Bristol-Myers Squibb Holdings Vs. Indoco Remedies Limited

The distinction between “coverage” and “disclosure” does not automatically invalidate a species patent

Introduction:

In the intricate tapestry of pharmaceutical patent litigation, where innovation battles generic competition, the case of Bristol-Myers Squibb Holdings Ireland Unlimited Company & Ors. vs. Indoco Remedies Limited, decided by the Delhi High Court on December 24, 2019, stands as a compelling narrative of patent enforcement and interim relief. This dispute revolves around Indian Patent No. IN247381 (the “suit patent” or “IN-381”), covering Apixaban, a vital anticoagulant drug. Bristol-Myers Squibb, a global pharmaceutical powerhouse, sought to restrain Indoco Remedies, an Indian generic manufacturer, from launching a generic version of Apixaban under the brand “Apixabid,” alleging infringement of IN-381. Indoco countered by challenging the suit patent’s validity, arguing that Apixaban was covered by an expired genus patent, IN243917 (IN-917), rendering it public domain. The Delhi High Court, presided over by Justice Mukta Gupta, navigated the complex interplay of patent validity, prior art, and public interest, granting an ad-interim injunction in favor of the plaintiffs. This case study delves into the factual matrix, procedural intricacies, legal issues, parties’ arguments, judicial precedents, the court’s reasoning, and the broader implications, offering a vivid portrayal of a high-stakes patent clash in India’s legal arena.

Detailed Factual Background:

Bristol-Myers Squibb Holdings Ireland Unlimited Company, incorporated in Ireland, is the patentee of Indian Patent No. IN247381, granted on April 4, 2011, and published on April 8, 2011, for “Lactam-Containing Compounds and Derivatives Thereof as Factor Xa Inhibitors.” This patent, valid until September 17, 2022, specifically claims Apixaban, an anticoagulant with the International Non-Proprietary Name (INN) Apixaban and IUPAC name 1-(4-methoxyphenyl)-7-oxo-6-[4-(2-oxopiperidin-1-yl) phenyl]-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c] pyridine-3-carboxamide (molecular formula: C25H25N5O4). Marketed as Eliquis, Apixaban addresses limitations of prior anticoagulants like warfarin by reducing bleeding risks and drug interactions, making it a critical treatment for thromboembolic diseases. Bristol-Myers Squibb India Private Ltd. and Pfizer Limited, co-plaintiffs incorporated in India, are involved in marketing and licensing Eliquis. 

The plaintiffs also hold Indian Patent No. IN243917, granted on November 11, 2010, for “Nitrogen Containing Heterobicycles as Factor Xa Inhibitors,” a genus patent with a Markush claim covering millions of compounds, including Apixaban generically, but not specifically disclosing it. IN-917, filed via a PCT application on December 17, 1999, and a national phase application on May 24, 2001, expired on December 17, 2019.

Indoco Remedies Limited, a research-oriented Indian pharmaceutical company, operates nine manufacturing facilities and markets formulations and active pharmaceutical ingredients across 55 countries. On December 21, 2019, the plaintiffs learned through credible sources that Indoco was preparing to launch Apixabid, a generic Apixaban product in 2.5 mg and 5 mg strengths. A product monograph obtained by Pfizer’s representative described Apixabid as “The Novel Anticoagulant with EXTRA Benefit,” referencing the “Aristotle Trial,” a study by Bristol-Myers Squibb evaluating Eliquis’s efficacy against warfarin. Indoco’s website listed Apixaban as an anticoagulant API, and the company had applied for CDSCO confirmation on July 15, 2019, for exporting Apixaban to the EU. Indoco also registered the trademark “Apixabid” on January 31, 2019, and filed a patent application (No. 201621001853) on January 19, 2016, for a process to prepare Apixaban’s pharmaceutical composition, admitting that Apixaban was disclosed in US Patent 6967208, equivalent to IN-381. Prior US litigation between the plaintiffs’ group companies and Indoco, settled confidentially, restricted Indoco from launching Apixaban in the US until at least 2022.

Detailed Procedural Background:

The dispute unfolded in CS(COMM) 731/2019, filed by Bristol-Myers Squibb and co-plaintiffs before the Delhi High Court, seeking a permanent injunction to restrain Indoco from infringing IN-381, alongside damages and other reliefs. The suit was accompanied by applications, including I.A. 18449/2019 for an ad-interim injunction under Order XXXIX Rules 1 and 2 of the CPC, I.A. 18450/2019 under Order XI Rule 1(4) of the Commercial Courts Act for filing additional documents, I.A. 18451/2019 for exemption from filing original documents, and I.A. 18452/2019 under Section 149 CPC for court fee payment. 

Issues Involved in the Case:

The case presented several pivotal legal questions at the nexus of patent law and interim relief:

Whether the distinction between “coverage” and “disclosure” in patent claims, as argued by Indoco, negated the plaintiffs’ rights under IN-381?

Detailed Submission of Parties:

The plaintiffs argued that IN-381, valid until September 2022, specifically disclosed and claimed Apixaban, unlike IN-917, which generically covered millions of compounds via a Markush claim without specific disclosure. They cited pages 421–531 of their paper book, detailing 1456 synthesized compounds and 104 additional molecules under IN-917, none of which disclosed Apixaban, asserting that a skilled person could not anticipate Apixaban from IN-917’s disclosure. The plaintiffs highlighted Indoco’s admissions in its 2016 process patent application, acknowledging Apixaban’s disclosure in US 6967208 (equivalent to IN-381), and in the Apixabid monograph, which used the plaintiffs’ “Aristotle Trial” and claimed Apixaban’s novelty and efficacy. They argued that Indoco’s launch on December 20, 2019, with only 40,000–50,000 strips manufactured (30,000 dispatched), was recent, and an investigator’s affidavit dated December 24, 2019, confirmed Apixabid’s market absence. The plaintiffs contended that a prima facie case of infringement existed, and without an injunction, they would suffer irreparable harm from market erosion, as generics could trigger a price spiral, citing Merck Sharp and Dohme vs. Glenmark. They asserted that the balance of convenience favored them, given their established Eliquis market and Indoco’s nascent launch.

Indoco argued that IN-917’s coverage of Apixaban, admitted in the plaintiffs’ Form-27 filings, placed it in the public domain upon IN-917’s expiry on December 17, 2019. Citing Novartis AG vs. Union of India (2013), they distinguished between “coverage” and “disclosure,” arguing that IN-381 was an evergreening attempt to extend monopoly rights, invalid under Section 3(d) of the Patents Act. Indoco claimed it launched Apixabid on December 20, 2019, under a bona fide belief that IN-917’s expiry freed Apixaban, manufacturing 40,000–50,000 strips, with 30,000 sold and 20,000 ready for dispatch, supported by prescriptions and invoices. They argued that an injunction would harm their business, proposing account maintenance as an interim measure. Indoco noted the plaintiffs’ contradictory stance in Form-27 filings, claiming Apixaban under both patents, and asserted that the Division Bench’s ruling in the Natco case, setting aside an injunction for lacking the triple test, cautioned against automatic injunctions.

Detailed Discussion on Judgments Cited by Parties:

The court’s analysis was shaped by a robust array of precedents, each contextualized to address patent validity, interim injunctions, and market dynamics. The key judgments, their complete citations, and their relevance are as follows:

Wander Ltd. vs. Antox India Pvt. Ltd., 1990 (Supp) SCC 727: The Supreme Court outlined the triple test for interim injunctions—prima facie case, irreparable loss, and balance of convenience—emphasizing that courts must weigh the plaintiff’s need for protection against the defendant’s right to exercise legal rights. The court relied on this to assess the plaintiffs’ case, noting Indoco’s recent launch as a factor favoring an injunction, as it had not fully established its market presence.

Novartis AG vs. Union of India, (2013) 6 SCC 1: The Supreme Court cautioned against evergreening and artful claim drafting, holding that patent scope should reflect intrinsic invention worth. Indoco cited this to argue that IN-381 extended IN-917’s monopoly, but the court clarified that Novartis did not bar species patents if they disclosed novel compounds, finding IN-381’s specific Apixaban disclosure valid prima facie.

Merck Sharp and Dohme Corporation vs. Glenmark Pharmaceuticals, FAO (OS) 190/2013, decided on March 20, 2015 (Delhi High Court): The Division Bench emphasized public interest in maintaining patent system integrity and the risk of irreparable market harm from generic price spirals. The court applied this to grant the injunction, noting that Indoco’s entry could destabilize Eliquis’s pricing, causing irreparable loss to the plaintiffs.

Bayer Corporation vs. Cipla, Union of India, 162 (2009) DLT 371: The Delhi High Court held that allowing non-patentees to reap a patentee’s efforts undermines the Patents Act’s objectives. The court used this to underscore the need to protect the plaintiffs’ monopoly, given IN-381’s validity.

SmithKline Beecham vs. Generics, (2002) 25(1) IPD 25005; SmithKline Beecham Plc vs. Apotex, [2003] EWCA Civ 137: UK courts granted interim injunctions, citing irreparable harm from price spirals caused by generic entrants. The court adopted this reasoning, finding that Apixabid’s launch risked unrecoverable price reductions for Eliquis.

Pharmacia Italia S.p.A vs. Interpharma Pty Ltd, [2005] FCA 1675 (Australia): The court considered the defendant’s knowledge of the patent as a factor for granting an injunction. The court applied this, noting Indoco’s caveat filing on December 17, 2019, and awareness of prior injunctions, indicating deliberate infringement.

K. Ramu vs. Adayar Ananda Bhavan, 2007 (34) PTC 689 (Mad); Bajaj Auto Ltd. vs. TVS Motor Company Ltd., 2008 (36) PTC 417 (Mad); National Research Development Corporation of India vs. The Delhi Cloth and General Mills Co. Ltd., AIR 1980 Del 132: These Indian cases factored the patentee’s market presence in granting injunctions. The court used this to favor the plaintiffs, given Eliquis’s established market versus Apixabid’s recent entry.

A.C. Edwards Ltd. vs. Acme Signs and Displays Ltd., [1992] RPC 131; Astellas Pharma Inc. vs. Comptroller-General of Patents, [2009] EWHC 1916 (Pat): Cited in Novartis, these UK cases distinguished coverage from disclosure. The court rejected Indoco’s reliance, finding IN-381’s specific disclosure distinct from IN-917’s generic coverage, per the plaintiffs’ evidence.

These precedents provided a comprehensive lens for evaluating IN-381’s validity, the propriety of interim relief, and the market’s vulnerability to generic competition.

Detailed Reasoning and Analysis of Judge:

The court delivered a cogent judgment, applying the triple test for interim injunctions—prima facie case, irreparable loss, and balance of convenience—while addressing Indoco’s challenge to IN-381’s validity. The court found that the plaintiffs established a strong prima facie case, bolstered by Indoco’s admissions and the patent’s unchallenged status. Indoco’s 2016 process patent application explicitly acknowledged Apixaban’s disclosure in US 6967208 (equivalent to IN-381), and its Apixabid monograph mirrored the plaintiffs’ “Aristotle Trial” and claimed Apixaban’s novelty, undermining its invalidity defense. The court noted that IN-381, valid until September 2022, faced only one revocation petition by Natco Pharma, pending since 2016, reinforcing its prima facie validity. The plaintiffs’ evidence that IN-917’s 1456 synthesized compounds and 104 additional molecules did not disclose Apixaban supported their claim that IN-381 was a distinct species patent, not anticipated by IN-917’s Markush claim.

On Indoco’s evergreening argument, the court relied on Novartis AG vs. Union of India, clarifying that while courts must guard against artful drafting, Novartis did not prohibit species patents. IN-381’s specific disclosure of Apixaban, described as more stable, active, and less toxic in IN-917’s claims, justified its novelty prima facie. The court rejected Indoco’s reliance on Form-27 filings, noting the plaintiffs’ consistent stance that IN-917 covered Apixaban generically but did not disclose it, only claiming it after IN-381’s invention. The distinction between coverage and disclosure, while acknowledged, did not negate IN-381’s validity, as Indoco’s evidence failed to show Apixaban’s specific anticipation in IN-917.

On irreparable loss, the court applied Merck Sharp and Dohme vs. Glenmark, emphasizing that generic entrants like Indoco, unburdened by R&D costs, could trigger a price spiral, causing unrecoverable market harm to Eliquis. Citing SmithKline Beecham cases, the court noted that prices may not recover post-trial, even if the patentee prevails, making monetary damages inadequate. The plaintiffs’ established market presence with Eliquis, contrasted with Indoco’s recent launch (40,000–50,000 strips, 30,000 dispatched), underscored this risk. The court also considered Indoco’s caveat filing on December 17, 2019, and knowledge of prior injunctions (December 12–19, 2019), per Pharmacia Italia, indicating deliberate infringement, negating its bona fide claim.

The balance of convenience favored the plaintiffs, as Indoco’s limited market entry (launched December 20, 2019) and the investigator’s affidavit confirming Apixabid’s market absence minimized harm to Indoco. The court cited Wander vs. Antox, noting that a defendant’s nascent enterprise reduces its equitable claim against an established patentee. Public interest in maintaining patent system integrity, per Bayer Corporation vs. Cipla, further tilted the balance, as allowing infringement would undermine the Patents Act’s objectives. The court distinguished the Natco Division Bench ruling, which set aside an injunction for lacking the triple test, finding that its status quo directive supported restraining Indoco’s further launch. Indoco’s proposal to maintain accounts was rejected, as continued sales risked irreparable market distortion, per Merck Sharp and Dohme.

Final Decision

On December 24, 2019, the Delhi High Court granted an ad-interim injunction in favor of the plaintiffs, restraining Indoco from further launching, delivering, or dispatching Apixabid, and directed Indoco to maintain status quo as of December 24, 2019, until the disposal of I.A. 18449/2019.

Law Settled in this Case:

The judgment clarified several principles governing patent infringement and interim relief in India:

A prima facie case for interim injunction is established when a patent, valid on its face, is infringed, especially with defendant admissions confirming the patented compound’s novelty and efficacy.

The distinction between “coverage” and “disclosure” does not automatically invalidate a species patent if it specifically claims a novel compound not anticipated by a genus patent’s Markush claim (Novartis AG).

Irreparable harm in patent cases includes market price spirals caused by generic entrants, as damages may not restore pre-infringement pricing, particularly for sole suppliers (Merck Sharp and Dohme, SmithKline Beecham).

Balance of convenience favors patentees with established markets over defendants with recent launches, especially when public interest supports patent system integrity (Bayer Corporation).

A defendant’s knowledge of a patent and prior injunctions, coupled with deliberate infringement, weakens its equitable defense and supports interim relief (Pharmacia Italia).

Courts must assess the triple test explicitly or implicitly in interim injunction orders, ensuring findings on prima facie case, irreparable loss, and balance of convenience are discernible (Wander vs. Antox).

Public interest in patent enforcement outweighs generic market entry when a strong infringement case exists, preventing distortion of legitimate monopolies.

Case Title: Bristol-Myers Squibb Holdings Ireland Unlimited Company & Ors. Vs. Indoco Remedies Limited

Date of Order: December 24, 2019

Case No.: CS(COMM) 731/2019

Name of Court: High Court of Delhi

Name of Hon'ble Judge: Justice Mukta Gupta

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

Bristol-Myers Squibb Holdings Vs. Natco Pharma

Section 105 of Patent Act’s non-obstante clause overrides Section 34 of the Specific Relief Act, requiring non-infringement declarations to comply with its specific conditions

Introduction

In the high-stakes arena of pharmaceutical patent litigation, where intellectual property rights collide with procedural stratagems, the case of Bristol-Myers Squibb Holdings Ireland Unlimited Company & Ors. vs. Natco Pharma, decided by the Delhi High Court on January 23, 2020, emerges as a pivotal exploration of jurisdictional competence and the misuse of legal processes.

This dispute centers on Indian Patent No. IN247381 (the “junior patent”), covering Apixaban, an anticoagulant drug, and its interplay with an earlier genus patent, IN243917 (the “senior patent”). Bristol-Myers Squibb, a global pharmaceutical titan, sought to enjoin Natco Pharma, an Indian generic manufacturer, from infringing the junior patent by selling Apixaban under the brand “Apigat.” Natco countered with an application under Section 10 of the Code of Civil Procedure (CPC), 1908, seeking to stay the Delhi suit, arguing that a prior suit it filed in Hyderabad’s City Civil Court should take precedence. The Hyderabad suit sought a declaration that Apixaban was disclosed but not claimed in the senior patent, rendering it public domain. The Delhi High Court, under Justice Rajiv Sahai Endlaw, dissected the procedural and substantive issues, ultimately dismissing Natco’s application and reinforcing the primacy of the Patents Act, 1970, over general statutes in patent disputes. This case study unravels the factual matrix, procedural maneuvers, legal issues, parties’ arguments, judicial precedents, the court’s reasoning, and the broader implications, painting a vivid picture of a legal chess game in India’s patent landscape.

Detailed Factual Background

Bristol-Myers Squibb Holdings Ireland Unlimited Company, the primary plaintiff, is a global pharmaceutical leader holding Indian Patent No. IN247381, granted on April 4, 2011, for Apixaban, an anticoagulant used to prevent and treat blood clots. Marketed under brands like Eliquis, Apixaban is a critical drug with significant commercial value. The junior patent, valid until September 17, 2022, grants exclusive rights under Section 48 of the Patents Act to prevent unauthorized manufacture, sale, or use. Bristol-Myers Squibb India Private Ltd. and Pfizer Limited, co-plaintiffs, are involved in marketing and licensing Apixaban in India. The plaintiffs also hold Indian Patent No. IN243917, granted on November 11, 2010, a genus patent covering nitrogen-containing heterobicycles as Factor Xa inhibitors, which expires on December 17, 2019. The senior patent’s Markush claim encompasses trillions of compounds, generically covering Apixaban but not specifically disclosing or claiming it, according to the plaintiffs. They reserved the right to sue for infringement of the senior patent but focused this suit on the junior patent, alleging that Natco’s Apigat infringed IN247381.

