Court Has To Err In Favour Of Public Interest Where Product In Question Is Life-Saving Drug: Delhi High Court In Plea Of Zydus Lifesciences
The Delhi High Court said that the mere fact that the injuncted product is a life-saving drug is no absolute armour against injunction.
Justice C. Hari Shankar, Justice Om Prakash Shukla, Delhi High Court
The Delhi High Court has emphasized that where the product in question is a life-saving drug, the Court has to err in favour of public interest.
The Court emphasized thus in an Appeal filed by Zydus Lifesciences Limited against E.R. Squibb and Sons LLC.
A Division Bench comprising Justice C. Hari Shankar and Justice Om Prakash Shukla observed, “Where the issue is triable, or involves complicated technical issues which would appropriately need a trial, then, in our opinion, where the product in question is a life-saving drug, the Court has to err in favour of public interest, and ensure securing of the plaintiff’s interest by alternate methods, short of making the drug unavailable to the public during the entire period for which the suit would remain pending. Withholding such therapy from the public can cause untold and irreparable prejudice to lakhs of lives, and it is, therefore, only where the Court is in possession of irrefutable material to indicate that a patented product is being released in the market without permission of the patentee, in breach of Section 48, that an injunction can issue.”
The Bench said that the mere fact that the injuncted product is a life-saving drug is no absolute armour against injunction.
Senior Advocates Abhishek Manu Singhvi and Dayan Krishnan represented the Appellant, while Senior Advocate Sandeep Sethi represented the Respondents.
Brief Facts
The rival products in this case were proteins. Proteins consist of amino acid sequences. The Respondent was the holder of Indian Patent No. IN 3400606, titled “Human Monoclonal Antibodies to Programmed Death 1 (PD-1) for use in treating Cancer”. The claims in the suit patent consisted of two main features: firstly, the fact that it “binds specifically to PD-1” and, secondly, that it consists of the specified amino acid sequences. By the impugned Order, the Court restrained the Appellant from manufacturing or releasing, in the market, its product ZRC 3276, which is an anti-cancer drug and is essential for treatment of a wide variety of life threating carcinomas, on the premise that the product infringes the Respondent’s patent.
According to the Appellant, treatment, using the Appellant’s product, would be 70% cheaper than treatment using the Respondent’s patented drug 5C4. The Single held that even in the absence of product-to-claim mapping, the fact that the Appellant’s product is in fact the product claimed in the suit patent stands prima facie established through other material. It was further held that the word ‘specifically’ does not mean ‘exclusively’, and that binding with other proteins of the CD 28 family is not, therefore, a factor which would take the Appellant’s product ZRC 3276 outside the scope of the suit patent. This was under challenge before the Division Bench.
Reasoning
The High Court in the above context of the case, noted, “This appeal throws up issues, for consideration, which are of fundamental importance, not merely as legal principles relating to the patent regime, but also vitally of public interest. … The Supreme Court has, in its decisions in Ramnik Lal Bhutta v. State of Maharashtra and Raunaq International v. I.V.R. Construction Ltd, held that, while considering pleas for injunction or stay, public interest is also a consideration to be borne in mind, apart from the classical troika of a prima facie case, balance of convenience and irreparable loss.”
The Court was of the view that the products which infringe patents of others cannot be permitted to circulate in the market and that the intellectual property rights are entitled to protection.
“This case, however, is peculiar, as there is admittedly no mapping of the appellant’s product ZRC 3276 onto the claims in the respondent’s suit patent at any stage. Injunction has, therefore, been granted without any product-to-claim mapping. … The impugned order seeks to justify this course of action on the ground that the suit is a quia timet action, instituted in anticipation of future infringement and that, therefore, as the appellant’s product is not commercially available, no product-to-claim mapping is possible”, it added.
The Court remarked that the Single Judge appears to have proceeded on the premise that the Respondent had carried out changes in the amino acid sequencing, which does not appear to be correct.
