13 August 2014Americas

Biotech industry reacts to USPTO’s Myriad/Mayo guidelines

A group of 12 international biotechnology associations has written to the US Patent and Trademark Office (USPTO), raising concerns about the office’s guidelines on determining the patent eligibility of natural products in the aftermath of the Myriad and Mayo cases.

The group, known as the International Bioindustry Associations, represents thousands of businesses, academic institutions and non-profit research centres, and includes EuropaBio, the UK BioIndustry Association, AusBiotech and the Japan Bioindustry Association.

In March this year, the USPTO issued its Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural Products, inviting the industry to comment and make suggestions on the guidance.

In its submission, dated July 31, the group suggested that establishing the guidelines will stymie innovation by disincentivising investment in research and development in biotechnology.

“Internationally harmonised, science-based regulatory and legal frameworks are important for competitiveness and innovation to ensure faster and more equitable access to new biotech products and processes for patients, farmers and consumers around the world,” the letter said.

The group said the guidance will be a “significant departure from internationally accepted norms of patentability,” particularly with regard to industrial, agricultural, and pharmaceutical preparations of naturally-derived substances, compositions and processes.

“Inventive preparations based on naturally-occurring substances have historically been of great importance in biotechnology, and innovation in this area has been spurred, at least in part, by the availability of patent protection,” it said.

“By singling out naturally-derived biotechnology inventions for special, disfavoured treatment, the guidance would establish peculiar disincentives for investment in research and development of entire categories of biotechnology.”

According to the letter, the group’s member companies have already received rejections from the USPTO for patents directed at pharmaceutical formulations having purified naturally-occurring substances as active ingredients, diagnostic laboratory procedures, and other inventions that were neither considered nor discussed in the US Supreme Court’s Myriad and Mayo decisions.

“Such rejections under the new guidance, if they were to become systemic, would seriously impair investment incentives in new, socially beneficial technologies.”

A statement on the AusBiotech website said that the US government, along with governments of EU member states and those of other major trading partners including Japan and South Korea, had been working to encourage the adoption of more uniform and consistent rules relating to patents.

Since the USPTO issued the guidelines in March, it has received suggestions from associations including the Association for Molecular Pathology and the American Civil Liberties Union, and from pharmaceutical companies Amgen, Novartis and Novo Nordisk.

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