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
