International bio-industry associations join to comment on the USPTO's subject matter eligibility guidance

A group of 12 international biotechnology industry associations, which included AusBiotech, has written to the United States Patents and Trademarks Office (USPTO) to express concern over the recent “judicial and administrative expansion of non-statutory patent law governing the patent-eligibility of certain classes of biotechnology inventions in the United States”.

The USPTO issued the ‘Guidance for Determining Subject Matter Eligibility of Claims Reciting or Involving Laws of Nature, Natural Phenomena, & Natural Products’ on 4 March 2014.

The submission from a group of associations representing thousands of biotech businesses, academic and non-profit research centres, and technology transfer organisations said: “Internationally harmonized, 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. It is in this context that we note with concern the significant departure from internationally accepted norms of patentability that would be established by the Guidance, 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. This is true for every sector of biotechnology. Examples include vaccine antigens, crop protection products, plant biotechnology and breeding, industrial enzymes, immunosuppressive drugs, anticancer compounds, and antibiotic drugs.

“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. Under the Guidance, our member companies are already receiving rejections in the USPTO of applications for recombinant industrial enzymes, for pharmaceutical formulations having purified naturally-occurring substances as active ingredients, for methods of treatment using medicinal molecules, for diagnostic laboratory procedures, and other inventions that were neither considered nor discussed in the US Supreme Court’s decisions. Such rejections under the new Guidance, if they were to become systemic, would seriously impair investment incentives in new, socially beneficial technologies.”

The US Government, together with the governments of EU member states Japan, Korea, Australia, and other major trading partners have been making efforts over a considerable period of time to encourage more harmonisation and the adoption of more uniform and consistent rules relating to intellectual property and, in particular, patents.

The group of bio-industry associations, which encouraged the USPTO to convene further meetings with the stakeholder community to discuss internationally prevailing best practices in this area and offered to contribute, included:

• ASEBIO - The Spanish Bioindustry Association
• AusBiotech, Australia’s Biotechnology Organisation
• Belgian Biotechnology Industry Organisation
• BIA, The UK BioIndustry Association
• BIO Deutschland
• BIOTECanada
• Biotechnology Industry Organization
• CropLife International
• EuropaBio
• HollandBIO
• Japan Bioindustry Association
• P-BIO, Portugal’s Biotechnology Industry Organization

See the full submission here.