A hidden technological assumption in patent law: The case of gene patents and the disclosure requirement

2019 ◽  
Vol 22 (5-6) ◽  
pp. 272-288
Author(s):  
Or Cohen‐Sasson
Keyword(s):  
Patent Law ◽  
Gene Patents ◽  
Disclosure Requirement

scholarly journals Current Policy Challenges in Genomic Medicine

2019 ◽  
Vol 66 (1) ◽  
pp. 61-67 ◽  
Author(s):  
Roger D Klein
Keyword(s):  
Genetic Testing ◽  
Molecular Genetic ◽  
Genomic Medicine ◽  
Patent Law ◽  
Genomic Testing ◽  
Molecular Genetic Testing ◽  
Gene Sequences ◽  
Gene Patents ◽  
Legislative Proposal ◽  
Next Generation Sequencing Ngs

Abstract BACKGROUND Molecular genetic testing has raised a variety of policy issues, ranging from privacy to reimbursement. Recently, payment policies have become of paramount importance as Medicare implemented the first significant change to test pricing since 1984 and announced a broad national coverage policy for the use of next-generation sequencing (NGS) in cancer patients that contains significant restrictions. Regulatory and oversight concerns have been important topics for discussion as the US Food and Drug Administration (FDA), Congress, and stakeholders have focused on new approaches to regulation of laboratory-developed tests (LDTs). Patents on gene sequences and relationships between genetic variants and clinical phenotypes have been points of contention since the field's inception. Two Supreme Court cases invalidated patents on gene sequences and biological relationships, ushering in the era of NGS and precision medicine. However, a recent legislative proposal threatens to reverse these gains and restore gene patents as barriers to progress in genetic and genomic testing and the implementation of genomic medicine. CONTENT This review discusses current issues in payment policy, laboratory oversight, and gene patenting and their potential impacts on genetic and genomic testing. SUMMARY Coverage and reimbursement policies present serious challenges to genetic and genomic testing. The potential for FDA regulation of LDTs looms as a significant threat to diagnostic innovation, patient access, and the viability of molecular genetic testing laboratories. Changes in patent law could cause gene patents to reemerge as barriers to the advancement of genomic medicine.

scholarly journals Disease Gene Patents: Overcoming Unethical Constraints on Clinical Laboratory Medicine

1999 ◽  
Vol 45 (3) ◽  
pp. 324-330 ◽  
Author(s):  
Jon F Merz
Keyword(s):  
Disease Gene ◽  
Clinical Laboratory ◽  
Conflicts Of Interest ◽  
Health Maintenance Organizations ◽  
Patent Law ◽  
Medical Community ◽  
Health Maintenance ◽  
Research Activities ◽  
Gene Patents ◽  
The Us

Abstract The rapidly growing number of disease gene patents—patents that claim all methods for diagnosis of a particular genetic condition—threatens the ability of physicians to provide medical care to their patients. In the past, patented diagnostic tests were made broadly available to the medical community in the form of test kits or licenses to use the patented test. Disease gene tests, however, are being monopolized by a small number of providers. Monopolization of medical testing services: (a) threatens to restrict research activities; (b) creates unacceptable conflicts of interest; (c) may reduce patient access to testing; (d) may lead to inequitable extensions of patent terms on tests and related discoveries; and (e) grants to patent holders the ability to dictate the standard of care for testing, and to otherwise interfere with the practice of medicine. Because of the risks raised by monopolization, amendment of the patent law to require compulsory licensing of physicians providing medical services is recommended. Vatican City (Reuters). The Vatican announced today that it has entered into an agreement with Dr. Mark Bogart of Honolulu, Hawaii, which grants to the Vatican exclusive rights to United States Patent no. 4,874,693. That patent, granted to Dr. Bogart in 1989, covers the human chorionic gonadotropin part of the maternal serum triple test for Down syndrome when performed between 18 and 25 weeks of pregnancy. Dr. Bogart, who was collecting royalties of several million dollars per quarter from hospitals, health maintenance organizations, and testing laboratories throughout the US, sold his interests in the patent for an undisclosed sum. The Vatican’s statement made clear that the Church intends to enforce its patent and prevent further use of the test in the US.

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