Evergreening of Patents and the Indian Patent Law Authors: Shanti Kumar, Dr.

Nitin Shukla, Tanushree Sangal Abstract: Inventive activity necessitates dissemination of information across the spectrum of intellectual provenance, to ensure advancement in research and development. The disclosure requirement in case of patents fulfills this very purpose. Obtaining monopoly over an invention is subject to the disclosure requirement, whereafter the monopoly rights can be exercised for the term of the patent. However, there are attempts to unjustifiably stretch this monopoly by obtaining patents over insignificant or trivial modifications of the invention. This paper seeks to analyse the practice of evergreening in the context of Indian Patents Act and discusses the famous Novartis case, where the test of evergreening efficacy was laid down. Introduction: The grant of a patent is based on the premise of full disclosure by the patentee of the best method of performing the invention so that the others are able to use the invention after the expiry of patent rights. However, sometimes, this patent protection is sought to be extended indefinitely by the Patentee through the practice of . Evergreening in case of pharmaceutical products refers to seeking patent protection for derivatives of a patented drug, resulting from trivial or insignificant changes, at the time of expiry of the patent so as to extend the existing monopoly over the drug. In the words of Federal Court of Appeal, it is like adding bells and whistles to the original products. Evergreening also results from a new use of a known substance. A form of evergreening occurs when the original manufacturers Stockpile patent protection by obtaining separate patents on multiple attributes of a single product. These patents can cover everything, right from manufacturing aspect to tablet colour, or even a chemical produced by the body when the drug is ingested and metabolized by the patient. How to avert Evergreening: Evergreening can be averted by: (i) (ii) Not granting patents on the basis of trivial and insignificant changes in the original pharmaceutical patented product; Ensuring that generic manufactures can manufacture the patented pharmaceutical product soon after the term of patent expires, by making use of Bolar provision.

Indian Patents Act and Evergreening

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To prevent the grant of patents to trivial and insignificant pharmaceutical inventions, the following provisions have been introduced under the Indian Patents (Amendment) Act, 2005: (i) Section 2 (1) (l) deals with new invention, which means any invention or technology which has not been anticipated by publication in any document or used in the country or elsewhere in the world before the date of filing of the application with complete specification, i.e., the subject matter has not flown in public domain or that it doesnt form part of the state of the art. Section 2 (1) (l) therefore, deals with absolute novelty. Accordingly it will be very difficult for patentees to obtain patents on trivial or insignificant changes in their earlier patents. (ii) Section 2 (1) (ja) defines inventive step which means those features of invention that involve technical advancement as compared to existing knowledge, or that have economic significance or both and which make the invention not obvious to a person skilled in the art. The basic principle behind this section is to allow only the inventions, which are not obvious. Accordingly, trivial or insignificant changes in earlier patents will not be permissible. (iii) Section 3(d) aims at preventing evergreening and denies patent cover to pharmaceutical inventions with trivial or insignificant changes, unless they result in enhancement of efficacy of a known substance. Section 3 (d) also prevents new use of known substances.

Section 3 (d) is reproduced below: 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 properly; or New use of a know substance; or The mere use of a know process, machine or apparatus unless such known process result in a new product or employs at least one new reactant. Explanation: For the purposes of this clause, salts, esters, ethers, polymorphs, metabolized, pure form, particle size, isomers, mixtures of isomers, complexes, combination and other derivatives of know substances shall be consider to be the same substances, unless they defer significantly in properties with regard to efficacy.

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Examples: 1. Sildenafil Citrate was originally discovered as a cardio vascular agent and patented by Pfizer. Later, its second medical use in treating impotence was also found. Even though second medical use patents are allowed in UK, it was refused by EPO owing to obviousness determined by articles published in journals. In India, second medical use is prevented by Section 3 (d). 2. Griseofulvin is an effective agent for fungal infections of skin to be applied locally. Later, it was found that if the dimensions of the particles of the drug were reduced, it could be used orally. This change in physical form of Griseofulvin is patentable as it shows increased functional efficacy. 3. New use of a known Compound: Minexodil is a drug used for hypertension. Recently it has been found that it can be used for hair growth, this new use is not patentable. (iv) To further limit the range of pharmaceutical inventions, the Indian Patents Act bars a method of medical treatment and product of nature from patentability vide Sections 3(i) and 3 (c). The German Patent Law ensures that patent monopoly on gene sequences is limited to only the specific function disclosed. This rule is also followed by the Indian Patent Office. Further, recently the Patent Office struck down the attempts of evergreening by multinationals and rejected a series of applications on the grounds that they were mere modifications or extensions of known substances. These include Pfizer's Caduet (cholesterol and hypertension), GlaxoSmithKline's rosiglitazone salt (diabetes), Gilead Science's Tamiflu (bird flu) and Hepsera (Hepatitis B).1-4 The Indian position on evergreening is best exemplified by the Novartis-Glivec case which has been the centre of debates in patent circles. Novartis Lost Efficacy test The Swiss Pharma Company Novartis had filed a patent application no. 1602/MAS/1998 for beta-crystalline form of imatinib mesylate (commonly known as Glivec), at Chennai Patent Office India on July 17, 1998. While the examination of the application was still pending, Novartis filed a suit against Indian companies producing and marketing generic version of cancer drug imatinib. The company was granted interim relief as one of first exclusive marketing rights (EMR) in India. It is noteworthy that soon after the grant of EMR the price of the drug Glivec increased from $230/= to $2740/=