Natco Pharma, a prominent Indian generic drug manufacturer, argued that Apixaban was disclosed in the senior patent’s written description, including its preparation method, but not claimed, placing it in the public domain upon the senior patent’s expiry. Natco contended that Bristol-Myers Squibb’s Form-27 filings for both patents listed Apixaban as covered, suggesting an attempt to extend monopoly rights through the junior patent, a practice known as evergreening. Natco had initiated a revocation petition against the junior patent before the Intellectual Property Appellate Board (IPAB) in 2016, alleging invalidity due to prior disclosure in the senior patent. The plaintiffs’ contradictory statements in the IPAB proceedings—admitting that the senior patent did not claim Apixaban but encompassed it in its disclosure—fueled Natco’s claim of mala fide intent to secure an extended monopoly.

Detailed Procedural Background

The dispute crystallized in CS(COMM) 342/2019, filed by Bristol-Myers Squibb and co-plaintiffs on July 4, 2019, before the Delhi High Court, seeking a permanent injunction against Natco for infringing the junior patent, along with ancillary reliefs like damages. The suit first came up on July 5, 2019, when Natco’s counsel appeared on caveat, and summons were issued. Natco filed a written statement defending its actions and an application (IA No.9768/2019) under Section 10 of the CPC, seeking to stay the Delhi suit due to a prior suit it filed in Hyderabad’s City Civil Court. On November 7, 2019, the court framed a preliminary issue: whether the Delhi suit should be stayed under Section 10 owing to the Hyderabad suit.

The Hyderabad suit, filed by Natco before the City Civil Court, sought a declaratory decree under Section 34 of the Specific Relief Act, 1963, asserting Natco’s right to manufacture Apixaban as a product disclosed but not claimed in the senior patent, thus in the public domain. It also sought a permanent injunction to restrain Bristol-Myers Squibb from threatening or hampering Natco’s business regarding Apixaban. Filed prior to the Delhi suit, it was heard on June 28, 2019, with summons and notice of an interim relief application issued for July 8, 2019. The plaintiffs were served on July 1, 2019, and filed an application under Order VII Rule 11 of the CPC in Hyderabad, challenging the suit’s maintainability. Natco argued that the Hyderabad suit’s priority and overlapping issues warranted staying the Delhi suit under Section 10.

Issues Involved in the Case

The case hinged on several critical legal questions at the intersection of patent law and civil procedure:

Whether the Hyderabad suit, filed earlier, met the requirements of Section 10 of the CPC to stay the Delhi suit, particularly regarding the competence of the Hyderabad court to grant the reliefs sought in both suits?

Whether the Hyderabad suit, filed under Section 34 of the Specific Relief Act, was maintainable given the specific provisions of Sections 105 and 106 of the Patents Act for non-infringement declarations and groundless threat remedies?

Whether the statutory framework of the Patents Act, as a special statute, precluded reliefs under the general provisions of the Specific Relief Act in patent dispute?.

How the absence of a proviso in Section 106 of the Patents Act, unlike similar provisions in the Trade Marks and Copyright Acts, affected the interplay between groundless threat suits and subsequent infringement actions?

Detailed Submission of Parties

Bristol-Myers Squibb’s argued that the Delhi suit should proceed as the Hyderabad suit was not maintainable under Section 34 of the Specific Relief Act. They contended that the Patents Act, as a special statute, exclusively governs patent-related reliefs, with Sections 105 and 106 providing specific remedies for non-infringement declarations and groundless threats.

The Hyderabad suit failed to meet Section 105’s prerequisites, such as written application to the patentee for acknowledgment of non-infringement, and lacked allegations of threats by circulars or communications required under Section 106. The plaintiffs emphasized that the senior patent’s Markush claim covered trillions of compounds without specifically disclosing Apixaban, and a skilled person could not envisage Apixaban from its disclosure, distinguishing it from the junior patent’s specific claims. They argued that the Hyderabad suit’s reliefs indirectly challenged the junior patent’s validity, a matter beyond the City Civil Court’s jurisdiction under Section 104’s proviso, which mandates High Court adjudication for revocation counterclaims.

The plaintiffs asserted that the parties and reliefs differed between the suits, and the Hyderabad suit was a strategic ploy to forestall legitimate infringement action, warranting dismissal of Natco’s Section 10 application.

Natco argued that the Hyderabad suit, filed earlier, triggered Section 10 of the CPC, as its issues were substantially similar to those in the Delhi suit, particularly the scope of the senior patent’s disclosure of Apixaban. They contended that Apixaban was disclosed but not claimed in the senior patent, placing it in the public domain upon its expiry, and that Bristol-Myers Squibb’s Form-27 filings and IPAB statements admitted this coverage, undermining the junior patent’s validity. Natco framed the Hyderabad suit under Section 34 of the Specific Relief Act, not Sections 105 or 106, arguing that Section 105’s non-obstante clause did not bar general declaratory reliefs. They cited UK patent law, where non-infringement declarations could be sought under common law, suggesting Indian courts retained similar powers under Section 34.

Natco asserted that the Hyderabad court had concurrent jurisdiction under Section 20 of the CPC, and a finding in Hyderabad that Apixaban was public domain would negate the Delhi suit’s infringement claim. They highlighted the absence of a proviso in Section 106, unlike the Trade Marks and Copyright Acts, arguing that a groundless threat suit could not be automatically terminated by an infringement action, supporting the stay of the Delhi suit.

Detailed Discussion on Judgments Cited by Parties

The court’s analysis was informed by a rich tapestry of precedents, each providing context to the issues of Section 10’s applicability, the Patents Act’s exclusivity, and jurisdictional competence. The key judgments, their complete citations, and their relevance are as follows:

Chitivalasa Jute Mills vs. Jaypee Rewa Cement, (2004) 3 SCC 85: The Supreme Court held that Section 10 applies when two suits involve the same matter in issue, ordering consolidation of a buyer’s suit in Rewa with a seller’s prior suit in Visakhapatnam. Natco cited this to argue that the Hyderabad suit’s priority warranted staying the Delhi suit, but the court distinguished it, noting the Hyderabad court’s lack of jurisdiction to grant the Delhi suit’s reliefs.

Pukhraj D. Jain vs. G. Gopalakrishna, (2004) 7 SCC 251: The Supreme Court clarified that Section 10 is a procedural rule, not conferring substantive rights, and courts may prioritize expeditious disposal. The court relied on this to reject Natco’s application, emphasizing that staying the Delhi suit would not serve justice given the Hyderabad suit’s jurisdictional flaws.

Telecommunications Consultants India Ltd. vs. TCIL Bellsouth Ltd., 2006 SCC OnLine Del 1035: The Delhi High Court held that judicial comity under Section 10 yields to the principle that a court must grant complete relief. The court applied this to find the Hyderabad court incompetent to adjudicate the Delhi suit’s infringement claims, prioritizing the High Court’s jurisdiction.

Cadbury UK Limited vs. Lotte India Corporation Ltd., 2019 SCC OnLine Del 9810: Justice Endlaw held that Section 10 cannot be applied pedantically if it causes injustice, particularly when a prior suit is an abuse of process. The court used this to deem the Hyderabad suit a preemptive tactic, justifying dismissal of Natco’s application.

Prabir Ram Borooah vs. Albert David Ltd., AIR 1957 Gau 120: The Gauhati High Court ruled that Section 10 does not apply to suits filed to abuse the judicial process. The court invoked this to find the Hyderabad suit strategically filed to forestall the Delhi suit, negating Section 10’s applicability.

Time Warner Entertainment Company LP vs. RPG Netcom Globe, (2007) 140 DLT 758; Entertainment Network (India) Ltd. vs. Super Cassette Industries Ltd., (2008) 13 SCC 30; Krishika Lulla vs. Shyam Vithalrao Devkatta, (2016) 2 SCC 521; Navigators Logistics Ltd. vs. Kashif Qureshi, (2018) 254 DLT 307; Satish Kumar vs. Khushboo Singh, MANU/DE/3411/2019: These cases established that copyright is a statutory right without common law basis. The court extended this principle to patents, holding that the Patents Act is the sole repository of patent rights, precluding reliefs under the Specific Relief Act.

Crocs Inc. USA vs. Aqualite India Ltd., 2019 SCC OnLine Del 7409; Micolube India Ltd. vs. Saurabh Industries, (2013) 199 DLT 740 (FB): These cases applied the statutory exclusivity principle to designs, which the court analogized to patents, reinforcing that patent reliefs must align with the Patents Act.

Gujarat State Co-operative Land Development Bank Ltd. vs. P.R. Mankad, (1979) 3 SCC 123; Belsund Sugar Co. Ltd. vs. State of Bihar, (1999) 9 SCC 620; P.S. Sathappan vs. Andhra Bank Ltd., (2004) 11 SCC 672: These cases established that special statutes prevail over general ones (generalia specialibus non derogant). The court applied this to hold that the Patents Act overrides the Specific Relief Act for patent-related reliefs.

Travellers Exchange Corporation Limited vs. Celebrities Management Private Limited, 2019 SCC OnLine Del 6943: Justice Endlaw clarified that a non-obstante clause gives overriding effect to a new enactment over inconsistent existing laws. The court used this to interpret Section 105’s non-obstante clause as excluding Section 34’s applicability for non-infringement declarations.

Manohar Lal Chatrath vs. Municipal Corporation of Delhi, (1999) 77 DLT 5; Spentex Industries Ltd. vs. Dunavant SA, 2009 SCC OnLine Del 1666 (affirmed in 2009 SCC OnLine Del 3447 (DB)); Roshan Lal Gupta vs. Parasram Holdings Pvt. Ltd., (2009) 157 DLT 712; P.K. Gupta vs. Ansal Properties & Industries, 2010 SCC OnLine Del 3538; Handicrafts & Handlooms Exports Corporation of India, 2010 SCC OnLine Del 2099; Devinder Kumar Gupta vs. Realogy Corporation, 2011 SCC OnLine Del 3050 (DB): These cases held that declaratory relief under Section 34 is discretionary and unavailable when efficacious statutory remedies exist. The court applied this to find the Hyderabad suit’s reliefs barred by Sections 105 and 106.

Ram Singh vs. Gram Panchayat Mehal Kalan, (1986) 4 SCC 364; Splendor Landbase Limited vs. Mirage Infra Limited, (2010) 169 DLT 126 (DB); Axis Bank Limited vs. Madhav Prasad Aggarwal, 2018 SCC OnLine Bom 3891 (DB): These cases emphasized that courts must look beyond clever drafting to the substance of claims. The court used this to characterize the Hyderabad suit’s reliefs as an invalidity challenge, outside the City Civil Court’s jurisdiction.

These precedents provided a robust framework for assessing the Hyderabad suit’s legitimacy and Section 10’s applicability, anchoring the court’s decision in established legal principles.

Detailed Reasoning and Analysis of Judge

The court delivered a comprehensive judgment, meticulously analyzing Natco’s Section 10 application against the backdrop of patent law’s statutory framework and procedural fairness. The court’s reasoning centered on three pillars: the Hyderabad court’s jurisdictional incompetence, the Patents Act’s exclusivity, and the Hyderabad suit’s abusive nature.

First, the court held that Section 10 requires the prior suit’s court to be competent to grant both the reliefs sought therein and those in the subsequent suit. Citing Sagar Shamsher Jang Bahadur Rana vs. Union of India (1978 SCC OnLine Del 222) and other precedents, the court found the Hyderabad City Civil Court lacked jurisdiction to adjudicate the Delhi suit’s infringement claims. The Hyderabad suit’s reliefs—declaring Apixaban’s public domain status and enjoining Bristol-Myers Squibb—effectively challenged the junior patent’s validity, a matter reserved for the High Court under Section 104’s proviso when revocation counterclaims are raised. Section 105(3) further barred validity challenges in non-infringement suits, and the City Civil Court could not issue a certificate of validity under Section 113, rendering it incompetent to grant the Hyderabad suit’s reliefs substantively.

Second, the court emphasized the Patents Act’s status as a special statute, precluding reliefs under the general provisions of the Specific Relief Act. Drawing on Gujarat State Co-operative Land Development Bank Ltd. vs. P.R. Mankad and related cases, the court applied the maxim generalia specialibus non derogant, holding that Sections 105 and 106 provide exclusive remedies for non-infringement declarations and groundless threats. Section 105’s non-obstante clause, as interpreted in Travellers Exchange Corporation Limited, overrode Section 34, requiring compliance with specific conditions (e.g., written application to the patentee) that Natco admittedly did not meet. The court rejected Natco’s reliance on UK law, noting that India’s codified declaratory relief under Section 34 differed from UK’s common law framework, and the absence of a saving clause in Section 105 (unlike the UK Patents Act, 1977) confirmed its exclusivity. The court also found the Hyderabad suit’s injunctive relief impermissible under Section 41(a) and (b) of the Specific Relief Act, which bar injunctions against judicial proceedings, and Section 41(h), which prefers statutory remedies like Sections 105 and 106.

Third, the court deemed the Hyderabad suit an abuse of process, filed to preempt the Delhi suit and delay enforcement of the junior patent. Citing Prabir Ram Borooah and Cadbury UK Limited, the court held that Section 10, as a procedural rule per Pukhraj D. Jain, could be disregarded when its application would perpetuate injustice. The court scrutinized the Hyderabad suit’s substance, per Ram Singh, finding its declaratory relief a disguised invalidity challenge, cleverly drafted to circumvent jurisdictional limits. The court noted Natco’s failure to invoke Sections 105 or 106, likely to avoid disclosing manufacturing details, further evidencing strategic intent. The Delhi suit, encompassing Natco’s invalidity defense and counterclaim, was a comprehensive adjudication, unlike the Hyderabad suit, which risked multiplicity of proceedings, contrary to Section 10’s objective.

The court also addressed Section 106’s legislative anomaly, noting its lack of a proviso (unlike the Trade Marks and Copyright Acts) that terminates groundless threat suits upon infringement actions. While tracing this to the UK Patents Act, 1932, and the Ayyangar Committee’s influence, the court deemed it unnecessary to resolve, as Natco explicitly disclaimed reliance on Sections 105 and 106. Ultimately, the court prioritized justice and judicial efficiency, refusing to stay a suit before a competent court for one in an incompetent forum.

Final Decision

On January 23, 2020, the Delhi High Court dismissed Natco’s application (IA No.9768/2019) under Section 10 of the CPC and decided the preliminary issue in favor of the plaintiffs, holding that the Delhi suit was not liable to be stayed. The court permitted the infringement proceedings to continue, finding the Hyderabad suit jurisdictionally flawed and abusive.

Law Settled in this Case

The judgment clarified several principles governing patent litigation and procedural stays in India:

The Patents Act, 1970, is the sole repository of patent-related rights and remedies, precluding reliefs under general statutes like the Specific Relief Act, 1963, per the maxim generalia specialibus non derogant.

Section 105’s non-obstante clause overrides Section 34 of the Specific Relief Act, requiring non-infringement declarations to comply with its specific conditions, excluding general declaratory reliefs for patent disputes.

Section 10 of the CPC applies only when the prior suit’s court is competent to grant both its own reliefs and those of the subsequent suit, with competence assessed substantively, including the ability to address validity challenges (Sections 104, 113).

Suits seeking to indirectly challenge patent validity, disguised as declaratory reliefs, are beyond the jurisdiction of courts inferior to the High Court when revocation is at issue, per Section 104’s proviso.

Section 10, as a procedural rule, can be disregarded when the prior suit is an abuse of process, filed to preempt legitimate actions, ensuring courts prioritize justice over technicalities.

The absence of a proviso in Section 106, unlike other IP statutes, does not automatically bar groundless threat suits but is irrelevant when such suits fail to meet statutory prerequisites.

Case Title: Bristol-Myers Squibb Holdings Ireland Unlimited Company Vs. Natco Pharma

Date of Order: January 23, 2020

Case No.: CS(COMM) 342/2019

Name of Court: High Court of Delhi, New Delhi

Name of Hon'ble Judge: Justice Rajiv Sahai Endlaw

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

Boehringer Ingelheim International GmbH Vs. Eris Lifesciences Limited

A credible challenge to patent validity, requires serious question to be tried

Introduction

In the intricate world of pharmaceutical patents, where innovation meets the crucible of legal scrutiny, the case of Boehringer Ingelheim Pharma GmbH & Co. KG Vs. Vee Excel Drugs and Pharmaceuticals Pvt. Ltd. and connected matters, decided by the Delhi High Court on March 29, 2023, stands as a landmark exploration of patent validity and interim relief. This batch of six suits revolves around Indian Patent No. 243301 (IN ‘301), covering Linagliptin, a critical drug for type 2 diabetes management. Boehringer Ingelheim, a global pharmaceutical leader, sought to restrain multiple Indian generic manufacturers from producing and selling Linagliptin, alleging infringement of IN ‘301.

The defendants, including Vee Excel, Alkem Laboratories, Micro Labs, Natco Pharma, and Mankind Pharma, countered by challenging the patent’s validity, alleging it was an impermissible attempt to extend monopoly rights beyond the expired genus patent, IN ‘719. The Delhi High Court grappled with complex issues of prior claiming, evergreening, and public interest, ultimately denying interim injunctions. This case study delves into the factual and procedural intricacies, legal issues, parties’ arguments, judicial precedents, the court’s reasoning, and the broader implications, offering a vivid narrative of innovation under legal siege in India’s patent regime.

Detailed Factual Background

Boehringer Ingelheim Pharma GmbH & Co. KG, a Germany-based pharmaceutical giant, and its Indian subsidiary, Boehringer Ingelheim (India) Pvt. Ltd., are renowned for developing and marketing innovative drugs. The plaintiffs hold Indian Patent No. 243301, granted on October 5, 2010, titled “8-(3-Aminopiperidin-1-yl)-Xanthine Compounds,” covering Linagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor used to treat type 2 diabetes. Marketed under brands like Trajenta, Trajenta Duo, and Ondero, Linagliptin was launched in India in 2012 and 2014, achieving significant commercial success. The patent, valid until August 18, 2023, grants Boehringer exclusive rights under Section 48 of the Patents Act, 1970, to prevent unauthorized manufacture, use, sale, or importation. The plaintiffs emphasized that no pre-grant or post-grant oppositions were filed against IN ‘301, and it was upheld in China, reinforcing its global validity. Boehringer’s substantial R&D investments, coupled with its licensing agreements with Lupin and Eli Lilly, underscored its commercial stake in Linagliptin.

