High Court Says Personalized Medicine Claims Not Patent Eligible Under Section 101

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By Tony Dutra  

A unanimous U.S. Supreme Court determined March 20 that claims on methods of use in the field of personalized medicine—adjusting a drug dosage after observing a patient's reaction to a drug administration—are not patent eligible subject matter under 35 U.S.C. §101 (Mayo Collaborative Services v. Prometheus Laboratories Inc., U.S., No. 10-1150, 3/20/12).

Overturning the U.S. Court of Appeals for the Federal Circuit, the court said that “to transform an unpatentable law of nature into a patent-eligible application of such a law, one must do more than simply state the law of nature while adding the words ‘apply it.' ”

The court concluded that the steps of the claims at issue in this case failed to “add enough” to the “inventive concept” of Prometheus Laboratories Inc.'s patents—the correlations between metabolite levels and effectiveness of the drug.

While the court provided no standards for determining when steps provide “enough,” it indicated that the inventive concept must be embedded in the application rather than in the law of nature.

The decision clears the way for Mayo Collaborative Services, a subsidiary of the Mayo Clinic, to introduce a competing diagnostic test.

Justice Stephen G. Breyer wrote the opinion of the court. Breyer is the lone remaining member of the court who dissented to dismissal of a similar case in 2005.

Federal Circuit Rules Twice Against Mayo

Prometheus is the exclusive licensee of two patents (6,355,623 and 6,680,302) which involve measuring the level of certain metabolites in the blood of patients taking thiopurine drugs, including the anti-Crohn's disease drug azathioprine, for treatment of autoimmune diseases.

The patented test is claimed as methods providing a means to administer a drug to a subject and then determine the metabolite levels, wherein metabolite levels outside certain threshold levels of either one provide a “warning” of toxicity or inefficacy and indicate to the treating physician that an adjustment in drug dosage may be required. The claims at issue do not include a step for further action by the physician.

Prometheus brought a patent infringement lawsuit against Mayo alleging that Mayo's tests measuring the same metabolites infringe the patents, though Mayo identified other threshold ranges as optimal.

The Federal Circuit in a 2009 ruling overturned a lower court's finding of patent ineligibility. The appeals court determined that the claims met the transformation prong of its then-definitive machine-or-transformation test. The Supreme Court, however, declared the machine-or-transformation test to be a valuable tool, but not determinative. Bilski v. Kappos, 129 S.Ct. 2735, 95 USPQ2d 1001 (2010).

A day after Bilski, the high court granted Mayo's petition for certiorari in the instant case, vacated the appellate court's panel decision, and remanded the case to the Federal Circuit for reconsideration in light of the Bilskidecision.

On remand, the appeals court again confirmed the patentability of the disputed claims. Prometheus Laboratories Inc. v. Mayo Collaborative Services, 628 F.3d 1347, 97 USPQ2d 1097 (Fed. Cir. 2010).

The court first repeated the results of its machine-or-transformation test. The court went further, though, and concluded that:

• the asserted claims did not preempt all uses of the correlations between the results of the diagnostic tests and the toxicity and efficacy of the drug dosage;

• the administration and determination steps were not mere data gathering; and

• the final warning step requiring no physical action by a physician did not negate patent eligibility.

The high court granted certiorari June 20. The patent community was strongly engaged, with 26 amicus briefs filed.

The LabCorp Backdrop

The court was faced with a similar patent claim in 2005 in Laboratory Corporation of America Holdings d/b/a LabCorp v. Metabolite Laboratories Inc., 548 U.S. 124, 79 USPQ2d 1065 (2006). The court first granted certiorari and then determined that it was improvidently granted.

Five members of the current court joined the majority in dismissing the LabCorp case. Breyer, joined by now retired Justices David H. Souter and John Paul Stevens, dissented to the dismissal, asserting that the court could find the claim invalid under Section 101 based on the record.

‘Peek' Into 102/103 Predicted at Oral Arguments

In the instant case at oral arguments Dec. 7, Breyer appeared to have softened his views in light of a brief on behalf of the U.S. government. The government supported Prometheus's patent eligibility argument, but said in its brief, “Properly conceived, however, petitioners' objections arise not under Section 101, but under the novelty and nonobviousness requirements of 35 U.S.C. 102 and 103.”

Breyer acknowledged that his dissent to the LabCorp dismissal did not provide an adequate standard for “how much must be added” to steps already known in the prior art to make a claim patent eligible under Section 101.

