AstraZeneca AB Vs. Intas Pharmaceuticals Limited

Species patents following a Markush patent must demonstrate a distinct inventive step

Introduction

The AstraZeneca AB & Anr. Vs. Intas Pharmaceuticals Limited case, decided on July 20, 2021, by the High Court of Delhi, represents a pivotal moment in Indian patent jurisprudence, particularly in the pharmaceutical sector. This dispute centered on the validity and infringement of patents covering Dapagliflozin (DAPA), a critical drug for managing type-II diabetes mellitus. AstraZeneca, a global pharmaceutical leader, sought to protect its intellectual property rights against multiple Indian generic drug manufacturers, including Intas Pharmaceuticals, Alkem Laboratories, and others. At the heart of the case was the interplay between two patents—a genus patent (IN 147) employing a Markush structure and a species patent (IN 625)—and whether DAPA was disclosed in the earlier patent, thereby challenging the validity of the later patent and AstraZeneca’s claim for interim injunctive relief. This case study provides an in-depth exploration of the factual and procedural background, the legal issues, the role of Markush patents, the submissions of the parties, the judicial reasoning, and the broader implications for patent law in India.

Detailed Factual Background

AstraZeneca AB, a Swedish entity, and its Indian subsidiary, AstraZeneca Pharma India Ltd., held two Indian patents: Indian Patent No. 205147 (IN 147), a genus patent granted on March 15, 2007, with an expiry date of October 2, 2020, and Indian Patent No. 235625 (IN 625), a species patent granted on July 9, 2009, with an expiry date of May 15, 2023. Both patents were originally granted to Bristol Myers Squibb Company and assigned to AstraZeneca AB via an Assignment Deed dated February 1, 2014. IN 147 was characterized as a Markush patent, covering a broad class of C-aryl glucosides that inhibit sodium-dependent glucose transporters (SGLT2), used to treat type-II diabetes and related conditions. This patent disclosed a Markush structure, a chemical formula representing a group of related compounds with permutations potentially encompassing millions of structurally diverse molecules, though only 80 compounds were specifically exemplified. IN 625, conversely, specifically claimed DAPA, a single molecule identified as a highly effective SGLT2 inhibitor.

AstraZeneca alleged that several Indian pharmaceutical companies, including Intas Pharmaceuticals, Alkem Laboratories, Zydus Healthcare, Eris Lifesciences, USV Pvt. Ltd., Torrent Pharmaceuticals, MSN Laboratories, Micro Labs, and Ajanta Pharma, were manufacturing and selling generic DAPA-based drugs, infringing both IN 147 and IN 625. The plaintiffs argued that while DAPA fell within the scope of IN 147’s Markush structure, it was not disclosed therein and was only specifically disclosed in IN 625, resulting from further research. They claimed DAPA was a novel, non-obvious invention, with IN 625 enjoying a presumption of validity, having been granted in over 70 countries and unchallenged in India until 2020.

The defendants countered that DAPA was disclosed in IN 147, rendering IN 625 invalid due to prior claiming, anticipation, and lack of inventive step. They highlighted AstraZeneca’s admissions in US proceedings, including before the US Patent and Trademark Office (USPTO) and in a Delaware lawsuit, where the company acknowledged DAPA’s coverage under the patent equivalent to IN 147. The defendants also alleged that AstraZeneca violated Section 8 of the Patents Act, 1970, by failing to disclose USPTO examination details and argued that the significant price difference between their generics and AstraZeneca’s branded drug justified denying interim relief in the public interest.

Understanding Markush Patents

A Markush patent, named after Eugene A. Markush, who pioneered this claim structure in the 1920s, is a specialized form of patent claim used primarily in chemistry and pharmaceuticals to cover a genus of compounds. The term originates from the US case Ex parte Markush, 1925 CD 126 (Com.Pat. 1924), where Assistant Commissioner Kinnan approved a claim format that enumerated alternative species within a genus, allowing a patent drafter to condense multiple dependent claims into a single claim. The court in the present case referenced In Re: Harnisch, 631 F.2d 716 (US Court of Customs and Patent Appeals, 1980), which clarified that a Markush claim is a type of definition by enumeration, not a novel invention but a drafting technique to broadly claim a group of related chemical compounds.

In a Markush claim, a general chemical structure is defined with variable substituents (e.g., “R” groups) that can be selected from a specified list, such as alkyls, halogens, or other functional groups. For example, a claim might state: “A compound of formula X, wherein R1 is selected from methyl, ethyl, or propyl, and R2 is selected from chlorine or bromine.” This structure allows the patentee to claim a vast number of compounds without listing each one, covering permutations that may run into millions, as in IN 147. The Harnisch case emphasized that Markush claims are not inherently “alternative” but are a legitimate way to claim a genus, provided the specification enables a person skilled in the art to practice the invention across the claimed scope.

In the context of Indian patent law, Markush claims are permissible under Section 10(5) of the Patents Act, 1970, which allows claims to relate to a single invention or a group of inventions linked by a single inventive concept. The court noted that IN 147’s Markush structure disclosed a core structure with multiple variables, exemplified by 80 compounds, but did not specifically name DAPA. AstraZeneca argued that this broad coverage did not constitute disclosure, as DAPA required further research to identify. The defendants, however, contended that coverage implied disclosure, particularly given AstraZeneca’s infringement claims for IN 147, relying on Novartis AG v. Union of India, (2013) 6 SCC 1, which suggested that compounds covered by a genus patent are known therefrom.

The significance of Markush patents in this case lies in their dual role: they enable broad protection for a class of compounds, potentially blocking competitors, but also pose challenges in establishing novelty and non-obviousness for subsequent species patents like IN 625. The court grappled with whether IN 147’s Markush claim disclosed DAPA sufficiently to invalidate IN 625 or whether DAPA’s specific disclosure in IN 625 constituted a distinct inventive step.

Detailed Procedural Background

AstraZeneca filed multiple suits in the High Court of Delhi under the Commercial Courts Act, 2015, seeking permanent injunctions to restrain the defendants from manufacturing and selling DAPA-based drugs. These suits included applications for interim injunctions. The suits were bifurcated into two sets: the first, against Intas Pharmaceuticals (CS(COMM) No.410/2020) and Alkem Laboratories (CS(COMM) No.411/2020), culminated in a common order on November 2, 2020, denying interim relief. The second set, against Torrent Pharmaceuticals, Micro Labs, Zydus Healthcare, Eris Lifesciences, USV Pvt. Ltd., MSN Laboratories, and Ajanta Pharma, resulted in a common order on November 18, 2020, also denying interim relief.

AstraZeneca appealed these orders, filing nine appeals under Section 13(1A) of the Commercial Courts Act, 2015, read with Order XLIII Rule 1(r) of the Code of Civil Procedure, 1908. The appeals, numbered FAO(OS)(COMM) 139/2020 to 161/2020, included applications for additional documents, stay, and interventions by third parties such as Natco Pharma and Shiv Shivam Pharma. The Division Bench, comprising Justice Rajiv Sahai Endlaw and Justice Amit Bansal, heard the appeals collectively via video conferencing from February 25, 2021, to May 28, 2021, reserving judgment on May 28, 2021, and delivering the final decision on July 20, 2021.

Issues Involved in the Case

The case raised several critical legal issues:

1. Disclosure of DAPA in IN 147’s Markush Structure: Whether DAPA, covered by IN 147’s Markush claim, was disclosed therein, either in law or fact, and whether such disclosure invalidated IN 625?
2. Validity of IN 625: Whether IN 625 was vulnerable to challenge on grounds of prior claiming, anticipation, lack of inventive step, or non-compliance with Section 8 of the Patents Act, 1970?
3. Infringement of Dual Patents: Whether the defendants’ manufacture and sale of DAPA infringed both IN 147 and IN 625, given AstraZeneca’s claim of infringement for both patents?
4. Entitlement to Interim Injunction: Whether AstraZeneca established a prima facie case, balance of convenience, and irreparable loss to warrant interim injunctive relief, considering the defendants’ credible challenge to IN 625’s validity?
5. Public Interest and Pricing: Whether the significant price difference between AstraZeneca’s branded drug and the defendants’ generics, coupled with the public health context of the COVID-19 pandemic, justified denying interim relief?

