Insight & Intelligence™: Dec 15, 2011
USPTO Tasked with Evaluating Impact of Gene Patents on Second-Opinion Testing
Diagnostic firms argue IP protection is key to innovation, while their opponents say it hurts medical practice.
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- The impact of available independent confirming testing on the ability to provide the highest level of medical care to patients and recipients of genetic diagnostic testing and on inhibiting innovation to existing testing and diagnoses.
- The effect of providing independent confirming genetic diagnostic testing on existing patent and license holders of exclusive genetic tests.
- The impact of current exclusive licensing and patents on genetic testing activity on medicine, including but not limited to interpreting testing results and performing testing procedures.
- The roles of cost and insurance coverage on accessing and providing genetic diagnostic tests.
Earlier this year as Congress wrestled with patent reform, Rep. Debbie Wasserman Schultz (D-FL) offered an amendment to the House of Representatives’ bill that created a safe harbor protection for providers of confirming genetic diagnostic tests from liability for infringement. It was added to the patent bill but with changes from House Judiciary Committee Chair Lamar Smith (R-TX) that Wasserman Schultz sought to reverse. She and Congress ultimately retreated from pursuing the safe harbor after medical groups and the American Civil Liberties Union (ACLU) complained that the amendment gave test providers too many exemptions. By the time President Barack Obama signed the Leahy-Smith America Invents Act on September 16, the genetic testing safe harbor amendment was watered down into a directive that the U.S. Patent and Trademark Office (USPTO) “conduct a study on effective ways to provide independent, confirming genetic diagnostic test activity where gene patents and exclusive licensing for primary genetic diagnostic tests exist.” That study must be completed by June 16, 2012, and address at least these topics: