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Balancing access and innovation: India's Supreme Court rules on imatinib.

The World Intellectual Property Organization defines a patent as “an exclusive right granted for an invention, which is a product or a process that provides a new way of doing something, or offers a new technical solution to a problem.”1 Patents provide their owners with these exclusive rights for a limited period of time to stimulate investment in innovation. The tension between providing a reward for innovation and the imperative to make the fruits of innovation widely available has confounded policy makers for centuries. James Madison, who helped convince Thomas Jefferson to include protection for patents in US law, wrote of his own concerns about patents more than 180 years ago: “grants of this sort can be justified in very peculiar cases only, if at all; the danger being very great that the good resulting from the operation of the monopoly, will be overbalanced by the evil effect of the precedent; and it being not impossible that the monopoly itself, in its original operation, may produce more evil than good.”2 The most recent entry in this age-old debate occurred on April 1, 2013, when India’s Supreme Court ruled that the Swiss pharmaceutical company Novartis could not obtain a patent in India on the form of its cancer drug imatinib (Glivec or Gleevec) that is used for the marketed product. Imatinib is a targeted therapy for chronic myeloid leukemia and a few other rare diseases. The active ingredient prevents a tyrosine kinase enzyme from initiating the signaling cascade necessary for cancer development, leading to cancer cell death by apoptosis. The issue in the imatinib case related to India’s recently developed and relatively unique patent law. Drug products were specifically excluded from the first iteration of India’s patent statute in 1970, although the process for making them could be patented. The rationale was that India was a poor country and such countries, as the Indian economist Jagdish Bhagwati noted, “have plenty of need for drugs, [but] they have no effective demand.”3 This meant that countries like India had a clear interest in less restrictive policies on intellectual property. By the early 2000s, however, 2 important changes occurred. First, India signed a World Trade Organization agreement governing intellectual property that bound the country to amend its patent law starting in 2005 to begin accepting therapeutic product patents, similar to the legal environment in Organisation for Economic Co-operation and Development countries such as the United States (retroactive for products invented between 1995 and 2005). Second, India had become a country in transition, with a small but increasing number of citizens who can afford drugs at high prices, a large number of citizens who still cannot afford these prices, a $10 billion export industry in generic drugs, and a strong need to attract foreign investment. According to one projection, India will be one of the top 10 global markets for drugs by 2020, with a market size of $50 billion.4 To address these various interests, India adopted a patent law with public health safeguards as implemented through 3 key provisions (Table). First, Section 3(d) prevents patents on drug products created through minor modifications to previously existing products that do not demonstrate enhanced efficacy. These socalled secondary patents are frequently criticized because of their role in pharmaceutical companies’ lifecycle management strategies aimed at extending market exclusivity on successful drug products past the patent expiration on the original active ingredient.5 Second, Section 25(1) allows third parties, including nongovernmental organizations and for-profit competitors, to oppose patents before they are granted through an adversarial administrative proceeding. This raises the cost of seeking a patent in India and, theoretically, improves the precision and quality of patents that are granted.6 Third, Section 84 allows for compulsory licensing. If 3 years after a patent is granted the invention is not available to the public at a “reasonably affordable price,” any interested person may petition the government to override the patent and grant a license to another producer. The Novartis case was a direct challenge to Section 3(d) because the patent at issue was for the beta crystal form of the active ingredient in imatinib. Novartis argued that this form had better bioavailability than the base compound and that it was useful for formulating the marketed product. The Indian government rejected the patent application, arguing that these properties did not change the curative effect of the drug. In deciding in favor of the Indian government, the Indian Supreme Court interpreted the term efficacy in the statute to mean that a new form of an existing drug must demonstrate some improvement in therapeutic effect, when compared with the old form, to receive a patent—a standard not met by the heat stability nor the minor improvement in bioavailability. The Indian Supreme Court did not say categorically that better bioavailability may never result in a change in the curative effect of a drug. The court’s narrow ruling thus leaves the door open for manufacturers to make convincing arguments about secondary patents that do impart enhanced therapeutic efficacy. Such a conclusion will require case-by-case evaluations and is thus more complex from a jurisprudential point of view, but it is reasonable on public health terms to permit pathways toward useful incremental innovation. The most immediate practical effect of this ruling is that the more than 300 000 patients in India who use VIEWPOINT