The application of medical technology in the pediatric setting must serve the best interest of the child. Genetic testing of children and infants presents unique challenges. In contrast to the testing of adult patients, most children cannot understand the risks and benefits or provide informed consent. The American Academy of Pediatrics (AAP) and the American College of Medical Genetics and Genomics (ACMG) recently issued recommendations regarding genetic testing or screening of infants and children. In Ethical and Policy Issues in Genetic Testing and Screening of Children (“Report”), the AAP and ACMG review the scenarios in which genetic testing or screening of minors may occur and recommend best practices for such testing.Continue reading this entry
Category Archives: Uncategorized
FDA Regulation of Laboratory Developed Tests: Benefit or Unnecessary Burden?
Posted in Companion Diagnostics; Diagnostic Methods; FDA; Personalized Medicine; UncategorizedThe 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
Myriad Posts Gene Patenting Victory in Australia
Posted in Gene Patents; UncategorizedIn 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.
Legal Analysis
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.
Supreme Court to Review “Gene Patenting”
Posted in UncategorizedThe U.S. Supreme Court decided today to consider the patent-eligibility of isolated DNA sequences by reviewing the Federal Circuit’s decision – Ass’n for Molecular Pathology v. Myriad Genetics, Inc., No. 2010-1406 (Fed. Cir. 2012).
China Issues Human Genetic Resources Management Regulations
Posted in Personalized Medicine; UncategorizedThose seeking to conduct research involving human genetic material within the People’s Republic of China or to import into China such material should review China’s recently issued draft regulations (“Draft”) for the management of its human genetic resources. The regulations apply to the collection, preservation, research, development, immigration and other activities involving human genetic material.
The Draft provides provides that only legal entities established by law in China may engage in the collection and preservation of human genetic material. Foreign entities can conduct research with the cooperation of a Chinese entity. Such cooperation shall be subject to the approval of Ministry of Science and Technology of P.R.C (MOST). In addition, the foreign entity shall ensure that staff from the Chinese entity take part in the substantive research and development activity during the collaboration. Though the Draft does not provide that the Chinese party will retain title to any intellectual property developed from the collaboration, the Chinese entity is required to provide a report to MOST regarding the research and development activities within three months from the ending of the international cooperation. The Draft allows the ownership of intellectual property generated from the collaboration to be decided by agreement between the Chinese and foreign entities.
The Draft also notes that the export of human genetic resource sourced from the territory of China shall be subject to the approval of MOST. Because the Draft prohibits trading of human genetic resources, the foreign receiving unit must be the foreign party to the international cooperation approved by MOST. Human genetic resource material imported into China shall be registered with MOST.
A copy of the Draft Regulation on Human Genetic Resources 2012 is attached.
Special thanks to Foley & Lardner’s Max Lin for summarizing the Draft regulations. Max is resident in Foley’s Shanghai office.
Personalized Multiplex Test on Market
Posted in UncategorizedA multiplex test that can analyze tumors for over 200 genes is now available from Foundation Medicine Inc., the Wall Street Journal reported today. The test will be used by Novartis, Sanofi SA, Johnson & Johnson and Celgene to analyze patients in early-stage clinical trials of new cancer drugs to identify patients most likely to benefit from the drug and to accelerate the drug approval process. Continue reading this entry