By Andrew Cohen
Samantak Ghosh ’13 has 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.
The annual Robert C. Watson Award honors an impactful contribution to intellectual property law that displays original, creative information not previously published. Ghosh’s paper will soon appear in the Journal of the Patent & Trademark Office Society as Prometheus and the Natural Phenomenon Doctrine: Let’s not Lose Sight of the Forest for the Trees.
In the article, Ghosh critiques the recent Supreme Court opinion in Mayo v. Prometheus, which rejected a drug-related patent claim for not extending far enough beyond merely identifying a natural law. By ruling that a method of administering drugs to a medical patient was not patent-eligible, Ghosh said the Court “recalibrated the natural phenomenon doctrine, which had been untouched for 30 years,” and that the case “was a poor vehicle for doing so.”
Although the doctrine of excluding natural phenomena from patent eligibility has existed for more than 150 years, the case law has been far from consistent. Part of the struggle to draw boundaries between patent-eligible inventions and natural phenomena, Ghosh noted, is that “every invention involves some application of a natural phenomenon.”
Courts have similarly struggled to delineate natural products and items derived from natural products. Over the past 60 years, purified Vitamin K1, adrenaline, and Vitamin B12 have been ruled patentable, while purified Vitamin C, glucoside, and extracts containing chlorophyll have been ruled ineligible.
Ghosh highlighted this inconsistency in an earlier paper, “Gene Patents: Balancing the Myriad Issues Concerning the Patenting of Natural Products,” which was published in the Berkeley Technology Law Journal. He argued that the patent-eligibility of genes cannot be addressed in isolation, and proposed a framework for assessing the patent-eligibility of all natural products, including genes.
Ghosh earned a Ph.D. in chemistry from Stanford before enrolling at Berkeley Law. He continued exploring the natural phenomenon doctrine and developed the award-winning paper in his Advanced Legal Scholarship course co-taught by Professors Robert Merges and Kathryn Abrams.
Pinpoint patent analysis
“The intellectual property faculty are very proud of Samantak for receiving this award,” Merges said. “It’s fantastic that he’s getting recognition on such a grand stage, and his work surely deserves it. Samantak’s understanding of natural genes, their chemical structure as well as function, was instrumental to his approach. This is the sort of informed, nuanced, and carefully reasoned analysis that the courts are looking for in this delicate policy area.”
“In Prometheus, the Supreme Court got the science behind the claimed invention wrong,” said Ghosh, who has worked on synthesizing artificial variations of DNA and explored their use in therapeutics and diagnostics. His paper questions the Court’s new standard of how the natural phenomenon doctrine will be administered and forecasts a troubling effect on the biotech and personalized medicine industries.
“Both industries apply natural processes to provide personalized interventions and have relied on these kinds of patents for decades,” Ghosh said. “To make matters worse, the Court merely described some general principles, leaving it to the lower courts to figure out how to apply them. This leaves a lot of uncertainty for patents in this area.”
Multiple studies, Ghosh said, show that most drugs prescribed in the U.S. are effective in fewer than 60 percent of treated patients—with a total cost of drug inefficacy estimated at $170 billion annually. He believes personalized medicine can greatly improve health care quality and dramatically reduce costs “by using diagnostic tests to obtain information on a patient’s biomarkers and then provide patient-specific treatment.”
However, noting the patent community’s outcry in the wake of Prometheus, Ghosh cautions against abandoning the natural phenomenon doctrine. “If it is to be rejected, that should be based on its merits rather than on the occasional mistakes of courts applying it,” he said. “The Supreme Court had previously used the doctrine’s flexibility to conform patentability to modern demands, and the doctrine plays a key role in allowing tools of future innovation to emerge.”
The Court will soon decide a case involving the patenting of human genes. Ghosh, who will join the patent litigation group at Wilmer Hale next fall, hopes the ruling clarifies the doctrinal contours involved in patenting natural phenomena set forth in Prometheus.
“The ethical, legal, and social issues involving patents covering natural phenomena, genetics, and personalized medicine are going to be some of the most important issues of our time,” he said. “The law is not only lagging behind science, it is hopelessly unclear.”