Genes improperly granted patents

By Dr. Ananya Mandal, MDApr 1 2010

Some time mid last year six breast cancer patients sued reputed Myriad Genetics, a company that holds patent of two vital genes BRCA1 and BRCA2 that play a role in increasing the risk of breast and ovarian cancers. The fees that the company charges for these genetic tests is a whopping $3,000 which these women claim they cannot afford and the most important of all these women cannot get a second opinion regarding the tests since no one else does them.

In a recent development Judge Robert W Sweet said that these genes involved a "law of nature" and the patents had been "improperly granted." According to U.S. law, products of nature cannot be patented because they are pre-existing substances found in the wild.

This verdict can have serious consequences on biotechnology companies since nearly 20% of the genes in human body are already patented. In a direct reaction stocks of many such companies fell on Tuesday. The question is what will be the long term impact of such a ruling.

Judge Sweet however said in his 152 page ruling that this judgment will not affect the industry in a detrimental way. Some other legal heads concurred that the actual effects of this ruling will be felt years from now. The immediate effects will also be limited because of the decision made in a District court.

A Myriad spokesperson said that they would appeal on Tuesday with legal advisors feeling that they could overturn the ruling.

The Supreme Court right now is on the verge of giving judgment in the Bilski case. This case is about a dispute over a method of hedging risk in commodities trading. This case could give the Supreme Court a chance to set new standards on what is patentable.

“We are still waiting, holding our breath for the Bilski case,” said Kari Stefansson, head of research at DeCode Genetics, which sells disease risk tests similar to those sold by Myriad.

However geneticists say patents for genes could hamper competition in gene based application development, academic research, innovations and newer diagnostics apart from the cost issues.