An Invention or a Discovery?

Human genes have been called unpatentable and anti-competitive. Everyone from the ACLU to patients who demand cheaper tests are weighing in on the debate. The controversy was complicated last week’s by the U.S. district court’s decision against Myriad Genetics, whose popular but costly diagnostic tests have until now been protected under patent law.

Those who do not believe that products which derive from human genes are patentable argue that (a) no one should own something that occurs in nature, (b) patents impede science and patient care, and (c) gene patents are too important and profitable to have one company own them. Synthesizing genes in the lab, they reason, is not something that any one company or individual can or should own.

The “monopoly” arguments have been heard before, with Edison and Bell, among others. Many feared that Edison would control electricity.

Watching Morley Safer’s on CBS’ 60 Minutes on Sunday night viewers were led to conclude that owning the process for identifying and manipulating genes is unethical if not illegal. In a predictable “60 Minutes” report the show gave a platform to the ACLU and women with family history of breast cancer who require the $3,200 tests to help them make life decisions.

30 Seconds on 60 Minutes

It is interesting that Morley left out of the discussion the most important component: the health insurance providers who may not be reimbursing sufficiently for the tests.

A lone dissenting voice on the 60 Minutes report was Kevin Noonan, a molecular biologist and patent attorney whose Patent Docs blog has done a good job familiarizing the legal and medical communities with the issues. Noonan is well aware of the need for government and the courts to continue to provide entrepreneurs and investors the incentive that a limited period of exclusivity does.

More balanced reporting than 60 Minutes’ (tic-tic-tic) can be found in “Gene Patents Shot Down in Court” on by Brandon Nafziger on Dot Med News. One of Nafziger’s sources suggested that gene patents do not impede innovation but facilitate it.

The anti gene patent proponents may be well-intended, but they are starting to sound like the antiretroviral/HIV drug mob. Compulsory licensing and competitive pricing may sound fair, at first, especially when the cost of an invention or discovery that can benefit large numbers of people makes it less accessible. But it is dangerous to confuse an economic issue with a legal one.

Compulsory licensing can only take innovation so far. If NIH, Pasteur Institute,  and research hospitals and universities could solve medical problems and provide therapies without the assistance of business they would. However, it is not that easy. It’s easy to demand access to therapeutic tests and other inventions once they actually work and are well-established in the market.

Should the individual or business that identifies a gene have the right to charge a toll to all others who want to manipulate it for invention? Without the incentive of patent ownership would researchers have had the impetus or capital to have identified a large portion of the human genome in the first place?

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There are no easy answers here. However, price-setting of the important discoveries/inventions once they are on their way to becoming a success is not necessarily best decided by a popular vote.

No one wants to deny patients the tests or therapies they require, but the court’s should not confuse economic or health insurance issues with those of invention and ownership.

What do you think?