Patent Docs author Dr. Kevin Noonan gave the following testimony at today's USPTO hearing on genetic diagnostic testing:

I want to thank the organizers for inviting me to testify today.

This study by the PTO is important because it should give the Office the opportunity to determine whether there is any evidence that "patents are the problem" with regard to patient access to genetic diagnostic testing.  It has become fashionable in some quarters (mostly the medical and legal academies) and in some industries to question the value of patenting in promoting innovation.  Those that do so analogize patents to a tax on innovation and even contend that patenting can retard innovation.  Judges and even some Justices have proposed that there needs to be a balance between patenting; like a judicial Goldilocks, there is abroad the idea that we need just the right amount of patenting, and that steps, like the "second opinion" exemption we are discussing today are ways to achieve that golden mean.

These ideas are current under circumstances where there is little evidence that patents are responsible for preventing patients from enjoying the benefits of the new genetic technology.  There is also little evidence that current genetic diagnostic test providers are beset by rampant error in the test results they provide.  It isn't as if no one has looked for these effects, but in every case the reports and studies are forced to begrudgingly admit that there is no apparent effect of patents on either access or quality, even while remaining steadfast that there could be or might be in the future.  This includes many academic studies as well as official U.S. government agencies including the Department of Health and Human Services SACGHS report.  I know of no study showing that limitations on patient access are not the consequence of behaviors and policies of private and government insurers, payors and providers rather than patents.  After all, in America, the one right patients don't have when it comes to medical treatment or diagnosis is an economic one.  Healthcare in this country depends on what each individual patient can afford, or if they have benefits through their employer, what their employer provides.  If an insurer won't pay for a genetic diagnostic test, it doesn't mean the test is too expensive -- it means the insurer has decided that it, and its insureds, can wait until the price comes down.  The patent system didn't create this situation and weakening patenting won't solve it...

Please see full testimony below for more information.