Curbing Drug Evergreening Using Competition Law
Author: LawSphereX
Category: Banking & Finance
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CURBING DRUG EVERGREENING USING COMPETITION
LAW
Gladys Geethanjali S, VIT School of Chennai
ABSTRACT
The concept of evergreening of patents is adopted by the pharmaceutical industry to extend patent protection through minor modifications of existing drugs. This has caused significant debate regarding the impact on market competition and consumer access to affordable drugs. This paper examines the interface between competition law and patent laws, in order to understand how practices that lead to monopolistic dominance, possibly stifling innovation and delaying the entry of generic alternatives, can be mitigated hand-in-hand. Furthermore, it explores the legal frameworks and judicial doctrines in the jurisdiction of the United States, European Union and India. It seeks to find the effectiveness of the current competition laws in addressing patent manipulation to balance the protection of genuine pharmaceutical innovations and public welfare.
INTRODUCTION
Patent grants are primarily purposed to provide exclusive rights to inventors over their inventions which may be a product or a process. This is done in order to protect the inventions. The invention must not be already publicly available. It is put to a test by a person who is either ordinarily skilled or skilled in the art. Once the application for the patent has been filed, there is a requirement to satisfy 3 important tests. Firstly, the novelty or newness of said invention. Secondly, the non-obviousness criteria from the previous closest invention (“prior art”). Finally, the industrial applicability or usefulness of the invention in the real world. On satisfying these three tests before the Controller of Patents (under the Indian Patent Office or IPO), proceeds to the approval of the patent for protection for a fixed time period.
This protection in the form of ‘exclusive rights’ performs a dual role. The primary role is to grant monopolistic rights to make, use, offer for sale, sell or import the product or process to the owner of the patent. Therefore, as a secondary benefit, it grants the owner the legal authority and power to prevent others from making, using or selling an invention for a specific period of time, in return for providing an enabling disclosure to the the public of the patented invention (Article 28 of the TRIPS Agreement). Enabling disclosure means the disclosure of the patent specification. It is a mandated requirement under patent protection as it ensures that the public has access to the operation of the invention.
It could make use of that invention for various purposes that do not violate the rights of the owner and specifically to innovate or figure out the invention through reverse engineering for the purpose of commercialization after the expiration of the time period of patent protection. This disclosure is only the essential details necessary to make the invention work. 1 In the pharmaceutical sector, companies acquire pharmaceutical patents to protect their innovations in drug development. This protection encourages companies to invest in research and development by giving them a strong reason to continue, especially when the projects requires a lot of money2. The standard limited time period of 20 years as given by the TRIPS agreement ensures that the patented inventions reap the investment that was sown into its 1 Robert T.
, The Chartered Institute of Patent Agents, London: Sufficiency of Disclosure (Enabling Disclosure, Disclosure of Prior Art, Best Mode) (2006), https://www. wipo. int/export/sites/www/meetings/en/2006/scp_of_ge_06/presentations/scp_of_ge_06_roberts. pdf.
2 Marianna, The Role of Patents in the Pharmaceutical Sector, MINESOFT (Oct. 29, 2024),
https://minesoft. com/the-role-of-patents-in-the-pharmaceutical-sector/. research and development, allowing the investors to get their returns. Limiting the rights through a temporary monopoly is aimed to incentivise inventors to invest time and resources in developing new technologies and products, which has potential to gain profits. Essentially, this makes it illegal for companies to make generic copies of patented drugs during this period except for certain exceptions such as experimental research (which is not commercial in nature). Upon patent expiry, the knowledge and information will become a part of the public domain and any company can create or use it to produce which would potentially result in industry competition and lower product prices. 3 A patent application must include many claims, with each one describing a specific right.
