Multi-Faceted Argument for Patent Eligibility Of Medical Treatment Methods in High Court

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By Tony Dutra

Medical treatment method patent owner Prometheus Laboratories Inc. responded Oct. 31 to the Mayo Clinic's claim that observed correlations between blood test results and patient health are not patent-eligible subject matter under 35 U.S.C. §101 (Mayo Collaborative Services v. Prometheus Laboratories Inc., U.S., No. 10-1150, briefing completed 11/7/11).

The company's brief presented several doctrinal arguments to support its position, and it further tried to distinguish its patent claims from those at issue in the LabCorp case five years ago.

Prometheus's views were supported seven days later by nine amicus briefs, including those filed by the two national intellectual property law associations and by the Pharmaceutical Research and Manufacturers of America and Biotechnology Industry Organization.

Oral arguments are scheduled for Dec. 7.

Patent for Measurement of Metabolite Levels

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 measure the level of two metabolites, whereby metabolite levels greater than 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 suit against Mayo Collaborative Services, a subsidiary of Mayo Clinic. Prometheus alleged that Mayo's tests measuring the same metabolites infringe the patents.

Federal Circuit Rules Twice Against Mayo

The Federal Circuit in a 2009 ruling overturned a lower court's finding of patent ineligibility. The court applied its then-definitive “machine-or-transformation” (MoT) test, determining that the claims met the transformation prong of the test. The Supreme Court's Bilskidecision, however, declared the MoT test to be a valuable tool, but not determinative. Bilski v. Kappos, 129 S.Ct. 2735, 95 USPQ2d 1001 (2010) (123 PTD, 6/29/10).

A day after Bilski, the Supreme 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 (124 PTD, 6/30/10).

On remand, a reconstituted Federal Circuit panel last December again upheld the patentability of the disputed claims. Prometheus Laboratories Inc. v. Mayo Collaborative Services, 628 F.3d 1347, 97 USPQ2d 1097 (Fed. Cir. 2010) (243 PTD, 12/21/10).

The court used the MoT test as an investigative tool, as the high court had allowed in Bilski, and again held that the claims asserted passed the transformation prong of the test. The court further 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; that the testing steps were not mere data gathering; and that a final “warning” step requiring no physical action by a physician did not negate patent eligibility.

The question presented in Mayo's March 17 certiorari petition was:

 

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.

The high court granted certiorari June 20.

The LabCorp Backdrop

The Supreme Court addressed a similar patent claim in LabCorp in 2005. The court first granted certiorari and then determined that it was improvidently granted. Laboratory Corporation of America Holdings d/b/a LabCorp v. Metabolite Laboratories Inc., 548 U.S. 124, 79 USPQ2d 1065 (2006) (121 PTD, 06/23/06).

Five members of the current court joined the majority in dismissing the LabCorp case. Chief Justice John G. Roberts Jr. took no part in the decision.

Justice Stephen G. Breyer, joined by now retired Justices David H. Souter and John Paul Stevens, dissented to the dismissal. “The parties and amici have fully briefed the question,” the justices argued. “And those who engage in medical research, who practice medicine, and who as patients depend upon proper health care, might well benefit from this Court's authoritative answer,” the dissent contended.

Mayo Relies on LabCorp, Preemption

Mayo filed its brief on the merits Sept. 2. “The Federal Circuit … glossed over the analysis in Justice Breyer's LabCorp opinion,” according to the brief, authored by Stephen M. Shapiro of Mayer Brown, Chicago.

Mayo made two arguments to support its reliance on the three dissenters in LabCorp, even though only Breyer remains on the court. First, Mayo claimed that the three opinions written in Bilski “each referenced LabCorp approvingly.” Second, the brief argued, “Justice Breyer's opinion [is] the only word by any Justice on the merits of this critical issue.” The brief quoted Breyer's dissenting opinion eight times.

Mayo's primary argument, though, was that the preemption doctrine trumps a finding that the patent claim passes the MoT test. “[T]he Federal Circuit reasoned that ‘the claims do not preempt all uses of the natural correlations; they utilize them in a series of specific steps,' ” Mayo said, “failing to recognize that the steps recited in the claims that lead up to a physician's review of the correlations are not uses of the correlations, and failing to recognize that the claims cover and preempt anything that a physician might do with the correlations.”

