India's Patent Regime - Examining The Rejection Of Bedaquiline Patent Evergreening And Its Implications

Author: LawSphereX

Category: Intellectual Property

Published: 2026-08-23T20:19:16.236562+00:00

Updated: 2026-08-26T17:11:09.6+00:00

INDIA'S PATENT REGIME: EXAMINING THE REJECTION

OF BEDAQUILINE PATENT EVERGREENING AND ITS

IMPLICATIONS

Harshitha. S, LL.B., Government Law College Namakkal, Tamil Nadu

ABSTRACT

Tuberculosis remains a life-threatening disease affecting almost every country in the world. The drug Bedaquiline is an effective treatment for the disease. The Indian Patent Office rejected Johnson and Johnson's secondary patent claim for the Fumarate salt of Bedaquiline. Several factors are said to have influenced India's decision, and this ruling has a range of implications. This paper examines the reasons for rejecting a secondary patent for Bedaquiline in the context of the existing criteria laid down by the Indian patent law, such as novelty, efficacy, and inventive step. It also analyses the judicial precedents that have set a normative guideline against patent evergreening and how it has been followed in reaching the verdict. This article briefly discusses the external factors, including India's TB-free campaign, that prompted India to act upon this matter.

Ultimately, this essay delves into the implications faced by the pharma companies that use secondary patents as a strategic tool to extend their monopoly in the drug market. Also, the ruling has an impending impact on India's foreign policy, such as Foreign Direct Investments and the export of drugs to various countries, which will be economically gratifying. Public health is guaranteed under international agreements, and the patent laws of India have been safeguarded in this decision. This paper suggests possible solutions to avoid future disputes over patent renewals. It highlights the need for reform in the Indian pharmaceutical sector to invest in domestic drug development to reduce dependency.

I. INTRODUCTION

When an invention is made it must benefit the creator and those who use it. A patent is an intellectual property right granted to the inventor for his invention for a limited time, usually

20 years.1 A patent shall confer on its owner the exclusive rights as to the subject matter of the

patent to prevent third parties from making use of a product or a process and such patent owners shall also have the right to assign, or to grant licenses to others to make use of their inventions2. The objective of granting a patent is to recognize the work of the inventor and permit him to make pecuniary profits from his inventions. After the expiry of the patents, the invention can be used by anyone for any purpose without restrictions. These patents are “territorial rights” and cannot be enforced in territories other than the country where the patent was granted. 3 India’s patent laws are governed by The Patent Act of 1970 (hereinafter ‘the Act’)4 and as per this law, an invention is granted a patent only if it satisfies the criteria such as ‘Novelty’, ‘Inventive step’, and ‘Industrial application’ and should not fall under the purview of sections 3 and 4 of the Act.

5 In pharmaceutical industries, a patent for drugs invented by them is granted in two ways: primary and secondary patent. 6 A patent claimed during the research phase of a drug, to protect the basic formula is called a primary patent, and an additional patent is claimed by the companies by making changes or enhancements to the patented formula regarding dosage, method of production, or chemical formulation in the later phase of research thereby extending the lifetime of the patent is called a secondary patent7. Pharmaceutical companies use the provision of secondary patenting as a tool to extend the patents of existing inventions to

1 Frequently Asked Questions: Patents, WORLD INTELL. PROP. ORG. [WIPO],

https://www.wipo.int/patents/en/faq_patents.html; What is a patent?, SWISS FED. INST. INTELL. PROP., (Dec. 2023), https://www.ige.ch/en/protecting-yourip/patents#:~:text=A%20patent%20is%20an%20IP,you%20own%20a%20valid%20patent. 2 TRIPS: 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) [hereinafter TRIPS Agreement] https://www.wto.org/english/tratop_e/trips_e/ta_docs_e/1_tripsandconventions_e.pdf.

3 DAVID KLINE & DAVID KAPPOS, INTRODUCTION TO INTELLECTUAL PROPERTY 10 (Openstax

2021), https://openstax.org/details/books/introduction-intellectual-property.

4 The Patents Act,1970, No.39, Act of Parliament,1970 (India) [hereinafter Patents Act].

5 Frequently Asked Questions - Patents, INTELL. PROP. INDIA (2020),

https://ipindia.gov.in/writereaddata/Portal/Images/pdf/Final_FREQUENTLY_ASKED_QUESTIONS_- PATENT.pdf.

6 Maria Jose Abud et al., An Empirical Analysis of Primary and Secondary Pharmaceutical Patents in

Chile,10(4) PLOS ONE 1, 17 (2015), https://doi.org/10.1371/journal.pone.0124257

7 Ibid.

establish their monopoly by making trivial modifications which is popularly referred to as ‘Evergreening’. 8 In 2005, Section 3(d) was added to the Act, which restricted the patent evergreening by providing that any modifications of the existing product or process must “differ significantly about efficacy. ”9 India has always been stringent with its decisions regarding patent extension attempts by drug companies and it has been proven once again by rejecting Johnson & Johnson’s secondary patent application for the fumarate salt of Bedaquiline, a Tuberculosis drug by the Indian Patent Office to restrict the drug monopoly and this decision is expected to have a powerful impact on drug accessibility throughout India.

10 This paper aims to examine the reason for the rejection of a secondary patent for the tuberculosis drug Bedaquiline in the light of the legislation existing in India regarding patents and previous judicial pronouncements and analyse India’s stand against pharmaceutical monopolies and its possible implications on India’s drug accessibility, health care, and other future policies.

