IPRResearch Article

THE MYRIAD PATENT CASE – A CRITIQUE



INTRODUCTION

The general rule towards Patent law is that anything and everything made my man could be Patented which should have a practical use in the welfare of the society and it should not merely be an idea. This rule is sometimes overlooked and confused among the scientist and researchers and they end up getting confused between Invention and Discovery.
Patent law encourages researchers and inventors to contribute more to the society by providing security to their invention which prevents from exploitation of their hard-work and also provides certain monopoly rights to the inventor.
With the growth of the scientific field, laws governing them should also be made more diversified but the legislature of any country is not that advance to think and make laws for all possible scenario which itself is a challenge to the scientific laws such as patent. Court also has rule making power which enables it to pronounce judgment and rules for case-to-case basis.
Myraid’s case is one of those landmark judgment pronounced in the US Apex Court which became landmark judgment in Patent Law throughout the world. It not only gives us clear cut idea of what can be patented but also raises conflict in the field of Bio-ethics.

BRIEF FACTS

In the year 1990, a group of researchers from the University of California at Berkeley proclaimed that they had tracked down a gene on chromosome 17 which gave the first proof of link between specific genetic deviations and breast cancer. That genetic deviation would have known to be BRCA1. In the subsequent year, a researcher group from the University of Utah’s Center for Genetic Epidemiology, with financial support from the ‘Eli Lilly’, a pharmaceutical company, created a small biotechnology company, Myriad Genetics.[1] Myriad Genetics sequenced the BRCA1, i.e., it located the nucleotide bases in DNA which combined together consist of the gene. This was successfully completed by the year 1994 and they obtained patents protecting the arranged gene, nearly 40 mutations or distinctions of BRCA1, and several diagnostic tests and process for identification of mutations of the gene. They also succeeded in creating a artificial form of BRCA1 called “cDNA”, which contained only the working parts of the gene, which are involved in the formation of mRNA, essential for protein synthesis. [2] In the Upcoming four years, Myriad competes with another scientific research group in the UK to sequence another gene, BRCA2, associated with breast cancer. Ultimately, Myraid filed for patents on BRCA2, its mutations, and diagnostic tests based on the genes.
The magnitude of the effort carried out by Myriad and other scientific groups cannot be overemphasized. Average American woman has a chance of 12-13% risk for developing breast cancer;[3] however, for women who possess genetic mutations such as those on BRCA1 and BRCA2, the risk dramatically increases to 50-80% for breast cancer and for ovarian cancer it is 20-50%. [4] Myriad insistently made use of its competitive advantage with the sales of its tests for these genes and their mutations as they secured the patents on the genes, their mutations, and the tests to identify the genetic characteristics. The company sent injunction notice to researchers involving themselves in isolating the genes also filed infringement cases against entities working in BRCA testing.
In 2010, a suit was filed against Myriad challenging its patents BRCA1 and BRCA2 and other patents stemming from these two genes.
Earlier, in 2009, many research groups and doctors filed claims in the Southern District of New York claiming that Myriad’s BRCA1, BRCA2, and cDNA patents were invalid under 35 USC s.101. The district court observed all three patents invalid under section 101 since the DNA segments were not distinct from nature (including cDNA, as it contains the identical protein coding informational content as the DNA in the body, even though differences exist in its physical form).
Myriad, aggrieved from the district court decision, appealed to federal circuit court got it reversed. The petitioners then appealed to the US Supreme Court, which vacated the Federal circuit court’s decision and sent the case back to be decided in light of Mayo Collaborative Services v. Prometheus Laboratories, Inc.; the landmark case which had laid down that “items or processes are not patentable unless they are themselves inventive or do not exist or occur without artificial modification”.
The federal circuit court gave out new perspective, with two out of three of the judges for different reasons, ultimately deciding that isolated DNA segments are qualified for patenting. Judge Alan Lourie’s reasoning behind his conclusion was that “the isolation process involved severing covalent bonds at both ends of a DNA segment, which technically formed molecules that do not occur naturally”. Judge Kimberly Moore, as well, held that the BRCA1 and BRCA2, both the patents are valid, but due to Myriad’s reliance on the patent’s approval for profit and business development. Although, Judge Bryson disagreed on the validity of patenting isolated DNA segments, all three judges agreed that cDNA was eligible for patenting as it was a man made creation and not merely isolated.This decision resumed Myriad’s patents.
The petitioners made their final move by moving in to the Supreme Court in the year 2013. They raised the question of whether human genes are patentable. The question was relied on the court’s understanding of the Patent Act and past precedent in this area of law. And, based on the Court’s scrutiny, the answer was a simple “no.”
Justice Clarence Thomas, stated that, though Section 101 of the Patent Act applies to “whoever invents or discovers any fresh and practical …composition of matter, or any useful improvements thereof”, the court has “already held that this provision contains an important implied exception such as the Laws of nature, natural phenomena, and abstract ideas” which are fundamental tools and hence, “lie beyond the domain of patent protection”. Patents subsist to encourage invention and to protect ideas, while the ingredients of nature are free to all men and kept back exclusively to none.[5] Myriad and the opposing parties agreed on a notable point that Myriad didn’t invent or modify the genetic information found within BRCA1 and BRCA2. All they did was expose the accurate location and genetic sequence of the two genes within their respective chromosomes. To conclude whether such a discovery could count as patentable, the court came across to two precedent cases

