The U.S. Department of Food and Drug Administration (“FDA”) has previously announced an interest in regulating diagnostic tests used in providing personalized medicine clinical care. Interested stakeholders such as the American Clinical Laboratory Association, the College of American Pathologists, and the Association for Molecular Pathology, have weighed in on whether the FDA can and should expand its jurisdiction to laboratory developed tests (“LDTs) performed by clinical laboratories. Continue reading this entry
In a companion case to the “gene patenting” dispute presently before the U.S. Supreme Court, Myriad Genetics, Inc. successfully defended the patent-eligibility of “gene patents” in Australia. In Cancer Voices et al. v. Myriad Genetics Inc. et al. [Myriad] the Federal Court of Australia held that a claim that covers an isolated naturally occurring nucleic acid – either deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) – is patentable provided that the other requirements for patentability have been met.
The Challenged Claims
The challenged patent entitled “In vivo mutations and polymorphisms in the 17q-linked breast and ovarian cancer susceptibility gene” claims isolated polynucleotides comprising all, or a portion of the BRCA1 locus or of a mutated BRCA1 locus. The polynucleotides can be RNA, DNA, cDNA and synthetic forms. The invention also includes detection methods, isolated antibodies, and screening methods.
In reaching its holding, the Australian court reviewed the relevant case law in Australia and the United States and its application to the patenting of products of nature. The court highlighted prior decisions where the technology may depend on the operation of natural laws or the natural properties of the materials involved. Similar to Judge Lourie’s reasoning in the companion U.S. case [see prior post of August 16, 2012], the Australian court focused on the isolated nature of genetic material. Isolated or purified nucleic acids, the court reasoned, is the product of human intervention. Moreover, the court placed importance on the long standing practice of patenting isolated DNA in Australia and other countries. The court also determined that it would be difficult, on any rational basis, to confine the holding of this case to patenting in other fields, such as the patenting of pure and isolated chemicals that occur in nature; where the consequences of such are unknown.
Myriad and the biotechnology community now wait for the U.S. Supreme Court’s review of the patent-eligibility of human genes. Oral argument is expected in April. Stay tuned.
Petitioners (The Association for Molecular Pathology et al., represented by the American Civil Liberties Union or ”Petitioner” or “ACLU”) filed their brief with the U.S. Supreme Court yesterday urging the Court to reverse the Federal Circuit’s decision and the USPTO’s decades long practice of granting patents on isolated DNA. Similar to their arguments in all prior briefings, the Petitioners argue that the patents issued to Respondent Myriad Genetics, Inc. et al. (“Myriad”) were erroneously issued because they claims products of nature. Petitioner also applied the Supreme Court’s Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S. Ct. 1289 (2012)(“Mayo”). A copy of the brief is attached [MyriadPetitionersMeritsBrief].Continue reading this entry
On January 17, 2013, the Office for Civil Rights of the U.S. Department of Health and Human Services (HHS) issued the long-awaited omnibus final rule (the Rule) implementing changes in current regulations under the Health Insurance Portability and Accountability Act of 1996 (HIPAA), pursuant to the Health Information Technology for Economic and Clinical Health Act (HITECH Act). Most of the Rule finalizes numerous proposed regulations set forth in a proposed rule dated July 14, 2010 (the Proposed Rule), which focused on the HITECH Act but also addressed other HIPAA provisions. The Rule also finalizes a proposed rule issued in 2009 that implements the HIPAA-related genetic privacy provisions of the Genetic Information Nondiscrimination Act (GINA).
Foley & Lardner, LLP provides an Executive Summary of the Rule and recommendations for preparing to comply. To learn more click here.
Patenting diagnostic methods is more challenging in the wake of the U.S. Supreme Court’s Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. __ (2012) (Prometheus) and the USPTO’s application of the decision, as set forth in its Guidance Document distributed to patent examiners. Patent examiners are advised to follow the Guidance Document in examining a process claim (e.g., medical method claim) in which a law of nature, a natural phenomenon, or naturally occurring relation or correlation (collectively referred to as a natural principle in the Guidance Document) is a limiting element or step. Thus, a medical diagnostic claim that correlates or relates to a genetic marker or physiological measurement (typical in personalized medicine) is subject to the Guidance Document as the claim necessarily includes an element interpreted by the USPTO as a natural principle. Continue reading this entry
The Food and Drug Administration (FDA) recently issued a guidance document related to the conduct of clinical trials to support approval of human drugs and biological products “Draft Guidance for Industry: Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products” (“Guidance Document”). The document is intended to provide guidance for enrichment strategies that can be used in clinical trials intended to support effectiveness and safety claims in new drug applications (NDAs) and biologics licensed applications (BLAs). Continue reading this entry
Increasingly, the development of new pharmaceuticals utilize genetic information to stratify patient subpopulations and/or predict efficacy and adverse events – the development paradigm of personalized medicine. A recent report by Thomas Reuters (“Spotlight On … Personalized Medicine, A Pharma Matters Report,” the “Report”) summarizes the technical, regulatory and economic challenges the pharmaceutical industry faces as they move from the traditional drug development model to a personalized approach. Historically, the development of new molecular entities rely on developing drugs with annual sales over $1.0 billion. In contrast, personalized medicine will develop drugs and therapies targeted to smaller patient populations with significantly reduced annual sales. The Report also underscores the benefits of personalized medicine and highlights progress the pharmaceutical industry has made toward providing targeted therapies. Continue reading this entry
The collection, analysis and sharing of large amounts of information, such as genetic data, is an important part of the implementation and management of personalized medicine. Many health care providers are moving applications and other IT infrastructure components into “the cloud” to share and manage this information. However, the use of cloud computing is not without legal risks associated with hosting and accessing clinical data in the cloud computing environment. Continue reading this entry
Following up on my post examining the Myriad gene patenting case, which is heading to the Supreme Court, I had the chance to discuss the subject with Colin O’Keefe of LXBN. In the interview, I discuss the legal and commercial issues at the core of the controversy, and whether or not genes are indeed patented.
On December 3, 2012, Representative Mike Honda of California introduced The Healthcare Innovation and Marketplace Technologies Act (HIMTA), to foster more innovation in the health care industry by removing barriers in wireless health. See HR 6626, attached.
Office of Wireless Health
The bill would establish an Office of Wireless Health at the Food and Drug Administration (FDA) to coordinate with other governmental agencies and private industry, and provide recommendations to the FDA Commissioner on how to develop and maintain a consistent, reasonable, and predictable regulatory framework on wireless health issues. The goal of the Office of Wireless Health, according to Representative Honda’s office, is not to expand the mandate or responsibilities of the FDA, but rather to seek to better clarify and simplify existing regulations while providing sorely needed expertise in this important field.
The bill will also establish an mHealth developer support program at the Department of Health and Human Services to help mobile application developers build their devices in line with current privacy regulations. An array of support resources are envisioned, such as a national hotline, an educational website, and a yearly report that will help translate the wide array of privacy guidelines into common English.
Other goals of the bill include creating a marketplace for innovation by creating a low-interest small business loan program to clinics and physician offices for the purchasing of new health information technologies. It also would create a tax incentive program to allow medical providers to deduct costs related to non-electronic health record information technology. A grant program would also be established to assist medical care providers in retraining their employees into new positions that use health information technology.
Implications for Personalized Medicine
Personalized medicine is more than targeted therapeutics, it also involves direct patient involvement in monitoring and selecting therapies. Smart phones and other mobile devices will lead the way, offering a cost-effective truly mobile means to collect and monitor patient care. This bill, if enacted, should foster innovation in this growing trend in health care delivery and facilitate the coming electronic revolution in health data storage and management.