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We're happy to bring you a guest post by Samantak Ghosh on the recent AMP v. Myriad Gene Patents case argued before the US Supreme Court on April 15th, 2013. Please see our previous post here for a detailed explanation on the background of the case. Samantak (JD Candidate ’13, Berkeley Law) also recently won the American Intellectual Property Law Association’s national student writing award for his paper on the policy ramifications of the Supreme Court’s recent decision involving patents covering natural processes.
U.S. Supreme Court hears the gene patents case
One of the most publicized patent law cases in the recent history finally got its day before the U.S. Supreme Court. On April 15th, the Court heard oral arguments on the patent-eligibility of human genes. The hearing brought out a persistent dilemma in this line of cases: how do you protect natural phenomena from private monopoly and at the same time provide sufficient incentives for their discovery? As Justice Breyer observed, “patent law is filled with uneasy compromises.” Even if isolated DNA were considered a natural product excludable from patent-eligibility, what about the policy ramifications of such a ruling? “It may be that the law allows you to prevail on the facts, that [DNA] . . . occurs in nature and there’s nothing new here,” Justice Kennedy noted. But he and the other Justices were justifiably concerned about the “substantial arguments” that patents may be necessary to incentivize private investment in the discovery of these DNA sequences. The Court tried to figure out whether alternative forms of incentives such as recognition, process patents on uses of DNA, and patents on primers and probes, could sufficiently inspire potential investors.
The analogies kept flying in as the Justices probed the attorneys on the distinction between isolated DNA, cDNA (complementary DNA), and native DNA. Comparisons with chocolate chip cookies, leaves, aspirin, whooping cough vaccine, baseball bat, plant sap, were all employed to tease out distinctions between natural and artificial products. Although the past few years have seen the Court’s increasing engagement in patent law cases the discomfort in dealing with complex technologies was apparent. Justice Breyer even joked about his limited scientific expertise when he attempted explaining the existence of cell-free DNA molecules. “I probably misread it. There’s a better chance that I’ve misread it,” he said, eliciting laughter from the chamber.
Predicting the outcome of patent law cases based on Supreme Court oral arguments is always fraught with danger. Keeping that in mind, it appeared that the Court was inclined to invalidate gene patents but uphold cDNA patents. As I noted in my paper, that may be a doctrinally correct result. Structurally and functionally, isolated gene sequences are not substantially different from the native form. Isolated cDNA sequences, on the other hand, have different nucleotide composition compared with the messenger RNA (mRNA) that they are derived from, and different function as well. In short, if we drew a line between natural and synthetic products, gene sequences would fall on the natural side, and cDNA on the artificial side.
But whether invalidating gene patents is the right approach as a matter of policy is a much harder question. The problem is that the empirical evidence is somewhat inconclusive on this issue. While it is known that the biotechnology industry relies on patents to recover the cost of research and development, it is also true that substantial amount of genomic discoveries are undertaken by public research institutes, where patents are not primary motivators of research. Similarly, the jury is out on whether gene patents substantially impact downstream innovation. It is possible that in the absence of product patents, process patents on uses of isolated DNA sequences may provide some incentive to the private developers. But, as I had observed in the aftermath of the Court’s Mayo v. Prometheus opinion, even that appears uncertain. One can only hope that the Court will take this opportunity to fine-tune the Prometheus doctrine to better address the policy concerns at issue.
U.S. Supreme Court hears the gene patents case
One of the most publicized patent law cases in the recent history finally got its day before the U.S. Supreme Court. On April 15th, the Court heard oral arguments on the patent-eligibility of human genes. The hearing brought out a persistent dilemma in this line of cases: how do you protect natural phenomena from private monopoly and at the same time provide sufficient incentives for their discovery? As Justice Breyer observed, “patent law is filled with uneasy compromises.” Even if isolated DNA were considered a natural product excludable from patent-eligibility, what about the policy ramifications of such a ruling? “It may be that the law allows you to prevail on the facts, that [DNA] . . . occurs in nature and there’s nothing new here,” Justice Kennedy noted. But he and the other Justices were justifiably concerned about the “substantial arguments” that patents may be necessary to incentivize private investment in the discovery of these DNA sequences. The Court tried to figure out whether alternative forms of incentives such as recognition, process patents on uses of DNA, and patents on primers and probes, could sufficiently inspire potential investors.
The analogies kept flying in as the Justices probed the attorneys on the distinction between isolated DNA, cDNA (complementary DNA), and native DNA. Comparisons with chocolate chip cookies, leaves, aspirin, whooping cough vaccine, baseball bat, plant sap, were all employed to tease out distinctions between natural and artificial products. Although the past few years have seen the Court’s increasing engagement in patent law cases the discomfort in dealing with complex technologies was apparent. Justice Breyer even joked about his limited scientific expertise when he attempted explaining the existence of cell-free DNA molecules. “I probably misread it. There’s a better chance that I’ve misread it,” he said, eliciting laughter from the chamber.
Predicting the outcome of patent law cases based on Supreme Court oral arguments is always fraught with danger. Keeping that in mind, it appeared that the Court was inclined to invalidate gene patents but uphold cDNA patents. As I noted in my paper, that may be a doctrinally correct result. Structurally and functionally, isolated gene sequences are not substantially different from the native form. Isolated cDNA sequences, on the other hand, have different nucleotide composition compared with the messenger RNA (mRNA) that they are derived from, and different function as well. In short, if we drew a line between natural and synthetic products, gene sequences would fall on the natural side, and cDNA on the artificial side.
But whether invalidating gene patents is the right approach as a matter of policy is a much harder question. The problem is that the empirical evidence is somewhat inconclusive on this issue. While it is known that the biotechnology industry relies on patents to recover the cost of research and development, it is also true that substantial amount of genomic discoveries are undertaken by public research institutes, where patents are not primary motivators of research. Similarly, the jury is out on whether gene patents substantially impact downstream innovation. It is possible that in the absence of product patents, process patents on uses of isolated DNA sequences may provide some incentive to the private developers. But, as I had observed in the aftermath of the Court’s Mayo v. Prometheus opinion, even that appears uncertain. One can only hope that the Court will take this opportunity to fine-tune the Prometheus doctrine to better address the policy concerns at issue.
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