Yesterday, September 8, 2011, the Senate passed by a vote of 89-9 the House version of the patent reform bill H.R. 1249, also known as the Leahy-Smith America Invents Act, without amendment. Consequently, after many years of discussion, debate and hand-wringing, significant patent reform is imminent. In fact, at this point, the legislation only requires action by President Obama, who has already promised to sign the bill.

Most provisions in the bill impact U.S. patent practice generally, including moving towards a first-to-file system, expanding prior user rights as a defense to infringement, eliminating interference proceedings, and creating new USPTO proceedings for post-grant review. One aspect of the bill, however, in a section entitled “Study on Genetic Testing,” impacts the personalized medicine industry in particular.  See previous discussion on this provision on our June 26 post and August 3 post.

Leahy-Smith America Invents Act

H.R. 1249 itself (originally passed by the House on June 23, 2011) is 150 pages. Despite its length and complexity, it may be worth a read by anyone practicing or interested in patent law. That said, many have written on this topic already. For a few excellent summaries, please see “Patent Reform Clears Final Hurdle–President Obama Expected To Sign America Invents Act Soon” (posted on PharmaPatents on Sept. 8); Foley & Lardner Legal News Alert “Senate Passes House Patent Reform Bill (H.R. 1249) — President Now Expected to Sign!”; and “Pressing The Patent Reform Panic Button” (posted on PharmaPatents on Sept. 5).

Section 27 in the Act:  “Study on Genetic Testing”

Beyond the various provisions impacting U.S. patent practice as it relates to all technology areas, the following short section in the bill is worth reading in its entirety as it relates to personalized medicine. Specifically, on pages 142-144, H.R. 1249 includes the following:

SEC. 27. STUDY ON GENETIC TESTING.

(a) IN GENERAL.—The Director [of the USPTO] shall 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.

(b) ITEMS INCLUDED IN STUDY.—The study shall include an examination of at least the following:

(1) The impact that the current lack of independent second opinion testing has had 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.

(2) The effect that providing independent second opinion genetic diagnostic testing would have on the existing patent and license holders of an exclusive genetic test.

(3) The impact that current exclusive licensing and patents on genetic testing activity has on the practice of medicine, including but not limited to: the interpretation of testing results and performance of testing procedures.

(4) The role that cost and insurance coverage have on access to and provision of genetic diagnostic tests.

(c) CONFIRMING GENETIC DIAGNOSTIC TEST ACTIVITY DEFINED.—For purposes of this section, the term ‘‘confirming genetic diagnostic test activity’’ means the performance of a genetic diagnostic test, by a genetic diagnostic test provider, on an individual solely for the purpose of providing the individual with an independent confirmation of results obtained from another test provider’s prior performance of the test on the individual.

(d) REPORT.—Not later than 9 months after the date of enactment of this Act, the Director shall report to the Committee on the Judiciary of the Senate and the Committee on the Judiciary of the House of Representatives on the findings of the study and provide recommendations for establishing the availability of such independent confirming genetic diagnostic test activity.

What Does Section 27 Mean Going Forward?

Interestingly, this section provides an avenue for Congress to step into the Myriad “gene patenting” and Prometheus/Classen diagnostic method claims fray. For background, please see, for example, August 31 post on Classen, August 9 post on Myriad and Prometheus, July 29 and July 31 posts on Myriad, and June 20 post on Prometheus.

As the section above indicates, the USPTO is to conduct a study, and provide a report based on that study within 9 months of the date of enactment, on “effective ways to provide independent, confirming genetic diagnostic test activity” in situations where such testing may otherwise infringe a gene or diagnostic method patent. In other words, Congress wants input from the USPTO as it pertains to diagnostic tests (such as the BRAC1/2 diagnostic tests at issue in Myriad) that provide “independent confirmation” of results obtained in another previously performed test (presumably sold by a patent owner). The idea of a second independent test that confirms a previous test result addresses a concern raised by patient/doctor plaintiffs in the Myriad case. The provision above suggests that Congress may wish to consider, at least at some point, the idea and impact of providing by law “the availability of such independent confirming genetic diagnostic test activity.”

This mandate raises many questions, not the least of which is whether it takes the USPTO beyond its realm of expertise. After all, the USPTO’s focus is on assessing the patentability of claims, not the quality of medical care, the impact of cost and insurance on access to medical care, or the monetization of patent rights. Who in the USPTO will conduct the study and how will it be designed, completed, and analyzed within nine months?  See earlier discussion on this point in our June 26 post.

The USPTO is soliciting public input on how it should implement many aspects of patent reform, including this one, and has provided contact information on its Leahy-Smith America Invents Act Implementation webpage. Interested parties in the personalized medicine industry should not miss out on this opportunity to have their voices heard.

For additional updates on patent reform, including updates relevant to other industries, please visit Foley & Lardner’s Patent Reform webpage.

Foley is hosting a patent reform webinar on Wednesday, September 14, 2011, at 1:30 pm eastern. Robert L. Stoll, Commissioner for Patents, is scheduled to be a special guest speaker. (The event is free, but pre-registration is required.)