The defendants, Indian pharmaceutical companies including Vee Excel Drugs and Pharmaceuticals Pvt. Ltd., Alkem Laboratories Ltd., Micro Labs Limited, Natco Pharma Limited, and Mankind Pharma Limited, are engaged in manufacturing and selling generic Linagliptin 5 mg tablets. Boehringer alleged that these products infringed IN ‘301, as they contained Linagliptin without authorization. The plaintiffs highlighted prior successful enforcement actions against other infringers, such as MSN Laboratories, before the Himachal Pradesh High Court. A key contention was the relationship between IN ‘301 and an earlier patent, IN ‘719, titled “Xanthine Compounds,” a genus patent covering a Markush formula that expired on February 21, 2022. The defendants argued that Linagliptin was covered and claimed in IN ‘719, rendering IN ‘301 an invalid attempt at evergreening to extend monopoly rights. They pointed to Boehringer’s admissions in prior litigations and regulatory filings, including Form 27 statements, which listed identical Linagliptin products for both patents, suggesting that IN ‘301 duplicated IN ‘719’s scope.

Boehringer countered that IN ‘301 was a species patent, claiming specific commercial embodiments of Linagliptin developed through further research after IN ‘719’s filing. They argued that Linagliptin was neither specifically claimed nor disclosed in IN ‘719, and the genus patent’s Markush formula did not anticipate IN ‘301’s inventive step. The plaintiffs also noted that the defendants began commercializing Linagliptin only after IN ‘719’s expiry, but this did not negate infringement of IN ‘301, which remained valid until August 2023. The defendants, in turn, emphasized public interest, highlighting their significantly cheaper Linagliptin products compared to Boehringer’s imported drugs, crucial for affordability in a country with high diabetes prevalence.

Detailed Procedural Background

The dispute unfolded through six suits filed before the Delhi High Court: CS(COMM) 239/2019, CS(COMM) 240/2019, CS(COMM) 236/2022, CS(COMM) 237/2022, CS(COMM) 238/2022, and CS(COMM) 296/2022. Boehringer sought permanent injunctions to restrain the defendants from infringing IN ‘301, alongside damages and other reliefs. Each suit was accompanied by applications for interim injunctions under Order XXXIX, Rules 1 and 2 of the Code of Civil Procedure (CPC), 1908, specifically I.A. 6797/2019, I.A. 6802/2019, I.A. 5801/2022, I.A. 5806/2022, I.A. 5811/2022, and I.A. 7109/2022. The defendants filed written statements and counterclaims seeking revocation of IN ‘301 under Section 64 of the Patents Act, 1970, alleging prior claiming, lack of inventive step, and evergreening.

In CS(COMM) 239/2019 and CS(COMM) 240/2019, summons were issued on May 10, 2019, with ad interim injunctions granted, restraining Vee Excel from manufacturing Linagliptin tablets. These orders persisted until the final judgment. For CS(COMM) 236/2022, CS(COMM) 237/2022, and CS(COMM) 238/2022, summons were issued on April 19, 2022, with a pro-tem arrangement agreed upon, prohibiting the defendants from manufacturing or selling Linagliptin, except for existing stock, pending disclosure of stock details. A similar arrangement was adopted in CS(COMM) 296/2022 on May 9, 2022. The court heard arguments on multiple dates in January 2023, reserving judgment on January 27, 2023, and delivering it on March 29, 2023.

Issues Involved in the Case

The case presented several pivotal legal questions at the nexus of patent law and interim relief:

Whether the age of IN ‘301, an “old” patent nearing expiry, warranted a presumption of validity for interim injunction purposes?

Whether the absence of pre-grant or post-grant oppositions, or the belated filing of revocation petitions, strengthened the plaintiffs’ claim to interim relief?

Whether the defendants raised a credible challenge to IN ‘301’s validity, particularly on grounds of prior claiming under Section 64(1)(a), evergreening, or non-compliance with Section 3(d) of the Patents Act?

Whether Boehringer’s assertions that Linagliptin was covered by both IN ‘719 and IN ‘301 in prior litigations estopped them from claiming it was only specifically claimed in IN ‘301?

Whether denying an interim injunction would cause irreparable harm to Boehringer, or if monetary damages could suffice, given its licensing arrangements?

How public interest, particularly access to affordable anti-diabetes drugs, should influence the court’s equitable discretion in granting interim relief?

Detailed Submission of Parties

Boehringer’s counsel argued that IN ‘301, granted in 2010 and valid until August 2023, conferred exclusive rights under Section 48, which the defendants violated by manufacturing Linagliptin without licenses. They highlighted the patent’s enforcement against other infringers, its global validity, and the absence of oppositions in India, citing National Research Development Corp. of India vs. Delhi Cloth & General Mills (1979 SCC OnLine Del 206) to argue that an old, worked patent should be presumed valid for interim relief. The plaintiffs contended that IN ‘719, a genus patent, did not specifically claim or disclose Linagliptin, as its Markush formula was too broad, and IN ‘301’s claims were distinct, supported by further research. They dismissed the defendants’ reliance on Form 27 filings as irrelevant, arguing that these did not admit invalidity. Boehringer rejected evergreening allegations, asserting that IN ‘301 was a legitimate species patent, not a patent of addition, and that prior art claims were hindsight-driven, citing FMC Corporation vs. Best Crop Science LLP (2021) 87 PTC 217 for the defendants’ burden to establish a credible challenge. On public interest, they argued that the Patents Act’s compulsory licensing provisions addressed affordability, and monetary damages could not compensate for market erosion.

The defendants’ counsel argued that IN ‘301 was invalid under Section 64(1)(a) for prior claiming, as Linagliptin was covered and claimed in IN ‘719, which expired in February 2022, rendering it public domain. They cited Boehringer’s admissions in Indian and Canadian litigations, Form 27 filings, and a 2008 reply to the Indian Patent Office’s Examination Report, where Linagliptin was listed among 371 compounds to secure IN ‘719, as evidence of coverage. The defendants invoked Section 13(4) and Bishwanath Prasad Radhey Shyam vs. Hindustan Metal Industries (AIR 1982 SC 1444) to argue that no presumption of validity exists, regardless of the patent’s age or lack of oppositions. They accused Boehringer of evergreening to extend monopoly rights, violating Sections 3(d), 10(4), and 53(4), and cited AstraZeneca AB vs. Intas Pharmaceuticals Ltd. (MANU/DE/1939/2020) and its Division Bench affirmation ((2021) 87 PTC 374) as controlling precedent. The defendants emphasized public interest, noting their significantly cheaper Linagliptin (a daily-use drug for diabetes) and Boehringer’s importation practices, arguing that monetary damages could compensate the plaintiffs, who licensed IN ‘301 to Lupin and Eli Lilly. They also alleged non-disclosure of material information under Section 8, further invalidating IN ‘301.

Detailed Discussion on Judgments Cited by Parties

The court’s analysis was shaped by a robust array of precedents, each contextualized to address patent validity, interim injunctions, and evergreening. The key judgments, their complete citations, and their relevance are as follows:

Bishwanath Prasad Radhey Shyam vs. Hindustan Metal Industries, AIR 1982 SC 1444: The Supreme Court held that Section 13(4) clarifies that patent grants do not guarantee validity, which can be challenged in revocation or infringement proceedings. The court used this to reject Boehringer’s claim of presumed validity for IN ‘301, affirming the defendants’ right to challenge it.

National Research Development Corp. of India vs. Delhi Cloth & General Mills, 1979 SCC OnLine Del 206: The Delhi High Court suggested that for old, worked patents (over six years), courts may presume validity for interim injunctions unless credibly challenged. Boehringer relied on this, but the court doubted its applicability, citing F. Hoffmann-La Roche vs. Cipla (2008 SCC OnLine Del 382), which treated it as a rule of caution, not practice.

F. Hoffmann-La Roche Ltd. vs. Cipla Ltd., 2008 SCC OnLine Del 382: A Single Judge held that the six-year rule is a cautionary principle, not a mandatory presumption, as patents remain vulnerable to challenge. The court adopted this to negate Boehringer’s reliance on IN ‘301’s age.

F. Hoffmann-La Roche Ltd. vs. Cipla Ltd., ILR (2009) Supp. (2) Delhi 551: The Division Bench clarified that even patents surviving pre-grant and post-grant challenges can be revoked on new grounds, reinforcing Section 13(4)’s stance against presumed validity, which supported the defendants’ challenge.

AstraZeneca AB vs. Intas Pharmaceuticals Ltd., MANU/DE/1939/2020: The court held that a credible challenge to a species patent’s validity, based on prior claiming in a genus patent, negates interim injunctions, especially when evergreening is alleged. The court found this directly applicable, given similar facts involving Linagliptin’s coverage in IN ‘719.

AstraZeneca AB vs. Intas Pharmaceuticals Ltd., (2021) 87 PTC 374 (DB): The Division Bench upheld the single judge, emphasizing that successive patents for the same invention violate the Patents Act’s intent to limit monopoly terms, supporting the defendants’ evergreening argument.

Novartis AG vs. Union of India, (2013) 6 SCC 1: The Supreme Court rejected distinctions between coverage and disclosure, holding that a patent’s claims must align with its disclosure to prevent evergreening. The court applied this to find that Boehringer’s claim that Linagliptin was not disclosed in IN ‘719 was untenable, given prior admissions.

Novartis AG vs. Natco Pharma Limited, 2021 SCC OnLine Del 5340: A Coordinate Bench distinguished AstraZeneca, suggesting it was fact-specific, but the court declined to follow it, finding AstraZeneca’s facts closely aligned with the present case and binding as a Division Bench ruling.

FMC Corporation vs. Best Crop Science LLP, (2021) 87 PTC 217: The Delhi High Court held that a credible challenge to validity requires cogent material, which Boehringer cited to argue the defendants’ burden. The court noted this preceded AstraZeneca’s Division Bench ruling and was less relevant.

FMC Corporation vs. GSP Crop Science Private Limited, 2022 SCC OnLine Del 3784: The court held that serial patenting to extend monopolies is impermissible under Section 3(d), supporting the defendants’ evergreening claim against IN ‘301.

Bristol-Myers Squibb Company vs. J.D. Joshi, MANU/DE/1889/2015: Cited in AstraZeneca, it was clarified that it does not limit defendants’ rights to challenge validity under Section 107, supporting the defendants’ position.

Smith vs. Grigg Ltd., (1924) 41 RPC 149 (UK): The origin of the six-year rule, it was referenced in National Research but doubted by the court, given India’s statutory framework under Section 13(4).

These precedents provided a comprehensive lens for evaluating IN ‘301’s vulnerability, the propriety of interim relief, and the perils of evergreening.

Detailed Reasoning and Analysis of Judge

The court delivered a meticulous judgment, applying the triple test for interim injunctions—prima facie case, balance of convenience, and irreparable harm—while addressing the defendants’ challenge to IN ‘301’s validity. The court framed four key issues: whether old patents presume validity, whether lack of oppositions or belated revocation petitions favored Boehringer, whether the defendants raised a credible challenge, and whether the balance of convenience supported an injunction.

On the first two issues, the court relied on Section 13(4) and Bishwanath Prasad to hold that no presumption of validity exists for any patent, old or new, as the Patents Act lacks a provision akin to Section 31 of the Trademarks Act, 1999. The court rejected Boehringer’s reliance on National Research, citing F. Hoffmann-La Roche (2008) to treat the six-year rule as cautionary, not mandatory. It further held that the absence of oppositions or delayed revocation petitions did not bolster IN ‘301’s validity, as challenges could be raised at any stage, per AstraZeneca.

On the third issue, the court found a credible challenge to IN ‘301’s validity under Section 64(1)(a) for prior claiming. Boehringer’s admissions in CS(COMM) 239/2019 and CS(COMM) 240/2019, Canadian litigation against Sandoz, and the 2008 reply to the Patent Office’s Examination Report for IN ‘719, where Linagliptin was listed among 371 compounds, confirmed its coverage in the genus patent. Identical Form 27 filings for both patents further evidenced that both protected the same Linagliptin products, violating Section 10’s prohibition on multiple patents for one invention. The court invoked Novartis to reject Boehringer’s distinction between coverage and disclosure, holding that Linagliptin’s inclusion in IN ‘719’s claims negated IN ‘301’s novelty. The court also found prima facie evidence of evergreening, as IN ‘301 extended monopoly rights beyond IN ‘719’s expiry, contrary to Sections 3(d), 10(4), and 53(4), and supported by AstraZeneca and FMC vs. GSP Crop Science. The court declined to assess other revocation grounds (e.g., obviousness, non-disclosure under Section 8), reserving them for trial.

On the balance of convenience, the court applied AstraZeneca to hold that it favored the defendants. Boehringer’s 20-year monopoly under IN ‘719, its importation practices, and licensing to Lupin and Eli Lilly indicated that monetary damages could compensate any loss, as the plaintiffs sought to monetize IN ‘301. The court emphasized public interest, noting Linagliptin’s role as a daily-use anti-diabetes drug and the defendants’ significantly cheaper products, critical amid India’s high diabetes prevalence and post-COVID comorbidities. Denying the injunction would cause no irreparable harm to Boehringer, but granting it would harm the defendants and public access to affordable drugs.

The court distinguished the Himachal Pradesh High Court’s ruling in Boehringer vs. MSN Laboratories (OMP No. 85/2022), finding it factually erroneous for relying on IN ‘719’s Examination Report as pertaining to IN ‘301, and legally inconsistent with Novartis and AstraZeneca for distinguishing “covered” and “encompassed.” The court concluded that Boehringer’s attempt to approbate and reprobate—claiming Linagliptin’s coverage in IN ‘719 for prior reliefs but denying it for IN ‘301—was impermissible, reinforcing the defendants’ credible challenge.

Final Decision

The Delhi High Court dismissed all interim injunction applications on March 29, 2023, with costs of Rs. 2,00,000 to each defendant and Rs. 2,00,000 to the Delhi High Court Legal Services Committee. The interim orders in CS(COMM) 239/2019 and CS(COMM) 240/2019, and pro-tem arrangements in the 2022 suits, were vacated. The defendants were permitted to manufacture and sell Linagliptin products, subject to regulatory approvals, and ordered to maintain half-yearly accounts. The court clarified that its observations were preliminary and would not affect the final trial outcome.

Law Settled in this Case

The judgment clarified several principles governing patent disputes and interim relief in India:

No presumption of validity exists for patents, regardless of age or lack of oppositions, as per Section 13(4), and challenges can be raised at any stage (Bishwanath Prasad, AstraZeneca).

A credible challenge to patent validity, requiring only a serious question to be tried, negates interim injunctions, particularly when prior claiming under Section 64(1)(a) is established (AstraZeneca, Novartis).

Evergreening through successive patents for the same invention violates Sections 3(d), 10(4), and 53(4), and courts must guard against attempts to extend monopolies beyond the statutory 20-year term (AstraZeneca, FMC vs. GSP Crop Science).

Admissions by patentees in prior litigations or regulatory filings (e.g., Form 27) can estop them from denying coverage in earlier patents, supporting invalidity claims (Novartis).

Public interest, especially access to affordable drugs for prevalent diseases like diabetes, outweighs patentee rights when a credible challenge exists, and monetary damages suffice when patentees license or import products (AstraZeneca).

Distinctions between “covered,” “claimed,” “disclosed,” or “encompassed” are untenable if the invention is protected by an earlier patent, aligning claims with disclosure (Novartis).

Case Title: Boehringer Ingelheim Pharma GmbH Vs Vee Excel Drugs and Pharmaceuticals Pvt. Ltd.

Date of Order: March 29, 2023

Case No.: CS(COMM) 239/2019

Neutral Citation: 2023:DHC:2272

Name of Court: High Court of Delhi

Name of Judge: 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

Boehringer Ingelheim International GmbH Vs. Eris Lifesciences Limited

Introduction
In the dynamic realm of pharmaceutical innovation, where intellectual property rights safeguard groundbreaking discoveries, the case of Boehringer Ingelheim International GmbH vs. Eris Lifesciences Limited, decided by the High Court of Himachal Pradesh on May 30, 2024, emerges as a pivotal chapter. This dispute, centered on Indian Patent No. 268846 for the drug Empagliflozin, underscores the delicate balance between protecting patent rights and ensuring public access to affordable medicines. Boehringer Ingelheim, a global pharmaceutical titan, sought to restrain Eris Lifesciences, an Indian company, from manufacturing and selling an allegedly infringing product under the brand "Linares-E." The case delves into complex legal questions surrounding patent validity, infringement, and the criteria for granting interim injunctions in patent disputes. By navigating the interplay of Indian patent law, international precedents, and equitable principles, the court’s ruling not only resolves the immediate conflict but also sets a significant precedent for handling patent disputes in India’s commercial courts. This case study offers an in-depth exploration of the factual and procedural nuances, legal issues, parties’ arguments, judicial precedents, the court’s reasoning, and the broader implications of the decision, painting a vivid picture of innovation under legal scrutiny.

Detailed Factual Background
Boehringer Ingelheim International GmbH, a Germany-based pharmaceutical giant, and its Indian subsidiary, Boehringer Ingelheim (India) Pvt. Ltd., are renowned for their contributions to human and veterinary medicine. The plaintiffs hold Indian Patent No. 268846 (IN ‘846), granted on September 18, 2015, for “Glucopyranosyl Substituted Benzenol Derivatives,” a pharmaceutical innovation covering Empagliflozin, a sodium-glucose co-transporter-2 (SGLT2) inhibitor used to treat type 2 diabetes mellitus. Empagliflozin, marketed under brand names like Jardiance, Jardiance Duo, and Glyxambi, was introduced in India in 2015 and 2018, achieving significant commercial success. The patent, valid until March 11, 2025, grants Boehringer exclusive rights under Section 48 of the Patents Act, 1970, to prevent unauthorized manufacture, use, sale, or importation of the patented product. Boehringer’s global R&D expenditure, exceeding 3.3 billion Euros in 2020, underscores its commitment to innovation, with Empagliflozin being a cornerstone of its metabolic disease portfolio. The plaintiffs emphasized that no pre-grant or post-grant oppositions were filed against IN ‘846, and the patent is registered in over 70 countries, reinforcing its robustness.

