Cipla Limited Vs. Novartis AG

Importation of Patented product constitutes “working” a patent in India if it meets public demand

Introduction: In the intricate realm of patent litigation, where innovation intersects with public health, the case of Cipla Limited vs. Novartis AG & Anr., decided by the Delhi High Court on March 9, 2017, stands as a pivotal exploration of patentee rights, public interest, and interim injunctive relief. This appeal, arising from a suit to restrain patent infringement, pitted Novartis AG, a Swiss pharmaceutical giant, against Cipla Limited, an Indian generic drug manufacturer, over the bronchodilator drug Indacaterol, patented under Indian Patent No. 222346. The dispute centered on whether Novartis’s importation-based working of the patent justified an injunction against Cipla’s generic version, or if public interest and alleged non-working warranted its denial. The Division Bench upheld the Single Judge’s interim injunction, navigating the complex interplay of the Patents Act, 1970, public health considerations, and global trade obligations. 

Detailed Factual Background:Novartis AG, a Swiss company (Respondent No. 1), holds Indian Patent No. 222346 for Indacaterol, a bronchodilator used to manage chronic obstructive pulmonary disease (COPD), marketed in India as Onbrez through Lupin Limited (Respondent No. 2), an Indian company, under a 2012 agreement. Indacaterol, a novel beta-agonist, offers 24-hour relief with rapid onset within five minutes, distinguishing it from other bronchodilators. Novartis manufactures Indacaterol in Switzerland, importing it into India without local production. 

Cipla Limited, an Indian pharmaceutical company, launched its generic Indacaterol under the brand Unibrez in October 2014, later renamed Indaflo following a trademark dispute. Cipla priced its drug at Rs. 130 for 10 tablets, significantly lower than Novartis’s Rs. 677, claiming greater affordability and access for COPD patients. Cipla alleged that Novartis imported only small quantities (e.g., 53,865 units in 2013, equating to roughly 4,000 patients’ monthly supply), insufficient for India’s estimated 1.5 crore COPD patients, thus failing to work the patent locally. N

ovartis countered that its imports met demand and denied the 1.5 crore patient estimate, asserting that Indacaterol’s unique efficacy justified its patent protection. A prior trademark suit (CS(OS) 3356/2014) saw Cipla undertake to cease using “Unibrez” on November 17, 2014, after Novartis alleged passing off. Cipla also filed a revocation petition under Section 66 of the Patents Act on October 22, 2014, citing public interest, shortly before launching its generic product.

Detailed Procedural Background:The dispute originated in CS(OS) 3812/2014, filed by Novartis in the Delhi High Court, seeking a permanent injunction to restrain Cipla from infringing Patent No. 222346, alongside damages, rendition of accounts, and delivery-up. Novartis filed IA 24863/2015 under Order XXXIX Rules 1 and 2 CPC for an interim injunction. On January 9, 2015, the Single Judge granted the injunction, restraining Cipla from manufacturing, selling, or importing Indacaterol or Indacaterol Maleate, pending either the suit’s resolution or the outcome of a compulsory license application, if Cipla filed one. The order allowed Cipla to seek modification if a compulsory license was granted. Aggrieved, Cipla appealed in FAO(OS) 21/2015, accompanied by applications CM Nos. 731/2015, 1288/2015, and 2098/2015. Novartis filed a cross-objection (CM No. 2090/2015), challenging the injunction’s limitation tied to compulsory licensing. 

Issues Involved in the Case:The case presented several critical legal questions at the nexus of patent law, public interest, and interim relief:

Whether Novartis’s importation of Indacaterol constituted sufficient “working” of the patent in India under the Patents Act, entitling it to an injunction under Section 48? Whether Section 83’s general principles, emphasizing local working and public interest, curtailed the patentee’s exclusive rights under Section 48, particularly for a life-managing drug like Indacaterol?

