Biologics occupy a peculiar and increasingly central place in modern medicine large, complex molecules manufactured through living cell systems rather than chemical synthesis, used to treat cancer, autoimmune disease and a growing list of conditions for which no small-molecule alternative exists. As the patents covering the first generation of blockbuster biologics Herceptin, Avastin, Rituxan, Humira have expired or been abandoned across major markets including India, a new and commercially vital category of pharmaceutical product has emerged to compete with them: the biosimilar or as Indian regulatory terminology calls it, the “similar biologic.” India today is among the most active biosimilar markets in the world, both as a manufacturing base for export and as a domestic market where access to affordable biologic therapy is a matter of genuine public health significance.
The legal architecture governing biosimilars in India is unusual in that it sits at the intersection of two regulatory systems that were not designed with each other in mind. The Patents Act, 1970, governs the question of whether a biosimilar manufacturer’s product or process can be patented and whether a biosimilar’s market entry might infringe a subsisting patent held by the originator. Separately, the Guidelines on Similar Biologics: Regulatory Requirements for Marketing Authorisation in India, 2016, issued jointly by the Central Drugs Standard Control Organisation (CDSCO) and the Department of Biotechnology (DBT), govern the wholly distinct question of whether a biosimilar product is safe, efficacious and similar enough to its reference biologic to be marketed in India at all. These two regimes do not talk to each other in any formal, statutory sense India has no Bolar-style patent linkage system requiring a drug regulator to check patent status before granting marketing approval, unlike the patent linkage mechanisms that exist in the United States under the BPCIA framework. The result is a distinctively Indian pattern of biosimilar disputes, exemplified by the decade-long Roche v. Biocon and Mylan litigation over trastuzumab, in which patent rights, regulatory approval and trademark and passing-off claims have all been litigated simultaneously, in parallel and not always consistently.
This article examines the full landscape of biosimilar patents in India: the statutory definitions and patentability standards applicable to biologic inventions under the Patents Act, 1970, the absence of any meaningful data or market exclusivity regime for biologics in India, the CDSCO-DBT regulatory pathway for similar biologics and its interaction with patent rights, the landmark Roche litigation that has shaped Indian biosimilar jurisprudence and the practical strategic considerations for both originator companies and biosimilar manufacturers operating in the Indian market.
What Makes a Biologic Different – And Why That Matters for Patent Law
A biologic is a therapeutic product manufactured in or derived from a living system bacteria, yeast or mammalian cell lines engineered to produce a target protein, antibody or other macromolecule. Unlike a small-molecule drug, which has a fixed and reproducible chemical structure that can be synthesised identically by any manufacturer who knows the formula, a biologic’s structure depends on the specific cell line, the precise fermentation and purification process and a host of manufacturing variables that affect glycosylation patterns, folding and other post-translational modifications. Two manufacturers using different cell lines and processes will never produce molecules that are chemically identical, even if they are biologically equivalent in clinical effect.
This has a direct consequence for biosimilar patentability and for the patent landscape biosimilar manufacturers must navigate. A biologic originator typically protects its product through a portfolio of patents covering not just the molecule itself, but the specific cell line used to produce it, the manufacturing process, the purification methods, the formulation and methods of treatment using the molecule. A biosimilar manufacturer must develop its own cell line and its own manufacturing process it cannot simply replicate the originator’s molecule using the originator’s process, because that process is itself patented and protected as a trade secret. This is fundamentally different from small-molecule generic drug development, where the chemical synthesis route is usually disclosed in the originator’s patent specification and a generic manufacturer can follow a published, non-infringing synthesis route once the compound patent expires.
The consequence in Indian patent practice is that biosimilar development inherently generates its own patentable subject matter the biosimilar manufacturer’s distinct cell line, process and formulation may themselves be patentable inventions, provided they meet the ordinary tests of novelty, inventive step and industrial applicability under Sections 2(1)(j) and 2(1)(ja) of the Patents Act, 1970. Biosimilar litigation in India is therefore not simply a question of whether a biosimilar infringes an originator’s patent it frequently also involves competing claims to process patents covering different manufacturing routes for biologically similar end products.
