Journalists and legal analysts have once again worked themselves up into a nearly bacchanalian revelry as the United States Supreme Court handed down another opinion addressing patent eligible subject matter this past week. Long the subject of public fascination, patent eligible subject matter cases include lengthy legal and philosophical discussion on whether a particular type of idea or invention should be entitled to patent protection pursuant to Article 1, Section 8, Clause 8 of the U.S. constitution. (“To promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries”). The Supreme Court has long held that laws of nature, natural phenomenon and abstract ideas are not patentable because they are available to all people everywhere and should be reserved for none. At their core, these cases tackle the question “is this really an invention,” a question upon which science enthusiasts, talking heads, and even the general public enjoy weighing in. Yet the fervor created by the media rush to play legal scholar glosses over the nuance of these cases and fails to acknowledge that often the most significant aspect of these cases is what the Supreme Court leaves unsaid.
The Association for Molecular Pathology v. Myriad Genetics, Inc. opinion, delivered by Justice Clarence Thomas on June 13, 2013 addressed the sexy new topic of isolated Deoxyribonucleic Acid (DNA) strands and complementary DNA (cDNA). Myriad is the holder of several patents claiming isolated parts of the BRCA 1 & 2 gene; as well as methods of testing for the gene. A common public misconception in this case is that Myriad did not perform any innovative activities, and was merely attempting to patent a gene. This is not true. DNA isolation is not something that the average person can accomplish at home in their spare time (at least I know I can’t) Isolated DNA strands are portions of genes that have been removed from their parent DNA strand via chemical severing of the covalent bonds that connect amino acids. The base question at issue in the case is whether this act of science, this extraction process, is an inventive step sufficient to render a naturally occurring phenomenon into patent eligible subject matter.
Doesn’t seem like a weighty enough issue to warrant a media hailstorm? But wait, there’s more. The BRCA 1 & 2 genes are more commonly known as “the breast cancer genes” responsible for increasing a carrier’s chances of developing breast cancer from the average 12-13%up to 60-80%. See, Assoc. for Molecular Pathology v Myriad Genetics, Inc., 4 (569 U.S. __)(2013). If Myriad and the scores of other companies who own isolated DNA patents are in possession of valid patents, then they can stop other genetic testing facilities from isolating their respective genes. The end result is a single company holding an effective monopoly on genetic testing for a particular gene, regardless of the technique used. If the isolated genes are not patent eligible subject matter, then only the specific methods of testing for the gene will be protected by patents, thereby opening markets to competition in genetic testing services as companies develop new and innovative testing methods. Greater market diversification brings down prices and stimulates new developments. Thus, the question of whether isolated DNA is patent eligible subject matter is important because it deeply affects the availability of genetic testing and the potential for ongoing development in these fields.
Patent eligibility of biological subject matter was addressed by the Supreme Court in Diamond v. Chakrabarty, a case involving the invention of bacteria that were genetically modified in a laboratory to give them the ability to break down ingested oil. (447 U.S. 308)(1980). The Chakrabarty Court held that the bacterium were patentable because they were “human made micro-organisms” that did not occur in nature without the intervention of science. Conversely, in Funk Brothers Seed Co. v. Kalo Inoculants Co., 333 U. S. 127 (1948), the inventor combined several naturally occurring bacteria into vegetable crop inoculants. Individually, the bacteria were known by farmers to act as inoculants but were not known in combination. The Supreme Court invalidated the inventor’s patent stating that he had not created anything, but had merely cleverly combined known natural phenomenon.
The difficulty presented by the Myriad case arises from the fact that isolation of DNA borrows from both Charkrabarty and Funk Brothers. Like the Chakrabarty inventor, Myriad has exerted scientific efforts and used complex artificial processes for extracting the DNA it seeks to patent, and we as scientists, lawyers, and intrigued onlookers, appreciate and empathize with the significant costs in time and money that such developments incur. Unfortunately for Myriad, it is also similar to the Funk Brothers inventor who did not create anything new, but instead utilized a naturally occurring phenomenon. The Supreme Court held that “extensive effort alone is insufficient” and ultimately ruled that isolated DNA is not patentable subject matter because the parent DNA is a naturally occurring phenomenon Assoc. for Molecular Pathology v Myriad Genetics, Inc., 14 (569 U.S. __)(2013).
Interestingly, in this case, the Court decided to say exactly what it wasn’t saying. Justice Thomas articulated the Court’s position that complimentary DNA (cDNA), which is manmade, is not a naturally occurring phenomenon and does not need to be addressed. The Court also stated that no method claims were at issue and that new and novel methods for isolating DNA could be patentable. Lastly, the Court declined to address the issue of manmade amino acid arrangements that result in artificial DNA. Assoc. for Molecular Pathology v Myriad Genetics, Inc., 16-17 (569 U.S. __)(2013). With these deference’s in hand, the patent community is free to explore creative claiming strategies for effectively obtaining coverage on DNA products, without actually claiming the DNA itself.