AstraZeneca’s Submissions

AstraZeneca argued that IN 147’s Markush structure, while covering DAPA within its broad scope, did not disclose it specifically. They emphasized that IN 147, granted in 2007 with a priority date of August 12, 1999, disclosed a core structure with millions of possible compounds, exemplified by 80 compounds, none of which were DAPA. DAPA was invented in 2001 and patented in IN 625, granted in 2009 with a priority date of May 20, 2002, following further research to identify the optimal SGLT2 inhibitor. AstraZeneca contended that DAPA was not obvious from IN 147, as the Markush structure provided no guidance on selecting DAPA, and any derivation relied on hindsight, which is impermissible under patent law (F. Hoffman-La Roche v. Cipla Ltd., 2015 (225) DLT 391).

The plaintiffs asserted that IN 625 enjoyed a presumption of validity, having been rigorously examined by the Indian Patent Office and granted in over 70 countries. They argued that the defendants’ 2020 challenges to IN 625 were mala fide, initiated as a counterblast to the infringement suits. On Section 8 compliance, AstraZeneca claimed they disclosed the US patent equivalent to IN 625 as a continuation-in-part of the US patent equivalent to IN 147, and the USPTO’s objection on obviousness-type double patenting was irrelevant, as it did not affect the Indian Patent Office’s assessment. They further argued that the balance of convenience favored them, as denial of interim relief would erode their market share and research investment, while the price difference (approximately Rs.1,100/month) was justified given their R&D costs.

Defendants’ Submissions

The defendants argued that DAPA was disclosed in IN 147’s Markush structure, as evidenced by AstraZeneca’s admissions in US proceedings. They noted that AstraZeneca agreed to align the validity period of the US patent equivalent to IN 625 with that of IN 147 before the USPTO and claimed infringement of the IN 147 equivalent in a Delaware lawsuit against Zydus Pharmaceuticals USA. Citing Novartis AG v. Union of India, (2013) 6 SCC 1, they argued that coverage in a genus patent implies disclosure, rendering IN 625 invalid for prior claiming and anticipation. They further contended that DAPA was obvious from IN 147’s example 12, which disclosed a methoxy-substituted compound close to DAPA’s ethoxy-substituted structure, as a skilled person could make the substitution (F. Hoffman-La Roche v. Cipla Ltd.).

The defendants alleged non-compliance with Section 8, claiming AstraZeneca concealed USPTO objections and their response, which admitted DAPA’s disclosure in the IN 147 equivalent. On interim relief, they argued that their credible challenge to IN 625’s validity precluded an injunction. They emphasized the balance of convenience, noting their domestic manufacturing versus AstraZeneca’s imports, and the public interest, given their generics’ lower prices (Rs.13.90–17.50 vs. Rs.54.40–57.29 per dose). They highlighted the need for affordable diabetes drugs during the COVID-19 pandemic, where diabetic patients faced heightened risks.

Detailed Discussion on Judgments Cited

The parties and the court referenced several judgments, each providing context to the Markush patent and other issues:

1. Novartis AG v. Union of India, (2013) 6 SCC 1: The defendants relied on this case to argue that there is no dichotomy between coverage and disclosure in a genus patent like IN 147’s Markush claim, suggesting DAPA’s coverage implied its disclosure. The Supreme Court in Novartis held that molecules covered by a genus patent are known therefrom, rejecting a strict separation of coverage and disclosure. However, the court in the present case noted that Novartis recognized a factual distinction, requiring case-specific analysis to determine whether IN 625’s specific disclosure of DAPA was distinct from IN 147’s Markush coverage.
2. F. Hoffman-La Roche v. Cipla Ltd., 2015 (225) DLT 391: Cited by the defendants to support their obviousness argument, this case held that prior art, even with multiple starting points, can suggest modifications to a skilled person. The court applied this to assess whether DAPA’s ethoxy substitution was obvious from IN 147’s methoxy-substituted example 12, impacting IN 625’s validity.
3. Wander Ltd. v. Antox India P. Ltd., 1990 Supp SCC 727: Referenced by the court to define the appellate review standard for interim injunctions, requiring perversity to warrant interference. The court used this to uphold both impugned orders denying relief, finding no perversity despite differing reasoning.
4. AZ Tech (India) v. Intex Technologies (India) Limited, Civil Appeal No.18892/2017 (Supreme Court, August 16, 2017): Cited by the court to critique exhaustive interim relief orders in IP cases, advocating for brevity. The court adhered to this by limiting its analysis and avoiding detailed discussion of all cited judgments.
5. In Re: Harnisch, 631 F.2d 716 (US Court of Customs and Patent Appeals, 1980): Referred to by the court to define Markush claims, explaining their origin as a drafting technique to enumerate species within a genus. This clarified IN 147’s structure as a Markush patent but did not resolve whether DAPA was disclosed, as the court focused on AstraZeneca’s admissions.
6. Ex parte Markush, 1925 CD 126 (Com.Pat. 1924): Implicitly referenced through Harnisch, this US decision established the legitimacy of Markush claims, allowing broad genus claims in chemistry. It provided historical context for IN 147’s claim structure, supporting its legal permissibility under Indian law (Section 10(5)).
7. FMC Corporation v. Best Crop Science LLP, CS(COMM) No.69/2021 and CS(COMM) No.661/2019 (Delhi High Court, July 7, 2021): Mentioned by AstraZeneca post-hearing to bolster their interim relief claim. The court distinguished it, as it involved a single patent, unlike the dual-patent claim involving a Markush structure in the present case.

Detailed Reasoning and Analysis of Judge

The Division Bench delivered a meticulous judgment, with the Markush patent issue at its core. The court framed the central question as whether DAPA, covered by IN 147’s Markush claim, was disclosed therein, impacting IN 625’s validity and AstraZeneca’s interim relief claim.

The court questioned AstraZeneca’s assertion of infringement for both IN 147 and IN 625, noting that claiming infringement of IN 147 implied DAPA’s disclosure therein, as infringement requires the infringing act to fall within the patent’s scope (Section 48). If DAPA was not disclosed in IN 147, no infringement could occur, undermining AstraZeneca’s dual-patent claim. The court emphasized that the Patents Act, 1970, limits a single invention to one patent with a 20-year term (Sections 2(j), 2(ja), 2(l), 3, 48). The identical field of invention descriptions in IN 147 and IN 625 suggested no technical advancement or economic significance in IN 625, raising doubts about its novelty and inventive step.

Regarding the Markush structure, the court acknowledged IN 147’s broad claim, covering millions of compounds but exemplifying only 80, none explicitly naming DAPA. Citing In Re: Harnisch, the court recognized Markush claims as a legitimate way to claim a genus under Section 10(5), allowing a group of inventions linked by a single inventive concept. However, AstraZeneca’s pleadings admitted DAPA’s coverage in IN 147, and their US actions—agreeing to align the US patent equivalent to IN 625’s term with IN 147’s and claiming infringement of IN 147’s equivalent—reinforced this admission. The court held that claiming infringement of IN 147’s Markush claim meant DAPA was disclosed therein, as coverage and disclosure are intertwined in infringement actions, aligning with Novartis’s broader interpretation but applying it factually to AstraZeneca’s admissions.

On obviousness, the court considered the defendants’ argument that IN 147’s example 12, disclosing a methoxy-substituted compound, was closeK close to DAPA’s ethoxy-substituted structure. The court found that a skilled person could substitute methoxy with ethoxy, both being lower alkyls, suggesting DAPA’s obviousness (F. Hoffman-La Roche). This rendered IN 625 vulnerable, as the Markush structure’s breadth did not negate the suggestive nature of its prior art.

The court also found AstraZeneca’s non-compliance with Section 8(2) of the Patents Act—failing to disclose USPTO objections and their response admitting DAPA’s disclosure in IN 147’s equivalent—further weakened IN 625’s validity. This non-disclosure was significant, as it could have influenced the Indian Patent Office’s assessment.

For interim relief, the court applied the triadic test: prima facie case, balance of convenience, and irreparable loss. AstraZeneca failed to establish a prima facie case due to IN 625’s vulnerability and their admissions regarding IN 147’s Markush claim. The balance of convenience favored the defendants, whose generics were 250–350% cheaper, serving public interest during the COVID-19 pandemic. The court noted that AstraZeneca could be compensated monetarily if they succeeded at trial, whereas injuncting the defendants would harm their market and public access to affordable drugs.

The court dismissed AstraZeneca’s arguments about IN 625’s long-standing validity (18 years) and global grants, as the Patents Act allows challenges at any stage (Section 13(4)). The differing reasoning in the two impugned orders did not warrant relief, as both denied injunctions without perversity (Wander Ltd.).

