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* IN THE HIGH COURT OF DELHI AT NEW DELHI Reserved on: 10.11.2025 Date of Decision: 17.03.2026 Judgment uploaded on: As per digital signature + C.A.(COMM.IPD-PAT) 244/2022 & I.A. 10126/2022 GERON CORPORATION .....Appellant Through: Mr. Sanjeev Kumar Tiwari & Mr.

Shatadal Ghosh, Advocates.

versus THE ASSISTANT CONTROLLER OF PATENTS AND DESIGNS .....Respondent Through: Mr. Pratima N Lakra, CGSC with Ms.

Kanchan Shakya, Mr. Shailendra Kumar Mishra, Mr. Priyam Sharma &

Mr. Chanakya Kene, Advocates.

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CORAM:

HON’BLE MS. JUSTICE MANMEET PRITAM SINGH ARORA

J U D G M E N T

MANMEET PRITAM SINGH ARORA, J C.A.(COMM.IPD-PAT) 244/2022

1. The present appeal has been filed under Section 117-A of the Patents Act, 1970 [‘the Patents Act’], read with Section 151 of the Code of Civil Procedure, 1908 [‘CPC’], against the order dated 31.12.2021 [‘impugned order’] passed by the Controller/Respondent.

BRIEF FACTS

2. Brief facts necessary for deciding the present appeal are set out below:

3. The Appellant/Geron Corporation is inter alia a large-stage clinical biopharmaceutical company that is focused on the development and potential commercialisation of imetelstst, a first-in-class telomerase inhibitor.

4. On 26.05.2015, the Appellant’s PCT application no. PCT/US2013/072302 titled ‘DIAGNOSTIC MARKERS FOR TREATING CELL PROLIFERATIVE DISORDERS WITH TELOMERASE INHIBITORS’ entered the national phase in India as Indian Patent Application No. 4506/DELNP/2015[‘Subject Patent Application’]. Subject Patent Application claimed methods for the identification of individuals previously diagnosed with a cell proliferative disorder, that would show benefit when treated with a telomerase inhibitor compound, based on the average relative length of telomeres in cancer cells from said individuals.

5. A request for examination of Subject Patent Application was filed on 24.11.2016, and pursuant to examination, the First Examination Report [‘FER’] was issued on 20.11.2019. The FER objected to the Patent Application on the following grounds:

a. Claims 1, 6-9, and 16 lacked novelty as required under Section

2(1)(j) of the Patents Act;

b. Claims 1-16 lacked inventive step as required under Section

2(1)(ja) of the Patents Act;

c. Claims 1-16 were not allowable under Section 3(i) of the Patents Act as the claims were directed towards a method of diagnosis.

d. Claims 1-16 were not allowable under Section 3(d) of the Patents Act, as the process had been disclosed in the prior art and was, hence, directed towards the mere use of known process.

e. Claims 1-16 were not allowable under Section 3(j) of the Patents Act, as the said claims related to biological samples from the individual.

f. Claims 1-16 were indefinite, broad, vague and did not clearly define the scope of the invention and did not comply with the requirements of Section 10(4)(c) of the Patents Act.

6. Thereafter, the Appellant filed a detailed response to the FER on 08.06.2020. A hearing notice was issued on 05.02.2021 scheduling the hearing for 05.03.2021, wherein certain objections in the FER as regards to the lack of inventive step under Section 2(1)(j) and (ja) and lack of patentable subject matter under Section 3(d), (i), and (j), sufficiency of disclosure under Section 10 of the Patents Act were maintained.

7. The Appellant addressed all objections through detailed oral arguments, discussed possible claim amendments, and explained the technical advancement of the invention over the cited prior art. Pursuant to the oral hearing, the Appellant filed detailed written submissions along with the amended set of claims and relevant documents on 19.04.2021. The Appellant submitted 14 amended claims, of which only Claim 1 (as follows) is an independent claim:

An in vitro screening method of selecting an individual diagnosed with or suspected of having cancer who will benefit from treatment with a telomerase inhibitor, the method comprising:

a. determining relative telomere length by analysing the relative length of telomeric nucleic acids in c