Esteve Pharamaceuticals S.A. v Controller of Patents and Designs (2026)

Summary

“The present appeal has been filed under Section 117A of the Patents Act, 1970 ... assailing the order dated 12.02.2020 ... refusing the Patent Application No.1435/DELNP/2012 titled ‘Co-crystals of Tramadol and Coxibs’ ... on the ground of lack of inventive step under Section 2(1)(ja) and lack of patentability under Sections 3(d) and 3(e) of the Act.” (para 1) Claim 1 read: “A co-crystal comprising tramadol either as a free base or as a physiologically acceptable salt and at least one coxib, being selected from celecoxib or salts thereof.” (para 14) The appellant “emphasised that D7 is the strongest/closest prior art cited by the Patent Office, which possibly discloses the co-crystal, however, insisted that unlike the claimed invention under the subject application, it does not disclose the efficacy.” (para 15)

The Court chose “to first examine and appreciate the controversy regarding the objections of lack of inventive step under Section 2(1)(ja) of the Act.” (para 14) It held that “reading of the prior art D5 (para 68) which discloses the combination of tramadol and celecoxib as a method of treating pain, along with the disclosure under prior art D7, would render the present invention obvious” (para 37), and that “the invention claimed under the subject application lacks inventive step and therefore, barred under Section 2(1)(ja) of the Act.” (para 40) Having so held, “there is no requirement of examining the other objections raised under Section 3(d) and 3(e) of the Act.” (para 41) “In view thereof, the present appeal stands dismissed, alongwith pending applications, with no order as to costs.” (para 43)

What the court decided

1. What D5 discloses. “Thus, the prior art D5 does disclose celecoxib as one such NSAID which may be used in combination with tramadol.” (para 20) D5 notes “that the person skilled in the art ... will know how this combination may be modified using other NSAIDs such as celecoxib from the prior art.” (para 20)
2. What D7 discloses. “The claim 6 of D7 specifies that each API” (“Active Pharmaceutical Ingredient”) “is selected from an API of Table IV and the said Table IV discloses both celecoxib as well as tramadol.” (para 25) “As per the Summary of the Invention of D7, the new co-crystalline forms of APIs can be obtained which improves the properties of APIs as compared to such APIs in a non-co-crystalline state.” (paras 25, 35)
3. The advantages compared. “The aforesaid comparison would amply suggest that the disclosure in D7 also specifies (i) increased bioavailability in the co-crystals compared to the individual APIs; (ii) dose response of the co-crystal is increased as compared to an API; (iii) increase in stability of the co-crystal. These parameters are also claimed in the present invention.” (para 34)
4. Hydrogen bonding. “D7 under claim 1 discloses the hydrogen bonding between the first API and the second API. Further, claim 5 of D7 specifies that the APIs are hydrogen bonded to a molecule. It is significant to note that at page 5 of the CS” (“Complete Specifications”) “of the present invention, it is clearly specified that the two compounds are held together by weak interaction, and the interaction is neither ionic nor covalent and includes hydrogen bonds.” (para 36)
5. Reading D5 with D7. “Therefore, reading of the prior art D5 (para 68) which discloses the combination of tramadol and celecoxib as a method of treating pain, along with the disclosure under prior art D7, would render the present invention obvious.” (para 37)
6. Teaching, motivation, suggestion. “That apart, the improvements specified under claim 6 of the prior art D7 provides teaching/motivation/suggestion to apply the co-crystal disclosed under D7 to improve the treatment under D5. Significantly, para 12 of D5 discloses that some of the combination products also have the advantage of producing a synergistic analgesic effect. Such disclosure under prior art D5 would motivate PSITA” (“person skilled in the art”) “to apply the co-crystal disclosed under D7 for better improvements.” (para 38)
7. The process. “Additionally, D7 under general methods of preparation as well as claim under 16, discloses that Co-crystals may be obtained by dissolving separate components in a solvent followed by the addition of one component to the other.” ... “Thus, the process disclosed in D7 and that in the present invention also overlap.” (para 39)
8. Inventive step. “In light of the above discussion and consideration of prior art documents D5 and D7, the invention claimed under the subject application lacks inventive step and therefore, barred under Section 2(1)(ja) of the Act.” (para 40)
9. Disposition. “In view thereof, the present appeal stands dismissed, alongwith pending applications, with no order as to costs.” (para 43)

What the court did not decide

Following Kroll Information Assurance v Controller General of Patents, the Court held: “Since this Court has, on merits, upheld the objection raised by the learned Controller on the ground of lack of inventive step under Section 2(1)(ja) of the Act, this Court is of the considered opinion that there is no requirement of examining the other objections raised under Section 3(d) and 3(e) of the Act.” (para 41) On the precedents the parties cited, “the said judgements need no reference.” (para 42)

Subsequent treatment

No later judicial treatment and no further appeal traced as of 17 October 2026.