Final Decision

The High Court of Delhi dismissed all nine appeals, upholding the lower courts’ orders denying interim injunctions. The court imposed costs of Rs.5,00,000 on AstraZeneca for each suit, payable to the defendants, reflecting the appeals’ lack of merit and the judicial resources wasted by AstraZeneca’s parallel litigation strategy.

Law Settled in This Case

This case clarified several aspects of Indian patent law, particularly regarding Markush patents:

1. Single Invention, Single Patent: A single invention like DAPA cannot be protected by multiple patents with successive terms, as this violates the 20-year patent term limit (Sections 2(j), 48).
2. Markush Claims and Disclosure: Claiming infringement of a Markush patent implies disclosure of the invention therein, impacting subsequent species patents’ validity. Markush claims must fully disclose the claimed invention to support infringement actions (Sections 10, 25).
3. Inventive Step in Species Patents: Species patents following a Markush patent must demonstrate a distinct inventive step, such as technical advancement or economic significance, to avoid invalidation for obviousness or prior claiming (Section 2(ja)).
4. Section 8 Compliance: Non-disclosure of foreign patent examination details, especially objections, can render a patent vulnerable, even at the interim stage (Section 8(2)).
5. Interim Injunctions: A credible challenge to patent validity, combined with public interest factors like drug affordability, can preclude interim relief, with monetary compensation sufficing if the patentee prevails at trial.

Case Title: AstraZeneca AB & Anr. Vs. Intas Pharmaceuticals Limited

Date of Order: July 20, 2021

Case No.: FAO(OS)(COMM) 139/2020

Name of Court: High Court of Delhi 

Name of Hon'ble Judges: Justice Rajiv Sahai Endlaw and Justice Amit Bansal

Disclaimer: The information shared here is intended to serve the public interest by offering insights and perspectives. However, readers are advised to exercise their own discretion when interpreting and applying this information. The content herein is subjective and may contain errors in perception, interpretation, and presentation.

Written By: Advocate Ajay Amitabh Suman, IP Adjutor [Patent and Trademark Attorney], High Court of Delhi

Vijay Kumar Salwani Vs. Union of India

Background

The petitioner, Vijay Kumar Salwani trading as M/s Modern Namkeen Bhandar, challenged the removal of his registered Trade Mark No. 641088 on the ground that no mandatory notice under Section 25(3) of the Trade Marks Act, 1999 was issued before the removal.

Government's Response

The Union of India admitted that while a notice was claimed to have been issued, the department had no available record to prove that the notice was actually sent.

Court's Observations

The Court held that issuing a notice under Section 25(3) is mandatory before removal of a trademark. Without proof of dispatch, the removal could not be sustained.

Judgment

The Court set aside the removal of the petitioner’s trademark and ordered its restoration. It allowed the Trade Marks Registry to issue a fresh notice and gave liberty to the petitioner to file for renewal. Further, the Court directed the Registry to process such renewal applications without technical objections in similar cases where no record of notice existed.

Case title: Vijay Kumar Salwani Vs. Union of India

Date of order: 28 May 2019

Case No.: W.P.(C) 9270/2015 

Name of Court: High Court of Delhi

Name of Judge: Hon'ble Mr. Justice J.R. Midha

L’Oréal S.A. Vs. Registrar of Trademarks

Background

L'Oréal S.A. filed an appeal under Section 91(1) of the Trade Marks Act, 1999, challenging the order dated 24 September 2019, whereby the registration of its trademark "GARNIER SKIN NATURALS" (Registration No. 1021740) in Class 3 was removed. The trademark had been in use since 2001 and was initially registered to Laboratoire Garnier Et Cie, which later merged with L'Oréal. The appellant filed for a change in ownership in 2012, which was duly recorded.

Discovery of Removal

In 2017, during a random website check, L'Oréal discovered that the subject mark was slated for removal due to non-renewal. They promptly filed an interlocutory petition for renewal and restoration on 5 January 2018. Despite this, the trademark was removed without allowing L'Oréal to pay the renewal fee.

Arguments

L'Oréal contended that they had not received the mandatory renewal notice under Section 25(3) of the Act, which was a precondition before removal. In defense, the Registrar of Trademarks produced a copy of the notice dated 6 April 2011 but failed to provide proof of its dispatch. L'Oréal consistently denied receiving any such notice.

Court's Findings

The Court observed that mere production of the notice without proof of dispatch could not suffice. Since L'Oréal filed the interlocutory petition before the actual removal and asserted non-receipt of notice, the removal of the mark was found unjustified.

Conclusion and Directions

The Court set aside the impugned removal order, directed restoration and renewal of the trademark, and instructed L'Oréal to deposit the renewal fee within two weeks.

Case title: L’Oréal S.A. Vs. Registrar of Trademarks

Date of order: 9 December 2022

Case No.: C.A.(COMM.IPD-TM) 30/2021

Name of Court: High Court of Delhi

Name of Judge: Hon'ble Mr. Justice Sanjeev Narula

Modern Snacks Pvt. Ltd. Vs. Kamran Ghani

Introduction

Modern Snacks Pvt. Ltd. filed a petition seeking rectification of the Trademark Register by cancelling the registration of the mark ‘MARDEM’ registered by Kamran Ghani in Class 30. The petitioner argued that ‘MARDEM’ was deceptively similar to their earlier and widely used trademark ‘MODERN’, also registered for similar goods like snacks and confectionery.

Background

The petitioner is engaged in the manufacturing and marketing of namkeens, snacks, and other food items under the mark ‘MODERN’, which was originally adopted in 1990 by their predecessor. They presented evidence of multiple registrations, domain names, significant sales figures, and wide recognition of the ‘MODERN’ mark.

Proceedings

Despite attempts, respondent Kamran Ghani was not personally served, but service was deemed complete through his authorized attorney. Respondent No. 1 did not appear, and thus the petitioner's allegations remained uncontroverted.

Court’s Observations

The Court noted the phonetic and visual similarity between ‘MODERN’ and ‘MARDEM’, and that both marks covered identical goods in the same class and geographical market. It was held that such similarity could cause confusion among average consumers. The Court referred to precedents stating that even minor variations in trademarks are immaterial when the resemblance is substantial enough to deceive.

Decision

The Court found that the petitioner was the prior adopter and user of the ‘MODERN’ mark. The respondent’s mark ‘MARDEM’ was deceptively similar and likely to cause confusion. Thus, the registration of ‘MARDEM’ was cancelled, and rectification of the Trademark Register was ordered.

Case Title: Modern Snacks Pvt. Ltd. Vs. Kamran Ghani and Anr.

Date of Order: 25 April 2025

Case No.: C.O. (COMM.IPD-TM) 76/2021

Neutral Citation: 2025:DHC:2905

Name of Court: High Court of Delhi

Name of Judge: Hon’ble Ms. Justice Mini Pushkarna

Vineet Kapur Vs Registrar of Trade Marks

Introduction

The case involves an appeal filed by Vineet Kapur under Section 91 of the Trade Marks Act, 1999, and Rule 156 of the Trade Marks Rules, 2017, challenging the rejection of his trademark application for the mark ‘2929’ in Class 3 (cosmetics, soaps, shampoos, etc.) by the Registrar of Trademarks.

Appellant’s Arguments

The appellant contended that ‘2929’ was a unique, arbitrary, and inherently distinctive mark, not known or used in the market for the relevant goods. He emphasized that numerical marks are recognized under Section 2(1)(m) of the Trade Marks Act and that similar numerical marks had previously been registered and protected by courts.

Respondent’s Arguments

The Registrar opposed the application on the grounds that the mark was merely a combination of common numbers without any inherent creativity or distinctive character. It was argued that such marks are generally not capable of distinguishing goods and thus should not be registered.

Court’s Observations

The Court reiterated that numerals and their combinations are included within the definition of ‘mark’ under the Trade Marks Act and can be registered if they possess distinctive character. It referred to multiple precedents where numerical marks like '501', '345', '22', '1001', '555', '7 O’Clock', and '91' were granted protection.

The Court found that the mark ‘2929’ was coined and arbitrary, bearing no connection to the nature of the goods. It held that a numeral combination inherently distinctive and unrelated to the goods’ description is eligible for trademark registration even without secondary meaning.

Decision

The Court set aside the Registrar's order dated 29 February 2024, directed that the appellant's application proceed to advertisement in the Trademark Journal, and clarified that the appellant would not claim exclusive rights over the numerals ‘2’ and ‘9’. It also directed the Registrar to notify the Office of the Controller General of Patents, Designs and Trade Marks for compliance.

Case Title: Vineet Kapur Vs Registrar of Trade Marks

Date of Order: 25 April 2025

Case No.: C.A.(COMM.IPD-TM) 22/2024

Neutral Citation:2025:DHC:2906

Name of Court: High Court of Delhi

Name of Judge: Hon’ble Ms. Justice Mini Pushkarna

R J Reynolds Tobacco Company Vs The Controller General of Patents

Background

R J Reynolds Tobacco Company filed an Indian patent application concerning a method for preparing a sugar-containing syrup from the stalk of a Nicotiana (tobacco) plant. Despite protracted prosecution and the grant of similar patents internationally, the Indian Patent Office refused the application on 19 September 2019 under Section 3(b) of the Patents Act, 1970, which bars patents for inventions whose use could harm human, animal or plant life, health, or the environment.

Grievances of the Appellant

The appellant argued that the refusal was arbitrary and lacked proper reasoning. They contended that 17 of the 18 pages of the rejection order merely copied the appellant's submissions without analysis. No consideration was given to the scientific data or comparative international patent grants presented by the appellant. The rejection was solely based on the generalized belief that tobacco is harmful, without specific evidence showing that the patented process itself caused serious health prejudice.

Contentions of the Respondent

Despite directions, the Controller General of Patents failed to submit any defense or clarifications. The refusal order thus remained unsubstantiated.

Court’s Observations

The Court noted that Section 3(b) is aimed at preventing patents that violate public order, morality, or health but emphasized that subjective and blanket assumptions without specific evidence are not sufficient grounds for rejection. The Controller’s order lacked independent reasoning, critical analysis, or evaluation of the appellant’s scientific material. The rejection reflected a prejudged stance rather than an informed decision based on the specific facts of the invention.

Court’s Decision

The Court set aside the impugned refusal order and remanded the matter back to the Controller for fresh consideration within four months, explicitly stating that no merits of the application had yet been adjudicated.

Case Title: R J Reynolds Tobacco Company Vs The Controller General of Patents, Designs and Trademarks 

Date of Order: 16 April 2025

Case No.: IPDPTA/31/2023

Name of Court: High Court at Calcutta

Name of Judge: Hon'ble Justice Ravi Krishan Kapur

Fresenius Medical Care Deutschland GmbH Vs. Controller General of Patents

Background and Rejection of Patent Application

Fresenius Medical Care Deutschland GmbH filed a patent application in India (No. 7493/DELNP/2012) concerning pharmaceutical compositions involving microvesicles (MVs) derived from adult stem cells for treating tumor diseases. The application was initially rejected by the Controller of Patents in February 2020 on multiple grounds, including lack of novelty and inventive step, insufficient disclosure, and non-patentability under Sections 3(e) and 3(i) of the Patents Act, 1970.

Filing of Appeal and Proposed Amendments

The appellant challenged this decision before the IPAB, and the matter was later transferred to the Delhi High Court following IPAB's abolition. The appellant submitted amended claims during the appellate proceedings, clarifying the inventive elements, including specific dosage and use of cytotoxic agents like doxorubicin or vincristine. These amendments aimed to overcome the original objections.

Court’s Analysis and Ruling on Amendments

The Court held that such amendments were permissible under Section 59 of the Patents Act as they served as clarifications and did not expand the original claim’s scope. Drawing from precedents such as Nestlé SA and Opentv Inc., the Court confirmed that appellate bodies could direct or accept amendments provided they meet statutory requirements.

Remand to Patent Office

Finding the amended claims to be within legal limits, the Court allowed them to be taken on record and remanded the matter back to the Patent Office for re-examination. The earlier rejection order was set aside, and the Patent Office was directed to decide afresh within three months.

Case title: Fresenius Medical Care Deutschland GmbH Vs. Controller General of Patents, Designs and Trademarks & Anr.

Date of order: 16th April, 2025

Case No.: C.A.(COMM.IPD-PAT) 302/2022

Neutral Citation:2025:DHC:2778

Name of Court: High Court of Delhi

Name of Judge: Hon’ble Mr. Justice Amit Bansal

FDC Limited Vs. Palsons Derma Private Limited

Background of the Dispute

FDC Limited, a well-established pharmaceutical company, filed a suit against Palsons Derma Pvt. Ltd., seeking to restrain the latter from using the mark "CHROMALITE" for cosmetic and skin brightening products, alleging it was deceptively similar to its own mark "KROMALITE", which had been in commercial use since 2016.

Claims of the Plaintiff

FDC claimed prior use and significant market presence of the "KROMALITE" mark in India, supported by registration in Class 5 and substantial sales. The mark, being a coined term with no prior industry use, had acquired distinctiveness. The plaintiff alleged that the defendant’s mark was phonetically and visually similar and adopted with dishonest intent to ride on their goodwill.

Defense by the Defendant

Palsons Derma argued that it independently adopted "CHROMALITE" in 2016 and began its use in 2022 after public demand to abandon its previous mark "FAIRLITE". It asserted that their mark was derived from the Greek word “Chroma” and denied knowledge of the plaintiff’s mark. The defendant contended that both parties’ marks coexisted on the trademark register and were distinguishable by packaging and target audience.

Court’s Findings

The Court held that the plaintiff was a prior user of the mark and had established goodwill and reputation through consistent use and sales. It found the two marks deceptively similar in sound and structure, with overlapping goods and trade channels, leading to a high likelihood of consumer confusion. The defendant’s argument of innocent adoption was rejected as irrelevant in a passing-off claim.

Legal Basis and Order

Relying on precedents including Syed Mohideen v. Sulochana Bai, the Court reiterated that rights of a prior user trump trademark registration in passing-off actions. The Court ruled in favor of the plaintiff, issuing an injunction restraining the defendant from using "CHROMALITE" or any deceptively similar mark during the pendency of the suit.

Case title: FDC Limited Vs. Palsons Derma Private Limited

Date of order: 15th April, 2025

Case No.: CS(COMM) 487/2023

Neutral Citation: 2025:DHC:2576

Name of Court: High Court of Delhi at New Delhi

Name of Judge: Hon’ble Mr. Justice Amit Bansal

Epifi Technologies Private Limited Vs Formula One Licensing

Dispute Over Non-Use of Trademark 'F1' in Class 36

Epifi Technologies Pvt. Ltd., a fintech startup offering digital banking and money management services under the brand name ‘FI MONEY’, filed a rectification petition under Sections 47 and 57 of the Trade Marks Act, 1999. The petition sought cancellation of the trademark ‘F1’ (No. 1988403 in Class 36) registered by Formula One Licensing BV, on the grounds of non-use and lack of bona fide intention to use.

The petitioner argued that their brand 'FI MONEY', adopted in 2021 and promoted extensively across India, faced hurdles in trademark registration due to opposition by the respondent, who relied on the 'F1' mark registered in 2010 on a 'proposed to be used' basis. The petitioner contended that in over 13 years, the respondent neither used the mark in relation to financial services in India nor obtained required regulatory approvals.

Despite settlement discussions, the respondent did not pursue the matter, failed to appear in court, and withdrew their opposition to Epifi’s trademark. The court held that, due to lack of denial from the respondent and no evidence of use, the ‘F1’ mark stood unused and blocked legitimate trademark registration. Citing precedent and Sections 47(1)(a) and (b) of the Act, the court directed removal of the impugned mark from the Trade Marks Register.

Case title: Epifi Technologies Private Limited Vs Formula One Licensing

Date of order: 15th April, 2025

Case No.: C.O. (COMM.IPD-TM) 20/2024

Neutral Citation: 2025:DHC:2874

Name of Court: High Court of Delhi 

Name of Judge: Hon’ble Mr. Justice Amit Bansal

The Indian Hotels Company Ltd. Vs. Ankit Sethi

Introduction

The Indian Hotels Company Ltd., part of the Tata Group and owner of the well-known hotel brand “GINGER,” filed a civil commercial suit seeking a permanent injunction and damages against several defendants, including Ankit Sethi. The company alleged infringement of its registered trademarks, misuse of copyrighted photographs, and passing off through fake websites that impersonated its official hotel booking platform.

Facts of the Case

The plaintiff is the registered proprietor of the GINGER trademark in Class 43 and owns the copyright in original professional photographs of its hotel properties. In late 2023, it discovered two fraudulent websites—www.gingerhotelmumbai.info and www.hotelgingermumbai.info—using its mark and photographs to impersonate the official GINGER Hotels website. These sites lured unsuspecting customers into booking fake hotel rooms, using mobile and banking details linked to the defendants.

Upon investigation, the plaintiff traced the registration and operation of the domain names to defendant no. 1, Ankit Sethi, who was allegedly operating a digital business under the name “Hackploit.” Other defendants were also found connected through common contact information, email addresses, and banking records, showing financial transactions related to the fake bookings.

