Geron Corporation v Assistant Controller of Patents and Designs (2026)

Summary

“The present appeal has been filed under Section 117-A of the Patents Act, 1970 ... against the order dated 31.12.2021 ... passed by the Controller/Respondent.” (para 1) “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” (para 4). Claim 1 claimed “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” (para 7), and the specification states that “In some embodiments, the telomerase inhibitor is imetelstat.” (para 29) The Controller held that “present claims 1-14 are directed to a non-patentable subject matter as defined u/s 3(i) of the Patents Act, being diagnostic method related to cancer in human subjects and has direct application in method of treating cancer in a patient” (para 12).

The Court held that “reliance of the Controller on the Guidelines cannot be said to be erroneous unless the relevant portion of the Guidelines relied on by the Controller is proved to be wrong or is inconsistent with the Patents Act” (para 19). Among its principles were that “the deciding factor is whether it is contributing to the decision-making by the medical practitioner for treatment” and that “Section 3(i) does not distinguish between in vivo and in vitro diagnosis, and, therefore, in vitro diagnostic processes can also be patent-ineligible” (para 25). It held that “The screening label of the method is insufficient to distinguish it from a diagnostic method, since it forms part of treatment decision-making” (para 32), and that “the subject matter covered in the claims of the Subject Patent Application, when read along with the detailed description provided therein, covers a diagnostic process that forms the basis of the treatment of human beings” (para 33). “Accordingly, the present appeal is dismissed.” (para 37)

