Gene patent case unlikely to succeed, but raises key issues

Gene patent case unlikely to succeed, but raises key issues

My first experience with intellectual property occurred several years ago when I watched a documentary on the patents on the genes BRCA1 and 2. Individuals with certain types of mutations within these genetic sequences are at a significantly higher risk for developing hereditary breast and ovarian cancer. Despite knowing little about both genetics and law at the time, the story peaked my interest in intellectual property law.

On May 12th, a lawsuit was filed against the USPTO, Myriad Genetics, and the University of Utah Research Foundation by several breast cancer patients as well as prominent medical researchers acting on behalf of more than 150 000 industry specialists. Myriad Genetics currently holds a United States patent for the two identified "breast cancer genes," BRCA1 and BRCA2. The complaint argues that the patents held by Myriad are invalid because the genes are merely products of nature.  The plaintiffs also argue that gene patents violate free speech rights and thus are unconstitutional under the First and Fourteenth Amendments to the US Constitution.

Gene patents allow the rights holder to prevent others from using or testing with the gene, which is argued to contribute to delays in research progress and access to important tests for genetically-linked diseases. Myriad Genetics requires that anyone who wants to be tested for mutations in either of these genetic sequences must send samples to the Myriad lab in Salt Lake City, Utah, and pay a fee of approximately $3 000. Not only is the cost high, but patients are prevented from getting a second opinion by having another company run a diagnostics test, limiting the ability of women to fully assess their options when faced with the possibility of cancer. Also, the cost for the test continues to rise without any improvements in the quality or accuracy of the test because genes that were linked to breast cancer after the patent was granted are not incorporated into the current test offered by Myriad.

The patents held by Myriad Genetics are certainly among the most controversial patents the USPTO has given out for genetic sequences. Some research centres ignored the Myriad patent and began to offer testing for mutations in the BRCA1 and BRCA2 genes, most notably the Ontario Ministry of Health and Long-Term Care. The Ontario government charged only a third of what Myriad was demanding from patients and delivered results up to two months sooner than the patent-holder Myriad. When Myriad tried to enforce its patent, the Ontario Health Minister was accused of ignoring Myriad's demands. European hospitals struggling to pay for the high price of the test but wanting to ensure that women had access to an important development in preventative medicine followed Ontario's lead and began offering the test. In 2004 The European Patent Office revoked Myriad's patents on the grounds that the "inventiveness" requirement for a successful patent application had not been met.

Despite these examples of "rebellion" against the Myriad patents, it is unlikely that this case will succeed. The plaintiffs' argument that gene patents restrict communication and thus violate free speech rights within the Constitution is debatable. The USSC has not recognized research as a form of free speech. Additionally, if the plaintiffs were to succeed, the viability of thousands of patents would be in danger and would cause uproar in the patent law community.

What seems to be the main issue is not that patents should be unavailable whenever genetic sequences are at issue, but that the USPTO's policies and understanding of biotechnology and science has not kept up with the pace of the industry itself. I coincidentally worked in a genetics laboratory for several years some time after seeing the documentary about BRCA1 and 2. Like my initial very strong pro-patent beliefs when I was involved in research, part of the problem with many patents is their overly broad nature. As the root of more and more diseases is being attributed to mutations within our genetic code, gene patents run the risk of limiting research if a disease is known to be caused by a genetic mutation. If gene patents are defined too broadly, patent holders theoretically could prevent research on proteins produced in the body associated with a disease because the proteins were encoded by genes. As has been stated by bioethics experts, patents are a privilege, not a right. Unless the USPTO steps in and clearly identifies what exactly is being patented so to limit patent protection appropriately, research will undoubtedly be stifled to some extent.

What was patented by Myriad in its original patent application in 1994? Myriad has not identified the exact genetic sequence that patients are paying the company to identify within their bodies since there is no feasible way to patent every variation of a gene found from person to person. Myriad holds a patent that allows it to restrict the use of breast cancer gene screening tests. However, in effect, this restriction gives Myriad a patent on all of the genetic variants. Nor has the company discovered the method for sequencing genetic material, splicing genes, or isolating genetic material from other cellular components. Yet Myriad's patent includes many of these processes related to the BRCA genes, which seems to raise serious questions as to the patent's over-reaching implications.

I believe gene patents are an important way to reward researchers for their work, but the slowly-evolving law has not been able to keep pace with research for many years now. Several Canadian health authorities have proposed that gene patents should be banned, but experience shows that absolute bans rarely achieve desired results. Perhaps licenses to limit who can perform the screening test would serve a better purpose than an over-arching patent on anything related to the BRCA genes. The gap will only grow larger unless we change how it is implemented and applied.