INTELLECTUAL PROPERTy
personalized medicine
patentIng controVersIes By: Carmela DeLuca and Katherine Bonter
Whether diagnostic and personalized medicine technologies or “gene patents” should be the kinds of inventions that can be patented (e.g. whether they are patentable subject matter) has been under scrutiny in a number of jurisdictions and the potential commercial implications hotly debated. Court challenges have been ongoing in Australia and the U.S. and most recently launched in Canada, bringing the controversy to our back yard.
H
ere the current state of patent protection in these jurisdictions is explored by comparing and contrasting recent court decisions and the existing legislative environment.
United States Exemptions to patent subject matter eligibility, as expressed by the U.S. courts, include: fundamental principles, laws of nature, natural phenomenon and abstract ideas, the building blocks of human ingenuity. Judicial exemptions are intended to prevent patents from broadly pre-empting or tying up the use of fundamental ‘building blocks’ and to restrict patents to inventions that are a “product of human ingenuity” (35 USC §101). Recent U.S. Supreme Court decisions have considered if certain inventions involving: a law of nature (Mayo 2012)1, a natural phenomenon (Myriad 2013)2 or an abstract idea (Bilski 20103 and Alice 20134) are patFebruary/March 2015 BIOTECHNOLOGY FOCUS 17
