By Renu Bala and Aastha Suri
Introduction
Article 33 of the TRIPS agreement states that the term of patent protection is 20 years from the date of filing a patent application. In the interest of extending the validity of patents beyond 20 years, patent holders in pharmaceutical industry, tend to employ different strategies such as new routes of administration for known drugs or use of existing compound, ever-greening of patents, development of biosmilars etc[1]. Patent rights being territorial in nature, implementing such strategies may vary across jurisdictions. This article focusses on the aspects that differentiates a couple of said strategies used in the pharmaceutical sector, relevant Indian jurisprudence, and analyzing the impact of local regulatory developments on the Indian pharmaceutical landscape.
Business Strategies in Pharmaceutical Sector
A typical business strategy used by certain patent owners, often by the pharmaceutical sector, is to extend the term of their patent rights beyond the original expiration date, a practice commonly known as “Ever-greening of Patents”. This is achieved by making minor modifications to the original product or by filing multiple successive patents for incremental innovations related to the original invention. As a consequence, a competitor can neither bypass the original invention nor develop a product around it without infringing on the existing patent. Thus, the term “Ever-greening of Patents” has become appropriately synonymous with being immortal.
Ever-greening of patents creates a monopoly, thereby preventing competitive growth, and a significant repercussion includes its impact on the accessibility as well as affordability of essential medicines, consequently becoming a threat to public health. From a Pharmaceutical company’s perspective, they make huge investments in R&D to arrive at a successful product, and therefore, they intend to increase their profitability by extending their exclusive legal right.[2]
Another strategy that prevails in the pharmaceutical sector involves biosimilars, which is a biological product clinically similar to already approved reference biological product. While ever-greening aims to extend patent protection, the development of biosimilars represents a distinct approach to pharmaceutical innovation. Both the strategies significantly impact drug accessibility and affordability but in contrasting ways.
What is a biosimilar?
Biosimilars are alternatively referred to as “Similar Biotherapeutic Product” or “Similar biologics”. Biosimilar is not a generic drug rather a product similar to an already approved reference biological product, in terms of quality, safety, and efficacy, in accordance with WHO’s guidelines. While the generic drugs are small-molecule products containing well-defined structures and formulae and are easily reproducible through chemical synthesis, biosimilars are large-molecule, bio-originated products having complex structures that can be developed from cell lines or living organisms[3].
India’s legal approach
In an attempt to prevent ever-greening of patents, the Indian Patents Act, 1970 includes Section 3(d)[4]. A detailed analysis on how Section 3(d) blends with TRIPS mandate, citing relevant case studies have been discussed in our previous article[5]. Further, some of the relevant judgements shaping the interpretation of Section 3(d) are as follows[6]:
- Novartis Ag V. Union of India (2013) wherein the Supreme Court of India, while affirming the rejection to grant a patent for “Glivec”, made a significant interpretation of the term “efficacy” in Section 3(d) as referring to therapeutic efficacy.
- Chugai Seiyaku Kabushiki Kaisha V. CGPDTM (2022), where the Court dismissed the appeal to grant a patent to the compound Tofogliflozin as there was no evidence of significant enhancement of the known efficacy in comparison with an already existing compound patented by the same applicant;
- In April 2023, a remarkable decision by Indian Patent Office to deny patent extension for Bedaquiline has nipped in the bud of delaying the entry of generic forms of Bedaquiline drug used in Tuberculosis treatment, in the Indian market, plausibly enhancing affordability and accessibility of the drug[7].
Such judgements/ decisions have highlighted India’s resistance to Ever-greening of patents, and marking an effort to make essential medicines affordable to the public.
In order to be aware of India’s position on biosimilars, one must analyze the pertinent guidelines. A biosimilar is developed based on a reference biologic. In 2012, regulatory guidelines for biosimilars (similar biologics) were developed by regulatory bodies of India, strengthening India’s position in the biopharmaceutical sector. Further, a revised version aimed to be in par with global standards, is in practice since 2016. An extensive characterization study is required to be conducted, revealing the molecular and quality attributes in comparison with the Reference Biologic. The guidelines states that the dosage form, strength, and route of administration of the Similar Biologic should be the same as that of the Reference Biologic; and the active ingredient must be shown to be similar. Thus, biosimilars are highly similar in respect of purity, safety, and potency to already existing biologic products and are structurally similar despite potential minor changes in the sequences or post-translational modifications.[8] Some of the similar biologics approved and available in India are Glaritus, Epofer, Abcixirel, Herceptin, Razumab, etc.[9]
India, a pioneer to approve biosimilar
India has been at the forefront of biosimilar approvals, reflecting India’s effort to balance IP protection alongside promoting innovation. India was the first country in the world to approve a biosimilar product, way back in the year 2000, preceding similar approvals in the US and Europe. Subsequently, guidelines for regulating the approval process of biosimilars (similar biologics) have been implemented. This regulatory framework balances state-of-the-art innovation, public health needs, and IP considerations. Further, this line of action indicates India’s endeavor to foster advanced pharmaceutical developments while addressing concerns about patent policies and providing broad access to essential medicines.[10]
Expanding economic impact of biosimilars
The global market statistics of 2025 indicate that, of late, the biosimilar market size has grown rapidly worldwide. Globally, it is expected to accelerate at a compound annual growth rate (CAGR) of 17.7%, reaching $21.95 billion in 2025 and $42.16 billion in 2029. Biocon has become a pioneer in this field by developing Trastuzumab. This biosimilar product has profoundly impacted global healthcare because the reference biologic was priced at an average of $20,000. By comparison, Biocon’s biosimilar version is estimated to be 65% cheaper, and thereby, it significantly increased public access to this life-saving cancer therapy drug. As a testament to being affordable, WHO has included Trastuzumab to the list of essential medicines. According to India BioEconomy Report (IBER) 2023, the market size of the biopharmaceutical sector encompassing biosimilars, is valued at $53.8 billion (35.8% share) and is expected to grow at a CAGR of 25.20% during the forecast period of 2025-2034, with values reaching as high as INR 16.6 billion by 2034. [11],[12],[13]
Is Ever-greening of patents interconnected with biosimilars?
