US publication on the patentability of biopharmaceutical inventions - Part I – Københavns Universitet

19. marts 2010

US publication on the patentability of biopharmaceutical inventions - Part I

Part 1 of the article has been published on March 18th in Chicago-Kent Journal of Intellectual Property, Spring 2010 issue. 9 Chi.-Kent J. Intell. Prop. 60 - 132.

In the wake of the seminal U.S. Supreme Court decision in KSR the law of non-obviousness has once again become a major topic in patent law. Of crucial importance to the biopharmaceutical industry is in particular the following question: Under what circumstances should an invention that was "obvious to try" be considered obvious in fact? In that regard, a comparative study of the present "inventive step" assessments in Europe is very interesting, since several biotech- and pharma-related EPO decisions, as well as recent high profile judgments of national courts, have not only provided new general guidelines on the European determination of "inventive step" but also addressed specific questions similar to those raised in KSR and In re Kubin .

Considering recent European case law developments, the main goal of this bi-partite article is not to provide yet another detailed analysis of post- KSR developments in the U.S. Instead, the focus is placed on an examination of recent EPO (Part I) and national European case law (Part II) in order to discuss the findings in the context of recent U.S. developments. Special emphasis is placed on DNA and protein -related technology and the "obvious to try" issue.

Based on the realization that recent legal and technological developments have made it considerably more difficult for a growing number of therapeutically interesting compounds to meet the non-obviousness standard, this article ultimately argues for a careful elaboration of specifically designed and more flexible exclusivity periods that would be granted after the successful completion of clinical trials. In the absence of sufficient governmental involvement in the development of pharmaceuticals it is hoped that this will assure the further development of obvious and thus unpatentable drugs with a high therapeutic potential.