II. BEDAQUILINE PATENT- AN INSIGHT

Tuberculosis is an airborne lung disease caused by the Bacillus Mycobacterium tuberculosis and about a quarter of the world’s population is estimated to have been affected by it. 11 Multidrug resistance Tuberculosis (MDR-TB) is one of the types of tuberculosis that does not respond to most of the first-line TB drugs and thus remains a global threat. 12 Bedaquiline (BDQ), a quinoline derivative [ TMC 207] is the first drug that has been proven to be more effective for MDR-TB treatment since the approval of Rifampicin forty years ago. 13 This drug was discovered by Jansen Pharmaceutica, a subsidiary company of Johnson & Johnson around 8 Vsevolod A Vorobiev, Secondary Patents in Chemistry and Pharmaceutics, IAM (2021), https://www. iammedia. com/global-guide/innovation-invention-yearbook/2022/article/secondary-patents-in-chemistry-andpharmaceutics. 9 The Patents (Amendment. ) Act, 2005, No.

15, Act of Parliament, 2005 (India) [hereinafter Patents (Amd) Act].

10 BINDU S. PERAPPADAN, J&J not to enforce patents on TB drug, THE HINDU, Oct. 2, 2023, at 1.

11 Global Tuberculosis Report 2023, WORLD HEALTH ORG. [WHO] (2023),

https://iris.who.int/bitstream/handle/10665/373828/9789240083851-eng.pdf?sequence=1 [hereinafter TB report 2023] 12 Tuberculosis-Fact sheet, WORLD HEALTH ORG. [WHO] (Nov. 7, 2023), https://www.who.int/newsroom/fact-sheets/detail/tuberculosis. 13 Sankalp Yadav et al., Bedaquiline: A Novel Antitubercular Agent for the Treatment of Multidrug-Resistant Tuberculosis, 10(8) J. CLINICAL & DIAGNOSTIC RSCH., (2016), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5028565/.

2002 and was granted a patent by India in 2005 [Patent No. 236811] for the base compound

Bedaquiline and sold as ‘Situro’ throughout India and it expired on July 18, 2023.14 In 2009, they applied for a secondary patent for “Fumarate Salt of (Alpha S, Beta R) -6-

BROMO-ALPHA-[2-(DIMETHYLAMINO)-ETHYL]-2-METHOXY-ALPHA-1-

NAPHTHALENYL-BETA-PHENYL-3-QUINOLINEETHANOL” (salt of Bedaquiline) under the application number 1220/MUMNP/2009 to the Indian Patent Office (IPO), claiming improvements to the existing drug. 15 This application was first opposed by the Network of Maharashtra People Living with HIV in 2013 by stating that the claims made by Jansen Pharmaceutica were already granted in the first patent. 16 The applicant amended the claims stating that the fumarate salt form of Bedaquiline improves the therapeutic effect, consists of a wetting agent, and is suitable for oral administration and in 2019, two TB survivors filed a pregrant opposition under section 25(1) of the Act, on the grounds that the product submitted for patent is neither an invention nor a new process and stressed that all such claims made, were covered under the prior patent17.

Finally, the Controller of the Indian Patent Office in the order dated March 23, 2023, decided to reject the application by Jansen Pharmaceutica for Fumarate salt of Bedaquiline by stating that “the bioavailability will not amount to therapeutic efficacy” and also the new drug lacks novelty. 18 This decision has been widely acclaimed across the country and is expected to have a major impact on the future decisions of the IPO regarding the grant of patent extension of drugs to pharmaceutical companies. The decision to reject the application reflects not only the strict nature of Indian law but also the country's stance against exploiting its people by any company for its profit.

14 UNITAID, A Review of the Bedaquiline Patent Landscape A scoping report, WORLD HEALTH ORG.

[WHO] (2014), http://unitaid.org/assets/TMC_207_Patent_Landscape.pdf. 15 Renu B. Rampal & Soujanya Sikha, Patent Evergreening- Not so green after all!, BAR & BENCH (Apr. 3, 2023), https://www.barandbench.com/law-firms/view-point/patent-evergreening-not-so-green-after-all; Bedaquiline Application, (Wo/2004/011436), PAT. OPPOSITION DATABASE (2005), https://www.patentoppositions.org/en/drugs/bedaquiline/patent_applications/521d9022835d76000200000a.

16 Network Of Maharashtra People Living with HIV (Nmp+) Opposition, Bedaquiline, (1220/Mumnp/2009

(Wo2008068231)), PAT. OPPOSITION DATABASE (Mar. 11, 2013), https://www.patentoppositions.org/en/drugs/bedaquiline/patent_oppositions/521d9555835d76000200000e.

17 Nandita Venkatesan And Phumeza Tisile (Tb Survivors) Opposition, Bedaquiline Fumarate,

(1220/Mumnp/2009), (Feb. 7, 2019), https://www.patentoppositions.org/en/drugs/bedaquiline/patent_oppositions/5c5c0b4bd2708f0005c98d08.

18 Rampal et al., supra note 15; Bedaquiline Decision, (1220/Mumnp/2009), PAT. OPPOSITION DATABASE

(Mar. 23, 2023), https://www.patentoppositions.org/en/drugs/bedaquiline/patent_office_decisions/641c1136d2708f00050ab275 [hereinafter Bedaquiline decision].