What the court decided

1. Reliance on the Guidelines. The appellant had argued “that the reliance made by the Controller on the Biotechnology Guidelines is incorrect since it lacks force of law.” (para 18) The Court held: “This Court has considered the argument of the Appellant. However, this Court is of the considered opinion that the Guidelines are established to ensure uniformity and consistency among examiners and controllers of the Patent Office in practices in the examination of patent applications in the relevant field. The role of Guidelines is not rule-making; however, they play a significant role in the examination process for patent applications at the patent office. Thus, reliance of the Controller on the Guidelines cannot be said to be erroneous unless the relevant portion of the Guidelines relied on by the Controller is proved to be wrong or is inconsistent with the Patents Act. In the present case, the Appellant has failed to show the same. Therefore, reliance by the Controller on the Guideline, which they are bound to do in appropriate cases, cannot be held against them.” (paras 18–19)
2. The principles under section 3(i). “From the Patents Act, Manual, Guidelines and judgments cited above, the principles relevant for adjudicating the present appeal concerning the exclusion of diagnostic methods under Section 3(i) of the Patents Act are as follows: I. The word ‘diagnostic’ in Section 3(i) must be construed as diagnosis for treatment of human beings, and not every test that is merely useful or relevant to medicine. II. The diagnostics may/may not reveal a medical condition. However, the deciding factor is whether it is contributing to the decision-making by the medical practitioner for treatment. III. Section 3(i) does not distinguish between in vivo and in vitro diagnosis, and, therefore, in vitro diagnostic processes can also be patent-ineligible. IV. Patent eligibility under Section 3(i) must be determined by examining the claims in the context of the complete specification, not by isolated phrases or drafting labels. V. The test is whether the claimed process is inherently capable of enabling a diagnosis for treatment, assuming a person skilled in the art” (“including a medical doctor”) “assesses the claim and its results. VI. A diagnosis need not be definitive to attract Section 3(i). If a process supports a diagnosis for treatment, even if subject to confirmation, it can still be excluded.” “VII. The distinction between ‘screening’ and ‘diagnosis’ is not determinative, and screening tests can be ‘diagnostic’ if they identify a disease/condition” (“or its aspects”) “for treatment. VIII. Processes employed by medical practitioners/paramedical staff/nurses are the principal target of Section 3(i) exclusions, reflecting a policy against monopolising treatment methods. IX. The ‘manner or process of diagnosis’ is not patentable, such as processes for checking blood pressure, performing swab tests, or checking glucose levels. X. Diagnostic products, tools and devices may be patentable, provided they meet patentability requirements. XI. The Guidelines indicate that biomarker-based monitoring of drug response in a patient is considered a diagnostic method and is, therefore, barred under Section 3(i) of the Patents Act. XII. The EPO” (“European Patent Office”) “practice shows four ... stages as constituents of the diagnostic method practised on the human/animal body, i.e., examination phase, comparison with standard values, finding of any significant deviation and decision phase.” (para 25)
3. The claimed method. “Now, in light of the principles laid above, this Court shall examine the claims and complete specification of the Subject Patent Application to enquire if the same falls within the exclusion of diagnostic methods under Section 3(i) of the Patents Act.” (para 26) “The afore-extracted Claim 1 of the Subject Patent Application covers 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.” (para 28) “The method is used to select individuals to determine whether they will benefit from telomerase inhibitor treatment. According to the said method, if the telomere length in the identified cell is ≤ the 50th percentile, the individual will benefit from treatment.” (paras 26, 28, 30) The Controller had found that “The description nowhere discloses any ‘in vitro screening method’” and that “when subject matter of the claims are same, the scope of the claim will remain same regardless of its preamble or way of drafting the claim by disguising to look different in scope of invention.” (para 12) The Court held: “It is also pertinent to note that the Controller in the impugned order has taken note of the original PCT Claims to understand the nature and scope of the claims of the Subject Patent Application. The Controller, on perusal of Claim 1, Claim 2 and Claim 3 of the original PCT application, concluded that the scope of the invention is for the diagnosis and treatment of Cancer. Pertinently, the said finding of the Controller is not disputed by the Appellant. The Controller has thereafter examined the corresponding voluntary amended claims dated 24.11.2016, and concluded that the expression ‘in vitro screening method’ has been inserted by amendment to disguise the method of diagnosis and treatment to appear as an ‘in vitro screening method’. Lastly, the Controller takes note of the amended claims filed in the post hearing written submissions and after comparing it with corresponding claims of the PCT application concludes that the change in the language of the amended claims does not affect the substance of the subject matter covered in the claims of the Subject Patent Application, which in his opinion is a diagnostic method for treatment of cancer. This analysis has been set out in detail by the Controller at paragraphs ‘6 to 8’ of the impugned order, and in the considered opinion of this Court, the said analysis of the Controller is correct and merits no interference.” (paras 12, 26–31)
4. Selecting patients for therapy. “The claimed method is an in vitro screening method used to select individuals eligible for telomerase inhibitor therapy for the cure or prevention of cancer. The decision of whether the individual is given the said treatment is made based on the result of the claimed method.” “This method involves the collection and examination of a sample from the selected patient, then comparison of the patient/suspected patient’s telomerase length with standard telomerase length, identifying the deviation and deciding whether the patient/suspected patient receives the telomerase inhibitor therapy.” “The screening label of the method is insufficient to distinguish it from a diagnostic method, since it forms part of treatment decision-making.” (para 32)
5. A method that reveals no disease. “The method, even though it does not reveal cancer, since the finding is the factor for deciding the treatment for the patient, will fall under the diagnostic method” (para 32). “The claims, even though they do not reveal the medical condition, are an essential part of the medical practitioner’s decision-making in prescribing a telomerase-inhibition treatment.” (paras 32–33)
6. In vitro methods. “This method, even though it is an in vitro method since it forms part of the treatment, and also since Section 3(i) of the Patents Act does not distinguish between in vivo and in vitro diagnostic processes, squarely falls within the exclusion of treatment methods under said provision.” (para 32)
7. Monopolising medical decision-making. “Granting a patent to this subject matter will result in monopolising a medical practitioner’s medical decision-making practice of measuring telomere length, and applying a threshold rule” ("≤50th percentile") “to select patients for telomerase inhibitor therapy. Such a monopolisation is in violation of Section 3(i) of the Patents Act.” (para 32)
8. Substance over drafting. “From the above inferences, it could be concluded that the subject matter claimed in the Subject Patent Application, though drafted as an ‘in vitro screening method’, is in substance a method for selecting cancer patients/suspected cancer patients who will benefit from treatment with a telomerase inhibitor, based on the determination of telomere length and application of a percentile threshold. ... Therefore, this Court is of the opinion that the subject matter covered in the claims of the Subject Patent Application, when read along with the detailed description provided therein, covers a diagnostic process that forms the basis of the treatment of human beings. In view of Section 3(i) of the Patents Act, as clarified in the Manual, the Guidelines, and various decisions, the claimed methods are not patentable.” (para 33)
9. Grants in foreign jurisdictions. “The Appellant’s reliance on the grant of a patent in the USA and Europe for a similar grant in India also does not stand any merit. It is now well settled that a mere grant in foreign jurisdictions would not lead to grant of the patent in India, as the examination of the Subject Patent Application is governed by the provisions of the Patents Act and since the Subject Patent Application has been held to be barred under section 3(i) of the Patents Act, the application has been rightly rejected.” (para 34)
10. The two Madras judgments. “The Appellant has relied upon the judgment of the Chinese University of Hong Kong v. Assistant Controller of Patents & Designs (supra), to rely upon the analysis of law on section 3(i) of the Patents Act. However, this Court notes that the same analysis of law is also set out in Chinese University of Hong Kong v. Controller of Patents & Designs, and has already been referred to above. The laws settled in these judgments do not persuade this Court to hold that the Appellant’s Subject Patent Application has been incorrectly rejected.” The second judgment, footnoted as “2023 SCC OnLine Mad 8616”, is The Chinese University of Hong Kong v Assistant Controller of Patents & Designs (2023). (para 35)
11. Disposition. “Accordingly, for the reasons discussed above, there is no error or infirmity in the finding of the Controller that the Subject Patent Application cannot be granted in terms of Section 3(i) of the Patents Act.” (para 36) “Accordingly, the present appeal is dismissed.” (para 37) “Pending application stands disposed of.” (paras 36–38) “The Registry is directed to supply a copy of the present order to the office of the Controller General of Patents, Designs & Trade Marks of India” (paras 36–39)

Subsequent treatment

No later judicial treatment and no further appeal traced as of 10 October 2026.