Student Project: Patentability of Genes: Case Law

This case established that one cannot broadly patent a scientific principle, here electromagnetism. An application of a scientific principle, however, to a specific use or process for making a product is patentable. The rationale is that a scientific principle or natural phenomenon, such as natural human DNA, is found in nature and should be free for all to use. Id. at 117-18.

Supreme Court held that inhibitory or non-inhibitory properties of bacteria were phenomena of nature and cannot be patented. In this case the inventor merely combined several different types of bacteria into one agricultural product. He did not do anything to change the natural state of the bacteria; he just combined them. Since the bacteria were the same as those found in nature, after the patentee's combination, the Supreme Court held that his invention was not patentable subject matter. Id. at 132.

Supreme Court held that a living micro-organism is patent-eligible under 35 U.S.C. Section 101, as long as it was made by man. Here, an existing bacterium was genetically engineered to break down oil for the purpose of treating oil spills. Prior to this Supreme Court decision there was confusion in the lower courts as to whether living organisms were patentable. In this case, the Court said that anything under the sun was patentable as long as it was made by man. The court did limit this broad interpretation of patentability by reiterating that laws of nature, physical phenomena and abstract ideas cannot be patented. Id. at 309.

One cannot patent a mathematical equation, but one can patent a process or machine that uses the equation for a particular application. Here, the patentee applied the Arrhenius equation in an iterative fashion to an on-line rubber molding process to calculate the appropriate cure time. Id. at 179. Although the Arrhenius equation is a scientific principle, here it was applied in manner that improved the process of making a molded rubber product. Therefore, the Court held that the patent was valid for the subject matter requirement. Id. at 192-93.

The Supreme Court granted certiorari to determine if Metabolite's patent should be declared invalid for claiming a "monopoly over a basic scientific relationship"; the case was dismissed. Id. at 125. Justice Breyer issued a dissenting opinion describing why this case should be decided by the Supreme Court. Id.

Supreme Court held that patents were invalid because they "effectively claimed the underlying laws of nature themselves". Here, the patentee claimed a process to determine the appropriate therapeutic dose level of a drug by measuring drug metabolite levels in the patient's blood at a certain period of time after administration. Id. at 1297-98. The Court held that this process is based upon the laws of nature, that is the way the body metabolizes a drug, and is therefore, not patentable. Id. at 1303-04. This case seems to reflect a raising of the bar for subject matter eligibility for patents.

The Court in Myriad held that a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated; cDNA is patent eligible because it is not naturally occurring. Id. at 2116-19. It is interesting to note that the Supreme Court granted certiorari for this case, but before deciding the case remanded it back to the Federal Circuit in light of the Mayo decision. The Federal Circuit affirmed its previous decision in Myriad and the case was again taken to the Supreme Court. The Supreme Court reversed in part and affirmed in part. Once again this decision seems to indicate that the Court is taking a stricter stand on subject matter eligibility for patents.