The US Supreme Court's unanimous decision last week to end the practice of patenting naturally occurring 'isolated' DNA gene sequences will have significant global effects on health security, the governance of intellectual property, and on health research and innovation.
But the debate over 'who owns our genes' is likely to continue as complementary DNA (cDNA) was deemed patent eligible as it is not naturally occurring. There is disagreement with this interpretation of the distinction between DNA and cDNA, however, for the biotech industry the cDNA decision is important as it applies to many commercial applications, including developing vaccines.
The Supreme Court's ruling was welcomed by many public health experts and consumer advocacy groups, but the medical and biotech industries have downplayed the decision. Both sides have claimed victory.
The decision means that naturally occurring DNA sequences such as BRCA breast and ovarian cancer genetic markers can no longer be monopolized. Myriad Genetics, which was the subject of the Supreme Court decision, held patents on the BRCA1 and BRCA2 genes and a monopoly on testing for the genes. Since the ruling, other private laboratories have indicated they will enter this market which will create more competition and significantly reduce the price of the BRCA test (currently sold at approx US$4000). Importantly, these tests can now be verified by an alternative service provider.
The various interests in the industry, particularly some patent attorneys' comments, are of interest. Several interpreted the decision as yesterday's problem - that Myriad's contested patents 'are a dying breed'. This interpretation ignores the enormous lobbying and financial effort by the patent industry from within the US and globally to defend the challenge to Myriad's patents. That Myriad's shares went up then down following the ruling, indicates a mixed reaction to the decision.
In contrast, the Supreme Court's decision that cDNA is patent eligible was generally welcomed by the biotech industry. Academics and IP lawyers will now examine the minutiae of both Supreme Court decision and the US government's amicus brief (initially presented during the appeal process) and reflected in the Supreme Court decision. Consequently, interpretations of determining just where the patent-eligible line will fall may not be a simple process.
The biotech industry and patent attorneys were highly critical of the position taken in the US government's amicus brief and generally dismissed it as having no clout in policy making. But the political, economic and social landscape has now altered in ways that would have been hard to predict when the case against Myriad was launched.
Governance and national interest
The scope of cDNA developed in laboratories, as well as the other patenting criteria (novelty and utility), will be tested in a new policy environment where awarding patent monopolies may now be carefully and critically assessed for national interest criteria.
The significance of reversing a 20-year-old policy with legally enforceable rights is not trivial. The governance consequences will no doubt be reflected within and between bureaucracies regarding policy coordination responsibilities and rules/obligations related to ensuring policy coherence.
Impact on international relations
Of interest in terms of global health security is how this policy reversal will be reflected in the US approach to bilateral and regional FTA negotiations and its position in several multilateral organisations - WHO, WTO, WIPO. The US places a high value on global harmonizing of IP policy and it is likely to encourage other countries to make similar rulings.
The Supreme Court’s decision brings US IP law closer to Brazil’s and those of other South American countries which do not allow produces of nature to be patented. That said, the decision on cDNA will require some analysis to see how this might still cut across political and legal differences in the approach to genetic resources.
The US will also have to contend with its like-minded partners who allow the patenting of 'isolated gene sequences' such as the EU, Japan and Australia.
Where to from here?
Some may view the decision by the Supreme Court as an end to the messy and destructive chapter which called into question the role and application of patent law. But closing the door on this contentious issue may not be easy because of the growing awareness among academics, politicians, lawmakers and the public about the economic and social costs of patents, highlighted for example in Angelina Jolie's critique of the cost of the BRCA Analysis test.
The patenting of genetic resources is therefore likely to remain politically contentious. The decisions made by the US Patent Office will be scrutinized by other national authorities and perhaps prompt their bureaucracies to assess the effectiveness of policy cohesion and the quality of governance within their own jurisdictions.
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