Brian R. Stanton, Ph.D.

The USPTO has released its ‘Report on Confirmatory Genetic Diagnostic Testing,’ which was prepared to fulfill the requirements of §27 of the Leahy-Smith America Invents Act. The USPTO did make an interesting observation that has been reflected in its patent examining guidelines. The USPTO Report concludes that ‘it is unlikely that exclusive provision of a diagnostic test, whether for an original diagnosis or to confirm the original result, will be possible based on patenting and licensing behavior.’ This statement reinforces the USPTO’s prior broad interpretations of the Court’s findings in Mayo and Myriad. Of note is that in the USPTO Report, the USPTO adopts the Supreme Court’s factually and scientifically unsupported distinction between genomic DNA and cDNA.

In a least one instance, a major laboratory test provider has indicated (in confidence) that it would not be entering the Ebola testing market for three principle reasons: (1) the lack of availability of exclusivity for genetic testing; (2) the liability attendant in disease diagnostics; and (3) the limited reimbursements available due to emerging cost control measures under Affordable Care Act reforms.

This was the SAWS program; an oversight procedure for bringing information to the attention of management. It was designed, by intention, to cast a broad and sweeping net. It was designed to permit resources to be brought to bear on high profile or complex legal, ethical, or controversial subject matter… The SAWS program is not a system of stalling patents. While the Bereznak Article asserts “(a)ny application that is categorized in SAWS … is placed in a special type of patent purgatory.” This is just not true.

We argue, hour by hour, day by day, about large issues of morality and ethics and discuss how to make our nation “green”. We discuss large high-level issues like “should we have a public option for healthcare?”, but we give less attention to the details regarding what such an option might look like. Similarly, in the patent system, the public…