INTRODUCTION
“Patents are the key to our technology; technology is the key to production.”
Franklin D. Roosevelt
One of the tools used by pharmaceutical industry to abuse patent law in India is EVERGREENING. Patent evergreening represents a legal concept which is also a business strategy used in health sector particularly by pharmaceutical companies to extend their control over the drug beyond legally prescribed ‘20 years-patent term’ to maintain their monopoly over that drug beyond the standard patent period. Through this practice companies in pharmaceutical industry file a secondary patent on minor modifications, new formulations, delivery systems, or applications of existing pharmaceutical compounds which is not genuine extension but an made up one to extend their monopoly on that particular drug. “Evergreening in a general sense refers to the extension of the duration of an existing temporary monopolistic or market dominant position by various means or strategies.”1 Because there is significant monetary benefit over a longer period of time from the previously established treatment due to patent evergreening, this creates incentives for strategic behavior within the pharmaceutical industry for not producing novel pharmaceutical solution and rely upon the increasing drug price which has far reaching effects on healthcare machinery worldwide. The misleading nature of patent evergreening is so prominent, because it undermines the fundamental purpose of patent system, that is monopolies of temporary nature in exchange for public disclosure. Due to these monopolies created by abusing the regulatory frameworks which affect the vulnerable population who are not able to afford these expensive medicines. Evergreening eventually creates barrier to access to affordable medicines, the generic version which should be available to them in public domain. The patent evergreening works against the basic and fundamental principle of social contract upon which patent laws came into being which is temporary monopoly which helps the inventors and after expiry of patent term the invention can made available in public domain. According to the World Health Organization’s comprehensive examination in 2021, the number of patent filings for genuinely new pharmaceutical innovations fell by 25% between 2010 and 2019, which points towards the diversion of resources by pharmaceutical companies from significant research which can help healthcare system, towards the minor modification which solely focuses towards extension of monopoly. This practice shows a major loophole in the innovation sector which promises that evergreening may promote innovation but in practice it may as well inhibit it.
INDIAN PATENT LAW AND ITS ANTI-EVERGREENING ASPECT
India’s response to this global challenge has been both pioneering and at times controversial. As a welfare state as reflected in preamble of its constitution, India is obligated to provide its citizens a basic healthcare facility. This obligation is rooted in article 212 of Indian constitution that talks about right to life and personal liberty, while explaining the scope of this article hon’ble supreme court of India in its many judgements held that right to health is integral part of right to life and personal liberty. Further support is found in Directive Principles of State Policy which are enshrined in Indian constitution they are the guidelines that government has to keep in mind while making legislative decision, they also talk about improving public health care system such as, article 383 which talks about that state should promote social welfare, article 414 says that there should be public assistance for sickness and disability, article 475 say that state should take initiative towards improving public health. Judicial pronouncement has also reinforced this interpretation, in judgment like, State of Punjab v Mohinder Singh Chawla6 honorable court held that right to health is integral to right to life, in another case Mohd. Ahmed(minor) v. Union of India7 court held that right to health include right to access to life saving drugs.
After recognizing the significant impact of evergreening on the people’s access to medicine. India implemented Section 3(d)8 of the Patents Act in 2005 as part of its compliance with the TRIPS Agreement9. This provision works on principle of “enhanced efficacy,”10 which creates the mandate on pharmaceutical industry to show enhanced efficacy before patenting any new forms of known substances, this step of Indian legislature shows its proactive approach towards combating pharmaceutical evergreening which is the most direct approach that is rarely adopted anywhere in the world.
This provision has become s benchmark in Indian patent jurisprudence, changing the basics upon which pharmaceuticals patents are evaluated and granted in world largest democracy. The importance of Section 3(d) has implications far beyond the Indian jurisdiction, many developing nations look towards India and observe its unique approach as welfare state in balancing both private and public interest by carefully adopting an appropriate approach towards the balancing of Intellectual property rights in such a way that it complements the public health and its welfare.
This provision has emerged as a benchmark through which the capabilities of developing countries are assessed in effectively utilising the flexibilities under the TRIPS Agreement to address evergreening, while simultaneously adhering to their international trade obligations.
INDIAN JUDICIAL APPROACH TOWARD EVERGREENING
• In the landmark judgment of Novartis AG v. Union of India11 the Supreme Court of India delivered the significant ruling which gave the world the Indian legal system stance upon the principle evergreening. Novartis, a pharmaceutical company, applied for a patent for an anticancer drug ‘Glivec’ to treat chronic myeloid leukemia and gastrointestinal stromal tumors on their invention of the beta crystalline salt form, imatinib mesylate. However, a pre-existing patent ‘ZIMMERMANN’ was registered in India, although the new application had nothing novel and it was understood that it was done only for monopoly and not for scientific and technological advancement. And it is mentioned in section3(d) of the act12 a mere variant is not considered an innovation unless it satisfies the requirement of enhanced efficacy. Thus, patent was denied on ground of no novelty in new patent.
