AstraZeneca AB v Intas Pharmaceuticals Ltd (2021)

Summary

“All these nine appeals, under Section 13(1A) of the Commercial Courts Act, 2015 read with Order XLIII Rule 1(r) of the Code of Civil Procedure, 1908” “impugn the orders/judgments of denial of interim relief, in suits instituted by the appellants/plaintiffs” (para 1), among them “the common order/judgment dated 2nd November, 2020” against Intas and Alkem (para 2), that is AstraZeneca v Intas Pharmaceuticals (2020), and “the common order/judgment dated 18th November, 2020” in seven further suits (para 3). The suits sought to restrain dealing in “the product comprising the compound ‘Dapagliflozin’” which “was the subject matter of Indian Patent No.205147” and “Indian Patent No.235625” (para 6). “Our doubts stemmed from, the appellants/plaintiffs averring and pleading manufacture and sale by the respondent(s)/defendant(s) of DAPA” (“Dapagliflozin”) “to be in infringement of two patents i.e. IN 147 and IN 625.” (para 18)

The Bench held: “In our opinion, with respect to one invention, there can be only one patent.” (para 21) It held that “once the appellants/plaintiffs, in the plaints in their suits claimed the action of the respondent(s)/defendant(s) of manufacturing medicines having DAPA as their ingredient to be an infringement of both IN 147 and IN 625, the appellants/plaintiffs are deemed to have admitted DAPA to be the invention subject matter of both” (para 32), and that “a single formulation as DAPA, is incapable of protection under two separate patents having separate validity period.” (para 46) “Suffice it is to state, that no perversity requiring interference in appellate jurisdiction, within the meaning of Wander Ltd. supra is found in the two orders/judgments.” (para 49) “There is thus no merit in the appeals, which are dismissed, with costs assessed at Rs.5,00,000/- to the respondent(s)/defendant(s) in each of the suits.” (para 52)