The patent challenger concluded that “transformations” do not automatically impart patent eligibility if they “are incidental to data-gathering, have no limiting effect on the claimed monopoly, and lack any connection to the goal of the patent system to promote innovation.”

The Mayo brief also relied considerably on a second phrase from the question presented, that the correlation step in Prometheus's method claim is supplemented only by “well-known” steps—“administering” a drug and “determining” metabolite levels—of gathering the information needed to make the correlation. The phrase was mentioned 14 times in the text of the brief; the phrase “long prevalent” was referenced another five times.

Those terms typically arise in an anticipation or obviousness context, in challenges to patent claims that otherwise pass muster under Section 101. However, the Supreme Court's Section 101 jurisprudence has repeatedly relied on what many in the patent community argue is a case on obviousness, Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 76 USPQ 280 (1948).

U.S. Brief Distinguishes Section 101 From 102/103

Solicitor General Donald B. Verrilli Jr. filed a brief on behalf of the U.S. government, also signed by Patent and Trademark Office representatives.

The brief asked the court to affirm the Federal Circuit's decision. “Petitioners have raised powerful arguments against affording patent protection to respondent's process,” the government acknowledged. “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.”

Other friends of the court filed 11 separate briefs within a week of Mayo's filing. Six supported Mayo with a variety of arguments, including a request that the court consider the First Amendment of the Constitution as a bar to patent eligibility. The medical establishment, in a brief filed by 11 associations including the American Medical Association, argued that “health care will be undermined if conventional medical applications of scientific observations of naturally-occurring bodily processes can be patented.”

Among those supporting neither party, a brief by four medical services companies countered, “A ruling that novel and nonobvious diagnostic tests are ineligible for patent protection would cripple the nascent personalized medicine industry.”

Prometheus Cites Federal Circuit's Claim Construction

Prometheus's brief was submitted by Richard P. Bress of Latham & Watkins, Washington, D.C.

As a central attack on Mayo's position, Prometheus rephrased the question presented:

 

Whether the Federal Circuit correctly held that concrete methods for improving the treatment of patients suffering from autoimmune diseases by using individualized metabolite measurements to inform the calibration of the patient's dosages of synthetic thiopurines are patentable processes under 35 U.S.C. §101.

Indeed, to emphasize the point, the brief used the word “concrete” to describe the asserted methods 12 times.

Prometheus rested much of its defense on its view that the Federal Circuit construed the claims at issue “as limited to the patient treatment context,” even though the appeals court never specifically referred to its own construction of claimed terms. That approach countered Mayo's charge that Prometheus wanted to enforce its patented claims against those who merely thought about the correlations, one of Breyer's concerns in the LabCorp dissent.

“The claims in this case are also drawn far more narrowly than the diagnostic method that the dissenters found objectionable in LabCorp,” the brief claimed. “Unlike Prometheus's claims, the claim in LabCorp was not limited to improving a specific medical treatment.”

Other Arguments Counter Mayo

Prometheus provided additional counter-arguments to Mayo's challenges.

• The patent owner argued that dismissing the first two steps as “well-known” amounted to creating a “point-of-novelty” approach that the Supreme Court rejected in Diamond v. Diehr, 450 U.S. 175, 209 USPQ 1 (1981).

• All patents “preempt particular applications of scientific knowledge,” Prometheus contended, but its claims do not preempt the underlying scientific principles themselves.

• The brief said that any categorical rule requiring an action step at the end “would just multiply byzantine claim drafting, [as a] patentee would be required to attempt to set out and claim all of the manifold branches of possible therapeutic decision trees.”

Prometheus also directed one argument to the government. Though the company appreciated the solicitor general's support of its Section 101 argument, it added, “With due respect to the government's preliminary thoughts, the complexity of the issues it raises argues powerfully against this Court making any determination about the appropriate analysis of these claims under §§102 or 103 without the benefit of factual development and full briefing.”

The respondent claimed that difficult questions of inherency were at issue and should be left for litigation on remand. “To weigh in prematurely, even in dicta, would risk unforeseen consequences and untoward damage to countless diagnostic patents and computer-aided inventions that end with algorithms permitting users to interpret information,” Prometheus said.

PhRMA, BIO, AUTM Support Prometheus

Nine more amicus briefs were filed by the Nov. 7 deadline. The major pharmaceutical and biotechnology associations decidedly favored Prometheus's views.

