Supreme Court Restores Restrictions on Biosimilar Drug Marketing: Genentech Inc. vs. Drug Controller General of India (2019)

Date of the Judgment: 17 December 2019

Citation: [Not Available in Source]

Judges: R. Banumathi, J., A.S. Bopanna, J., Hrishikesh Roy, J. (authored the judgment)

Can a pharmaceutical company market a biosimilar drug by claiming similarity to an innovator drug, even if they haven’t completed all the required clinical trials? The Supreme Court of India recently addressed this critical question in a case involving the drug ‘Trastuzumab’ and its biosimilar version ‘TrastuRel’. The court had to consider the balance between promoting market competition and ensuring patient safety. This judgment clarifies the conditions under which biosimilar drugs can be marketed in India, especially when the patent for the original drug has expired. The bench was composed of Justices R. Banumathi, A.S. Bopanna, and Hrishikesh Roy, with Justice Roy authoring the judgment.

Case Background

M/s Genentech Inc. (appellant no. 1), along with Roche Products (India) Pvt. Ltd. (appellant no. 2) and F. Hoffmann-La Roche, AG (appellant no. 3), filed a suit before the High Court of Delhi against M/s Reliance Life Sciences Pvt. Ltd. (respondent no. 3). Genentech Inc. claimed to be the innovator of the monoclonal antibody drug ‘Trastuzumab’, marketed under the brand names HERCEPTIN, HERCLON, and BICELTIS. This drug is globally approved for cancer treatment. The appellants sought to restrain Reliance from launching, marketing, or selling their biosimilar version of ‘Trastuzumab’, named ‘TrastuRel’. They also challenged the approval granted by the Drug Controller General of India (DCGI) to Reliance for manufacturing and marketing ‘TrastuRel’.

The appellants’ patent for ‘Trastuzumab’ had lapsed on 3.5.2013. However, they sought to prevent Reliance from representing their product as a biosimilar to ‘Trastuzumab’. The appellants argued that Reliance had not conducted the necessary trials and generated sufficient data to establish the safety, efficacy, and immunogenicity of ‘TrastuRel’ as per the Drugs and Cosmetics Act, 1940, and other applicable guidelines. Reliance contended that since the patent had lapsed, they could rely on the appellants’ Phase I and II trial data available in the public domain.

Prior to this, the appellants had filed a similar suit against F. Hoffmann-La Roche, AG, and Mylan Inc. concerning their biosimilar versions of ‘Trastuzumab’. The High Court had allowed Biocon and Mylan to market their products under the condition that they would not claim biosimilarity with the appellants’ products. In the Reliance suit, the Single Judge initially found the DCGI’s approval for Reliance’s biosimilar drug more problematic than in the case of Biocon. Consequently, an interim order was passed on 2.11.2015, restraining Reliance from launching and selling ‘TrastuRel’. However, this was later modified on 25.04.2016, allowing Reliance to market their product with certain restrictions.

Timeline:

Course of Proceedings

The High Court of Delhi initially passed orders in the suits filed against Biocon and Mylan, permitting them to market their biosimilar drugs under specific conditions. However, in the Reliance suit, the Single Judge initially restrained Reliance from launching ‘TrastuRel’. Later, the Single Judge modified this order on 25.04.2016, allowing Reliance to market their drug but with certain conditions to safeguard public health and protect the innovator of ‘Trastuzumab’. These conditions included not calling their product “biosimilar,” not using the INN name ‘Trastuzumab’ prominently, and not using the appellants’ data. The Single Judge also stated that if Reliance wanted to claim biosimilarity, they would need to re-apply for a license.

Aggrieved by these restrictions, Reliance approached the Division Bench of the High Court. The Division Bench, in its order dated 18.09.2019, allowed Reliance’s application and granted interim stay of the Single Judge’s order. The Division Bench observed that the regulatory authorities had approved Reliance’s biosimilar drug and that the approval could not be considered illegal. It also noted that the patent for the original drug had expired. The Division Bench allowed Reliance to market their product on the same terms as Biocon and Mylan. This order was then challenged before the Supreme Court.

Legal Framework

The case primarily revolves around the interpretation and application of the Drugs and Cosmetics Act, 1940 (referred to as “the Act”) and the guidelines issued by the regulatory authorities for the approval of biosimilar drugs. The appellants argued that Reliance had not adhered to the required testing protocols and guidelines, particularly the 2012 Guidelines, for biosimilar drug approval. The core issue was whether Reliance could market their drug ‘TrastuRel’ as a biosimilar to ‘Trastuzumab’ without conducting the necessary trials and obtaining proper approvals.

The appellants contended that Reliance had not conducted Phase I and II clinical trials, which are mandatory for biosimilar drug approval. They also alleged that Reliance had misappropriated and reproduced the appellants’ data in their test dossiers and marketing materials. The Single Judge had noted these concerns and imposed conditions on Reliance’s marketing activities to protect public health and safety. The Division Bench, however, did not consider the concerns raised by the Single Judge.