Patentability of Biologics Under the Patents Act, 1970 – Sections 3(b), 3(c), 3(j) and 3(d)
Several provisions of Section 3 of the Patents Act, 1970, which enumerates non-patentable subject matter, bear directly on biologic and biosimilar inventions and any practitioner advising in this space must engage with each.
Section 3(b) excludes from patentability inventions whose primary or intended use or commercial exploitation would be contrary to public order or morality or which cause serious prejudice to human, animal or plant life or health or to the environment. This provision has occasionally been invoked, though rarely successfully, against biologics where opponents have argued that genetically modified organisms or their products pose environmental or health risks; in practice, Indian patent examiners and courts have applied this provision narrowly and have not used it as a significant barrier to legitimate biologic patents supported by appropriate regulatory clearances.
Section 3(c) excludes the mere discovery of a scientific principle or the formulation of an abstract theory or the discovery of any living thing or non-living substance occurring in nature. This provision is directly relevant to biologics because many therapeutic proteins and antibodies are derived from or closely resemble naturally occurring substances. The boundary Indian patent examination draws is between mere discovery identifying a naturally occurring protein and its function and genuine invention, which requires that the claimed subject matter be a product of human technical intervention: an isolated, purified or recombinantly produced form of the protein that does not exist in that form in nature or a modified version (such as a humanised monoclonal antibody) that involves inventive human intervention beyond mere isolation.
Section 3(j) is the provision most frequently engaged in biotechnology patent prosecution. It excludes from patentability plants and animals in whole or any part thereof other than micro-organisms, but including seeds, varieties and species and essentially biological processes for the production or propagation of plants and animals. The critical carve-out within this exclusion is that micro-organisms themselves remain patentable in India, a position reinforced by India’s accession to the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purpose of Patent Procedure. Recombinant cell lines, engineered bacterial or mammalian expression systems and the micro-organisms used to manufacture biologics and biosimilars therefore fall within patentable subject matter, provided the other patentability criteria are met, while the broader category of “essentially biological processes” for producing plants and animals remains excluded. This distinction matters enormously for biosimilar process patents, which typically claim the engineered cell line and the specific fermentation, expression and purification process all of which sit on the patentable side of the Section 3(j) line, distinct from any claim that might attempt to monopolise a naturally occurring biological process.
Section 3(d), the provision made famous by the Supreme Court’s ruling in Novartis AG v. Union of India, (2013) 6 SCC 1, is also directly relevant to biosimilar patent strategy, though its application to biologics differs somewhat from its application to small-molecule pharmaceuticals. Section 3(d) excludes the mere discovery of a new form of a known substance that does not result in enhanced efficacy and the mere discovery of a new property or new use of a known substance. For biologics, this provision becomes relevant where an originator or biosimilar manufacturer seeks a patent for a modified version of an existing biologic a new glycosylation pattern, a new formulation, a PEGylated variant or a biobetter version of an established molecule. Just as with small-molecule polymorphs and salts, the applicant must demonstrate that the modification produces a significant enhancement in therapeutic efficacy, not merely improved stability, manufacturability or pharmacokinetic convenience, to overcome the Section 3(d) bar. This has real strategic significance for “biobetter” development in India, where companies seeking to patent improved versions of existing biologics face the same efficacy-enhancement threshold that pharmaceutical polymorph patents face.
The Absence of Data Exclusivity and Patent Linkage in India
One of the most consequential features of the Indian biosimilar landscape and one that distinguishes it sharply from the regulatory environment in the United States and the European Union is the complete absence of any statutory data exclusivity period for biologics and the absence of any patent linkage mechanism connecting drug regulatory approval to patent status.
In the United States, the Biologics Price Competition and Innovation Act, 2010 (BPCIA), grants reference biologic products twelve years of data exclusivity, during which a biosimilar applicant cannot rely on the originator’s clinical trial data to support an abbreviated approval pathway. The European Union similarly provides data and market exclusivity periods for biologics under its centralised authorisation framework. India has no equivalent statutory provision. The Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945, as amended, together with the New Drugs and Clinical Trials Rules, 2019, govern the approval pathway for biosimilars in India, but none of these instruments creates a period during which a biosimilar applicant is barred from relying, in whole or in part, on the comparability data generated against the reference biologic.
