[A big thanks to Praharsh for his inputs on the post.]
In early July, I wrote (here) about the grant of an interim injunction to Roche by a single-judge bench (SB) of the Delhi High Court (DHC), presided over by Justice Sanjeev Narula in F-Hoffmann-La Roche AG & Anr. v. Zydus Lifesciences Limited (pdf) [hereinafter referred to as “SB Order 1”]. This dispute, primarily a suit for a permanent injunction (CS(COMM) 159/2024) regarding infringement of the Pertuzumab patent, was intriguing because the DHC misgauged the need for such an injunction by focusing solely on Zydus’s conduct without first making a prima facie finding on the existence of a triable issue regarding the infringement, which is required for quia timet injunctions. Fast forward to October, and the drama surrounding this dispute over Pertuzumab took another turn. On 9 October 2024, a Single Bench (SB) of the DHC, led by Justice Saurabh Banerjee, issued an order (pdf) [hereinafter referred to as “SB Order 2”] and a judgment (pdf). All this only for things to take an unexpected twist a week later.
On 16 October 2024 a Division Bench (DB), consisting of Justices Yashwant Varma and Ravinder Dudeja, stayed (pdf) the SB’s Judgement rejecting the injunction under SB Order 1 and reinstating the injunction. This post dives into these updates in light of their implications for the ongoing saga of the Pertuzumab dispute.
A Look at the Pertuzumab Dispute’s History
The plaintiffs, Roche, secured a temporary injunction on 9 July 2024, which restrained the defendants, Zydus, from marketing or selling their product Sigrima (patents numbered IN 268632 and IN 464646—a biosimilar to Roche’s Perjeta, or pertuzumab) until the next hearing date.
On the next date, an SB of the DHC dismissed Roche’s application seeking an interim injunction against Zydus’s breast cancer drug Sigrima (“SB judgement”) due to a lack of claim mapping conducted by Roche. Interestingly, then an order was issued on the same date (SB Order 2) to extend the 9 July interim injunction (SB Order 1) for an additional two weeks with the intent to grant Roche more time to file an appeal against the judgement. Eventually, on 16 October, the SB Judgement was then stayed by the DB of the DHC.
What did the SB Judgement Say?
The heart of the SB judgement is that claim mapping is required to obtain an interim injunction. Roche alleged that Zydus had infringed two of its patents for the HER2-positive breast cancer drug Perjeta. In dismissing Roche’s application, the Court held that Roche had not established that Zydus’s product was likely to or was actually infringing its patents. The injunction was denied because the plaintiff did not perform any claim mapping and relied solely on having a patent.
A major takeaway from the SB judgement (para 29) is: “Granting an injunction merely on the basis of a registered patent, without putting it to the test of ‘claim mapping’ or similar processes, cannot be the intention of the legislature.“
To briefly comment on claim mapping as an essential aspect of obtaining an injunction, the SB in its judgement clarifies that it involves comparing the features, types, components, compositions, and functions of the claims to a similar product. This process helps determine whether the two products are similar and the degree of that similarity. It is distinct from “claim construction,” which focuses on interpreting the meaning and scope of a patentee’s claims.
But Why an Order Too?
Here, Justice Banerjee has vacated Justice Narula’s 9 July order, noting that no prima facie case was made out. Interestingly, despite this observation and a clear rejection of the interim injunction for Roche, Justice Banerjee later issued an order suspending the judgment for two weeks to allow F-Hoffmann to file an appeal. The rationale provided by the SB was that since an injunction had been granted for about three months, it was fair to allow an additional two weeks for Roche to take appropriate action to appeal. But is this a fair ground to grant an injunction? Firstly, parties already have a statutory period within which they can file an appeal (90 days from the date of the judgment or order as per Section 14 of the Code of Civil Procedure 1908). This right to appeal doesn’t depend on the court granting an extension of the injunction; they can appeal even if the injunction is no longer in effect. So, what is the rationale behind reviving and extending the injunction in such cases? Secondly, the SB hasn’t seen the factors usually analysed for granting/extending an injunction. Were the factors affording a grant of an injunction previously still relevant and applicable now to allow for an extension? Doesn’t seem like it, since the reasoning of the Court here is only to allow more time for filing an appeal and not because of irreparable harm, etc. but purely superficial reasoning. Moreover, given that the grant of the very initial quia timet injunction by J. Narula itself is a matter of scrutiny, extending the same can’t possibly be on appropriate grounds either.
The net effect of these orders was that Justice Narula had wrongly injuncted Zydus in the 9 July order, and the 9 October order restored the situation after three months. Zydus had frozen its market activities at this point, and the injunction remained in effect for another two weeks due to this order. Interestingly, all of this occurred without any clear case for an injunction, as indicated by the SB judgement.
And Then The DB Steps In
During this extended two-week period for seeking relief, the DB heard Roche’s appeal against the SB’s judgement. The DB noted that the SB in its judgement had explicitly mentioned it would not evaluate the validity of the SB Order 1, yet when it framed its final decision, it ended up doing exactly that. The DB ultimately held that the vacation of SB Order 1 was “wholly unsustainable” (para 4). However, the DB itself did not take into account or comment upon the aspect of ‘lack of claim mapping’ observed by the SB at all.
It seems the questionable two-week extension of the injunction in SB Order 2 served its intended purpose, as Roche’s appeal has now been allowed and the SB’s decision stayed. So the injunction is back in place. Interestingly, however, I found that Sigrima was available for purchase on almost all major online pharmacy platforms (like here, here, here, and here—priced at an average of 67,000 for a 420 mg dosage, as checked last on 24 October 2024).
Moreover, the DB observed that its order shall “not be construed as an expression of opinion on the merits of the injunction that had been granted or the prayer for its vacation.” This is a more appropriate stance, as reinstating SB Order 1 granting the injunction was itself improper due to the lack of claim mapping. This also raises the question: why wasn’t the issue of lacking claim mapping addressed by Justice Narula from the beginning?
While the SB’s judgement seemed more appropriate in setting aside an improperly granted injunction, the DB has now stayed the order, bringing the dispute back to square one. Additionally, although the SB commented that it would not determine the merits of SB Order 1 order, if it did assess them, why vacate the decision? Now, the merits of SB order 1 will have to be reanalysed by the DB to determine whether they were correct or not—and the answer is likely to be negative due to the lack of claim mapping, as already noted by the SB, unless Roche presents other extenuating circumstances.
Another interesting aspect is that this isn’t the first time the lack of claim mapping has been highlighted in an injunction sought by Roche. Previously, in a 23 February 2024 order by the SB, composed of Justice Narula, an injunction request was denied due to inadequate claim mapping. Following this, Rochemapped the claims in their rejoinder on 04 April 2024. It’s rather amusing that the plaintiff repeated this in the current application by failing to map the claims again, perhaps rooting their application solely on Zydus’ alleged semi-exclusive license with Dr. Reddy’s (see para. 3.3). It seems the Pertuzumab saga still has several chapters yet to unfold before it reaches its conclusion.