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  • Writer's pictureKirk Hartley

Huge Win for Science and the Free Flow of Information – Gene Patents Invalidated for BRCA Gen

Back in law school, we all heard something about the awesome power of federal judges and probably wondered what it’s like to go home at the end of the day knowing you made a real difference in the world. That power was on real display this past Monday when a federal judge in New York expeditiously exercised some of the vast power by issuing a momentous and massive 154 page opinion on cross-motions for summary judgment. The opinion is one that will produce a massive future cascade of events. One hopes the judge and his staff all enjoyed a well-earned respite on Monday evening.

What happened? Judge Robert W. Sweet struck down the patent claims to the BRCA 1 and 2 genes. Those two genes, if found together, signal a materially increased risk (over 80%) of developing breast cancer. More broadly, the rationale of the opinion suggests the same result is proper for most if not all patent claims to gene sequences. In a careful and thorough opinion, Judge Sweet accepted the patent invalidity claims put forward a by a well- crafted consortium of plaintiffs seeking to invalidate the patents. In short, the patents were rejected because the patents amount to a claim of rights for simply reporting the order of the nucleotides that make up a gene, and patents are not awarded for reporting biological facts.

Why is this a big deal? Start with the numbers. 4,382 patents are claimed in the US for the just under 24,000 genes that comprise a typical genome. See Opinion at 70. That’s about 20% of all the genes.

Most of all, this opinion matters because it is a huge win for science and the free flow of information. Simply put, the mere existence of patents creates doubts and claims that lawyers turn into delays, negotiations and lawsuits. I’ve been following this case for some time, and read the main briefs, and some of the declarations. The papers present various disagreements and claims about the future of science if gene sequence patents are invalid. But, the indisputable facts are that gene patents create delays in research. Today, delays are adverse and matter because because science today can move so fast if allowed to do so. And, even more to the point, people with cancer cannot wait. Today, almost 1.5 million Americans are diagnosed with cancer every year. That translates into thousands of daily decisions for mothers, fathers, children and lovers who need the best possible information to make life altering decisions on how or whether to treat a particular set of facts and risks. Patents indisputably block the fastest possible flow of information.

Congratulations to the plaintiffs and their lawyers for such a careful and well done pursuit of a massively important lawsuit that brought together a wide range of individuals and organizations. The individual plaintiffs included both scientists blocked from further medical researchers, and breast and ovarian cancer patients unable to pay the $ 3,000 required for one of Myriad’s tests to determine if they carry the BRCA genes. Organizational plaintiffs included a wide range of highly respected associations of doctors and scientists. Numerous amicus briefs also were submitted by well-known medical groups. The plaintiffs were represented by the American Civil Liberties Union and the Public Patent Foundation at Cardozo Law School. .

Defendants? Myriad Genetics and the University of Utah. Their lawyers are from Jones Day.

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