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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 bestmethod of performing the invention so that the others are able to use the invention afterthe expiry of patent rights. However, sometimes, this patent protection is sought to beextended indefinitely by the Patentee through the practice of . Evergreening in case ofpharmaceutical products refers to seeking patent protection for derivatives of a patenteddrug, resulting from trivial or insignificant changes, at the time of expiry of the patent soas to extend the existing monopoly over the drug. In the words of Federal Court ofAppeal, it is like adding bells and whistles to the original products. Evergreening alsoresults from a new use of a known substance.

A form of evergreening occurs when the original manufacturers Stockpile patentprotection by obtaining separate patents on multiple attributes of a single product. Thesepatents can cover everything, right from manufacturing aspect to tablet colour, or even achemical produced by the body when the drug is ingested and metabolized by the patient.

How to avert Evergreening:

Evergreening can be averted by:

(i) Not granting patents on the basis of trivial and insignificant changes in theoriginal pharmaceutical patented product;

(ii) Ensuring that generic manufactures can manufacture the patentedpharmaceutical product soon after the term of patent expires, by making useof 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 ortechnology which has not been anticipated by publication in any document orused in the country or elsewhere in the world before the date of filing of theapplication with complete specification, i.e., the subject matter has not flownin 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 willbe very difficult for patentees to obtain patents on trivial or insignificantchanges in their earlier patents.

(ii) Section 2 (1) (ja) defines inventive step which means those features ofinvention that involve technical advancement as compared to existing

knowledge, or that have economic significance or both and which make theinvention not obvious to a person skilled in the art.

The basic principle behind this section is to allow only the inventions, whichare not obvious. Accordingly, trivial or insignificant changes in earlier patentswill not be permissible.

(iii) Section 3(d) aims at preventing evergreening and denies patent cover topharmaceutical inventions with trivial or insignificant changes, unless theyresult in enhancement of efficacy of a known substance. Section 3 (d) alsoprevents 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 inthe enhancement of the known efficacy of that substance;

orThe mere discovery of any new properly;

orNew use of a know substance;

orThe mere use of a know process, machine or apparatus unless such known processresult 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 thesame substances, unless they defer significantly in properties with regard toefficacy.

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Examples:

1. Sildenafil Citrate was originally discovered as a cardio vascularagent and patented by Pfizer. Later, its second medical use in treatingimpotence was also found. Even though second medical use patents are

allowed in UK, it was refused by EPO owing to obviousness determinedby articles published in journals. In India, second medical use is preventedby Section 3 (d).

2. Griseofulvin is an effective agent for fungal infections of skin to beapplied locally. Later, it was found that if the dimensions of the particlesof the drug were reduced, it could be used orally. This change in physicalform of Griseofulvin is patentable as it shows increased functionalefficacy.

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 hairgrowth, this new use is not patentable.

(iv) To further limit the range of pharmaceutical inventions, the Indian Patents Actbars a method of medical treatment and product of nature frompatentability vide Sections 3(i) and 3 (c).

The German Patent Law ensures that patent monopoly on gene sequences islimited to only the specific function disclosed. This rule is also followed bythe Indian Patent Office.

Further, recently the Patent Office struck down the attempts of evergreening bymultinationals and rejected a series of applications on the grounds that they were meremodifications or extensions of known substances. These include Pfizer's Caduet(cholesterol and hypertension), GlaxoSmithKline's rosiglitazone salt (diabetes), GileadScience's Tamiflu (bird flu) and Hepsera (Hepatitis B).1-4 The Indian position onevergreening is best exemplified by the Novartis-Glivec case which has been the centreof debates in patent circles.

