IntroductionEgenis Co-Director Professor Steve Hughes continues his reflections on gene patents and the US courts.
In an on this site I wrote about the exhaustively considered disallowance by Judge Sweet in the New York District Court of core claims to DNA sequences in Myriad Genetics’ patent relating to the diagnosis of susceptibility to certain forms of breast cancer (Brca1 and Brca2 variant alleles). I made the ultra-safe prediction that Judge Sweet’s ruling would trigger a vigorous riposte from the bio-industries fearful of a domino effect affecting all DNA/gene–based patents..
The riposte is here and takes the form of an open letter to the US Secretary for Agriculture, Tom Vilsack, signed by 15 senior officers of member companies of the Biotechnology Industry Association. They seek his influence in articulating their fears about the effects of the Sweet judgment to the Department of Justice and the White House administration.
The letter makes interesting reading. The appeal to Secretary Vilsack seems to draw on the assumption that locally accommodative patent regimes stimulate investment and innovation, and cites the sorts of innovation imperative to the development of responses to the challenges of climate change and intensive agriculture (the letter emphasises the case of genes for drought resistant crops) in the context of US pre-eminence.
The concerned captains of industry might have done better to reflect as much upon the causes as upon the effects of the Sweet judgment in their aspirations to have it reversed. Judge Sweet clearly found to his satisfaction that the US Patent and Trademark Office had been wanting in its application of the tests of patentability in its grant to Myriad Genetics and its partner academy. To suggest that this needs to be overridden in the name of US international competitiveness portrays an unfortunate isolationist turn. The inappropriate award of monopoly rights to a stretch of DNA is anti-competitive in all contexts, national and international, and does no service to the bio-industries. Stringent application of criteria by examiners in all jurisdictions, whether they relate to subject matter (unsubstantially transformed products of nature?), inventiveness (merely fitting a newly identified stretch of sequence into an established procedure?), utility or ethical abhorrence must be regarded as the only standard of practice worthy of society. Special pleading for something less on grounds of a projected outcome is a case of consequentialism gone too far. Judge Sweet made a systematic, intellectually argued case. Only an equally argued case (and I’m prepared to admit that such may be possible) can oppose his judgment.
I look forward to witnessing the bio-industries getting in close with philosophers of biology rather than lawyers or lobbyists to construct their intellectually sound rebuttal. Either way the next chapter in the round of appeals is bound to be interesting.