Each claim undergoes the test of “patentable subject matter” which is governed by each country. They are the heart of a patent application. The claims of the patent are given to define the scope of legal protection and outlining the invention’s boundaries. The patent protects only the technology that has been converted in the claims. If the invention has been described in detail under the description but the claims are not properly drafted, then it could become a part of the prior art when the patent is published. This means that any one is at liberty to use this information without the patent owner’s permission as it is unprotected. This gap that exists is oftentimes used in order to extend the course of their protection over their inventions. Allowing for wider claims or narrower claims is monitored by the authority.
One such tactic that is adopted by pharmaceutical companies is evergreening of drug patents which leads to acquiring unjustifiable monopoly rights. For patent applications to be qualified, the criteria of novelty, inventive step and industrial applicability needs to be satisfied. This is the universal standard set by the TRIPS Agreement and accepted by signatory countries. The WHO Commission has defined evergreening as “a term popularly used to describe patenting strategies when, in the absence of any apparent additional therapeutic benefits, patent holders use various strategies to extend the length of their exclusivity beyond 20 year patent term. ”4 Companies rely on ‘evergreening’ of drug patents as means to prolong their gains and protect their competitive advantage over other competitors.
When a patent’s duration is extended beyond what is necessitated for incentivizing innovation, a check system needs to be kept in
3 M.E. List, The Hollow Rhetoric of Evergreening, 61 JURIMETRICS 495, 495–522 (2021),
https://www.jstor.org/stable/27190062.
4 WORLD HEALTH ORGANIZATION, Public Health Innovation and Intellectual Property Rights 131 (World
Health Organization 2006). place. A system which challenges the intentions of said extensions and whether they are anticompetitive in nature, prolonging market dominance and abuse of their dominant position. Such activities are well-capable of preventing generic manufacturers from entering into the market, to provide less costly alternative drugs for the public. Competition law could potentially be invoked to challenge this. The extent of the effectiveness of competition law in regulating the practice of evergreening in the pharmaceutical industry in the Indian territory needs to be examined. It is recognised that there is a need for reforms to arise which balance innovation incentives with public interest in affordable access to medicines.
Therefore, it also explores the need for legal and policy reforms after studying different jurisdictions and their patent systems in balancing this intersection. PHARMACEUTICAL SECTOR AND EVERGREENING IN INDIA: The Indian pharmaceutical industry is a global powerhouse and it is valued at around 50 billion USD. It is specially known for its generic medicines and low cost drugs globally. It is the biggest supplier of generic medicines, accounting for a global supply by volume of 20% and fulfilling 60% of the world's vaccine demand. It ranks 14th worldwide in production by volume. The expiration of the exclusivity rights of the patent owner results in the production and marketing by others as a generic product.
A generic drug is designed to be the identical as an already approved brand-name drug in dosage form, safety, strength, route of administration, quality, effectiveness and intended use. It works in the same way and provides the same therapeutic efficacy5 Most of the major generic drugs are developed on reverse-engineering brand-name drugs, using slightly altered methods. Therefore, making it an equivalent substitute for its brand name counterpart. Such non-proprietary versions are sold at a cheaper price due to the lack of clinical trials and research and development costs. The authorities are responsible to ensure this bioequivalence before approving of this drug to enter into the market. Every drug comprises active and inactive ingredients. Minor differences in the inactive ingredients does not alter the effect of the drug as much as the active ingredients do.
Most generic drugs may exhibit few minor differences when compared with the brand name 5 FDA, Generic Drugs: Questions & Answers, FDA (Mar. 16, 2021), https://www. fda. gov/drugs/frequentlyasked-questions-popular-topics/generic-drugs-questions-answers. wers products, specifically in the inactive ingredients. 6 Drug patents can protect both the active ingredients (known as active pharmaceutical ingredients or APIs) and the formulation of a drug. Sometimes, such patents are given for minor alterations, improvements or new uses of already existing patents. There is no basis for new technical solutions in these patents. Recouping of existing protected drugs may seem ideal from the perspective of the companies, but the public as consumers would be affected at large, having been restricted access to affordable alternatives and there is a contention that it stifles competition.
Brand names play a crucial role, when it comes to affinity with the active ingredients. Most drugs are identified with the active ingredient and once a brand creates a strong association with said active ingredient, the public’s demand for the drug will be delivered by the brand name. Additionally, a patient’s association and satisfaction with a branded drug and its effects, will initiate a reluctance in them to shift to any other generic version. 7 The regulatory burden faced by the branded drugs is much higher than that of the generic drug. Applicants are often required to demonstrate bioequivalence with an existing approved drug rather than providing the proof of safety and efficacy through clinical trials as in the case of the original drug.
8 Incremental development of drugs is capable of increasing the benefits for the patients and it does even support and sustain the industry through innovation. It does encompass certain risks which cannot be forfeited in its entirety, especially when the benefit is marginal or non-existent. The outcome of evergreening would result in medicines that are no longer effective and for which there is less clinical experience. 9 There is a huge revenue loss for the drug industry as exclusivity rights on major drug patents expire. 10 In order to prevent such losses, a company can obtain a patent for a new drug as the original patent nears expiration, and secure a new patent for an enhanced version of the same drug. This could involve modifications such as different manufacturing processes, an alternative dosage form or a revised dosage.
These minor modifications do not necessarily provide any additional benefits for patients. Even if these changes are relatively small, they 6 Kenfox Law, Evergreening Strategy: Extending Patent Protection, Innovation or Obstruction? (Aug. 12, 2024), https://kenfoxlaw. com/evergreening-strategy-extending-patent-protection-innovation-or-obstruction.
7 Supra
8 Margaret K. Kyle, Competition Law, Intellectual Property, and the Pharmaceutical Sector, 81 ANTITRUST L.J. 1, 1–36 (2016), https://www.jstor.org/stable/26478192.
9 Id at 5
10 A. W. Hitchings, E. H. Baker & T. K. Khong, Making Medicines Evergreen, 345 BMJ BRIT. MED. J. 18, 18–20 (2012), http://www. jstor. org/stable/41724482. can help the company maintain its market exclusivity for a longer period. In many ways, it also does stump the growth and development of drugs with improved efficacy and depriving the patients who are in dire need of cheaper alternatives from getting their treatment. PHARMACEUTICAL COMPANIES IN DOMINANT POSITION AND COMPETITION LAWS: The pharmaceutical sector is frequently examined for anti-competition behaviour. While patent protection offers legal exclusivity over invention, competition law serves to regulate this exclusivity by preventing market abuse and restricting anti-competitive practices.
11 Despite being founded on contradictory economic theories, both legal frameworks should be made to work together in such a way as to enhance inventions and public welfare. As one of the methods of combating evergreening of patents, the Intellectual Property Rights - Competition Law discipline must be considered by the legislators. Without the former, the latter would fail to protect the rights of the inventors. Whereas, without the latter, the former would result in monopolist giants dominating the market and the economy. There is a risk of the market transforming into a closed and monopolistic market at any point of time. The strategy of such monopolies is to increase prices, consequently maximising profits and decreasing the overall size of the market instead of increasing supply, not taking into consideration the competitors or the consumers. 12 A.
EU JURISDICTION: Article 102 of the TFEU directs against the dominant position abuse. Under Patent laws, there is a dominant position given to the patent holder in the market. Besides promoting the benefits of competition such as cheaper alternatives, improved products, wider choice and greater effectiveness, it also serves to protect consumers. 13 Anything done to prejudice consumers is prohibited, even if the damage is not direct but having any detrimental effect through the 11 P. S. Mehta, U. Kumar & P. S. Ghuman, Interface Between Competition Policy and Intellectual Property Rights: Select Case Studies from India, in Corridors of Knowledge for Peace and Development 136, 136–162 (S. S. Aneel, U. T. Haroon & I. Niazi eds. , Sustainable Dev. Pol’y Inst. 2020), http://www. jstor. org/stable/resrep24374. 18. 12 T. A.
