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6 June 2019Big Pharma

US patent reforms could re-establish gene patent eligibility, industry experts warn

A group of more than 100 medical, scientific, patient advocacy and women’s health organisations have opposed a recent proposal to amend section 101 of the US Patent Act.

The letter, which was published by the American Civil Liberties Union (ACLU) on Monday, June 3, was addressed to a group of senators from the Senate Judiciary Subcommittee on Intellectual Property. The group said the proposed legislation would “wipe out 150 years of case law” by permitting the patenting of human genes.

As reported by LSIPR’s sister publication WIPR on May 22, US senators released a draft bill to reform section 101 of the country’s Patent Act.

As part of the proposed reforms, senators discussed whether patent law should be broadened to include genes along with other “natural phenomena” and even “laws of nature”.

At a hearing on Tuesday, June 4, senators Chris Coons and Thom Tillis heard testimony from 45 industry professionals, Tiller said the goal of the patent reform “was to strike a balance” between protecting and encouraging innovation.

He said the proposal “would not change the law to allow a company to patent a gene as it exists in the human body”.

However, Kate Ruane, a senior legislative counsel at ACLU in New York, said the proposed reforms would have “unintended consequences”.

In Monday’s letter, industry groups agreed. They said the proposed reforms, which will permit exclusivity over naturally occurring associations between genes and diseases, will impede the discovery of novel treatments for diseases such as cancer, Alzheimer’s disease and other diseases as it will mean competitors cannot innovate in these areas.

“If enacted, this threatens to take us back to a time of greater uncertainty regarding patent eligibility,” the letter said.

As it stands, the group said the Supreme Court has held that laws of nature, natural phenomena and abstract ideas are not patent-eligible.

The ACLU gave the example of Association for Molecular Pathology v. Myriad Genetics, in which Myriad claimed patents over the testing of two human genes; BRCA1 and BRCA2. According to the letter, these patents granted Myriad a monopoly over the genes, “which had serious consequences for patients”.

“Myriad had exclusive rights to clinical testing of the BRCA1 and BRCA2 genes and shut down genetic testing performed by other laboratories,” the letter said.

This was eventually overturned by the US Supreme Court which recognised a fundamental truth: “genes and other naturally occurring matter and relationships should never be granted to anyone as intellectual property,” the group said.

The group said that permitting exclusivity over genes or naturally-occurring correlations between genes and diseases will “impede the progress of medicine and healthcare”.

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