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Evergreening of Patents with reference to the Novartis Case

Intellectual Property laws are one of the most complex laws that exist today. 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 right by obtaining patents over insignificant or trivial modifications of the invention.

India, in order to strengthen its patent regime and align it with the TRIPs agreement, introduced amendments to the Patent Act in 2005, with a special focus on the pharmaceutical industry. This was done in order to prevent the process of evergreening, a process whereby patents are extended without any enhancement in the therapeutic efficacy of the drug. This was also done in order to increase access of the public to patented drugs, by avoiding unnecessary protection to the inventors.

India’s commitment to stop the process of evergreening was reflected in the case of Novartis v. Union of India. However, the need of the hour is a balanced approach that serves public interest, and at the same time, protects the rights of inventors. This project seeks to analyse the practice of evergreening in the context of the Indian Patents Act and discusses the famous Novartis case, where the test of evergreening efficacy was laid down.

Introduction:
Evergreening is referred to the practice whereby pharmaceutical firms extend the patent life of a drug by obtaining additional 20-year patents for minor modifications or other iterations of the drug, without necessarily increasing the therapeutic efficacy. However it has become a practice in the pharmaceutical industry where on one hand innumerable patients struggling to afford the high priced patented drugs, while on the other hand innovators struggling to give immortal value to their creation.

A patent as described in the Indian Patent Act, 1970[1] refers to “a grant or a right to exclude others from making, using or selling ones invention and includes right to license others to make, use or sell it”. In the Webster’s Ninth New Collegiate Dictionary, it is defined as an official document conferring a right or a privilege, letters patent, writing securing to an inventor for a term of years the exclusive right to make, use and sell his invention, the monopoly or right granted. This monopoly right is given only for a certain number of years.

After the expiration of this duration, this right is taken away from them and the technology or the product becomes easily accessible to any other person and he may not earn any more profit from his own creation.

Section 3(d) of Chapter II of the Indian Patent Act, 1970 deals with what is not patentable; which reads “the mere discovery of a new form of a known substance or 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”. This provision aims to prevent ever greening and protect the genuine innovators.

How To Avert Evergreening:

Evergreening can be averted by:
  1. Not granting patents on the basis of trivial and insignificant changes in the original pharmaceutical patented product[2];
  2. 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:

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:
  1. 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 doesn’t form part of the state of the art. Section 2 (1) (l) therefore, deals with “absolute novelty”.
     
  2. 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.
     
  3. Section 3(d)[3] 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.

The Novartis Case:

The Swiss Pharma Company Novartis had filed a patent application 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.

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[4]. Out of the six oppositions filed, one was withdrawn, and other five were examined by the Controller.

After hearing the opponents, the Controller refused to grant the patent on the grounds that beta crystalline form of imatinib mesylate is the salt of a known substance and does not 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:
  1. First to challenge the orders of the Controller refusing the grant of the patent;
  2. Second to challenge the constitutional validity of Section 3(d) of the Patent (Amendment) Act, 2005.
     
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. 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 the TRIPS agreement and thus against the spirit of a binding International Treaty.
  • That by inserting Section 3 (d), the Government of India had violated its obligation under the 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. 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.

New Patent Regime India:

The Indian Patents (Amendment) Act, 2005 introduced product patents in India and marked the beginning of a new patent regime aimed at protecting the intellectual property rights of patent holders. The Act was in fulfillment of India’s commitment to the World Trade Organization (WTO) on matters relating to the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS).

The TRIPS agreement was compatible with the Indian Patents (Amendment) Act, 2005 and addressed few important issues regarding patents[5]:
  1. Adopting the definition of pharmaceutical substance;
  2. Exclusion of ‘mere discovery of new form of known substance’ and the ‘new use for a known substance’; and
  3. Manufacturing products which may be granted patent protection in the new regime.
Furthermore, the Act brought in a definition of the term ‘new invention’ and also introduced restrictions as to the scope of patentability under Section 3(d).

It is explicitly mentioned in Section 3(d) that patents would not be granted on the following grounds:
  1. The mere discovery of a known substance, which does not result in the enhancement of the known efficacy of that substance,
  2. The mere discovery of any new property or new use for a known substance, and;
  3. 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.

The Indian Patents (Amendment) Act 2005 was India’s final step towards attaining TRIPs compliance. It was an attempt to balance the competing interests of different stakeholders which include domestic generic manufacturers, civil society groups concerned with access to medicines, the research and development community, foreign multinational companies and the intellectual property lawyers.

However, this legislative effort had greater international significance because of introduction of pharmaceutical patents and the subsequent threats to an internationally famous generic industry that had so far, guaranteed the supply of affordable drugs. Hence, India while complying with the TRIPs agreement and introducing a product patent regime for new drugs that were invented, also added a safeguard enabling refusal of patents on discovery of new forms or new uses of old drugs (i.e. preventing ever-greening).

Conclusion:
The 2005 Amendment and the ruling in the Novartis case signals that India has chosen to adopt an IP regime that is in keeping with the spirit of WTO, but at the same time, makes a provision for inexpensive access to medicines by prohibiting patent ‘evergreening’. 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. However, the Novartis case is a landmark decision in upholding the spirit of Indian Patent Law to curb ‘evergreening’ of patents. 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.

End-Notes:
  1. Sushmita R., Introduction, EverGreening: An Abuse of the Patent System ( Mar.2, 2021,7:55 PM), https://www.lawctopus.com/academike/evergreening-an-abuse-of-the-patent-system/
  2. Shanti Kumar, Dr. Nitin Shukla, Tanushree Sangal, How to avert Evergreening, Evergreening of Patents and the Indian Patent Law (Mar.2, 2021, 10:31 PM), https://papers.ssrn.com/sol3/papers.cfm?abstract_id=1420003
  3. Shanti Kumar, Dr. Nitin Shukla, Tanushree Sangal, How to avert Evergreening, Evergreening of Patents and the Indian Patent Law (Mar.2, 2021, 10:31 PM), https://papers.ssrn.com/sol3/papers.cfm?abstract_id=1420003
  4. Shanti Kumar, Dr. Nitin Shukla, Tanushree Sangal, How to avert Evergreening, Evergreening of Patents and the Indian Patent Law (Mar.2, 2021, 10:31 PM), https://papers.ssrn.com/sol3/papers.cfm?abstract_id=1420003
  5. Sushmita R., New Patent Regime In India, EverGreening: An Abuse of the Patent System (Mar.2, 2021,10:49 PM), https://www.lawctopus.com/academike/evergreening-an-abuse-of-the-patent-system/

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