Väisänen, Competition Law and Intellectual Property Rights, in Enforcement of FRAND Commitments Under Article 102 TFEU: The Nature of FRAND Defence in Patent Litigation 27, 27–32 (1st ed. 2011), http://www. jstor. org/stable/j. ctv941w6t. 6. 13KENFOX IP & Law Office, Evergreening Strategy: Extending Patent Protection, Innovation or Obstruction? , KENFOXLAW. COM (May 8, 2024), https://kenfoxlaw. com/evergreening-strategy-extending-patent-protectioninnovation-or-obstruction. market structure. Consumer welfare makes the regulation be protective of the competitive process rather than the competitors. Viewed from the perspective of evergreening as an abuse of dominant position, it is not easy to determine as it does not fall under any of the stated examples in Article 102. It needs to be analysed on a case to case basis, and see if the particular evergreening practice fulfills the criteria.
In the case of AstraZeneca AB & AstraZeneca plc v European Commission, the Court of Justice of the European Union held that AstraZeneca misused its dominant position by blocking generic manufacturers from entering into the market. The company had deregistered one of their main drugs and launched in parallel a tablet formulation of that same today. Under the EU regulations, for a generic drug to enter into the market, there is a requirement for a registered reference product. Therefore, the generic manufacturers were not able to use any reference product for their capsules, preventing their entry into the market. 14 This was one of the prominent cases that dealt with abuse of dominant position by a pharmaceutical company in the light of evergreening of drug patents. It has been observed that evergreening usually occurs in a regulatory context affecting the market i. e.
, legal barriers, unlike classical abuses which create economic barriers. However, the market effect is prevalent in both cases. This does not cause any problems in the application of Article 102 to evergreening, as the provision restricts any activity that has an impact on the market, even when the conduct is outside the market. B. US JURISDICTION: In the U. S jurisdiction, the legal doctrine of obviousness-type double patenting is often placed as a barrier for evergreening of patents, as it prevents unjustified patent extensions for the same invention or an obvious variant. It often acts as a checkpoint for such applications. It is an affirmative defence as it is a ground for invalidating one or more claims of the secondary patent application. Under 35 US Code § 101 prohibits “double patenting”.
The identical claims to those of issued patents are considered as “same invention-type double patenting”. When claims 14AstraZeneca AB & AstraZeneca plc v. European Commission, Case T-321/05, ECLI:EU:T:2010:266 (Gen. Ct. 2010), aff’d, Case C-457/10 P, ECLI:EU:C:2012:770 (CJEU 2012). https://unctad. org/ippcaselaw/sites/default/files/ippcaselaw/2020- 12/AstraZeneca%20AB%20v%20European%20Commission%206%20December%202012. pdf are rejected on the basis of judicial reasoning and non-distinctiveness over issued patent claims, it is referred to as “obviousness-type double patenting”. 15 US Patent laws provide for continuation patent applications which are important tools for inventors and startups who require prolonged protection of their technologies.
It is a distinct application that ebales the pursuit of further claims derived from the same description and disclosures as the original (parent) patent application. Such continuation applications can be filed before the patent application is granted, allowing for broader and more thorough claim coverage. 16 Such legal provisions are strategically implemented by pharmaceutical companies to extend exclusivity. One such method of patent exclusivity is by creating “patent thickets” whereby companies collect a large number of patents on their blockbuster drugs. There is an overlapping set of patent rights and it would involve either single or multiple parties creating a large web of patents to deter or delay competitor market entry. 17 such pharmaceutical patent thickets are formed from “secondary patents” which evolve through minor modifications of the issued patents.
These have the possibility of being a part of evergreening strategy used by companies when there is no actual enhancement in the drug. Majority of the pharmaceutical patents are secondary in nature and they are often aimed at complicating generic entry by increasing the costs for generic manufacturers. In 2022, the Director of PTO and Commissioner of the FDA took on plans to prevent the patent system from unfairly hindering or delaying the entry of generic drugs and biosimilars into the market. 18 Humira, a patented drug by the manufacturer AbbVie Inc, generated a huge profit of 22 billion in revenue over the period from 2007 - 2021, despite its expiration in 2016. There was a lack of competitive entry that favoured this success caused by the additional patents on Humira.