The PhRMA brief was filed by Harry J. Roper of Jenner & Block, Chicago. “Today, ‘the most important advances in treatment' often come from new uses for existing pharmaceuticals—products ‘whose properties were not completely understood until intensive research after the drug was introduced,' ” the brief said, quoting from a journal article by John Calfee, “The Golden Age of Medical Innovation,” The American (Mar./Apr. 2007).

Jeffrey P. Kushan of Sidley Austin, Washington, D.C., submitted a brief on behalf of BIO. “Announcing a broad rule of ineligibility concerning diagnostic and therapeutic methods that exploit knowledge gained from the study of biological systems would threaten harm to the biotechnology industry,” he said, “and devastation to the nascent field of ‘personalized medicine,' which promises substantial benefits to patients through its capacity to match focused and appropriate treatments and improved diagnostic methods.”

The brief by the Association of University Technology Managers, filed by Donald R. Ware of Foley Hoag, Boston, also expressed alarm that the loss of the patent incentive would greatly harm innovation, from the perspective of technology transfer organizations associated with research universities.

U.S. IP Associations Back Prometheus As Well

A brief filed by the Intellectual Property Owners Association, submitted by Gary M. Hoffman of Dickstein Shapiro Morin Oshinsky, Washington, D.C., cited the same industry-based policy reasons, and then appeared to define a categorical rule for use of the MoT test.

“Transformative methods of treatment should be patent-eligible,” the IPO argued succinctly. “In the context of a specific category of disease, a novel method for the application of a naturally-occurring correlation with treatment steps that involve transformations of the body is eligible for patent protection.”

In the earlier round of amicus briefs, the New York Intellectual Property Law Association made a similar argument, urging the court to go one step beyond Bilski. “NYIPLA respectfully submits that in order for the machine-or-transformation test to remain a useful tool, the Section 101 inquiry must end when the test is met,” wrote Ronald M. Daignault of Robins, Kaplan, Miller & Ciresi, New York.

The American Intellectual Property Law Association's brief, filed by Denise W. DeFranco of Finnegan, Henderson, Farabow, Garrett & Dunner, Cambridge, Mass., added an argument in the context of the recently enacted patent reform legislation, the America Invents Act.

“In the AIA, Congress amended many provisions of the patent statute, but notably Congress declined to amend section 101, even though the process included numerous occasions for it to consider policy issues concerning patentable subject matter,” according to the brief. In fact, the AIPLA said, Congress seriously considered limitations on diagnostic methods of genetic testing, but only as to second opinions and only with respect to exclusive licensing, and ultimately did no more than call for a study.

Four More Briefs Against Mayo

“When considering the patent eligibility of medical diagnostic processes, this court should take care not to disrupt patenting of software and other computer technologies,” according to a brief filed by Erika H. Arner of Finnegan, Henderson, Farabow, Garrett & Dunner, Reston, Va., on behalf of SAP America Inc., in favor of affirming the Federal Circuit's opinion.

Myriad Genetics Inc. filed a brief, authored by Gregory A. Castanias of Jones Day, Washington, D.C. supporting Prometheus.

Myriad is involved in a Section 101 case of its own, on the patent eligibility of isolated DNA patent claims. Association for Molecular Pathology v. U.S. Patent and Trademark Office, No. 2010-1406, 99 USPQ2d 1398 (Fed. Cir. 2011) (147 PTD, 8/1/11). Its opponents, the American Civil Liberties Union and the Public Patent Foundation, recently announced plans to file a petition for writ of certiorari in that case (199 PTD, 10/14/11).

Evan A. Young of Baker Botts, Austin, Texas, filed Novartis Corp.'s brief, which went further than Prometheus to argue that the claims in LabCorp, in fact, should be considered patent-eligible.

Paul R. Juhasz of the Juhasz Law Firm in Houston filed a brief offering a revised version of the MoT test as a Section 101 standard. “The clue to patentability should lie in whether steps that are central to the claim (i.e., not token extra-solution activity) have a ‘physical' or ‘virtual' link to a specific physical or tangible object,” Juhasz said.


Prometheus's brief at http://pub.bna.com/ptcj/101150PrometheusOct31.pdf  

Mayo's brief at http://pub.bna.com/ptcj/101150MayoSep2.pdf  

Hoffman is a member of this journal's board of advisors.