Emerging New Biotechnologies and the Patent Attorneys' Struggle to Best Protect Them

Profession:Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
 
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By David S. Forman and Bryan C. Diner

Originally published inTRENDS in Biotechnology, January 2001

The Patenting in the Age of Genomics conference was sponsored by Euroforum and held in London, UK, 5-6 July 2000.

Only a week after the announcement of the completion of a draft of the entire human genome, almost 100 patent practitioners gathered in London this past summer. Racing to keep up with the rapid pace of innovation, patent attorneys are struggling to find ways to patent not only DNA and genes, but also inventions in new fields such as genomics, proteomics and bioinformatics.

The resolution of a debate that has festered for almost a decade might finally be at hand; whether the discovery of a partial DNA sequence (an expressed sequence tag, or 'EST') entitles its discoverer to claim the complete gene of which the EST is a part. This debate has raged for almost a decade in the US, while companies have continued to file patent applications claiming an estimated 500 000 ESTs. David Forman (Finnegan, Henderson, Farabow, Garrett & Dunner, L.L.P., Washington, DC) explained that, after years of controversy and input from the public, the United States Patent and Trademark Office (USPTO) has issued revised guidelines for patent examiners explaining how to apply the 'written description' and 'utility' requirements of the US patent law when examining claims to DNA.

Under the USPTO analysis, a novel EST sequence would not provide a legally adequate 'written description' of a complete gene containing the EST and encoding a complete protein. At most, the patent applicant might obtain a claim to the specific EST for use as a probe. Furthermore, the USPTO will place new emphasis on the requirement that to be patentable an invention must have 'utility'. The revised guidelines require the utility to be credible, specific and substantial. A 'substantial utility' is one with practical, 'real world' benefits, and excludes the situation where the only utility of the invention (e.g. a novel DNA) is to study it to determine its utility. Under the new guidelines, which the USPTO has acknowledged raise the bar for patentability, even the complete DNA sequence of an open reading frame encoding a protein would be unpatentable if the utility of the encoded protein is completely unknown. The USPTO will, however, recognize predicted utilities based on sequence homology to known useful proteins. The new written description and utility examination guidelines apply not only to biotechnology...

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