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This chapter traces the CCR5 gene’s intellectual property lineage. It discusses how genes became patentable in the United States by offering a history of patent law, particularly cases that have been cited as precedents for gene patenting. One of those cases, known as the “adrenalin patent”, was upheld by Judge Learned Hand in 1911 with a view to assist US pharmaceutical companies against their German rivals. Many argue that genes are not patent eligible due to the so-called product-of-nature doctrine. It turns out that the history of patenting products of nature is convoluted, and those who wish to unearth a clear trajectory or stance will be disappointed.

Using the CCR5 patent as a guide, this chapter analyses how various legal precedents based on chemistry have proven to be inappropriate to genes. Gene patents are controversial not simply because of their eligibility for intellectual property protection. This patent is particularly interesting because it occurred at a time when the status of patenting genes was being renegotiated, when the accuracy of computer sequencing for determining function and utility of a gene product was being challenged, when the role of utility-based patents to downstream research was being debated, and when the nature of the deposited object and its written specification were being defined.

This chapter explores how the CCR5 gene was patented by several companies both in the United States and in Europe. It discusses how one of the patent holders patented the incorrect sequence and did not know the precise function of the gene’s product. The patenting of the gene illustrates how lenient the United States Patent and Trademark Office (USPTO) was in granting gene patents back in the 1990s with a view to encourage growth in the biotechnology sector. It also discusses the views of numerous biomedical researchers on the patenting of the gene by sequencing companies.

This Chapter presents a synopsis of the argument advanced in the book. It recognizes the comprehensiveness of TRIPS and the theory of comparative advantage that underlies its adoption as part of a trade regime. But it challenges the understanding of TRIPS as a “supranational code,” a comprehensive code of intellectual property law that dictates exactly how WTO members must protect knowledge-intensive goods. Instead, it emphasizes that intellectual property is a complex regime that reflects notions of balance, diversity and historical contingency. There must be a balance between the interests of proprietors in securing a return from their investments and the interests of followers and the public in a robust domain of accessible knowledge. Because countries with different economic and cultural conditions will need to adopt different approaches to intellectual property, a one-size-fits-all code is undesirable. And as the creative ecosystem evolves, so too must intellectual property law. These features of intellectual property law support the need to view TRIPS through a neo-federalist lens. The Chapter illustrates the stakes involved in looking at TRIPS as a code and, conversely, at the advantage of seeing it from a neofederalist perspective, by examining the controversy over gene patents.

This chapter describes the internalization of science in modern law. It begins by examining internalization of scientific markers in abortion cases and law's reluctance to abandon those markers as they prove inadequate for resolving the issues. It then examines the use of scientific lines in Internet searching cases and the inevitable failure of the technical distinctions chosen. Finally, it explores the example described above concerning gene patent cases.

The introductory chapter proffers an overview of the history of the CCR5 gene. It discusses the rush to patent a sequence, whose precise function was unknown at the time of the patent. It also explores how the function of the gene was elucidated by various laboratories worldwide. Finally, this chapter outlines how an important mutation, Δ32‎, confers near immunity to AIDS and what the distribution of that allele is around the globe. The distribution of this allele worldwide added to the debate about race and the genome.

This final chapter brings us up to date with the current state of affairs in gene patenting. It discusses the recent US Supreme Court’s decision on the breast cancer patents held by Myriad Genetics. It also discusses the recent move by the FDA to prohibit personal genomics companies from offering their clients medical information based on their genetic sequence. Finally, it considers the role of history of science in current policy issues.

The chapter presents intellectual property rights issues in biotechnology. It analyzes various fields of intellectual property where possible protection and promotion of biotechnology could be found. The expansion of patent law canopy in the US and Europe, which resulted in patenting biotechnology innovations across the world, including India, is analyzed. Vivid theoretical and doctrinal debates on patenting biotechnology are presented with the help of number of classical and landmark case laws. Trademarks and trade secrets protection of biotechnology is debated and presented alongside patent protection. Developments in this regard from the perspective of the US, Europe, and India have been analyzed through debating on patenting of plant, animal, genetic material, and such other biotechnology products. The aim was to explore the intellectual property law regime to ensure possible protection for living innovations of biotechnology under different fields of intellectual property law in different regions.

This chapter discusses the patenting of the CCR5 gene in Europe. It compares and contrasts the practices of the United States Patent and Trademark Office (USPTO) with the European Patent Office (EPO) with regard to gene patenting. It also focuses on the anatomy of opposing a European patent and offers an informative glimpse into the world of patent litigation. A contrast between the USPTO and the EPO is informative since it points out that there are alternatives: questions of human value are embedded differently in various legal regimes. The situation in which the US finds itself is not inevitable.

Medical research and patents are two distinct areas of study. This book addresses some of the recent developments in the field of genetics and microbiology and the ethical issues concerning the subjects in their application for patient care. Much of the research takes place in the field of understanding anatomy and physiology of humans for identifying the causes for the various diseases. Even a dead body has immense value as a subject of research and has potential as property. In the new patent regime, there are new requirements for indigenous pharmacological research and issues of consent and protection against health risks to persons undergoing clinical trial have assumed serious public concern with several reported cases of death and serious illness to human subjects of clinical trial. The imperatives of disclosure of risks and informed consent have never been more crucial than now. The state initiatives for health care to regulate tobacco consumption and promote manufacture and sale of iodized salt have not yielded significant results. Enforcement of standards of drugs through licensing and prosecution of manufacturers for spurious drugs are literally non-existent.