Ever-greening of bio-pharmaceutical patents delays the entry of biosimilar into the market, maintaining the originator’s monopoly and subsequently affecting the economy of developed as well as developing countries. In contrast, biosimilars not only enhance accessibility but also promote market competition and price moderation. Hence, ever-greening of patents and biosimilars are intricately linked in the biopharmaceutical industry.
Path ahead
Biosimilars seems to be mutually beneficial for pharmaceutical sector as well as public health. It is apparent that India is on the verge of becoming a global leader in biosimilar, producing a wide range of products that have revolutionized the treatment of chronic and life-threatening conditions. However, to capitalize on this, it is necessary to overcome some ongoing challenges such as complicated manufacturing process, diverse regulations across globe that impact the quality of biosimilar approvals etc.
One of the recent judgements pronounced by the Delhi High Court highlights such a concern. In 2024, a landmark injunction was ordered by the Delhi High Court to restrain Zydus and Dr. Reddy from marketing/selling their product “Sigrima”, which is a biosimilar of Roche’s “Pertuzumab”. In the case of F Hoffmann-La Roche Ltd. & Ors. V. Drugs Controller General of India & Ors. Roche filed a suit seeking a declaration that the approval granted to ‘Cadila Healthcare Limited’ and ‘Hetero Drugs Limited’ by the DCGI for manufacturing authorization under the Drugs and Cosmetics Act, 1940, was invalid. The Delhi High Court ruled in favor of Roche, directing Cadila and Hetero to produce the relevant documents within 4 weeks. This judgement emphasizes the significance of transparency in the approval process of drugs that impact public health. Further, it highlights the judiciary’s role in reinforcing regulatory compliance and, hence, protecting public interest in the pharmaceutical sector.[14]
Conclusion
Certainly, ever-greening of patents assists pharmaceutical companies in raising the bar concerning profits as well as shielding them from infringers. Despite being favourable for pharmaceutical companies, the said strategy fails to showcase public welfare. In comparison to ever-greening of patents, biosimilar certainly paves a mutually beneficial path between pharmaceutical industry and the public health. However, the variable nature and complexity of biologic molecules pose challenges in keeping up consistency, efficacy, and safety across several batches of the products in the pharmaceutical sector. Although India has leaped forward in the biosimilars market, it is crucial to continue with regulatory refinements as well. The Government of India and the regulatory bodies must persistently prioritize the rigorous scrutiny of the regulatory process and approvals in the pharmaceutical industry. Maintaining high standards for biosimilar approvals is essential to upholding India’s reputation as the pharmaceutical leader. To assist this, the regulatory bodies must periodically update the guidelines to align with the latest international standards, ensuring integrity in the biosimilar market. By meeting these standards, India shall not only strengthen its position as a trustworthy leader in the global biosimilar market but also strike a balance between innovation, accessibility, and regulatory compliance.
Shanmuhapreya D, Patent Agent at S.S.Rana & Co. has assisted in the research of this article.
[1] Patent protection strategies
[2] Biosimilars and The Issue of Evergreening
[3] Guidelines on evaluation of biosimilars
[4] Strong IP laws prevent so-called “evergreening” of patents to enhance access to TB drugs in India
[5] How to analyze section 3(d) of Indian Patent Act?
[6] Court orders disclosure of regulatory documents in bio-similar drug dispute: High Court of Delhi
[7] India’s Decision to Deny an Extension of Patent for Bedaquiline: A Public Health Imperative
[8] GUIDELINES ON SIMILAR BIOLOGICS
[9] Biosimilars in India; Current Status and Future Perspectives
[10] Why India must turn Biosimilar Powerhouse by 2030
[11] Biosimilars Global Market Report 2025
[12] India Bioeconomy Report 2024