After Myriad, What Types of Claim Amendments Change a Patent Ineligible Isolated Gene Claim Into an Eligible Patent Claim That Is ‘Markedly Different’ From Nature?

May 29, 2018

Using a novel research method, this paper examines the types of claim amendments that have transformed isolated gene claims from patent-ineligible into eligible subject matter. It also provides clarity into the threshold of eligibility for gene-related patents.

via After Myriad, What Types of Claim Amendments Change a Patent Ineligible Isolated Gene Claim Into an Eligible Patent Claim That Is ‘Markedly Different’ From Nature? by Mateo Aboy, Johnathon Liddicoat, Kathleen Liddell, Matthew Jordan, Cristina Crespo :: SSRN


The Genetic Information Nondiscrimination Act at Age 10: GINA’s Controversial Assertion that Data Transparency Protects Privacy and Civil Rights

May 13, 2018

The genomic testing industry is an edifice built on data transparency: transparent and often unconsented sharing of our genetic information with researchers to fuel scientific discovery, transparent sharing of our test results to help regulators infer whether the tests are safe and effective, and transparent sharing of our health information to help treat other patients on the premise that we gain reciprocity of advantage when each person’s health care is informed by the best available data about all of us. Transparency undeniably confers many social benefits but creates risks to the civil rights of hapless individuals whose genetic information is shared. Touted as a major civil rights law at the time of its passage, the Genetic Information Nondiscrimination Act of 2008 has endured ten years of criticism that its protections are ineffectual, insufficient, or even unethical and overtly unsafe for the people it aims to protect. At the center of this controversy are provisions of GINA that expand people’s access to genetic information that others store about them—a heavily contested assertion that data transparency implies sharing data not just with third parties, but with the people whose data are being shared. This article traces the decades-long roots of this assertion and explores pathways to resolve the controversy that engulfs it. It is important to resolve this controversy. As GINA enters its second decade, genomics is finally starting to gain sufficient predictive power to support discriminatory and other nefarious uses that GINA was designed to prevent. We are entering a positive feedback loop in which the genomic research that exposes us to risk of unwanted data disclosures simultaneously fuels discoveries that make such disclosures potentially more damaging.

via The Genetic Information Nondiscrimination Act at Age 10: GINA’s Controversial Assertion that Data Transparency Protects Privacy and Civil Rights by Barbara J. Evans :: SSRN


Who Knows What, and When?: A Survey of the Privacy Policies Proffered by U.S. Direct-to-Consumer Genetic Testing Companies

May 7, 2018

Direct-to-consumer genetic testing (DTC-GT) companies have proliferated in the past several years. Based on an analysis of genetic information submitted by consumers, these companies offer a wide array of services, ranging from information about health and ancestry to identification of surreptitiously-gathered biological material sent in by suspicious spouses. Federal and state laws are ambiguous about the type of disclosures these companies must make about how the genetic information they obtained is collected, used and shared. In an effort to assist in developing such laws, this article reports a survey of the privacy policies these companies purport to follow. It canvasses 90 DTC-GT companies operating in the United States and provides a detailed analysis of whether and to what extent their policies inform consumers about how their genetic information will be used and secured, with whom it will be shared, and a host of other issues. Using the Federal Trade Commission’s articulation of the Fair Information Practice Principles and the agency’s proposed Privacy Framework as the baseline, we conclude that most DTC policies fall well short of the ideal.

via Who Knows What, and When?: A Survey of the Privacy Policies Proffered by U.S. Direct-to-Consumer Genetic Testing Companies by James Hazel, Christopher Slobogin :: SSRN


A Telltale Heart: Exploring the Constitutionality of the Use of Personal Technology to Incriminate Individuals

May 5, 2018

In the first case to use a beating heart as incriminating evidence, an Ohio judge ruled the defendant’s pacemaker data, which was obtained by the police pursuant to a search warrant, was admissible evidence against him. This case is significant because it suggests that an individual’s most intimate personal technology may be admitted as incriminating evidence in a court of law. This decision raises serious questions concerning a defendant’s Fourth Amendment right to privacy and Fifth Amendment privilege against self-incrimination. This paper explores the potential implications of admitting individuals’ most personal data into evidence and examines the weakness of current privacy laws.

via A Telltale Heart: Exploring the Constitutionality of the Use of Personal Technology to Incriminate Individuals by Caroline McLeod :: SSRN


Myriad’s Impact on Gene Patents

December 18, 2017

In the three years since the US Supreme Court’s decision in AMP v Myriad, there has been much debate and speculation about the impact of the Myriad case on the biotech industry, particularly on the status of gene patents. Was it a significant decision or, as Lord Tennyson might have argued, just another decision in a myriad of single instances that make up a confused and confusing law of patents?

via Myriad’s Impact on Gene Patents by Mateo Aboy, Kathleen Liddell, Johnathon Liddicoat, Cristina Crespo :: SSRN


Mitochondrial Replacement Therapy: The UK and US Regulatory Landscapes by Rosa Castro :: SSRN

November 24, 2016

This note discusses the UK regulatory framework for mitochondrial replacement therapies and compares it to the US landscape. It focuses on the regulatory and ethical discussions in both countries to find some lessons for debates about editing human germ cells.The first section introduces some biological characteristics of mitochondria and their implications for mitochondrial diseases, medical interventions and ethical as well as regulatory questions. The second section discusses the regulatory pathway leading to the adoption of the UK 2015 regulations and the main features of the approved text. The third section considers the current regulatory landscape in the US. The fourth section discusses some regulatory and bioethical questions raised by Mitochondrial replacement therapies.

Source: Mitochondrial Replacement Therapy: The UK and US Regulatory Landscapes by Rosa Castro :: SSRN


Metaphor after Myriad: The Effect of Legal Rhetoric on Intellectual Property Protection for Biological Sequences by Charlotte A. Tschider :: SSRN

November 13, 2016

The Association for Molecular Pathology v. Myriad Genetics (‘Myriad’), the U.S. Supreme Court’s first code-level determination of patent eligibility for biological sequences, ultimately barred isolated DNA patents in the United States while granting patent protection of cDNA. Myriad’s decision has, since 2013, continued to pose questions regarding legal protection for biological sequences as a whole: which types of biological sequences are patent-ineligible, and what legal strategy organizations should use to protect these sequences. As biotechnology companies continue to perform genetic testing and market pharmacogenomics products to the general public, the industry will likely demand appropriate legal instruments to safeguard significant investment in research and development. Although no clear direction has emerged for protecting biological sequences holistically, analyzing metaphors used in the Myriad decision may suggest a legal direction compatible with court reasoning. Based on metaphors used most prevalently in Myriad, courts seem to suggest thin compilation copyright and trade secret protection offer potential solutions for legally protecting biological sequences.

Source: Metaphor after Myriad: The Effect of Legal Rhetoric on Intellectual Property Protection for Biological Sequences by Charlotte A. Tschider :: SSRN