III. EXAMINING THE REASON FOR REJECTION

A. Indian Legislation

To grant a patent for an innovation, the Indian patent law lays down certain criteria19 to be satisfied and it has been strictly interpreted in every case so far. (i) Novelty: Novelty means something different from a previous invention and should not resemble a prior invention. 20 Section 2(1)(j) of the Act requires an invention to be “a new product or a process capable of industrial application”21 and to come under the purview of the term “new invention” as defined under section 2(1)(l) of the Act, the invention must not be anticipated to be published anywhere or to exist in other countries before applying for a patent. 22 The inventor must be the first person to conceptualize the invention and present it as a new product or process to claim a patent for his invention.

23 As per section 25(1)(d) of the Act, patents are not to be granted on ‘inventions’ that have been published before the date of filing of the patent application because those claims would have been granted rights in the primary patent itself. 24 The patent IN236811, for the Bedaquiline base compound and its base addition salts, has been granted already and the so-claimed invention was just a mixture of priorly patented inventions, and making a mere derivative of a product of the existing invention is not considered to be a ‘new invention’ as given under Indian law and so a patent cannot be granted for a product that is neither more effective nor innovative than the existing one. 25 (ii). Efficacy: Section 3(d) of the Act was added to the legislation in the amendment of 2005 which states that

19 Sameeksha Shukla, Indian Patent Law: Understanding the patent rights & obligations, SAGACIOUS IP

(Mar. 2023), https://sagaciousresearch.com/blog/indian-patent-law-understanding-the-patent-rights-obligations/. 20Patentability criteria for an invention in India, GLOB. PAT. FILING (Dec. 19, 2022), https://www.globalpatentfiling.com/blog/Patentability-criteria-for-an-invention-in-India-.

21 Patents Act, supra note 4.

22 Ibid.

23 Ghayur Alam & Aqa Raza, Difference of Novelty and Inventive Step: Reading or Misleading of Statutory Text in Judicial Decisions 50 BANARAS L. J.119, (2021), https://ssrn.com/abstract=4047954.

24 Ibid.

25 Grounds for Opposing Patent Application for Bedaquiline Formulation in India, MEDECINS SANS

FRONTIERES-ACCESS CAMPAIGN [MSF] (Feb. 2019), https://msfaccess.org/sites/default/files/2019- 02/BDQ%20Opposition_Briefing%20Document_India_Fab2019_ENG.pdf [hereinafter Opposing grounds, MSF]; Bedaquiline decision, supra note 18.

“any salts, esters, polymorphs, etc. , must differ significantly with regards to efficacy”26 and this provision seems like a restriction to the drug companies to establish their monopoly in the pharmaceutical industry by extending the lifetime of the patent of the drugs by making trivial changes in the existing drugs. 27 The case of Novartis,28 an unprecedented decision concerning the term ‘efficacy’ under section 3(d) of the Act, had set its meaning as “therapeutic efficacy” and thereby determined that any pharmaceutical company claiming a secondary patent is obliged to prove that the enhancement made in the existing invention must have a beneficial improvement in the treatment of the disease which it claims to treat. 29 It also declared that “an increase in bioavailability does not amount to therapeutic efficacy.

”30 For example, a company invented a drug with 'component A' which it claims cures headaches and it is granted a patent. Later, it combined ‘component A’ with ‘component B’ and invented a new drug that they claimed cures both headaches and nausea and applied for a new patent for the new drug. If the new invention is proven to be more effective in treating headaches and nausea, a patent shall be granted. Though the applicant Jansen Pharmaceutica claimed that the invention helped in increasing the availability of the drug by the addition of the wetting agent to the formulation, it failed to prove any significant impact caused by the new formulation in the treatment of tuberculosis.

31 This decision proves that the verdict in the Novartis case has been followed thereby reaffirming India’s stance against the attempts for evergreening of drug patents by companies to establish their monopoly empire in the pharmaceutical industry. (iii) Inventive Step: As per Section 2(1)(ja) of the act, “inventive step means a feature of an invention that involves technical advance as compared to the existing knowledge or having economic significance or both and that makes the invention not obvious to a person skilled in the art. ”32 We can infer that to be an inventive step, the invention must have a significant development in its technical

26 Patents (Amd) Act, supra note 9.

27 SINGH & ASSOCIATES, Section 3(d) of Indian Patents Act 1970: Significance and Interpretation,

LEXOLOGY (Feb. 7, 2014), https://www.lexology.com/library/detail.aspx?g=3f92413f-107c-4886-aca7- 24633a341e22#.

28 Novartis AG v. Union of India & Others, (2014) 6 SCC 1[hereinafter Novartis case].

29 Ibid.

30 Ibid.

31Bedaquiline decision, supra note 18.

32 Patents Act, supra note 4.

aspect or have change in its economic aspect like making the drug cheaper, improving an existing drug for the same price, etc. , and also should be non-obvious. 33 The case, Bishwanath Prasad Radhey Shyam v. Hindustan Metal Industries34, concerned a patent challenged by the defendant for lack of novelty and inventive step in respect of an apparatus and method for making utensils. The Supreme Court held the patent was invalid because it lacked inventive step and novelty as the product was known before. The court said “An improvement on something known before or a combination of different matters already known should be something more than a mere workshop improvement... must produce a new result, or a new article or a better or cheaper article than before.

