The USA Supreme Court has released on June 13, 2013 an opinion addressing an appeal regarding a decision of the Federal Circuit that found both isolated DNA and cDNA patent eligible. The case involved the Association for Molecular Pathology and others versus Myriad Genetics, Inc. and others. The earlier basically wanted anything related to DNA products be non-patent eligible while the latter preferred the opposite. The decision of the court has of course significant economic impact as investors in companies involved in the groundbreaking genome related products have much to gain or lose depending on the level of protection awarded.
Patenting of DNA sequences is an area of dispute for quite some time now, the controversy arising from the question if the discovery of the precise location and sequence of a gene should be considered patent eligible. Today it is possible to extract the DNA from cells and isolate certain segments. Science has developed also the capability of synthetically creating composite DNA, cDNA for short, that comprise only of exons without intervening introns. Myraid received several patents for the BRCA1 and BRCA2 genes and was further able to receive a patent on BRCA which is a cDNA.
Originally the District Court sided with the Association for Molecular Pathology and others issuing a summary judgment that concluded that the Myraid patents were invalid under 35 U.S.C. §101, as it would not comply with the requirements for patentability, because they basically “covered products of nature” as “laws of nature, natural phenomena and abstract ideas… are basic tools of the scientific and technological work” and that they “lie beyond the domain of patent protection”. The Federal Circuit reversed the decision and “found both isolated DNA and cDNA patent eligible”.
In its released opinion the Supreme Court distinguished between the cases of the DNA claims and the cDNA claims of Myraid. With respect of the DNA claims the Court argues that they do not satisfy the exception to the “new and useful… composition of matter” as it “falls within the law of nature exception”. That is, the Court has found that despite the fact that though the discovery of BRCA1 and BRCA2 may be “groundbreaking, innovative or even brilliant” but that is not sufficient to overcome the exceptions of the law of nature. The Court noted that “Myraid did not create or alter either the genetic information encoded in the… genes or the genetic structure of the DNA”. Therefore it seems that the Court has concluded that in the case of the DNA claims there was merely a discovery of a law of nature and hence the claims were not patent eligible. The Court also noted that in the description of the patent Myraid clearly showed that it had gone through an extensive process of discovery, however, such efforts, regardless of scope, are insufficient to determine patent eligibility. The Court also noted that the claims suffered from other deficiencies.
The Court took a different stand when examining the case of the cDNA claims. Simply stated, it noted that the cDNA claims do not amount to a “product of nature”, that is, they do not occur naturally and regardless of the teachings made by the inventors. Specifically, the Court notes that “cDNA does not present the same obstacles to patentability as naturally occurring, isolated DNA segments.” By contrast, the Court agrees that the cDNA claims result in an exon-only molecule, which is not naturally occurring”. Moreover, though the order of the exons within the cDNA “may be dictated by nature” still the fact that the introns were removed from the DNA sequence results in a new composition of matter which is patent eligible.
Realizing that this is a precedent setting case the Court also noted in the Opinion that this case does not involve all possible kinds of claims. For example, method claims for extracting a BRCA1 or BRCA2 gene where not decided upon in this case, as well as other potential patent areas, and hence the decision seems to be limited to cases of composite of matter.
Israel’s patent law, section 3, defines a claim to be patent eligible if the invention, being a product or a process in any technological domain, is new, useful, has an industrial use and includes and inventive step. However, an exception is defined in section 7 of the law, stating that a patent will not be granted for (1) a method for medical treatment of a person, and (2) for new types of plants or animals, other than micro-biological organisms that have not been extracted from nature. It therefore seems that the patent law in Israel is consistent with the Court’s decision. A DNA claim will therefore be considered as being extracted from nature, and therefore not patent eligible, while a cDNA claim would be considered as not being extracted from nature, and therefore patent eligible.
In conclusion it seems that Myraid tried to test new grounds in getting patents and that the Court has restricted the allowable scope of such claims relating to genetic work. It is therefore important to carefully construct claims that adhere with the Court’s decision and moreover take note of the Court’s remarks regarding the requirements of description when dealing with such matter. A description that focuses on the discovery process may more easily lend itself to be determined as not patent eligible by the inventors’ own admission.