Supreme Court might legalize medical patents

December 9, 2011

On the 7th December, the U.S. Supreme Court heard oral arguments in a case that raises a fundamental question of whether a physician can infringe a patent merely by using scientific research to inform her treatment decisions. ars technica covered the matter quite well: 

Prometheus (the company responsible for the particular case) claims much more than its specific testing process. It claims a physician administering thiopurine to a patient can infringe its patent merely by being aware of the scientific correlation disclosed in the patent—even if the doctor doesn’t act on the patent’s recommendations. 

The extraordinary claim prompted a broad coalition of public interest groups to write amicus briefs urging the Supreme Court to invalidate the patent and others like it. For example, the American Medical Association stated this within its brief:

If claims to exclusive rights over the body’s natural responses to illness and medical treatment are permitted to stand, the result will be a vast thicket of exclusive rights over the use of critical scientific data that must remain widely available if physicians are to provide sound medical care

On the other hand, the American Civil Liberties Union brief pleads to the First Amendment:

If any portion of a claim restricts a person’s ability to think about a specified subject, it is unconstitutional under the First Amendment. Because the final step in this claim does exactly that, it is invalid.

 An analogy may be helpful. Assume Henry Ford obtained a patent on the process of the moving assembly line consisting of first having one person put on the hood and then, after the body of the car has been moved by a conveyor belt, a second person put on the trunk. Assume that is a patent eligible process. Assume further that General Motors obtained a patent on the same hood-trunk process by adding a third step, “wherein if the process takes more than 5 minutes consider whether to reverse the order.” Applying the Federal Circuit’s transformation analysis, the hood-trunk “transformative” steps would justify General Motors’ claim if other patent law criteria were satisfied, even though the third step describes pure thought. In our view, the First Amendment prohibits such a patent even if patent law does not.

Under this hypothetical patent, General Motors’ engineers could think about reversing the order in which parts are assembled based on the speed of the assembly line. Personnel at Ford, or any other plant, who engaged in the same “mental step” would be infringing the patent.

 This case presents precisely the same situation. Prometheus personnel who administer the drug and the test can look at the results and think about the dosages. Researchers who are simply reviewing dosage studies can think about dosages. People at Mayo can lawfully administer the drug and the test. But, people at Mayo cannot look at the results and think about the dosages. 

And a coalition of  representatives from the Cato Institute, Reason Foundation, and the Competitive Enterprise Institute reminded the court of Thomas Jefferson in their brief

Thomas Jefferson, the author of the Patent Act of 1793, was one of the key framers of this country’s intellectual property jurisprudence. In 1966, the Supreme Court thus characterized his views on the subject:

[Jefferson believed] [t]he patent monopoly was not designed to secure to the inventor his natural right in his discoveries. Rather, it was a reward, an inducement, to bring forth new knowledge. The grant of an exclusive right to an invention was the creation of society—at odds with the inherent free nature of disclosed ideas—and was not to be freely given.

Graham, 383 U.S. at 8-9.

Enforcing the patents at issue here will not “bring forth new knowledge.” Id. at 9. Instead, it would further an improvident and unconstitutional expansion of patentable subject matter which has primarily served to slow rather than to spur innovation.

Continuing on this path by permitting medical-diagnostic patents will only serve to further slow the economy, retard technological innovation, distort the free market, and place human health at risk. 

According to ars technica, most of the justices gave no consideration to the arguments outlined above.

At one point, Justice Kagan offered some advice to Prometheus’s lawyer. “What you haven’t done is say at a certain number you should use a certain treatment, at another number you should use another treatment,” she said. “I guess the first question is why didn’t you file a patent like that? Because that clearly would have been patentable. Everybody agrees with that.”

The step to expand patent law to cover medical practices (and not just drugs) is highly significant since it will drastically reduce the ability of physicians to perform their job to the best of their ability. Once again one has to question the legitimacy of a U.S. Supreme Court that prioritizes the interests of the corporate sector over the interests of people.  

ars technica: Oblivious Supreme Court poised to legalize medical patents
American Medical Association brief
American Civil Liberties Union brief
Cato Institute, Reason Foundation, and Competitive Enterprise Institute brief



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