1. Diamond v. Chakrabarty [6] relates to the addition of four plasmids to a bacterium, allowing the bacterium to split into a variety of components of crude oil. The court decided that the customized bacterium was patentable since the addition of the plasmids rendered it new, “with noticeably different characteristics from any found in nature”. However, the court added that groundbreaking, innovative, or even sparkling discovery does not independently satisfy the Supreme Court’s “law of nature” exception.
2. Funk Brothers Seed Co. v. Kalo Inoculant Co.,[7] the patent was for a fusion of naturally occurring bacteria strains which help plants extracting nitrogen from air and attach it in the soil, improving nitrogen levels, a discovery made by farmers. This fusion was not considered patentable by the court since the farmers had not altered the bacteria in any way and hence the bacteria, either on its own or mixed together, fell straight within the exception of law of nature.
The Supreme Court understood the importance of Myriad’s work on the BRCA1 and BRCA2 genes. It had identified and sequenced significant genes that would facilitate researchers and clinicians in their understanding and cure for breast and ovarian cancers, but unscrambling a gene from its surrounding genetic material is not considered as an act of invention and discovery, on its own accord, does not cause to create the BRCA genes patent-eligible. Justice Thomas even saw to Myriad’s own patent descriptions to focus the problem of the company’s claim. Myriad methodically explained the “iterative procedure” for locating and sequencing the genes, but the patents affirmed neither any modification to the chemical structure of the genes nor an exclusive molecule that would deem their work patentable.
The only patent-worthy upshot before the court remained was cDNA, a artificially created DNA that holds the “same protein-coding data found in a piece of natural DNA but that excludes portions within the DNA segment that do not code for proteins. The judges rationalized that, although cDNA holds the same nucleotide sequence that is seen in naturally occurring DNA, the lab technician indisputably produces something new when cDNA is made. While the doctors and researchers who were the petitioner in the case argued that cDNA should not be eligible for patenting owing to the similarities of its nucleotide sequence to DNA, the court found it as distinct from a product of nature.[8]

REASONING BEHIND THE JUDGMENT:

Myraid Gentics Inc. had identified and sequenced significant genes but unscrambling a gene from its surrounding genetic material is not considered as an act of invention. It is a mere discovery which cannot be patented. Although they created cDNA which is non-natural i.e., human made product and hence it was patented but not BRCA1 and BRCA2

