Thursday, March 29, 2012

Interesting Empirical Study Looks at Role of DNA Patents and Tech Transfer Licensing Policies in the Development of Diagnostic Tests

Before becoming an independent consultant, Lori Pressman was Assistant Director of the MIT Technology Licensing Office. She recently published an article in the Bloomberg BNA Life Sciences Law & Industry Report that provides interesting empirical insight into the role of "DNA patents" in the development of diagnostic tests, and a comparison of the licensing practices of the NIH and independent academic institutions with respect to these patents and technologies.

Ms. Pressman conclused that the results of her study suggest that "broad patent eligibility combined with field specific license exclusivity and diligence best serve innovation in diagnostics and personalized medicine."

Her article is described in a recent press release issued by the Association of University Technology Managers (AUTM), which includes a link to the article. An abstract of the article is provided below.


Abstract:

To investigate the effect of exclusivity in license agreements, licensing outcomes for patents with DNA sequences in their claims “DNA Patents” managed under the Bayh-Dole Act at academic institutions “AI’s”, and under the Stevenson-Wydler Technology Innovation Act and the Federal Technology Transfer Act of 1986 at the NIH OTT were studied; the former permits and favors more exclusivity than the latter. Timelines for i) patent filing, ii) patent publication, iii) license execution, and iv) receipt of a first earned royalty , for products which read on DNA Patents are generated and analyzed. The fraction of patents ever licensed and the duration of the licenses, are documented and compared. The data show that, relative to AI managed DNA Patents, fewer NIH OTT managed DNA Patents are ever commercially licensed, and that more NIH OTT licenses to DNA Patents end early and unexpectedly, before either patent expiration, or a predetermined end date. The data suggest that products associated with AI managed DNA Patents may get to market sooner than products associated with NIH OTT managed DNA Patents, -though the data sets are small and the null hypothesis can’t be ruled out. The data also suggest that at both the NIH OTT and at academic institutions, licenses with exclusivity are executed more consistently before a product sale, and thus are more consistent with incentive creation than nonexclusive licenses, which tend to be “just-in-time” licenses, executed at about the same time as a product sale.

Using a relational database which maps NIH OTT managed DNA Patents to licenses and from there to products, the sensitivity and specificity of i) the bioinformatic algorithm for identifying “DNA Patents” alone, and ii) the algorithm refined by expert curators, are tested for their ability to predict which patents will cover “genetic diagnostic tests”. The data show that the field of use in the license agreement is significantly more specific and sensitive a predictor than the patent claims. Timeline analysis applied to NIH products associated with DNA Patents suggests that diagnostics generally take longer to develop than reagents, but not as long as therapeutics.

The author concludes that these results considered in concert with i) the publication of the human genome in 2001, ii) increased emphasis on enablement and written description by the USPTO, and iii) the blurring distinction between therapeutics and diagnostics, suggest that broad patent eligibility combined with field specific license exclusivity and diligence best serve innovation in diagnostics and personalized medicine.

4 comments:

Anonymous said...

Good for Lori. Have you called your Congressman and Senators yet? You are aware that the chances Congress will even attempt to legislatively overturn a 9-0 decision of the Supreme Court are south of cheese, are you not? Do what I have been suggesting for YEARS: create a marketing exclusivity period for new tests just as is done for NCEs. Easier said than done, but it CAN be done. There will be a trade-off, namely that tests will have to be subject to a marketing approval process. In theory this already exists, although for home-brew tests (e.g., BRACAnalysis) this does not exist at all. FDA says that it has the authority to regulate home-brew tests, but it doesn't actually exercise that authority in any meaningful way. I would think 5 years of exclusivity is plenty. It doesn't cost that much to launch a test. You and others of your ilk make it seem like this costs $100 million. It is peanuts in the scheme of things.

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