Cogency of genetic patents considered

Genetic patents will have their day in court

Genetic patents will have their day in court -- today, to be exact.

Many healthcare entities note that there is a lot at stake with the case surrounding genetic property, which centers around the ethical soundness of patents held by Myriad Genetics over two human genes that have the potential, when mutated, to up the risk for women to contract breast or ovarian cancer. As they stand, the patents afford Myriad a monopoly over testing with the two genes.

For opponents of Myriad’s practices, the patents not only represent a cap on a profitable business venture, but serve to halt scientific progress in the fight against cancer and other ailments as well.

As outlined by The New York Times:  “Opponents of gene patents say no company should have rights to what is essentially part of the human body. They contend that Myriad’s monopoly has impeded medical progress and access to testing — in some cases denying patients their own genetic information.”

The American Medical Association (AMA) backed this challenger prerogative in a letter addressed to the Supreme Court the morning of April 15, claiming that the existence of genetic patents is harmful to patient care and crosses legal limitations.

“Human genes are products of nature and not patent eligible. Isolating a genetic sequence from human DNA does not make it any more patentable than removing a mineral from the surrounding rock,” wrote AMA president Jeremy Lazarus, MD, on behalf of his organization — one of many healthcare entities to sign an amicus brief defending a federal court ruling that invalidated the patents. 

The letter continued: “Exclusive patent rights over human genes conflict with long-standing principles of medical ethics regarding the sharing of natural scientific information to further advance science, technology and medical care. Medical innovations that provide insight into natural human biology must remain freely accessible and widely disseminated, not hidden behind a vast thicket of exclusive rights. Blocking this information interferes with diagnosis and treatment of patients and inhibits new medical discoveries.”

Myriad Genetics itself approaches the issue from a vantage of accountability — the company simply wishes to “own its findings,” Peter D. Meldrum, president and CEO of Myriad wrote in an op-ed for USA Today.

“There are several misconceptions about this case,” Meldrum wrote. “We did not patent the genes in anyone's body. That is not possible under U.S. patent law. Instead, we patented our own discoveries — the synthetic molecules we isolated and created in the lab to provide life-saving tests.”

“Those isolated synthetic molecules are different from the DNA in your cells. They do not exist in nature by themselves. As our legal brief outlines, ‘They were never available to the world until Myriad's scientists applied their inventive faculties to a previously undistinguished mass of genetic matter and created a new chemical entity.’ The patents have promoted significant advances beyond just our diagnostic tools, including significant research as evidenced by the 18,000 scientists who have published more than 10,000 scientific papers on the BRCA genes.“

Find a complete copy of the amicus brief posed to the Supreme Court here.

Follow the case progress here.


Image courtesy of the National Cancer Institute via Creative Commons licensing.