I. INTRODUCTION II. PATENTING GENES IN INDIA: EXPLORING THE LEGAL SPACE A. Options for Regulating Gene Patenting vs. Banning Gene Patenting B. Banning Gene Patenting in India: Violation of TRIPS? C. Evolution of Patents Law in India D. The Indian Patent Act E. Gene Patents: How Does the Indian Patent Act, 2005, Measure Up? . F. Ensure Strict Patentability Criteria III. CONCERNS ARISING FROM GENETIC PATENTING IV. RECOMMENDATIONS A. Non-Infringement of Patent Provision B. Ordre Public C. Compulsory Licensing V. CONCLUDING OBSERVATIONS
The recent Myriad litigation in the United States (1) has reinvigorated the debate over gene patenting. (2) Furthermore, the issue of access to affordable medication continues to be debated around the world, (3) and many countries, including China, have recently reformed their patent laws in light of the challenges posed by the patent law and its implications for access to health care. (4)
India has struggled with patent reform in general since 1995, spawned by its international treaty obligations, but there has been little policy debate concerning gene patenting. (5) It is critical that Indian policy makers track global developments regarding gene patenting and establish an equitable legal framework that allows for access to research and therapeutic products.
Access to efficient and affordable healthcare remains one of the predominant concerns in developing countries, especially India. (6) Health biotechnology offers the long-term possibility of providing new approaches to the prevention and management of many intractable diseases. (7) Of the various health biotechnologies, DNA genetic engineering research carries the most potential for health solutions in developing and developed countries. (8) The products of genetic research, such as new genetic diagnostics tests, vaccines, and drugs can be useful for not only genetic disorders, but for diseases like cancer, HIV/AIDS, and tuberculosis. (9) The Human Genome Project, (10) for example, is perceived as one of the most important developments in the recent past. (11)
A 2005 study conducted by researchers at the University of Toronto's Joint Centre for Bioethics identifies genetics as one of the technologies most relevant to developing countries. (12) The study reports that genetically engineered vaccines would be cheaper and more effective than current vaccines, and that they offer renewed hope for fighting widespread infections like HIV/AIDS, tuberculosis, and malaria. (13) Furthermore, genetic drugs, such as inhalants, may make drug administration safer and potentially less expensive, (14) particularly in the context of AIDS in South Africa and tuberculosis in India. (15)
While the introduction of gene therapy promises to deliver a healthier future for developing countries with respect to infectious and parasitic diseases, certain legal and ethical concerns must be addressed particularly in regards to the patenting of genetic applications. (16) There are also serioussocio-cultural concerns surrounding the patenting of life forms and its moral acceptability. (17) Moreover, it is important to note that the patenting of genetic applications may lead to increases in drugs and treatments created by these applications, which could limit access to these treatments for poorer populations. (18) Evidence suggests that public and private laboratories may be unable to offer diagnostic tests due to costly license and royalty fees. (19)
This Article critically evaluates whether and to what extent there has been substantive debate on the ethical aspects of patenting genetic material in light of the widely held opinion that the association of human biological material with property rights is unethical. The ethical concerns are twofold. Some believe that patenting genetic material implies a reduction of its status to "information," rather than acknowledging it as an integral part of human identity. …