The Y Factor: Scientists discover a genetic secret that threatens to wipe Israel off the map...

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Many are adopting new strategies for appropriating returns. Some are experimenting with claiming strategies that protect products and processes that differ sometimes only slightly from those found in nature. Other firms are said to be keeping information about natural phenomena and correlations among them as trade secrets. In the view of these organizations, other provisions of patent law, including the requirements of newness, nonobviousness, and disclosure, will take care of most problematic cases.

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However, because research and diagnostics can be easily outsourced to places where they can be performed without legal impediment, 20 right holders will want to ensure global exclusivity. Thus, any change in the patentability of products and laws of nature in the United States is likely to find its way into the next rounds of international negotiations on intellectual property protection.

The time has therefore arrived to consider sensible ways in which to revise the legal regime: to devise a rule on patentable subject matter that deals with technologies that function as commercial outputs and research inputs and are significant for patient care, and to consider whether changing the scope of patentability also requires rethinking other facets of the patent regime.

Proposals such as those made by the IPO, AIPLA, and ABA have been greeted with considerable skepticism on the ground that other provisions of patent law are too difficult and fact-bound to apply as readily as a subject matter exclusion or that the newness, nonobviousness, and disclosure requirements will not be sufficient to deal with the problems that patenting nature presents.

We take a different tack.

We compare the situation in the United States with that of Australia. In our view, that comparison is particularly helpful because the Myriad case was litigated to the highest court of Australia at roughly the same time as the case was sub judice in the United States. It was motivated by similar considerations and based on a similar statute, one that is similarly inflected with considerable judicial gloss. Yet the outcomes and impact of the cases appear to be quite different.

But given the reality that changes in the law are likely to be made, we next consider a remarkable feature of the Australian case, where the Myriad decision made little difference in terms of access to genetic information. We examine the factors in Australian practice that ameliorated the effects of gene patenting prior to the decision in Myriad and suggest ways in which US law could better reflect those factors to create greater certainty for all stakeholders.

The paper proceeds as follows. In Part I, we consider the US Myriad decision and its case law progeny, along with PTO guidelines and survey evidence on how these guidelines are applied. Part II examines the alternative approach in Australia. Here we argue that the factorial test propounded by the Australian High Court, as elaborated in Patent Office guidance, significantly improves decision-making.

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Still, we argue that this approach holds considerable appeal. Part III considers what should occur if Congress concludes that the current state of subject matter jurisprudence is not tolerable and expands the reach of patenting to include all technological arts. Here, Australian practice is particularly illuminating. After describing the reasons why patenting did not create a thicket impeding access there, this section discusses the ways in which those practices can be translated into positive law for the United States. This was an important finding as mutations of BRCA change the protein the gene produces in ways that are associated with early-onset breast and ovarian cancer.

A race to characterize the gene ensued; it was won in by Mark Skolnick, a University of Utah geneticist and cofounder of Myriad Genetics, who quickly moved to patent the isolated gene and its mutations; Skolnick also set up diagnostic testing facilities to detect the sequences in patients.

He repeated these efforts a year later, when he found the BRCA2 gene, which is likewise associated with early-onset breast and ovarian cancer, on chromosome However, in Myriad began to assert its US patents and clear both the diagnostic and research markets; in , it apparently started to keep information on mutations, correlations with cancer risk, and algorithms for interpreting genetic information as trade secrets.

Scientists Discover a Genetic Secret that Threatens to Wipe Israel Off the Map...

From a public relations perspective, these actions proved Myriad's undoing. As studies commissioned by the Health and Human Services Secretary's Advisory Committee on Genetics, Health, and Society SACGHS later found, 34 centralizing genetic testing in a single organization's laboratories eliminated the ability of patients to obtain second opinions a significant problem for a diagnosis that can lead to surgery to remove breasts and ovaries.

Exclusivity also reduced the incentive to improve the tests or keep them current with advances in the underlying science; it also made it impossible to ensure the quality of the existing test by comparing results from different laboratories. Concerned about freedom of speech and the implications of recognizing exclusive rights over genetic knowledge for patients, researchers, and science, the American Civil Liberties Union challenged these patents in , naming as plaintiffs individuals and organizations with varying relationships to the Myriad patents. But because we question the Court's disposition, the opinions generated along the way bear consideration.

The trial court quickly focused on the traditional challenges under the Patent Act, rather than the novel claims sounding in constitutional law. According to the court, isolation, including removal of noncoding regions, did not change that fundamental character.

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In addition, the court held that analysis and comparison of DNA sequences, as described in the diagnostic claims, were abstract mental processes that failed to satisfy the then-prevailing view that a machine or physical transformation was the key to patentability. The Federal Circuit agreed that the diagnostic claim was not patentable, 45 but in all other respects, it reversed the trial court.

Thus, it was, in his view, patentable. Judge Moore concurred, albeit reluctantly on claims to long gDNA strands. Whereas she thought the short strands were patentable because they were not only markedly different from nature, but also had utilities not found in nature, the longer strands had only the differences in the bonding to distinguish them from nature.

However, because she recognized a strong reliance interest in DNA patents, she concurred in the result, leaving it to Congress to determine whether such claims promote or inhibit science. Judge Bryson agreed with the others on the disposition regarding cDNA and the method claims. Noting that it referred to a sequence that was 24, nucleotides long with numerous gaps, he argued that: An almost incalculably large number of new molecules could be created by filling in those gaps with almost any nucleotide sequence, and all of those molecules would fall within the scope of [the] claim.

Included in that set are many important molecular variations to the BRCA1 gene that Myriad had not yet discovered and could not have chemically described.

The Y Factor

Yet those molecules would share only one unifying characteristic: each codes for the same protein as the naturally occurring BRCA1 gene. Given the split decision on the DNA claims, it was not surprising that the Supreme Court agreed to entertain the case. Indeed, in many ways it was primed to hear it. Starting in the early s the Court had become concerned with the impact of patents on scientific and medical advancement.

More important, soon after the Federal Circuit's decision in Myriad , the Court reviewed a case that raised the Metabolite issue concerning diagnostics. As foreshadowed by Justice Breyer's dissent in Metabolite , in Mayo the Court invalidated a patent on a method for determining whether a patient was receiving the correct dose of a drug.