Analysing Method of Diagnosis through the lens of – Geron Corporation v. The Assistant Controller of Patents and Designs
The Hon’ble Delhi High Court’s decision in Geron Corporation v. The Assistant Controller of Patents and Designs (C.A.(COMM.IPD-PAT) 244/2022) marks another significant development in the evolving jurisprudence on Section 3(i) of the Patents Act, 1970. The judgment revisits the scope of the statutory exclusion relating to methods of treatment and diagnosis, providing important guidance on the interpretation of one of the most debated provisions governing patent eligibility in India.
Facts of the case:
The Appellant, Geron Corporation filed a PCT application (PCT/US2013/072302) titled ‘DIAGNOSTIC MARKERS FOR TREATING CELL PROLIFERATIVE DISORDERS WITH TELOMERASE INHIBITORS’ that entered the national phase in India as Indian Patent Application No. 4506/DELNP/2015 on May 26, 2015. The Application was directed to 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.
The method claims had the preamble as “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 Appellant explained that the subject-matter as claimed did not determine whether an individual is suffering from cancer or determines the nature of the disease. Instead, the claimed method is applied only after the individual has already been diagnosed with, or is suspected of having, cancer. Thus, the subject-matter as claimed does not attract the provisions of Section 3(i) of the Act. The Appellant also challenged the reliance of the respondent on the Guidelines for Examination of Biotechnology Applications, as they do not constitute rule-making, and, hence, lack the force of law. The Applicant further submitted that the patent has been granted in several jurisdictions, including Europe, the US, and Japan, and that the European grant is significant since Article 53(c) of the EPC contains a provision analogous to Section 3(i) of the Patents Act, 1970.
The Respondent, The Assistant Controller of Patents and Designs, submitted that the claimed method involves analysing a biological sample obtained from a patient, assessing telomere length as a diagnostic marker, and using the results to determine suitability for telomerase inhibitor therapy, thus falling squarely under the ambit of Section 3(i) of the Patents Act, 1970. It contented that short telomere length indicates increased telomerase activity, which forms the basis for administering telomerase inhibitor treatment. The Respondent contended that the term “diagnosis” under Section 3(i) should not be narrowly interpreted as being limited only to the initial identification of a disease, since diagnosis may also occur at different stages of disease management, including assessing parameters that influence treatment decisions. It was further submitted that the exclusion of diagnostic methods under the TRIPS framework was intended to address public health concerns, including affordability and access to healthcare, particularly in contexts where expensive diagnostic methods may not be widely accessible.
Accordingly, the issue arising for consideration before the Hon’ble Delhi High Court was the patentability of an in vitro screening method for cancer patients or suspected cancer patients to determine suitability for telomerase inhibitor therapy under Section 3(i) of the Act.
Analysis Of The Hon’ble Delhi High Court
The Hon’ble Delhi High Court, while addressing the Appellant’s challenge to the reliance on the Biotechnology Examination Guidelines, held that although the Guidelines do not have the force of law, they ensure consistency in patent examination and serve as relevant aids for Examiners and Controllers. Therefore, reliance on the Guidelines cannot be considered erroneous unless the relevant provisions are shown to be inconsistent with the Patents Act, 1970.
The Hon’ble Delhi High Court, further maintained the position that language of Section 3(i) or in any other provisions of the Patents Act do not lead to the inference that the expression ‘diagnostic’ should be confined to in vivo diagnosis. The Hon’ble Delhi, High Court also clarified that Article 27(3)(a) of the TRIPS agreement also does not support exempting in vitro diagnostic processes or methods from patent ineligibility.
The Hon’ble Delhi High Court, further distinguished the provision of Section 3(i) in India, from that of Articles 52(4) and 53(c) of the EPC (European Patent Council), having a similar provision. It held that Section 3(i) excludes from patent eligibility any process for the diagnostic treatment of human beings, whereas Article 52(4) and 53(c) exclude only diagnostic methods practised on the human body. The Hon’ble Delhi, High Court held that the term “diagnostic” under Section 3(i) must be interpreted in accordance with its statutory context and purpose; and it cannot be narrowly restricted to only in vivo diagnosis or definitive diagnosis, as such a limitation would not align with the language and scope of the provision.
The Hon’ble Delhi High Court, also discussed the distinction between screening and diagnostic; noting that medical literature generally distinguishes screening as a process involving asymptomatic individuals or persons at risk of a disease, through preliminary tests aimed at early detection, whereas diagnostic tests are conducted on individuals exhibiting symptoms to identify or confirm a disease, disorder, or condition. The Hon’ble Delhi High Court opined that, if a screening test is capable of identifying the existence or nonexistence of disorder/disease for treatment of human beings, irrespective of whether the person concerned is symptomatic or asymptomatic, such screening test would qualify as a diagnostic test. The Hon’ble Delhi High Court, thereby mentioned that the determinative factor, whether a test is diagnostic is to ask the question, if the test is inherently and per se capable of identifying the disease, disorder or condition for treatment of the person.
The Hon’ble Delhi High Court, largely relied on the cases of Chinese University of Hong Kong v. Assistant Controller of Patents & Design and Sequenom Inc & Anr. v. The Controller of Patents, to conclude that the screening label of the method claimed by the Appellant is insufficient to distinguish it from a diagnostic method, since it forms part of treatment decision-making. It further opined that 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.
The Hon’ble Delhi High Court, 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. 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. Therefore, 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.
Key takeaway:
- Yet again the Court concluded that the Section 3(i) does not differentiate between in–vitro and in vivo method when determining the scope of the invention under Section 3(i)
- The determining factor for the provision of Section 3(i) is that whether the process is inherently capable of identifying a disease, disorder, or condition relevant to treatment.
- A method need not independently detect the disease to qualify as diagnostic-even if the test only provides information that guides a doctor’s treatment decision, it may fall within the scope of Section 3(i).
- Section 3(i) has a broader scope than the EPC exclusion, thereby unlike the European provision, which focuses on diagnostic methods practised on the human body, Section 3(i) excludes diagnostic processes more broadly, including in vitro
- Patent examination guidelines, though not legally binding, can serve as interpretative aids for Controllers and Examiners, provided they remain consistent with the Patents Act.
- The decision reinforces a case-by-case assessment approach in determining whether a claimed invention constitutes a diagnostic method requires analysing the actual function and purpose of the claimed process rather than relying solely on claim terminology.
Author of the Article:
Mr. Manish Sanwal, Associate Partner
Co-Author:
Mrs. Kathakali Banerjee, Senior Associate