The Indian pharmaceutical landscape has seen the emergence of biosimilars like Bevacizumab and Trastuzumab (used as first-line treatment of advanced HER2-positive gastric cancer) commanding a market worth around 640 crores. In this (delayed yet relevant) post, we will discuss the bizarre ongoing Trastuzumab and Bevacizumab litigation before the DHC, focussing on the September 11, 2023 joint judgement passed in two connected cases (Roche versus DCGI, and versus Cadila, respectively). It is bizarre because Roche is exerting rights with respect to biosimilars approved by the DCGI that skipped essential trials, risking patient safety, while also using extended passing off to challenge the approvals.
First, the brief facts:
Cadila had received approval for “ Vivitra” a biosimilar version of Trastuzumab, and Hetero for “Cizumab”, a biosimilar of Bevacizumab. The list of approved r-DNA-based drugs in the country by the DCGI (pdf) includes the two drugs in dispute (though neither trade name is mentioned in the approval sheet).
Roche claimed that irregularities had taken place in the approval process for these two drugs. Roche also argued that these unauthorised biosimilars amounted to extended passing off since the authorised biosimilar versions were deficient in comparison to their biologics counterparts. Cadila and Hetero tried to dismiss this suit by filing an application, arguing that no rights of Roche have been violated by the approval. They also argued that Roche did not exploit the alternate remedies available under Rule 122DC of The Drugs and Cosmetics Rules, 1945. The Court did not find Cadila and Hetero’s arguments persuasive, stating there was a valid cause of action, and dismissed Cadila and Hetero’s application for dismissing the suit.
While seemingly procedural, this does open out a number of important issues. For example, one immediate concern is that if Roche’s arguments have a basis in fact, then regardless of their standing in the current suit, it may mean that patients are receiving unregulated or badly regulated drugs instead of the original, potentially life-saving medications, raising serious safety and efficacy concerns for unwary patients. At the same time, there’s the consideration that once approval has been granted to a biosimilar version, allowing the challenging of the same on the basis of seemingly unconnected claims, can contribute to these drugs, often in thousands of dollars, remaining unaffordable. And of course, there remains the confounding situation: how can an extended passing-off action by claiming misrepresentation of goods be justified when the government regulatory body has already granted approval for the product to make the claim in question? It is also very relevant to keep in mind that Roche’s patent on Trastuzumab expired in 2013, leading to concerns from some quarters (read more about it here, here, here, here, here and here) that it is attempting to stifle competition through other means.
Arguments and Allegations
In its suit, Roche’s claims that Cadila and Hetero authorization was invalid rested upon 3 points:
(a) failure to conduct mandatory human trials before granting approval for manufacturing and distribution;
(b) irregularities in pre-clinical trials; and
(c) skipping certain phases of clinical trials.
Roche also sought a permanent injunction against Cadila and Hetero, preventing them from claiming their versions as biosimilar to Roche’s drugs Trastuzumab and Bevacizumab.
Cadila and Hetero, in response, defended their position by claiming bio-similarity with Roche’s drugs but did not respond on the specific substantive issues as much as they relied on the authorization granted by the Regulator.
Unfortunately, from the CDSCO’s website, there is no information available as to which individual steps have been verified or approved in giving of the authorisation.
Availability of Alternate Remedy
As mentioned above, the defendants also argued in their application that Roche did not exploit the ‘alternate remedy’ available to them. Cadila argued that the suit was barred due to the availability of an alternative remedy under Rule 122DC of the Drugs Rules, which provided for an appeal to the Central Government against DCGI’s approval. While the Court noted that the alternative remedy mentioned was only available to “any persons aggrieved” (a phrase that refers specifically to parties directly affected by a refusal to grant or renew a license, and not those indirectly affected by the approval of licenses, such as the plaintiffs) and that Roche would not be an aggrieved person here, it regardless said that the availability of an alternate remedy is not a conclusive factor for rejection. The Court commented that innovator drug manufacturers, like the plaintiffs in this case regarding the drug ‘Trastuzumab’, were justified in pursuing a civil suit to protect their rights, as Rule 122DC did not offer them an effective remedy. (see paras 53-54)
The Prior Litigation
Another thing to keep in mind is the set of prior litigations that Roche has been entangled in. It has a history of various legal battles with companies including Reliance Life Sciences (discussed here), Biocon, and Mylan (discussed here) in connection with its innovative drugs in the past. In the Indian market, Roche markets Herceptin as ‘Herclon’, while Reliance Life Sciences’ ‘TrastuRel’ and Zydus Cadila’s ‘Vivitra’ are approved biosimilars. However, the DCGI’s approval of these biosimilars has been controversial and has been criticized for relying on clinical data from the original drugs. The core issue in these disputes is the alleged non-compliance with the stringent requirements of the Drugs and Cosmetics Rules, 1945, and the 2012 Biosimilar Guidelines. In the case against Biocon and Mylan, Roche contended that they bypassed the 2012 guidelines’ approval process, posing a risk to patient wellbeing, as their approval took a mere eight days. Despite these concerns, Biocon and Mylan prevailed in the legal proceedings.
