16 April 2013Patents

Myriad: the oral arguments

On Monday, April 15, the US Supreme Court heard oral arguments on whether genetic material is patent eligible subject matter and in particular, whether Utah-based Myriad Genetics’ patents covering isolated human genes linked to breast and ovarian cancer are valid and enforceable.

The case has the potential to reverse 30 years of patent office practice: while US patent law states that naturally occurring products are not patent eligible, the US Patent and Trademark Office has granted thousands of patents for isolated DNA molecules.

The case was appealed to the Supreme Court for a second time in 2012; after Myriad’s patents were challenged by the Association for Molecular Pathology and the American Civil Liberties Union, invalidated by a New York District Court in 2010 and upheld twice by the US Court of Appeals, most recently in August last year.

A decision is expected in June this year and while it’s too early to tell what the court will decide, Jennifer Camacho, a shareholder at Greenberg Traurig in Boston, said yesterday’s discussions were in many ways “surprising”.

“There was immediate scepticism from the court towards Myriad’s counsel - this isn’t unusual, as the fact that the Supreme Court granted certiorari to review the Federal Circuit’s decision means that they did not necessarily agree with the analysis or outcome of the decision.

"But what was particularly surprising is that there was little discussion in yesterday’s oral hearing about whether the Supreme Court’s ruling in Mayo v Prometheus [in which it decided that claims covering medical tests that helped to decide what dosage of a drug to give a particular patent were not patent eligible] should be applied to Myriad,” she said.

In the first appeal, the Supreme Court granted centiorari and remanded Myriad to be reviewed again by the Federal Circuit in light of its decision in Mayo, yet Camacho says there was no direct discussion by the Court of this point in yesterday’s proceedings.

“It was only towards the end of the oral arguments that the idea of pre-emption and whether  products of nature may pre-empt further invention as laws of nature may—a key discussion in Mayo—was mentioned, and that was only in passing.”

Camacho also said that while the court granted certiorari in Myriad on whether genes are patentable, the oral arguments focused on patentability of new methods of extracting products from nature and uses of such products, as well as the gene itself.

“The arguments didn’t focus strictly on the BRCA1 and BRCA2 molecules and instead seemed to focus on where the line should be drawn on what is and isn’t a patentable invention when it comes to products of nature,” she added.

While the case could go either way, Camacho said the court’s scepticism has led many to believe it will find that Myriad’s BRCA1 and BRCA2 genes are not patentable, which could have significant implications for rights holders whose portfolio includes isolated genetic material.

“It would leave a lot of issued patents very vulnerable and far less likely to be enforced, particularly as patenting isolated genes has become much more common over the past decade. But as the Myriad patent challenge has been in play for a while, the biotech and pharma industries have been looking at different layers of patent protection and securing overlapping claims, rather than relying solely on the isolated gene as the core of the patent portfolio,” she said.

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