Human gene patents limit access to care

When a physician needs information about a patient's genetic makeup, should the doctor have to worry about infringing on a gene patent?

In the exam room or even in the operating room, concern about running afoul of a gene patent raises the prospect of blocking fully informed treatment. It suggests a new type of urgent consult, not medical but legal, in hopes of unraveling the legalities of patent infringement. This chilling scenario was cited by the Litigation Center of the American Medical Association and the State Medical Societies, along with other medical organizations, in an amicus brief filed in what promises to be a landmark case concerning gene patents.

In 2009, the Assn. for Molecular Pathology and others filed a lawsuit against Myriad Genetics, challenging the validity of Myriad's patents on two genes associated with breast and ovarian cancers. The suit claimed that some women were unable to confirm their cancer test results elsewhere because Myriad had exclusive rights to use of the BRCA1 and BRCA2 genes and related diagnostic testing. The suit also said some women could not afford the $3,000 test. Myriad argued that the genes it isolated were different from those naturally occurring in the body.

On March 29, 2010, the U.S. District Court for the Southern District of New York invalidated Myriad's patents on the genes. District Judge Robert W. Sweet ruled the patents violated long-standing precedents that barred the patentability of natural phenomena. The ruling cast doubt on existing patents that cover 20% of the human genome and sparked debate about whether patents on human genes help or hinder medical innovation. Myriad appealed to the U.S. Court of Appeals for the Federal Circuit, which oversees patent cases.

The AMA is asking the court to uphold Sweet's decision. The practice of medicine is harmed by patents on gene sequences, DNA molecules and comparisons of gene sequences, the AMA and its partners state in their court brief. Such patents interfere with medical innovation, access to care, diagnosis and treatment. The brief cites an example of a company that filed for patent protection of a genetic sequence that indicates whether patients would benefit from its asthma medication. The company said during the patent's 20-year term that it would not let anyone use the sequence to see if the drug would help or harm patients.

Research shows how gene patents hinder medical and scientific innovation. Consider that 49% of members of the American Society of Human Genetics had to limit their research because of gene patents. A survey of laboratories that perform DNA-based genetic tests found that one in four labs stopped doing some genetic tests due to patent restrictions or excessive royalty fees.

Myriad's control of the BRCA1 and BRCA2 sequences has led to misdiagnosis of patients, according to the brief. Patents on gene sequences increase health care costs and make genetic tests inaccessible to many patients. Existing non-patent incentives should be sufficient to promote innovations in genetics. Helping mankind, the prospect of a major award and achieving academic advancement have long inspired scientists and physicians to conduct genetic research.

The AMA Code of Ethics prohibits doctors from patenting medical procedures because such patents compromise care. In June 2010, the AMA House of Delegates adopted policy that the AMA oppose patents on human genes and their naturally occurring mutations. It said the AMA supports legislation requiring that existing gene patents be broadly licensed so they don't limit access through exclusivity terms, excessive royalties or other unreasonable terms. In addition, the Association supports legislation exempting from claims of infringement those who use patented genes for medical research and diagnosis.

Physicians need access to genetic information to make accurate diagnostic and treatment decisions. Patents should not interfere with determining what disease a patient has or what are the best medications to treat it. The sharing of medical and scientific information is necessary to advance medical care. It's what allows physicians do their necessary work and patients to benefit from it.