Patent Law Practice Center

Post-Bilski: “Patent Strategy for Personalized Medicine”

Today’s guest post comes from Michael J. Shuster, Ph.D. (a partner in Fenwick & West’s Intellectual Property group and co-chair of  the lifes sciences group) and Pauline Farmer-Koppenol (associate in Fenwick & West’s intellectual property group).

Protecting inventions in personalized medicine with patents is essential to making the investment in research and development of those inventions worthwhile.  Absent meaningful patent protection, however, companies will be less likely to pursue such innovation since there is nothing to prevent competitors from free-riding on the back of the many hours and millions of dollars expended by the innovator company.

Personalized medicine diagnostics can produce meaningful improvements in patient outcome and medical economics.  Diagnostic innovations developed by University of California Professors Dan Pinkel and Joe Gray allowed for the first time sensitive and accurate measures of gene amplifications in breast cancer patient biopsies. This allows physicians to determine whether Herceptin® (trastuzumab) treatment is likely to improve the patient’s outcome because only tumors with the amplification respond to Herceptin®.  Pinkel and Gray’s remarkable invention was exclusively licensed to Abbot Laboratories which devoted years of effort and millions of dollars to bring this innovation to market.  Considering the cost of a full course of treatment with Herceptin®, approximately $70,000, the development of the HER2/neu amplification diagnostic test is valuable not only in minimizing the use of an expensive treatment for patients for whom it is unlikely to provide benefit, but it also helps patients by not wasting valuable time pursuing a treatment that is unlikely to be beneficial. (more…)