Top Patent Cases of 2025 in India: Critical Decisions Reshaping IP Jurisprudence

Introduction

The Indian patent landscape in 2025 has witnessed transformative judicial pronouncements that have fundamentally redefined how inventors, pharmaceutical companies, technology firms, and patent practitioners approach IP strategy. From groundbreaking decisions on biosimilar enforcement to landmark FRAND licensing determinations and important clarifications on Section 3(k) patentability, the year’s landmark cases have generated precedents with far-reaching implications across industries. This comprehensive analysis examines the ten most significant patent cases decided in 2025, dissecting their factual backgrounds, legal arguments, court findings, and the strategic lessons they impart for the IP ecosystem.

Case 1: Aquestia Limited vs Automat Industries Pvt Ltd & Ors. (Delhi High Court, August 2025)

Background Facts

Aquestia Limited, an Israeli innovator, held Indian Patent No. 427050, granted on March 27, 2023, for “A Fluid Control Valve.” The patent claimed a revolutionary fluid control mechanism featuring an asymmetric sealing diaphragm with differential surface areas—the portion extending over the inlet path has a larger area than that extending over the outlet path. This asymmetry enables superior performance under low-pressure conditions, making it particularly suitable for irrigation systems.

Automat Industries Pvt. Ltd. and its affiliated entities (including distributor Delhi Mill Stores and Managing Director Tushar Jain) marketed irrigation valves under the brand “Hydromat.” Aquestia alleged that these Hydromat valves embodied the asymmetric sealing diaphragm technology claimed in its patent and thus constituted infringement. Aquestia sought an interim injunction to restrain Automat from manufacturing, selling, distributing, or exporting the allegedly infringing products.

Plaintiff’s Arguments

Aquestia contended that the Hydromat valves incorporated the distinctive asymmetric sealing diaphragm with differential diaphragm surface areas as claimed in the suit patent. The company argued that the curved sealing bridge employed by Automat was immaterial because the suit patent covered both straight and concave embodiments of the diaphragm configuration. Aquestia emphasized that its patent had been granted after thorough examination and represented a genuine technical innovation meriting protection.

Defendant’s Arguments

Automat’s primary defense rested on a separate patent of their own—Indian Patent IN’536. The defendants argued that their product was protected by this independently granted patent, incorporated a curved sealing bridge with symmetrical diaphragm design, and operated on fundamentally different technical principles. Automat further contended that granting an interim injunction would disrupt critical irrigation projects and cause irreparable commercial harm.

Significantly, Automat relied heavily on a “product-to-product comparison” strategy, providing handouts comparing their physical product design to Aquestia’s marketed product, rather than addressing claim-to-product infringement mapping.

Court’s Findings

Justice Amit Bansal delivered a landmark judgment that fundamentally clarified a critical principle in Indian patent law: the grant of a patent to the defendant does not constitute a valid defense against an infringement action. The Court explained that while a patent confers an exclusionary right under Section 48 of the Patents Act, 1970, it does not confer a right to practice the patented invention if doing so infringes another’s prior patent.

The Court rejected Automat’s defense, holding that patent infringement must be assessed through “claim-to-product comparison,” not “product-to-product comparison” or “patent-to-patent comparison.” The Court found that Aquestia had established a prima facie case of infringement by demonstrating that the Hydromat valves embodied the claimed asymmetric sealing diaphragm with the differential surface area features. The balance of convenience was found to favor Aquestia, whose commercial interests would suffer irreparable harm from continued unauthorized sales.

Final Decision

The Delhi High Court granted the interim injunction, restraining Automat Industries and affiliated entities from manufacturing, selling, distributing, advertising, exporting, or otherwise dealing in any product infringing the suit patent. The Court directed the removal of all listings of the Hydromat valves from online and third-party e-commerce platforms. The Court clarified that these findings were confined to the interim stage and would not prejudice the final determination of the suit.

Key Learnings

1. Patent Grant is Not an Infringement Defense: This judgment definitively establishes that a defendant cannot escape infringement liability merely by obtaining a patent of their own. The coexistence of two valid patents does not negate infringement of the senior patent.
2. Claim-Centric Infringement Analysis: Infringement assessment must center on the claims of the suit patent, not on product-to-product or patent-to-patent comparisons. This reinforces the claim-centric approach to infringement analysis in Indian jurisprudence.
3. Prima Facie Standard for Interim Relief: The judgment illustrates how courts assess “prima facie” infringement through technical claim mapping, a standard that continues to shape interim relief determinations.
4. Practical Implication for Patent Holders: Patent holders can pursue interim relief against competitors who obtained their own patents if the underlying products infringe the senior patent’s claims. This significantly strengthens enforcement strategies.
5. Competitive Landscape Implication: For competing manufacturers, obtaining a patents for a product does not guarantee freedom to operate if the product infringes an earlier patent’s claims.

Case 2: F. Hoffmann-La Roche AG & Anr. vs Natco Pharma Ltd. (Delhi High Court, March and October 2025; Supreme Court, October 2025)

Background Facts

Swiss pharmaceutical giant F. Hoffmann-La Roche AG (“Roche”) held Indian Patent No. 334397 for compounds claimed to treat Spinal Muscular Atrophy (SMA), valid until May 11, 2035. The patent claimed specific compounds and their pharmaceutical formulations related to Risdiplam, a breakthrough oral medication that had transformed SMA treatment by offering patients a non-invasive alternative to expensive intravenous therapies.

In 2024, Natco Pharma Ltd., a leading Indian generic manufacturer, announced its intention to launch a generic version of Risdiplam. Natco’s regulatory filings to the Central Drugs Standard Control Organization (CDSCO) became known to Roche, triggering alarm bells regarding potential patent infringement and commercial harm. Roche moved before the Delhi High Court seeking an interim injunction to restrain Natco from manufacturing, selling, or distributing the generic drug pending final resolution of the patent infringement suit.

Plaintiff’s Arguments

Roche argued that its patent for Risdiplam compounds was valid and enforceable, representing years of research investment and significant therapeutic value to SMA patients. Roche contended that Natco’s generic drug would infringe the suit patent, causing irreparable harm to its commercial interests and investment returns. Roche emphasized the novelty and non-obviousness of the claimed compounds and sought to prevent Natco’s market entry through interim relief.

Defendant’s Arguments

Natco raised a comprehensive challenge to the validity of Roche’s patent on grounds of anticipation and obviousness under Section 64(1) of the Patents Act. Natco argued that the claimed Risdiplam compounds lacked inventive step because they were obvious derivations from Roche’s own genus patents already disclosed in the prior art. Natco contended that the specific compounds claimed in IN’334397 represented a predictable variation within the known chemical space and did not involve any unexpected technical effects or synergistic benefits.

Additionally, Natco invoked the broader public interest in ensuring affordable access to life-saving medicines for SMA patients, emphasizing that SMA treatment in India remained prohibitively expensive and that generic availability was critical for healthcare equity.

Court’s Findings (Single Judge – March 2025)

In March 2025, a Single Judge of the Delhi High Court examined Natco’s invalidity defense and found credible grounds for the patent’s vulnerability. Specifically, the Court found that Roche’s patent was prima facie vulnerable to invalidation on grounds of obviousness under Section 64(1)(f) of the Patents Act. The Court noted that Natco had raised substantial arguments demonstrating that the specific compounds claimed in Roche’s patent could be considered obvious derivations from the applicant’s own genus patents.

Based on these findings, the Court declined to grant the interim injunction sought by Roche, reasoning that when validity is seriously challenged and a credible case for invalidity is made, the Court should hesitate to grant interim relief that would effectively enforce a potentially invalid patent.

Court’s Findings (Division Bench – October 2025)

Roche appealed the Single Judge’s decision to a Division Bench. In a judgment dated October 9, 2025, the Division Bench (Justice C. Hari Shankar and Justice Ajay Digpaul) upheld the Single Judge’s refusal to grant the interim injunction. While the Division Bench made certain corrections to the Single Judge’s novelty analysis, it upheld the finding of prima facie obviousness, thereby maintaining that Roche’s patent was vulnerable to invalidation.

The Division Bench’s concurrent findings significantly weakened Roche’s negotiating position and legal standing, effectively clearing the regulatory runway for Natco’s generic product to remain on the market pending final resolution of the suit.

Supreme Court’s Decision (October 2025)

Roche escalated the matter to the Supreme Court, seeking a stay of the Division Bench’s order and emergency interim relief. A Supreme Court bench comprising Justice P.S. Narasimha and Justice Atul Chandurkar examined the matter on October 16, 2025. The Court recognized that while Roche’s petition raised important questions, the interim nature of the Division Bench’s order and the concurrent findings of both the Single Judge and Division Bench counseled caution against interference.

The Supreme Court dismissed Roche’s petition and declined to interfere with the Delhi High Court’s order. Significantly, the Court directed the Delhi High Court to expeditiously decide the main suit on merits, signaling that final resolution should proceed with urgency. The Supreme Court clarified that its observations were confined to the interim stage and would not prejudice the final determination of patent validity.

This decision left Natco’s generic Risdiplam on the Indian market, ensuring continued patient access to affordable SMA treatment, while the underlying validity question awaited final adjudication.

Final Decision

As of the end of 2025, the Delhi High Court had not issued a final judgment on the merits of the patent validity challenge. However, the combined effect of the interim orders is that Natco’s generic Risdiplam remains available to Indian patients, and Roche’s patent protection has been effectively suspended pending trial. The case exemplifies how courts balance patent protection against public health imperatives in life-saving pharmaceutical contexts.

Key Learnings

1. Obviousness Challenges in Pharmaceutical Patents: Patents claiming specific compounds within a known genus are vulnerable to obviousness challenges if the specification fails to demonstrate unexpected efficacy or synergistic benefits over the genus.
2. Public Interest in Healthcare Access: Indian courts have demonstrated receptiveness to public interest arguments regarding affordable access to life-saving medicines, particularly in contexts involving rare diseases and high patient costs.
3. Interim Relief Standards Under Patent Validity Challenges: When a defendant raises a credible challenge to patent validity, courts may decline interim relief even where infringement is prima facie established, reflecting judicial caution about enforcing potentially invalid patents.
4. Concurrence Doctrine: When both a Single Judge and Division Bench make concurrent findings, the Supreme Court shows deference and reluctance to interfere, particularly on interim matters.
5. TRIPS Compliance and Section 3(d): This case reinforces that India’s patent regime, emphasizing genuine innovation over incremental variations, remains TRIPS-compliant and reflects India’s commitment to balancing IP protection with public health access.
6. Strategic Implication: Generic manufacturers facing infringement threats from patents with questionable validity should aggressively pursue validity challenges, as Indian courts have shown willingness to scrutinize patent claims rigorously.

Case 3: Dong Yang PC, Inc. vs Controller of Patents and Designs (Delhi High Court, July 2025)

Background Facts

Dong Yang PC, Inc., a Korean inventor specializing in automated parking systems, filed a patent application (Application No. 2554/DEL/2013) on August 29, 2013, for an invention titled “Vertical Rotary Parking System.” The system was engineered to optimize vehicle parking in narrow urban spaces by employing a vertical circulation mechanism with support plates attached at regular intervals to a circulating main chain fitted within an endless track.

The appellant’s invention represented a refinement of an earlier parking system technology it had itself patented (prior art document D-5). In the earlier system, female portions of the suspension chain coupling mechanism were used. In the subject invention, Dong Yang modified the coupling configuration by replacing female portions with male portions of the suspension, while maintaining the overall vertical circulation architecture.

Patent Office’s Rejection

The Patent Office examined the application and issued a First Examination Report (FER) in August 2018. Despite Dong Yang’s substantive response in January 2019, the Controller ultimately rejected the application on the grounds that the claimed invention lacked inventive step and did not demonstrate any technical advancement over the prior art document D-5. The Controller characterized the modification as merely a “workshop modification” involving a simple interchange of coupling configurations (male for female), which the Controller deemed routine and obvious to a person skilled in the art.

Appellant’s Arguments

Dong Yang argued that the Controller’s rejection reflected a simplistic and mechanistic approach that failed to appreciate the genuine technical advancement embodied in the modified coupling configuration. The appellant emphasized that while D-5 disclosed a vertical rotary parking system with female coupling portions, the subject invention employed male portions instead. This modification, though seemingly minor, addressed fundamental technical challenges present in the earlier D-5 system.

Specifically, Dong Yang highlighted that the D-5 system’s female coupling portions had created design complexity, involving multiple chains, sprockets, and power transmission components that generated significant friction and noise during operation. By modifying the coupling configuration to male portions, the subject invention reduced frictional resistance and noise generation, thereby improving system efficiency and operational reliability.

Dong Yang argued that the innovation demonstrated technical awareness and engineering sophistication and that simplicity of conception should not disqualify an invention from patentability if genuine technical advancement is present.

Controller’s Position

The Controller maintained that the cited prior art (D-5) disclosed essentially the same vertical rotary parking system, and the claimed modification represented only an obvious workshop variation that would be readily apparent to a person skilled in the parking systems technology. The Controller found that no authoritative technical evidence supported the conclusion that the coupling modification produced unexpected results or surprising effects.

Court’s Analysis and Findings

Justice Hariom Pandey examined the application with exacting technical scrutiny. The Delhi High Court rejected the Controller’s simplistic reasoning and held that simplicity of an invention does not, by itself, disqualify the invention from being patentable. The Court emphasized that the question is not whether an invention is simple, but whether it demonstrates technical advancement over the prior art in addressing a recognized technical problem.

The Court found that the Controller had failed to provide adequate technical reasoning for the rejection. Specifically, the judgment criticized the Controller for:

1. Lack of Technical Analysis: The Controller’s order did not analyze the technical consequences of replacing female coupling portions with male portions or explain why this modification would be obvious to a person skilled in the art.
2. Absence of Evidentiary Support: The Controller cited no technical literature, engineering principles, or established practices demonstrating that the modification was routine or obvious.
3. Inadequate Reasoning: The characterization of the modification as a mere “workshop modification” was conclusory and lacked substantive technical justification.
4. Failure to Consider Advantages: The Controller did not grapple with Dong Yang’s arguments regarding the reduced friction, noise reduction, and improved operational efficiency flowing from the coupling modification.

The Court found that while D-5 and the subject invention shared the overall vertical circulation architecture, the technical differences in the coupling mechanism were material. The substitution of male for female portions, while appearing minor, represented a considered engineering decision addressing specific technical challenges.

Final Decision

The Delhi High Court remanded the application to the Controller for reconsideration. The Court directed the Controller to conduct a thorough technical examination, properly analyze the differences between D-5 and the subject invention, and provide reasoned findings on whether the claimed modification demonstrated technical advancement warranting patent protection.

The judgment effectively reversed the summary rejection and granted the appellant a fair opportunity for patent grant, conditioned on the Controller’s more rigorous technical analysis on remand.

Key Learnings

1. Simplicity Is Not an Obstacle to Patentability: Indian courts have clarified that simple inventions can be patented if they solve recognized technical problems through novel approaches. The focus must be on whether genuine technical advancement is demonstrated, not whether the invention is mechanically complex.
2. Rigor in Patent Examination: Patent controllers must provide detailed technical reasoning for rejections, supported by evidence and authoritative references. Conclusory characterizations of modifications as “obvious” or “routine” without substantive analysis are insufficient.
3. Technical Problem-Solution Analysis: Courts apply a structured technical problem-solution approach: Identify the technical problem in the prior art → Demonstrate the solution in the claimed invention → Analyze whether the solution produces unexpected technical advantages.
4. Burden of Proof: While applicants bear the burden of demonstrating patentability, examiners must discharge their own burden of articulating credible reasons for rejection backed by evidence.
5. Practical Implication for Applicants: Applicants facing rejections for “lack of inventive step” should vigorously challenge the examiner’s reasoning with detailed technical evidence, comparative analysis, and expert testimonies demonstrating the technical advantages of their modifications.
6. Substantive Examination Standard: The judgment reflects a commitment to substantive examination rather than formulaic or mechanical assessment of patentability, requiring meaningful technical engagement with the claimed innovation.

Case 4: Idemia Technologies vs Controller of Patents and Designs (Madras High Court, January 2025)

Background Facts

Idemia Technologies filed a patent application claiming a method and system for implementing constant-time encryption to prevent timing attacks in cryptographic calculations. The innovation addressed a recognized vulnerability in cryptographic systems: side-channel attacks exploiting variations in computation time to compromise encryption security.

The claimed invention employed probabilistic insertion algorithms within cryptographic implementations to mask the time taken for encryption operations. Regardless of the message being processed or the computational complexity required, the system ensured that the encryption process consumed constant time, thereby eliminating temporal variations that attackers could exploit.

Patent Office’s Objection

The Controller of Patents initially rejected the application under Section 3(k) of the Indian Patents Act, 1970, which excludes from patentability “a mathematical method or a computer program per se or algorithms.” The Controller characterized Idemia’s invention as essentially a mathematical formula or algorithm applied to encryption, falling squarely within the Section 3(k) exclusion.

The rejection order was notably “non-speaking”—it provided minimal reasoning or explanation for the substantive objection, raising serious natural justice concerns regarding the applicant’s opportunity to be heard and adequately respond to the grounds of rejection.

Applicant’s Arguments

Idemia argued that while its invention involved probabilistic insertion algorithms, it provided a technical solution to a recognized technical problem and thus transcended the scope of the Section 3(k) exclusion. The applicant emphasized that the invention was not merely a mathematical abstraction but a concrete implementation designed to improve cryptographic security in real-world systems.

Idemia contended that:

1. Technical Effect: The invention produced a tangible technical effect—masking computation time to prevent timing attacks. This technical effect directly improved the security and efficacy of cryptographic systems.
2. Technical Problem: The invention addressed a recognized technical problem in cryptography: side-channel vulnerabilities in encryption systems. The technical contribution was solving this problem, not merely advancing mathematical theory.
3. System Integration: The invention was not a standalone algorithm but a system integrated with cryptographic hardware and software, demonstrating a practical technical implementation.
4. Authoritative Guidelines: Both the Indian CRI (Computer Related Inventions) Guidelines and European Patent Office guidelines recognized that algorithms and mathematical methods are patentable when applied to solve technical problems and produce technical effects beyond the mere execution of abstract calculations.

Madras High Court’s Analysis

Justice [name not specified in sources] found that the Patent Office’s non-speaking order violated principles of natural justice. The Court proceeded to substantively examine the Section 3(k) patentability question.

The Court held that technical applications of mathematical methods and algorithms are patentable when they produce a technical effect that improves system functioning or provides a technical solution to a technical problem. The Court clarified that the exclusion under Section 3(k) is not a blanket bar against all inventions involving mathematical methods or algorithms; rather, it applies to mathematical methods or algorithms “per se”—meaning in their abstract, untethered form.

The Court emphasized that the critical inquiry is whether the invention contributes a technical effect beyond the mere execution of algorithmic steps. In Idemia’s case, the constant-time encryption mechanism represented a tangible technical contribution that improved cryptographic security. The invention was not presented as a novel mathematical formula for academic interest but as a practical cryptographic security enhancement.

The Court further noted that modern patent systems internationally have recognized the patentability of software and algorithms when they solve technical problems and produce technical effects. Idemia’s timing-attack prevention mechanism qualified under this standard.

Final Decision

The Madras High Court quashed the Patent Office’s rejection order and directed the Controller to reconsider Idemia’s patent application. The Court mandated that the Controller must provide a detailed, reasoned examination order addressing Idemia’s technical contributions and explaining any grounds of rejection with reference to prior art and established examination criteria.

Key Learnings

1. Section 3(k) Is Not an Absolute Bar: The exclusion under Section 3(k) applies to mathematical methods, algorithms, and computer programs “per se” but does not exclude technical applications of these methods when they solve technical problems and produce technical effects.
2. Technical Effect is the Touchstone: The critical inquiry is whether the claimed invention produces a technical effect—a tangible improvement in system functioning, security, or efficacy. Inventions demonstrating such technical effects transcend the Section 3(k) exclusion.
3. System Integration Matters: Algorithms and mathematical methods integrated within broader systems to solve technical problems (rather than standing alone as abstract theories) are more likely to qualify as patentable inventions.
4. Natural Justice in Patent Examination: Patent offices must provide reasoned, substantive examination orders explaining grounds of rejection. Non-speaking orders that provide minimal justification violate natural justice and are vulnerable to judicial challenge.
5. Convergence with International Standards: Indian patent law is increasingly aligning with international norms (European and US standards) recognizing the patentability of computer-related inventions when they solve technical problems and produce technical effects.
6. Strategic Implication for Software/Crypto Applicants: Applicants in cryptography, cybersecurity, and software fields should emphasize the technical problems their inventions solve and the tangible technical effects they produce, positioning their claims as technical solutions rather than abstract algorithmic advances.
7. CRI Guidelines Relevance: The Court’s reference to Indian CRI Guidelines affirms their importance in interpreting Section 3(k) and suggests that applicants citing these guidelines in examination responses can strengthen their positions.

Case 5: Celator Pharmaceuticals Inc. vs Post-Grant Opposition (Patent Office, August 2025)

Background Facts

Celator Pharmaceuticals Inc. held Indian Patent No. 315447, protecting a novel lyophilized gel-phase liposomal composition encapsulating daunorubicin and cytarabine. The patent claimed a specific pharmaceutical formulation combining an anticancer drug combination with a distinctive liposomal delivery system, designed to improve stability, bioavailability, and therapeutic efficacy in treating hematologic malignancies.

Following grant of the patent, two major Indian pharmaceutical companies—Cipla Ltd. and Mylan Laboratories Ltd.—filed post-grant oppositions challenging the patent’s validity under various grounds, including anticipation, obviousness, and the Section 3(d) “new form of known substance” exclusion.

Opponent’s Arguments

Cipla’s Position: Cipla cited prior art document D1 (a clinical study of CPX-351, an earlier liposomal formulation) and a published patent application (WO2006055903) arguing that Celator’s claimed composition was anticipated and disclosed in these prior art references. Cipla contended that D1 discloses a lyophilized liposomal formulation with similar components and characteristics, rendering Celator’s claims non-novel.

Additionally, Cipla invoked Section 3(d), arguing that the claimed composition was merely a new form of a known substance (the drug combination and liposomal technology) without demonstrated enhanced therapeutic efficacy. Cipla submitted that the opponents failed to provide experimental data proving significantly enhanced efficacy over known formulations.

Mylan’s Position: Mylan adopted similar arguments regarding anticipation and prior publication. Mylan further argued that Celator’s composition represented an obvious combination of known liposomal delivery technology with known anticancer drug combinations. Mylan contended that the person skilled in pharmaceutical formulation would find it obvious to combine the drug pair with liposomal technology to achieve improved delivery.

Patent Office’s Analysis

The Patent Office’s Opposition Board initially recommended revocation of the patent, accepting the opponents’ arguments regarding anticipation and lack of enhanced efficacy. However, upon review, the Controller of Patents adopted a different view, ultimately upholding the patent and dismissing the oppositions.

The Controller’s critical finding was that the Opposition Board’s recommendation was not binding on the final patentability determination. The Controller proceeded with an independent substantive examination, applying the legal framework for Section 3(d) assessments.

Specifically, the Controller noted that:

1. PSITA Standard: The opponents failed to properly identify the “Person Skilled in the Art” (PSITA) in the field of liposomal pharmaceutical formulations. Without establishing the PSITA’s knowledge, capabilities, and approach, the obviousness analysis remained incomplete.
2. Synergistic Composition: The claimed invention was not a mere admixture of known components but a synergistic composition wherein the liposomal structure, internal cryoprotectant, and drug combination interacted in specifically defined ranges to achieve unexpected advantages. These advantages included long-term stability, retention of encapsulated drugs, and maintenance of liposome size post-reconstitution.
3. Experimental Evidence: Celator provided detailed experimental data supporting the stability and synergistic behavior of the composition, demonstrating significantly enhanced therapeutic advantages over known formulations.
4. Section 3(d) Sufficiency: The claimed composition satisfied the enhanced efficacy requirement under Section 3(d), as the specification included detailed descriptions, working examples, and the best method known to the applicant.

Final Decision

The Controller upheld Indian Patent No. 315447, dismissing post-grant oppositions filed by both Cipla and Mylan. The decision affirmed Celator’s exclusive patent rights to the lyophilized liposomal composition.

Key Learnings

1. Opposition Board Recommendations Are Not Binding: While Opposition Boards provide valuable recommendations, they do not bind the final patentability determination. Controllers may conduct independent substantive examination and reach different conclusions based on rigorous application of the legal framework.
2. PSITA Identification Is Critical: In obviousness and anticipation analyses, opponents must establish the Person Skilled in the Art and demonstrate how such PSITA would be motivated to combine prior art. Failure to establish PSITA weakens opposition arguments substantially.
3. Synergistic Compositions Warrant Protection: Pharmaceutical formulations demonstrating synergistic interactions among components, with unexpected technical effects, deserve patent protection even where individual components are known. The key is demonstrating the unexpected benefits flowing from the specific combination.
4. Section 3(d) Requires Genuine Enhanced Efficacy: Opponents invoking Section 3(d) must establish that the claimed composition is a “new form of a known substance” and lacks enhanced efficacy. Claimants demonstrating genuine technical advantages, supported by experimental data, can overcome Section 3(d) objections.
5. Specification Quality Matters: Comprehensive specifications with detailed working examples, experimental data, and demonstrations of the best method known to the applicant significantly strengthen patentability positions in opposition proceedings.
6. Burden of Proof Dynamics: While applicants bear the ultimate burden of demonstrating patentability, opponents bear the burden of establishing grounds for revocation. Mere assertion of anticipation or obviousness, without rigorous technical evidence, proves insufficient.
7. Strategic Implication for Generic Manufacturers: Generic manufacturers opposing pharmaceutical patents must invest in detailed technical analysis, PSITA identification, and experimental evidence demonstrating that claimed compositions lack genuine inventive step or enhanced efficacy.

Case 6: E.R. Squibb & Sons LLC & Ors. vs Zydus Lifesciences Ltd. (Delhi High Court, August 2025)

Background Facts

E.R. Squibb & Sons LLC (“Squibb”) held Indian Patent No. 340060, claiming the monoclonal antibody Nivolumab, an anti-PD-1 immunotherapy used to treat various cancers. The patent specifically claimed the 5C4 antibody and variants, with amino acid sequence specifications. The patent term was set to expire on May 2, 2026.

Zydus Lifesciences Ltd. (“Zydus”), a leading Indian pharmaceutical company, developed a biosimilar to Nivolumab designated ZRC-3276. Zydus conducted comparative clinical trials using Squibb’s Nivolumab as the reference biologic, following the WHO Similar Biologics Guidelines. In its regulatory filings to the Central Drugs Standard Control Organization (CDSCO) for marketing approval, Zydus identified Nivolumab as the reference biologic.

In anticipation of Zydus’s planned commercial launch, Squibb filed a “quia timet” suit (action seeking relief for a threatened but not yet completed injury) before the Delhi High Court, seeking an interim injunction to restrain Zydus from manufacturing, stockpiling, or launching the biosimilar ZRC-3276.

Plaintiff’s Arguments

Squibb argued that:

1. Patent Validity: The suit patent IN’340060 was valid, novel, and non-obvious, representing genuine inventive contribution to biotechnology.
2. Infringement Through Biosimilarity: Zydus’s biosimilar ZRC-3276, designed to be equivalent to Nivolumab and identified as such in regulatory filings, infringed the suit patent by incorporating the same amino acid sequences and binding characteristics.
3. Regulatory Filings Establish Infringement: Zydus’s own regulatory filings to CDSCO, identifying Nivolumab as the reference biologic, constituted an admission that ZRC-3276 was designed to replicate Nivolumab’s amino acid sequences. This regulatory strategy itself established infringement of the patent claiming those sequences.
4. Bolar Exception Limits Inapplicable: While research and clinical trials during the patent term are permitted under the Bolar exemption, manufacturing and stockpiling the biosimilar constitute patent infringement. Zydus’s intended commercial preparations and stockpiling before patent expiry exceeded permissible research bounds.
5. Irreparable Harm: Allowing Zydus to launch before patent expiry would cause irreparable harm to Squibb’s commercial interests and devalue the remaining patent term.

Defendant’s Arguments

Zydus raised several defenses:

1. Delay in Suit: Zydus argued that Squibb delayed in filing the suit, having known of Zydus’s development activities. Zydus contended that the cause of action should be deemed to have arisen much earlier, and Squibb’s delay constituted laches.
2. Invalidity Challenges: Zydus argued that the suit patent was vulnerable to invalidity on grounds including:
   • Lack of novelty (the antibody sequences were previously disclosed in prior art)
   • Lack of inventive step (the claimed antibody was an obvious selection from a known class)
   • Lack of patentability (natural antibodies lack human intervention and are products of nature)
3. Non-Infringement Through Different Binding Profile: Zydus argued that its biosimilar ZRC-3276, while sharing similar amino acid sequences, demonstrated a different binding profile. Specifically, ZRC-3276 bound not only to PD-1 (like Nivolumab) but also to other CD28 family receptors. This broader binding spectrum, Zydus argued, fell outside the scope of Squibb’s patent claims, which specifically required binding to PD-1.
4. Biosimilarity ≠ Infringement: Zydus argued that biosimilarity under WHO guidelines does not constitute patent infringement. Biosimilarity is a regulatory concept based on product-to-product comparison, whereas infringement requires claim-to-product mapping.
5. Bolar Exception Applicability: Zydus argued that its manufacturing activities fell within the permissible scope of research and development under the Bolar exemption and did not constitute infringement.
6. Public Interest in Biosimilars: Zydus emphasized the public interest in biosimilar availability, arguing that preventing generic biosimilar entry would harm cancer patients’ access to affordable immunotherapy.

Court’s Analysis and Findings

Justice [name not fully specified] of the Delhi High Court conducted a rigorous analysis of each defense raised by Zydus.

On Delay: The Court rejected Zydus’s delay argument, holding that the cause of action for infringement arose only in April 2024, when information regarding Zydus’s proposed commercial launch first came to Squibb’s attention. Prior knowledge of developmental activities did not constitute the cause of action; commercial launch intention did.

On Patent Validity: The Court examined Zydus’s invalidity challenges and found them lacking in credibility. The Court held that:

• The prior art cited by Zydus (EP1537878 B1) did not disclose the specific amino acid sequences claimed in Squibb’s patent
• The specificity of the claimed antibody sequences represented genuine inventive contribution, not an obvious selection
• Monoclonal antibodies, while derived from natural sources, involve substantial human intervention in their discovery, characterization, and manufacturing, rendering them patentable (rejecting Zydus’s “product of nature” argument)

On Infringement Through Binding Profile: The Court rejected Zydus’s argument that different binding profiles rendered the product non-infringing. The Court held that:

• The term “binds specifically to PD-1” in the patent claim does not mean “binds exclusively” to PD-1
• The patent specification disclosed that cross-reactivity with other CD28 family members was permissible
• Regulatory characterization of ZRC-3276 as a biosimilar to Nivolumab constituted an admission that the product embodied the claimed antibody sequences
• Thus, the broader binding profile did not take Zydus’s product outside the scope of the patent claims

On Claim-to-Product Mapping: The Court held that infringement must be established through claim-to-product mapping, not merely biosimilarity. However, having conducted the necessary mapping, the Court found that ZRC-3276 shared key features with Nivolumab (identical amino acid sequences, PD-1 binding characteristics) and therefore infringed the patent claims.

On Bolar Exemption: The Court clarified that while research and clinical trials are permitted during the patent term (Bolar exemption), manufacturing and stockpiling the biosimilar in preparation for commercial launch constitute infringement. The Court held that Zydus’s intended manufacturing runs and stockpiling of ZRC-3276 exceeded permissible research bounds and constituted patent infringement.

On Public Interest: While acknowledging the public interest in biosimilar availability, the Court held that public interest does not justify undermining statutory IP rights. The Court observed that post-patent expiry (May 2, 2026), Zydus could lawfully launch its biosimilar. Granting interim relief maintained the integrity of the patent system. The Court noted that ensuring IP protection during the patent term ultimately encourages innovation and the development of life-saving therapies.

Final Decision

The Delhi High Court granted an interim injunction restraining Zydus from:

• Manufacturing, using, selling, or dealing with any biosimilar of Nivolumab
• Launching any product during the patent pendency

The Court directed Zydus to file an affidavit within four weeks disclosing the quantity of biosimilar already manufactured. The Court clarified that the findings were confined to the interim stage and would not prejudice the final determination of the patent validity suit.

Key Learnings

1. Biosimilar Regulatory Filings Establish Infringement Intent: Identifying an originator drug as the reference biologic in regulatory filings constitutes an admission that the biosimilar is designed to replicate the originator’s amino acid sequences and functional characteristics. Courts view such filings as evidence of infringement.
2. Binding Profile Variations Don’t Negate Infringement: A biosimilar’s broader binding spectrum (binding to multiple receptors rather than a single target) does not necessarily establish non-infringement if the patent claims permit such cross-reactivity or specify only the primary binding target.
3. Cause of Action Timing in Biosimilar Cases: The cause of action for biosimilar infringement arises when the defendant discloses its intention for commercial launch, not merely when it commences research or clinical trials. This distinction is critical for limitation periods and laches arguments.
4. Bolar Exemption Has Limits: While research, development, and clinical trials are permitted during the patent term, manufacturing in commercial quantities and stockpiling in preparation for post-patent-expiry launch constitute infringement. The boundary between permissible research and prohibited manufacturing is fact-specific but courts will scrutinize the scale and intent of manufacturing activities.
5. Patent Validity in Biologics Context: Monoclonal antibodies and other biologics, even when derived from natural sources, are patentable when they involve substantial human intervention in their development, characterization, and manufacture. The “product of nature” doctrine does not negate patentability of engineered biologics.
6. Public Interest Cannot Trump IP Rights: While courts recognize the public interest in affordable medicines, they will not permit that interest to override statutory patent protection during the patent term. Post-patent-expiry access remains available as the ultimate public interest safeguard.
7. Strategic Implications:

• Patent holders should monitor regulatory filings by potential competitors and initiate quia timet suits promptly upon learning of biosimilar development
• Generic/biosimilar manufacturers should avoid identifying specific reference biologics in regulatory filings if aiming to argue non-infringement
• The judgment significantly strengthens patent protection for biologics in India, potentially affecting generic manufacturers’ market entry strategies

Case 7: Johnson & Johnson vs Pritamdas Arora & Medserve (Delhi High Court, March 2025)

Background Facts

Johnson & Johnson (“J&J”), the global healthcare conglomerate, holds registered trademarks for medical device brands including SURGICEL, ETHICON, and LIGACLIP—all used for surgical products including hemostatic agents (blood clotting agents), sutures, and surgical clips. These are critical medical devices used in surgical procedures to control bleeding and facilitate wound closure.

Beginning in 2019, J&J discovered that counterfeit surgical devices bearing its registered trademarks were circulating in the global supply chain. Investigation traced the counterfeit products to Medserve, a company based in New Delhi, owned and operated by defendant Pritamdas Arora. Medserve had engaged in a sophisticated counterfeiting operation involving:

1. Manufacturing Counterfeit Products: Third-party manufacturers in Turkey and China produced fake surgical devices replicating J&J’s SURGICEL, ETHICON, and LIGACLIP products.
2. Repackaging and Adulteration: Medserve repackaged these counterfeit products using J&J’s registered trademarks and packaging designs. Significantly, Medserve also repackaged expired J&J products with falsified expiration dates to extend their apparent shelf life.
3. International Distribution: The counterfeit products were exported to at least nine countries, infiltrating medical supply chains and hospital procurement systems globally.
4. Product Defects: Examination revealed that counterfeit SURGICEL products were:
   • Non-sterile and contaminated with bacterial infections
   • Inadequately oxidized (affecting hemostatic efficacy)
   • Unsafe for surgical use

These defects posed grave risks to patient safety, as non-sterile surgical products could introduce infections during critical surgical procedures.

Plaintiff’s Arguments

J&J argued that:

1. Trademark Infringement: Medserve and Pritamdas Arora unlawfully reproduced, distributed, and sold products bearing J&J’s registered trademarks without authorization, constituting blatant trademark infringement.
2. Deliberate Counterfeiting: The evidence established deliberate, willful counterfeiting with intent to defraud consumers and profit from J&J’s brand reputation and goodwill.
3. Public Health Threat: Counterfeiting of medical devices is not merely a trademark issue but a grave public health threat. Counterfeit surgical products endanger patient safety and life.
4. Damages and Injunctive Relief: J&J sought both compensatory damages for losses suffered and exemplary damages for the defendants’ willful conduct, along with permanent injunctive relief.

Defendant’s Response

The defendants offered minimal substantive defense, with the case ultimately decided largely based on the evidence presented by J&J, including:

• Seized counterfeit products from Medserve’s premises
• Electronic communications and financial records establishing the counterfeiting operation
• Expert reports confirming product defects and non-compliance with safety standards
• Evidence of international distribution through intermediaries in the UAE and United States

Court’s Analysis and Findings

Justice Amit Bansal examined the evidence and findings of Local Commissioners appointed by the Court who had conducted raids on Medserve’s premises.

Established Facts:

• Medserve had manufactured, repackaged, and exported counterfeit J&J surgical products
• The counterfeit products were non-sterile, contaminated, and defective
• Medserve had falsified expiration dates on expired products
• The defendants engaged in deliberate, willful infringement with knowledge of their conduct’s unlawfulness
• International distribution involved multiple intermediaries and countries

Court’s Key Observations:

The Court made landmark observations regarding counterfeiting of medical devices:

“The counterfeit medical products sold by the defendants pose a significant threat to public health. Counterfeiting of medical devices is not merely a case of trade mark infringement, it is a grave offence that endangers the lives of people. The defendants’ conduct demonstrates a deliberate effort to mislead the public, jeopardize the consumer safety and exploit consumer trust for financial gain.”

The Court held that counterfeiting of medical devices represents a qualitatively distinct and more serious violation than ordinary trademark infringement, as it directly jeopardizes public health and patient safety.

Final Decision

The Delhi High Court issued the following orders:

1. Permanent Injunction: The Court granted a permanent injunction restraining Medserve, Pritamdas Arora, and all persons acting in concert with them from:
   • Manufacturing counterfeit medical devices
   • Using J&J’s registered trademarks
   • Distributing or selling counterfeit products
   • Engaging in any related counterfeiting activities
2. Damages Award: The Court awarded ₹3.34 crore (approximately USD 400,800) in damages to J&J, comprising:
   • ₹2.34 crore in compensatory damages: Calculated as 25% of the estimated ₹9.39 crore in sales generated by defendants from counterfeit products
   • ₹1 crore in exemplary damages: Imposed due to the defendants’ deliberate, willful, and contumacious conduct
3. Destruction Order: The Court ordered the destruction of all counterfeit products seized from the defendants’ premises.
4. Asset Seizure: The Court authorized seizure and forfeiture of assets derived from the counterfeiting operation.

Key Learnings

1. Counterfeiting of Medical Devices Is a Public Health Violation: Courts treat counterfeiting of medical devices as qualitatively distinct from ordinary trademark infringement due to the direct threat to public health. This elevated characterization justifies higher damages awards and stringent injunctive relief.
2. Damages Calculation Methodology: Courts may calculate compensatory damages as a percentage (here 25%) of the profits derived from counterfeit sales. The percentage reflects factors including the infringer’s culpability, the violation’s severity, and deterrence considerations.
3. Exemplary Damages for Willful Conduct: Deliberate, conscious counterfeiting of medical devices warrants exemplary damages designed to punish the infringer and deter similar conduct. Exemplary damages can exceed compensatory damages in egregious cases.
4. International Supply Chain Vulnerability: Manufacturers must be vigilant regarding counterfeit products infiltrating their international distribution networks. Evidence of distribution across multiple countries and through intermediaries strengthens claims of deliberate, large-scale counterfeiting.
5. Expert Evidence on Product Defects: Expert testimony establishing that counterfeit products are defective, non-sterile, and non-compliant with safety standards is critical to demonstrating the public health threat and justifying enhanced remedies.
6. Injunction Scope in Medical Device Cases: Injunctions in counterfeiting cases involving medical devices should broadly restrain all manufacturing, distribution, and sale activities, given the public health implications.
7. Strategic Implications:

• Medical device manufacturers should implement robust supply chain monitoring and authentication systems
• Damages awards in counterfeiting cases now reflect not merely lost sales but the grave public health and safety threats involved
• Prosecutors and enforcement agencies are increasingly viewing counterfeiting of medical devices as a serious crime warranting criminal prosecution in addition to civil remedies

Case 8: Dolby International AB & Anr. vs Lava International Ltd. (Delhi High Court, July 2025)

Background Facts

Dolby International AB (“Dolby”), the renowned audio/video technology company, holds a portfolio of standard-essential patents (SEPs) covering Advanced Audio Coding (AAC) technology. AAC is a widely adopted audio compression standard used in digital media devices, smartphones, and entertainment systems globally. Dolby’s AAC portfolio comprises over 940 licensed patents worldwide.

Lava International Limited (“Lava”), an Indian consumer electronics manufacturer, produces feature phones and smartphones. In December 2018, Dolby approached Lava regarding licensing for the AAC patents. Over the subsequent six years, from December 2018 to May 2024, the parties engaged in intermittent licensing negotiations without reaching agreement.

During negotiations, Lava consistently requested details regarding Dolby’s licensing terms, technology implementation, and patent scope. However, Lava notably failed to:

• Provide its sales data or device specifications
• Make substantive licensing proposals until the suit was filed
• Demonstrate good faith engagement or willingness to negotiate

Dolby offered pool licensing through Via LA Licensing (a patent pool operator) and bilateral licensing arrangements. Lava made only minimal counter-proposals, offering to deposit ₹5.13 per device sold—an amount Dolby rejected as “wholly inadequate” and lacking “sound economic basis.”

In May 2024, after six years of fruitless negotiations, Dolby filed a patent infringement suit before the Delhi High Court alleging that Lava’s feature phones and smartphones infringed Dolby’s AAC SEPs. Dolby sought damages covering past sales (2019-2024) and prospective injunctive relief.

Plaintiff’s Arguments

Dolby contended that:

1. SEP Essentiality: The suit patents were essential to the AAC standard. Lava’s devices implemented AAC technology and thus necessarily embodied Dolby’s patented technologies.
2. FRAND Commitment: Dolby had made a FRAND (Fair, Reasonable, and Non-Discriminatory) commitment to standards-setting organizations regarding its AAC SEPs. This commitment obligated Dolby to license on fair and reasonable terms while reserving the right to enforce patents against unwilling licensees.
3. Lava as Unwilling Licensee: Lava, despite six years of negotiations, failed to reach agreement or provide substantive counter-proposals. Lava’s conduct reflected an “unwilling licensee” strategy—prolonging negotiations while selling infringing devices without paying royalties.
4. Device Implementation: Dolby presented test reports confirming that Lava’s devices implemented AAC standards and were thereby technically compatible with Dolby’s patents.
5. Market Advantage from Non-Payment: By selling infringing devices without paying royalties, Lava derived an unfair competitive advantage over licensees who paid Dolby reasonable royalties. Lava’s competitors paid licensing fees; Lava did not, creating a pricing advantage.
6. Good Faith Negotiations Absent: Lava’s strategy of merely requesting information without providing sales data or substantive proposals lacked good faith. Lava’s first meaningful counter-offer came only after Dolby initiated the suit, reflecting belated and reluctant engagement.

Defendant’s Arguments

Lava raised limited substantive defenses:

1. Patent Invalidity: Lava argued that certain patents in Dolby’s suit portfolio had expired prior to the suit’s institution (five of eight patents). The validity of remaining active patents was questioned, though Lava did not present detailed technical challenges.
2. Non-Infringement: Lava argued that it had not deliberately infringed Dolby’s patents, suggesting that even if its devices implemented AAC, the infringement was inadvertent.
3. Licensing Rate Disputes: Lava maintained that Dolby’s proposed royalty rates were excessive and unreasonable, justifying Lava’s refusal to enter into licensing agreements.
4. Pool Licensing as Adequate Alternative: Lava contended that Dolby’s offer to license through Via LA (the patent pool) provided an alternative path, implying that Dolby’s conduct did not rise to bad faith.

Court’s Analysis

Justice Amit Bansal conducted a thorough analysis of FRAND obligations, SEP licensing standards, and the conduct of both parties.

On SEP Essentiality and Infringement:

• The Court confirmed that Dolby’s patents were essential to the AAC standard
• Test reports filed by Dolby established that Lava’s devices implemented AAC and were thereby technically compatible with the suit patents
• A prima facie case of infringement was established

On FRAND and Patent Licensing:
The Court articulated important principles regarding FRAND licensing of SEPs:

“The suit patents have been licensed by Dolby to various third parties in India and across the world. A Prima facie case of validity of the suit patents has been made out in favour of Dolby. Dolby has placed on record claim-chart mapping in order to prima facie establish essentiality of the suit patents. Lava’s devices implement the standards and this fact has been admitted by them on their website and is also evidenced by the test reports filed by Dolby. Hence, a prima facie case of infringement is made out.”

The Court held that FRAND licensing involves mutual obligations:

• Patent holders must offer reasonable licensing terms and negotiate in good faith
• Implementers must demonstrate willingness to license, provide necessary information, and make substantive proposals

On Lava’s Conduct:
The Court found that Lava acted as an “unwilling licensee” by:

• Engaging in negotiations for six years without providing sales data or device specifications
• Failing to make any substantive licensing proposal until after the suit was filed
• Requesting detailed information from Dolby while withholding information essential to determining reasonable royalties
• Continuously delaying resolution through information requests rather than substantive engagement
• Making a derisory counter-proposal (₹5.13 per device) only after being sued

The Court observed:

“Despite being in discussions with Dolby for over five years, Lava failed to propose any quantifiable licensing terms or provide its sales data until the present suit was instituted. Such conduct undermines the very spirit of good faith negotiations that is central to the FRAND framework.”

and

“Throughout the negotiations that were carried out for six years, Lava kept on asking for details and information from Dolby, without providing any evidence to show that it is not using Dolby’s technology. Lava’s strategy was simply to delay the negotiations.”

On Royalty Rate Determination:
The Court evaluated Dolby’s proposed royalty rates as reasonable given:

• The widespread licensing of Dolby’s AAC patents (940+ licenses globally)
• The essential nature of the technology
• The commercial value of AAC implementation
• Consistent terms offered to other licensees

The Court calculated the total royalty that a willing licensee would have paid: $2,340,456.98 (approximately ₹20.08 crore at prevailing exchange rates), covering all sales from 2019 to 2024.

On Market Advantage:
The Court held that Lava’s failure to pay royalties while its competitors licensed Dolby’s patents and paid royalties created an unfair competitive advantage. This market distortion supported the case for damages and injunctive relief.

Final Decision

The Delhi High Court issued the following orders:

1. Pro Tem Deposit: The Court directed Lava to deposit ₹20.08 crore (the calculated total royalty) with the Delhi High Court’s Registrar General within eight weeks from the judgment date.
2. Bank Guarantee: Alternatively, Lava was required to post a bank guarantee for the same amount, ensuring compliance.
3. Prospective Injunctive Relief: The Court directed that failure to deposit or post the guarantee within the prescribed period would entitle Dolby to move for an interim injunction/restraint order against Lava, prohibiting further sales of AAC-infringing devices in India.
4. Damages and Costs: The judgment established liability for damages covering all infringing sales from 2019 to 2024, with final damages to be determined after trial.
5. Expedited Trial: The Court directed expedited trial proceedings to finalize damages and permanent injunctive relief.

Key Learnings

1. FRAND Obligations Are Bilateral: Patent holders must negotiate in good faith and offer reasonable terms, but implementers must reciprocate with substantive engagement, information sharing, and serious licensing proposals. Unilateral delay tactics by either party violate FRAND principles.
2. Unwilling Licensee Conduct: Refusing to license SEPs despite six years of offers, while continuing to sell infringing devices, constitutes “unwilling licensee” conduct. Courts will impose damages and injunctive relief against such conduct.
3. Information Asymmetry in Negotiations: Implementers who continuously request information from patent holders while withholding their own sales data and device specifications violate good faith negotiation standards. FRAND licensing requires mutual transparency.
4. Royalty Rate Reasonableness: Courts assess royalty reasonableness based on:

• The patent’s essentiality to standards
• Global licensing patterns and rates
• The commercial value of the technology
• Consistency with rates offered to other licensees

5. Delay as Bad Faith: Prolonging licensing negotiations for six years without substantive engagement, making derisory proposals only after litigation, constitutes bad faith and undermines FRAND commitments.
6. Market Advantage from Non-Payment: Selling infringing devices without paying royalties creates an unfair competitive advantage relative to competitors who license and pay royalties. This advantage is remediable through damages and injunctive relief.
7. SEP Enforcement Standards: Courts in India are becoming increasingly robust in enforcing SEPs against unwilling licensees, particularly when implementers engage in protracted delay tactics and strategic non-engagement.
8. Strategic Implications:

• Implementers of SEPs must demonstrate good faith engagement, provide necessary information, and make substantive licensing proposals within reasonable timeframes
• Delay tactics and strategic non-engagement will be characterized as bad faith conduct warranting damages and injunctive relief
• Royalty calculations may cover multiple years of past sales, creating substantial financial exposure for non-licensees
• Patent holders are increasingly willing to pursue litigation against implementers refusing reasonable licensing terms

Case 9: Vifor International Limited & Anr. vs MSN Laboratories Pvt. Ltd. & Ors. (Delhi High Court, January 2025)

Background Facts

Vifor International Limited (“Vifor”) held Indian Patent No. 536 (hereinafter “IN’536”), claiming a pharmaceutical composition comprising ferric carboxymaltose (FCM), an iron-replacement therapy for iron deficiency anemia. The patent employed a product-by-process claim—the product was defined primarily by its manufacturing process rather than its chemical structure alone.