Court Proceedings and Findings

The Delhi High Court had earlier granted an ad-interim ex parte injunction in December 2023, directing the suspension of the impugned domains, blocking of associated bank accounts, and disclosure of KYC and ownership details by relevant telecom and banking entities. Defendants failed to respond or file written statements despite repeated opportunities.

The court examined detailed evidence, including website screenshots, financial records, and customer complaints, which confirmed that the defendants fraudulently misrepresented themselves as the plaintiff’s business, thereby committing trademark infringement, passing off, and copyright violations. The court applied the doctrine laid down in Satyam Infoway Ltd. vs. Siffynet Solutions, holding that domain names are entitled to the same protection as trademarks, especially when used for commercial purposes.

Judgment

Finding no real defense or merit on the part of the defendants, the court passed a summary judgment under Order XIII-A of CPC. A decree of permanent injunction was granted restraining the defendants from using the impugned domain names and infringing the plaintiff’s IP rights. The court also awarded damages of Rs. 20 lakhs in favor of the plaintiff, to be paid jointly and severally by the defendants within four months.

Case Title: The Indian Hotels Company Ltd. Vs. Ankit Sethi

Date of Order: 3rd March, 2025

Case No.: CS(COMM) 882/2023

Neutral Citation: 2025:DHC:2266

Name of Court: High Court of Delhi

Name of Judge: Hon’ble Ms. Justice Mini Pushkarna

Mars Incorporated Vs. Registrar of Trademarks

Introduction

This case arose from the abandonment of a trademark application filed by Mars Incorporated, a well-known multinational company, by the Indian Trade Marks Registry. The application was deemed abandoned under Section 21(2) of the Trade Marks Act, 1999, due to an alleged failure to file a counter-statement following opposition notices. Mars challenged the abandonment on grounds of non-receipt of the opposition notices.

Background

Mars Incorporated filed an application for registration of a mark in Class 30 on 11 February 2019. This application was published in the Trade Marks Journal in September 2021. Two parties, including Cadbury UK Ltd., filed oppositions in January 2022. The Registry claimed that notices of opposition were served on Mars in March 2022 via email. However, the company argued that it never received any such notices through email or any other communication mode.

In February 2023, Mars discovered that its application had been marked as abandoned in a public notice issued by the Registry. Mars immediately filed a representation and later a formal review petition seeking restoration of the application. Despite an earlier directive by the Registry withdrawing similar abandonment notices in other cases, Mars’ application remained marked as abandoned. The review petition was rejected in October 2024, prompting the present appeal.

Legal Arguments and Court’s Analysis

Mars contended that there was no proof of effective service of the opposition notices, and therefore the statutory period to file a counter-statement had not begun. They submitted affidavits affirming non-receipt and relied on various precedents including Rishabh Jain, Purushottam Singhal, and Samsudeen A, where courts had interpreted Rule 18 of the Trade Marks Rules harmoniously with Section 21(2) of the Act.

The Registrar relied on email success reports and claimed that notices were sent to the registered email addresses. However, the Court noted that there was no acknowledgment or confirmation of delivery to Mars or its agents.

The Court emphasized that a literal reading of Rule 18 would lead to procedural inconsistency. It concluded that actual receipt of the notice is essential for the limitation period to start, as required under Section 21(2). Thus, the court found that Mars had not been properly served and had therefore not defaulted.

Conclusion and Directions

The Court set aside the order of abandonment dated 25 October 2024. It remanded the matter to the Trade Marks Registry, directing it to serve fresh opposition notices to Mars’ counsel and allow Mars to file its counter-statement within the statutory period thereafter. The case was disposed of accordingly.

Case Title: Mars Incorporated vs. Registrar of Trademarks & Ors.

Date of Order: 2nd April, 2025

Case No.: C.A.(COMM.IPD-TM) 88/2024

Neutral Citation: 2025:DHC:2463

Name of Court: High Court of Delhi

Name of Judge: Hon’ble Mr. Justice Amit Bansal

Hermès International Vs. Coco J through Sole Proprietor Ms. Sonal Chadha

Introduction

This case concerns an intellectual property dispute filed before the Delhi High Court by Hermès International, a renowned French luxury fashion house, and its Indian subsidiary, against M/s Coco J, a sole proprietorship run by Ms. Sonal Chadha. The plaintiffs alleged rampant trademark infringement, passing off, and misappropriation of their iconic luxury products by the defendant.

Background of the Plaintiffs and Their Trademarks

Hermès, established in 1837, is globally known for high-end fashion products including the KELLY and BIRKIN handbags and H ORAN sandals. The brand owns numerous trademark registrations in India and internationally, including word marks, device marks, and three-dimensional shape marks. These products have gained iconic status worldwide, including India, where their popularity has been boosted by appearances in media and cinema.

Allegations Against the Defendant

The plaintiffs alleged that the defendant, through her website and social media channels, was manufacturing and selling counterfeit versions of their luxury products under deceptive names like JELLY KELLY, CANVAS KELLY, KIN, and ADELE. These names and designs closely mimicked Hermès’ registered trademarks and iconic designs, leading to confusion among consumers and dilution of brand value. It was also alleged that the defendant used Hermès' trademarks on promotional materials and engaged in direct references on Instagram.

Evidence Presented

Hermès submitted screenshots, comparison tables, and evidence of online purchases showing that the defendant’s products bore clear visual and conceptual similarities to Hermès' originals. These included the copying of distinctive bag shapes, names suggestive of the original products, and the unauthorized use of the H ORAN sandal design. The plaintiffs also provided photographic evidence from the defendant’s Instagram posts and product listings on her website.

Court’s Findings and Interim Relief

The Court, presided by Justice Amit Bansal, found a strong prima facie case in favor of Hermès. It held that the defendant’s products were deceptively similar to the plaintiffs’ trademarks and constituted trademark infringement and passing off. The Court noted that allowing the defendant to continue such acts would cause irreparable harm to Hermès’ reputation and mislead the public.

An interim injunction was granted restraining the defendant from manufacturing, selling, advertising, or displaying the infringing products online or offline. The defendant was also directed to take down all listings of the impugned products from her website and social media platforms.

Case Title: Hermès International & Anr. Vs. Coco J through Sole Proprietor Ms. Sonal Chadha

Date of Order: 17th April, 2025

Case No.: CS(COMM) 343/2025

Name of Court: High Court of Delhi

Name of Judge: Hon’ble Mr. Justice Amit Bansal

H D U.S.A., LLC Vs Vijaypal Dhayal

Parties Involved

The plaintiff, H-D U.S.A., LLC (Harley-Davidson USA), is a globally recognized manufacturer of motorcycles and branded merchandise. The defendant, Vijaypal Dhayal, is the owner and proprietor of Red Rose Industries, operating from Gurugram, Haryana.

Nature of the Dispute

The plaintiff filed a commercial intellectual property suit alleging infringement of its trademarks and copyrights. It claimed that the defendant was selling footwear bearing a logo deceptively similar to Harley-Davidson’s iconic “Eagle” and “Bar & Shield” marks, which diluted its brand and misled consumers.

Trademark Background

Harley-Davidson began using the ‘HARLEY-DAVIDSON’ trademark in 1903 and introduced the ‘Bar & Shield’ logo in 1910. Over time, it secured more than 2,200 trademark registrations worldwide, including numerous registrations in India. The brand enjoys a significant presence with sales in over 90 countries and a vast dealership network.

Discovery of Infringement

In July 2023, the plaintiff discovered through its representatives that the defendant was marketing footwear using a nearly identical logo under the brand “RONTEX.” The infringing goods were available both physically and on e-commerce platforms like Amazon, Flipkart, and IndiaMART.

Legal Proceedings

The court, on 1st September 2023, issued summons and appointed a local commissioner who, during an inspection, found 640 pairs of infringing shoes at the defendant’s premises. On 25th September 2023, the court granted an interim injunction restraining the defendant from manufacturing or selling any product using the infringing mark.

Despite receiving several opportunities, the defendant failed to submit a written statement or reply to the court. Consequently, the right to file a written statement was closed, and the plaintiff moved for summary judgment.

Court’s Findings

The court found that the defendant had copied Harley-Davidson’s eagle logo almost entirely. The design elements—eagle figure, ribbon, and shield layout—were replicated with only the textual element changed to “Sports Casual.” The court held that the similarities were likely to mislead consumers into believing that the goods were associated with the plaintiff.