What the court decided

1. Procedure. The appellate standard. The Bench was “only exercising appellate powers within the domain of Wander Ltd. Vs. Antox India P. Ltd. 1990 Supp SCC 727, to see whether there is any perversity in the orders/judgments of the Commercial Divisions in denying interim injunction to the appellants/plaintiffs.” (para 10) “We are also of the opinion, that the mere fact that there is a difference in the reasoning in the two impugned orders/judgments, would not entitle the appellants/plaintiffs to interim injunction.” “Though for different reasons, both the impugned orders/judgments find the appellants/plaintiffs to be not entitled to interim relief. Suffice it is to state, that no perversity requiring interference in appellate jurisdiction, within the meaning of Wander Ltd. supra is found in the two orders/judgments.” (paras 10, 49)
2. Procedure. Length of interim judgments. Recording that the Supreme Court in AZ Tech (India) Vs. Intex Technologies (India) Limited “commented on the disturbing trend, of the orders of disposal of applications for interim relief in Intellectual Property Rights matters governing parties for a long time, with exhaustive judgments, virtually on merits of the suit, being written” (para 15), the Bench held: “However if we, in this judgment deal with each of the said judgments, this judgment will fall foul of what has been held in AZ Tech (India) supra and In Re: Case Management of Original Suits supra.” (paras 15, 48)
3. One invention, one patent. “In our opinion, with respect to one invention, there can be only one patent. The appellants/plaintiffs herein however, while claiming one invention only i.e. DAPA” (“Dapagliflozin”) “, are claiming two patents with respect thereto, with infringement of both, by the respondent(s)/defendant(s). The same alone, in our view, strikes at the very root of the claim of the appellants/plaintiffs and disentitles the appellants/plaintiffs from any interim relief.” (para 21) “Rights of a patentee, unlike that of the proprietor of a trade mark, are not natural or common law rights, but are a creation of law i.e. are statutory rights.” (paras 21–22)
4. The field of invention. “As would immediately be obvious from above, there is complete identity, without any difference whatsoever, between the field of invention as set out in the two patents i.e. IN 147 and IN 625.” (para 28) “It cannot be lost sight of, that the inventor of both, IN 147 and IN 625 and/or of US equivalents thereof was/is the same.” “Once the inventor himself, while writing and seeking the patent, has not mentioned so, the subsequent claims of the assignee of the patent, in this regard, at least at the stage of judging prima facie case, cannot be accepted and have to be necessarily put to trial.” (paras 28–29)
5. The person in the know. “The tests of ‘obvious to a person skilled in the art’ and ‘anticipation by publication’ and ‘use before the date of filing of patent application with complete specification’, in the context of an earlier patent and its specifications, in our view, have to be different, when the inventor of both is the same.” “However merely because there are such delays, would not be a reason for the Court to give to the patent a longer life than provided in the statute. The cure therefor is with the Legislature and not with the Courts, by allowing more than one patent with respect to the same invention.” “When the inventor is the same, the tests aforesaid, in our opinion, cannot be in the context of ‘person ordinarily skilled in the art’ but have to be of the ‘person in the know’. The enquiry, in such a situation, has to be guided by, whether the inventor, while writing first patent, knew of the invention claimed in the subsequent patent.” (para 30)
6. The limited life of a patent. “If patents with respect to the same invention can be granted more than once, successively in time, the same will negate the legislative intent of limiting the life of the patent and enable the patentee to prevent others from making, using or offering for sale, the new product invented by the patentee, till the time patentee successively keeps on obtaining patent therefor.” (para 31)
7. Infringement pleaded on both patents. “Without DAPA being disclosed in IN 147, there could be no patent with respect to DAPA in IN 147 and which was being infringed by the respondent(s)/defendant(s) by manufacturing drugs/medicines with DAPA as ingredient.” (para 32) “If IN 147 did not disclose DAPA and specifications thereof did not describe DAPA or the best method of industrially manufacturing DAPA, there could be no infringement of IN 147 from the action of the respondent(s)/defendant(s) making and selling medicines/drugs with DAPA as ingredient thereof.” “At least at this stage the same has to be treated as an admission of DAPA being known while obtaining IN 147.” (paras 32, 39)
8. The specification is self-sufficient. “All these provisions show that the patent once granted, is complete, disclosing to the world at large the product with respect whereto patent is granted and from a mere reading whereof, anyone else, but for the exclusivity granted to the patentee, can manufacture the product for which the patent is granted.” (para 35) “From the aforesaid provisions it follows, that from IN 147 and/or US equivalent thereof, the invention as described therein could be worked by anyone, save for the exclusivity for the term thereof in favour of the appellants/plaintiffs.” (paras 35–36)
9. A group of inventions. “Section 10(5) obviated the need for the appellants/plaintiffs to apply for and obtain separate patents with respect to each of the said 80 compounds specifically disclosed. Section 10(5), in our view also empowers and enables an inventor/patentee to sue for infringement, a person, who merely by making a slight change in the group of inventions relating to a single inventive step subject matter of such a patent, claims his product to be different.” “That, in our view, is the reason for the appellants/plaintiffs, in the suits from which these appeals arise, claiming infringement not only of IN 625 but also of IN 147--the inventive step being subject matter of IN 147 only and which could not in law again be the inventive step of subsequent patent IN 625.” (para 38)
10. No patent at the breakthrough stage. “The provisions afore noticed of the Patents Act, in our view, do not permit a patent to be granted with respect to the important stage in the inventive process and at which stage there is no product capable of industrial application, even if having technical advancement as compared to the existing knowledge.” (para 39) “‘Product’ is understood as something that is made to be sold, usually something that is produced by an industrial process or, less commonly, something that is grown or obtained through farming.” (paras 39, 43)
11. A compound and a composite product. “A telephone instrument, though perceived by the consumer thereof as one product, comprises of several components, each of which is also a product in itself and capable of independent patent. However, DAPA is disclosed to be a single compound and cannot have more than one patent.” (para 40)
12. Disclosure and two terms. “However, as held in the impugned judgment/order dated 2nd November, 2020, the question of the respondent(s)/defendant(s), by working DAPA, infringing IN 147 could arise only if DAPA was disclosed in IN 147. If DAPA was disclosed in IN 147, even if better disclosed in IN 625, cannot enjoy two rounds of 20 years of protection, when the legislative policy is to grant protection for a period of one term of 20 years only.” (para 43) “The appellants/plaintiffs themselves are found to be pleading DAPA to have been disclosed generally in IN 147 and specifically in IN 625. In the face of the said pleading, no case for injuncting the respondent(s)/defendant(s) during the pendency of the suits is made out.” (paras 43–45)
13. Section 3(d). “In our opinion, a single formulation as DAPA, is incapable of protection under two separate patents having separate validity period.” “From the field of the invention subject matter of the two patents being verbatim same, at this stage, it also appears that there is no enhancement of the known efficacy, within the meaning of Section 3(d) of the Act, between the product subject matter of IN 147 and the product subject matter of IN 625.” (para 46)
14. Research in the same field. “To hold, that an inventor, merely on the basis of his work, research, discovery and prior art, but which has not yielded any product capable of commercial exploitation, is entitled, by obtaining patent thereof, to restrain others from researching in the same field, would in our view, not be conducive to research and development and would also be violative of the fundamental duties of the citizens of this country, enshrined in Article 51A of the Constitution of India, to develop the scientific temper and a spirit of inquiry.” (para 47)
15. The US terminal disclaimer. “We are also of the prima facie view, that once the appellants/plaintiffs, before the USPTO” (“US Patent and Trademark Office”) “applied for and agreed to the validity period of US patent equivalent of IN 625 ending on the same day as the validity period of the US patent equivalent to IN 147, the appellants/plaintiffs, in this country are not entitled to claim different periods of validity of the two patents.” (para 50)
16. A suit on one patent only. Of the judgment of 7 July 2021 “titled FMC Corporation Vs. Best Crop Science LLP”, the Bench held: “In taking the view aforesaid, we have considered the said judgment also, in which infringement of one patent only was claimed.” (para 51)
17. Disposition. “There is thus no merit in the appeals, which are dismissed, with costs assessed at Rs.5,00,000/- to the respondent(s)/defendant(s) in each of the suits.” (para 52)

