Gene-patenting and access to healthcare: achieving precision.

• Author: Jain, Dipika

1. 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 I. INTRODUCTION

   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. (20) Another concern is that genetic material is a product of nature rather than a man-made invention, and, hence, it is immoral to patent it. (21) Garforth says that the very "language" of patent law renders it unsuitable for the patenting of higher living organisms. (22) In order for higher life to fall within the ambit of patentable material, the essential ethical dilemma of reducing animate beings to objects to be owned and protected arises. (23) Furthermore, this Article evaluates whether the necessary regulatory and policy tools (such as patent laws) are available in India. These regulatory tools are needed to construct a patent policy for human-gene patenting that provides equitable and adequate access to the treatments and technologies derived from these developments. Part Two of this Article examines the legality of gene patenting in India and analyzes the Indian Patent Act, looking specifically at provisions that uphold the exclusive rights to microorganisms. This part further explores intellectual-property policies on gene patenting in other countries to draw a critical and comparative perspective. Part Three examines the concerns arising from patenting genes. Moreover, this Part will reflect on other countries facing similar concerns, including the United States, and critically evaluates the available solutions. Part Three also evaluates whether India would violate the Trade Related Intellectual Property Rights ("TRIPS") (24) provisions if it sought to restrict or even limit gene-patent rights. Part Four provides recommendations gleaned from other countries' experiences with gene patenting. Part Five offers concluding observations.

2. PATENTING GENES IN INDIA: EXPLORING THE LEGAL SPACE

   Despite being a source of controversy, genes have been patented in many countries, most prominently in the United States, Canada, Japan, Germany, and France. (25) Notably, the patent system originally excluded the patenting of higher life forms, (26) but the rapid and consistent transformation of industrialization from chemical and pharmaceutical industries to the current biotechnology industry has "expanded [the] scope of patentable subject-matter to accommodate the claims of th[e]se emerg[ing] industries." (27) In more recent times, the scope of patentable material has expanded greatly given the ongoing path of industrialization away from pharmaceutical industries towards biotechnology and the need to accommodate these new industries' requirements. (28) The determination of what constitutes patentable subject matter has been largely a subject of judicial scrutiny rather than legislative intervention. (29) This is evident in Diamond v. Chakrabarty, wherein the U.S. Supreme Court made life forms patentable for the first time. (30) The patent system initially was not designed to include life forms, but rather predominantly was intended to include mechanical inventions and technology. (31) Higher life forms were not considered to fall within the category of patentable material since they were products of nature, (32) but as industrialization extended from mere mechanical inventions to endeavors of a chemical nature, and subsequently biotechnology, higher life forms became increasingly considered patentable. (33) This expansion of the ambit of "patentable material" did not come about as the result of proactive legislative changes, but rather from inclusion by the judiciary of higher life forms within this definition. (34) Critics of genetic patenting argue that because chemical compounds may be recognized as composition of matter for the purpose of patenting, they constitute "discoveries" rather than "inventions," and therefore, do not meet the criteria of patents. (35) But if the substance is a "[p]roduct[] of nature, [it] may not be patented." (36) Various American courts have held that if an inventor isolates and purifies a substance, it becomes patentable, provided that the substance meets all other patentability criteria. (37) American courts also consider whether any "commercial" or "therapeutic value" has been added to an isolated and purified, naturally occurring substance when deciding whether a substance is patentable. (38) Subsequently, genes have been patented in various countries based on this logic. (39)

   The next section will consider two important questions: (1) whether India will be violating TRIPS if it decides to ban patenting for gene-related inventions; and, (2) how India can prevent the frivolous patenting of genes and ensure sufficient access to drugs in the case where a genetic application, diagnostic tool, or genetic drug is patented.

   1. Options for Regulating Gene Patenting vs. Banning Gene Patenting

      Although genes are being patented in many countries, it is important to critically examine whether India needs to approach the issue of gene patenting more cautiously--especially in light of the fact that recent anti-cancer drugs (mostly biotech-based drugs) are prohibitively expensive and beyond the reach of millions in India. (40) It is worth examining whether India, as a matter of policy, should ban gene patenting and whether a ban would violate India's international obligations under TRIPS. Indeed, the Indian Patent Act was amended in 2002 to incorporate the patenting of microorganisms. (41) This amendment comported with India's TRIPS obligation. (42)

      The recent Myriad litigation in the United States, which concerns two human genes (BRCA1 and BRCA2) associated with the development of breast and ovarian cancer, (43) has brought attention to the debate surrounding the banning of gene patents. (44) "Myriad's patents have raised significant controversy on a global scale because the patents held by Myriad not only cover the BRCA gene mutations themselves, but also include diagnostic tests and the use of the genes for advances in predictive medicine." (45) The cost of procedures stemming from this patent are prohibitively expensive and beyond the reach of many women around the world. (46)

      1. Recent Development in the...