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| Evergreening Is A Shameful of Pharmaceuticals Industries | |||||||
| Paper Id :
15864 Submission Date :
11/03/2022 Acceptance Date :
20/03/2022 Publication Date :
25/03/2022
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| Abstract | India is a developing country with a large population of the world, So it becomes more important to pay attention to the problem, while for the production of generic drugs, domestic and foreign big pharmaceutical companies in the pharma industry through patent law to make more profit. After twenty years, to get a new patent on the old drugs, they make big profits by making small changes in their chemical formula or changing the color and repackaging the old medicine in new packaging for the next twenty years instead of repackaging them at expensive prices. The question is, Is it necessary to ban monopoly of this pharma industry in a developing country like India and why? Regarding these questions, how much will Section 3 (d) of the Patent Act 1970 Amendment Act 2005 prove to be helpful? | ||||||
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| Keywords | Evergreening, Generic medicines, Therapeutic Efficacy. | ||||||
| Introduction |
Good health protection is a fundamental right of every citizen under Article 21 of the Constitution of India and the right to international and Thai health according to Article 25(1) of the Universal Declaration of Human Rights "Everyone shall have a right to health and well-being of himself and his family." There is an important right to an adequate standard of living, including the need for medical care. Under social services - "International Convention on Economic, Social and Cultural Rights (ICESCR) Article 12(1) everyone has the right to "enjoy the highest attainable standard of physical and mental health". Section 52 of the Thai Constitution (2007) “All mankind have an equal right to access to quality public health care”. ‘Double patenting’ is prohibited. That is to say the same invention cannot be covered by more than one patent. [1] In this sequence, India has tried to give importance under Section 3 (d) of the Patent Amendment Act 2005, according to which- “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” [2]
Meaning of Evergreening- Evergreening is the practice whereby pharmaceutical firms extend the patent life of a drug by obtaining additional 20-year patents for minor reformulations or other iterations of the drug without necessarily increasing the therapeutic efficacy for patients.
Benefits of Evergreening to patent holders- Evergreening allows pharmaceutical companies to obtain or extend monopoly protection for old drugs simply by making minor modifications to existing formulations or dosages, or by identifying a new therapeutic use for an existing medicine. |
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| Aim of study | Analysis the effect of Indian Patent Law Section 3(d) on Evergreening involved in pharma industry. Objectives- 1. The proposed research work would examine the viability of existing law. 2. The proposed research work would suggest the new legal regime in the light of Intellectual property right of Indian law concerning Evergreenig. 3. To find out contribution to the progress of science and technologies. 4. To find out perfeet the legal protection of generic Pharma Industry for new invention. 5. To observed balance between patients and patents, and prescribed a solution for these problems. | ||||||
| Review of Literature |
Intellectual property laws are one of the most important complex laws that exist these days. India introduced an amendment to the Patent Act in 2005 to strengthen its patent regime and align it with other agreements, with a special focus on the drug trade. It was an order terminated to stop the process of evergreens, a process that has been extended to the medical world of patenting drugs without any sweeteners. It provides an additional efficient mechanism to bar patent recipients from releasing generic products. It is not enough to describe the problems caused by strict patent laws or the perpetuity of patents. It is also important to go over the answers to these questions. The need is to strike a balance between patent laws and their extension, while keeping a stipulation for proprietary medicine, so that they are cheap by the people of India. There are several ways this will help reduce the cost of proprietary drugs. (Shushmita R, Christ law college Bangalore, Evergreening; An abuse of the patent system,16 Jan 2015). “The patent system, all the way back to the Statute of Monopolies [a British act passed in 1624], recognizes that it is good for the economy to encourage people to take these risks and to bring new things forward. (Drug patents: the Evergreening problem, Rogar collier 2013 Jun 11).Evergreening of pharmaceutical patents has emerged as a serious challenge for access to affordable drugs as it aims to delay the generic competition by extending the length of the exclusivity period beyond the legitimate patent term without any considerable improvement in therapeutic benefits of the already patented pharmaceutical drug. This paper endeavors to question the legitimacy of the Evergreening of pharmaceutical patents.( Evergreening of pharmaceutical patents: A blithe disregard for the rational e of the patent system, Muhammad Z Abbas 16, May2019). |