In fact, he cited Novartis Corp.'s amicus brief for noting “what my opinion lacked, frankly.” The Novartis brief had pointed out the same concerns expressed in the U.S. government's brief, but Novartis specifically attacked Breyer's LabCorp dissent for trying to come up with a categorical rule under Section 101 when Sections 102, 103, and 112 “are fully capable of addressing [the LabCorp dissent's] concerns.”

But Justice Anthony M. Kennedy remarked, “It's hard to resist the temptation to peek into the obvious component or the nonobvious component and then go back and apply it to 101.”

Breyer's March 20 opinion certainly “peeked,” with a number of references to what was “well known in the art.”

The Intersection of Basic Principles

The opinion began by citing the “intersection” of two basic principles. While the court has repeatedly said that laws of nature, natural phenomena, and abstract ideas are not patentable, it has added that an application of such laws, phenomena, or ideas may be patent eligible.

The court thus set the question as “whether the claimed [Prometheus] processes have transformed these unpatentable natural laws into patent-eligible applications of those laws.”

After describing the Prometheus claims in more detail, the court asked, “To put the matter more precisely, do the patent claims add enough to their statements of the correlations to allow the processes they describe to qualify as patent-eligible processes that apply natural laws? We believe that the answer to this question is no.”

Prometheus Claim Steps Not ‘Enough.'

The court concluded that a representative claim provided for an “administering” step, a “determining” step, and a “wherein” step, none of which were “sufficient to transform the nature of the claim”:

• The administering step failed because it merely identified a “pre-existing audience” of doctors treating the relevant diseases at issue here.

• The determining step failed because “methods for determining metabolite levels were well known in the art. … Purely ‘conventional or obvious' ‘[pre]-solution activity' is normally not sufficient to transform an unpatentable law of nature into a patent-eligible application of such a law.”

• The wherein step failed because it simply told the targeted audience about the law of nature.

The ordering of the three steps added nothing to confer patent eligibility, the court said, because “the combination amounts to nothing significantly more than an instruction to doctors to apply the applicable laws when treating their patients.”

The court thus concluded:


To put the matter more succinctly, the claims inform a relevant audience about certain laws of nature; any additional steps consist of well-understood, routine, conventional activity already engaged in by the scientific community; and those steps, when viewed as a whole, add nothing significant beyond the sum of their parts taken separately. For these reasons we believe that the steps are not sufficient to transform unpatentable natural correlations into patentable applications of those regularities.

Precedents Support Conclusion

The court found support from multiple precedents, with a focus on distinguishing the patent eligible claims in Diamond v. Diehr, 450 U.S. 175, 209 USPQ 1 (1981), from the unpatentable claims in Parker v. Flook, 437 U.S. 584, 198 USPQ 193 (1978).

Both involved use of a mathematical formula—“like a law of nature,” the court said. However, the court in Diehr “nowhere suggested that [the application] steps, or at least the combination of those steps, were in context obvious, already in use, or purely conventional,” the instant court said. In contrast, the additional claim steps in Flook“were all ‘well known,' to the point where, putting the formula to the side, there was no ‘inventive concept' in the claimed application of the formula.”

The representative claim at issue in the instant case is “no stronger than the (unpatentable) claim in Flook,” the court said.

Claims Cannot Tie Up Further Invention

“The Court has repeatedly emphasized … a concern that patent law not inhibit further discovery by improperly tying up the future use of laws of nature,” the opinion continued, citing precedents back to its 1853 decision in O'Reilly v. Morse, 56 U.S. (15 How.) 62 (1853), denying patent eligibility to a claim on the use of telegraphy in general.

“[T]here is a danger that the grant of patents that tie up the[] use [of new laws of nature and principles] will inhibit future innovation premised upon them, a danger that becomes acute when a patented process amounts to no more than an instruction to ‘apply the natural law,' or otherwise forecloses more future invention than the underlying discovery could reasonably justify,” the court explained.

The court rejected the argument, made by both Prometheus and some amicus briefs, that a law of nature relevant only to a limited application eliminates this concern about future innovation:


[T]he underlying functional concern here is a relative one: how much future innovation is foreclosed relative to the contribution of the inventor. … A patent upon a narrow law of nature may not inhibit future research as seriously as would a patent upon Einstein's law of relativity, but the creative value of the discovery is also considerably smaller. And, as we have previously pointed out, even a narrow law of nature (such as the one before us) can inhibit future research.