The Implication
Coming back to Roche’s case. It raised two primary issues: first, concerns with the Drugs Controller General’s Office, and second, the application of extended passing off. But it’s important to note that just because they had a patent, the use of International Non-proprietary Names (INNs) by the defendants becomes misleading and constitutes extended passing off. The Court took a narrow view on this issue, focusing mainly on the principles of Order 7 Rule 11 of the CPC, which assesses whether a plaintiff has asserted a valid right with supporting evidence and whether they are entitled to relief in law.
The Court’s judgement, while addressing the alternative remedy issue, did not delve deep into the acceptance or rejection of the extended passing-off claim. They considered the defendants’ actions as classic textbook cases of extended passing off, viewing them as potentially diluting Roche’s reputation and giving the defendants an unfair advantage. The Court highlighted public safety concerns, emphasizing the need for adequate testing and assessment of biosimilar drugs’ safety, efficacy, quality, and composition. Using INNs without proper testing was deemed legally impermissible and could lead to public confusion.
Here, the Court’s approach is rather myopic. The Courtonly superfluously checked the law and the cause of action. While it checked whether an alternative remedy applies or not, there was no other discussion on accepting extended passing off and proper order by the controller. Such a precedent sets a poor guideline for the Court to abide by in future cases of extended passing off, and greater caution should have been employed.
Won’t a Public Interest Litigation Be the Right Way to Address Roche’s Concerns?
Furthermore, the issue of public safety, raised in the context of extended passing off, might be better suited for a Public Interest Litigation (PIL) rather than Roche’s civil suit in this case. If the law lacks clarity, an overarching review of the law itself is a more rational approach rather than private litigation (a civil suit in the extant case). The need to shed light on the challenge of balancing intellectual property rights with the need for affordable healthcare through generic versions, calls for clearer guidelines or legislative updates to address these conflicts more effectively, and the filing of a PIL could have achieved that. Notably, in the judgment, the Court also commented that: “The Rule (122DC) also does not protect or enforce the rights of an innovator and the procedure of granting approvals to manufacturers of biosimilar drugs does not involve a lis between the manufacturers of the innovator drug and the manufacturers of the biosimilar drugs and neither does DCGI determine such rights of the parties. In any event, existence of an alternative remedy never bars a Civil Court’s jurisdiction and this test is applicable only to writ petitions, where Courts exercise discretionary jurisdiction.” There lie questions about whether Roche attempted to deliberately avoid this path regardless of the potential larger implications beyond their specific case.
Furthermore, another concern is that this case, even after six years of deliberation, lies pending, and who knows for how many more years? It is being looked at very expectantly by the pharmaceutical and IP community as it will set a precedent for handling similar cases involving biosimilar drugs. However, if the parties settle privately, it will leave the larger question unanswered for others. A PIL would have ensured that such concerns never arose.
Clearly, there is a pressing need to create a mechanism that ensures if a precedent is set, it doesn’t allow any patent holder to continually use the concept of extended passing off to safeguard their inventions through litigation. This underscores the need for a broader discussion on this issue to provide clarity and avoid misuse of legal avenues in the future.
Three other orders have come after the one in September 2024: 11 December 2023 (pdf), 22 February 2024 (pdf), and 4 March 2024 (pdf). An interesting point to highlight is in the third order, wherein the plaintiff filed an application asking for the disclosure of some documents by the defendant, and J. Dayal gave directions with respect to this. Previously, one of our anonymous readers informed us that Roche (who would almost definitely cite its regulatory filings as a trade secret) is making a demand for disclosure of Cadila and Hetero’s regulatory submission for approval of their biosimilar. I am not sure if this application is the same one asking Cadilla and Hetero to disclose their regulation submissions. But considering the Court has expressed its willingness to form a confidentiality club in the future, it may suggest that it is indeed the application seeking disclosure of the above information, which many companies would deem to be a trade secret or confidential. Keeping in mind this development, it seems like the case is far from being over. The next date of hearing is scheduled for July 26, 2024.
[H/T to Prashant Reddy T. for news of this development, and to Swaraj and Praharsh for helping frame some points herein.]