A gene patent refers to a patent protection on a specific isolated gene sequence, the particular molecular composition, and as well, the procedure to obtain the isolated gene.
Myriad Genetics, Inc. a molecular diagnostic company in Salt Lake City, has been developing tests to identify genes which could have potential correlation to specific human diseases. BRCA1 and BRCA2, the two genes which were isolated by Myriad Genetics, are viewed as the potential indicators used in probing and determining the risk of breast cancer and ovarian cancer. The two isolated genes were granted 20-year patents, which would give the company exclusive rights for the genetic exam for the aforementioned cancers. In 2009, the plaintiffs coordinated by the American Civil Liberties Union (ACLU) and the Public Patent Foundation (PUBPAT) filed a lawsuit against Myriad Genetics and alleged that the patents were illegal. Furthermore, it was also claimed that the patents protection may limit data sharing which is viewed as one of the most important drivers to accelerating the innovation / development in medical research/practice. The lawsuit against Myriad Genetics was originally ruled by the District Court with the decision that all claims including the isolated gene patents, and the methods to “compare” and “analyze” the isolated genes to diagnose cancer risk were not patentable. The company then appealed to Federal Circuit, and the Circuit Court, and this time, it recieved differring decisions; one ruled that the “isolated DNA” was patentable, however the diagnostic methods were not. The plaintiffs appealed again, but was unable to get the ruling changed; so, the two patents remain valid. In September 2012, the plaintiff filed the petition with the Supreme Court again and currently the case remains unresolved.
The case is controversial because some voices argue that according to the First Amendment and Patent Law, “product of nature” is not patent eligible and the “genes” should be viewed as the products of nature. Besides, the exclusive right/data limited to only Myriad Genetics impede the research in the future medical practice.
Other voices argued that, the two genes, BRCA1 and BRCA2 are not naturally occurring in composition, and therefore do not exist in nature. Instead, they are isolated by the technology invented by Myriad Genetics. Therefore, the patents should be granted to protect the investment and resources dedicated by Myriad.
In class, we’ve talked about the Patent Law, and it is true that according to Title 35, Section 101: “Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.” Although the patent laws grants broadly protection provisions under a specific patent, there are still some exceptions; for those “law of nature, physical phenomena, and abstract ideas” many may not be patented. Therefore, generally, laws of nature can’t be patented.
It seems like both voices have their respective merits; concerns are heightened for the case because if the firm wins the patent case, it could have control on the genetic testing pricing, and the patent protection could hinder other biotech companies in creating improved gene identifying processes. Besides this fact, patients may not be able to receive the second opinion on the test or the patents prevent other firms from developing potential alternatives. However, if it lost the case, it might impede the speed or innovation motivation for the biotech industry as a whole to invest resources on the new innovations to improve human’s lives because the economic incentive is removed. With the advancement of the biotechnology, there may be more and more similar cases, therefore, the final decision of the case “association for Molecular Pathology v. Myriad Genetics” may serve as a precedent case to the industry where biotechnology companies and medical researchers need to have a clear definition of level of protection for incentives and economic motivations in order to pursue further innovation.