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High Court Remands Myriad Isolated DNA Patent Challenge for Review in Light of Mayo

Monday, April 2, 2012
A week after its surprising unanimous decision rejecting method claim patent eligibility, the U.S. Supreme Court on March 26 remanded to the U.S. Court of Appeals for the Federal Circuit the case testing whether patent claims on isolated DNA are patent eligible subject matter under Section 101 of the Patent Act, 35 U.S.C. §101 (Association for Molecular Pathology v. Myriad Genetics Inc., U.S., No. 11-725, remanded 3/26/12).

The court granted the petition for writ of certiorari filed by the American Civil Liberties Union and the Public Patent Foundation on behalf of the Association of Molecular Pathology and other medical associations, eight individuals involved in medical research, two breast cancer counselors, and six women diagnosed with or seeking diagnosis for cancer.

However, it simultaneously vacated the appeals court's opinion and remanded the case for reconsideration in light of its decision in Mayo Collaborative Services v. Prometheus Laboratories Inc., No. 10-1150 (U.S. March 20, 2012) (54 PTD, 3/21/12). The court in Mayoheld that method steps encompassing well known activities cannot transform a law of nature into a patent-eligible application of such a law.

Parallels Between the Cases
At first glance, the issues in Mayo are different from those in Myriad.

The high court recognizes three exceptions to patent eligibility under Section 101--laws of nature, natural phenomena, and abstract ideas--often referred to together as “fundamental principles.” The Mayo method claims invoked the law of nature exception.

In Myriad, however, the isolated DNA claims challenged in the cert petition are on compositions of matter, not methods, and the challengers have referenced as unpatentable a “product of nature.” One interpretation is that the reference invoked the natural phenomenon exception.

Alternatively, the challengers' argument could be that isolated DNA is an unpatentable product based on a law of nature. To that end, the “inventive concept” of the Mayo claims was, according to the high court, a correlation between metabolite levels and drug efficacy, and arguably the inventive concept claimed by Myriad Genetics Inc. is a correlation between the specific genetic mutations it isolated--BRCA 1 and BRCA2--and breast cancer.

That possible parallel was analyzed in comments to BNA a day after theMayo opinion was issued (55 PTD, 3/22/12). According to one stakeholder, for example, the challengers could argue that, since the “transformation” by the human body creating the metabolites did not add “enough” to confer patent eligibility to the correlation in Mayo, the “human intervention” that takes extracted DNA and prepares it for sequencing is not be enough to save Myriad's correlation.

The high court's remand suggests that it expects the Federal Circuit to consider that or some other parallel with Mayo.

ACLU, PUBPAT Challenge Patent Eligibility.


The Myriad case arose from a 2009 declaratory judgment challenge by the ACLU and PUBPAT against patents for which Myriad is the exclusive licensee.

The plaintiffs argued that nine composition of matter and six method claims of the patents on the BRCA1 and BRCA2 genes were ineligible for patenting under Section 101.

Three Federal Circuit panel judges agreed that only one of the method claims and all claims to cDNA are patent eligible, but they split 2-1 as to claims to isolated DNA. Association for Molecular Pathology v. U.S. Patent and Trademark Office, 653 F.3d 1329, 99 USPQ2d 1398 (Fed. Cir. 2011) (147 PTD, 8/1/11).

The majority reversed a lower court's ruling against patent eligibility for such claims. 702 F. Supp. 2d 181, 94 USPQ2d 1683 (S.D.N.Y. 2010).

Question Presented: Patent Eligibility
In the petition, filed Dec. 7, the challengers phrased the question presented as: “Are human genes patentable?”

Gregory A. Castanias of Jones Day, Washington, D.C., represents Myriad and filed the brief in opposition Jan. 13.

“Rather, the question correctly answered by the Federal Circuit was whether particular isolated molecules of DNA, which were never available to the public until humans invented them, and whose utility is clear and unquestioned, were eligible for patenting as 'compositions of matter' under 35 U.S.C. §101,” Myriad argued.