” Similarly, J&J’s patent application was rejected because making mere salt from the known drug Bedaquiline is not an inventive step as it lacks any economic significance or technical advancements. A salt form of an existing invention would not amount to ‘non-obviousness’ unless it differs significantly from the existing drug in terms of economy or technical advancement. 35 Even if the patent was granted, the company would not make any changes in its pricing, and still be expensive for people to afford the drug. Thus, the Indian Patent Office has rightly rejected the patent extension claim by J&J.

B. External Factors

(i) TB- Free Campaign by India As per the Global Tuberculosis Report, India is one of the countries on the global TB burden list and is estimated to contribute about 25 per cent of the global TB population.36 In the United Nations General Assembly, all the countries made a declaration to end TB by the year 2030 by adopting effective strategies.37 The Government of India is determined to eradicate TB by the year 2025 and has been taking

33 Criteria for Patent Registration: Indian Approach, SETINDIABIZ (Dec. 1, 2023, 11.06 PM),

https://www.setindiabiz.com/learning/step-by-step-procedure-for-patent-registration-in-india.

34 (1979) 2 SCC 511.

35 Opposition grounds, MSF, supra note 25.

36 TB report 2023, supra note 11.

37 New global action pledge to end TB by 2030, UN NEWS (Sep. 22, 2023),

https://news.un.org/en/story/2023/09/1141307.

effective steps in the meantime. 38 The estimated cost of Bedaquiline is about Rs 3,700 per month per patient and its generic version is expected to cost about Rs 658-1,316. 39 Considering these things, it is regarded that the rejection of the patent extension of Bedaquiline will pave the way for other companies in India to manufacture the same drug for a cheaper rate thereby making it more accessible to all the patients who are suffering from tuberculosis. 40 (ii) MSF campaign Médecins Sans Frontières (MSF) is an independent international organization based in France and its main objective is to deliver medical aid to people affected by war, disasters, pandemics, and epidemics throughout the world.

41 A campaign called “Access Campaign” was initiated by the MSF and this campaign supports their work by advocating for effective drugs for diseases and also to make it affordable so that it can be accessed by everyone. 42 They launched a global campaign against the Johnson & Johnson company to withdraw their claim for patent extension of Bedaquiline43 and also requested India and other countries not to grant a secondary patent for this drug. 44 The said campaign (in the author’s personal opinion) had also influenced India’s decision by pressuring the Indian government with warnings about all the implications of the evergreening of the TB drug and therefore, the claim for patent extension was rejected. (iii) Judicial Pronouncements: In the case of Novartis45, in 1998 a Swiss pharmaceutical company filed for a secondary patent 38Neetu C.

Sharma, India aims to eliminate tuberculosis by 2025: Narendra Modi, MINT (Mar. 13, 2018), https://www. livemint. com/Politics/a3hJk9Sqqil1PZUtO0vAHN/PM-Modi-launches-campaign-to-eradicate-TBfrom-India-by-2025. html. 39India must reject Johnson & Johnson’s attempt to extend monopoly on lifesaving TB drug bedaquiline, MEDECINS SANS FRONTIERES- ACCESS CAMPAIGN (Jan. 16, 2023), https://www. msfaccess. org/indiamust-reject-johnson-johnsons-attempt-extend-monopoly-lifesaving-tb-drug-bedaquiline [hereinafter India must reject J&J, MSF]. 40PT Jyothi Datta, Three Indian firms line up to make TB drug Bedaquiline as patent expires, THE HINDU BUSINESSLINE (Jul. 18, 2023), https://www. thehindubusinessline. com/news/national/three-indian-firms-lineup-to-make-tb-drug-bedaquiline-as-patent-expires/article67094970. ece. 41What is MSF? , MEDECINS SANS FRONTIERS- ACCESS CAMPAIGN (Nov.

24, 2023, 4:08 PM), https://msf-seasia. org/4818. 42James Orbinski, "What we as a civil society movement demand is change, not charity", MEDECINS SANS FRONTIERES- ACCESS CAMPAIGN [MSF] (Jan. 17, 2023), https://www. msfaccess. org/about-us. 43MSF launches global campaign urging Johnson & Johnson to reduce price of life-saving TB drug, MEDICINS SANS FRONTIERS- ACCESS CAMPAIGN [MSF] (Oct. 10, 2019), https://msfaccess. org/msf-launches-globalcampaign-urging-johnson-johnson-reduce-price-life-saving-tb-drug.

44 India must reject J&J, MSF, supra note 39.

45 Novartis case, supra note 28.

for a beta-crystalline form of imatinib mesylate, a drug used to treat chronic leukaemia, and in 2006, the patent office rejected the application because it was not a new invention, but a mere modification of the existing invention, and it did not have any enhanced therapeutic efficacy, as mentioned in Section 3(d) of the Indian Patents Act, 1970. 46 Novartis appealed against the decision in the Supreme Court, claiming that its product was inventive, the bioavailability of the product was increased and had a significant impact when compared to the existing drug, but in 2013, the Supreme Court upheld the patent office’s decision by holding that section 3(d) was a valid provision to prevent evergreening and shall be interpreted in a strict sense thereby securing the interest of public health. 47 In the next case of Bayer Corporation v. Union of India.