Further, it noted that the defendant appeared to be a habitual infringer, engaging in similar practices with other well-known brands. With no valid defense or denial on record, the court determined that trademark infringement and passing off were clearly established.

Judgment and Relief

The court held that there was no realistic prospect of the defendant successfully defending the suit. Exercising powers under Order XIII-A of the Code of Civil Procedure, it delivered a summary judgment. The plaintiff was granted a permanent injunction. The defendant was directed to destroy all infringing goods in the presence of an authorized representative of the plaintiff. The court also awarded damages and legal costs amounting to five lakh rupees in favor of the plaintiff.

Case Details

Case Title: H-D U.S.A., LLC Vs Vijaypal Dhayal

Date of Order: 2nd April, 2025

Case No.: CS(COMM) 609/2023 & I.A. 42209/2024

Neutral Citation: 2025:DHC:2489

Name of Court: High Court of Delhi

Name of Judge: Hon’ble Mr. Justice Amit Bansal

Obiter Dictum of Full Bench of High Court is not binding on Single Judge of same High Court: Delhi High Court

Introduction: Delhi High Court through recent Judgement pronounced on 27.03.2025 in CM(M)-IPD 5/2025 ,Neutral Citation: 2025:DHC:2322,titled as  Balar Marketing Pvt. Ltd. Vs. Lakha Ram Sharma addressed the question of judicial precedent which involved binding authority of Division Bench obiter dicta even if they lacked supporting rationale on single judge of same High Court.

Procedural Background: Balar Marketing Pvt. Ltd. through its predecessor-in-interest began manufacturing electrical goods under "KUNDAN" and "KUNDAN CAB" trademarks since 1975. Lakha Ram Sharma trading as Kundan Cable India sells comparable electrical goods under the trademarks "KUNDAN" and "KUNDAN CABLE."

Multiple Suit proceeding: A prolonged series of trademark disputes between Balar Marketing Pvt. Ltd. and Lakha Ram Sharma, trading as Kundan Cable India, spanning from the 1990s included multiple suits for trademark infringement and passing off incidents and also copyright infringement claims consisting of TM Nos. 968/2016, 971/2016, 1030/2016, 932/2016 and 931/2016 which underwent consolidation for trial proceedings.

Trademark Cancellation Proceeding and continuance of passing off action in view of of judicial precedents from Puma Stationer Pvt. Ltd. & Anr. v. Hindustan Pencils Ltd., 2010 (43) PTC 479 (Del) (DB): In the meanwhile cancellation petition was filed against Registered Trademark of Lakha Ram before High Court of Delhi, hence under Section 124 of Trademarks Act 1999, trial in both passing off action and Infringement action was sought to be stayed. Through its May 30th 2022 order the Trial Court elected to let the passing off suits continue but kept all infringement proceedings on hold as Trademark rectification petition was pending in Delhi High Court. This order because of judicial precedents from Puma Stationer Pvt. Ltd. & Anr. v. Hindustan Pencils Ltd., 2010 (43) PTC 479 (Del) (DB) and J.K. Oil Industries v. Adani Wilmar Ltd., 2007 (75) PTC 44 (Del), which says that during pending of Trademark rectification petition, only infringement remedy has to be stayed and not passing off.

Stay of Passing off and Infringement in view of Later Amrish Aggarwal Trading as Mahalaxmi Product v. Venus Home Appliances, 2024 SCC OnLine Del 3652 Judgement: Lakharam Sharma again made an application in January 2025 under Section 124 of the Trade Marks Act, 1999 asking for stay of all proceedings including passing off claims because of a single reference to passing off in paragraph 44 of Amrish Aggarwal Trading as Mahalaxmi Product v. Venus Home Appliances, 2024 SCC OnLine Del 3652, Delhi High Court. The Division Bench Judgement observed that under Section 124 of Trademarks Act 1999, infringement and passing claim has to await decision in cancellation petition. In view of the above ,the Trial Court suspended infringement and passing off action both, except the Copyright Act case, as Trademark rectification petition was pending in Delhi High Court. Following this order, the subject matter Revision Petition was filed.

Rival Contention in Court: The petitioner argued that the "passing off" terminology in Amrish Aggarwal lacked binding authority because it was without supporting reasoning and hence being Obiter Dictum, not binding on Single Judge. Section 124 of the Trade Marks Act applies strictly to trademark infringement cases whereas passing off claims proceed through common law channels without any association to registered trademarks.

The Petitioner used decisions like Mohinder Singh Gill & Anr. v. Chief Election Commissioner, New Delhi & Ors., (1978) 1 SCC 405 and State of Orissa v. Sudhansu Sekhar Misra & Ors., Air 1968 SC 647 along with Gudri v. Ram Kishun, Air 1984 All 5 to support his case that Judicial comments in passing that were made in cases where issues remained un raised or undetermined lack the legal binding power or that Obiter Dictum of Full Bench of High Court is not binding on Single Judge of same High Court.

While respondent argued that Division Bench's decision in Amrish Aggarwal specifically identified infringement and passing both off claims as subject to stay so the Trial Court properly relied on it through paragraph 34 and 44. The respondent used Naseemunisa Begum v Shaikh Abdul Rehman (2002 (2) Mah LJ 115) and Crocs Inc. USA v Aqualite India Ltd. (2019 SCC OnLine Del 11957) to support their argument that smaller benches have an obligation to follow observations made by larger benches..

Judicial Analysis and Reasoning: The Single Judge clarified that  main dispute in Amrish Aggarwal DB was about continuance of suit and  rectification proceedings in same High Court after IPAB dissolution. The DB issued a verdict in this context. While doing so, a single mention of “passing off” appeared during paragraph 44 of the judgement without providing any assessment or analytical discussion of that point. The Single Judge considered this matter against the precedent set by earlier Puma Stationer  DB in which the Division Bench observed explicitly that infringement suits need temporary stays yet passing off claims should carry forward. The Single Judge , in this case clarified that the trial court wrongly did not implement the ruling of earlier Puma Stationer DB because later Amrish Aggarwal DB. The Single Judge noticed that passing-off comment from Amrish Aggarwal DB lacked proper legal reasoning and hence finding of DB was regarded as mere obiter dictum, having no binding effect.

The Single Judge relied upon State of Orissa v. Sudhansu Sekhar Misra judgement  established that only planned statements or practical comments found in judicial rulings create binding authority. The judgment in Gudri v. A reference to Gudri v. Ram Kishun illustrated that larger bench observations without direct adjudication of an issue remain non-binding for later benches required to address the matter independently.

Decision: The Delhi High Court approved the petition while reversing the Trial Court decision from 18 January 2025 that ceased all pending proceedings including those about passing off. The Court has directed infringement and passing off action, both to continue .The Single Judge further observe that  reference to passing off in Amrish Aggarwal DB occurred unintentionally yet lacked any force for binding decisions. The Court ordered proceeding of consolidated suits especially those concerning passing off to start without unnecessary delay. This Single Judge followed earlier Puma Stationer Pvt. Ltd DB, which ordered for continuance of passing off action, while adjudicating Section 124 of Trademarks Act 1999 objection.

Principles Laid Down in this case: The Single Judge  made it clear that Section 124 of the Trade Marks Act 1999 merely affects infringement suits without interfering with passing off trials. The decision confirms that passing off functions as an unregistered common law remedy. The ruling defines a crucial principle about obiter dicta of Division Bench of a High Court , lacks binding authority on Single Bench of Same High Court.

Advocate Ajay Amitabh Suman, Patent and Trademark Attorney, Delhi High Court

AstraZeneca AB Vs P Kumar

Superior metabolic stability, was insufficient to rule out objection under Section 3 (d) of the Patent Act , as it did not explicitly demonstrate therapeutic efficacy

Introduction:

The pharmaceutical industry is a battleground where innovation meets accessibility, and intellectual property rights often clash with public health imperatives. The case of AstraZeneca AB & Ors v. P Kumar & Anr, alongside related suits against T Rao & Anr and Dr. Reddy’s Laboratories Limited, represents a pivotal legal skirmish in India’s patent landscape. At its core, this dispute revolves around AstraZeneca’s efforts to protect its patents for Ticagrelor, a critical antiplatelet drug marketed as Brilinta, against alleged infringement by generic manufacturers. The case, adjudicated by the High Court of Delhi, delves into complex issues of patent validity, evergreening, and the delicate balance between rewarding innovation and ensuring affordable access to life-saving medications. This case study explores the factual and procedural intricacies, the legal arguments advanced by the parties, the judicial reasoning, and the broader implications of the court’s decision.

