The refusal of a patent application for a therapeutic drug composition based on the grounds of it being a method of treatment is erroneous; claims must be recognized as product claims, distinguishing them from treatment methodologies.

JUDGMENT

INTRODUCTION

1. This Appeal has been filed under Section 117A of the Patents Act, 1970 (“Act”) against the order (“Impugned Order”) dated 21.12.2023, passed by the Assistant Controller of Patents and Designs (“Respondent / Controller”), refusing the Patent Application No. 202117034705 (“Subject Application”) on the grounds under Section 3 (i) of the Act.

FACTUAL MATRIX

2. The Impugned Order passed by the learned Controller, refusing the Subject Application titled ‘PROPHYLACTIC OR THERAPEUTIC DRUG FOR NEURODEGENERATIVE DISEASES’ under Section 3 (i) of the Act.

3. The subject matter of the invention relates to a medicine / drug composition / pharmaceutical formulation useful for the treatment of a neurodegenerative disease, as well as capable of reducing adverse side effects.

4. The originally filed Claims 3 to 13 disclose a prophylactic / therapeutic drug where rifampicin, as well as resveratrol, are administered as a dosage regimen depending on the body weight of the subject through trans nasal administration over a period of a specified time.

5. The Appellant filed a request for examination on 26.12.2022. The First Examination Report dated on 20.01.2023 (“FER”) was issued by the Patent Office in connection with the Subject Application.

6. Thereafter, the Appellant filed the response to FER at the Patent Office within the extended deadline under Rule 24B(5) of the Patents Rules. 7. On 21.09.2023, the Respondent notified the Appellant that an official hearing had been appointed. Thereafter, the Appellant, on 06.10.2023, filed the written submissions along with amended claims.

8. The Respondent passed the Impugned Order on 21.12.2023, rejecting the Subject Application on the ground that the claims do not meet the criteria of patentability under Section 3 (i) of the Act.

SUBMISSIONS ON BEHALF OF THE APPELLANT

9. The learned Counsel for the Appellant submitted that the learned Controller has wrongfully refused the Appellant’s Subject Application under Section 3 (i) of the Act as the Respondent has failed to recognise that the invention claimed in Claim 1 of the Subject Application pertains to a composition and not a method of treatment. Further, this is evident from a plain reading of Claim 1 in light of the complete specification, as Claim 1 is a product claim and not a method claim. Hence, the refusal of Claim 1 under the objection of Section 3 (i) of the Act is manifestly erroneous. According to the Appellant, Claim 2 of the invention under the Subject Application also relates to a ‘kit’, a product that includes the medicinal agent of Claim 1. Claim 2 does not contain ‘method of treatment’ steps.

10. The learned Counsel for the Appellant submitted that the Respondent’s refusal of the Subject Application under Section 3 (i) of the Act is patently incorrect, as reading of the claims with the complete specification clearly indicates that the claimed subject matter is a prophylactic / therapeutic drug composition.

11. The learned Counsel for the Appellant further submitted that this interpretation of the Respondent goes against the object of the Act, which recognizes product / formulation patents subject to the requirements of S