48, a German pharmaceutical company, obtained a patent in India for sorafenib tosylate, a drug used to treat liver and kidney cancer in

2008 whilst Natco, an Indian generic drug manufacturer, applied for a compulsory license

under section 84 of the Act to manufacture and sell a generic version of the same drug in 2011 by claiming that Bayer’s product was overpriced and not sufficiently available throughout India. 49 Section 84 (1) of the Act is the provision that grants compulsory license to any person interested under the condition that “After the expiration of three years from the date of the grant of a patent on any of the following grounds: a) the reasonable requirements of the public with respect to the patented invention have not been satisfied, or b) the patented invention is not available to the public at a reasonably affordable price, or c) the patented invention is not worked in the territory of India.

”50 The patent office granted the compulsory license to Natco and aggrieved by this decision, Bayer appealed to the Intellectual Property Appellate Board (IPAB) and later to the Bombay High Court where the appeal was dismissed by both and the court held that the patent system

46 Ibid.

47 Ibid.

48 2009(41) PTC 642 (Del) [hereinafter Bayer case].

49 Ibid.

50 Patents Act, supra note 4.

in India must balance the rights of the patent holder as well as the interest of the public in matters of health, affordability and accessibility of the drugs. 51 In the following case of F. Hoffmann-La Roche Ltd. v. Cipla Ltd. ,52 Roche, a Swiss pharma company, obtained a patent in India for erlotinib hydrochloride in 2007 which is a drug used to treat lung cancer and Cipla, an Indian drug manufacturer, manufactured and sold a generic version of the same drug in 2008 by claiming that Roche’s patent was invalid and they made the said drug more affordable and accessible to the patients, but Roche filed a suit for patent infringement and sought an injunction to restrain Cipla from selling its product.

53 The Delhi High Court denied the injunction by quoting “A mere difference in physical property is a well-known conventional variation of the same pure substance not showing unobvious properties” thereby declaring the patent claims in respect of the same invention amounts to the evergreening of patents which is against public interest and must be avoided. 54 All the above-mentioned decisions by the Indian judiciary in the matter of pharmaceutical patents have always been in the interest of public health by considering the availability of the necessary drugs in the market, easy accessibility of those drugs by the people, and also the affordability of such drugs. If the decision to reject the secondary patent for Bedaquiline is viewed in the light of these judicial decisions, the IPO seems to have prioritized public health over other matters and delivered its order.

Tuberculosis, a virulent disease has been a threat to India for the past decade and rejection of the patent extension of the TB drug will have a significant impact on public health because people can afford the drugs and get access to them since it will be available at a comparatively cheaper rate. The Patent Office also established its stand against the attempts of evergreening of patents by the pharma companies by delivering its verdict in this matter. 51 Bayer case, supra, note 48; Bayer Corporation Vs. Union of India and Others (Bayer v. Natco) Summary, UN

CONF. ON TRADE & DEV. [UNCTAD] (2013),

https://unctad.org/ippcaselaw/sites/default/files/ippcaselaw/2020- 12/Bayer%20Corporation%20Vs.%20Union%20of%20India%20and%20Others%20IPAB%202013.pdf.

52 148 (2008) DLT 598.

53F. HOFFMANN-LA ROCHE LTD. AND ANR. V. CIPLA LIMITED CASE ANALYSIS, JUDICATEME (2020),

https://www.judicateme.com/wp-content/uploads/2020/07/F.-Hoffmann-La-Roche-Ltd.-And-Anr.-V.-Cipla- Limited_JudicateMe.pdf. 54Ibid.

IV. IMPLICATIONS OF THE DECISION

The decision to reject the secondary patent of Bedaquiline has some significant impact not only on the aspect of public health but also on India's play in future policies and also has a huge impact on the pharmaceutical companies who were enjoying their monopoly right in the drug by extending its patent by using secondary patent as a strategic tool.

A. Pharma Monopolies

Pharmaceutical companies invest billions of dollars to develop a new drug in order to sell it in the market and it is not an easy process for a drug to reach the market, as it has to go through several stages of scrutiny.55 Pharmaceutical companies go through several phases in drug discovery and it is pointed out in simple terms as follows,

1. Discovering the molecule that seems to be effective for a particular disease

2. Research and development phase (R&D) that involves various clinical trials

3. getting the approval of the national regulation authority

4. Patenting of the drug

5. Marketing and selling. 56

Therefore, a company going through a tenacious process of developing a drug and selling it in the market can expect to gain profit for its invention through the monopoly right granted to it in the form of a patent for 20 years, and the company alone can sell the drug under their brand name and fix the price for the drug. 57 Usually, after the expiry of 20 years, the patented drug can be manufactured by any company as a ‘generic drug’ with a comparably lower price than the patented drug. 58 The profit of the drug company will be significantly reduced once the 55 Ingrid Torjesen, Drug development: the journey of a medicine from lab to shelf, THE PHARM. J. (May. 12, 2015), https://pharmaceutical-journal. com/article/feature/drug-development-the-journey-of-a-medicine-fromlab-to-shelf. 56Amol B. Deore et al. , The Stages of Drug Discovery and Development Process, 7(6) ASIAN J. PHARM. RSCH.

& DEV. 62, 67 (2019), https://doi. org/https://doi. org/10. 22270/ajprd. v7i6. 616. 57 Olga Gurgula, Strategic Patenting by Pharmaceutical Companies – Should Competition Law Intervene? ,

51(9) IIC INT’L REV. INDUS. PROP. & COPY. L. 1062, (2020),

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7592140/pdf/40319_2020_Article_985.pdf.