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| Methodology | In this research, the information obtained through library, primary and secondary data has been described by compiling the views, opinions and advice of the researcher / authors / thinker. Overall design is rigid, research environment formal, some flexibility, cost medium, findings conclusive, statistical design planed access to the nature of research. It Characteristics is marked by prior formulation of specific hypothesis, preplan and structured design with secondary and primary sources of data and date. The data analyzed with qualitative method. |
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| Findings | 1. Indian patent law Section 3(d) and Problem of Pharma Industry- Section 3(d), as introduced in April 2005 into the Indian patent law, represents a unique requirement to be fulfilled for patentability of certain types of pharmaceutical inventions. That is, unless there is a suitable new invention in a newly known substance, it is not possible to recognize it under this section; it cannot be considered a new discovery. India had granted Novartis the approval to market Glivec in 2001 but in faced a new challenge in 2005 when the Indian patents Amendment act was enacted and India accepted a global regime that guarantees a 20 year patent protection for new drugs. In 2006 Novartis case, the Indian patent office ruled that the new substance form did not deserve a new patent, since it did not meet the provision of “increased efficacy” required under Sec. 3(d). At that time Mr. Ranjeet Sahani managing director Novartis India was says Investor wants returns but Indian intellectual property environments is unfavorable in India so big pharma would not want to invest in India. But Mr. YK Hamid, chairman Cipla was says we are pleased with judgment which prevents the use of frivolous patents to deny assess to medicines for patients. The concluding statements was forward Mr. Anand Sharma, Commerce and industry Minister "the historic judgment reaffirms the position of Indian law.....which mandate needs substantive innovation (for granting) a fresh patent. [3] But in fact on one hand we have a large number of companies who have invested billions in research, in developing new molecules, in new drug discoveries and in research. On the other hand, there is a social obligation to provide affordable and cheap drugs and healthcare. We have to strike the right balance. 2. IPAB- (stands for Intellectual Appellate Tribunal Board, It works under the ministry of commerce and industry) also rejected the Novartis’s claim. The IPAB had upheld the contention of the Indian Patent Office that the drug, Glivec, is simply a new form of Imatinib and hence not patentable as per Section 3 (d) of Indian Patent Act. With the formation of the 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 were heard and the decision was reserved. In the writ challenging the constitutional validity of Section 3(d) of the Indian Patent Act, Novartis made the following submissions: • That the provisions of Section 3(d) were inconsistent with Article 27 of TRIPS and thus against the terms of a binding international treaty. • That by inserting section 3(d) the Government of India had breached its obligation under the TRIPS Agreement. Hence the stream should be declared null and void. • That there is no guideline under section 3(d) with respect to words like "increased efficacy" or "significant difference in qualities with respect to efficacy". This clause gives the controller arbitrary powers to reject patent applications and therefore violates the right to equality under Article 14 of the Indian Constitution. [4] 3. Functional/Therapeutic Efficacy- In 2007 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] On consideration of the above submission, the High Court held that it has no jurisdiction to decide the validity of Section 3(d). In this regard, the Court relied on the decision of the Salmon v Commissioner of Customs and Eller man Lines Ltd., and upheld the argument that when a domestic law is challenged on the ground of breach of an international treaty, the domestic courts have there is no jurisdiction to decide on this issue. The court further said that the proper mechanism is to settle the dispute only under the international treaty. Madras High Court had in 2007 held that the appropriate route to challenge non-compliance with TRIPS is the WTO Dispute Settlement Body and not the Indian courts, Then Novartis moved the case to Supreme Court in 2009. It is important to note that the Supreme Court did indeed clarify that Section 3(d) does not bar patent protection for all incremental inventions of chemical and pharmaceutical substances, provided they pass the test of the expanded scope of Section 3(d) and in 2013 Supreme Court Denied the Patent of this company product. In India, about 2, 00, 000 people suffer from chronic myeloid leukemia and about 30,000 are added every year. After this judgment, the prices of the drug will remain low, all these people would benefit. 