Monday, 29th July, 2013
Another blow for diagnostic patents and personalised medicine?
In the wake of the US Supreme Court decision in Association for Molecular Pathology v. Myriad Genetics, Senator Patrick Leahy wants the director of the National Institutes of Health to consider exercising their "march-in" rights under the Bayh-Dole Act to ensure greater access to genetic testing for breast and ovarian cancer.
On Friday, 17 July 2013, Dr Francis Collins, the director of the National Institutes of Health (NIH) received a letter from Senator Patrick Leahy (Democrat-Vermont). In the wake of the US Supreme Court decision in Association for Molecular Pathology v. Myriad Genetics, Inc1, the senator wants the director to consider exercising the NIH's "march-in" rights under the Bayh-Dole Act to "ensure greater access to genetic testing for breast and ovarian cancer."
Although the justification is somewhat different, both the Australian and New Zealand Patent Acts contain similar provisions for "Crown use" of a patented invention. In both countries, "Crown use" provisions ensure that governments in Australia and New Zealand can balance the grant of the exclusive rights of the patent holder needs of the Australian and New Zealand public.
Senator Leahy is not the first person make such a request. On four previous occasions the NIH has been asked to exercise their right, under the Bayh-Dole Act 1980, to "march in" and require a patent owner or exclusive licensee grant a license to a responsible party under 'reasonable terms" (see 35 U.S.C 2032). To date, no petition has been granted.
To protect U.S. taxpayers from being charged twice; ie, from paying businesses for inventions that had already been paid for with public dollars, a section of the Bayh-Dole Act gives a Federal funding agency the right to "march in" and ignore the exclusivity of a granted patent, requiring the patentee to grant a license to their invention. If the patentee refuses, the Agency itself is empowered by Bayh-Dole to grant such a license itself if one of four particular circumstances is met. Briefly reiterated, the four circumstances are that:
- the patentee has not taken reasonable and effective steps to achieve practical application invention
- the health or safety needs of the public are not reasonably satisfied by the patentee
- the requirements for public use specified by Federal regulations are not reasonably satisfied by the patentee
- the patented product is not manufactured substantially in the US or the patentee has not shown that under the circumstances manufacture in the US is not commercially feasible.
The basis of Senator Leahy's recent request is that the cost of Myriad's BRCA1/BRCA2 test is prohibitive, and therefore the health needs of the US public are not reasonably satisfied by the patentee because many women are unable afford the Myriad test. However, a review of previous petitions shows that in the cases of both NORVIR3 and Xalatan4, the NIH has taken the clear position that it has no role to play in addressing the issue of drug pricing. This role can only be played by Congress (ie, the legislature). As stated in the case of Xalatan the NIH considers that "the extraordinary remedy of march-in was not an appropriate means for controlling prices".
Implications for diagnostics and personalised medicine
At the very least, Senator Leahy's letter continues to highlight the ongoing debate in the US, and worldwide5, regarding the validity of "gene" patents1 and the moral and ethical issues involved in patenting diagnostic and treatment methods in human medicine; ie, "personalized medicine".
Looking at the current IP climate in the US, including proposed legislation to limit "patent trolls", and recent court cases attacking the validity of patents directed to "genes"1 and "laws of nature"6, this request is another interesting thread in a flow of apparent efforts to restrict the rights of patents in this area.
We have seen similar efforts in Australia with the Myriad patent surviving an attack5 (read more on this case here), and the failed Patent Amendment (Human Genes and Biological Materials) Bill 20107 (read more on this bill here). Such strong actions have not yet been taken recently in New Zealand, or elsewhere amongst Australia and New Zealand's largest Asian and European trading partners.
For now, all eyes remain on the United States to see how this latest foray plays out.
5Cancer Voices Australia v Myriad Genetics, Inc  FCA 65 - currently under appeal.
6 The US Supreme Court decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc addresses diagnostic methods. The decision in Mayo arguably places severe limitations on the ability of inventors to obtain diagnostic method patents that rely on natural correlations, bringing into question the validity of such diagnostic method claims where the claims do not recite transformative steps that are not purely conventional or obvious pre-solution activity.