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AIPLA President’s blog: When sequestration hits the genetic fan …



Jeffrey I. D. Lewis


As you probably know, I have been watching the Myriad lawsuit closely – that’s the case where the ACLU is challenging the patentability of a discovery that certain genes (ones isolated by the inventors) correlate with an increased risk of breast and ovarian cancer.

AIPLA JeffWhile we are waiting for Supreme Court to decide the case, which should happen any day now, the real world has more than emphasized that these types of advances should be considered patentable subject matter.

One real world event is that Angelina Jolie recently discussed her reliance on the Myriad genetic test to evaluate her significant familial risk of breast cancer, resulting in her double mastectomy, as I discussed recently. That medical choice made the popular press, and while that certainly impacts the popular view, the patent debate has been over taken by Congress’ budget sequestration.

One argument that people made against patentability was that there is no need to incentivize private research investment because the government will fund all medical research. In fact, that was one of the arguments that ACLU’s attorney made to the Supreme Court (see page 12 of the transcript, where counsel talks about "taxpayers" paying, and page 15). To that I respond: REALLY?

The National Institutes of Health, NIH, the nation’s medical research agency, is considered one of the leading supporters of biomedical research in the world. But, that was back when the US government was considered an unlimited piggy bank. In March NIH also was hit with financial sequestration along with other government agencies. (I’m already on record as questioning the sequestration as applied to the USPTO.

On June 3, NIH said that it had cut 5% off of its projects, budgets and research funding, about $1.55 billion for this fiscal year (perhaps a small portion of the US deficit, but still real money). The official fact sheet says that approximately 700 fewer grants now will be awarded, and the National Clinical Center will accept roughly 7% fewer patients. The fact sheet, however, is fairly light on specifics; based upon my discussions with senior individuals at research institutions, the expected cuts will amount to between 15% and 20% of research grant funding.

As I reflect on this, with a sense of frustration, I come back to this point: we do not need to keep looking to the government to fund all research. The US Constitution creates a mechanism to incentivize inventors, ie to "promote the progress of science and the useful arts". That system is called a patent. The Myriad case should not continue to rely on finding more government funding to undermine the patent system – genetic research is patentable subject matter and the Supreme Court should hold as such.

Thanks for reading,

Jeff

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@KellyIPllp Well done to all at the firm!

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