Arguments

Appellants’ Submissions:

• The Division Bench failed to comply with the Supreme Court’s order to hear the appeals and interim applications of both parties simultaneously. The Division Bench only considered Reliance’s application on merit.

• The Drug Controller General of India (DCGI) did not consider Reliance’s drug to be at par with Biocon and Mylan’s products. The Division Bench ignored this vital fact when granting parity to Reliance.

• Reliance has been participating in government tenders with their drug ‘TrastuRel’. The conditions imposed by the Single Judge should not have been interdicted without a final decision in the Reliance suit.

• Reliance is not entitled to use the International Non-Proprietary Name (INN) ‘Trastuzumab’ because their drug was approved without undergoing required testing under the Act, Rules, and 2012 Guidelines.

• Reliance did not conduct Phase-I and II of the mandatory three-phase sequential clinical trials and misappropriated the appellants’ data in their test dossiers and marketing material.

• The direction to Reliance to add a qualifier to the word ‘Trastuzumab’ was to avoid jeopardizing patient health and distinguish Reliance’s drug from the innovator’s drug.

Respondents’ Submissions:

• The Division Bench considered all arguments from the appellants and complied with the Supreme Court’s order.

• The appellants’ patent on ‘Trastuzumab’ lapsed in 2013. The conditions imposed by the Single Judge should not continue to the prejudice of Reliance.

• Reliance faced difficulties in participating in tenders where the product is described by its generic name ‘Trastuzumab’. They are unfairly restricted compared to other Indian manufacturers like Biocon and Mylan.

• The condition imposed by the Single Judge on packaging/labeling is contrary to Rule 96 of the Drugs and Cosmetic Rules, 1945.

• The suit was filed by the appellants just when Reliance was ready to launch their product after obtaining all approvals, including manufacturing and marketing authorization.

• The package insert and carton package were duly approved by the Subject Expert Committee, but the Single Judge’s interim order forced Reliance to revise their packaging, qualifying the INN name ‘Trastuzumab’ with the company’s name.

Issues Framed by the Supreme Court

The Supreme Court did not explicitly frame issues in a separate section. However, the core issues that the court addressed can be summarized as follows:

1. Whether the Division Bench of the High Court had correctly interpreted and applied the Supreme Court’s order dated 8.3.2019, which required simultaneous consideration of the appeals and interim applications of both parties.
2. Whether the Division Bench was correct in granting parity to Reliance with Biocon and Mylan, despite the DCGI not considering them to be on the same footing.
3. Whether the conditions imposed by the Single Judge on Reliance’s marketing of ‘TrastuRel’ were appropriate, given the concerns about the approval process and potential public health risks.

Treatment of the Issue by the Court

The following table demonstrates as to how the Court decided the issues:

Authorities

The judgment does not explicitly cite any cases or books. However, it refers to the following legal provisions and guidelines:

• The Drugs and Cosmetics Act, 1940: The court considered the provisions of this Act in the context of the approval process for biosimilar drugs.
• The Drugs and Cosmetic Rules, 1945: The court noted Rule 96 of these rules in relation to the packaging and labeling requirements for drugs.
• 2012 Guidelines: The court discussed the 2012 guidelines for biosimilar drug approval and whether Reliance had adhered to them.

Judgment

How each submission made by the Parties was treated by the Court?

How each authority was viewed by the Court?

The Court considered the following authorities:

• The Drugs and Cosmetics Act, 1940: The Court emphasized the importance of adhering to the provisions of this Act for drug approvals, particularly for biosimilars.
• The Drugs and Cosmetic Rules, 1945: The Court noted the relevance of Rule 96, but did not find that it justified disturbing the existing interim arrangement.
• 2012 Guidelines: The Court highlighted the importance of these guidelines for biosimilar drug approval, noting the Single Judge’s concern about non-adherence.

What weighed in the mind of the Court?

The Supreme Court’s decision was primarily influenced by the following factors:

• Procedural Compliance: The Division Bench’s failure to simultaneously consider the applications of both parties as directed by the Supreme Court was a significant factor. The court emphasized the importance of adhering to procedural fairness and the specific directions of the higher court. The court noted that the Division Bench had only considered the application of respondent no.3 and had not considered the application of the appellants.

• Public Health and Safety: The court was concerned about the potential risks to public health if biosimilar drugs were allowed to be marketed without proper testing and adherence to guidelines. The court noted the concerns raised by the Single Judge about the approval process for ‘TrastuRel’ and the potential for public health risks. The court also emphasized the need to protect the health and safety of the patients.

• Balance of Convenience: The court noted that the interim order passed by the Single Judge had been in operation for three and a half years without causing significant hindrance to Reliance. The court found that the Division Bench had disturbed the prevailing situation without considering the balance of convenience. The court also noted that the Reliance was participating in government tenders with the drug.

• Data Misappropriation: The court took note of the Single Judge’s observation that Reliance had allegedly misappropriated data from the appellants, which was a significant point of concern.