Detailed Submission of Parties: Cipla argued that the injunction was unjust, as Novartis failed to work the patent in India. Cipla contended that Section 48’s patentee rights, prefaced by “subject to the other provisions contained in this Act,” were subordinate to Section 83’s principles, which require patents to be worked commercially in India, not merely imported, and to ensure affordable public access. Cipla highlighted Novartis’s limited imports (e.g., 53,865 units in 2013, serving ~4,000 patients against 1.5 crore COPD patients), arguing that this constituted non-working and impeded public health, per Section 83(d). Cipla’s Indaflo, priced at Rs. 130 versus Onbrez’s Rs. 677, better served public interest by enhancing access. Cipla cited F. Hoffmann La Roche vs. Cipla (2009) for public interest as a fourth factor in injunctions, alongside Article 7 of TRIPS, the Doha Declaration, and India’s GATT submissions, which prioritize public health and local working. Cipla also referenced Franz Xaver Huemer vs. New Yash Engineers (1996), where non-use justified denying an injunction, and Glaverbel S.A. vs. Dave Rose (2010), suggesting royalties as an alternative. Cipla argued that the Single Judge erred in excluding Section 83’s principles from civil court considerations, asserting that public interest warranted denying the injunction.

Novartis defended the injunction, arguing that Section 48 granted exclusive rights to prevent unauthorized use, unimpeded by Section 83, which applies to compulsory licensing under Chapter XVI, not civil injunctions. Novartis emphasized that its patent faced no credible validity challenge, establishing a prima facie case. It denied Cipla’s 1.5 crore patient estimate, asserting that its Swiss-manufactured imports, marketed via Lupin, sufficiently met India’s COPD demand, per Telemecanique & Controls vs. Schneider Electric (2002). Novartis highlighted Indacaterol’s unique efficacy, justifying its patent protection and higher pricing. It accused Cipla of mala fide conduct, citing the Unibrez trademark imitation and premature generic launch post-revocation filing, undermining Cipla’s equitable standing. Novartis distinguished Cipla’s precedents: Hoffmann La Roche involved a challenged patent, unlike the present case; Franz Xaver Huemer concerned total non-use, not applicable to Novartis’s imports; and E Bay’s public interest test was U.S.-specific. Novartis’s cross-objection challenged the injunction’s linkage to compulsory licensing, arguing that Section 48 rights were absolute pending trial.

Detailed Discussion on Judgments Cited by Parties: The court’s analysis was shaped by a robust array of precedents, each contextualized to address patent rights, public interest, and interim relief. The key judgments, their complete citations, and their relevance are as follows:

F. Hoffmann La Roche Limited vs. Cipla Limited, 2009 (40) PTC 125 (Del) (DB): The Division Bench recognized public interest as a fourth factor in injunctions, alongside prima facie case, balance of convenience, and irreparable harm, noting that access to life-saving drugs in India warranted caution. Cipla relied on this to argue that Indacaterol’s role in COPD and its pricing disparity favored public interest over injunction. The court distinguished it, noting that Hoffmann La Roche involved a challenged patent, unlike Novartis’s unchallenged patent, and Indacaterol was not a life-saving drug.

Franz Xaver Huemer vs. New Yash Engineers, 1996 PTC (16) 232 (Del) (DB): The Division Bench held that a patentee’s non-use disentitled them to interim injunctions, citing English and U.S. authorities like Plympton vs. Malcolmson (1875). Cipla cited this to argue that Novartis’s non-manufacture constituted non-working. The court distinguished it, finding that Novartis’s imports constituted working, unlike the total non-use in Huemer.

Telemecanique & Controls (I) Limited vs. Schneider Electric Industries SA, 2002 (24) PTC 632 (Del) (DB): The Division Bench held that imports suffice for working a patent if they meet public demand, rejecting the need for local manufacture. Novartis relied on this to defend its importation model. The court applied this, finding no conclusive evidence that Novartis’s imports were insufficient, pending trial.

Glaverbel S.A. vs. Dave Rose, 2010 (43) PTC 630 (Del): A Single Judge suggested royalties as an alternative to injunctions in certain patent disputes. Cipla cited this to propose royalties over injunction. The court found it inapplicable, as Novartis’s prima facie case and Cipla’s infringement warranted injunctive relief.

Bard Peripheral Vascular, Inc. vs. C.R. Bard, Inc., 670 F.3d 1171 (Fed. Cir. 2012): The U.S. Court of Appeals considered royalties in lieu of injunctions in licensing disputes. Cipla cited this to support royalties. The court deemed it irrelevant, as no licensing arrangement existed, and U.S. law differed from India’s patent regime.

Novartis AG vs. Mehar Pharma, 2005 (30) PTC 160 (Bom): The Bombay High Court denied an injunction due to a challenged patent’s validity. Cipla cited this to question injunctions, but the court distinguished it, noting no credible challenge to Novartis’s patent.