• In Bishwanath Prasad v. H.M. Industries13 the Supreme Court of India held that basic principle kept in mind while granting a patent is that invention which is made should be new and useful, the focus is upon utility and novelty. It is important to notice that the invention should be new idea of inventor not any preexisting idea or any mere verification of known idea. The invention must be more than a mere workshop improvement.
• In E Hoffmann La Roche Ltd. v. Cipla Ltd14 decided by Justice Manmohan Singh. The conflict between intellectual property rights and public health can be seen in the dispute over the lung cancer drug Erlotinib. A pharmaceutical company had patented its version of the drug and sold it at a very high price, making it difficult for many patients to afford. Subsequently, India produced a generic version of the drug at a lower cost, making it more affordable. This resulted in a court battle, with the patent owner attempting to ban the sale of the generic version. But the court did not ban the generic drug, taking into account the public interest. This example shows that Indian courts may prioritize the need for affordable drugs over strict enforcement of patents, particularly in the context of life-threatening diseases.
CHALLENGES
The Indian approach towards evergreening of patent have many criticisms and challenges, some of them are given below –
• Pressure from multinational pharmaceutical companies– as section 3(d) of the Indian patent act make evergreening of patent super complicated and hard, so many big multinational pharmaceutical companies think twice before investing or introducing new drug in India as it will hamper their monetary benefit as India focus more on providing generic medicine to its citizen. Which creates unique challenge for Indian government regarding economic growth of nation.
• Complication in genuine innovation– It is very hard to ascertain that innovation which is made by the company in existing drug is an evergreening tactics or genuine efforts for improving the preexisting drugs. Because of such harshly regulated process of evergreening in Indian patent system it discourages companies from making any better innovation to existing drug.
• There is tussle between TRIPS regulation like free trade agreement which advocates for data exclusivity and section 3(d) of Indian patent act because at one end TRIPS advocate the companies’ data should be protected whereas section 3(d) and Indian legal system advocates of cheap generic medicine which is accessible to all.
• Administrative hurdles- Indian patent offices are not well equipped as countries in the west because of which it faces backlog and it is not well equipped for carrying out high
quality bio-examinations.
SUGGESTION AND PROSPECTS
• Enhanced determining criteria regarding evergreening- Indian patent office should scrutinize the new innovation in patent carefully so that essential and much needed patent can be given only.
• India as pharmacy of world- Indian government should work towards creating a hub for exporting generic medicine to developing nation as Indian evergreening law is drafted in a way which can help large number of people in developing nation also.
• Encouraging R&D and innovation- As India has created significant high bar for evergreening any patent, it incentivizes pharmaceutical companies for making better R&D so that new innovation in drug can be patented through Indian evergreening law.
• Role of judiciary- Indian judiciary is becoming more and more well equipped while giving decision regarding evergreening which show that Indian court are able to spot “Lifecyle management” tactics.
• Development of Indian local pharma sector- Due to such a strict patent regime Indian manufacturer are making high level of innovation to their products which is helping them in competing to international standards.
CONCLUSION
The investigation reveals that Indian legislature didn’t just device a section in from of section 3(d) of Indian Patent act,1970 not only for fulfilling technical basis but it represent the core value and principle of Indian legal system as it encourages the personal innovation, the intellectual property right over an innovation while making sure citizen of India have access to cheap and good quality of healthcare. All of this is made possible through well drafted provision on Indian patent act which put restriction over evergreening. Indian judicial system has been a guiding light for evergreening concept in India as time to time hon’ble supreme court of India has given decision and made sure that companies cannot create unnecessary monopoly and also made sure that only genuine innovation move forward so that public health need and innovation encouragement can happen side by side. Even though there a few critical points to Indian patent system but Indian as developing nation is moving forward in right direction and its being successful in achieving its dual objective of public welfare and encouraging private inventions.
*****
Footnotes
1. Ove Granstrand & Frank Tietze, “IP strategies and policies for and against evergreening”, 1 Centre for Technology Management Working Paper Series 4,(2014).
2. INDIA COST. art. 21 .
3. INDIA COST. art. 38.
4. INDIA COST. art. 41.
5. INDIA COST. art. 47.
6. State of Punjab v Mohinder Singh Chawla, AIR 1997 SC 1225.
7. Mohd. Ahmed(minor) v. Union of India, 2014 SCC OnLine Del 1508.
8. Indian patent act,1970 , No. 39 , Act of parliament, 1970 (India) .
9. Agreement on Trade-Related Aspects of Intellectual Property Rights, Apr. 15, 1994, Marrakesh Agreement Establishing the World Trade Organization, Annex 1C, 1869 U.N.T.S. 299, 33 I.L.M. 1197 (1994)
10. Novartis AG v. Union of India, Novartis AG, 2013 (6)SCC 1.
11. Novartis AG v. Union of India, Novartis AG, 2013 (6)SCC 1.
12. Indian patent act,1970 , No. 39 , Act of parliament, 1970 (India) .
13. Bishwanath Prasad v. H.M. Industries, A.I.R. 1982 S.C. 144.
14. E Hoffmann La Roche Ltd. v. Cipla Ltd, (2015) SCC Online Del 13619, RFA(OS) 92/2012 and 103/2012.