Prometheus' decision impacts the layout of American biotechnology? ㈠

The Supreme Court of the United States recently overturned the judgment of the Court of Appeals for the Federal Circuit, and found that the case did not meet the eligibility of the patent subject matter stipulated in the US Patent Law. The judgment of Prometheus case not only limits the possibility of obtaining patent protection by inventing methods related to medical testing in the future, but also has a wide impact on the future patent layout direction of American biotechnology and pharmaceutical industry. _

On March 20 12, the Supreme Court of the United States made a judgment on the high-profile case of Mayo Cooperative Services Company v. Prometheus Laboratories Company (hereinafter referred to as Prometheus case).

The verdict unexpectedly overturned the original judgment of the US Court of Appeals for the Federal Circuit.

It is concluded that the invention of a detection method for injecting a certain dose of 6- thioguanine (6-TG) into human body and detecting the concentration of metabolites in human blood to determine whether the dose achieves the best drug effect does not have Article 10 1 (35 U.S.C. 65438+) of the United States Patent Law.

Qualification criteria for patent application:

Methods, machines, articles of manufacture and combinations of articles

Article 10 1 of the U.S. Patent Law lists four kinds of inventions as qualified patents: process, machine, manufacturing and material location.

In its previous judgment (Diamond v. Chakrabarty, 447 U.S. 303 (1980)), the Supreme Court of the United States pointed out that although the provisions in legislation have a wide scope of application, their scope is not unlimited.

In practice, natural laws, physical phenomena and abstract concepts are still excluded from the object of patent protection.

In the judgment of Prometheus case, the Supreme Court of the United States held that this case revealed a natural law, that is, the correlation between the concentration of specific metabolites in the blood and the possibility of drug effects or side effects after human metabolism of specific drugs.

Even if it takes human behavior (drug administration) to make correlation appear in a specific human body, correlation itself exists independently of anyone's behavior and is the result of human drug metabolism, so it should be a completely natural process.

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