The current system for genetic testing in America functions by having the patent holder of a particular genetic test control the testing process and results interpretation of that test. There is concern that, inherent in that current system, there is a lack of independent second opinion testing available – testing which has the potential to make the results more accurate.

On January 25, 2012 the USPTO invited the public to comment on the availability of independent second opinion genetic diagnostic testing and its relationship to the medical field.  More specifically, the U.S. government is looking for information on the medical detriment of the patent system controlling genetic testing and whether changing the law would stifle innovation in the area. 

The information was to be used in accordance with section 27 of the America Invents Act (hereafter “AIA”) to assist the director of the USPTO in delivering his recommendations on the subject to congress no later than June 15, 2012.  Along with two public hearings set up at American colleges, the USPTO also received written comments from intellectual property organizations, academic research institutions, companies, and individuals (all are posted on the USPTO website).

The positions of many of the intellectual property organizations followed closely with the interests that they represent.  For example, the Pharmaceutical Research and Manufacturers of America (“PhRMA”) has taken the position that the current patent system is essential to support innovation. They also assert that there is not enough information to support a conclusion that independent second opinion testing, done by relaxing patent law, is even medically necessary.  The Duke Institute for Genome Sciences and Policy offered only anecdotal evidence from patients and researchers they have talked to about the desire for independent second opinion genetic testing.  Indeed one of the only groups that appeared to offer a full analysis of the current issue was one made by the American Bar Association (hereafter “ABA”).  Their comment begins by outlining the history of genetic testing and the role that it can play in modern diagnostics.  Starting with the discovery of the structure the DNA in 1953, the comment discusses the initial costs of mapping the human genome and what the current costs are to sequence DNA.  The focus then moves to the intellectual property issues, where the cost of these new innovations is identified and where the strongest argument for where intellectual property protection comes from.  They state that the research is funded largely by third-parties and, without protection of intellectual property, investors will likely not fund medical research.

Most importantly, the ABA comment also evaluates the goal of public access to the newest and best diagnostic tests.  In the medical field, more than in any other field of innovation, there is a goal of using knowledge gained for the good of the public.  The ABA identifies that patented tests are often much more expensive than the generic ones that are created after the patents expire.  They also identify the cost of initial innovation as the main reason for why the price of a patented product might be higher than that of a generic.  They conclude that while competition would undoubtedly decrease prices, the resulting cost to new innovation would be to the overall detriment of the medical field. These issues are understandably complex.  Medical patents come under a great deal of scrutiny because promoting access to healthcare is a primary goal of most governments. 

The USPTO no doubt acknowledges this complexity because the final report and recommendations that their director was to make before congress were delayed.  When he did appear before congress to discuss the AIA on June 20^th, 2012, Mr. Kappos (the director of the USPTO) could only state that the USPTO “solicited comments and held two public hearings on the issue of genetic testing and are finalizing our report to Congress”.  It is worth noting that the AIA doesn’t propose to change the law on second opinion genetic testing; section 27 of the act only calls for a study to be compiled on the subject. Therefore any information the USPTO has obtained does not necessarily need to be available before the AIA comes into effect on September 16, 2012.

Adam Stevenson is a JD Candidate at Western University, Faculty of Law.

Posted in IP, Jurisdiction, Patents, Regulatory Policy, US