AbbVie was granted 132 patents out of 247 patent applications creating a patent thicket, providing market dominance until the year 2037. With such exclusivity in every aspect 15N. S. Pierce, Inventorship, Double Patenting, and the America Invents Act, 30 Berkeley Tech. L. J. 1613 (2015), http://www. jstor. org/stable/43917615. 16 Andrew Rapacke, Patent Continuation: A Comprehensive Guide to Evolving Your Patent Protection, THE RAPACKE LAW GROUP (Sept. 11, 2023), https://arapackelaw. com/patents/patent-continuation/. 17 Carl Shapiro, Navigating the Patent Thicket: Cross Licenses, Patent Pools, and Standard Setting, in Innovation Policy and the Economy 119, 119 (Adam B. Jaffe, Joshua Lerner & Scott Stern eds. , 2001), https://www. nber. org/system/files/chapters/c10778/c10778. pdf.
18 Michael A. Carrier & S. Sean Tu, Why Pharmaceutical Patent Thickets Are Unique (Mar. 6, 2024)
(unpublished manuscript), https://doi. org/10. 2139/ssrn. 4571486. of the drug created an environment hard for generic companies to receive the approval to enter into the market. 19 There was a case filed alleging that AbbVie’s patent thicket is in violation of US Antitrust laws (The Sherman Antitrust Act). Section 1 of the Act restraints “every contract, combination in the form of a trust or otherwise or conspiracy, in restraint of trade or commerce... ”. Section 2 of the Sherman Act, 1890 imposes penalties upon “every person who shall monopolise or attempt to monopolise or combine or conspire with any other person or persons to monopolize any part of the trade or commerce.. ”.
20 There were arguments on the violation of Section 1 that there was an abuse of monopoly power and extended biosimilar entry and violation of Section 2 on the grounds that there were “payfor-delay” or reverse settlement agreements. In such agreements, the brand-name drug manufacturer, in order to escape the chances of losing the patent, incentivises the generic manufacturer to settle through payments, promising a delay in its entry into the market. 21 The court ruled in favour of AbbVie as it was too speculative to draw conclusions based on potential outcomes. Despite the ruling, there are many important doctrines drawn that helped understand the position of the pharmaceutical sector and antitrust laws.
Understanding the prominence of “sham patents” that are obtained through deceptive practices and an intent to deter competition, highlights the crucial role of regulatory authorities in addressing the effects of the same. India does not explicitly include such doctrines under its legislations. However, conceptually it runs parallel with the domestic legislations. C. INDIAN JURISDICTION: The Patent Act, 1970 after its amendment in 2005, introduced a patent protection for pharmaceutical products as required under TRIPS. It was made clear that widening the scope of patent protection must not be detrimental to the generic industry. Section 3 of the Act elucidates on inventions that are not patentable in an exhaustive list. Specifically, section 3(d) withholds patents for the mere discovery of a new form of a known substance unless increased efficacy is shown.
Therefore, excluding incremental innovation, as it promotes evergreening 19 Ryan Knox & Gregory Curfman, The Humira Patent Thicket, the Noerr-Pennington Doctrine, and Antitrust's Patent Problem (Sept. 11, 2022) (unpublished manuscript), https://doi. org/10. 2139/ssrn. 4215822. 20 D. Arant, Section 2 of the Sherman Act, 37 Antitrust L. J. 643 (1968), http://www. jstor. org/stable/40841831 21 Clifford Chance, Antitrust Review of Reverse Payment Agreements to Settle Patent Disputes – The Emerging Legal Landscape in Mainland China, CLIFFORD CHANCE, https://www. cliffordchance. com/insights/resources/blogs/talking-tech/en/articles/2023/11/antitrust-review-ofreverse-payment-agreements-to-settle-patent-disputes. html (last visited Apr. 19, 2025). and harm to public interest and welfare. Such a provision can be debated to be a useful mechanism to limit unnecessary patents.