58 Generic drugs - availability and patent status, DRUGS.COM (Dec. 17, 2023),

https://www.drugs.com/availability/.

patent expires. 59 To avoid that, the company makes minor variations to the existing patented invention and files for a secondary patent before the expiration of the first patent in an attempt to extend their monopoly rights to commercialize the product and to extend the shelf life of that product and this is generally termed as the ‘Evergreening’ of a patent. 60 The provision for the grant of secondary patents for an invention as given under Article 31(l)(i) of the TRIPS agreement puts down the condition that any invention that claims a second patent must have “an important technical advance of economic significance in relation to the invention claimed in the first patent. ”61 Though the TRIPS agreement is more liberal in the view of granting secondary patents and its implication reflects on countries like the U. S and U. K.

which have high granting rates of patents, India has comparably lower granting rate because it has always opted for minimizing the patent extension and so section 3(d) was introduced in the Act in the 2005 amendment by laying down an obligation to the pharma companies to prove increased efficacy of the new drug. 62 Therefore, the decision of the Indian Patent Office to reject a secondary patent for the fumarate salt of Bedaquiline will most definitely serve as a threat to other pharma empires who are sustaining in the drug market by claiming an extension of the existing drug and as a consequence of this decision the pharma companies may lose their market share retention due to the loss of monopoly rights63 and may also have a reduction in their profits after the patent for the drug expires. 64

B. Foreign Policies

A Free trade Agreement (FTA) is an agreement signed between two or more countries in which

they agree to certain conditions proposed in the agreement in matters of trade, investors’ protection, intellectual property rights, and other related matters.65 In January 2022 India and 59Alam & Raza, supra, note 23.

60 Shilpi Kumari, Ever-Greening of Patents: An Introductory Brief, MONDAQ (Aug. 7, 2020),

https://www.mondaq.com/india/patent/974246/ever-greening-of-patents-an-introductory-brief.

61 TRIPS Agreement, supra note 2.

62 Bhaven N. Sampat, B & Kenneth C. Shalden, Secondary Pharmaceutical Patenting: A Global Perspective, 46(3) RSCH. POL’Y 693, (2017), https://www.sciencedirect.com/science/article/pii/S0048733317300057. 63 Top Strategies for Pharma Profitability after Drug Patents Expire. DRUG PAT. WATCH (Dec. 17, 2023, 5:49 AM), https://www.drugpatentwatch.com/blog/top-strategies-for-pharma-profitability-after-drug-patents-expire/. 64 Gerard T. Vondeling et al., “The Impact of Patent Expiry on Drug Prices: A Systematic Literature Review”,

16 APPLIED HEALTH ECON. & HEALTH POL’Y, 653, (2018),

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6132437/. 65Free trade Agreement overview, INT’L TRADE ADMIN., https://www.trade.gov/free-trade-agreementoverview (last visited Dec. 23, 2023).

the United Kingdom initiated the negotiation process for a new FTA between them66 and on

31 October 2022, a chapter regarding Intellectual Property rights of the draft proposal of the

FTA was leaked and the propositions seemed to be against Indian patent laws.67 Articles E.10 and E.12.2 of the leaked chapter suggest the evergreening of UK pharmaceutical companies and restrict the pre-grant opposition provision.68 India, however, is resisting the move as it wants to protect its generic drug industry and consumers and is against the evergreening of patents.69 Since the agreement is yet to be signed, rejection of the Bedaquiline patent extension may cause India to refrain from agreeing upon the evergreening conditions in the India-UK FTA. If India sticks to its guns, it will have a major impact on the foreign policy of other countries in the future.

C. Foreign Direct Investments:

Foreign direct investment (FDI) means the investment made by foreign companies in India to take advantage of the privileges (labour, tax exemption, etc.,) available in India and contribute to the economic development of India by acting as a non-debt financial resource.70 Over the last five years, FDI inflows in the pharmaceutical sector are estimated to be over Rs 43,000 crore, with a growth of 58% in the fiscal year 2022-23.71 Such investment in India's pharmaceutical sector will pave the way for the generics market to flourish, thereby meeting the drug needs of the Indian people.72 However, the evergreening strategies of large

66 India-UK joint statement on the JETCO, GOV.UK (Jan. 14, 2022),

https://www.gov.uk/government/news/india-uk-joint-statement-on-the-jetco. 67 Leena Mengheney, MSF responds to UK’s disastrous proposal on intellectual property in UK-India Free Trade Agreement, MEDECINS SANS FRONTIERES- ACCESS CAMPAIGN [MSF] (Nov. 2, 2022), https://www.msfaccess.org/msf-responds-uks-disastrous-proposal-intellectual-property-uk-india-free-tradeagreement.

68 Damaging provisions for access to medicines in the UK-India FTA negotiation text, MEDECINS SANS

FRONTIERES- ACCESS CAMPAIGN [MSF] (Nov. 2, 2022), https://msfaccess.org/damaging-provisionsaccess-medicines-uk-india-fta-negotiation-text; UK-India FTA: draft intellectual property chapter, BILATERALS.ORG (2022), https://www.bilaterals.org/IMG/pdf/ukindia_fta_ip_chapter_dated_april_2022_68_.pdf. 69 Amiti Sen, India-UK FTA: Gaps yet to be covered in several chapters, THE HINDU BUSINESSLINE. (Nov. 6, 2023), https://www.thehindubusinessline.com/economy/india-uk-fta-gaps-yet-to-be-covered-in-severalchapters/article67504629.ece.

