The Myriad Case- An‘Air Strike’ On Patenting Of Isolated DNAs

INTRODUCTION

In the historic case of Diamond v. Chakrabarty[i], the Supreme Court of the United States (SCOTUS) after several deliberations held that “anything under the sun that is made by man is patentable” and that “the patent laws will be given a wide scope”. This decision opened the doors for patenting of life forms including plants and trans-animals in the United States. However, in the year 2009, the validity of gene-patenting in the United States was challenged in the case of Association for Molecular Pathology v. Myriad Genetics, Inc.[ii] which bought to rest all the speculations on the current subject matter. The case brought about by the American Civil Liberties Union, turned out to be less of a patents case and more of a civil rights case.

FACTS OF THE CASE

Myriad Genetics, Inc. is a Utah based American Molecular diagnostic company. In the year 1994, the company discovered two genes, namely BRCA1 and BRCA2 and was subsequently granted a patent over them by the US PTO.These genes were instrumental in diagnosing breast and ovarian cancer among women as women possessing these genetic mutations were more susceptible of having breast cancer (nearly 50-80%) and ovarian cancer (nearly 20-50%) later in their lives.[iii]

Myriad threatened to sue any lab which was offering tests for BRCA or related genes. The company took complete advantage of the exclusive rights that the patent has vested on it. It charged humongous costs for the diagnostic tests. The actual price accrued was not even a fraction of the amount that was charged. Gradually, it stopped sharing data with the international scientific community.  The most bothersome issue was that for several years, it denied to upgrade the lists. These lists included the subsidiary and ancillary mutations. The major drawback of not upgrading the lists was that several women who have taken the test within this time frame received the wrong result.[iv] As a result of the gene monopoly, no other lab was in a capacity to provide for the tests, prompting the suffering of numerous women with no fault of theirs.

Subsequently in the year 2010, a case was filed against Myriad Genetics by a group of several experts, physicians, geneticists, patients, advocacy and scientific research groups challenging the validity of patents granted over the BRCA1 and BRCA2 genes.

JUDGMENT

The matter was brought up by the plaintiff before the Southern District Court of New York. The Court ruled in favor of the plaintiffs in March 2010. Judge Robert W. Sweet in his 152-page decisionruled that “the patents at issue directed to isolated DNAs containing sequences found in nature are unsustainable as a matter of law and are deemed as non-patentable subject matter” and thereby invalidating patents on the BRCA1 and BRCA2 genes. Myriad moved to the US Court of Appeals for the Federal Circuit by way of an appeal. In a vital and significant move in the case, the US government switched sides. Where previously in the district court, the submissions of the government were being made in Myriad’s favour, however in the appellate court it blatantly made submissions favouring the opposition side by contending that isolated DNAsare not eligible for patent protection. The Court of Appeals reversedthe decision of the district court in part and affirmed in part, stating that patent can be granted over an isolated DNA that does not occur alone in the nature.[v]

This led to filing of a petition before the SCOTUS and the question resurfaced that‘Are human genes patentable?’. The Supreme Court finally ruled in favor of the plaintiff stating that “a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated…”.[vi] Thus, differentiating between the concepts of ‘invention’ and ‘discovery’, SCOTUS had rightfully stated that nothing new was created by Myriad and only discovery of an important and useful gene was made by it, which does not come under the ambit of an invention.

CONCLUSION

The whole Myriad judgment on the gene-patenting hoopla can be beautifully summed up by way of a simple analogy- if the DNA is metaphorically understood as gold and isolating DNA is extracting gold from a mountain or taking it out of a stream bed, then the process or the procedure of mining the gold may be patented but not the gold itself. Inspite of enduring a lot of effort in digging the gold out of the mountain, gold per se can still not be patented.

Author: Kartik Tyagi, B.A. LL.B (Hons.), 5th year, Amity Law School, Noida, Intern at Khurana & Khurana, Advocates and IP Attorneys. In case of any queries please contact/write back to us at niharika@khuranaandkhurana.com

References:

[i]447 U.S. 303 (1980).

[ii]569 U.S. 576 (2013).

[iii]https://onlinelaw.wustl.edu/blog/case-study-association-for-molecular-pathology-v-myriad-genetics-inc/accessed on Oct. 22, 2019.

[iv]https://www.wipo.int/wipo_magazine/en/2006/04/article_0003.htmlaccessed on Oct. 22, 2019.

[v]https://journalofethics.ama-assn.org/article/supreme-court-myriad-genetics-synthetic-dna-patentable-isolated-genes-are-not/2015-09accessed on Oct. 23, 2019.

[vi]https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4665038/accessed on Oct. 23, 2019.




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