Intellectual Property 2008/2009 Winter Bulletin.
Mondaq Business Briefing › Nbr. 2009, January 2009
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Intellectual Property 2008/2009 Winter Bulletin.
CONTENTS
Protecting Patents for Personalized Medicine The Fallout From Bilski: Significant Change in What is Considered Patentable Quick Updates Ninth Circuit Applies Its Implied License Test to Software Minsky v. Linden Research Inc. – Tiffany v. eBay Revisited Consideration of Prior Art by Courts Does Not Bar Subsequent Consideration in Reexaminations California Supreme Court Rejects the "Narrow Restraint" Exception to Noncompetition Agreements Protecting Patents for Personalized Medicine By Michael J. Shuster, Ph.D. And Pauline Farmer-Koppenol Personalized medicine companies should implement new strategies to deal with the challenges associated with protecting their inventions. Personalized medicine uses various types of diagnostic information to improve outcomes and reduce healthcare costs by determining in advance whether a patient is likely to respond to a proposed treatment. The best-known and earliest success of the use of diagnostics in personalized medicine relates to measuring HER2/neu amplification in breast cancer patients. Only those patients whose tumors carry this amplification respond to Herceptin (trastuzumab), and the drug's use is indicated only in such patients. Current study results indicate that treatment for a year reduces risk of recurrence by half in these patients. The cost of Herceptin treatment is about $3,000 per month and is easily justified because of the benefits it provides. New Challenges in Patent Protection Getting patent protection for such diagnostics, however, recently became more difficult. The United States Patent and Trademark Office (USPTO) has made it difficult to obtain patent protection for certain types of personalized medicine technology. Unlike the test used for distinguishing Herceptin responders, which is a simple measurement of amplification of a single gene, other personalized medicine diagnostics require measuring gene or protein levels for a number of biomarkers. These measurements are used with sophisticated predictive modeling algorithms to generate a score associated with drug response or disease severity. One difficulty encountered in obta...See the full content of this document
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