4. What is the Pranab Sen Task Force on Drug Pricing all about?-In 2003 Supreme Court passed an order that all essential drugs should remain under price control. Therefore, Government of India set up a Task Force under Dr. Pronab Sen on drug pricing. It submitted its final report in 2005. 5. Roll of TRIPS (Trade related Aspects of intellectual property right) in Pharma Industry- The Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) is an international agreement administered by the World Trade Organization (WTO) that sets down minimum standards for many forms of intellectual property (IP) regulation as applied to nationals of other WTO Members. TRIPS Article 27.1 requires that “patents shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application. TRIPs Flexibilities- Provisions in the TRIPs agreement that allows countries to break or work around patents Ways to break patents/achieve lower drug costs: a) Price Negotiations b) Voluntary Agreements c) Patentability Standards d) Exceptions to Patent Rights e) Parallel Importation f) Patent Challenges g) Compulsory licensing: Government use/Noncommercial use of patents 6. Compulsory/Statutory license; issuing for public welfare don’t for earn profit - Under the TRIPS (Trade related Aspects of intellectual property right) to which India is a signatory nation can grant compulsory license to make generic if they feel most people cannot afford the patented drugs. A compulsory license, also known as statutory license or mandatory collective management, provides that the owner of a patent or copyright licenses the use of their rights against payment either set by law or determined through some form of arbitration. In essence, under a compulsory license, an individual or company seeking to use another's intellectual property can do so without seeking the rights holder's consent, and pays the rights holder a set fee for the license. In March 2012, India granted its first compulsory license ever. The license was granted to Indian generic drug manufacturer Natco Pharma Ltd for Sorafenib tosylate, a cancer drug patented by Bayer. | ||||||
| Conclusion | The present study is designed to analyze the evergreen validity of pharmaceutical patents from a competition law perspective. By reviewing the elements needed to make this analysis, in particular the pharmaceutical sector, jurisprudence and competition law, it is the author's collaborative expectation that the reader has acquired an understanding of the objectives of the pharma industry's competitive policy. Should be taken into account after Whether or not explicit conduct constitutes cooperative abuse. The results of this study suggest that to date, once Evergreening is legally linked, it cannot fully confirm a dominant position being abused unless explicitly stated in the law. The quality of such collaborative evaluation, combined with the absence of case law, leads to the conclusion that the legal position is unclear. At the very least, some comments and suggestions will be made that may be helpful in creating a test to draw the road between once legal use and illegal abuse. | ||||||
| Suggestions for the future Study | 1. A health sensitive system ought to permit governments to act expeditiously in cases of emergencies together with pandemic crises. 2. The govt. ought to produce a framework for pharmaceutical patenting, particularly regulation access to life saving medicine. 3. Recognizing its international obligations, every country ought to form its jurisprudence in step with its socio-economic wants and objectives within the interest of public health. 4. The pliability of mandatory licensing ought to be extremely exercised within the developing and least developed countries. Easier procedure ought to be devised for grant of mandatory license. |
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| References | 1. Is ‘Evergreening’ a cause for concern? A legal perspective Scott Parker and Kevin Mooney Date Received (in revised form): 7th August, 2007 and Indian patent act 1970.
2. MINISTRY OF LAW AND JUSTICE (Legislative Department) New Delhi, the 5th April, 20051Chaitra 15,1927 (Saka) TIIE PATENTS (AMENDMENT) ACT, 2005 No. 15 OF 2005 An Act further to amend the Patents Act, 1970. [4thAprii, 2005;]
3. Source-http://swapsushias.blogspot.com/2014/02/decoding-novartis-natco-pharma-issue.html
4. Evergreening of Patents and the Indian Patent Law Authors: Shanti Kumar, Dr. Nitin Shukla, Tanushree Sangal.
5. http://www.cmaj.ca/cgi/content/full/175/12/1508.
6. Shushmita R, Christ law college Bangalore, Evergreening; An abuse of the patent system,16 Jan 2015
7. Drug Patents: the Evergreening Problem, Rogar collier 2013 Jun 11
8. Evergreening of pharmaceutical patents: A blithe disregard for the rational of the patent system, Muhammad Z Abbas 16, May 2019 |
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