United States: Emerging New Biotechnologies and the Patent Attorneys´ Struggle to Best Protect Them

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 but to all technologies.

With the publication of the sequence of the entire human genome, the opportunity to claim newly discovered genes per se might be drawing to a close, and emphasis might shift to patenting methods of using those genes. Patent practitioners are also considering other ways to protect biotechnological inventions based on discoveries in proteomics and bioinformatics and new methods for characterizing receptor sites, synthesis of potential drugs using combinatorial chemistry, and discovering active compounds using high throughput screening. The implications of these new discoveries were the focus of many of the speakers. For example, Leo Polz (Hoffmann Eitle, Munich, Germany) considered the extent to which one might obtain patent rights to compounds defined by their biological targets or receptor binding, for example, by claiming every compound in terms of their binding to a structurally defined active site of an enzyme. Gordon Wright (Elkington & Fife, Sevenoaks, UK) explored functional claiming through definitions that describe drugs in terms of their molecular shape, size, charge, and interactions with receptors as an alternative to conventional claiming based on organic formulas. Judith Pritchard (Zeneca Agrochemicals, UK) discussed the types of patent rights that might be claimed by the inventors of novel methods of high throughput screening. For example, is it possible to obtain a patent that covers all inhibitors of an enzyme that are identifiable by a novel high throughput screening assay?

R. Keith Percy (BTG International, London, UK) discussed opportunities for patenting in proteomics, the large scale analysis of proteins and their expression (the protein analog of 'genomics'). A source of controversy was US Patent No. 6 064 754, assigned to Oxford Glycosciences Ltd., which broadly claims methods for computer-assisted isolation of proteins based on imaging of 2D arrays such as 2D electrophoresis.

Alison Blakey (SmithKline Beecham, UK) showed how it might be possible to patent combinatorial chemistry libraries that contain enormous numbers of compounds for screening. She warned, however, that there might be disadvantages, likening such patents to 'patenting a gold mine but not the gold in the mine.' The implications of high throughput screening technology were also discussed in a panel by Rochelle Seide (Baker Botts, New York, USA), Catriona Hammer (Amersham Pharmacia Biotech, Amersham, UK) and Anna Denholm (Eli Lilly and Co. Ltd., UK).

Ethical questions about patenting biotechnology (including such hot topics as the cloning of Dolly and other animals, stem cell research, and whether drug patents help or harm the public) were the subject of a stimulating panel by Andrew Sheard (Kilburn & Strode, London, UK) and Alastair Kent (Genetics Interest Group, UK). Sheard argued that although patents make new drugs more expensive, the choice is not between cheap and expensive drugs but rather between new drugs that are initially expensive and no new drugs in the absence of an incentive to develop them.

Other speakers reviewed the practical problems that face patent practitioners as they tried to patent these novel technologies. Bryan Diner (Finnegan, Henderson, Farabow, Garrett & Dunner, LLP) highlighted the many confusing changes and problems caused by recent changes in United States patent law, but also pointed out how the law might allow patent applicants to potentially lengthen their enforceable patent term. Bill Tyrrell (SmithKline Beecham plc, UK) presented tips on how to prepare patent applications that can support a claim to priority. Problems in sufficiently supporting in obtaining broad claims to biotechnological inventions in Europe were discussed by Huw Hallybone (Carpmaels & Ransford, UK). Tony Rollins (Amersham Pharmacia Biotech, Amersham, UK) analyzed the many factors that can affect the commercial value of a patent portfolio.

Exciting new technologies are rapidly emerging and patent attorneys have only begun to find ways to apply the patent law to those new technologies.

Copyright © 2002 Finnegan, Henderson, Farabow, Garrett & Dunner, LLP. The information provided in this article is for informational purposes only and is not intended and should not be construed as legal advice. This memorandum may be considered advertising under applicable state laws.