This absence of data exclusivity was the central factual and legal premise of the long-running Roche litigation against Biocon and Mylan over their trastuzumab biosimilar, discussed in detail below. Counsel for Biocon explicitly noted, following one of the favourable rulings in that litigation, that the Delhi High Court had confirmed there is no data exclusivity regime in India for biologics a confirmation with major commercial implications, because it means that an Indian biosimilar manufacturer’s regulatory pathway does not depend on waiting out an exclusivity clock once the originator’s patent protection has lapsed or been abandoned, in the way that it would in the United States.
The absence of patent linkage is equally significant and operates differently from the absence of data exclusivity. In jurisdictions with patent linkage most notably the United States under the BPCIA’s “patent dance” provisions a biosimilar applicant and the reference product sponsor are required to exchange patent information and litigate patent disputes within a structured framework tied to the regulatory approval timeline, often before the biosimilar can be marketed. India has no such mechanism. The CDSCO and DBT, in granting marketing authorisation for a similar biologic, do not investigate, consider or rule on the patent status of the reference biologic or the applicant’s product. A biosimilar can receive full marketing approval in India while patent litigation concerning the same product is entirely unresolved, ongoing or has not even been initiated. This was precisely the situation in the Roche-Biocon-Mylan dispute, where CANMAb and Hertraz received DCGI approval and were launched commercially while parallel litigation over Roche’s data and trademark rights proceeded through the courts for years.
The Regulatory Pathway – Guidelines on Similar Biologics, 2016
The substantive regulatory framework for biosimilar approval in India is set out in the Guidelines on Similar Biologics: Regulatory Requirements for Marketing Authorisation in India, 2016, jointly issued by CDSCO and DBT, which updated and replaced the earlier 2012 guidelines. These guidelines define a “similar biologic” as a product that is similar in terms of quality, safety and efficacy to an already approved reference biological product, based on a comprehensive comparability exercise.
The regulatory architecture involves multiple bodies operating in coordination. The Review Committee on Genetic Manipulation (RCGM) under the DBT, oversees the development, preclinical evaluation and biosafety aspects of the genetically modified organisms and cell lines used to manufacture the biosimilar. The Institutional Biosafety Committee (IBSC) provides institutional-level review and biosafety clearance. The Genetic Engineering Appraisal Committee (GEAC), under the Ministry of Environment, Forest and Climate Change, is involved where products derived from living modified organisms raise environmental release considerations. The CDSCO, through the Drugs Controller General of India (DCGI), serves as the apex authority for clinical trial approval and marketing authorisation.
The substantive comparability standard requires the applicant to demonstrate, through a structured comparability exercise spanning analytical characterisation, preclinical studies and clinical trials, that the similar biologic does not differ significantly from the reference biologic in terms of critical quality attributes and key quality attributes. Where similarity is convincingly demonstrated at the analytical and preclinical stages, the guidelines permit a reduced clinical data package, recognising that exhaustive Phase III trials replicating the full development programme of the original biologic would be both economically prohibitive and scientifically unnecessary once analytical and preclinical comparability has been robustly established. The guidelines require that the reference biologic itself be one that is approved and marketed in India, or, in defined circumstances, approved in a jurisdiction with a stringent regulatory framework recognised under the ICH (International Council for Harmonisation) framework.
Nothing in this comparability-driven regulatory pathway makes any reference to patent status. The approval process is purely a question of scientific and clinical comparability quality, safety and efficacy and is administered entirely independently of the question of whether the reference biologic, the manufacturing process or the cell line used by the applicant might be covered by a subsisting Indian patent.
The Roche v. Biocon/Mylan Trastuzumab Litigation – India’s Defining Biosimilar Dispute
The most extensive and instructive body of biosimilar case law in India arises from the decade-long litigation between Roche (through its subsidiary Genentech) and the Indian biosimilar manufacturers Biocon and Mylan over trastuzumab, the active ingredient in Roche’s blockbuster breast cancer drug marketed in India as Herceptin, Herclon and Biceltis. This litigation is essential reading for any practitioner working in Indian biosimilar law because it illustrates, in a single sustained dispute, the full range of legal theories patent, regulatory compliance, trademark and passing off that originator companies can deploy against biosimilar entrants in the absence of a dedicated biosimilar patent litigation framework.
The background is instructive in itself. Genentech, a Roche subsidiary, held a formulation patent for trastuzumab in India effective from May 3, 1993, which lapsed on March 3, 2013. In a development that attracted considerable commentary, Roche made the strategic decision not to pursue patent protection for trastuzumab through to its full term in India, reportedly in part because of concerns that a compulsory licence application under Section 84 of the Patents Act, 1970 following the precedent set by the Bayer-Nexavar compulsory licence might be sought against Herceptin given its high price and the seriousness of the medical need. Shortly after Roche’s patent lapsed, Biocon and Mylan jointly developed and launched a biosimilar version of trastuzumab under the brand names CANMAb and Hertraz respectively, following DCGI regulatory approval.
Roche’s response was not a patent infringement suit there was no longer a subsisting patent to infringe but rather a suit grounded in regulatory non-compliance and passing off. Roche alleged, in proceedings before Justice Manmohan Singh of the Delhi High Court in late 2013 and early 2014, that Biocon and Mylan had not satisfied the regulatory requirements applicable to biosimilars under the relevant CDSCO-DBT guidelines and separately, that Biocon and Mylan were passing off their products as equivalent in quality and class to Herceptin by describing them using the term “biosimilar version of Trastuzumab/Herceptin.” The Delhi High Court found merit specifically in the passing-off argument and granted an interim injunction restraining Biocon and Mylan from referring to their products using the term “biosimilar” in relation to Herceptin, while declining to find merit in the broader regulatory non-compliance argument at that interim stage.
The litigation continued through multiple rounds over the following years. A particularly consequential decision came from the Single Judge of the Delhi High Court in two related matters – Roche Products (India) Private Limited v. Drug Controller General of India & Ors. concerning the Biocon/Mylan product and a parallel matter involving Reliance Life Sciences’s biosimilar decided on April 25, 2016. This Single Judge ruling imposed significant restrictions on the sale and marketing of biosimilar trastuzumab, holding among other things that the defendants could not rely on Roche’s own product insert data and clinical trial information to support marketing of their biosimilars for cancer indications beyond the one for which their own independent comparability data had been generated and that the appeal remedy available under Rule 122DC of the Drugs and Cosmetics Rules did not preclude Roche from bringing a civil suit. This was a ruling with serious commercial consequences for the biosimilar manufacturers, given that the additional cancer indications early breast cancer and metastatic gastric cancer, beyond the initially approved metastatic breast cancer indication represented substantial portions of the addressable market for the drug.
Biocon appealed and the Division Bench of the Delhi High Court, comprising Justice Badar Durrez Ahmed and Justice Sanjeev Sachdeva, stayed the Single Judge’s restrictive order on April 28, 2016, allowing Biocon and Mylan to continue marketing their biosimilar pending further hearing. The matter proceeded through further rounds of litigation, with the Division Bench ultimately, in a decision in March 2020, allowing Biocon and Mylan to market their trastuzumab biosimilar by then established under the brand names CANMAb and Hertraz for all three indications, including early breast cancer and metastatic gastric cancer, on the basis of the product inserts approved by the DCGI. Biocon’s counsel, Pratibha Singh, characterised this decision as confirming definitively that India does not maintain a data exclusivity regime for biologics a characterisation that has since become the standard legal proposition cited in discussions of Indian biosimilar regulation. Roche subsequently filed and then withdrew a Special Leave Petition before the Supreme Court challenging this ruling, allowing the Delhi High Court’s position to stand as the operative legal framework.
A separate but related strand of the same broader dispute involved suits filed by Roche against Cadila Healthcare and against Hetero Drugs Ltd, again involving the DCGI and the Department of Biotechnology as parties, concerning their respective trastuzumab biosimilars. These suits, numbered CS(COMM) 1119/2016 and CS(COMM) 540/2016, proceeded principally on questions of maintainability whether Roche’s suits could proceed given the existence of an appellate remedy under Rule 122DC of the Drugs and Cosmetics Rules and the Delhi High Court’s orders in these matters, including one discussed in detail in early 2020, confirmed that the appeal remedy under Rule 122DC did not bar Roche’s civil suits, allowing the litigation to proceed on the merits.