Eris Lifesciences Limited, a publicly listed Indian pharmaceutical company with operations in Himachal Pradesh, Assam, and Gujarat, markets a product under the brand “Linares-E,” containing Empagliflozin and Linagliptin (25 mg/5 mg). Boehringer alleged that this product infringes IN ‘846, as it replicates the patented Empagliflozin formulation without consent. The plaintiffs discovered Linares-E in the market and argued that Eris’s actions constituted a blatant violation of their exclusive patent rights, causing substantial financial harm. They further noted that Eris’s manufacturing and sales activities occurred within the territorial jurisdiction of the Himachal Pradesh High Court, justifying the court’s authority to hear the case. Boehringer highlighted its vigilance in protecting IN ‘846, citing prior successful legal actions against other infringers in courts in Himachal Pradesh, Vadodara, and Dehradun.

Eris, in response, did not dispute manufacturing and selling Linares-E but challenged the validity of IN ‘846, arguing that it lacked inventive step and was vulnerable to revocation. Eris pointed to prior art documents—WO2001027128 (D1, Dapagliflozin Genus) and WO2003099836 (D2, Dapagliflozin Species)—claiming that Empagliflozin was obvious to a person skilled in the art (POSA). Additionally, Eris alleged that Boehringer concealed the revocation of a corresponding patent in China, accusing the plaintiffs of approaching the court with unclean hands. Eris further emphasized the public interest, noting that Linares-E, priced at Rs. 25 per tablet compared to Boehringer’s Rs. 86 per tablet, enhances affordability for diabetic patients, a critical factor given diabetes’s chronic nature.

Detailed Procedural Background
The dispute unfolded through multiple legal filings before the High Court of Himachal Pradesh. Boehringer filed Civil Suit (COMS) No. 09 of 2023 and COMS No. 02 of 2024, seeking a permanent prohibitory injunction to restrain Eris from infringing IN ‘846, alongside other reliefs such as damages. Concurrently, Boehringer filed OMP No. 409 of 2023 under Order XXXIX, Rules 1 and 2, read with Section 151 of the Code of Civil Procedure (CPC), 1908, requesting an interim injunction to halt Eris’s manufacture, sale, and marketing of Linares-E during the suit’s pendency. Eris responded with counterclaims (COMS No. 01 of 2024 in COMS No. 09 of 2023 and COMS No. 07 of 2024 in COMS No. 02 of 2024), challenging the validity of IN ‘846 under Section 64 of the Patents Act, 1970, and opposing the interim injunction.

The court, presided over by Justice Ajay Mohan Goel, reserved the matter on May 3, 2024, and delivered its judgment on May 30, 2024. The plaintiffs were represented by Senior Advocates Ashok Aggarwal and Vinay Kuthiala, supported by a team of advocates, while Eris was represented by Senior Advocate Chander Lall and his legal team. The court’s task was to determine whether Boehringer had established a prima facie case, balance of convenience, and irreparable harm to justify an interim injunction, while also assessing Eris’s claim that IN ‘846 was vulnerable to revocation. The procedural complexity was heightened by Eris’s counterclaims, which sought to leverage prior art and international patent invalidations to undermine the plaintiffs’ case.

Issues Involved in the Case
The case raised several critical legal issues at the intersection of patent law and interim relief:
Whether Boehringer established a prima facie case of patent infringement by demonstrating that Eris’s Linares-E product violated the exclusive rights under IN ‘846.
Whether Eris raised a credible challenge to the validity of IN ‘846, rendering it vulnerable to revocation, thereby negating the plaintiffs’ entitlement to an interim injunction.
Whether the non-disclosure of the revocation of a corresponding patent in China constituted suppression of material facts, affecting Boehringer’s claim to equitable relief.
Whether the balance of convenience favored Boehringer, considering the commercial impact of infringement, or Eris, given the public interest in affordable medicines.
Whether the absence of an interim injunction would cause irreparable harm to Boehringer, or whether monetary damages could adequately compensate any loss.
How the court should weigh public interest arguments, such as access to affordable drugs, against the statutory protections afforded to patentees under the Patents Act, 1970.

These issues required the court to balance the proprietary rights of a patentee against the defendant’s right to challenge patent validity, all while considering equitable principles and public welfare.

Detailed Submission of Parties
Boehringer’s counsel argued that IN ‘846, valid until March 11, 2025, conferred exclusive rights under Section 48 of the Patents Act, 1970, which Eris infringed by manufacturing and selling Linares-E. They emphasized the patent’s registration in 70 countries, its commercial success since 2015, and the absence of pre-grant or post-grant oppositions in India, underscoring its strength. The plaintiffs highlighted Empagliflozin’s technical superiority, with a selectivity for SGLT2 (~2500) surpassing prior art compounds like Dapagliflozin (~1200) and WO’128’s Example 12 (~900), establishing inventive step. They dismissed Eris’s prior art claims, noting that these were examined by patent offices globally without challenging IN ‘846’s validity. On the China revocation, Boehringer clarified that a re-trial petition was pending before China’s Supreme People’s Court, and patent laws vary by jurisdiction, rendering the revocation irrelevant to India. The plaintiffs argued that Eris’s lower pricing was an attempt to exploit Boehringer’s R&D investments, and public interest was safeguarded by the Patents Act’s provisions for compulsory licensing, which Eris had not pursued. Boehringer asserted a prima facie case, balance of convenience, and irreparable harm, citing long-term market damage if infringement continued.

Eris’s counsel countered that IN ‘846 was vulnerable due to lack of inventive step, relying on prior art documents WO2001027128 and WO2003099836, which disclosed Glucopyranosyloxy-Substituted Aromatic Groups as SGLT2 inhibitors. They argued that Empagliflozin was obvious to a POSA, supported by an expert affidavit from Dr. Prabuddha Ganguli. Eris accused Boehringer of concealing the China revocation, claiming this breached the clean hands doctrine, especially since the same prior art underpinned the revocation. On public interest, Eris highlighted Linares-E’s affordability (Rs. 25 vs. Rs. 86 per tablet), arguing that an injunction would disrupt patient access to cost-effective treatment for a chronic condition like diabetes. They contended that Boehringer’s licensing of IN ‘846 to Torrent, Lupin, and Cipla indicated a monetary value, suggesting damages could compensate any loss. Eris asserted that a credible challenge to patent validity negated the need for an injunction, as the court need only find vulnerability at the interim stage, not definitive invalidity.

Detailed Discussion on Judgments Cited by Parties
The court’s analysis was informed by a robust array of Indian and international precedents, shaping its approach to patent validity, interim injunctions, and the clean hands doctrine. The key judgments, their complete citations, and their context in the case are as follows:

