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This chapter examines efforts to resist the implementation of the new patent regime in India out of concern for the price of essential medicines. The Indian pharmaceutical sector has been a principle source of low cost medicines for developing countries, but may no longer be able to produce inexpensive copies of medications patented elsewhere. India’s WTO-compliant patent law has a silver lining, however, since it requires companies to demonstrate increased effectiveness of new drugs over the standard of care, provisions against “evergreening” of patents that are not required by US patent laws. Activists in India have been able to defeat several recent patent applications under this provision. The pharmaceutical giant Novartis challenged this provision in the Indian Supreme Court while at the same time the company was holding patents for medical products that were derived from India’s indigenous ayurvedic medical system.

This chapter examines intellectual property rights in the context of the right to health. It presents the Novartis patent claim for the anti-cancer drug ‘Glivec’ in India as a case-study to highlight the infringement of health rights in the context of the high prices of patented drugs, which make vital drugs inaccessible to a vast majority of people, particularly poor people. The case brings to the fore issues of drug patenting, survival of generic drugs, and their impact on access to medicines, which are vital to the preservation of the right to health, an aspect of human rights, as well as a constitutional rights in many countries.

We might have thought that the concept of nerves ended in 1957 when the United States Post Office Department initiated a fraud proceeding against John Winters of New York City, who had been promoting a product called Orbacine containing bromide and niacin for “every-day nervousness and its symptoms.” Although Winters’ claims went a bit beyond nerves, the Post Office wanted an end to the whole business and Orbacine disappeared. But the concept of nerves had enemies other than the Post Office. Three in particular had tried to do away with it: psychoanalysis, psychopharmacology, and the DSM series. All failed to kill it completely, and the concept lingers on because of its obvious face value: Our patients clearly have a nervous illness or something resembling it. They do not have a “mood disorder.” In medicine the nervous syndrome, the condition that dare not speak its name, has taken on various allures. Once upon a time, hysteria was the equivalent of a nervous diagnosis in women. There were physicians who had little patience with calling their former hysteric patients “depressed”: They remained hysteric! Jacques Frei, a member of the department of psychiatry of the University of Lausanne in Switzerland, noted in 1984 “the importance that depressive symptomatology has taken today as a call for help among female hysterics. . . . It seems that the hysterical woman today has a better chance of a hearing if she presents with a depressive picture, even evoking suicidal ideas.” Although hysteria today is discredited as a diagnosis, it is interesting that older clinicians such as Frei saw it as a diagnosis that trumped depression; he even argued that his patients at Cery Hospital were modeling their symptoms to conform to the new diagnoses. The 1950s and 1960s saw alternative diagnoses to the nervous syndrome come and go, fragments of clinical experience that seemed to make sense to individual physicians but were not more widely taken up because their originators did not have prestigious academic appointments. Take “the housewife syndrome” that Palma Formica proposed in 1962.

One of the first high-profile patent cases after 2005 was the patent application filed by Novartis for the protection of Glivec, a sensational new drug which dramatically increased the survival rate of patients with a rare form of cancer called chronic myeloid leukaemia (CML). A patent application filed by Novartis for a certain salt form that was marketed as Glivec was rejected by the Indian patent office on the grounds that it was barred by Section 3(d). Not only did the rejection sparked a series of appeals by Novartis but it also led to Novartis challenging the constitutionality and TRIPS compatibility of Section 3(d) before the Madras High Court. Novartis lost both the cases. This chapter starts with the story of how Glivec was invented and explains the various legal issues raised by Novartis in its long battle to patent Glivec.

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.

Patents are not granted uniformly across nations as the standards for patentability varies across nations. This chapter analyses standards of patentability, specifically nonobviousness and the enhancement of efficacy, for pharmaceutical patents. The new definition of nonobviousness laid down by the Patents Act has serious ramifications in terms of raising the bar on inventions that can be patented. A further significance of the new definition is that it places the burden of disclosure squarely on the patent applicant. This chapter then examines the threshold requirement of enhancement of efficacy. The provision itself has been introduced to curb any initiative to patent bioequivalents. The judicial determination of the meaning of the term ‘efficacy’ and the legislative intent behind the provision are explained herein.