The mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant. Explanation: For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy.The plaintiffs (India’s Cancer Patients Aid Association, among others) argued that Novartis's application for a patent on a beta crystalline form of Gleevec could not meet the laws’s requirement that new form of a known substance (here, Gleevec) must be shown to have increased efficacy (therapeutic effectiveness). In a lengthy consideration of the various chemical properties that were changed in the beta form (such as bioavailability), the court nonetheless concluded that these properties had not been shown by Novartis to result in the increased efficacy ("the beta crystalline form of Imatinib Mesylate certainly cannot be said to possess enhanced efficacy over Imatinib Mesylate"). The pharmaceutical patent was denied for lack of invention (not new), inventive step (non-obvious), and failure to meet the specific standard set by Section 3(d) for a new form of a known substance. As a result, no patent can issue. The impact of this ruling will be to curtail attempts to evergreen patents on brand name pharmaceuticals in India as a means of blocking generic competition (e.g, India's Cipla and Natro can sell generic Glivec at about one-tenth the cost of the brand name Gleevec in India.) Because India is a leading international supplier of low-cost pharmaceuticals, the decision is likely to confine holders of brand name patents in India to exploitation of the initial term of patent, without the likelihood that extensions can be easily procured. The generics can enter the market more quickly. Although U.S. patent law does not have a specific "anti-evergreening" standard for drug patents, existing legal standards do prevent the patenting of obvious variations of known subject matter (35 U.S.C. Section 103) as well as a prohibition against double patenting when a successive and obvious patent application originates from the same inventive entity holding patent rights to dominant subject matter, a concept that is often applied in the context of drug patent litigation.
April 1, 2013
India's Supreme Court Validates Anti-Evergreening Patent Law in Denying Novartis Gleevec Patent
The Supreme Court of India issued a landmark patent ruling today regarding the patentability of a form of the Novartis biotechnology drug, Gleevec (Imatinib, a monoclonal antibody), used to treat leukemias. India is home to a significant generic drug industry that has supplied low-cost drugs worldwide. Prior to 2005, India's patent law did not allow patents on drug products (only on processes to produce them) and as a result, its generic industry was not constrained by any existing product patents in the country, and India became a generic powerhouse. As a result of India’s signing on to the TRIPS treaty in 1994 (Trade-Related Aspects of Intellectual Property, intended to achieve international patent harmonization), India was required to bring its patent law into compliance with respect to TRIPS patentable subject matter requirements (what can be patented). So as of 2005, pharmaceutical product patents became available. However, in drafting the new patent law extending protection to drug products, India, mindful of its position as a leading supplier of drugs around the world, decided to confront the potential for patent owners to conduct an “evergreening” of patent rights. Evergreening is a strategy whereby companies holding patents on brand name drugs, faced with the expiration of patent rights, apply for patents on new formulations of the active ingredient or on minor chemical variations in an effort to extend patent protection and frustrate generic competitors. The net effect can be to allow a company to obtain new patent rights on essentially the same drug, and to delay generic entry. In the 2005 redrafting of India's Patents Act, an anti-evergreening Section 3(d) was added: