The Delhi High Court’s decision of March 13, 2024, in the case of Bayer Pharma Aktiengesellschaft vs the Controller General of Patents and Designs (C.A.(COMM.IPD-PAT) 255/2022), accentuated that the mere recitation of the unit numbers/concentration of ingredients of a composition in patent claims cannot disqualify the invention from patent eligibility under Section 3(i) of the Patents Act. This section prohibits the grant of a patent to “Any process for the medicinal, surgical, curative, prophylactic [diagnostic, therapeutic] or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products”.
The refused claim pertained to “A composition comprising;
i. two units containing 3 mg estradiol valerate,
ii. 5 units containing 2 mg estradiol valerate and 2 mg dienogest,
iii. 17 units containing 2 mg estradiol valerate and 3 mg dienogest,
iv. 2 units containing 1 mg estradiol valerate, and
v. 2 units containing placebo.”
The claimed composition was refused on the ground of non-patentability under sections 3(e) and 3(i) of the Patents Act. Notably, the Controller had not mentioned the objection under section 3(e) in the hearing notice.
The Court held that:
• The application’s refusal under section 3(e) violated the principles of natural justice. The Court concluded that the petitioner was not afforded the opportunity to prepare their submission concerning the objection because the objection was not communicated to the petitioner in the hearing notice. The Court underscored the Controller’s obligation to enumerate all pending objections in the hearing notice to allow the applicant to address each objection adequately. Consequently, the order was deemed arbitrary and flawed due to procedural irregularities.
• Section 3(i) was wrongly applied to the petitioner’s invention. Noting that the refused claim did not refer to any disease/treatment or any mode/manner of administration of the composition, the Court held that the mere recitation of the unit numbers of the components does not render the claim patent ineligible under section 3(i) of the Patents Act. The Court highlighted section 10(4)(c) of the Patents Act and underscored the necessity of interpreting the scope of claims for understanding the applicant’s invention. Because claim 1 is related to a product and not a process, the Respondent’s argument that the invention was a method of treatment due to the inclusion of a dosing regimen in the working examples was deemed incorrect. It was emphasized that the claims, not the working examples, define the extent of patent protection. The working examples are merely illustrative, demonstrating the practical application and feasibility of the invention.
In conclusion, the Court set aside the impugned order and remanded the matter to the Controller for reconsideration.
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