Tag: DNA
23 Skidoo – Genomes, Gamesmanship and the First Amendment
On November 22, 2013, the Inquisition collided with the Internet. On that date, the Food and Drug Administration issued a Warning Letter threatening 23andMe, Inc. with seizure of product, injunctions and civil monetary penalties based on allegations that 23andMe – which provides customers with information about their personal genomes – is selling misbranded and adulterated medical devices. In plain terms, FDA has sought to restrict dissemination of this information for no other reason than an undocumented fear people might misuse it. If FDA follows through on its threats of regulatory action, this dispute could provide the forum for defining the First Amendment limits of the FDA’s power to regulate public health by restricting dissemination of information.
By way of brief background, for $99, 23andMe provides a receptacle for a saliva sample and a mailer. Upon receipt, 23andMe extracts selected genetic information … Read More »
FDA’s Warning Letter to 23andMe: Ethical and Legal Issues
The FDA’s warning letter to 23andMe, the maker of mail-order genetic tests, highlights the challenging legal and ethical issues posed by such products. While the FDA’s letter focuses on charges that (a) 23andMe’s DNA collection kit is an adulterated Class III medical device because it has not obtained prior regulatory clearance, and (b) the product is misbranded because 23andMe has failed to provide adequate evidence that its product provides accurate results, the situation raises additional questions.
For example, should direct-to-consumer medical genetic testing (DTCMGT) be regulated as “the practice of medicine”? To date, DTCMGT, which takes place outside of the traditional medical setting, has not been subjected to state law regulatory requirements applicable to “the practice of medicine” imposed on medical providers. Such requirements could assure involvement of a genetics professional in the testing, which could reduce risks of inadequate informed … Read More »
Navigating the Isolated DNA Patent Eligibility Jungle
Introduction
For over 150 years the Supreme Court has provided three categories of exceptions to patent eligibility under 35 U.S.C §101: abstract ideas, laws of nature, and physical phenomena, since these are the basic tools of scientific and technological work.[1] The Roberts Court has revised the standard for review of “abstract ideas” and “laws of nature” in Bilski v. Kappos and Mayo v. Prometheus, respectively. The Court’s much awaited decision in AMP v. Myriad addressed the “physical phenomena” exception with respect to patents claiming isolated DNA.[2]
The recent decision in Myriad will have an impact reaching far beyond the patentability of isolated DNA. Patent eligibility for isolated DNA is crucial for the continued growth of the biotechnology and diagnostics industries. The decision, disallowing patenting of isolated DNA, will have a chilling effect on these industries. Furthermore, the decision casts a cloud on … Read More »