Subsequent treatment

• Appealed — On 19 July 2022 the Supreme Court, in SLP (C) 15650–15658/2021, held: “We are not inclined to interfere with such interim order in the present special leave petition. The trial will proceed uninfluenced by the findings recorded by the High Court.” It directed that “The costs imposed by the High Court shall abide the final Judgment and decree to be passed in the suits.”
• Followed — In Novo Nordisk v Dr Reddys Laboratories (2026) a Division Bench of the Delhi High Court (9 March 2026) held: “Where the inventors are common, the Division Bench of this Court has, in AstraZeneca AB v. Intas Pharmaceuticals Ltd., held that the aspect of obviousness would have to be viewed from the perspective of a ‘person in the know’, rather than a ‘person skilled in the art’.” “The ‘person in the know’ test may, therefore, be regarded as having been accorded Apical affirmation.” (para 61)
• Explained — In Kudos Pharmaceuticals v Natco Pharma (2024) (Delhi High Court, 1 March 2024) the Court held that “in a case where the species patent alone is asserted, and no infringement of the genus patent is pleaded, the decision in FMC-II would continue to hold the field” (para 39), and that “in a case where a species patent alone is asserted, Astrazeneca-I upholds the decision in FMC-II as representing the correct legal position.” (para 40)
• Followed — In Sulphur Mills v Dharmaj Crop Guard (2021) the Delhi High Court, setting out para 30 of this judgment on the tests to be applied where the inventor of both patents is the same, held: “Thus, unless and until the Defendant No.1 is able to show that the fertiliser product which is contained in IN'429, was in the knowledge of the Plaintiff at the time when the first patent was filed, the invention cannot be held to be obvious.” (para 83)