Bio Ethics

The case of Myraid makes it evident how technical grounds of patentability also plays an important role in safeguarding the public interest, focused on ensuring that patents are only granted on genuine progress in knowledge, and are not used to eliminate access to material in the public domain.
This case also emphasizes on the securing patent of human genes in general and, more exclusively, on the patenting of genes used in diagnostics because of uncertainties that such patents may restrict new diagnostic methods. The European Parliament expressed its concern in a 2001 resolution against the Myriad patents, calling on the European Patent Office to ensure the “principle of exception of securing Patent of humans, their genes or cells in their natural environment” and defending that the human genome should be unreservedly accessible for research purposes.[9] The balance between them remains a difficult one. As long as people rely mostly on private entities to invest in developing new genetic research-based treatments and diagnostics, biopharmaceutical corporations like Myriad will continue to require some degree of exceptionality over these technologies as a means of acquiring a return on their investment. But the concern remains that some gene patents are drafted too broadly, with the aim of over-compensating the patent holder by including all future applications.
Ethics in licensing
The main focus remained throughout this case was the ethics of patent rights and how they were exercised commercially and not just the validity of the patent
Myriad’s opponent blamed that its licensing policy, and the expensive cost for testing under the patented technologies, prevents other laboratories in countries where the patent was in use from carrying out diagnostic testing.[10] This case brought up questions as to whether regulators should intervene to deal with concerns about licensing practices, and if so how? This led to few government interventions, and reportedly influenced the evolution of French patent law. A number of soft-norm initiatives have aimed to classify good licensing practices. The Organization for Economic Co-Operation (OECD) guidelines for the licensing of genetic inventions recommends a comparatively open approach to licensing, predominantly for genetic tests.[11]

CONCLUSION

Myriad patents complied with the technical grounds for patentability showed how these technical norms can help to safeguard the public interest, specifically in such vulnerable areas of technology. Finally, the case inspires important questions as to the moral dimension of licensing custom of genetic inventions.
The landmark decision in Myriad Genetics is a significant ruling amidst a scientific landscape that is shifting more than most can comprehend. It helped to define the limitations between those products of inquisition that are unearthed in their natural form and those that are the consequence of human innovation and creation. This judgment should help in the field of genetics and medicine a clear cut idea of which ideas can merely be lauded for their public good and which can also be worked for private gain.


REFERENCES

[1] Ashish M. Bakshi, Gene patents at the Supreme Court: Association for Molecular Pathology v. Myriad Genetics, Journal of Law and the Biosciences, https://doi.org/10.1093/jlb/lsu007
[2] Case Study: Association for Molecular Pathology v. Myriad Genetics, Inc. https://onlinelaw.wustl.edu/blog/case-study-association-for-molecular-pathology-v-myriad-genetics-inc/
[3] American Cancer Association, Breast Cancer: Early Detection, http://www.cancer.org/cancer/breastcancer/moreinformation/breastcancerearlydetection/breast-cancer-early-detection-pdf
[4]American Cancer Association, Ovarian Cancer, http://www.cancer.org/cancer/ovariancancer/detailedguide/ovarian-cancer-pdf23
[5]Tobin Klusty and Richard Weinmeyer, Journal of Ethics, Supreme Court to Myriad Genetics: Synthetic DNA is Patentable but Isolated Genes Are Not, https://journalofethics.ama-assn.org/article/supreme-court-myriad-genetics-synthetic-dna-patentable-isolated-genes-are-not/2015-09
[6] Diamond v Chakrabarty, 447 US 303 (1980)
[7] Funk Brothers v Kalo Inoculant Co, 333 US 127 (1948)
[8] WIPO, Bioethics and Patent Law: The Case of Myriad https://www.wipo.int/wipo_magazine/en/2006/04/article_0003.html
[9] Kartik Tyagi, MONDAQ, The Myriad Case- An ‘Air Strike’ On Patenting Of Isolated DNAs https://www.mondaq.com/india/patent/870728/the-myriad-case-an-air-strike39-on-patenting-of-isolated-dnas
[10] OECD, GUIDELINES FOR THE LICENSING OF GENETIC INVENTIONS http://www.oecd.org/science/emerging-tech/36198812.pdf
[11]Michele Wales and Eddie Cartier, The Impact of Myriad on the Future Development and Commercialization of DNA-Based Therapies and Diagnostics https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4665038/

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