The Legal Lessons of the Roche Litigation for Biosimilar Strategy in India
The trastuzumab litigation saga offers several durable lessons for both originator companies and biosimilar manufacturers navigating the Indian market.
First, the absence of patent protection does not leave an originator company without recourse against a biosimilar competitor. Roche’s trastuzumab patent had lapsed before Biocon and Mylan launched their product, yet Roche was able to mount a sustained and partially successful legal challenge using passing-off principles and arguments about regulatory compliance and data reliance. Trademark and passing-off law, alongside regulatory compliance litigation, function as an important supplementary toolkit for originator companies in the Indian biosimilar space, particularly where patent protection has expired, lapsed or as in Roche’s case was deliberately not pursued to avoid compulsory licensing exposure.
Second, the question of whether a biosimilar manufacturer can rely on the reference biologic’s own clinical data and product information to support marketing for additional indications, beyond the indication for which the biosimilar’s own comparability studies were conducted, is a genuinely contested area of Indian law that the courts addressed inconsistently across the different stages of the Roche litigation. The Single Judge’s 2016 ruling restricting such reliance, followed by the Division Bench’s eventual 2020 decision permitting it on the facts before it, illustrates that this question remains fact-sensitive and dependent on the specific regulatory dossier and approval history of each biosimilar product, rather than settled by a single bright-line rule.
Third, the absence of any patent linkage mechanism in India means that a biosimilar can obtain full DCGI marketing approval and be commercially launched while patent and regulatory litigation concerning the same product remains entirely unresolved. This creates significant commercial risk for biosimilar manufacturers, who may invest heavily in launch and market development only to face injunctive relief as Biocon and Mylan did at multiple points during the trastuzumab litigation based on claims that emerge after launch rather than being resolved, as they would be under the BPCIA patent dance framework, before market entry.
Fourth, the use of the term “biosimilar” itself and language describing a product as similar to or a version of a reference biologic, carries trademark and passing-off risk independent of patent considerations. Originator companies hold a powerful argument that the use of such descriptive language, particularly in marketing and labelling, can constitute misrepresentation of equivalence if the comparability exercise underlying that biosimilar’s approval is incomplete or contested and Indian courts have shown a willingness to grant interim relief on this basis even where the broader patent and regulatory merits remain unresolved.
Compulsory Licensing and the Shadow It Casts Over Biologic Patent Strategy
The Bayer Corporation v. Union of India, 2014 (60) PTC 277 (Bom), litigation concerning India’s first compulsory licence granted under Section 84 of the Patents Act, 1970, for the cancer drug sorafenib (Nexavar) does not directly concern a biologic, since sorafenib is a small-molecule drug. But the spectre of that decision and the broader compulsory licensing framework under Sections 84 to 92 of the Act, has had a documented influence on originator company patent strategy in the biologic space in India, as the Roche trastuzumab episode illustrates directly. Roche’s reported decision not to pursue continued patent protection for trastuzumab in India, in the period following the Bayer-Nexavar compulsory licence, reflects a calculated assessment that maintaining patent protection over a high-priced, high-need cancer biologic in India carried meaningful compulsory licensing risk under the reasonable requirements of the public, reasonably affordable pricing and adequate working criteria set out in Section 84(1) of the Act.
This dynamic is a distinctively Indian feature of biologic patent strategy. In jurisdictions without an active compulsory licensing track record, originator companies typically maintain the fullest possible patent protection over biologics for as long as legally available, given the very high cost of developing competing biosimilars and the resulting de facto market exclusivity that patent protection over manufacturing processes and cell lines can provide even without statutory data exclusivity. In India, the credible threat of compulsory licensing demonstrated concretely by the Bayer Nexavar precedent introduces a strategic calculation that has, in at least the trastuzumab case, led an originator to forgo continued patent enforcement rather than risk a compulsory licence determination with its associated adverse publicity and the broader precedential consequences for the company’s global patent portfolio.
Comparative International Context – BPCIA Patent Dance and EU Biosimilar Framework
The Indian position can be usefully understood by contrast with the two dominant international frameworks for biosimilar regulation and patent interface.
The United States Biologics Price Competition and Innovation Act, 2010, establishes the abbreviated licensure pathway for biosimilars under Section 351(k) of the Public Health Service Act and crucially links this pathway to a structured patent dispute resolution process colloquially known as the “patent dance.” Under this framework, a biosimilar applicant must disclose its application and manufacturing information to the reference product sponsor, who in turn identifies patents it believes are infringed; the parties then negotiate which patents will be litigated before commercial launch, in a structured pre-launch litigation framework intended to resolve patent disputes before the biosimilar enters the market. The twelve-year data exclusivity period under the BPCIA runs independently of and in addition to this patent dance mechanism.
The European Union’s biosimilar framework, administered through the European Medicines Agency under a centralised authorisation procedure, similarly does not require patent resolution as a precondition for regulatory approval, but European national patent systems generally provide robust supplementary protection certificate mechanisms that extend originator patent terms and litigation over biosimilar patent infringement in major EU markets such as Germany and the UK has developed a substantial and sophisticated body of case law addressing process patent infringement by biosimilar manufacturers.
India’s framework, by contrast, has neither a structured pre-launch patent dispute mechanism comparable to the BPCIA patent dance nor a data exclusivity period comparable to either the US or EU regimes. This makes India one of the most permissive biosimilar entry environments among major pharmaceutical markets, a feature that aligns with India’s broader public health and access-to-medicines policy orientation as reflected in the National IPR Policy, 2016, but one that creates correspondingly higher litigation risk and uncertainty for both originators and biosimilar manufacturers, who must resolve patent, regulatory and trademark disputes through ordinary civil litigation after the fact rather than through a structured pre-market mechanism.
Practical Guidance for Originator Companies and Biosimilar Manufacturers
For originator companies holding patents over biologics marketed in India, the practical lessons from the trastuzumab litigation and the broader regulatory framework point toward a multi-pronged enforcement and protection strategy. Patent protection should be pursued and maintained as far as possible over the full lifecycle of the molecule covering not just the core protein or antibody but the specific cell line, manufacturing process, formulation and methods of treatment recognising that process and cell line patents often provide more durable protection in the biologic space than product patents, given the practical difficulty biosimilar manufacturers face in replicating manufacturing processes exactly. Originators should also build trademark and passing-off claims into their enforcement toolkit from the outset, recognising that these remedies can provide meaningful protection even where patent protection has lapsed or been strategically foregone. Given the compulsory licensing risk illustrated by Bayer Nexavar, originators pricing biologics in India should carefully document the reasonableness of pricing relative to Indian market conditions and demonstrate adequate efforts toward local working, to reduce exposure under Section 84 of the Patents Act, 1970.
For biosimilar manufacturers, the absence of data exclusivity and patent linkage in India is a genuine commercial advantage relative to other major markets, but it does not eliminate legal risk. Biosimilar developers should conduct thorough freedom-to-operate analysis covering not just the originator’s product patents but process and cell line patents, which may remain in force even after a core product patent has expired or lapsed. Manufacturers should also exercise considerable care in how they describe their products relative to the reference biologic in marketing materials and product literature, given the trademark and passing-off exposure illustrated by the early stages of the Roche litigation and should ensure that any reliance on the reference biologic’s clinical data for additional indications is supported by a sufficiently robust comparability dossier to withstand the kind of regulatory compliance challenge that characterised the middle years of the trastuzumab dispute.
Conclusion
Biosimilar patent law in India occupies a distinctive position among the world’s major pharmaceutical markets shaped by a patentability framework under Sections 3(c), 3(d) and 3(j) of the Patents Act, 1970, that broadly accommodates genuine biotechnological invention while excluding mere discoveries and essentially biological processes; by a regulatory approval pathway under the CDSCO-DBT Guidelines on Similar Biologics, 2016, that operates entirely independently of patent status; and by the complete absence of any data exclusivity period or patent linkage mechanism comparable to the BPCIA framework that governs biosimilar entry in the United States. The decade-long Roche v. Biocon and Mylan trastuzumab litigation stands as the defining case study in this space, illustrating how originator companies in India must rely on a combination of patent strategy, trademark and passing-off claims and regulatory compliance litigation to protect their market position once patent protection has lapsed, expired or been strategically foregone in light of compulsory licensing risk.
The trajectory of Indian biosimilar law points toward continued growth in both the volume of biosimilar approvals and the intensity of associated litigation, as more first-generation biologics reach the end of their patent terms globally and Indian manufacturers already among the world’s most significant biosimilar producers pursue both the domestic market and substantial export opportunities. For practitioners, the absence of a settled patent-regulatory interface mechanism in India means that biosimilar disputes will continue to be litigated through the more improvisational combination of patent, trademark, passing-off and regulatory compliance theories that the Roche litigation has demonstrated, rather than through any dedicated statutory biosimilar litigation framework. Until and unless India legislates a more structured interface whether through patent linkage, data exclusivity or some hybrid mechanism this multi-front litigation pattern will remain the defining feature of biosimilar patent practice in India.
References
- Patents Act, 1970 (as amended) – Sections 3(b), 3(c), 3(d), 3(j) – https://ipindia.gov.in/writereaddata/Portal/IPOAct/1_31_1_patent-act-1970-11march2015.pdf
- Guidelines on Similar Biologics: Regulatory Requirements for Marketing Authorisation in India, 2016 – CDSCO – https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/biologicals/CDSCO-DBT2016.pdf
- Novartis AG v. Union of India, (2013) 6 SCC 1 – https://main.sci.gov.in/judgment/judis/40212.pdf
- Drugs and Cosmetics Act, 1940 and Rules, 1945 – https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documentsacts_rules/2016DrugsandCosmeticsAct1940Rules1945.pdf
- New Drugs and Clinical Trials Rules, 2019 – CDSCO – https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/NewDrugs_CTRules_2019.pdf
- Bayer Corporation v. Union of India, 2014 (60) PTC 277 (Bom) – Compulsory Licence Order – https://ipindia.gov.in/writereaddata/Portal/IPOAct/1_69_1_CL-Order.pdf
- Budapest Treaty on the International Recognition of the Deposit of Microorganisms WIPO – https://www.wipo.int/treaties/en/registration/budapest/
- WTO TRIPS Agreement, Article 27 (Patentable Subject Matter) – https://www.wto.org/english/docs_e/legal_e/27-trips_04d_e.htm
- Department of Biotechnology – Review Committee on Genetic Manipulation (RCGM) – https://dbtindia.gov.in
- CGPDTM – Manual of Patent Office Practice and Procedure – https://ipindia.gov.in/patent-manual.htm
- National IPR Policy, 2016 DPIIT https://dpiit.gov.in/sites/default/files/National_IPR_Policy_English.pdf
- Delhi High Court Judgments Portal (Roche v. DCGI and related orders) https://delhihighcourt.nic.in
Frequently Asked Questions:
- Are biosimilars patentable in India?
Yes – while naturally occurring substances and essentially biological processes are excluded under Sections 3(c) and 3(j) of the Patents Act, 1970, biosimilar manufacturers can patent their distinct cell lines, manufacturing processes, and formulations if they meet the standard tests of novelty, inventive step, and industrial applicability. - Does India have a data exclusivity period for biologics?
No – unlike the US, which grants twelve years of data exclusivity under the BPCIA, India has no statutory data exclusivity regime for biologics, a position confirmed through the Roche v. Biocon and Mylan trastuzumab litigation. - What was the outcome of the Roche v. Biocon trastuzumab case?
After Roche’s patent lapsed, Biocon and Mylan launched biosimilar trastuzumab; Roche pursued passing-off and regulatory compliance claims rather than patent infringement, and the Delhi High Court ultimately allowed the biosimilars to be marketed for all approved indications. - How does Section 3(d) of the Patents Act apply to biologics?
Section 3(d) requires that a modified version of a known biologic, such as a new formulation or glycosylation variant, demonstrate enhanced therapeutic efficacy rather than mere manufacturing or stability improvements to qualify for patent protection. - Is there a patent linkage system for biosimilars in India?
No – India has no mechanism connecting drug regulatory approval to patent status, meaning a biosimilar can receive full CDSCO/DCGI marketing approval even while related patent litigation remains unresolved.
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