Bayer Pharm Aktiengesellschaft v Controller General of Patents and Designs (2024)

Summary

The appellant’s “patent application No. 5818/DELNP/2006” had been “refused through order dated 16th May, 2012” ... “under Section 15 of the Patents Act, 1970” ... “on the ground that the claims recited in the subject application do not fulfil the criteria laid down under Section 3(e) and Section 3(i) of the Act.” (para 1) Claim 1 claimed “A composition comprising” “two units containing 3 mg estradiol valerate”, “5 units containing 2 mg estradiol valerate and 2 mg dienogest”, “17 units containing 2 mg estradiol valerate and 3 mg dienogest”, “2 units containing 1 mg estradiol valerate, and” “2 units containing placebo.” (para 2) The appellant contended that it “was deprived of a fair opportunity to address the objection under Section 3(e) of the Act, as this specific ground was not mentioned in the notice preceding the hearing” (para 4.1).

The Court held that “the Controller of Patents is obliged to enumerate all pending objections in the hearing notice” (para 6) and that “the hearing notice failed to enumerate the objections under Section 3(e) of the Act. Consequently, the Court concurs with Mr. Banerjee’s argument that the order in question infringes upon the principles of natural justice.” (para 7) On section 3(i) it held that “Claim 1, as delineated, clearly indicates to the Court that it pertains exclusively to a product rather than a process” (para 8) and that “while working examples are essential for demonstrating the feasibility and workability of an invention, they do not define the patent’s scope.” (para 9) “The impugned order dated 16th May, 2012 is set aside and the matter is remanded to the Respondent for de novo consideration.” (para 11) “With the above directions, the appeal stands disposed.” (para 12)

What the court decided

1. Procedure. Objections omitted from the hearing notice. “As regards non-communication of objection under Section 3(e) of the Act, this Court has consistently maintained, across multiple decisions, that the Controller of Patents is obliged to enumerate all pending objections in the hearing notice. This practice is fundamental to ensure procedural fairness, as it allows the Applicant to adequately prepare and present their arguments concerning the specified objections. A failure to do so is violative of the principles of natural justice that can significantly prejudice the Applicant’s ability to effectively address and counter the objections raised.” Citing Perkinelmer Health Sciences INC and Ors v. Controller of Patents and Dolby International AB v The Assistant Controller of Patents and Designs, the Court set out the Controller General’s Circular No. 4 of 2011: “If upon Examination of the response submitted by the Applicant, the Examiner reports that some objections are still outstanding or raises further objection(s), such objections shall be communicated alone with the notice of hearing, giving reasonable time to the Applicant.” (para 6)
2. The section 3(e) ground. “Evidently, in the present case, the hearing notice failed to enumerate the objections under Section 3(e) of the Act. Consequently, the Court concurs with Mr. Banerjee’s argument that the order in question infringes upon the principles of natural justice. The omission deprived the Appellant of the opportunity to address this specific ground, thereby impairing their ability to defend their application fully. Therefore, the impugned order to that extent, is arbitrary and suffers from procedural irregularities, and ought to be remanded to the Patent Office.” (para 7)
3. Product or method of treatment. “Regarding the objection under Section 3(i) of the Act, the Court observes that the impugned order lacks a substantive basis for dismissing the subject application on this specific ground. Moreover, under Section 10(4)(c) of the Act, to consider the invention as articulated by the Applicant, it is imperative to interpret the scope of the claims. Claim 1, as delineated, clearly indicates to the Court that it pertains exclusively to a product rather than a process. Consequently, based on the claim’s composition and its representation within the application, the Court determines that Section 3(i) of the Act, which pertains to methods of treatment, does not apply to the case at hand.” (para 8)
4. Unit numbers in the claim. “Therefore, the Court finds merit in the contention of Mr. Banerjee that mere recitations of the unit numbers of the components in claim 1 cannot render it ineligible for patent protection under Section 3(i) of the Act. Notably, in the said claim, as defined, there is neither any reference to a particular disease/ treatment, nor any reference regarding the modes/ manner of administration of the composition.” (para 9)
5. Claims and working examples. “In patent law, the claims of a patent define the boundaries of the patent protection. That is, they set out the legal limits of what the patent covers.” “Working examples, on the other hand, are provided in the subject application to demonstrate the practical implementation of the invention.” “Thus, while working examples are essential for demonstrating the feasibility and workability of an invention, they do not define the patent’s scope. The scope is determined by the claims, which must be interpreted in light of the description and any examples provided. The reasoning for applying Section 3(i) of the Act to the subject application is therefore, misplaced.” (para 9)
6. The Nestle decision. Recording that in Societe Des Produits Nestle SA v. The Controller of Patents and Design and Anr. the Court “held that the claims in respect of the composition are patentable, and not hit by Section 3(i) of the Act”, the Court held: “In the present case as well, the claim 1, as defined, in the opinion of the Court, does not render the application to be non-patentable.” (para 9)
7. Procedure. Directions on remand. “In view of the above, the present appeal deserves to be allowed and the following directions are issued:” “The impugned order dated 16th May, 2012 is set aside and the matter is remanded to the Respondent for de novo consideration.” “The subject application is restored to its original number.” “Prior to deciding the matter afresh, Appellant shall be granted a hearing, and the notice of such hearing must clearly delineate the objection(s), if any.” “After completion of hearing, the decision thereon shall be rendered within a period of three months from the date of conclusion of hearing.” “The Respondent shall decide the application uninfluenced by any observations made in the impugned order, and all rights and contentions of the parties are left open.” (para 11) “With the above directions, the appeal stands disposed.” (paras 11–12)

What the court did not decide

“It must also be clarified that although in the hearing notice, several other grounds were raised, however, the impugned order does not clearly specify whether such objections were met or remained outstanding. The Court has thus, not expressed any opinion regarding those objections.” (para 10)

Subsequent treatment

• Followed — In Array Biopharma v Deputy Controller of Patents and Designs (2026) the Delhi High Court held that “The aforesaid view is fortified by the judgement of this Court in Bayer Pharma Aktiengesellschaft vs. The Controller of Patents and Design, Neutral Citation: 2024:DHC:2395, wherein, it was emphasised that the working examples are essential for demonstrating the feasibility and workability of an invention, and do not define the patent’s scope.” (para 50)