The Supreme Court’s unanimous decision that isolated DNA is a product of nature and thus not patentable could undermine patents on biotechnology inventions that utilize DNA molecules, although the court’s support for the patentability of synthetic DNA may reduce the decision’s impact somewhat.

In its June 13 opinion in The Association of Molecular Pathology v. Myriad Genetics Inc., the court followed the advice of the Solicitor General and held that while DNA isolated from the body cannot be patented, complementary DNA is patentable since it is not naturally occurring. Justices had indicated during oral arguments that they were inclined to take this middle ground (See Also see "Supreme Court Appears Dubious Of Gene Patents, But Wary Of Halting Innovation" - Medtech Insight, 22 April, 2013..)

At issue in the case were Myriad patents covering the composition of DNA isolated from BRCA1 and BRCA2 genes, mutations of which are the cause of most cases of hereditary breast and ovarian cancers.

Writing for the court, Justice Clarence Thomas said Myriad’s principal contribution was uncovering the precise location and genetic sequence of the BRCA1 and BRCA2 genes within chromosomes 17 and 13. But he said the company “did not create anything.”

“To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention,” Thomas wrote.

Thomas noted that the court’s 1980 decision in Diamond v. Chakrabarty, in which it held that a genetically engineered microorganism useful for digesting oil spills was patent-eligible because it had “markedly different characteristics from any found in nature,” is central to the Myriad case. In contrast to the invention in Chakrabarty, he said Myriad did not create or alter the genetic structure of DNA.

As for complementary DNA, “the lab technician unquestionably creates something new when cDNA is made,” the court stated. “cDNA retains the naturally occurring exons of DNA, but it is distinct from the DNA from which it was derived.”

BRACAnalysis Patent Protection Extends Beyond 2018, Myriad Says

Myriad used the genetic sequence of the BRCA1 and BRCA2 genes to determine their typical nucleotide sequence. This discovery enabled it to develop its BRACAnalysis test to detect mutations in the genes. The American Civil Liberties Union and the Public Patent Foundation filed suit against Myriad on behalf of medical organizations, researchers and breast cancer and women’s health groups claiming that isolated DNA was not eligible to be patented. They contended that Myriad held a monopoly on BRAC gene testing and was blocking others from using alternative tests.

In a media teleconference, the ACLU said the ruling was a victory and would enable others to use competing tests. Harry Ostrer, a plaintiff in the case and professor at the Albert Einstein College of Medicine of Yeshiva University, said the cost of genetic testing in general should come down significantly as other sources become available.

However, a Myriad spokesperson noted that the company has 24 patents with 520 remaining patent claims that provide strong patent protection for its BRACAnalysis test. The first patents expire in 2015 but others extend through 2018 and as far as 2028.

Gregory Castanias, who argued on behalf of Myriad before the court, also said the decision would have no impact on Myriad since its cDNA and remaining patent claims provide patent protection for its test. The ACLU challenged nine claims in three patents. The court struck down five of nine claims and left four claims intact.

“The court was trying to strike a middle ground to preserve inventions of biotechnology and personalized medicine,” Castanias, a partner at Jones Day, stated. The opinion is “a win for the biotech industry and a win for our client.”

Ruling Is “Troubling Departure,” BIO Says

The biotech industry expressed worry about the ruling, however.

Jim Greenwood, CEO of the Biotechnology Industry Organization, said in a statement that the decision offers certainty for companies that rely on cDNA patents for investment in innovation. But he said it “represents a troubling departure from decades of judicial and Patent and Trademark Office precedent supporting the patentability of DNA molecules that mimic naturally-occurring sequences.”

Former PTO Director Q. Todd Dickinson said he was troubled that the opinion was not clear on the meets and bounds of Section 101 of the patent law, which describes patentable subject matter, to provide guidance going forward. He noted that the court’s Myriad decision, along with its rulings in Bilski and Mayo, have been the only cases in which the court has addressed patent eligibility since its Chakrabarty decision.

“Is the Supreme Court anti-patent or trying to set bounds?” Dickinson asked. The Myriad decision follows two other high-profile decisions in recent years. The court ruled in 2012 in Mayo Collaborative Services Inc. v. Prometheus Laboratories Inc. that Prometheus’ diagnostic test for determining the proper dosage of a thiopurine drug does not add enough to natural laws to be eligible for a patent. (See Also see "Supreme Court Overturns Personalized Medicine Patents, Creating Confusion In Diagnostics Realm" - Medtech Insight, 26 March, 2012..) And in its 2010 decision in Bilski v. Kappos the court loosened the rules on what processes can be patented, finding that the U.S. Court of Appeals for the Federal Circuit’s machine-or-transformation test is not the only test to determine patentability. (See Also see "Supreme Court Gives Some Relief, But Leaves Open Questions For Dx Patents" - Medtech Insight, 5 July, 2010..)

“A little bit of worry I have is that anytime you say a category is not patentable you run the risk people will keep it as a trade secret,” Dickinson, executive director of the American Intellectual Property Law Association, added.

The ACLU asserted that the court’s decision overturns the PTOs’ three-decade-old policy of issuing patents on isolated DNA. There had been a split in the government over the issue as the PTO declined to sign onto the Solicitor General’s brief.

Myriad had argued that the PTO’s past practice of awarding gene patents was entitled to deference. But the Supreme Court said that the Solicitor General’s argument that isolated DNA was not patent eligible undercut the patent office’s past practices.

Ruling Does Not Address Method Claims

The court concluded its 18-page ruling by pointing out that the decision does not address method claims, applications of knowledge about the BRCA2 and BRCA2 genes, or the patentability of DNA in which the order of the naturally occurring nucleotides has been altered.

“It is important to note what is not implicated by this decision,” Thomas wrote. “First, there are no method claims before this court. Had Myriad created an innovative method of manipulating genes while searching for the BRCA1 and BRCA2 genes, it could possibly have sought a method patent.”

However, the court noted that the processes used by Myriad to isolate DNA were well understood at the time of its patents.

Justice Antonin Scalia concurred with the opinion except for the opening – which described the human genome, nucleotides, the creation of proteins from DNA, and mutations in genetic sequence – and other portions of the opinion “going into fine details of molecular biology.”

“I am unable to affirm those details on my own knowledge or even my own belief,” Scalia said in a one paragraph statement.

[Editor’s note: This story was contributed by “The Pink Sheet” Daily, providing daily, in-depth analysis of the key developments shaping the biopharma industry. www.thepinksheetdaily.com.]

Myriad Gets Mixed Decision in Supreme Court; Biotech Industry Fears Fallout

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