Thursday, June 13, 2013

BREAKING: Supreme Court Rules Against "Natural" Gene Patents

We have some rare good news in the area of intellectual property (IP) law. The Supreme Court ruled today that Myriad Genetics' patents on two breast cancer gene mutations are invalid.

Myriad Genetics offers a test which lets women know whether they are at increased risk for breast cancer. The test tells women whether they have BRCA gene mutations. Women with these mutations are up to 65% more likely to develop breast or ovarian cancer. Myriad's patent covered ANY use of the mutations including ANY OTHER test for those mutations. Although Myriad claimed to allow further scientific research on these mutations, it isn't clear that they actually allowed all research to go forward. More importantly, Myriad used the patent to block all competitors from introducing other (different) tests. Patients who couldn't afford the tests had no other option. Even those who could afford the tests had to option to get a second opinion (important as no tests are fool-proof).

SCOTUS ruled today quite rightly that patents cannot cover naturally occurring genes. SCOTUS has drawn some fairly bright lines this year. Past cases have shown that patents of human transplanted genes are valid and those patents. The ruling earlier this year on the replanting of Roundup Ready Soybeans shows that those patents are broadly enforceable. This ruling shows that patents of naturally occurring genes are not valid. Note that in the Roundup Ready Soybean case, the genes in question did occur naturally, but were transplanted from a bacterium into soybeans.

UPDATE: Supreme Court Rules in Favor of Monsanto in Gene Pattent Dispute

The Supreme Court ruled in favor of Monsanto in the case of the agri-business giant vs. small Indiana farmer.

But the ruling was narrower than it could have been. The court ruled that Vernon Bowman violated the patent intentionally. He was in violation because he actually made an attempt to use the patented soybean seed without paying for it. It appears that those who violate the patent accidentally (because of plants spreading seed on their own) would not be considered in violation, but SCOTUS did not specifically rule on this issue. This point of law is crucial considering that genetically modified (GMO) wheat has popped up in a field in Oregon despite never having been distributed beyond test crops. On the other hand, farmers can't sue Monsanto preemptively to prevent patent enforcement on accidental cultivation of patented seed.