Detailed Factual Background:

AstraZeneca AB, a global pharmaceutical giant, held three Indian patents related to Ticagrelor: IN 209907 (Species Patent), IN 247984 (Polymorph Patent), and IN 272674 (Formulation Patent). Ticagrelor, an antiplatelet drug, is prescribed to reduce thrombotic events in patients with acute coronary syndrome (ACS), such as heart attacks or unstable angina. Approved in the USA in 2011 and in India in 2012, Ticagrelor is marketed by AstraZeneca under the brand name Brilinta at approximately Rs. 50 per tablet. The plaintiffs claimed that Ticagrelor fell within the scope of IN 907 and IN 984, with its finished formulation covered by IN 674. They asserted that these patents were valid, subsisting, and unchallenged since their publication, except for a revocation petition filed by Micro Labs Limited in 2015, which was pending before the Intellectual Property Appellate Board (IPAB).

The defendants—Micro Labs Ltd., Natco Pharma Ltd., and Dr. Reddy’s Laboratories Ltd.—were accused of planning to launch generic versions of Ticagrelor under brand names such as Bigrelor, an unnamed generic, and Ticaflo, respectively. AstraZeneca alleged that these actions infringed their patents, citing credible market intelligence about the defendants’ imminent launches. The plaintiffs emphasized Ticagrelor’s therapeutic significance, noting that before its introduction, approximately one in three ACS patients faced death, repeat myocardial infarction, or re-hospitalization within six months despite existing treatments. They argued that generic launches would irreparably harm their business and public interest.

The defendants countered that Ticagrelor was disclosed and covered by an earlier patent, IN 241229 (Genus Patent), which expired on July 14, 2018. They alleged that AstraZeneca was engaging in evergreening—extending patent monopolies through subsequent patents without significant therapeutic advancements. The defendants pointed to admissions by AstraZeneca in regulatory filings and foreign litigation, claiming that Ticagrelor was anticipated by IN 229, rendering the suit patents invalid. They also argued that the suit patents lacked novelty, inventive step, and enhanced therapeutic efficacy under Section 3(d) of the Patents Act, 1970, and that AstraZeneca had suppressed material facts about foreign patent revocations.

Detailed Procedural Background:

The case comprised three suits filed by AstraZeneca: CS(COMM) 749/2018 against P Kumar and Micro Labs Ltd., CS(COMM) 792/2018 against T Rao and Natco Pharma Ltd., and CS(COMM) 1023/2018 against Dr. Reddy’s Laboratories Ltd. Each suit included applications for interim injunctions under Order 39 Rules 1 and 2 of the Code of Civil Procedure (CPC) to restrain the defendants from marketing Ticagrelor in violation of AstraZeneca’s patents. Additionally, in CS(COMM) 749/2018, Micro Labs filed an application under Order 39 Rule 4 CPC to vacate the interim orders.

On March 22, 2018, the Delhi High Court granted an ex parte interim injunction in CS(COMM) 749/2018, restraining Micro Labs from selling Ticagrelor. A similar order was passed on April 23, 2018, in CS(COMM) 792/2018 against Natco Pharma, despite the defendants’ initial claim of not having launched the drug. The court noted that Natco had launched the drug during the pendency of the suit. On July 18, 2018, an interim injunction was granted in CS(COMM) 1023/2018 against Dr. Reddy’s. The defendants filed written statements and counterclaims, seeking revocation of the suit patents under Section 64 of the Patents Act, alleging invalidity on grounds of anticipation, obviousness, and non-compliance with statutory requirements.The court consolidated the hearing of the injunction applications (IA Nos. 3986/2018, 4771/2018, 9332/2018) and Micro Labs’ application to vacate the interim orders (IA No. 5096/2018). 

Issues Involved in the Case:

The case presented several critical legal and factual issues:

Whether Ticagrelor was disclosed and covered by the expired Genus Patent (IN 229), thereby anticipating the suit patents and rendering them invalid?Whether the suit patents were invalid under Section 3(d) of the Patents Act for being derivatives of a known substance without enhanced therapeutic efficacy?

AstraZeneca’s Submissions:

AstraZeneca argued that the suit patents were valid and infringed by the defendants’ planned generic launches. They contended that IN 229, the Genus Patent, covered 150 quintillion compounds but did not specifically disclose Ticagrelor, which was isolated through the Species Patent (IN 907). They asserted that a person skilled in the art could not have identified Ticagrelor from IN 229’s teachings, negating claims of anticipation under Section 13(1)(a). On prior claiming under Section 13(1)(b), they argued that IN 229 lacked a specific claim to Ticagrelor, making the suit patents novel.

Regarding Section 3(d), AstraZeneca denied that Ticagrelor was a derivative of a known substance from IN 229, arguing that structural similarity alone did not trigger the provision. They relied on an affidavit by Dr. Robert Riley, submitted by Dr. Reddy’s, to claim that Ticagrelor exhibited superior metabolic stability and bioavailability, satisfying the enhanced efficacy requirement if Section 3(d) applied. On Section 8, they admitted revocations of equivalent patents in China and Europe but noted pending appeals with automatic stays and grants in 55-60 countries, asserting substantial compliance.

AstraZeneca emphasized their service to six lakh patients annually and argued that generic launches would cause irreparable harm. They distinguished the Supreme Court’s decision in Novartis AG v. Union of India, claiming it addressed specific disclosure of a known compound, unlike the present case where Ticagrelor was not disclosed in IN 229.

Defendants’ Submissions:

The defendants, represented by Micro Labs, Natco Pharma, and Dr. Reddy’s, argued that the suit patents were invalid as Ticagrelor was disclosed and claimed in IN 229, which expired on July 14, 2018. They relied on AstraZeneca’s admissions in Form 27 filings, where Brilinta and Axcer were declared as working IN 229, and in US litigation against Mylan Inc., where AstraZeneca claimed infringement of US Patent 910 (equivalent to IN 229) by Ticagrelor generics. They contended that these admissions established anticipation and prior claiming, rendering the suit patents invalid under Sections 64(1)(a), (d), (f), and (k).

The defendants accused AstraZeneca of evergreening, arguing that the suit patents were attempts to extend IN 229’s monopoly without significant therapeutic advancements, violating Section 3(d). They highlighted the plaint’s silence on enhanced efficacy and argued that Ticagrelor, being structurally similar to compounds in IN 229, required proof of superior therapeutic efficacy, which was absent. They also alleged non-compliance with Section 8, citing AstraZeneca’s failure to disclose revocations of equivalent patents in China, Europe, and South Korea.

The defendants emphasized public interest, noting that their generics, priced at Rs. 20 per tablet, were significantly cheaper than Brilinta. They argued that the interim injunctions caused irreparable harm to patients and that any loss to AstraZeneca could be compensated monetarily. They relied on judicial precedents, including Novartis AG and F. Hoffmann-La Roche v. Cipla, to assert that a credible challenge to patent validity justified denying interim relief.

Detailed Discussion on Judgments Cited by Parties:

The parties relied on several landmark judgments to bolster their arguments, each addressing specific aspects of patent law. Below is a detailed analysis of these judgments and their context in the case:

Novartis AG v. Union of India, (2013) 6 SCC 1:

The Supreme Court’s decision in Novartis was central to the defendants’ argument on coverage versus disclosure and Section 3(d). The court rejected the appellant’s claim that a patent’s coverage could extend beyond its disclosure, emphasizing that patents grant monopolies in exchange for public disclosure. It held that Section 3(d) sets a higher threshold for pharmaceutical patents, requiring new forms of known substances to demonstrate enhanced therapeutic efficacy. The defendants cited this to argue that IN 229’s coverage of Ticagrelor negated AstraZeneca’s claim of non-disclosure and that the suit patents, as derivatives, failed the efficacy test. AstraZeneca countered that Novartis involved a known compound (Imatinib Mesylate) specifically disclosed in the prior patent, unlike Ticagrelor, which was not disclosed in IN 229. The court found Novartis persuasive, rejecting AstraZeneca’s coverage-disclosure dichotomy and holding that the suit patents prima facie required enhanced efficacy under Section 3(d).

Bishwanath Prasad Radhey Shyam v. Hindustan Metal Industries, AIR 1982 SC 1444

Cited by the court, this Supreme Court judgment clarified that novelty and inventive step are mixed questions of law and fact, dependent on circumstances. It outlined tests for obviousness, asking whether the invention was publicly known or would naturally suggest itself to a skilled person. The court applied this to assess whether IN 229 disclosed Ticagrelor, noting that the issue required expert evidence and could not be conclusively determined at the interim stage. This supported the court’s finding that the defendants’ challenge was credible but required trial scrutiny.