70 Ministry of External Affairs- Investment, EMBASSIES OF INDIA (2018),

https://eoi.gov.in/eoisearch/MyPrint.php?1148?001/0010. 71 Press Release, Cabinet Committee on Economic Affairs (CCEA), Cabinet approves foreign investment of up to Rs.9589 crore in M/s Suven Pharmaceuticals Limited, PRESS INVESTIGATION BUREAU, https://pib.gov.in/PressReleasePage.aspx?PRID=1956906. 72 Nidhi Tewathia, Foreign Direct Investment in Indian Pharmaceutical Industry: An Assessment, 2 INT’L J.

SOC. SCI. & HUMAN. RSCH. 20, 26 (2014),

https://www.researchpublish.com/upload/book/Foreign%20Direct%20Investment%20in%20Indian%20Pharmac eutical%20Industry-378.pdf.

pharmaceutical companies remain a threat to FDI in the pharmaceutical sector in India.73 Since the decision in the matter of Bedaquiline by the IPO established India’s stance against evergreening, it is imperative to say that these evergreening strategies will pose less of a threat to foreign companies investing in India. This will in turn boost the development of India’s pharma sector as well as its economy.

D. Health Imperative

Low- and middle-income countries (LMICs) were apprehensive that having to grant patents on pharmaceuticals would increase prices and undermine the government's ability to protect public health. 74 The Doha Declaration of 2001 stated that the TRIPS Agreement should not be an obstacle to action by members to protect public health and reaffirmed the right of governments to make effective use of the flexibilities in the TRIPS Agreement. 75 A country can promote its public health by way of improving the accessibility and affordability of essential drugs to all its people. 76 Generic drugs are drugs that are generally used interchangeably with an original product, manufactured without a license from the originator company, and marketed after the expiry of the patent.

77 They are typically 30%–80% cheaper than their original version and the effective use of generic drugs will ensure sound treatment options for the patients. 78 However, the delay of the entry of generic drugs into the market is due to the secondary patents granted to the pharma companies who continue to earn profit by extending their monopoly rights over the drug. 79

73 Ibid.

74 Brigitte Tenni et al., What is the impact of intellectual property rules on access to medicines? A systematic review, 18 GLOB. HEALTH, 40 (2022), https://doi.org/10.1186/s12992-022-00826-4.

75 The Doha Declaration explained, WORLD TRADE ORG. [WTO],

https://www.wto.org/english/tratop_e/dda_e/dohaexplained_e.htm (last visited Dec. 23, 2023). 76 Sitanshu S. Kar et al., Concept of essential medicines and rational use in public health, 35 IND. J. COMMUNITY MED., 10,13 (2010), https://doi.org/10.4103/0970-0218.62546. 77 Karan B. Thakkar & Gauri Billa, The concept of: Generic Drugs and patented drugs vs. brand name drugs and non-proprietary (generic) name drugs, 4 FRONT. PHARMACOL. (2013) https://www.frontiersin.org/articles/10.3389/fphar.2013.00113/full. 78 S S Joshi, Y C Shetty & S Karande, Generic drugs - The Indian scenario, 65(2) J. POSTGRADUATE MED. 67, (2019), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6515776/.

79 Tenni et al., supra note 74.

Bedaquiline is listed as one of the essential medicines in the WHO's list of essential medicines80 and in the national list of essential medicines of India81 and also WHO prescribed dosage for effective treatment of tuberculosis.82 Three Indian pharmaceutical companies, namely Lupin, Natco, and Macleods, are expected to launch their generic versions of bedaquiline once J&J's patent expires.83 Rejecting the patent extension claim by J&J will pave the way for these generic drug manufacturing companies to manufacture the TB drug for a much cheaper rate thereby increasing the accessibility of this drug which in turn positively impacts public health.84 The impact of the decision will not only be limited to the TB drug but also to all other drugs for several virulent diseases like HIV, Cancer, etc., that are essential for the development of the public health sector in India.

E. Global Forerunner

Following India’s rejection of the patent extension claim by J&J on 23 March 2023, the company decided not to enforce its patent extension claims in 134 countries that are recognized as LMICs. 85 This decision will be extremely beneficial not only for India but for all other nations with a high burden of TB and other infectious diseases that pose a threat to human lives due to the poor health systems of those countries. 86 India has always been seen as the world’s pharmacy due to its successful export of pharma products to the countries in need. 87 The export of Indian pharma products is estimated to have increased up to 125 per cent in the last decade as pharmaceuticals exports constitute 5. 71 per 80 The selection and use of essential medicines 2023 Web Annex A World Health Organization Model List of Essential Medicines – 23rd List, WORLD HEALTH ORG. [WHO] (2023), https://iris. who.

int/bitstream/handle/10665/371090/WHO-MHP-HPS-EML-2023. 02-eng. pdf? sequence=1.

81 National List of Essential Medicines (NLEM), 2022, MINISTRY OF HEALTH & WELFARE (2022),

https://main.mohfw.gov.in/?q=newshighlights-104. 82 WHO consolidated guidelines on tuberculosis. Module 4: treatment - Drug-resistant tuberculosis treatment

2022 update, WORLD HEALTH ORG.[WHO] (2022),

https://iris.who.int/bitstream/handle/10665/365308/9789240063129-eng.pdf?sequence=1.