FCM is a complex iron-carbohydrate composition that proved difficult to define structurally due to its polymeric nature. Vifor’s approach was to claim the product by reference to the manufacturing process producing it. The patent specified that the product was manufactured using a particular oxidizing agent in a specific oxidation process.

Beginning in 2020, three major Indian generic manufacturers—MSN Laboratories Pvt. Ltd., Corona Remedies Pvt. Ltd., and Dr. Reddy’s Laboratories Ltd.—announced intentions to launch generic versions of FCM. Each company claimed that their respective manufacturing processes for FCM differed from Vifor’s patented process, particularly in the choice of oxidizing agent (e.g., MSN used a different oxidizing agent), and therefore their products did not infringe the patent.

Vifor filed an infringement suit seeking interim injunctive relief to prevent the generic manufacturers from launching their FCM products. A Single Judge initially denied interim relief, accepting the defendants’ arguments that their products, manufactured through different processes, did not fall within the scope of the product-by-process claim.

Key Legal Issue

The central legal issue was: What is the scope of infringement for a product-by-process patent claim? Specifically, does a product manufactured through a different process infringe a product-by-process patent?

Single Judge’s Decision

The Single Judge, taking a narrow approach, held that product-by-process claims protect only the product when manufactured through the specific claimed process. If the defendants manufactured the identical product through a different process, the Single Judge reasoned, infringement did not occur.

This reasoning implied that product-by-process patents afforded narrow protection—limited essentially to preventing others from using the specific claimed manufacturing process.

Division Bench’s Analysis

Vifor appealed the Single Judge’s decision to a Division Bench of the Delhi High Court. The Division Bench conducted a comprehensive analysis of product-by-process claim jurisprudence.

Key Holdings:

The Division Bench held that product-by-process claims must protect the product itself, not merely the process, provided the claimed product is:

• Novel: Not previously known in the prior art
• Non-obvious: The product represents a genuine inventive contribution
• Distinct: The product exhibits characteristics or properties that distinguish it from known products

The Bench articulated the correct approach:

If a product-by-process claim discloses a product that is genuinely novel and non-obvious (unknown in the prior art), the patent protection extends to the product as such, irrespective of the manufacturing process used. The process is merely the mechanism by which the product’s novelty and non-obviousness are established or enabled.

However, if the product-by-process claim describes merely an obvious variation achievable through routine process modifications, the claim receives narrow protection limited to the specific claimed process.

In Vifor’s case, the Bench found that FCM, as defined by Vifor’s manufacturing process, represented a novel and inventive product with distinctive characteristics. The specific formulation and oxidation methodology produced an FCM product with superior bioavailability, stability, and clinical efficacy compared to prior formulations.

Therefore, the patent protected the FCM product itself, and any product sharing FCM’s distinctive characteristics (regardless of manufacturing process variations) would infringe the patent.

Applying this principle, the Bench found that:

• MSN’s FCM, despite using a different oxidizing agent, had similar formulation characteristics and clinical properties
• Corona’s FCM, while claimed to be a different product entirely, exhibited the same characteristic features as Vifor’s patented FCM
• Dr. Reddy’s FCM, similarly produced through a different process, shared the defining characteristics of Vifor’s patented product

All three products therefore infringed Vifor’s patent.

Final Decision

The Division Bench set aside the Single Judge’s order and granted interim injunctive relief to Vifor. The Court restrained MSN Laboratories, Corona Remedies, and Dr. Reddy’s Laboratories from launching their respective FCM products, pending final adjudication of the infringement suit.

Key Learnings

1. Product-by-Process Claims Protect the Product, Not Merely the Process: If a product-by-process patent discloses a genuinely novel and non-obvious product (unknown in the prior art), the patent protects the product itself, irrespective of the process used. The process is merely a disclosure mechanism for the product’s novelty.
2. Applicability Threshold: Product-by-process protection extends to the product only if it is:

• Novel: Not previously disclosed or known
• Non-obvious: Representing genuine inventive contribution
• Distinctive: Exhibiting characteristics distinguishing it from known alternatives

3. Product Identification Is Critical: In infringement analysis, courts must identify the essential characteristics or properties that define the claimed product. If an accused product shares these characteristics, infringement occurs despite process variations.
4. Pharmaceutical Formulation Context: In pharmaceutical cases, where structural complexity makes conventional product claims impractical, product-by-process claims provide a legitimate and important patent protection mechanism. Courts recognize the practical necessity of process-based product definitions in pharmaceutical technology.
5. Process Variations Don’t Negate Infringement: Minor variations in manufacturing process (e.g., using a different oxidizing agent or slightly different reaction conditions) do not establish non-infringement if the resulting product shares the defining characteristics of the patented product.
6. Burden on Defendants: Generic manufacturers cannot escape product-by-process infringement claims by simply employing different manufacturing processes. Defendants must demonstrate that their products are materially different in their characteristics or properties.
7. Expert Evidence Importance: Establishing product identity (or difference) requires detailed technical evidence demonstrating the characteristics, formulation parameters, and properties of both the claimed product and the accused product.
8. Strategic Implications for Patent Holders:

• Product-by-process patents, when properly drafted and claiming genuinely novel products, provide robust protection
• Patent holders should emphasize the novel characteristics and non-obvious properties flowing from the claimed manufacturing process
• Interim relief is available when prima facie infringement is established through product characteristic comparison

9. Strategic Implications for Generic Manufacturers:

• Process modifications alone do not establish non-infringement
• Genuine non-infringement requires demonstrating that the accused product is materially different in its characteristics or properties
• Validity challenges (arguing that the claimed product is obvious or lacks novelty) may be more promising than non-infringement arguments

Case 10: AbbVie Biotherapeutics Inc. vs Controller of Patents and Designs (Delhi High Court, June 2025)

Background Facts

AbbVie Biotherapeutics, Inc. (“AbbVie”) filed a patent application claiming an anti-cMet (c-mesenchymal epithelial transition receptor) antibody-drug conjugate (ADC)—a sophisticated biopharmaceutical combining a monoclonal antibody targeting cancer cells with a covalently attached cytotoxic drug payload. The application claimed methods of treating non-small cell lung cancer (NSCLC) and other cancers with specific dosing regimens and patient selection criteria.

During prosecution, the Patent Office raised objections under Sections 3(i) (methods of treatment excluded from patentability) and 2(1)(j) (lack of industrial applicability). The original claims were directed to methods of treating specific cancers, which fall within the Section 3(i) exclusion.

In response, AbbVie filed an amendment under Section 59(1) of the Patents Act, 1970, seeking to convert the method-of-treatment claims into product claims (the anti-cMet ADC composition itself) without therapeutic use limitations. This amendment strategy aimed to circumvent the Section 3(i) exclusion by shifting from method claims to product claims.

Amendment Proposed by AbbVie

The key changes in the amendment were:

1. Original Claims: Defined the invention as “a method of treating NSCLC or other specified cancers comprising administering the anti-cMet ADC in specific dosing regimens”
2. Amended Claims: Sought to claim “an anti-cMet antibody-drug conjugate” without specifying any therapeutic use, disease limitation, or dosing parameter

This shift effectively broadened the scope from a disease-specific method claim to a general product claim covering the ADC composition in any context or application.

Patent Office’s Rejection

The Controller rejected the amended claims under Section 59(1) of the Patents Act, finding that the amendments:

• Introduced new subject matter not originally disclosed
• Broadened the scope of the claims beyond what was originally disclosed
• Violated the strict limitations on amendments imposed by Section 59(1)

The Controller upheld the rejection of the original claims under Section 3(i) and 2(1)(j), finding that the method claims lacked industrial applicability and fell within the statutory exclusion for methods of treatment.

AbbVie’s Arguments on Appeal

AbbVie argued that:

1. Right to Amend: The Patents Act (Sections 57(6) and 59) permits amendments at any stage during the application pendency, even if amendments were not made at the PCT (international) stage.
2. Overcomiing Objections: The amendment was necessary to overcome the Controller’s objection under Section 3(i). By converting method claims to product claims, AbbVie sought to obtain patent protection for the innovative ADC composition itself.
3. Allergan Precedent: AbbVie cited the case of Allergan, where a court permitted amendments from method claims to product claims.
4. Industrial Applicability: The amended product claims possess clear industrial applicability as the ADC is a pharmaceutical composition with manufacturing, storage, and commercial applications.

Court’s Analysis

Justice Amit Bansal, presiding over the appeal, conducted a rigorous examination of Section 59(1) amendments and claim scope.