Advanced Cardiovascular Systems vs. Medtronic Vascular, 579 F. Supp. 2d 554 (D. Del. 2008): A U.S. court considered prior licensing in injunction decisions. Cipla cited this, but the court found it inapplicable absent licensing in the present case.

eBay Inc. vs. MercExchange, L.L.C., 547 U.S. 388 (2006): The U.S. Supreme Court included public interest in its four-factor injunction test. Cipla relied on this, but the court rejected its applicability, noting India’s distinct statutory framework.

Baer vs. Union of India, WP 1323/2013 (Del, decided on 15.07.2014): A compulsory licensing case irrelevant to civil injunctions. Cipla cited it, but the court dismissed its relevance.

The court also considered Article 7 of TRIPS, the Doha Declaration, and India’s GATT submissions, cited by Cipla, but found them more relevant to compulsory licensing than civil injunctions.

Detailed Reasoning and Analysis of Judge: The Division Bench meticulously upheld the Single Judge’s injunction, grounding its decision in statutory interpretation, precedent, and equitable principles. The court first addressed the patent’s validity, noting no credible challenge to Patent No. 222346, establishing Novartis’s prima facie case under Section 48, which grants exclusive rights to prevent unauthorized manufacture, sale, or import. Cipla’s infringement, by launching Indaflo, was undisputed, strengthening Novartis’s claim.

On the interplay between Sections 48 and 83, the court rejected Cipla’s argument that Section 83’s principles curtailed Section 48 rights in civil injunctions. Section 48’s preface, “subject to the other provisions,” did not extend to Section 83, which operates under Chapter XVI (Working of Patents, Compulsory Licenses, and Revocation) and guides authorities, not courts, in exercising powers like granting compulsory licenses. Section 83’s own preface, “without prejudice to the other provisions,” further insulated Section 48 from its ambit. The court clarified that Section 83’s considerations—local working, public health, affordability—apply to compulsory licensing proceedings, not interim injunctions, ensuring that patentee rights remain robust absent statutory overrides like Section 84 or 85.

The court addressed the “working” issue, relying on Telemecanique to hold that imports constitute working if they meet demand. Cipla’s data (e.g., 53,865 units for ~4,000 patients) and Novartis’s counter-articles on COPD prevalence were inconclusive without trial evidence, but the court found no basis to deem imports insufficient at the interim stage. Indacaterol’s non-life-saving status, unlike cancer drugs, and the availability of other COPD treatments, diminished Cipla’s public interest argument.

On public interest, the court acknowledged its relevance, per Hoffmann La Roche, but held it insufficient to override a valid patent’s protection absent a challenged validity or exceptional circumstances. Cipla’s pricing advantage was noted, but the court prioritized Novartis’s statutory rights, finding that denying the injunction would cause irreparable harm via market erosion, uncompensable by damages. Cipla’s mala fide conduct—trademark imitation and launching Indaflo post-revocation filing—further weakened its equitable standing.

The court dismissed Novartis’s cross-objection, finding the Single Judge’s linkage to compulsory licensing a reasonable interim measure, though not affecting Section 48’s primacy. The court concluded that the balance of convenience favored Novartis, given the patent’s validity and Cipla’s clear infringement, and public interest did not sufficiently countervail to deny relief.

Final Decision:On March 9, 2017, the Delhi High Court dismissed Cipla’s appeal (FAO(OS) 21/2015) and Novartis’s cross-objection (CM No. 2090/2015), upholding the Single Judge’s interim injunction restraining Cipla from manufacturing, selling, or importing Indacaterol or Indacaterol Maleate until the suit’s resolution or a compulsory license determination. No costs were ordered.

Law Settled in this Case: The judgment clarified several principles governing patent injunctions and public interest:

Section 48 of the Patents Act grants patentees exclusive rights to prevent unauthorized use, subject only to provisions directly impinging on those rights, not Section 83’s general principles.

Section 83’s principles, emphasizing local working and public interest, apply to compulsory licensing and revocation under Chapter XVI, not civil court injunctions.

Importation constitutes “working” a patent in India if it meets public demand, negating the need for local manufacture .

Public interest is a factor in interim injunctions but does not override a valid patent’s protection absent a credible validity challenge or exceptional circumstances.

A patentee’s prima facie valid patent and clear infringement establish entitlement to an injunction, with irreparable harm presumed from market erosion.

Mala fide conduct, like trademark imitation or premature generic launches, weakens a defendant’s equitable claim against injunctions.