This criteria is met only through “enhanced efficacy”. India is one of the few countries that have adopted a strict approach towards patentability of new forms or new uses of known substances. Section 3(d) is similar in intent as that of double patenting doctrine under the US jurisdiction. The idea for the amendment in 2005 was to prevent ‘ever-greening’ of patents. If this was to be removed from the legislation, there would be no restriction on the same phenomena from happening. In 2014, US bought a Special 301 Report which is a yearly reporting by the US Trade Representative, under the US Trade Act 1974, evaluating how sufficient and effective intellectual property protection and enforcement measures are in place among trading partners. Under said report, India was classified as a “priority watch list country” for various concerns including non-patentability under section 3(d).
This unilateral measure to increase IPR protection beyond the TRIPS by the US failed, as it is a mere extra territorial application of the domestic law and the Indian framework is wellestablished to safeguard the IP Rights. 22 In the case of Novartis AG vs Union of India, there was a new patent application filed for the beta-crystalline form of Imatinib Mesylate by Novartis in 1998. The original patent for the drug Gilvec covered imatinib and its salt forms (filed in 1992). The new variation was capable of being soluble in the human body and therefore enabling oral administration. The Indian Patent Office (IPO) rejected the application in 2006, after keeping it under the Mailbox application as per the temporary system. There was a failure to express “significantly enhanced efficacy” of the crystalline form over its original talk as per section 3(d) of the Act.
Studies that were conducted show a 30% increase in the efficacy over the original drug. The Supreme Court interpreted “efficacy” as therapeutic efficacy and in no relation with the physico-chemical properties. A question as to whether increased bioavailability of the form constituted enhanced therapeutic efficacy was placed by the court. 23 Bioavailability is the proportion of a drug that enters the systemic circulation of the body when administered. This affects the impact levels
22 U.S. Opposition to Section 3(d) of the Indian Patent Act,
https://pib. gov. in/newsite/printrelease. aspx? relid=107612(last visited Apr. 19, 2025) 23 Novartis AG v. Union of India & Others, No. SLP(C) 25076/2013, 2013 WL 12089753 (India Dec. 1, 2013), available at https://unctad. org/ippcaselaw/sites/default/files/ippcaselaw/2020- 12/Novartis%20AG%20v. %20Union%20of%20India%20%26%20Others%20Indian%20Supreme%20Court%2 02013_0. pdf or the effectiveness of the drug in the body. 24 Optimizing bioavailability helps pharmaceutical companies to develop more effective and safer drugs. The court, in the case of Novartis, clarified that this is not the norm; increased bioavailability does not result in increased therapeutic efficacy. There is a requirement for the submission of data from the clinical trials proving the bioavailability indicating the therapeutic efficacy.
Novartis failed to provide evidence for the enhancement, therefore, leading towards the rejection of the patent. Section 3(d) of the Act can be considered as pro-competition in one perspective, even if not explicitly termed as such. Competition laws in India are governed by the Competition Act, 2002. Competition law is applied to the core issues solely to either restrict or expand the extent of patent utilization. Competition laws are given to provide “reasonable restrictions” on the IP holders whilst exercising their rights. This can be done when IP owners attempt to distort the market competition by refusing to license their IP. They refuse in order to maintain their dominant position in that particular market.
25 The Act permits the use of IPR as a defence in cases involving anti-competitive agreements [Section 3(5)], but his defence is not applicable in matters related to the abuse of dominant position. The Act expressly prohibits such conduct under Section 4, the abuse of dominant position by an enterprise or group who are (i) imposing unfair or discriminatory conditions or prices in the purchase or sale of goods or services (ii) restricting or limiting the production of goods and services, (iii) engaging in practices that lead to denial of market access is prohibited. 26 In the Competition (Amendment) Bill, 2020, there was a proposed extension of section 3(4) of the Act and cases involving dominant positions by the IPR Safe Harbour. Under Section 3(4), the term ‘any other agreement’ was incorporated, broadening the application of anticompetitive agreements.
