Gene Patents Invalidated – What’s Next?

Last Tuesday, a landmark ruling invalidated most gene patents and called into question most others. The debate as to whether genes should be patented had been raging for some time and now, Judge Robert Sweet, a U.S. district judge in Manhattan, ruled that parts of patents held by Myriad Genetics covering two breast cancer genes – BRCA1 and BRCA2 – were invalid.

After the landmark ruling the question on most biotech exec’s minds is: What does this mean?

Most biotech stocks fell last Tuesday following the news because the industry is built on more than 40,000 gene patents. To date, about 20 percent of the human genes have been patented, including those associated with Alzheimer’s disease, muscular dystrophy, colon cancer, asthma, and many other illnesses.

Biotechnology advocates have long argued that patenting genes is necessary to attract investment and remove incentives to develop tests. Not having the patents could slow the move toward personalized medicine, which will requires diagnostic tests.

The Genomics Law Report wrote a story called “Pigs Fly,” where authors Dan Vorhaus and John Conley called the ruling “jaw dropping.” This long, but definitely worthwhile post, defines what the judgment means, how it came about, why Myriad’s process claims failed, and what will happen next.

In terms of practical implications, Vorhaus and Conley ask readers “not to overstate either [the rulings] legal significance or its practical effect.” They go on to say, “Biotechnology businesses and investors are… unlikely to use this decision as the basis for significant departures from their current approaches with respect to gene patents.”

Andrew Pollack of the NYTimes provided some nice background on the ruling and notes that many lawyers were stunned by the ruling since it “invalidates many many patents on which the biotechnology industry has invested considerable money,” according to Rebecca Eisenberg, University of Michigan law professor, and well-known authority on the patent implications of gene patents.

My take on the ruling? First, I think it’ll be business as usual. An attorney friend of mine pointed out it’s ONE federal judge basically telling the patent office to change their policies (compared to the full federal circuit bank on the Ariad vs. Lilly decision). The likelihood of that happening are very slim. Second, savvy entrepreneurs and lawyers will look at this ruling as a challenge to innovate. If genes are unpatentable, then innovation will need to focus on the way you interact with a specific gene or the processes your product will use to interact with a gene.

This story is far from over since Myriad plans to appeal. So stay tuned.

Other points of view at the ACLU (the plaintiffs in the case, which is the first time I’ve ever written the word ‘plaintiff’ in a post) “Who Owns Your Genes? You Do,” Discover Magazine, Genome Web, Genome Boy’s After the Gold Rush (which is not as negative as it sounds), and Wired (which includes nice debate in the comments section).

BTW, I’m sure that it’ll just be a couple of days before someone starts saying, here’s another reason to hate the ACLU.