44 Pages Posted: 18 Feb 2005
Twenty-five years ago, Federal courts opened the door to the biotechnology revolution by granting patents on genetic inventions. The nature of such inventions, however, increasingly conflicts with the implications of rules created for mechanical products. In particular, across five disparate doctrines, courts are struggling with the question of whether the definition of a biotech invention should include things beyond the state of the art at the time of the invention. Reaching beyond the state of the art may make sense for mechanical inventions, but it is wreaking havoc in doctrines related to biotechnology. A doorknob is a doorknob, regardless of whether it is made of wood or glass. A doorknob has no parts we can't identify, and there is no hint that the doorknob may be integrating with the door in ways we never dreamed of. Can we really say, however, that an antibody is an antibody, no matter how it works or what materials it is made out of? This article argues that in uncertain arts such as biotechnology, the definition of an invention should be limited to the state of the art at the time of the invention. Granting rights beyond knowledge at the time of the invention projects an enormous shadow across the future and creates untenable results. The temptation to restrain that reach has led to strange doctrinal twists and an unworkable body of law. After twenty-five years of experience, it is time to rethink our view of the proper shape of rights in this realm.
Keywords: biotech, biotechnology, gene, genes, inherency, written description,enablement,patent
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