After the Indian Patents (Amendment) Act 2005 came into force, the application was examined under the provisions of said Act during which six independent pregrant oppositions were filed against it under Section 25 (1) of Indian Patents Act, 2005. Of the six oppositions filed one was withdrawn, and other five were examined by the Controller. After hearing the Opponents, Controller refused to grant the patent on the grounds that beta crystalline form of imatinib mesylate is the salt of known substance and doesnt show any increase in efficacy as required under section 3(d). Aggrieved by the decisions of the Controller, Novartis filed two writ petitions in the Madras High Court: (i) (ii) First to challenge the orders of the Controller refusing the grant of the patent; Second writ to challenge the constitutional validity of Section 3(d).

Contentions of Novartis and the stance of Madras High Court With the constitution of Intellectual Property Appellate Board (IPAB) in 2003, the Madras High Court transferred the first five writ petitions to IPAB, Chennai for disposal. The said appeals have been heard and judgment reserved. With respect to writs challenging the constitutional validity of section 3(d) of the Indian Patents Act, Novartis made the following submissions : That the provisions of section 3(d) were inconsistent with article 27 of TRIPS and thus against the sprit of a binding International Treaty. That by inserting section 3 (d), the Govt. of India had violated its obligation under TRIPS agreement. Accordingly, the section should be declared null and void. That there is no guideline in respect of the words like enhancement of efficacy or differ significantly in properties with regard to efficacy under section 3 (d). The section confers arbitrary powers on the Controller to refuse patent applications and hence violates the right to equality under Article 14 of the Indian Constitution.

On consideration of the above submissions, the High Court held that it had no jurisdiction to decide the validity of Section 3 (d). In this connection, the Court relied on Salmon v Commissioner of Custom and Ellerman Lines limited and upheld the reasoning that when a domestic law is challenged on the ground of violating an International Treaty, the domestic courts have no jurisdiction to decide on the issue. The Court further said that there is a dispute settlement mechanism under the International Treaty itself. On the ground of ambiguity under section 3 (d) and conferring absolute discretion to the Controller with regard to deciding patentability, the Court held that the amended section 3 (d) with the explanation has laid down a test to show whether the invention has resulted in the enhancement of the known efficacy of the substance. The Court also clarified the meaning of efficacy. It said that the patent applicant has to show how effective the new invention would be in healing a disease. Thus the meaning of efficacy was equated with therapeutic effect in the body. The patent applications must

show an enhanced therapeutic effect in order to obtain a patent for a new form of a known substance or for its derivatives. The court also held that the amended section 3 (d) cannot be said to be vague or ambiguous. On the ground of arbitrary power conferred on to the Controller, the Court held that firstly, the Controller has the technical expertise and training to decide the patentability of the application on the ground of efficacy and secondly, he has to issue a reasoned order. Hence, an appeal could be preferred by the aggrieved party against the order of the Controller. Moreover, mere possession of discretionary power cannot be a ground for declaring the section null and void. It cannot be assumed that the authorities will administer the law with an evil eye and an unequal hand. In the light of above observation, it was held that section 3 (d) of the Patent (amendment) Act 2005 does not violate Article 14 of the Indian Constitution. Conclusion : Madras High Court for the first time interpreted the word efficacy as functional/therapeutic efficacy and impeded the misuse of patent rights through evergreening. There have been landmark decisions worldwide, to support the curtailing of evergreening.5 However Novartis case is a landmark decision in upholding the spirit of Indian Patent Law to curb evergreening of patents. This case has clarified the bar imposed on evergreening by section 3(d) and has elaborated on the criterion of efficacy. More decisions in future may further elucidate the efficacy criterion and lay down a proper guideline to discern trivial inventions from genuine ones. Such clarity in law is desirable to encourage uninhibited transmission of knowledge and information in order to ensure progression through the employment of inventive activity. This necessitates preventing a patentee from exercising exclusivity to produce and market a substance that should ordinarily lie in the public domain. References: 1. http://www.dancewithshadows.com/pillscribe/india-rejects-patents-for-pfizerscaduet-gsks-rosiglitazone-salt/. 2. http://www.dancewithshadows.com/pillscribe/india-rejects-patents-for-gileadsadefovir-hespera-roches-erlotinib-tarceva-salts/. 3. http://economictimes.indiatimes.com/News/News-By-Industry/Healthcare-Biotech/Pharmaceuticals/Glaxo-Pfizers-patent-claims-turneddown/articleshow/4432350.cms. 4. http://economictimes.indiatimes.com/News/News-By-Industry/Healthcare-Biotech/Pharmaceuticals/Gileads-Hepatitis-patent-plearejected/articleshow/4473819.cms. 5. http://www.cmaj.ca/cgi/content/full/175/12/1508.