Case brief: Indoco Remedies Ltd. v. Bristol Myers Squibb Holdings 

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Citation	AIRONLINE 2020 DEL 1280
Court	Delhi High court
Decided on	18 September 2020
Plaintiff	Indoco remedies ltd
Defendant	Bristol myers Squibb holdings

 

Introduction 

The case of Indoco Remedies Ltd vs Bristol Myers Squibb Holdings Ireland revolves around a patent infringement claim. Bristol Myers holds a patent for "Lactam-Containing Compounds and Derivatives thereof, as Factor Xa Inhibitors," specifically concerning the anticoagulant Apixaban (patent IN 247381). The litigation began with Bristol Myers alleging that Indoco Remedies, among other companies, infringed this patent through the manufacture and sale of a generic formulation named APIXABID.   In a prior judgment dated 24th December 2019, the learned Single Judge granted an ad interim injunction, maintaining the status quo regarding the manufacture and sale of products that purportedly infringe upon the patent. This injunction was based on the assertion that the suit patent was valid until 17th September 2022, and any manufacturing or sale of Apixaban by other parties without a license would constitute infringement, causing irreparable harm to Bristol Myers.   Indoco Remedies sought relief from this injunction amidst the COVID-19 pandemic, arguing for the necessity of their product as a therapeutic agent in treating thromboembolic conditions associated with the virus. They aimed to sell approximately 58,000 strips of APIXABID manufactured prior to the injunction. The case underscores significant issues related to patent rights, public health needs, and the balance between intellectual property protections and the urgent demands posed by a public health crisis.   The ongoing legal proceedings and appeals highlight the conflict between innovation and generics in the pharmaceutical industry, particularly regarding access to essential medications during a health emergency.   

Facts of the case

Here are the key facts of the case Indoco Remedies Ltd vs Bristol Myers Squibb Holdings Ireland:  

1. Parties Involved:

  - The applicant in the case is Indoco Remedies Ltd (the applicant), seeking to manufacture and sell its product APIXABID, a generic version of Apixaban.   - The respondent is Bristol Myers Squibb Holdings Ireland Unlimited Company (Bristol Myers), which holds a valid patent for the formulation.  

2. Patent Details:

  - Bristol Myers owns Indian patent IN 247381, which covers a specific class of compounds, including Apixaban, a Factor Xa inhibitor used as an anticoagulant.  

3. Judgment and Injunction:

  - On 24th December 2019, a Single Judge issued an ad interim injunction preserving the status quo regarding the manufacture and sale of products infringing the patent, indicating that the patent was valid until 17th September 2022.  

4. Alleged Infringement:

  - Bristol Myers accused Indoco Remedies and several other companies, including Torrent Pharmaceuticals, Cipla Limited, and Emcure Pharmaceutical Limited, of infringing the IN 247381 patent by manufacturing and selling Apixaban or its generics.  

5. Manufacturing Context:

  - Indoco Remedies manufactured 58,000 strips of APIXABID prior to the Single Judge's injunction and sought permission to sell these strips amidst the urgent need for medications during the COVID-19 pandemic.  

6. Public Health Argument:

  - Indoco's counsel argued that Apixaban is essential for treating thromboembolic complications in COVID-19 patients, and the availability of their cheaper generic version would help patients who cannot afford the brand-name product.  

7. Previous Court Decisions:

  - Indoco's application referenced an earlier court decision allowing NATCO Limited to sell its Apixaban product, arguing that there was no justification for treating them differently.  

8. Legal Awareness of Injunctions:

  - It was acknowledged that Indoco manufactured the strips while aware of the existing injunctions, highlighting the tension between protecting patent rights and addressing public health needs.   These facts set the stage for the ongoing legal debate regarding patent rights, the need for public health interventions during a pandemic, and the balance of interests between pharmaceutical companies and the healthcare needs of the population.   

Arguments by the parties 

Indoco Remedies Ltd (Applicant) Arguments:  

1. Public Health Necessity:

  - Indoco argued that APIXABID is essential for patients suffering from thromboembolic conditions, especially during the COVID-19 pandemic, where the need for anticoagulants has increased significantly. They maintained that this need justified the permission to sell the previously manufactured strips.   

2. Affordability:

  - Indoco claimed that their generic version of Apixaban is much cheaper than the brand version offered by Bristol Myers. They emphasized that many patients infected with COVID-19 might not afford the more expensive brand-name anticoagulants, thus necessitating the availability of their product.  

