NOVARTIS AG V. UNION OF INDIA: WHY THE COURT'S NARROW INTEPRETATION OF ENHANCED EFFICACY THREATENS DOMESTIC AND FOREIGN DRUG DEVELOPMENT

By Tarsa, Kevin | Boston College International and Comparative Law Review, January 1, 2016 | Go to article overview

NOVARTIS AG V. UNION OF INDIA: WHY THE COURT'S NARROW INTEPRETATION OF ENHANCED EFFICACY THREATENS DOMESTIC AND FOREIGN DRUG DEVELOPMENT


Tarsa, Kevin, Boston College International and Comparative Law Review


Introduction

In April 2013, the Supreme Court of India upheld the Indian Patent Office's rejection of Novartis's patent application for the final form of its therapeutic drug Gleevec.1 Gleevec, which comprises the beta crystalline form of a chemical compound called imatinib mesylate, is a drug that treats chronic myeloid leukemia and certain tumors.2 In deciding whether to grant Novartis a patent, the Supreme Court of India faced tremendous pressure to satisfy competing interests: encouraging scientific innovation and making life-saving drugs available to the world's neediest citizens.3 On the one hand, the court was urged to promote scientific research and development by affording monopolistic protection to the producers of novel drugs, in keeping with India's obligations under international treaties. 4 On the other hand, nongovernmental organizations and legal-aid societies implored the court to protect India's generic drug producers and thus maintain India's status as the "pharmacy of the world."5

Novartis AG v Union of India is significant because it tests the ambit and purpose of the Indian Patents (Amendment) Act of 2005 (2005 Amendment).6 One of the core issues of the case is whether, under Section 3(d) of the 2005 Amendment, the final version of Gleevec enhances the "known efficacy" of the previous form of the drug.7 Novartis contended that Section 3(d) was immaterial to the case, but the court did not find this argument persuasive.8 It ruled that Section 3(d) serves as an additional bar for drugs to clear in order to prevent "evergreening," the practice of making trivial changes to an existing product simply to extend the patentee's exclusive rights over the product.9

Part I of this Comment provides background on the facts of Novartis AG, the history of Indian patent law, and procedural history of the legal proceedings in India. Part II discusses the statutory provisions at issue in the case, the court's analysis of these issues, and its holding. Part III critiques the court's narrow interpretation of enhanced efficacy, analyzes the court's poor understanding of evergreening, and explains why Novartis AG has created uncertainty for drug producers seeking secondary patents in the future.

I. Background

A.Novartis Obtains Patent for Gleevec in the United States

On May 28, 1996, a medicinal chemist named Jürg Zimmermann received a U.S. patent for a number of chemical derivatives (the "Zimmermann patent")-including the compound imatinib, which can be used to create antitumoral drugs.10 Nearly five years later, the U.S. Food and Drug Administration (FDA) approved Gleevec in the form of 50- and 100-milligram capsules, which used imatinib mesylate as their active ingredient.11 Shortly thereafter, Gleevec hit the market on the basis of the Zimmermann patent.12

On January 18, 2000, Novartis applied for a U.S. patent for the beta crystalline form of imatinib mesylate.13 The patent examiner initially rejected Novartis's application, but, on appeal, the Board of Patent Appeals and Interferences reversed the patent examiner's decision.14 The board determined that although the Zimmermann patent teaches any person skilled in the art how to use imatinib in a pharmaceutical product to treat tumors, it does not explain how to use the beta crystalline form to do so.15 Thus, Novartis's development of the beta crystalline form in a pharmaceutical composition constituted a "manipulative step"16 in the treatment of tumor disease.17 Consequently, the U.S. patent board granted Novartis a patent for the beta crystalline form on May 17, 2005. 18

B.Novartis Seeks Patent for Gleevec in India

Novartis filed a patent application for the beta crystalline form of imatinib mesylate on July 17, 1998, in the Chennai Patent Office.19 Novartis claimed that its product was superior to imatinib mesylate in its free-base form for a variety of reasons, including that it stored better and was easier to process. …

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