Sufficiency of imports to meet demand is a triable issue, not determinable at the interim stage without conclusive evidence.

Case Title: Cipla Limited Vs. Novartis AG & Anr.

Date of Order: March 9, 2017

Case No.: FAO(OS) 21/2015

Name of Court: High Court of Delhi

Name of Hon'ble Judge: Justice Badar Durrez Ahmed, Justice Sanjeev Sachdeva

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

Burger King Corporation Vs. Techchand Shewakramani

Use under the Trade Marks Act, per Sections 2(2)(c), 28, 29, and 56, encompasses non-physical activities like online promotions

Introduction: In the vibrant arena of trademark litigation, where brand identity clashes with territorial boundaries, the case of Burger King Corporation vs. Techchand Shewakramani & Ors., decided by the Delhi High Court on August 27, 2018, emerges as a landmark exploration of jurisdictional competence in intellectual property disputes. 

The plaintiff, Burger King Corporation, a U.S.-based fast-food giant, sought to protect its iconic trademarks “Burger King” and “Hungry Jack’s” against alleged infringement by a group of Mumbai-based defendants operating under the same “Burger King” mark. 

The defendants challenged the Delhi High Court’s jurisdiction, arguing a lack of cause of action and territorial nexus. The court meticulously dissected the interplay of the Trade Marks Act, 1999, and the Code of Civil Procedure, 1908, dismissing the defendants’ applications to reject or return the plaint. This case study delves into the factual matrix, procedural intricacies, legal issues, parties’ arguments, judicial precedents, the court’s reasoning, and the broader implications, painting a vivid picture of a jurisdictional chess game in India’s trademark landscape.

Detailed Factual Background:Burger King Corporation, a renowned U.S.-based fast-food chain, holds global trademark registrations for “Burger King” and “Hungry Jack’s,” used for its restaurants and corporate identity. Planning to launch franchise outlets in New Delhi, the plaintiff had entered into agreements, sought regulatory approvals, and established a business presence in the city. 

The defendants, all based in Mumbai, included individuals and companies allegedly infringing the plaintiff’s trademarks. Defendant No. 5, Burger King Restaurant Pvt. Ltd., and Defendant No. 6, Hungry Jacks Fast Food Pvt. Ltd., were companies operating at 99/C, Rosewood Chambers, Tulsiwadi, Tardeo, Mumbai. Defendant No. 7, Ras Resorts and Apart Hotels Pvt. Ltd., shared the same address and was promoted by the same individuals. Defendant No. 1 was a director of Defendants No. 5 and 7; Defendant No. 2 was an executive director of Defendant No. 7 and a director of Defendants No. 5 and 6; Defendant No. 3 was the managing director of Defendant No. 7 and a director of Defendants No. 5 and 6; and Defendant No. 4 was a director of Defendant No. 6. The plaintiff alleged that the defendants were using “Burger King” for restaurants and carts in locations like Silvassa, Daman, and Pune, and were actively promoting the mark through a website, theburgerking.in, registered by Defendant No. 3 on July 9, 2014. 

This website, linked to Ras Resorts, offered franchise opportunities and listed the administrative office as Ras Group of Hotels, suggesting a nexus with Defendant No. 7. The plaintiff apprehended that the defendants planned to expand into Delhi, citing franchise queries from Delhi areas like Madangiri, Okhla, and Dwarka, and a Business Digest article dated July 30, 2014, quoting Defendant No. 3 on nationwide expansion plans. The defendants’ Memorandum of Association further declared intentions to establish branches across India, reinforcing the plaintiff’s concerns.

Detailed Procedural Background:The dispute crystallized in CS(COMM) 919/2016, filed by Burger King Corporation before the Delhi High Court, seeking a permanent injunction to restrain trademark infringement and passing off, along with damages. The suit was accompanied by a counterclaim, CC(COMM) 122/2017, by the defendants. The defendants filed three applications: I.A. 23496/2014 by Defendant No. 7 under Order VII Rule 11 CPC, seeking rejection of the plaint for lack of cause of action and territorial jurisdiction; I.A. 17220/2015 by Defendants No. 1, 2, 3, and 5 under Order VII Rule 10 CPC, seeking return of the plaint for lack of jurisdiction; and I.A. 17221/2015 by Defendant No. 6 under Order VII Rule 11 CPC, mirroring the jurisdictional objections. 