The court’s reasoning was a blend of factual analysis (procedural lapses, existing market conditions) and legal considerations (adherence to guidelines, public health concerns). The legal aspects, particularly the need for procedural compliance and adherence to the Drugs and Cosmetics Act, 1940, and the 2012 Guidelines, weighed more heavily in the decision.

Logical Reasoning

The court considered alternative interpretations but rejected them because they did not align with the need for procedural compliance, public health safety, and the specific facts of the case. The court emphasized that the interim order of the Single Judge was appropriate given the concerns about the approval process and the potential for harm.

The court’s decision was to set aside the Division Bench’s order and restore the interim direction given by the Single Judge on 25.4.2016. This means that Reliance was once again restricted from marketing their product as a biosimilar to ‘Trastuzumab’ and had to adhere to the conditions imposed by the Single Judge.

The court’s reasoning was based on the following points:

• The Division Bench failed to comply with the Supreme Court’s order to hear both parties’ applications simultaneously.
• The Division Bench did not adequately address the concerns raised by the Single Judge regarding the approval process for ‘TrastuRel’.
• The interim order of the Single Judge had been in operation for three and a half years without causing significant hindrance to Reliance.
• The court was concerned about the potential risks to public health if biosimilar drugs were allowed to be marketed without proper testing and adherence to guidelines.

The court quoted the following from the judgment:

• “When the impugned order of the Division Bench is read in the context of the express direction of this Court, it is clearly discernible that the Division Bench had only considered the appeal and application filed by Reliance on merit… without entertaining the appellants’ application.”
• “In the interim order passed by the learned Single Judge on 25.4.2016, the conditions imposed on Reliance’s product by the DCGI were taken into account. The said interim order was operating without causing much hindrance and respondent No. 3 was successful in participation in government tenders and supplies, with their drug.”
• “Because of the foregoing, and more particularly because the Division Bench did not keep in view the order of this Court dated 8.3.2019 to ensure analogous consideration of the interim applications of both sides in terms of this Court’s earlier direction and having regard to the fact that the position prevailing since last three and a half years… have been upset without considering the issue of balance of convenience, we are persuaded to hold that the Division Bench was in error.”

Key Takeaways

• Procedural Compliance: High Courts must strictly adhere to the directions of the Supreme Court, especially regarding the simultaneous consideration of applications from all parties involved in a dispute.

• Biosimilar Drug Approval: The judgment underscores the importance of adhering to the Drugs and Cosmetics Act, 1940, and the 2012 Guidelines for the approval of biosimilar drugs. Manufacturers must conduct all required tests and trials before marketing their products.

• Public Health and Safety: Regulatory authorities and courts must prioritize public health and safety when dealing with pharmaceutical products. Any deviation from established procedures must be thoroughly scrutinized.

• Interim Orders: Interim orders passed by lower courts should not be disturbed without a thorough consideration of the balance of convenience and the specific facts of the case.

• Data Usage: Pharmaceutical companies cannot use data from innovator drugs without proper authorization and should not misrepresent their products as biosimilars without proper testing and approval.

This judgment could have a significant impact on the pharmaceutical industry, particularly in the area of biosimilar drug development and marketing. It reinforces the need for strict adherence to regulatory guidelines and emphasizes the importance of protecting public health. The judgment also highlights the Supreme Court’s commitment to ensuring that lower courts follow its directions and that interim orders are not disturbed without proper justification.

Directions

The Supreme Court gave the following directions:

• The impugned order of the Division Bench was set aside.
• The interim direction given by the Single Judge on 25.4.2016 was made operational.
• The High Court was requested to dispose of the CS (OS) No. 3284/2015 expeditiously, preferably within 12 months of receipt of the order.
• To avoid prejudice to respondent No. 3, whenever government procurement is proposed for the drug by its generic name ‘Trastuzumab’, the Reliance should be allowed to participate with their biosimilar product, without any impediment.

Specific Amendments Analysis

There is no specific amendment analysis in this judgment.

Development of Law

The ratio decidendi of this case is that High Courts must strictly adhere to the directions of the Supreme Court, especially regarding the simultaneous consideration of applications from all parties involved in a dispute. This case also reinforces the importance of adhering to the Drugs and Cosmetics Act, 1940, and the 2012 Guidelines for the approval of biosimilar drugs, emphasizing the need for proper testing and adherence to regulatory guidelines. Furthermore, the court clarified that the suit was not about patent enforcement but about extended passing off and data misuse. There is no change in the previous position of law but it reinforces the existing position.

Conclusion

In the case of M/s Genentech Inc. & Ors. vs. Drug Controller General of India & Ors., the Supreme Court of India set aside the Division Bench’s order and restored the interim order of the Single Judge, which had imposed restrictions on Reliance’s marketing of their biosimilar drug ‘TrastuRel’. The Supreme Court emphasized the need for procedural compliance, public health safety, and proper adherence to regulatory guidelines. The court also clarified that the suit was not about patent enforcement but about extended passing off and data misuse. The case underscores the importance of ensuring that biosimilar drugs are marketed only after proper testing and approval, and that lower courts must follow the directions of the Supreme Court.