Social Policy: Myth v. Reality
The critics say that gene patents are bad social policy—they hinder research, raise costs, and limit patient access to care.
Academic researchers believe that scientific advancement occurs through the publication of research results. Society agrees that research is valuable and encourages it through billions of dollars of taxpayer-funded grants. However, this culture of information-sharing and government grants appears to have created a culture of entitlement where the property rights of others, specifically patent rights, are expected to be freely available in the name of research.
As with any human activity, even one as important as scientific research, there have to be limits. Respecting the patent rights of others has to be one of those limits if society is going to gain the benefits of the patent system.
As a practical matter, however, academic scientists who ignore patent rights have little to fear. The vast majority of patent owners simply do not want the adverse publicity of suing scientists and their universities, and the economic recovery is seldom worth the effort and money spent. They want patents in order to exclude competitors, trade them for needed technology, or raise money from investors.
The often-cited case of Madey v. Duke University (307 F.3d 1351 (Fed. Cir. 2002)), where a former Duke University professor sued the university for infringement of patents that he owned, is an aberration. The university had forced Madey out of his position as a laboratory director, and he responded with a powerful weapon that he had at hand—a patent-infringement suit.
More importantly, the fact that Duke was found to have infringed his patents goes to a fundamental aspect of the patent law. The law recognizes a limited research exemption from infringement. This exemption is limited to an examination of the patented invention; that is, research on the invention. This is completely consistent with the policy underlying the patent law of encouraging others to build upon the knowledge disclosed in the patent, including developing improvements or “inventing around” the patent.
This is quite different from using the patented invention in research. Simply because an organization is a nonprofit entity and/or engaged in a noble enterprise like scientific research does not mean that the organization or its employees have the right to infringe the patents of others. A patented reagent may cost more, but that is simply a cost of engaging in the activity, like any other cost.
Critics have also charged that patents raise costs to patients and/or limit patient access to medical care. One cited study is Cho et al., J. Mol. Diagn., 5: 3-8 (2003). The article reports the results of a telephone survey of 211 directors of laboratories that do molecular diagnostic testing. Of 122 respondents, 25% reported discontinuing performing patented genetic tests, and 53% stated they did not develop new tests because of patents.
However, a closer examination of the article shows that the respondents simply did not want to pay to license the patented tests. One of the respondents even acknowledged this by stating, “People shouldn’t be complaining that they can’t run tests. They should just pay.” Access to patented technology is a cost of doing business. Facilities and reagents are not free, and employees do not work for free. Why should new technology be free? The tests are available. It’s just a question of cost.