83 Datta, supra note 40.

84 Sankalp Yadav et al. , India’s decision to deny an extension of patent for Bedaquiline: A public health imperative, CUREUS (Nov. 28, 2023), https://www. cureus. com/articles/202667-indias-decision-to-deny-anextension-of-patent-for-bedaquiline-a-public-health-imperative#! /. 85 Johnson & Johnson confirms intent not to enforce patents for SIRTURO® (bedaquiline) for the treatment of multidrug-resistant tuberculosis in 134 low- and middle-income countries, JOHNSON & JOHNSON (2023), https://www. jnj. com/johnson-johnson-confirms-intent-not-to-enforce-patents-for-sirturo-bedaquiline-for-thetreatment-of-multidrug-resistant-tuberculosis-in-134-low-and-middle-income-countries. 86Joshi et al. , supra note 78. 87 Robert M. Califf, India’s unique opportunity and responsibility as pharmacy to the world, U. S. FOOD & DRUG ADMIN. (2023), https://www. fda.

gov/news-events/fda-voices/indias-unique-opportunity-and-importantresponsibility-pharmacy-world.

cent of the country’s total exports and the top countries where the exports are being made are the USA, UK, Belgium, Brazil and South Africa. 88 So, India’s export of generic versions of Bedaquiline to other countries will not only boost India’s economy but also increase drug accessibility in countries with high TB burden such as Belarus, Ukraine, and many other countries in the African region. 89 The decision of the IPO to reject the secondary patent of Bedaquiline will act as a global precedent to all other countries to prioritize their public health over intellectual property rights and also will increase the accessibility of TB drugs across the world.

90 The primary patent of a TB drug similar to Bedaquiline called Delamanid, owned by Japan's Otsuka Pharma, expires at the end of 2023, and India's decision to reject the Bedaquiline patent could have an impact on other countries as they decide the issue of Delamanid's patent extension by prioritizing people's health. 91

V. POSSIBLE SUGGESTIONS

The battle between innovation and accessibility in the pharmaceutical industry has been going on ever since patents were granted for medicines, and the burden of setting a domain for each of them falls on the legislator as well as the deciding authority. 92 Some possible solutions are proposed below to make effective decisions in the future and to avoid potential conflicts. • The government should give priority to health by setting up councils and committees comprising legal professionals, health experts, scientists, and NGOs to scrutinize the feasibility of the modified drugs seeking secondary patents, to assess their potency and applicability in society and also their implications on public health. The costs and benefits must be analysed and the decision to prolong the patent must be taken after rigorous analysis.

88 Press Release, Ministry of Health and Family Welfare, India’s Pharma Exports grow over 125% in last 9 years Investment of Rs. 21,861 Crore received under PLI Schemes, PRESS INFO. BUREAU (Jun. 13, 2023), https://pib. gov. in/PressReleasePage. aspx? PRID=1932026.

89 High TB Burden Country Profiles, WORLD HEALTH ORG. [WHO] (2022),

https://www.who.int/teams/global-tuberculosis-programme/tb-reports/global-tuberculosis-report-2022/high-tbburden-country-profiles.

90 Yadav et al., supra note 84.

91 PERAPPADAN, supra note 10.

92 Chunming Xu & Debao Zhu, Solving the conflict between accessibility and patent protection of drugs based on public safety, INT’L J. SAF’Y & SEC. ENG’G (2020), https://doi.org/10.18280/ijsse.100209; What are the obstacles to innovation in the pharmaceutical industry?, DRUG DISCOVERY WORLD [DDW] (2020), https://www.ddw-online.com/what-are-the-obstacles-to-innovation-in-the-pharmaceutical-industry-689-201108/.

A checklist of criteria to be met for the grant of a secondary patent should be available to the deciding authority. As the authority has not followed such a checklist procedure, there is no defined set of criteria and this creates a hurdle in the decision-making process for secondary patent extension. 93 A comprehensive and descriptive set of rules should be formulated by the government or the patent office, and various levels of examination should be carried out before a decision is made. 94 • The government should take the initiative to organize awareness campaigns to sensitize the public about the importance of access to medicines, the impact of patents on access to medicines, and also to enlighten them about the provisions of the Indian Patent laws regarding opposition to the grant of patents on certain inventions.

• Any country seeking to develop its health sector by circumventing the threat of evergreening by pharmaceutical companies has to make effective use of TRIPS flexibilities such as compulsory licensing, bilateral exemptions, parallel imports, and research exemptions while a drug is being submitted for granting of a patent extension. 95

VI. CONCLUSION

A single decision by the Indian Patent Office has various implications for the health, marketing,

and economy of the country and of the world. After the Novartis decision, the guidelines were not strictly followed and seemed to have been watered down, but the IPO's decision to reject the application for a secondary patent on Bedaquiline has revived the Novartis decision on patent evergreening and given hope to all. To avoid future conflicts with foreign pharmaceutical companies over the extension of patents, India must take the initiative to develop its indigenous pharma companies and formulate effective policies to promote various inventions in India through incentives and stipends so that the pharmaceutical sector in India can flourish. 96 As India is emerging as an indispensable power in the global economy, its contribution to the pharmaceutical sector will play a crucial 93 Feroz Ali et al.

, Pharmaceutical patent grants in India: How our safeguards against evergreening have failed, and why the system must be reformed, INFOJUSTICE (2018), https://infojustice. org/archives/39890.

94 Ibid.

95 Joshi et al., supra, note 78.

96 Feroz Ali et al., supra note 93.

role in its economic development. Therefore, India must take effective measures to achieve it more swiftly and efficiently for the collective benefit of its people.