“MERE REGISTRATION OF A PATENT DOESN’T ENTITLE PATENT INFRINGEMENT:
IMPORTANCE OF “CLAIM MAPPING” IN A SUIT
CS(COMM) 159/2024 DEL HC
”
The Hon’ble Delhi High Court on October 9, 2024, explicated the importance of “claim mapping” in a suit for permanent injunction of patents infringement filed by the plantiff i.e. F- HOFFMANN -LA ROCHE AG & ANR. against the defendant i.e. ZYDUS LIFESCIENCES LIMITED. The plaintiffs, F. Hoffmann-La Roche AG and Genentech Inc., claimed that Zydus Lifesciences product “Sigrima” infringed their patents, covering both the composition and the formulation of “Pertuzumab”. The plaintiffs sought an interim injunction to stop Zydus from manufacturing or selling the drug in India. The court observed that while Hoffmann-La Roche had valid patents (IN 464646 and IN 268632) relating to the Pertuzumab drug, they failed to demonstrate how Zydus’ biosimilar drug “Sigrima” violated those patents. The defendant’s Zydus Lifesciences, argued that Hoffmann-La Roche failed to present adequate evidence of infringement and lacked proper claim mapping to show the overlap between the patented claims and the biosimilar product. Moreover, there wasn’t any denial anywhere from Zydus Lifesciences regarding the launch of their impugned product ‘Sigrima’.
The court quoted when a party like the plaintiffs herein approaches a Court of law in a suit for infringement of patent which is accompanied by an application wherein also the said party like the plaintiffs herein is seeking an ad interim injunction, there is a fourth limb as well i.e. ‘claim mapping’ or like whereby it is necessary for such a party to establish and cross the hurdle of showing that the impugned product like ‘Sigrima’ of the defendant in the present case is likely to and/or is actually infringing their suit patents. To establish the above, the only mechanism available to a party like the plaintiffs, was/is to establish their case of ‘claim construction’ as well as ‘claim mapping’. Since defining scope of the patents involved is very necessary because broad interpretation of the patents might cover more subject matter, increasing the chance of infringement. Thus, narrow interpretation restricts the scope of patent. Therefore, both ‘claim construction’ and ‘claim mapping’ form the very fulcrum of a patentee like the plaintiffs herein for alleging that the claim/s made by it in its patent is/are indeed being infringed by a rank outsider like the defendant herein without having any authority to do so.
The court elucidated that mere registration of a patent in favour of a patentee is not itself sufficient for seeking the grant of an ad interim injunction in an application of the present nature in a suit for infringement of a patent. After all, an ad interim injunction with respect to the suit on the mere basis of preponderance of probabilities hypothetically without any basis cannot be granted. Doing so will mean that any patentee who is holding a valid subsisting registration of a/any patent shall be automatically entitled to an ad interim injunction whence it/they approach a/any Court of law. Meaning thereby, such a patentee would be entitled to an ad interim injunction axiomatically as what will be registered, in that case merely a stamp/seal (of confirmation) from a/any Court of law.
The court concluded granting an injunction merely on the basis of a registered patent to a/any/every patentee like the plaintiffs without putting it to the test of ‘claim mapping’ or like, cannot be the intention of the legislature. In such circumstances, allowing the present application of the plaintiffs would amount to an ad-interim injunction to them simply because they have two suit patents subsisting in their names. The same shall render the purpose of the existence of the provisions of the Patent Act, 1970 otiose. More so, since in terms of Section 3 of the Patents Act, 1970, there are more than one factor/s which governs grant of a patent. In the considered opinion of this Court, it is too bold for it to grant an order of ad interim injunction on the basis of probabilities. Lastly, the grant of relief of an-injunction is of a discretionary nature, for grant of which the party like the plaintiffs herein have to satisfy a Court of law by setting out that it has a prima-facie case in their favour with the balance of convenience also in their favour and that they are likely to suffer irreparable loss and injury as well as ‘claim mapping’ or like in a suit of patent infringement of the present nature, in terms of the aforesaid.
The single bench of the Hon’ble Delhi High Court vacated the injunction restraining Zydus from selling or marketing its product ‘Sigrima’ vide its order dated October 9, 2024. However, the court had extended the injunction for an additional two weeks, until October 23, 2024, to allow Hoffmann-La Roche to file an appeal. Zydus subsequently challenged this extension of injunction before the Division Bench of the Hon’ble Delhi High Court, which, after hearing the matter, accepted Zydus’s plea and permitted the sale and marketing of “Sigrima” as on 15 October 2024. On 16 October 2024, the Division Bench of the Hon’ble Delhi High Court, upon hearing the appeal of Hoffmann-La Roche ( FAO(OS) (COMM) 236/2024, CM APPL. 60690/2024, CM APPL. 60691/2024, CM APPL. 60694/2024 ), reinstated the injunction in favor of Hoffmann-La Roche, which once again restrains Zydus from manufacturing, selling, or marketing Sigrima.
As the current state of affairs, the Division Bench of Delhi High Court, on October 16, 2024, reinstated the injunction preventing Zydus Lifesciences from manufacturing, selling, or marketing its breast cancer drug Sigrima, a biosimilar of Hoffmann-La Roche’s Pertuzumab (Perjeta). The decision, made in response to Hoffmann-La Roche’s appeal on October 16, 2024, reversed an earlier order from October 9, 2024. This now reinstates the legal position previously pronounced by the Delhi High Court in its order dated July 9, 2024 where it had originally barred Zydus from launching Sigrima due to ongoing patent infringement litigation initiated by Hoffmann-La Roche.
The concerned subject matter is related to Injunction and the Interpretation of Law, Senior Advocate appearing for Zydus on hearing before Single-Judge of Hon’ble Delhi High Court on November 5, 2024, notified that they have filed a Special Leave Petition (SLP) before the Hon’ble Supreme Court against the Reinstatement of the interim Injunction.
Any subsequent developments in the concerned subject matter shall be notified by a separate newsletter.
Name: Siddharth Khuttan
Designation: Patent Analyst
Date: November 29, 2024
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