Key Holdings:

1. Section 59(1) Imposes Strict Limits: Section 59(1) restricts amendments to:

• Disclaimers, corrections, or explanations
• Incorporation of facts
• Amendments that do not introduce new subject matter
• Amendments that do not broaden the scope beyond the original disclosure

2. Scope Broadening Test: The Court applied a rigorous test for scope broadening:

• Compare the original claims with the amended claims
• Assess whether the amended claims claim matter not originally claimed
• Determine whether the amended claims encompass subject matter outside the original disclosure

3. Disease Limitation Removal Constitutes Scope Broadening: The Court held that removing disease-specific limitations from method claims substantially broadens the scope of the patent. The original claims limited the invention to treating NSCLC and other specified cancers. The amended claims sought protection for the ADC composition without any therapeutic use limitation.

By removing the disease limitation, AbbVie’s amendment effectively expanded the patent from specific therapeutic applications to unlimited applications of the ADC composition. This expansion was impermissible under Section 59(1).

4. Distinction from Allergan: The Court distinguished AbbVie’s case from Allergan, noting that:

• In Allergan, the amended claims retained disease-specific references
• In AbbVie, the amended claims completely eliminated disease-specific references
• Allergan’s amendment was a narrowing or clarifying change
• AbbVie’s amendment was a broadening expansion

5. No Blanket Right to Amend: The Court held that while patents are amendable under Sections 57(6) and 59, these provisions do not confer unlimited amendment rights. Amendments must comply with the strict Section 59(1) limitations.
6. Original Claims Remain Non-Patentable: The Court upheld the Controller’s finding that the original method-of-treatment claims fall within the Section 3(i) exclusion and lack industrial applicability under Section 2(1)(j).

Final Decision

The Delhi High Court upheld the Controller’s rejection of both the original and amended claims. The Court held that:

1. The original claims are non-patentable under Sections 3(i) and 2(1)(j)
2. The proposed amendments violate Section 59(1) by broadening the scope
3. The amended claims are therefore not permissible

AbbVie’s patent application was definitively rejected without modification.

Key Learnings

1. Section 59(1) Amendments Are Strictly Construed: Amendments that broaden claim scope or introduce new subject matter violate Section 59(1) and are impermissible. Courts apply rigorous scrutiny to amendment requests.
2. Removal of Therapeutic Limitations Constitutes Scope Broadening: Removing disease-specific or therapeutic use limitations from method claims significantly broadens the scope of the patent. Such broadening amendments are impermissible.
3. Method-of-Treatment Claims Face Patentability Obstacles: Under Section 3(i), method-of-treatment claims for human therapeutic purposes are generally excluded from patentability in India. Applicants cannot circumvent this exclusion through claim amendments.
4. Industrial Applicability of Pharma Compositions: While pharmaceutical compositions per se may possess industrial applicability, claiming compositions without any therapeutic context or use specification may raise concerns regarding enablement and practical utility.
5. Amendment Strategy Matters: Applicants must carefully consider amendment strategies during prosecution. Attempting to overcome objections by removing limitations and broadening scope is typically unsuccessful. Instead, applicants should:

• Add technical details and specific formulation parameters within the original disclosure scope
• Narrow claims to avoid Section 3(i) issues while maintaining adequate protection
• Consider alternative claim types (e.g., dosage forms, specific combinations)

6. Section 3(i) Remains a Significant Bar: For biological and pharmaceutical inventions, Section 3(i) remains a significant barrier to patent protection for methods of treatment. Applicants must carefully draft original claims to avoid triggering this exclusion.
7. Precedent Boundaries: While Allergan established that certain amendments may be permissible, each case involves fact-specific analysis. Courts distinguish cases based on whether amendments narrowed or broadened scope.
8. Strategic Implications for Biotech Companies:

• Focus on claiming compositions and formulations rather than methods of treatment when seeking to avoid Section 3(i)
• Ensure original specifications disclose sufficient technical details regarding compositions, structures, formulations, and parameters to support amendment flexibility
• Recognize that removing limitations generally constitutes scope broadening and is impermissible
• Work closely with patent attorneys during prosecution to develop claim strategies that obtain protection within statutory constraints
• Consider alternative jurisdictions (e.g., US, Europe) where biotech composition patents face fewer restrictions

Conclusion: Emerging Trends and Strategic Implications

The ten landmark patent cases decided in India during 2025 reveal several converging trends reshaping the Indian patent landscape:

Emerging Trends

1. Robust Patent Enforcement Against Infringement: Courts have demonstrated increasing willingness to grant interim injunctive relief when prima facie infringement is established, even against defendants who claim their own patents or alternative technologies. The Aquestia case exemplifies this trend—courts no longer accept patent-grant-as-defense arguments.
2. Stringent Scrutiny of Patent Validity Claims: Defendants raising patent validity challenges must present credible, substantive evidence. The Roche-Natco case illustrates that claims of obviousness or anticipation require detailed technical analysis; conclusory arguments are insufficient.
3. Public Health Balanced Against IP Protection: While courts recognize public interest in healthcare access, they generally decline to override statutory IP rights during patent terms. The Roche-Natco and Squibb-Zydus cases establish that post-patent-expiry access serves as the ultimate public interest safeguard.
4. FRAND Licensing Becomes Increasingly Enforced: The Dolby-Lava case exemplifies courts’ growing assertiveness in enforcing FRAND principles and penalizing “unwilling licensee” conduct. SEP holders are increasingly confident in pursuing damages and injunctive relief against non-licensees.
5. Biosimilar Enforcement Strengthens: The Squibb-Zydus decision suggests that patent protection for biologics and biosimilar antibodies is becoming more robust. Regulatory filings identifying reference biologics are treated as admissions of infringement intent.
6. Section 3(k) Software Patents Are Increasingly Patentable: The Idemia case signifies India’s movement toward recognizing software and algorithm patents when they solve technical problems and produce technical effects. This aligns Indian law with international norms.
7. Strict Limits on Claim Amendments: The AbbVie case reinforces that Section 59(1) amendments are strictly construed, and scope-broadening amendments are impermissible. This creates challenges for applicants seeking to overcome examination objections.
8. Product-by-Process Claims Receive Meaningful Protection: The Vifor case establishes that genuinely novel product-by-process claims protect the product itself, irrespective of process variations. This strengthens pharmaceutical patent protection.

Strategic Implications for Stakeholders

For Patent Holders:

• Pursue interim relief aggressively when infringement is prima facie established; courts increasingly grant such relief
• FRAND licensees should carefully document negotiation efforts and maintain good faith throughout licensing discussions
• For biosimilars and biologics, monitor regulatory filings by competitors and file quia timet suits promptly
• Carefully draft product claims and product-by-process claims with detailed specification support
• Emphasize technical effects and technical problem-solution approaches for software/algorithm inventions

For Generic/Biosimilar Manufacturers:

• Validity challenges require rigorous technical evidence and detailed prior art analysis
• Avoid identifying originator products as reference biologics in regulatory filings
• Demonstrate genuine process differences or product variations if relying on non-infringement arguments
• Ensure good faith engagement in FRAND licensing negotiations; delay tactics invite damages and injunctive relief
• Consider international jurisdictions if India’s Section 3 exclusions significantly limit patentability

For Patent Offices and Examiners:

• Provide detailed, reasoned examination reports explaining grounds for rejection
• Cite specific prior art and technical evidence supporting obviousness or anticipation conclusions
• Engage substantively with applicant responses and amendment proposals
• Apply rigorous technical analysis rather than formulaic or mechanistic rejections

For Legal Practitioners:

• Master claim-to-product mapping and technical analysis for infringement cases
• Develop expertise in FRAND principles and SEP licensing standards
• Stay current with evolving Section 3(k) jurisprudence on software and algorithm patentability
• Carefully advise clients on amendment strategy during prosecution, emphasizing scope-narrowing rather than scope-broadening changes
• Recognize the importance of detailed specifications with working examples and technical details

Final Observations

The 2025 patent cases demonstrate that India’s patent system is maturing toward robust, technically rigorous enforcement. Courts are increasingly sophisticated in analyzing infringement, validity, and compliance with statutory provisions. Patent holders can pursue enforcement strategies with greater confidence, while competitors must engage seriously with validity challenges and licensing obligations. For practitioners, these cases underscore the importance of deep technical expertise, rigorous claim analysis, and strategic thinking about claim drafting and prosecution strategy.

The Indian patent landscape continues to evolve toward greater IP protection and enforcement while maintaining balance with public health and competition policy. Stakeholders who understand these emerging trends and adapt their strategies accordingly will be best positioned to succeed in India’s dynamic IP ecosystem.