Myriad Genetics Inc vs AMP responses
Myriad Genetics Inc vs AMP (responses). The Myriad case is critical to the diagnostics industry. Whether you agree or disagree with the Supreme Court ruling, how would you defend Myriad in this case? Name at least 2 points to bolster your defense.
Response 1: Ashley Johnson
Many will reference the case, Association for Molecular Pathology v. Myriad Genetics, for decades to come. It sparked conversations amongst medical institutions, industry organizations, patient advocacy groups, and scientists as the ruling determined if genes could be patented (Kesselheim et al., 2013). The supreme court ruled affirmed in part and reversed in part with Myriad. It was stated, “genes and the information they encode are not patent-eligible because they have been isolated from surrounding genetic material.” However, cDNA is patent-eligible as it is created within the lab and not naturally found in nature (Supreme Court of the United States, 2013). Regarding the Myriad case, I could make several valid arguments in Myriad’s defense. These arguments consist of:
- Identifying the precise location and sequence of the BRCA1 and BRCA2 genes was not an easy task; it was a task that utilized an excessive amount of time and resources. Myriad should obtain a patent for this novel discovery to recuperate some of the losses the company took to obtain this information. BRCA1 and BRCA2 genes are located on chromosomes 17 and 13, respectively, where chromosome 17 has approximately 80 million nucleotides, and chromosome 13 has about 114 million. Within those nucleotides, BRCA1 and BRCA2 only account for 80,000 of those nucleotides highlighting the difficulty of initially identifying them (Supreme Court of the United States, 2013). The search for BRCA1 and BRCA2 took decades; much of it was completed by Dr. Mary-Claire King. BRCA1 was cloned and sequenced by a group led by Mark Skolnick of Myriad Genetics in 1994, followed by the first commercial test for mutations in BRCA1 and BRCA2 brought to market in 1996 (Hurst, 2014). A patent would allow this company to earn enough income to make up for its initial investment and continue to complete more groundbreaking research.
- The court’s ruling was based on the US Supreme Court held in Mayo v Prometheusthat “laws of nature, natural phenomena, and abstract ideas are not patentable… one must do more than simply state the law of nature, they must ‘apply it'” (Ngo, 2014). Essentially, the courts applied an inventive step needed to obtain a patent. DNA may be found in nature; however, the test itself that identifies these genes are not, and thus, the test for BRCA1/2 should be patentable. Patent law is about things that are made, designed, and require human ingenuity (Ngo, 2014). I believe Myriad lived up to this expectation when creating their diagnostic test.
Response 2: Alverta Joseph Mikhael
Thank you for your post. Admittedly, it’s very interesting that a naturally occurring DNA segment should be considered non patent eligible as it’s a product of nature while the cDNA is patent eligible because it’s not naturally occurring (a created synthetic DNA) (Supreme court of the United States, 2012). On the other hand, people may claim that patent eligibility should be given to who invents or discovers something first even if its naturally occurring or not, because preventing someone from the patency this way will hinder the development and funding of other researches in the same field that could present a major help to humanity (Wales & Cartier, 2015). Furthermore, I wanted to point out something important, patent eligibility may differ from one country to another. For example, the US patent and Trademark Office has recently issued new guidelines which enforce more strict criteria to patent natural products such as antibiotics, peptides and proteins, but the genetic sequences, in general, are currently still patent-eligible in the European Union and in Australia if certain conditions are fulfilled and it may be expected to take more time to reach a solution acceptable regarding patent-eligibility of genetic sequences to all relevant parties (Goossens et al., 2015).
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