“Indeed, if there were in fact changes in the amino acid sequencing, there would have had to be an “unchanged” amino acid sequence. There is none. … In any case, once the impugned judgment that biosimilar products can be chemically different – in fact, it asserts that they would be chemically different – it is impossible to understand how Section 48(1) of the Patents Act would at all apply, as it employs the expression “that product”, it observed.
The Court said that the fact that the Respondent had obtained registration of the suit patent by pleading novelty, originality, and lack of anticipation vis-à-vis prior art on the ground that there was no statistically significant binding vis-à-vis non-PD-1 proteins, and had set a ‘p’ value of less than 0.05 as demonstrating statistically significant binding, has been totally overlooked by the Single Judge.
“Once, therefore, the litmus test to determine statistical significance had been cited, by the respondent itself, before the Registrar, as a ‘p’ value of less than 0.05, the prima facie inexorable sequitur would be that antibodies with ‘p’ values of 0.05 would not map onto the claims in the suit patent”, it added.
The Court further noted that it would be erroneous to injunct the Appellant from releasing its product in the market without any product-to-claim mapping with the suit patent.
“While product-to-claim mapping may not be a cast-in-iron imperative in every case, in its absence, there must be overwhelming circumstantial material to indicate that the defendant’s product maps onto the suit patent. There must be, in a manner of speaking, a continuous and unbroken chain of circumstances to that effect. There is no room for assumption and presumption”, it enunciated.
The Court also said that the Courts have to be acutely conscious of their duties in such matters and the tightrope is shaky, and walking it is not always an enviable enterprise.
“Our oath of office, however, obligates us to do so and, while doing so, we have to bear in mind our duty to the teeming citizenry of this country who may be in dire need of the therapy, the release of which a plaintiff seeks to injunct”, it emphasised.
Conclusion
Furthermore, the Court remarked that the Courts are to swing to the other extreme, and openly allow circulation, in the market, of drugs which infringe valuable pharmaceutical patents, the incentive to invent would be altogether lost, which might result in ebbing the stream at the source.
“There would be no incentive to expend valuable time, energy and often cripplingly huge financial resources in inventing a new and more efficacious drug, if one is not ensured of patent protection as available in law. … As we said, the tightrope is shaky, and walking it often an ordeal. Perhaps, the Court can hardly ever rest content in the conviction that it has fulfilled its task appropriately, much less adequately”, it clarified.
The Court elucidated that where a clear-cut case of patent infringement, within the meaning of Section 48, is made out, on the basis of product-to-claim mapping, and there is no credible challenge made out to the validity of the asserted suit patent, the Court has to protect the patentee from infringement.
“Where, however, no product-to-claim mapping has been attempted, and the Court is relying on other collateral material, that material, to our mind, has to be so conclusive, even at the prima facie stage, as to indicate that the defendant’s product is that product of which the plaintiff holds the patent, before its dissemination to the public can be restrained”, it concluded.
Accordingly, the High Court allowed the Appeal to an extent and modified the impugned Order by vacating the injunction granted and requiring the Appellant, instead, to file, with the Registry of the Court and an advance copy to the Respondent, audited accounts of the amounts earned by the Appellant by sale of the allegedly infringing product, till the expiry of the suit patent.
Cause Title- Zydus Lifesciences Limited v. E.R. Squibb and Sons, LLC & Ors. (Neutral Citation: 2026:DHC:178-DB)
Appearance:
Appellant: Senior Advocates Abhishek Manu Singhvi, Dayan Krishnan, Advocates Adarsh Ramanujan, Bitika Sharma, Vrinda Pathak, P.S. Manjunathan, Rajnish Kumar, Aakashi Lodha, Shreedhar Kale, Parth Singh, Chanan Parwani, and Rishi Agrawala.
Respondents: Senior Advocate Sandeep Sethi, Advocates Pravin Anand, Archana Shanker, Prachi Agarwal, Devinder Singh Rawat, Elisha Sinha, Manan Mondal, Krisna Gambhir, and Shreya Sethi.
