of laws of nature, natural phenomena, or abstract ideas.

Should you have any questions, please contact your Bracewell & Giuliani LLP patent attorneys. We will, of course, keep you advised as to any new developments in this area.

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1No. 10-1150, 566 U.S. ___, 2012 WL 912952 (S. Ct. Mar. 20, 2012) (for a more thorough discussion of Mayo and the particular facts and determinations involved,see Update: Can’t Touch This – Supreme Court Finds Personalized Medicine Patent Claims Invalid, Bracewell & Giuliani LLP (Mar. 20, 2012).

2See Memorandum: Supreme Court Decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc. (Mar. 21, 2012).

© 2012 Bracewell & Giuliani LLP

Supreme Court Invalidates Biotech Method Patent in Mayo v. Prometheus

Recently an article by Richard G. Gervase, Jr. and Daniel W. Clarke, Ph.D. of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. regarding Biotech Patents recently appeared in The National Law Review:

On March 20, 2012, the United States Supreme Court handed down a groundbreaking decision in the field of biotechnology; however, the repercussions of this decision will be felt throughout the patent community. In a highly anticipated decision, the Court reversed the United States Court of Appeals for the Federal Circuit in Mayo Collaborative Services and Mayo Clinic Rochester v. Prometheus Laboratories, Inc., unanimously finding that process claims directed to optimizing the dosage of a drug for treatment of an immune-mediated gastrointestinal disorder are invalid because they effectively claim no more than an underlying law of nature.

The two patents at issue are exclusively licensed to Prometheus, who sells diagnostic tests that employ the patented processes. At first, Mayo bought and used these diagnostic tests; however, in 2004, Mayo decided to use and sell a slightly different diagnostic test. Prometheus responded by bringing an infringement action in the United States District Court for the Southern District of California, which found that although Mayo infringed a claim of a Prometheus-licensed patent, the asserted claims were invalid for being drawn to non-statutory subject matter. The District Court reasoned that the patents claimed “natural laws or natural phenomena,” which are not entitled to patent protection. Specifically, the District Court opined that the correlations between metabolite levels and the toxicity and efficacy of drug dosages are patent-ineligible laws of nature. The Federal Circuit reversed, and held that the claims were directed to patent-eligible subject matter because they “transform an article into a different state or thing,” and the transformation was “central to the purpose of the claimed process.” The Federal Circuit subsequently reaffirmed this decision on remand from the Supreme Court for reconsideration in view ofBilski v. Kappos.

The question presented to the Supreme Court in Mayo v. Prometheus was “whether the claimed processes have transformed unpatentable natural laws into patent-eligible applications of those laws.” The Court recognized that the threshold inquiry to determine whether a claim is directed to patent-eligible subject matter is governed by 35 U.S.C. § 101, which provides “[w]hoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.”

The representative claim analyzed by the Court was directed to methods of calibrating the optimal dosage of a thiopurine drug by administering the drug, and determining the level of subsequent metabolites, where certain metabolite levels correlate with certain results. The Court relied on case precedent, including Diamond v. Diehr and Gottschalk v. Benson, for the proposition that the meaning of “process” in § 101 has been limited to exclude fundamental principles, such as “laws of nature, natural phenomena, and abstract ideas,” but noted that “an application of a law of nature or mathematical formula to a known structure or process may well be deserving of patent protection.” The Court concluded that the claims were not patent eligible, reasoning that the claims were merely instructions to apply a natural law, i.e., a natural correlation.

Specifically, the Court stated that the additional steps of “administering” and “determining,” along with the “wherein” clauses, “add nothing specific to the laws of nature other than what is well-understood, routine, conventional activity, previously engaged in by those in the field.”

Although the Court recognized that in determining whether additional claim steps are routine or conventional, a § 102 novelty inquiry and a § 101 statutory subject matter inquiry “might sometimes overlap,” Justice Breyer repeatedly emphasized that from a policy perspective, a patent should not preempt natural correlations, thereby improperly inhibiting future innovation. The Court also warned that a non-statutory law of nature cannot be transformed into subject matter that is eligible for patent protection by mere clever claim drafting that amounts to no more than “insignificant post-solution activity.”

How the Supreme Court’s decision will impact medical diagnostic patents and patent applications in the future remains to be seen. We note that the Court declined to opine on the desirability of increased protection for diagnostic correlations, inviting Congress to develop “more finely tailored rules” for patent eligibility should the legislature disagree with the Court’s conclusion.

©1994-2012 Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.