Issues Involved in the Case:The case presented several critical legal questions at the intersection of trademark law and civil procedure:Whether the Delhi High Court had territorial jurisdiction under Section 20 of the CPC, given the defendants’ Mumbai-based operations and the plaintiff’s claim of imminent infringement in Delhi?Whether the plaintiff’s invocation of Section 134(2) of the Trade Marks Act, based on its business activities in Delhi, conferred jurisdiction, or if it was barred by precedents limiting such claims.Whether the defendants’ promotion of the “Burger King” mark through websites, franchise queries, and public statements constituted “use” under the Trade Marks Act, creating a cause of action in Delhi?Whether the plaintiff’s apprehension of the defendants’ expansion into Delhi was credible and sufficient to establish a cause of action under Section 20(c) of the CPC?Whether subsequent events, such as franchise queries post-filing, could be considered to determine jurisdiction, or if jurisdiction was fixed at the date of filing?

Detailed Submission of Parties:The plaintiff argued that the Delhi High Court had jurisdiction under both Section 134(2) of the Trade Marks Act and Section 20 of the CPC. Under Section 134(2), the plaintiff claimed to carry on business in Delhi through agreements, contracts, and regulatory approvals for its imminent Burger King franchise launch. Under Section 20(c), the plaintiff asserted a credible apprehension of the defendants expanding into Delhi, evidenced by franchise queries from Delhi, the interactive website theburgerking.in, and Defendant No. 3’s public statements on nationwide expansion. 

The defendants argued that the Delhi High Court lacked jurisdiction, as all defendants resided and operated in Mumbai, with no infringing activities in Delhi. They cited Indian Performing Rights Society Ltd. vs. Sanjay Dalia (2015) and Ultra Home Construction Pvt. Ltd. vs. Purshottam Kumar Chaubey (2016) to argue that Section 134(2) did not apply, as the plaintiff’s Delhi presence was insufficient without a cause of action arising there. Under Section 20, they contended that the plaintiff’s apprehension was speculative, lacking evidence of actual sales or operations in Delhi. Defendant No. 7 emphasized its distinct business (Ras Resorts) and lack of connection to the “Burger King” mark, arguing that its website (rasresorts.com) was unrelated to the infringement. The defendants asserted that the cause of action, if any, was quia timet and arose in Mumbai, where their operations were based. They further argued that subsequent events, like post-filing franchise queries, could not confer jurisdiction, and the issue was purely legal, not requiring factual inquiry.

Detailed Discussion on Judgments Cited by Parties:The court’s analysis was informed by a rich array of precedents, each providing context to jurisdictional principles in trademark disputes. The key judgments, their complete citations, and their relevance are as follows:

Indian Performing Rights Society Ltd. vs. Sanjay Dalia, (2015) 63 PTC 1 (SC): The Supreme Court clarified that Section 134 of the Trade Marks Act and Section 62 of the Copyright Act provide additional forums where the plaintiff resides or carries on business, but do not oust Section 20 of the CPC. The defendants relied on this to argue that the plaintiff’s Delhi branch office did not confer jurisdiction without a cause of action, but the court distinguished it, noting that Section 20(c) independently applied due to the defendants’ use of the mark in Delhi.

Ultra Home Construction Pvt. Ltd. vs. Purshottam Kumar Chaubey, 227 (2016) DLT 320 (DB) (Delhi High Court): The Division Bench outlined scenarios for jurisdiction under Section 134(2) and Section 62(2), emphasizing that a plaintiff with a principal office cannot sue at a subordinate office unless the cause of action arises there. The defendants cited this to challenge the plaintiff’s Section 134(2) claim, but the court held that Section 20(c) jurisdiction was established, rendering Section 134 analysis secondary.

Laxmikant V. Patel vs. Chetanbhat Shah, AIR 2002 SC 275: The Supreme Court held that passing off actions consider future business harm, not just existing facts, and likelihood of damage suffices for injunctions. The plaintiff relied on this to justify jurisdiction based on the defendants’ expansion plans, and the court applied it to find that the defendants’ promotional activities in Delhi created a credible cause of action.

Federal Express Corporation vs. Fedex Securities Ltd., 2018 (74) PTC 205 (Del) (DB): The Division Bench ruled on jurisdiction under Section 134, not Section 20. The defendants cited it to argue lack of jurisdiction, but the court found it inapplicable, as the plaintiff’s case rested on Section 20(c) due to the defendants’ activities in Delhi.

