Write a review paper on Myriad and Mayo cases
Peer Responses: You are required to post 2 Peer Responses each week. Your Peer Response should be 200 words and should build upon the author’s first post. You should include at least 2 APA formatted reference/citation that differs from the source in your Original Post. it is not enough to agree or disagree with your peer. Any statement of opinion should be supported by factual data to bolster your point of view.
Author Ellie: The Mayo v. Prometheus’ court case is regarded as one of the most controversial rulings for intellectual property in the biotech industry. The Supreme Court’s decision is based on failure to satisfy patent-eligibility requirements of 35 U.S.C. § 101, stating that patents involving a natural law are not valid (Bauman, 2020; Klaiber & Goodman, 2012). Many claim that this court decision gave rise to an environment that discourages biotech companies from developing diagnostic tests as many are apprehensive of patenting the technology (Bauman, 2020). Others view this as an attempt to threaten companies’ potential to defend their intellectual property (Bauman, 2020). To defend the Supreme Court’s decision, one can go back to the idea of a natural law. While the Supreme Court’s definition of natural law can be vague, it generally revolves around the concept of a natural or intrinsic process. For the Mayo case, the natural association between a disease and the corresponding antibody is not something that can be patented (Bauman, 2020). The Court saw that allowing for patents on naturally occurring processes within the body will impede developments in diagnostic research (Thomas, 2012). If there is a legal claim over an innate boy reaction to a disease, research on the subject cannot continue and physicians are unable to receive important clinical data (Thomas, 2012).
In addition, another defense point is the lack of a “inventive concept”, or an original idea that expands a naturally occurring process (Klaiber & Goodman, 2012). In other words, in order to receive a patent, a company must develop an innovative idea that does not just rely on inferred knowledge and contributes significant developments (Klaiber & Goodman, 2012). The steps in the Prometheus patents listed “administering a drug providing” chemical substance and then “determining” the level of substance in the patient’s bloodstream (Klaiber & Goodman, 2012). These two steps were determined to already well understood information to the physicians, as the first step does not require stating to administer the drug and the second step simply states to “determine the level” (Klaiber & Goodman, 2012). The Court saw this as irrelevant information that did not contribute any significant information to an already knowledgeable audience (Klaiber & Goodman, 2012).
Author Jennifer: The Module 3 Learning Materials this week have helped us take a dive into better understanding intellectual property and what that means in terms of applicability within the biomedical diagnostics industry. William Mulholland’s review of patents, developing patent strategies, and commercialization aspects helped provide me the framework for unpacking the Mayo versus Prometheus case (Mulholland, 2015). An interesting piece that I had not known before was the U.S. Code in reference to Title 35 – Part 2, Chapter 10, Patentability of Inventions, Sections 101-103 that provides the legal definitions and structure for patents filed within the United States. Where the statutory subject matter (Section 101), novelty (Section 102), and non-obvious (Section 103) clauses define the legal conditions necessary for patentability (Patentability of Inventions, 1952). Understanding this framework assisted in my ability to defend Mayo Collaborative Services after Prometheus Laboratories Inc. filed suit for infringement on licensee of two patents solely belonging to their company (Thomas, 2012).
In 2012, the U.S. Supreme Court reviewed the Mayo versus Prometheus case and ultimately made the decision that claims made by Prometheus were not patentable because they were directed towards the laws of nature (Thomas, 2012). Prometheus’s claim of developing a method for optimizing therapeutic efficacy for treatment were based off of two supporting claims: a) administration a drug and b) determining the level of a drug (Thomas, 2012).
Reflecting back on the legal clauses necessary for patentability and reviewing the claims made by Prometheus help bolster the defense of Mayo and provide explanation as to why the suit and the patent do not hold true. In the first step of the claim regarding the of administration of a drug is simply referencing the act of the intended audience and only limiting the use of a natural law, and therefore is not a patentable claim (Thomas, 2012). In the second step of the claim regarding the determination of a level of drug is only providing advice to measure constituents in a patient’s specimen, something that is not novel and is routine practice in the field of medicine and therefore is not a patentable claim (Thomas, 2012). The Court also affirmed that Prometheus did not satisfy the machine-or-transformation test because nothing was being transformed (e.g. human blood) and that only measurements were being taken with the patient’s specimen (Thomas, 2012). Reviewing these aspects and applying the legal requirements help build a foundational defense and decisions like this help promote the accessibility to innovative technologies and information that can be utilized to further explore biomedical endeavors.