April 3, 2012 9:36 pm

Myriad’s gene patent case may still end up at Supreme Court

This article is provided to FT.com readers by BioPharm Insight—a news service focused on providing insight into the most price sensitive issues in the global pharmaceutical market. www.biopharminsight.com

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The Supreme Court’s decision to remand the Myriad Genetics (NASDAQ: MYGN) gene patent case back to the Federal Circuit was expected, but the case might still ultimately return to the Supreme Court, intellectual patent attorneys told Biopharm Insight.

Further, the Prometheus v Mayo Supreme Court decision is likely to leave patent seekers to add more language to method claims, despite the decision explicitly looking to preempt such actions, they added.

On 20 March, the Supreme Court handed down a unanimous decision in the Mayo Collaborative Services v. Prometheus Laboratories case, in which the latter’s claims to methods of administering drugs to treat gastrointestinal autoimmune diseases are not patentable subject matter under section 101 of the Patent Act.

The Federal Circuit initially found the Prometheus claims patentable in 2009. The request for Supreme Court review in 2010 was not granted, but instead remanded to the Federal Circuit in light of the Supreme Court’s recent decision in Bilski v. Kappos. The Federal Circuit again upheld the claims, and subsequently the Supreme Court granted certiorari (“cert”) and heard the case.

On 26 March, the Supreme Court remanded the Association for Molecular Pathology v. Myriad Genetics case to the Federal Circuit for further consideration in light of the Prometheus decision. Myriad holds the patents on the genes known as BRCA1 and BRCA2.

The cert petition for the Myriad case had been pending for some time, likely because the court was waiting for a decision on Prometheus first, said Dianne Elderkin, partner, Akin Gump Strauss, Hauer & Feld, LLP.

Still, whatever the outcome at the Federal Circuit level, the Myriad case will probably go back to the Supreme Court, like Prometheus did, said Mark Nuell, PhD, partner, Birch, Stewart, Kolasch & Birch, LLP. The Federal Circuit might try, however, to consider some of the questions still left open by the Supreme Court’s Prometheus decision, ultimately framing the questions for the Supreme Court to then look at, he said.

A Myriad spokesperson said none of Myriad’s patent claims are impacted by the recent Prometheus decision, as the ACLU only appealed nine composition of matter claims in five patents, with no method claims being appealed to the Supreme Court, with the Prometheus decision solely on method claims.

She said there is no direct impact to Myriad with the Prometheus decision, with Myriad confident its method claims would be deemed transformative and novel. The Prometheus decision was limited to method claims and did not mention composition of matter. Further, the decision noted that the activity was not novel nor did it adequately meet the transformation hurdle used by the court. “We believe that our 200-plus method claims would meet this hurdle and, additionally, would be considered novel,” according to the spokesperson.

Myriad product claims to cDNA and isolated DNA may not be upheld

There has been a trend of the Supreme Court overturning Federal Circuit decisions, such that “it doesn’t bode well for Myriad,” said Konstantin Linnick, PhD, partner, intellectual property department, Nutter McClennen & Fish LLP.

In theory, Prometheus and Myriad should be unrelated, but because they deal with the question of patentability, and whether something is naturally occurring or not, Myriad may be affected, said Linnick. Applying parallel logic to Myriad as was applied to Prometheus may yield the isolated DNA sequence in question – the BRCA1 and BRCA2 fragments - is close enough to what is occurring in nature that “everything else” in Myriad’s claims is not substantial enough for patentability, he said.

Indeed, once the part of Myriad’s claims dealing with natural phenomena are “stripped away” from the rest of the patent, the court will then consider how inventive the rest of the claims are, said Charles Lyons, PhD, partner, Intellectual Property Group, Choate, Hall & Stewart LLP. If all that is left are the oligonucleotide probes, “it could be risky,” for Myriad’s claims to be upheld, he added.

DNA is a natural phenomenon, and the information in the DNA is what the Supreme Court recognizes as a law of nature, said Edward Ramage, chair, Intellectual Property Group, Baker, Donelson, Bearman, Caldwell & Berkowitz, PC. The important discovery here is the genetic sequence of BRCA1 and BRCA2, and mutations in these sequences correlate with a higher likelihood of breast cancer, he explained. The argument is this correlation is a law of nature, which cannot be patented, he said. It then comes down to whether Myriad added anything non-routine or non-conventional, beyond that law of nature, to make it patentable, he said.

Yet, the steps of isolating the DNA, and creating the cDNA library, as done by Myriad, are well-understood, conventional techniques, said Ramage. He was not certain the Federal Circuit will reverse its previous decision on Myriad, and estimated a 50% chance the Supreme Court takes the case during its next term.

Further, Ramage noted a concern about exclusivity has also been raised with the Myriad case, in which scientists are unable to look at the BRCA sequences without in some way infringing on the patent claims in order to do research, which is something the Supreme Court “does not like.”

Prometheus decision to resonate more widely than Bilski

It would be an unfortunate turn of events if these types of discoveries are found to not be eligible for patent protection, said Anthony Figg, member, Rothwell, Figg, Ernst & Manbeck, PC. It would impact how people perceive the impact of patentability of research, he said.

Indeed, the overall potential impact of Prometheus is much larger than Bilski, said Ramage. The Prometheus case has garnered so much attention because it could have long reaching implications in personalized medicine, as the core of personalized medicine is getting the right drug to right patient at the right time, with the innovation in finding that correlation, he said. Yet, this decision found that this correlation is not patentable, he said.

The Prometheus decision has a greater preclusive effect on patentable subject matter based on what is covered by natural phenomenon, said Nuell, adding, “I’m not sure this decision helps a lot, as it leaves a lot unclear,” with the Myriad case to ultimately hopefully add some clarity.

The decision gave no simple “black or white” rule for what additional steps to add to claims to make them patentable, Ramage said. The Supreme Court did not give guidance on what would be sufficient to make something go beyond the laws of nature and thus be patent eligible, said Roberte Makowski, an IP attorney with Connolly Bove Lodge & Hutz, LLP. Going forward, this is “really going to confuse things,” she added.

There is some language in the decision suggesting if this Prometheus claim had been drafted differently it might have been patentable, said Elderkin. This being the Supreme Court’s decision, some people “will run with it,’ and try to over reach and attack a lot of claims for not being patentable subject matter, which will fall to the lower courts to straighten out, she said. In the meantime, this will create a lot of litigation, and cause a lot of uncertainty, she added.

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