Adrenomed AG v. The Deputy Controller of Patents and Designs

IMPORTANT ISSUE

1. Whether the Controller General erred in rejecting the patent under Section 15 of the Indian Patents Act, on the grounds of non patentability under section 3(i)

SUMMARY

Subject matter of patent: Subject matter of the present disclosure is an anti-adrenomedullin (ADM) antibody or an antiadrenomedullin antibody fragment or an anti-ADM non-lg scaffold for use in therapy of a chronical or acute disease or acute condition of a patient for prevention or reduction of organ dysfunction or organ failure.

FACTUAL MATRIX

1. The instant application 1189/MUMNP/2014 was filed at IPO as PCT National phase application, with originally filed 26 claims.
2. The First Examination Report (FER) was issued on 10/01/2019 on the ground of lack of inventive step, sections 3(d), 3(e) and 3(i).
3. The appellant submitted the response to the FER and submitted amended set of claims with 22 claims and hearing notice was issued on 05/11/2019.
4. After the hearing, the appellant submitted written arguments under Rule 28(7) on 04/12/2019 in response to the objections raised.
5. The respondents, considering the facts and finding, hearing proceedings under section 14, written submission filed on 04/12/2019, refused the grant of patent under Section 15 of the Patents Act, 1970 on the ground of non patentable subject matter of claim 12-14 under Section 3(i) of the Patents Act, 1970.

SUBMISSION BY APPELLANT

1. The impugned order issued by the controller does not provide proper reasoning. The order had quoted extracts from the complete specification which are irrelevant to the applicability of Section 3(i) of the Act and provides erroneous reasoning as to how Claims 12-14 of the instant application are non-patentable in accordance with Section 3(i) of the Act.
2. The instant application, in its entirety was rejected, on the sole ground of non-patentability of subject matter of Claims 12-14 under Section 3(i) of the Act, where the patentability of Claims 1-11 of was already accepted.
3. The subject matter of the claimed invention is ADM antibody or an antiADM antibody fragment binding to adrenomedullin or an anti-ADM non-Ig scaffold binding to adrenomedullin. Thus it is not process or method of treatment but a product/composition.
4. The Appellant submitted that the pharmaceutical products as claimed in Claims 12 to 14 used in combination with vasopressors are for ameliorating the acute condition in the patient who is in need for stabilizing the circulation and not to “render (the patient) free of disease” as required in Section 3(i) of the Act.

SUBMISSIONS BY RESPONDENTS

1. According to the respondent, the amended Claims 12 -14 read along with fig 7 and example 5 in description fall under section 3(i) of The Patents Act, 1970 as these claims are related to use of claimed Anti- adrenomedullin (ADM) antibody or anti ADM antibody fragment in combination of vasopressors such as catecholamine.
2. The claims 8, 9, 1 are related to disease condition in patient to be treated by combination therapy as defined in claim 12-14, while claim 1 is related to antibody for use in therapy of an acute disease or acute condition of a patient that suffers from an chronic and/or acute disease or acute condition for prevention or reduction of organ dysfunction or prevention of organ failure.

HELD

• The court explained that, in such cases where the claims are directed to method of treatments in the guise of combination/composition of drugs, section 3(i) could be invoked as specified in Pharmaceutical Guidelines and Bio-Technology Guidelines of Indian patent office.
• The court held that amended claims 12-14 in the instant patent application are related to the use of claimed Anti adrenomedullin (ADM) antibody or anti ADM antibody fragment in combination of vasopressors. Such ‘use’ claims are rejected under section 3(i) of the Patents Act, 1970.
• Thus, the court directed to amend the set of claims, by deleting claims 12-14 from the body of the claims and submit existing claim 1-11 within 3 weeks from the issuance of this order, as there is no objection on to these claims in the impugned order of the respondent.

Citation: MANU/IC/0011/2021
IPAB order No: OA/12/2020/PT/MUM
Copy of judgement