F. Hoffmann-La Roche Ltd. v. Cipla Ltd., 2009 (40) PTC 125 (Del):

The defendants heavily relied on this Delhi High Court Division Bench decision, which held that a credible challenge to patent validity, particularly under Section 3(d) or Section 64, could deny interim injunctions. The court emphasized full disclosure of patent specifications and related applications in injunction applications. The defendants argued that AstraZeneca’s failure to disclose IN 229’s workings and foreign revocations mirrored the suppression in Roche, justifying vacation of the interim orders. The court agreed, finding AstraZeneca’s omissions material and the defendants’ challenge credible, aligning with Roche’s principles.

F. Hoffmann-La Roche Ltd. v. Cipla Ltd., 2015 (225) DLT 391:

Cited by the court on Section 8 compliance, this Division Bench decision clarified that non-compliance with Section 8 is discretionary under Section 64(1)(m), depending on the intent and materiality of the omission. The court found AstraZeneca’s explanations for foreign revocations reasonable, holding that non-disclosure was not material enough to warrant vacating the interim orders, consistent with this judgment.

Bristol-Myers Squibb Company v. J.D. Joshi, 2015 (64) PTC 135 (Del):

The defendants and the court referenced this Delhi High Court decision, which held that challenges under Section 64 are fact-dependent or mixed questions, and a credible challenge to validity can preclude interim relief. The court applied this to find that the defendants’ arguments on anticipation and Section 3(d) raised substantial questions, rendering the suit patents vulnerable.

Merck Sharp & Dohme Corporation v. Glenmark Pharmaceuticals Ltd., 223 (2015) DLT 454:

Cited by the court, this Delhi High Court decision emphasized the reliance on expert testimony in complex pharmaceutical patent disputes, as courts lack technical expertise. The court noted that the issue of Ticagrelor’s disclosure in IN 229 required expert evidence, reinforcing the need for a trial to resolve the dispute.

Chemtura Corporation v. Union of India, 2009 (41) PTC 260 (Del):

The court cited this Delhi High Court decision to outline Section 8’s requirements for disclosing foreign patent applications. It found AstraZeneca’s disclosures sufficient, as they provided reasonable explanations for foreign revocations, aligning with Chemtura’s emphasis on materiality.

Dr. Reddy’s Laboratories (UK) Ltd. v. Eli Lilly & Co. Ltd., [2008] EWHC 2345 (Pat):

AstraZeneca cited this UK High Court decision to argue that a genus patent’s general formula does not disclose specific compounds unless individually described. The court’s finding that a theoretical penumbra of compounds does not negate novelty supported AstraZeneca’s claim that IN 229 did not disclose Ticagrelor. However, the Delhi High Court found this less persuasive in light of AstraZeneca’s admissions and Novartis’s rejection of the coverage-disclosure dichotomy.

Eli Lilly & Company Ltd. v. Apotex Pty Ltd., [2013] FCA 214:

AstraZeneca relied on this Federal Court of Australia decision, which held that selecting a specific compound from a genus patent’s broad class requires significant effort, negating obviousness. AstraZeneca argued that Ticagrelor’s isolation from IN 229’s 150 quintillion compounds was inventive. The court acknowledged this but prioritized AstraZeneca’s admissions and Indian legal standards under Novartis.

Apotex Inc. v. Sanofi-Synthelabo Canada Inc., [2008] 3 SCR 265:

AstraZeneca cited this Supreme Court of Canada decision to defend selection patents, which encourage improvements over genus patents. The court recognized selection patents’ validity but found that AstraZeneca’s admissions and Section 3(d) concerns raised credible challenges, limiting the judgment’s applicability.

Detailed Reasoning and Analysis of Judge:

Justice Jayant Nath’s judgment meticulously analyzed the competing claims, focusing on three key issues: Ticagrelor’s disclosure in IN 229, compliance with Section 3(d), and Section 8 violations. The court’s reasoning was grounded in Indian patent law principles and judicial precedents, balancing the plaintiff’s proprietary rights against the defendants’ public interest arguments.

On the issue of Ticagrelor’s disclosure in IN 229, the court examined AstraZeneca’s admissions in Form 27 filings and US litigation. The identical Form 27 returns for IN 229, IN 907, IN 984, and IN 674, declaring Brilinta and Axcer sales, suggested that AstraZeneca treated Ticagrelor as working all four patents, implying disclosure in IN 229. The US litigation against Mylan Inc., where AstraZeneca claimed infringement of US Patent 910 by Ticagrelor generics, further reinforced this. The court found AstraZeneca’s explanation—that IN 229 was worked through Ticagrelor only after its isolation via IN 907—unconvincing, as the plaint omitted these details. Citing Novartis, the court rejected the coverage-disclosure dichotomy, holding that AstraZeneca’s admissions prima facie indicated that Ticagrelor was anticipated by IN 229, raising a credible challenge under Sections 64(1)(a), (d), (f), and (k).

Regarding Section 3(d), the court noted the plaint’s silence on enhanced therapeutic efficacy, a critical requirement for derivatives of known substances. AstraZeneca’s belated reliance on Dr. Riley’s affidavit, claiming Ticagrelor’s superior metabolic stability, was insufficient, as it did not explicitly demonstrate therapeutic efficacy over IN 229’s compounds. The court applied Novartis and Roche, concluding that the suit patents prima facie failed the Section 3(d) test, as they appeared to be derivatives of IN 229’s compounds without proven efficacy enhancements.

On Section 8, the court accepted AstraZeneca’s explanations for foreign revocations, noting pending appeals and grants in multiple countries. Citing Chemtura and Roche (2015), the court held that the non-disclosure was not material enough to warrant vacating the interim orders, as AstraZeneca substantially complied with statutory requirements.

The court applied the principles from Roche (2009) and Bristol-Myers, emphasizing that a credible challenge to patent validity precludes interim injunctions. The defendants’ arguments on anticipation and Section 3(d) raised substantial questions, rendering the suit patents vulnerable. The court also considered public interest, noting the defendants’ lower-priced generics (Rs. 20 vs. Rs. 50 per tablet) and the expiration of IN 229, which tilted the balance of convenience in their favor. To safeguard AstraZeneca’s interests, the court mandated the defendants to maintain accurate sales accounts.

Final Decision:

On August 8, 2019, The court vacated the interim injunctions granted on March 22, 2018, April 23, 2018, and July 18, 2018, in CS(COMM) 749/2018, CS(COMM) 792/2018, and CS(COMM) 1023/2018, respectively. The court held that AstraZeneca failed to establish a prima facie case, as the defendants raised a credible challenge to the suit patents’ validity under Sections 64(1)(a), (d), (f), (k), and 3(d). The balance of convenience favored the defendants, given the lower price of their generics and IN 229’s expiration. The defendants were directed to maintain quarterly sales accounts, supported by affidavits and authenticated by chartered accountants, to enable potential compensation if AstraZeneca prevailed at trial. The applications were disposed of accordingly.

Law Settled in This Case:

This case reinforces several key principles of Indian patent law:

A credible challenge to patent validity, based on grounds under Section 64 or Section 3(d), is sufficient to deny interim injunctions in infringement suits, as established in F. Hoffmann-La Roche v. Cipla. The coverage-disclosure dichotomy is untenable in India, as per Novartis AG v. Union of India, requiring specific disclosure for patent validity and infringement claims.Section 3(d) imposes a stringent requirement for pharmaceutical patents, mandating proof of enhanced therapeutic efficacy for derivatives of known substances, with silence in the plaint being fatal.Non-compliance with Section 8 is discretionary under Section 64(1)(m), and non-material omissions do not necessarily warrant revocation, as clarified in Chemtura and Roche (2015).Public interest, particularly access to affordable generics, is a significant factor in balancing convenience in patent disputes, especially post-expiration of foundational patents.

Case Title: AstraZeneca AB Vs P Kumar

Date of Order: August 8, 2019

Case No.: CS(COMM) 749/2018

Name of Court: High Court of Delhi at New Delhi

Name of Judge: Hon’ble Mr. Justice Jayant Nath

Disclaimer: The information shared here is intended to serve the public interest by offering insights and perspectives. However, readers are advised to exercise their own discretion when interpreting and applying this information. The content herein is subjective and may contain errors in perception, interpretation, and presentation.

Written By: Advocate Ajay Amitabh Suman, IP Adjutor [Patent and Trademark Attorney], High Court of Delhi