Novartis Lost Efficacy test

The Swiss Pharma Company Novartis had filed a patent application no. 1602/MAS/1998for beta-crystalline form of imatinib mesylate (commonly known as Glivec), at ChennaiPatent Office India on July 17, 1998. While the examination of the application was stillpending, Novartis filed a suit against Indian companies producing and marketing genericversion of cancer drug imatinib. The company was granted interim relief as one of firstexclusive marketing rights (EMR) in India. It is noteworthy that soon after the grant ofEMR the price of the drug Glivec increased from $230/= to $2740/=

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After the Indian Patents (Amendment) Act 2005 came into force, the application wasexamined under the provisions of said Act during which six independent pregrantoppositions were filed against it under Section 25 (1) of Indian Patents Act, 2005. Of thesix 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 doesntshow any increase in efficacy as required under section 3(d). Aggrieved by the decisionsof the Controller, Novartis filed two writ petitions in the Madras High Court:

(i) First to challenge the orders of the Controller refusing the grant of the patent;(ii) 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 writschallenging the constitutional validity of section 3(d) of the Indian Patents Act, Novartismade the following submissions :

That the provisions of section 3(d) were inconsistent with article 27 of TRIPS andthus against the sprit of a binding International Treaty.

That by inserting section 3 (d), the Govt. of India had violated its obligation underTRIPS agreement. Accordingly, the section should be declared null and void.

That there is no guideline in respect of the words like enhancement of efficacyor differ significantly in properties with regard to efficacy under section 3 (d).

The section confers arbitrary powers on the Controller to refuse patentapplications and hence violates the right to equality under Article 14 of the IndianConstitution.

On consideration of the above submissions, the High Court held that it had no jurisdictionto decide the validity of Section 3 (d). In this connection, the Court relied on Salmon vCommissioner of Custom and Ellerman Lines limitedand upheld the reasoning that whena domestic law is challenged on the ground of violating an International Treaty, thedomestic courts have no jurisdiction to decide on the issue. The Court further said thatthere is a dispute settlement mechanism under the International Treaty itself.

On the ground of ambiguity under section 3 (d) and conferring absolute discretion to theController with regard to deciding patentability, the Court held that the amended section3 (d) with the explanation has laid down a test to show whether the invention has resultedin the enhancement of the known efficacy of the substance.

The Court also clarified the meaning of efficacy. It said that the patent applicant has toshow how effective the new invention would be in healing a disease. Thus the meaning ofefficacy was equated with therapeutic effect in the body. The patent applications must

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show an enhanced therapeutic effect in order to obtain a patent for a new form of aknown 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 ofthe 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 theController. Moreover, mere possession of discretionary power cannot be a ground fordeclaring the section null and void. It cannot be assumed that the authorities willadminister the law with an evil eye and an unequal hand. In the light of aboveobservation, it was held that section 3 (d) of the Patent (amendment) Act 2005 does notviolate Article 14 of the Indian Constitution.

Conclusion :

Madras High Court for the first time interpreted the word efficacy asfunctional/therapeutic efficacy and impeded the misuse of patent rights throughevergreening. There have been landmark decisions worldwide, to support the curtailingof evergreening.5 However Novartis case is a landmark decision in upholding the spirit ofIndian Patent Law to curb evergreening of patents. This case has clarified the barimposed on evergreening by section 3(d) and has elaborated on the criterion ofefficacy.

More decisions in future may further elucidate the efficacy criterion and lay down aproper guideline to discern trivial inventions from genuine ones. Such clarity in law isdesirable to encourage uninhibited transmission of knowledge and information in order toensure progression through the employment of inventive activity. This necessitatespreventing a patentee from exercising exclusivity to produce and market a substance thatshould ordinarily lie in the public domain.

References:

1. http://www.dancewithshadows.com/pillscribe/india-rejects-patents-for-pfizers-caduet-gsks-rosiglitazone-salt/.

2. http://www.dancewithshadows.com/pillscribe/india-rejects-patents-for-gileads-adefovir-hespera-roches-erlotinib-tarceva-salts/.

3. http://economictimes.indiatimes.com/News/News-By-Industry/Healthcare--Biotech/Pharmaceuticals/Glaxo-Pfizers-patent-claims-turned-down/articleshow/4432350.cms.

4. http://economictimes.indiatimes.com/News/News-By-Industry/Healthcare--Biotech/Pharmaceuticals/Gileads-Hepatitis-patent-plea-rejected/articleshow/4473819.cms.

5. http://www.cmaj.ca/cgi/content/full/175/12/1508.

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