As you may know, I’m already worked up over the inane 152-page ruling by Judge Sweet in Association for Molecular Pathology v. USPTO (aka “the gene patent case”). See Foaming at the Mouth: The Inane Ruling in the Gene Patents Case . In AMP, Judge Sweet declared 15 claims in Myriad’s patents relating to the BRCA1 and BRCA2 gene sequences invalid under 35 U.S.C. § 101 as not being patent-eligible subject matter. This ruling was soon followed by a biased and factually distorted 60 Minutes segment which has generated a popular media “tsunami” that has unfairly vilified Myriad (and the patenting of gene technology) as the new “Evil Empire.” Never mind that Judge Sweet’s ruling will likely be trounced on appeal by the Federal Circuit as it is factually and legally flawed.
But it gets worse. Enter Congressman Xavier Becerra (D-California) who has proposed his new but equally inane proposal that would make Judge Sweet’s ruling law by banning gene patenting. Some may recall that Congressman Becerra (aka “The Gene Patent Terminator) previously proposed a similar bill (at the prompting of the late Michael Crichton) which, according to its misrepresentative title, would have banned the patenting of human gene sequences. In fact, by its language, the “old” Becerra bill would have also banned the patenting of all gene sequences, human or otherwise. Fortunately, the “old” Becerra bill never made it out of committee.
As others have noted, the new Becerra bill goes even further than the “old” bill to ban the patenting of not only “isolated” gene sequences (human or otherwise) but also: (1) complements of such sequences (e.g., cDNA); (2) any “function or correlation” of such sequences or their complements (e.g., patented medical diagnostics based on such correlations); and (3) “naturally-occurring products” (whatever they might be) that such sequences or their complements “specifies” (whatever that means). As already hinted at, the language in this proposed bill is poorly written and unclear, and could potentially ban patents on “synthetic” gene sequences which don’t even exist in nature, and are structurally so dissimilar that nature couldn’t possibly make them.
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In my opinion, Congressman Becerra should be focusing his attention on more important matters, like how we’re going to pay for the mind-boggling health care package that he and his Democratic cronies just passed without imposing on America a tax-burden which will simply stifle all economic growth, including in the biotech sector. Also, what about encouraging business and job growth in America, e.g., a growing and healthy biotech sector? But once Congressman Becerra has destroyed the American biotech industry with this misguided bill, how does he plan retrain all those unemployed biotech folks? Frankly, Congressman Becerra, “The Gene Patent Terminator,” needs to get a life.
But for those who feel I’m simply a “naysayer,” I do have a suggested alternative on the patenting of gene sequences that is far more sensible (and won’t kill our biotech sector) than the “all or nothing” approach of the new Becerra bill. Instead of banning the patenting of gene sequences, why not provide the U.S. government with something similar to the “march-in-rights” provision that currently exists in Bayh-Dole for patented technology developed through federally-sponsored research that is underutilized? Admittedly, this “march-in-rights” provision would have to be carefully structured so it isn’t abused by the federal government, as well as those who would push for its too frequent use because they feel “entitled.”
In conjunction with this “march-in-rights” provision, you would also need to provide the patent owner with the ability to secure “reasonable compensation” for what would likely amount to a “compulsory license” in the Court of Claims, similar to an action under 28 USC 1498 for patent infringement by the federal government. There is precedent for this approach in certain provisions of the Clean Air Act enacted in the ‘70s which provided for the compulsory licensing of air pollution prevention and control technologies. At least the patent owner wouldn’t be completely deprived of any ROI just because some take the extreme view that patenting gene technology is “immoral.”
One of the “scare tactics” in the AMP case is that Myriad has imposed a “chilling effect” on basic academic research on the BRCA1 and BRCA2 gene sequences. First, let’s clarify that Myriad has not tried to directly prevent academia from carrying out basic BRCA1 and BRCA2 gene research, only those who want to offer competitive commercial alternatives to Myriad’s diagnostic tests. In fact, one of the parties being sued in AMP is the University of Utah Research Foundation, a research arm of the University of Utah. But if it would help negate this alleged (and so far unproven) “chilling effect,” why not enact an “academic research exemption” (as was suggested after Madey v. Duke University) that would allow academia and other non-profits to do basic gene research without fear of a patent infringement suit?
The alternative I propose for responding to the unfortunate media “hysteria” regarding Myriad’s alleged “gene patenting” would certainly require some refining, as well as buy-in from the many special interests involved in this controversy. But what I propose has the prospect of removing the emotion (as well as the morality) from this controversy, as well as creating a potential “win-win” for all other than the most extreme views on either side of this controversy. Anything would better than this new oxymoronic Becerra bill which will simply stifle, as well as unnecessarily gut, the American biotech industry.
© 2010 Eric W. Guttag.