Saturday, March 31, 2012

Gene Patents

For those of you interested in whether human genes can be patented . . . the Supreme Court has just issued a couple of important decisions on this topic. This is from an article I wrote for my law school's newspaper. It will be interesting to see what happens next with these cases . . .

In March 2012, the U.S. Supreme Court issued two landmark decisions which will have a significant impact on the ability to patent human genes. On March 20th, the Court discarded patents owned by Prometheus Laboratories, Inc., a company based in San Diego, CA, that develops diagnostic tests designed to promote individualized patient care. The company’s patents had been issued for various blood tests that examine the body’s reaction to certain drugs to better determine safe and effective dosages. Justice Stephen Breyer, who authored the opinion in the case, explained that the company’s testing methods simply observed naturally occurring phenomena and were not sufficiently inventive to justify patent protection.

Following this decision on March 26th, the Supreme Court invalidated patents for certain isolated genes known to increase the risk of several cancers. The two genes in question, known as BRCA1 and BRCA2, have been isolated by Myriad Genetics, a molecular research company in Salt Lake City, UT. Myriad designed a method which examines DNA taken from these genes for the presence of mutations that can lead to an increased risk of breast and ovarian cancers. Patents on these genes would prevent other laboratories from using the genes for similar procedures and could greatly increase costs for individuals who need to assess their genetic risks of developing the cancers.

Myriad’s patents on the genes were overturned earlier in U.S. District Judge Robert Sweet’s 2010 ruling, in which he ruled that the mere isolation of strands of DNA does not change the DNA from its naturally occurring state and thus does not warrant a patent. However, in July 2011, a federal appeals court which handles patent cases reversed this ruling in a 2-to-1 decision, claiming that isolated DNA has a very different chemical structure from DNA naturally existing in the body. The most recent ruling will send the Myriad case back to the U.S. Court of Appeals for the Federal Circuit for rehearing, but the litigation may not reach a conclusion for several years.

Throughout the Myriad case, the controversy focused on whether individual human genes, as isolated sequences of DNA, are inventions that are worthy of patent protection or merely products of nature. Although gene patents are a relatively new development, the U.S. Patent and Trademark Office has issued over 2,500 patents for isolated DNA sequences in the past thirty years. Gene patents are expected to have a major impact on the emerging area known as “personalized medicine.” In this field, doctors use individualized procedures to establish whether patients are likely to contract certain diseases, or whether they would respond well to certain types of medications. Advocates of the patents claim that a lack of patent protection could reduce incentives for the development of personalized medicine. Many products in this field would be unprofitable if innovative research efforts were not rewarded with patent protection.

Although the personalized medicine and biotechnology industries tend to support gene patents, many doctors, patients, and researchers believe that the patents will ultimately hinder genetic research and render important medical procedures prohibitively expensive. The American Civil Liberties Union, which filed the initial lawsuit against Myriad, has argued throughout the case that the gene patents will raise costs for patients and prevent them from obtaining a second opinion on their diagnoses. Opponents of the patents also assert that patent holders could eventually gain monopolies on new research in certain diseases and in particular areas of patient care.

While the final outcome of the Myriad case is uncertain, the ACLU has expressed confidence that the Supreme Court’s invalidation of the patents owned by Prometheus Laboratories predicts a similar ruling on the validity of Myriad’s patents. However, representatives for Myriad believe their patents are fundamentally different, because they pertain to the isolated genes themselves rather than to the testing methodology previously covered by the Prometheus patents. Regardless of the outcome, the legal and scientific issues related to gene patents will play a major role in the future of medical research and patient care.

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