M/s Bishwanath Prasad Radhey Shyam vs. Hindustan Metal Industries, (1979) 2 SCC 511: The Supreme Court held that the grant of a patent does not guarantee its validity, which can be challenged in revocation or infringement proceedings, as expressly provided by Section 13(4) of the Patents Act, 1970. The court used this to affirm Eris’s right to challenge IN ‘846’s validity despite its registration.
Dalpat Kumar and Another vs. Prahlad Singh and Others, (1992) 1 SCC 719: The Supreme Court outlined the triple test for interim injunctions—prima facie case, irreparable injury, and balance of convenience—emphasizing that irreparable injury need not be physically irreparable but material, and damages may not suffice. The court applied this to assess Boehringer’s entitlement to relief.
Ten XC Wireless Inc. and Others vs. Mobi Antenna Technologies (Shenzhen) Co. Ltd., 2011 SCC OnLine Del 4648: The Delhi High Court summarized principles for patent injunctions, noting no presumption of validity under Sections 13(4), 64, and 107, and that a credible challenge to validity precludes injunction. The court adopted this to evaluate Eris’s challenge.
Natco Pharma vs. Novartis AG and Anr., FAO(OS) (COMM) 178/2021, decided on 24.04.2024 (Delhi High Court): The Division Bench clarified that there is no statutory presumption of validity, and a defendant need only raise a credible challenge at the interim stage, not prove invalidity. The court used this to set the threshold for Eris’s challenge.
F. Hoffmann-La Roche Ltd. & Anr. vs. Cipla Ltd., ILR 2009 Supp (2) Del 551: The Delhi High Court held that a defendant’s credible challenge to patent validity, raising a serious question, suffices to resist an interim injunction, without requiring a stronger case than the plaintiff. The court relied on this to assess the strength of Eris’s challenge.
UCB Farchim SA vs. Cipla Ltd. & Ors., 2010 SCC OnLine Del 523: The Delhi High Court reiterated that Section 13(4) negates any warranty of validity from pre-grant investigations, supporting the court’s view that IN ‘846’s grant did not presume validity.
Standipack Pvt. Ltd. vs. Oswal Trading Co. Ltd., AIR 2000 Del 23: The Delhi High Court emphasized that patent validity is tested at trial, not interim stages, guiding the court to limit its inquiry to vulnerability.
Bilcare Ltd. vs. Amartara Pvt. Ltd., (2007) 34 PTC 419 (Del): The Delhi High Court underscored the need for a substantial challenge to validity, which the court applied to Eris’s prior art arguments.
Surendra Lal Mahendra vs. Jain Glazers, 1980 SCC OnLine Del 219: The Delhi High Court reinforced that validity challenges are permissible in infringement suits, supporting Eris’s counterclaim.
Beecham Group Ltd. vs. Bristol Laboratories Pty Ltd., (1967-68) 118 CLR 618 (Australia): The Australian High Court held that a defendant alleging invalidity need only show a serious question to be tried, a principle the court adopted for interim relief.
Australian Broadcasting Corporation vs. O’Neill, (2006) 229 ALR 457 (Australia): The Australian High Court reiterated the “serious question” standard, aligning with the court’s approach to Eris’s challenge.
Hexal Australia Pty Ltd. vs. Roche Therapeutics Inc., 66 IPR 325 (Australia): The Australian court held that invalidity at the interim stage requires showing a triable question, which the court used to evaluate Eris’s prior art.
Abbot Laboratories vs. Andrx Pharmaceuticals Inc., No. 05-1433 (U.S. Court of Appeals, Federal Circuit, 22.06.2006): The U.S. court held that vulnerability, not actual invalidity, is the issue at the preliminary injunction stage, requiring less proof than at trial. The court applied this to Eris’s burden.
Helifix Ltd. vs. Blok-Lok Ltd., 208 F.3d 1339 (Fed. Cir. 2000): The U.S. court clarified that a substantial question of invalidity suffices at the interim stage, guiding the court’s analysis.
Erico International Corp. vs. Vutec Corp., No. 2007-1168 (Fed. Cir.): The U.S. court emphasized a substantial question of invalidity to show vulnerability, reinforcing the court’s standard.
Satish Khosla vs. M/s Eli Lilly Ranbaxy Ltd., MANU/DE/0763/1998: The Delhi High Court stressed the clean hands doctrine, requiring full disclosure of material facts, which the court used to assess Boehringer’s non-disclosure of the China revocation.
S.P. Chengalvaraya Naidu vs. Jagannath and Others, MANU/SC/0192/1994: The Supreme Court held that a litigant withholding vital documents to gain advantage commits fraud on the court, informing the court’s clean hands inquiry.
Arunima Baruah vs. Union of India, MANU/SC/7366/2007: The Supreme Court emphasized that suppression of material facts impacts equitable relief, relevant to Boehringer’s conduct.
Charanjit Thukral and Ors. vs. Deepak Thukral and Ors., MANU/DE/1814/2010: The Delhi High Court held that plaintiffs must disclose all material facts, and failure to do so justifies denying injunction, guiding the court’s analysis.
Aura Synergy India Ltd. vs. New Age False Ceiling Co. Pvt. Ltd., 2016 SCC OnLine Del 1109, approved in 2016 SCC OnLine Del 7530-DB: The Delhi High Court held that suppression in IP disputes can preclude injunction, but the court distinguished this due to procedural differences.
FMC Corporation vs. GSP Crop Science Private Limited, 2022 SCC OnLine Del 3784: The Delhi High Court recognized suppression as a ground to challenge injunctions, but the court found it less applicable absent specific rules.
Bayer Healthcare LLC vs. Natco Pharma Limited, 2023 SCC OnLine Del 4458: The Delhi High Court denied an injunction for concealment, but the court noted the absence of similar patent rules in Himachal Pradesh.
Gujarat Bottling Co. Ltd. vs. Coca Cola Co., (1995) 5 SCC 545: The Supreme Court held that equitable relief depends on the plaintiff’s conduct, supporting the court’s clean hands scrutiny.
Freebit AS vs. Bose Corporation, No. 18-2365 (U.S. Court of Appeals, 08.10.2019): The U.S. court invalidated a patent, cited by Eris to argue vulnerability, but the court found it less relevant to India.
Bose Corporation vs. Freebit AS, [2018] EWHC 889 (Pat) (U.K.): The U.K. Patent Court invalidated a patent, but the court deemed it jurisdiction-specific.
Freebit AS vs. Exotic Mile Private Limited, FAO(OS) (COMM) 15/2024 (Delhi High Court, 31.01.2024): The Division Bench upheld denial of injunction due to non-disclosure of international invalidations, but the court distinguished it due to procedural differences.
Wander Ltd. vs. Antox India (P) Ltd., 1990 Supp SCC 727: The Supreme Court held that appellate courts should not interfere with discretionary injunction rulings unless arbitrary, guiding the court’s approach.

These precedents provided a comprehensive framework for evaluating patent vulnerability, interim relief, and equitable conduct.

Detailed Reasoning and Analysis of Judge
Justice Ajay Mohan Goel delivered a nuanced judgment, meticulously applying the triple test for interim injunctions—prima facie case, balance of convenience, and irreparable harm—while addressing Eris’s challenge to IN ‘846’s validity. The court began by acknowledging the undisputed fact of IN ‘846’s registration on September 18, 2015, with an expiry date of March 11, 2025, and Eris’s admission of manufacturing Linares-E without a patent. The absence of pre-grant or post-grant oppositions bolstered Boehringer’s prima facie case, as did the patent’s registration in 70 countries and its commercial success.

On Eris’s vulnerability argument, the court adopted the principles from Bishwanath Prasad and Natco Pharma, recognizing that patent grants carry no presumption of validity under Section 13(4). However, it held that Eris’s reliance on prior art (WO2001027128 and WO2003099836) and the expert affidavit did not sufficiently establish a credible challenge. The court noted Boehringer’s rebuttal that Empagliflozin’s superior selectivity (~2500 vs. ~1200 for Dapagliflozin) demonstrated inventive step, and prior art was considered by global patent offices without undermining IN ‘846. The court, guided by F. Hoffmann-La Roche and Ten XC Wireless, concluded that Eris’s challenge lacked the substantiality required to render the patent vulnerable at the interim stage, as it did not raise a serious question for trial.

The court addressed the China revocation, a cornerstone of Eris’s clean hands argument, by distinguishing Freebit AS and Satish Khosla. Unlike the Delhi High Court, which operates under the Patent Suits Rules, 2022, requiring disclosure of international patent statuses, Himachal Pradesh lacked such rules. The court held that non-disclosure of the China revocation, where a re-trial was pending, was not a material suppression under Order XI, Rule 1 of the CPC, as amended by the Commercial Courts Act, 2015. It emphasized that patent laws are jurisdiction-specific, and invalidation in one country (China) did not inherently affect IN ‘846’s validity in India, especially given its registration in 70 other jurisdictions. The court rejected Eris’s claim that Boehringer’s conduct disentitled it to equitable relief, finding no intent to mislead.

On public interest, the court dismissed Eris’s affordability argument, noting that the Patents Act’s provisions for compulsory licensing (Chapter XVI) and government use (Chapter XVII) address public access in emergencies, which had not been invoked. Citing Gujarat Bottling, the court held that commercial rivals like Eris could not leverage public interest to justify infringement, as this would undermine the statutory framework. The court found the balance of convenience favored Boehringer, given its established market and R&D investments, and that continued infringement would cause irreparable harm by eroding market share and goodwill, which damages could not fully remedy (Dalpat Kumar).

The court concluded that Boehringer satisfied the triple test, while Eris failed to demonstrate IN ‘846’s vulnerability. It granted the interim injunction, restraining Eris from infringing IN ‘846 pending the suit’s resolution, ensuring the plaintiffs’ rights were protected without prejudicing a full trial on validity.

Final Decision
The High Court of Himachal Pradesh allowed OMP No. 409 of 2023 on May 30, 2024, granting an interim injunction. Eris Lifesciences Limited, its directors, licensees, stockists, distributors, and agents were restrained from infringing Indian Patent No. 268846 by manufacturing, advertising, selling, importing, or exporting Empagliflozin in any form, including under the brand “Linares-E,” until the civil suit’s disposal.

Law Settled in this Case
The judgment clarified several principles for patent infringement and interim relief in India:
A registered patent establishes a prima facie case of validity, but defendants may challenge its vulnerability at the interim stage without proving actual invalidity, requiring only a credible, substantial question (Natco Pharma, F. Hoffmann-La Roche).
Non-disclosure of international patent invalidations does not automatically constitute suppression of material facts absent specific procedural rules, and jurisdiction-specific patent laws limit the relevance of foreign revocations (distinguishing Freebit AS).
Public interest arguments, such as drug affordability, cannot override patent rights unless supported by statutory mechanisms like compulsory licensing, as commercial rivals are not entitled to invoke public welfare to justify infringement.
The triple test for interim injunctions—prima facie case, balance of convenience, and irreparable harm—applies rigorously in patent cases, with irreparable harm encompassing long-term market damage beyond monetary compensation (Dalpat Kumar).
In the absence of a credible challenge to patent validity, a patentee with a registered patent and evidence of infringement is entitled to interim protection to preserve its exclusive rights pending trial.

Case Title: Boehringer Ingelheim International GmbH Vs. Eris Lifesciences Limited
ate of Order: May 30, 2024
Case No.: COMS No. 09 of 2023
Neutral Citation: Not provided in the document
Name of Court: High Court of Himachal Pradesh, Shimla
Name of Judge: Justice Ajay Mohan Goel

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