As per the Amendment Committee, IPR holders should be granted protection in cases involving the abuse of a dominant position, provided that such protection is subject to reasonable limitations and regulatory safeguards. 27 However, if such a provision 24Greg Price & D. A. Patel, Drug Bioavailability, in StatPearls (2023), available at https://www. ncbi. nlm. nih. gov/books/NBK557852/ 25 P. S. Mehta, U. Kumar & P. S. Ghuman, Interface Between Competition Policy and Intellectual Property Rights: Select Case Studies from India, Sustainable Development Policy Institute (2020), available at http://www. jstor. org/stable/resrep24374. 18.
26 Competition Act, No. 12 of 2003, India Code (2002)
27 Admin & Admin, Changing Relation of IPR Law and Competition Law, IIPRD (Apr. 28, 2023), available at https://www. iiprd. com/the-indian-perspective-on-intellectual-property-rights-and-competition-legislation/. is in place, there would be an unrestricted power granted to the IPR holders, with a potential to negatively impact the markets. There must be focus given to the term “reasonable condition” and it must be interpreted in a narrow sense, if there is a necessity to restrict the actions of enterprises. There also must be sufficient powers given to the CCI for the determination of abuse of dominance in cases of IPR, extending beyond section 19(4)(m). The use of this provision recklessly cannot be denied, despite the attempt to mitigate the imbalance of competition law and IP law.
An harmonious construction and a narrow interpretation is required in order to attain a desired balance between the laws. 28
CONCLUSION
The implementation of competition law within the pharmaceutical industry yields an advantage for society as a whole. When pharmaceutical industry leaders engage in anti-competitive practices, specifically evergreening of drugs , the consumers should have a redressal mechanism through the Competition Commission of India (CCI). There needs to be another channel opened for consumers to get redressal through the CCI. However, this can occur only if the CCI claims jurisdiction to deal with patent-protected drugs. The decision taken by the Court of Justice in the case of AstraZeneca, strongly underscores the argument regarding the enforcement of competition law in relation to patent rights within the pharmaceutical sector and its repercussions on consumer welfare and access to generic medicines. A parallel can be drawn from the EU’s stance to that of the Indian jurisprudence.
29 However, it is necessary to analyse the adequacy of the current competition law in addressing problems in pharmaceutical markets. The policy aims to reduce the barriers faced by generics in entering the market, then excluding secondary-type of patents from the definition of patentability must be done. Competition laws need to address the unique practices adopted by pharmaceutical companies and include them under the scope of ‘anti-competitive’. 30 Allowing a narrow restriction by the authority upon the industry, as per the Amendment of 2023, could 28 Priyal Jain & Indra Kumar Lahoti, Analysis of IPR and Abuse of Dominant Position in Light of the Draft Competition (Amendment) Bill, 2020, NLUJ Law Review (June 11, 2020), available at https://nlujlawreview. in/competiton-law/analysis-of-ipr-and-abuse-of-dominant-position-in-light-of-the-draftcompetition-amendment-bill-2020/.. 29A.
Hussain & VidhiAagaz, Combating Evergreening and Abuse of Dominance: The Role of Patent Litigation and Competition Law in Pharma, Int'l J. Legal Sci. & Innovation, 6(4), 437–45 (2024), available at https://ijlsi. com/wp-content/uploads/Combating-Evergreening-and-Abuse-of-Dominance. pdf 30 M. K. Kyle, Competition Law, Intellectual Property and the Pharmaceutical Sector, Antitrust L. J. , 81(1), 1–36 (2016), available at https://www. jstor. org/stable/26478192. possibly render the industry from any proper governance and control. The patent owners use their patents to the utmost extent and thereby it is the responsibility of the legislators to establish clear guidelines defining the point at which the lawful exercise of rights transitions into unlawful conduct.