Ten amicus briefs were filed, all supporting the petitioners.

Question Presented: Standing
The petitioners presented a second question as well, as to the requirements for standing in the case.

The appeals court held that only one plaintiff--Harry Ostrer, a researcher at New York University School of Medicine who was allegedly interested in sequencing the BRCA1 and BRCA2 genes--met the requirements for declaratory judgment standing under the Supreme Court's decision inMedImmune Inc. v. Genentech Inc., 549 U.S. 118, 81 USPQ2d 1225 (2007)--“a substantial controversy … of sufficient immediacy and reality” and “meaningful preparation” to conduct potentially infringing activity.

The petitioners asked the court to also consider:

Did the court of appeals err in adopting a new and inflexible rule, contrary to normal standing rules and this Court's decision in MedImmune …, that petitioners who have been indisputably deterred by Myriad's “active enforcement” of its patent rights nonetheless lack standing to challenge those patents absent evidence that they have been personally and directly threatened with an infringement action?

In its brief, Myriad reprised the argument that even Ostrer should have been denied standing, based on his move to a different lab just before the Federal Circuit's decision.

The ACLU and PUBPAT replied Jan. 20, primarily to counter Myriad's standing arguments.

The Federal Circuit may well have to consider the standing issue as well before reaching a decision on the merits.

Parties Respond
The ACLU issued a press release immediately after the high court's order was announced.

“In light of recent rulings from the court that mere laws of nature cannot be patented, we hope that the lower court will come to the correct conclusion this time around,” said Chris Hansen, staff attorney with the ACLU Speech, Privacy and Technology Project. “It's inconceivable that a company can own a patent on something as naturally occurring as DNA.”

“Nobody 'invents' genes, so no one should be able to claim ownership of them,” added Daniel B. Ravicher, executive director of PUBPAT and co-counsel in the lawsuit. “We are not talking about a new drug or a new tool to fight cancer. We are talking about a genetic marker that occurs naturally in the human body. That cannot, and should not, be patented.”

However, Myriad's counsel Castanias discounted the effect of the Mayodecision. “Method claims like those that were at issue in Mayo are often drafted in broad and abstract fashion, while our claims are drawn to specific compositions of matter,” he told BNA March 26.

Second, “there is a long-standing history” of granting claims like those owned by Myriad, he said, citing the Patent and Trademark Office's 2001 Utility Examination Guidelines. “Isolation of the DNA molecules results in a human-made invention,” he said. “Tens of thousands of patent claims reliant on that interpretation.”

“Myriad's claims are something fundamentally different than what was at issue in Mayo,” Castanias said, predicting little or no impact of the decision on his case. “The composition of matter [claimed in Myriad's patents] never before existed. The public now has it available and can take advantage of it.”

Hansen's colleague at the ACLU's Women's Rights Project, Sandra Park, said in contrast, “In Myriad, we have repeatedly argued that the prohibition on laws and products of nature bars patents on isolated DNA, in part because patents on the DNA itself blocks follow-on testing and research,” referring to a significant concern evident in the Supreme Court's opinion.

“The court remanded and ordered the Federal Circuit to reconsider Myriadin light of Mayo, making clear that its Section 101 analysis applies to Myriad,” she said in an email message to BNA.

Castanias, however, said that the remand was not a surprise. “In Mayo, the court told the bar its latest thinking with respect to the scope of Section 101,” he said. “It is not unexpected they would then send our case back to the Federal Circuit.”


Certiorari petition at /uploadedFiles/Content/News/Legal_and_Business/Bloomberg_Law/Legal_Reports/MyriadCertPetDec7(1).pdf

Myriad opposition brief at /uploadedFiles/Content/News/Legal_and_Business/Bloomberg_Law/Legal_Reports/110725MyriadJan13(1).pdf

ACLU reply at /uploadedFiles/Content/News/Legal_and_Business/Bloomberg_Law/Legal_Reports/MyriadCertPetDec7(1).pdf


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