Myriad Genetics, a Salt Lake City based company, was the first group to isolate the gene sequences known as BRCA 1 and BRCA 2 that indicate whether a woman has a high risk of developing breast or ovarian cancer. Myriad then used these sequences to develop a diagnostic test that screens a woman’s genome and identifies whether she has the gene or not. The US Patent and Trademark Office granted Myriad patents on their test and the isolated DNA sequences, which effectively provided them a monopoly on determining whether a woman was at risk of developing either type of cancer. After conflicting decisions in the U.S. Federal District Court and the U.S. Court of Appeals for the Federal Circuit, these patents are now being challenged in the U.S. Supreme Court by breast cancer patients and cancer researchers whose patent litigation attorneys argue that these gene patents cover naturally occurring products and should not be granted patent protection. They also argue that the patents stymie further research and allow Myriad to control the price of the test without threat of competition, denying the test to those who cannot afford it.
On the other side of the debate, Myriad’s patent attorneys respond that if a gene patent is not granted in situations like this, the research necessary to make these types of advancements will not take place because of the significant investment in time, effort, and dollars required. Moreover, Myriad is not the first company to patent a genetic sequence. Gene patents have long been allowed by the U.S. Patent and Trademark Office. Other proponents of gene patents, including other biotech and agricultural companies, agree that without a patent at the end of the process, the financial incentive is lost and there aren’t enough altruistic scientists out there who will explore important issues like these just out of the sheer advancement and pursuit of knowledge.
Patent attorneys on both sides seem to make valid points and the situation illustrates just one of several challenges that the patent system is currently facing. The U.S. patent system has recently come under attack for its inability to appropriately handle the rapid development of emerging areas of science and technology. One of the rationales for the patent system is to encourage the development and growth of science by striking a bargain between the inventor and the government/public. Article I, Section 8, Clause 8 of the U.S. Constitution empowers Congress “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 inventor is granted a temporary monopoly to exclude others from practicing their new invention in exchange for providing society the benefit of the invention by disclosing the invention to the public. The inventor is able to profit from his or her invention for a limited time while the public is educated about the nature of the invention expanding the knowledge base of science and technology.
Both society and the inventor are intended to benefit from this system. The Myriad case highlights the tension that often exists between providing the inventor exclusivity and society’s desire to benefit from the progress of science now. The tension is particularly heightened in cases where benefit of the invention is saving lives, and society wants to inexpensively save lives now.
The Supreme Court heard oral arguments from both sides in the Myriad case on April 15th and will likely decide the outcome of the case in June.
Understanding the current state of patent law and how you can protect your company’s intellectual investments can be the key to your business’s success. Trust the patent attorneys at Clegg Law with your patent needs.