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US Supreme Court squares off on Human Gene Patentability

, July 25, 2013, 0 Comments

The United States Supreme Court delivered its much anticipated judgment in the Myriad case (Association for Molecular Pathology v. Myriad Genetics) on June 13, 2013 putting an end to the generally accepted USPTO practice and overruling what appeared to be settled since the Court’s landmark decision in Diamond v Chakrabarty – the patentability of human genes.

For three decades, the United States Patent and Trademark Office or USPTO had awarded patents on naturally-occurring human genes. But those patents have been rejected by this unanimous ruling by nine justices which held that companies cannot patent parts of naturally-occurring human genes, but afforded legal protection to synthetically produced genetic material under extant patent laws.

In a decision with both immediate benefits for some cancer patients as well as seemingly long-lasting repercussions for biotechnology research, the apex court found that human DNA sequences were a ‘product of nature’. As such the Court concluded that merely isolating a gene from its surrounding genetic material cannot be deemed an invention or a technological discovery and accordingly, the same did not qualify for patent protection.

Background
Association for Molecular Pathology v. Myriad Genetics[1] was a significant case challenging the validity of gene patents in the United States, specifically challenging certain claims in issued patents jointly owned/controlled by Myriad Genetics along with the University of Utah Research Foundation that covered isolated DNA sequences, methods to diagnose propensity to cancer through mutated genetic codes, and methods to identify drugs using such isolated DNA sequences for cure. Prior to the case, the USPTO accepted patents on isolated DNA sequences as a composition of matter.

Gene Patents in India
The legality of gene patents has long been a bone of contention. On one hand, it may be argued that the isolation of a gene amounts to ‘discovery’ and not ‘invention’ and hence the same is not patentable. On the other hand, it may also be asserted that the subject matter is not the isolated gene per se but the purified gene which comes under the realm of ‘invention’ and therefore, patentable. The question as to whether a purified gene is a part of the human body remains moot.

Under the present Indian patent regime, ‘naturally occurring’ human genes cannot per se be patented but when modified with significant human intervention coupled with industrial applicability, they are considered a valid patentable subject matter under the Patents Act, 1970. Further, the Draft Manual of Patent Practice and Procedure, 2008 prescribes that diagnostic methods employing DNA are patentable to the extent the same is performed on tissues or fluids which have been permanently removed from the body.

Implications of the Decision
As a result of the ruling, the Court struck down patents held by Utah-based biotechnology company, Myriad Genetics on a pair of genes linked to increased risk of breast and ovarian cancer, namely BRCA1 and BRCA2.

Myriad’s patents on BRCA genes made testing for them its monopoly. The company’s breast cancer gene test was recently brought into the public eye by Hollywood actress, Angelina Jolie, who revealed that she had undergone a preventive double mastectomy procedure after learning that she herself carried a defective BRCA1 gene which put her at high risk for developing breast and ovarian cancer. The actress who lost her mother and grandmother to ovarian cancer openly acknowledged that BRCA testing was rather expensive.

Gene patents claim underlying fundamental information about genetic behaviour which is pertinent for both upstream and downstream research activities. The very nature of gatekeeper patents mandates that all uses of the gene including gene therapy and other pharmacological modulations must go through the original gene patentee before any invention pertaining to such gene is practiced. Such patents can therefore easily acquire the character of ‘blocking’ patents which can have an ‘anti-commons’ effect on the society.

This split legal outcome is representative a victory for cancer patients, researchers and  physicians who have claimed that a single company’s patent raised costs, restricted research and sometimes forced women to have breasts or ovaries removed without sufficient facts or second opinions. Myriad itself emphasized the bright side of the decision for the company – that complementary DNA or cDNA, which is not naturally occurring, remains patentable, as a result of which, it said, 24 patents containing more than 500 valid claims remain in effect. Moreover, what appears to be the most significant positive outcome of such a decision is that the cost of breast and ovarian cancer testing has fallen, thereby making it more easily available to lower-income groups or those lacking quality health insurance.

However, the more conservative justices have criticized the decision pronounced by Justice Clarence Thomas, and regarded it as a complete denial of patent rights, which could potentially jeopardize investments by other biotechnology companies, and in turn limit progress on a range of research. Genetic research is a fairly young science whose full potential is yet to be tapped. A legal framework protecting gene patents would promote and accelerate clinical research in this niche, as it would assure investors participating in such high-risk activities of a decent return from commercialization of their research output.

While genes are certainly a product of nature, the isolation of fragments and knowledge of their properties are the outcome of the huge financial and material resources invested with its attendant risks, whose importance cannot be denied.

Another major drawback of the said decision to bar gene patents is that it would also result in researchers — who discover human gene sequences responsible for a particular disease — do not have necessary incentive to disclose the new discovery. This indirect and unintended bar on public disclosure is a major shortcoming that encroaches upon public welfare. Similarly, scientific exploration activities for new and rare organisms that have incredible economic value, which could be in hostile areas like the bottom of the oceans or the edge of a volcano, will also get a setback as the inability to patent the genome makes such projects unfeasible.

In light of this decision, it would be worthwhile for players in the global biotechnology industry review their existing patents portfolio as also re-allocate spending in research and development initiatives.

[1] 569 U.S. 12-398 (2013)






About author
Anumeha Iyer works at Advaya Legal, a full service commercial law firm with a boutique intellectual property practice based in Mumbai, India. Anumeha has had wide ranging experience in corporate, capital markets and real estate, both on the advisory and transactional side.....more ...more