The Human Genome Landscape Post 2013- Analysis Of The Myriad Judgement

Picture Courtesy : http://blogs.nature.com/naturejobs/files/2015/09/164480115_genome_istock_thinkstock.jpg

This article was written by Ananya Bose, a student of Symbiosis Law School, Pune.

What Are Gene Patents?– A gene patent is the exclusive set of rights to a given to a specific sequence of DNA (a gene) given by a government to an individual, an organization, or a corporation who claims to have first identified the gene.

Once granted a gene patent, the holder of the patent dictates how the gene can be used, in both commercial settings, such as clinical genetic testing, and in non-commercial settings, including research, for 20 years from the date of the patent[1]. Gene patents usually give companies sole ownership of genetic testing for the patented genes.

The Myriad Case

However, in June 2013, in the case of Association for Molecular Pathology v. Myriad Genetics, Inc., the U.S. Supreme Court held that human genes do not fall in the category of patentable inventions because they are a product of nature and they belong to it and since, nothing new is created when discovering a gene, there is no intellectual property to protect, and therefore patents cannot be granted. By virtue of this decision, the two patents namely, BRCA1 and BRCA1 held by Myriad Genes were rendered invalid along with the other 43000 patents which were granted prior to this ruling. This decision of the Supreme Court was landmark in its nature because it made genes available for research and for commercial genetic testing.

While ethical and policy arguments were considered to be major features of the debate surrounding the case, the decision focused mainly on the definitions of two codes: the genetic code and the patent code. All nine Justices on the Court agreed to the fact that the segments of DNA that make up human genes are not patentable subject matter under Section 101 of the Patent Act because they are products of nature.

This decision also gave a wide scope to interpret that lab-made gene patterns or DNA manipulated in a lab is eligible to be patented because DNA sequences which are altered by humans materially do not occur in nature. The Court also mentioned the patentability of the type of DNA called as the complimentary DNA(cDNA). This type of DNA is called synthetic DNA as it is produced from a molecule that serves as the instructions for making proteins (called messenger RNA). Although complementary DNA (“cDNA”) may be patent-eligible under 35 U.S.C. § 101, isolated genomic DNA is not.

Implications Of The Myriad Decision

The decision of Myriad left a lot of ambiguity and a lot of questions were left unanswered as to the difference between purifying substances as opposed to creating something synthetically. For example, the Justices denied patentability for isolated DNA and approved patentability for cDNA―which they described as synthetically created DNA. They seemed ignorant of the fact that DNA itself can be constructed synthetically, rather than isolated, and did not indicate how that might viewed. The Justices also did not clarify whether isolation resulting in a different substance might qualify.

Just because cDNA, and other lab creations that differ from nature, are within the realm of things that are considered the proper subject matter of a patent, this does not mean that any particular one will meet the full demands of patentability. It is still held that Section 101[2] is not the sole test for determining patentability.

Pre Myriad

Myriad represents the third in a series of decisions since 2010 in which the Supreme Court has redefined the boundaries of its three main exclusions from patentability—laws of nature, natural phenomena, and abstract ideas.

The first case, Bilski v. Kappos[3], in 2010 involved an abstract idea and the Court  struck down a patent on an investment strategy announcing that it supported a “high enough bar” on patenting abstract ideas and that it “would pre-empt use of this approach in all fields.”

In Mayo v. Prometheus[4], Mayo used the drug thiopurine to treat autoimmune diseases and as different patients metabolized the drug differently, the patent holder determined correlations between metabolite levels and dosage levels so that physicians could pinpoint whether a particular patient’s dose was too low such that it was likely to be effective or too high such that it risked harmful side effects. The Supreme Court found the diagnostic method unpatentable and again rejected the Federal Circuit’s analysis.[5]

Post Myriad

The guidelines published in 2014 by the United States Patent and Trademark Office in its ‘Performance and Accountability Report’ applied the interpretation of said Supreme Court judgment on patent eligibility not only to DNA, but also to all products of nature. This changed the conventional examination standards for biotechnology drastically. If patentability is denied only on the grounds that the claim is not recognizably different than the substance found in nature, the scope may include chemicals, microorganisms, cells, antibiotics, antibodies, and other elements. This examination standard of the U.S. is very distinct by virtue of its nature internationally.