HSIL Ltd. vs. Marvel Ceramics, 2018 (73) PTC 77 (Del) (DB): The Division Bench found no cause of action in Delhi under Section 134. The defendants relied on this, but the court distinguished it, noting that the defendants’ franchise solicitations and promotions in Delhi established a cause of action under Section 20(c).

Additionally, the court referenced Kerly’s Law of Trade Marks and Trade Names (13th Edn., 2001) to define “use” under Section 2(2)(c) of the Trade Marks Act, encompassing advertising, promotion, and franchise solicitations, which supported the plaintiff’s jurisdictional claim.

Detailed Reasoning and Analysis of Judge: The court first addressed the defendants’ interconnectedness, noting that Defendants No. 1, 2, and 3 were common directors across Defendants No. 5, 6, and 7, all sharing the same Mumbai address. The website theburgerking.in, registered by Defendant No. 3, listed Ras Resorts as its administrative office and offered franchise forms, linking Defendant No. 7 to the infringing mark. This nexus undermined the defendants’ claim of independence, justifying their joinder in the suit.

On jurisdiction, the court held that Section 20(c) of the CPC was satisfied, as the defendants’ actions constituted “use” of the “Burger King” mark in Delhi, creating a cause of action. The court expansively interpreted “use” under Section 2(2)(c) and Sections 28, 29, and 56 of the Trade Marks Act, per Kerly’s Law, to include promotion, advertising, and franchise solicitations. The defendants’ website, franchise queries from Delhi (e.g., Madangiri, Okhla), and Defendant No. 3’s public statements on nationwide expansion, corroborated by a Business Digest article and the Memorandum of Association, evidenced active promotion in Delhi. The court emphasized the modern context of e-commerce, noting that online franchise solicitations targeting Delhi customers conferred jurisdiction, reflecting the dynamic nature of trademark use.

The court distinguished IPRS vs. Sanjay Dalia and Ultra Home, clarifying that while these cases limited Section 134(2) jurisdiction, they did not dilute Section 20(c)’s applicability. The plaintiff’s agreements and approvals in Delhi supported Section 134(2), but the court found Section 20(c) independently sufficient, as the cause of action arose from the defendants’ Delhi-directed activities. The court rejected the defendants’ argument that jurisdiction was fixed at the filing date, citing Laxmikant V. Patel to hold that passing off considers future harm, and each instance of mark use creates a fresh cause of action. The defendants’ own documents, including franchise requests and a counterclaim asserting Delhi jurisdiction, further undermined their objections.

The court also addressed procedural fairness, criticizing indiscriminate document denials under the Commercial Courts Act. It directed fresh admission/denial affidavits to focus on genuine disputes, warning against delays through unjustified denials, aligning with the Act’s efficiency goals. The defendants’ lack of cause of action argument was dismissed, as their promotional activities and expansion plans established a credible threat of infringement in Delhi.

Final Decision:On August 27, 2018, the Delhi High Court dismissed I.A. 17221/2015, I.A. 17220/2015, and I.A. 23496/2014, upholding its jurisdiction to entertain the suit. 

Law Settled in this Case:The judgment clarified several principles governing jurisdiction in trademark disputes: Section 20(c) of the CPC confers jurisdiction where a cause of action arises, including through trademark “use” such as promotion, advertising, or franchise solicitations in the forum’s territory.“Use” under the Trade Marks Act, per Sections 2(2)(c), 28, 29, and 56, encompasses non-physical activities like online promotions and franchise queries, reflecting e-commerce realities.Passing off and infringement actions consider future business harm, and jurisdiction is not fixed at the filing date, as each mark use creates a fresh cause of action .Section 134(2) of the Trade Marks Act supplements, but does not exclude, Section 20 of the CPC, allowing jurisdiction based on the plaintiff’s business activities or cause of action (IPRS vs. Sanjay Dalia).Interconnected defendants, sharing directors or addresses, can be joined in a suit if linked to the infringing mark, preventing jurisdictional evasion.In commercial suits, indiscriminate document denials violate the Commercial Courts Act’s efficiency goals, and courts may impose sanctions for unjustified delays.A credible apprehension of trademark infringement, supported by promotional activities or expansion plans, suffices to establish a cause of action in quia timet actions.

Case Title: Burger King Corporation Vs. Techchand Shewakramani

Date of Order: August 27, 2018

Case No.: CS(COMM) 919/2016

Name of Court: High Court of Delhi

Name of Hon'ble Judge: Justice Prathiba M. Singh

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. 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