Gene Patents Invalid?...Stay Tuned

On March 29, 2010, a federal court judge held that gene patents claiming the breast cancer markers BRCA1 and BRCA2 (owned by Myriad Genetics) are invalid under the US Patent Act, on grounds that the patent claims are directed to "products of nature", which are unpatentable.

The suit against Myriad Genetics and the US Patent Office was brought by lawyers for the American Civil Liberties Union (ACLU) on behalf of medical organizations, doctors and patients who are opposed to patents on DNA molecules and living things. Judge Robert W. Sweet of the US District Court for the Southern District of New York handed down the decision, which took the patent bar by surprise. Previously, it was widely held that US law allows patents of this type, and most patent law experts agreed that the case had little merit.

It has long been a basic tenet of US patent law that "products of nature" are not patentable. However, patentees claiming DNA as the subject of a patent have avoided the "product of nature" doctrine by claiming isolated recombinant DNA fragments, which typically include DNA elements obtained from more than one species. Because such isolated recombinant DNA molecules generally do not exist in nature, they are considered to be man made.

In the landmark case Diamond v. Chakrabarty, 447 U.S. 303 (1980), the US Supreme Court held that patentable subject matter includes "anything under the sun made by man". Cases that followed ruled that isolated recombinant DNA molecules are man made, as are transgenic plants and animals carrying man made recombinant DNA. Based on this interpretation of the law, biotechnology companies proceeded to seek patents for their creations and the courts routinely enforced them. Until now. Currently there are some 40,000 issued US patents covering DNA molecules, including those directed to an estimated 2,000 human genes. If the Court's decision is upheld on appeal, then most, if not all of these patents will be invalid and thus worthless to their owners.

This case has major implications for the biotechnology industry, which has spent millions of dollars over the past few decades patenting various fragments of the human genome and the genomes of microbes, plants and non-human animals as well. Myriad's stock fell 4.82 percent per share the day after the ruling, closing at $23.70. Myriad said the day after the decision that it will appeal the case to the Court of Appeals for the Federal Circuit, which decides all appeals in patent cases nationwide. Parties on both sides of the issue will be following closely as the appeal unfolds.

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