3. Unexpected Circumstances:

  - The applicant argued that the pandemic created an extraordinary situation that warranted reconsideration of the injunction and that standard legal principles should not apply rigidly during such times.  

4. No Evidence of Shortage:

  - Indoco asserted that they found no evidence of a shortage of Apixaban, indicating that their application was not based on presumed scarcity but rather on their right to sell a lawful product.  

5. Manufacturing Before Injunction:

  - They argued that the strips in question were manufactured before the injunction was put in place, therefore their sale should not infringe upon the patent rights as the product was already in their inventory.    Bristol Myers Squibb Holdings Ireland (Respondent) Arguments:  

1. Patent Infringement:

  - Bristol Myers contended that permitting Indoco to sell APIXABID would amount to infringing their valid patent (IN 247381) during its remaining life, which could result in irreparable harm to their patent rights and business interests.   

2. Awareness of Injunction:

  - They highlighted that Indoco manufactured the strips while knowing about the existing injunctions against the sale of infringing products, thus acting at their own peril.   

3. Adequate Supply of Apixaban:

  - Bristol Myers maintained that there was sufficient supply of their Apixaban product available in the market, refuting Indoco's claims of a shortage and arguing that the opposition to the sale of APIXABID was in the public interest.   

4. Unreasonable Request:

  - Bristol Myers presented that allowing Indoco’s request would contradict established patent law principles, which prioritize protecting intellectual property rights even in emergencies, and argued that Indoco failed to demonstrate an overwhelming public interest in their favor.  

5. Lack of Evidence:

  - They pointed out the lack of substantial evidence from Indoco to support their claims regarding affordability issues or shortages of the product in the market, arguing that the pleas raised by Indoco were artificially constructed and unsupported by credible data.    These arguments illustrate the conflict between the necessity of public health interventions during a pandemic and the protection of established patent rights held by pharmaceutical companies.    Analysis of the court    The court's analysis in Indoco Remedies Ltd vs Bristol Myers Squibb Holdings Ireland focused on several critical aspects, weighing both the legal principles surrounding patent rights and the implications of public health needs during the COVID-19 pandemic. Here’s a breakdown of the court's analysis:  

1. Legal Standing of the Patent:

  - The court reaffirmed the validity of the patent held by Bristol Myers (IN 247381) and emphasized that, until any successful challenge to that patent was made, it must be respected. The court highlighted that Indoco's actions constituted a violation of this patent due to the existing injunction against infringing products.   

2. Injunctions and Patent Rights:

  - The court noted that the injunction issued on 24th December 2019 remained in effect and emphasized the principle that parties must clear their path before engaging in activities that could infringe on existing patents. The court highlighted past rulings where similar injunctions were respected in patent disputes.  

3. Public Health Argument:

  - The court acknowledged the heightened need for medications like Apixaban during the pandemic. However, it concluded that the mere assertion of public interest could not override established patent rights, especially in the absence of clear and compelling evidence of a shortage of the drug or affordability issues for patients. The court found that Indoco had failed to provide substantial evidence supporting the claims of public necessity.  

4. Evidence of Availability:

  - Bristol Myers provided assurances regarding the availability of their Apixaban product in the market, countering Indoco's claims of urgency. The court noted that there was no official government notification or evidence indicating a shortage of Apixaban, thereby diminishing Indoco's argument regarding public interest and urgency.  

5. Balancing Interests:

  - The court evaluated the balance of convenience and irreparable harm criteria. It concluded that granting Indoco the right to sell APIXABID without resolving the patent infringement matter would unfairly disadvantage Bristol Myers and undermine intellectual property protections. The court highlighted that allowing such sales would set a concerning precedent that could imperil patent rights under the guise of public interest.  

6. Final Conclusion:

  - Ultimately, the court decided against granting the application by Indoco Remedies Ltd. It insisted that the request to sell the APIXABID strips was insufficiently supported by any legal grounds or compelling public health rationale that would justify overriding the injunction in place. The court emphasized the need for adherence to patent jurisprudence, asserting that any perceived public interest must be substantiated by credible evidence, which Indoco failed to provide.   In summary, the court's analysis highlighted the importance of upholding patent rights while recognizing the challenges posed by pandemics. However, it maintained that such challenges must be addressed through established legal processes rather than through circumvention of patent law.