After the Myriad case, in In re Roslin Inst.[6] And in In Re BRCA1- And BRCA2-Based Hereditary Cancer Test Patent Litigation13 (Myriad II[7]), the Supreme Court held that both cloned sheep and DNA segments that are created by somatic cell nuclear transfer (SCNT) technology were unpatentable subject matters respectively since they were not markedly different than equivalent substances found in nature.

However, health-care providers cheered the decision as a removal of barriers to increase access, reduce costs, and allow for innovation.[8] The Court’s decision may also remove barriers in the way of research into new tests and treatments for genetic diseases, as patents on genes have been shown to inhibit genetic research in the past,[9] and researchers will be able to segment natural DNA without worrying about infringing on a patent.

The Universal Declaration on the Human Genome and Human Rights declares the human genome to be “the heritage of humanity” and that “the human genome in its natural state shall not give rise to financial gains.”[10]

CONCLUSION

There are four main conclusions that can be inferred from the decision of the U.S. Supreme Court in the Myriad case. Firstly, the Supreme Court has made it clear that patent practice for 30 years has granted exclusive rights in the genre of granting patents that are too broad and covers products of nature as well. But the two unanimous decisions of the United States Supreme Court in Myriad and Mayo respectively about diagnostic technologies have narrowed the range of patentable subject matter of both methods and DNA molecules. Secondly, the boundaries of patentable subject matter including and excluding genes are still ambiguous. Though the Supreme Court has unanimously ruled that lower courts should not have upheld the patent claims yet it has not indicated how to draw the line between methods and molecules that are patent-eligible and those that are not. Thirdly, it is not clear where the line is drawn regarding  how many genes one needs to test to avoid infringement liabilities. But it is highly likely that those holding patent claims on individual genes will not be able to enforce them against whole-genome analysis. Finally , defining the boundaries of future genetic testing, the Supreme Court has declared that it will permit patents only on those DNA sequences or gene patterns which will have the innovative aspect  to it and which would in turn be more in proportion than the discovery step.

[1]  (35 USC 154(a)(2))

[2] U.S. Patent Act; U.S. Patent and Trademark Office, Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural Products (March 4, 2014) at 3-5 (using a balancing test to determine whether a claim recites something “significantly different” from a judicial exception to patentability). The long-term impact will depend on how examiners decide whether something is significantly different. It is entirely possible that different units of the USPTO and even different examiners may approach the question differently, creating uncertainties.

[3] Bilski v. Kappos, 130 S.Ct. 3218 (2010)

[4] Mayo Collaborative Serv. v. Prometheus Labs, Inc., 566 US., 132 S. Ct. 1289 (2012)

[5] Id. at 1305.

[6] (Fed. Cir. May 8, 2014)

[7] 133 S. Ct. 2107 (2013).

[8] Jaslow R., Supreme Court’s gene patent ruling could boost patient care, CBS News. 2013. Jun 13, [cited 2013 Nov 30]. Available from: URL: http://www.cbsnews.com/8301-204_162-57589253/supreme-courts-gene-patent-ruling-could-boost-patient-care-experts-say.

[9] Cho M, Illangasekare S & Weaver MA, Leonard DG, Merz JF, Effects of patents and licenses on the provision of clinical genetic testing services. J Mol Diagn, 2003;5:3–8.

[10]  United Nations Educational, Scientific and Cultural Organization. [accessed 12^th March, 2017]; Universal Declaration on the Human Genome and Human Rights. :Art. 1, 4. Available at:

http://portal.unesco.org/en/ev.php-URL_ID=13177&URL_DO=DO_TOPIC&URL_SECTION=201.html.