Contrary Arguments Rejected

The court criticized the Federal Circuit's ruling below for its continued reliance on the machine-or-transformation test. The court said, “in stating that the ‘machine-or-transformation' test is an ‘important and useful clue‘ to patentability, we have neither said nor implied that the test trumps the ‘law of nature’ exclusion,” referring to its Bilskiholding.

The government's argument—using Section 101 as a coarse filter and relying on Sections 102, 103, and 112 to screen for unworthy patents—was no more persuasive. “[T]o shift the patent eligibility inquiry entirely to these later sections risks creating significantly greater legal uncertainty, while assuming that those sections can do work that they are not equipped to do,” the court said.

The court explicitly declined to address another argument made by Prometheus and supporting amici as to the incentive value of patents specifically in advancing diagnostic research. Noting that other parts of the medical establishment expressed opposing concerns in amicus briefs, the court said that “patent law's general rules must govern inventive activity in many different fields of human endeavor, with the result that the practical effects of rules that reflect a general effort to balance these considerations may differ from one field to another.”

According to the court, it is for Congress to decide whether “increased protection for discoveries of diagnostic laws of nature is desirable.”

The court thus reversed the Federal Circuit's ruling.

Mayo Supporters Surprised and Delighted

Proponents of Mayo's view in the case were quick to express their support of the high court's decision.

“We are pleased by the court's strong reaffirmation that patents on laws of nature and natural phenomena are invalid because they impede, rather than encourage, innovation,” according to Sandra Park, staff attorney for the American Civil Liberties Union's Women Rights Project. “The ruling will allow physicians and researchers to examine something as simple as how a patient reacts to a drug without fear of being sued for patent infringement.”

The ACLU is involved in a higher profile challenge under Section 101—against patents on isolated DNA—with a cert petition before the Supreme Court, Association for Molecular Pathology v. Myriad Genetics Inc.,No. No. 11-725 (U.S., review sought Dec. 7, 2012), and Park identified a connection to the Mayoresult.

“Similarly, patents on human genes are a barrier to advancements in genetic research because they grant a monopoly on the gene itself,” Park told BNA. “Today's decision bodes well for the ultimate outcome of the Myriad litigation.”

Joshua D. Sarnoff, professor at the DePaul University College of Law, Chicago, who submitted a brief on behalf of nine law professors supporting Mayo's position, told BNA that he was “surprised and delighted” by the result. “I did not expect the result, much less a unanimous decision,” he said.

“Although the court clearly understood the need for more than mere application of a new discovery, it continued to justify the requirement in terms of too much restriction on sequential invention, rather than on inadequate creativity of the claimed application,” Sarnoff added.

Bruce M. Wexler of Paul Hastings, New York, though, emphasized that the decision is a narrow one. “I am pleased that the court's decision remains focused on the particular patent at issue, rather than making broad pronouncements about patent-eligibility in fields of science,” he told BNA.

Patent Blogs Fault Justices for Conflating Provisions

Individuals who supported Prometheus's position have resisted requests for a same-day response to the surprising decision, and this journal will provide their considered responses in a follow-on report.

However, patent blogs have been quick to condemn the high court.

“In its opinion, the Supreme Court continues to make the all too common mistake of conflating patent eligibility with novelty and obviousness (inventive step) or claim breadth (§112),” according to a posting on the Inventive Step blog. Referring to the court's use of words such as “well understood” and “conventional” to describe the claim steps, the posting continued, “If the Court's statement is true, the claims should be unpatentable because they lack novelty or are obvious. There is simply no need to add another step of complexity to the analysis.”

The IP Watchdog blog agreed, in less kind terms. “The Supreme Court is wrong, and the fact that they have either through ignorance or intent conflated patent eligibility with novelty and non-obviousness will be a plague on the entire patent system for years to come,” according to the blog's president and founder, Gene Quinn.

He concluded, “It is truly troubling that all 9 of the Justices concurred in what history will regard as one of the worst decisions in the patent space EVER!”

Stephen M. Shapiro of Mayer Brown, Chicago, represented Mayo. Richard P. Bress of Latham & Watkins, Washington, D.C., represented Prometheus. Solicitor General Donald B. Verrilli Jr. represented the government's views at the Dec. 7 oral arguments.

For More Information

Opinion at http://pub.bna.com/ptcj/101150Mar20.pdf


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