2023 (10) TMI 1453 - HC - Indian Laws

Rejection of application of the Chinese University of Hong Kong for grant of patent - Interpretation of diagnostic methods in the context of patent law - scope of words diagnostic, therapeutic after the word prophylactic in Section 3(i) - HELD THAT - The language of Section 3(i) uses the expression diagnostic...or other treatment of human beings and thereby appears to point in the direction of examining embodiments or use cases of processes to determine if they are diagnostic. Nonetheless, it should not be lost sight of that patent eligibility is decided at the threshold by examining claims that could have multiple use cases. Consequently, in the context of diagnostic processes, I am of the view that the embodiments of a claimed invention are relevant only for the purpose of ascertaining whether the process of the claimed invention per se points to a diagnosis for treatment. If such process does not uncover pathology for any reason, it would not be diagnostic for purposes of Section 3(i). What is determinative, therefore, of whether a process is diagnostic is to ask the question whether the process is inherently and per se capable of identifying the disease, disorder or condition for treatment of the person. It bears repetition that such capability of the process should, in turn, be determined by assuming that a person(s) skilled in the art, including a medical doctor, examines the results. If the person(s) skilled in the art would not be in a position to diagnose the disease, disorder or condition, as the case may be, on the basis of the process because the process is not designed to diagnose diseases, disorders or conditions, such process, whether labelled as screening or anything else, would not qualify as diagnostic for purposes of Section 3(i) - The corollary would be that the Controller would be required to make this determination on a case- by-case basis. Into which category, the claimed invention falls remains to be considered. It cannot be concluded that the process described by the claimed invention is not diagnostic because neither definitive nor comprehensive diagnosis is a prerequisite to qualify as diagnostic. Once it is concluded that the claims are patent ineligible, it is not necessary to deal with the other grounds of decision, such as lack of inventive step, and sufficient to record that the impugned order does not warrant interference. Application dismissed.

Summary

Issues Involved:

1. Patent eligibility under Section 3(i) of the Patents Act, 1970.
2. Interpretation of "diagnostic" methods in the context of patent law.
3. Applicability of prior art and inventive step.
4. Consideration of amended claims and their impact on patent eligibility.
5. Examination of in vitro versus in vivo diagnostic methods.

Issue-wise Detailed Analysis:

1. Patent Eligibility under Section 3(i) of the Patents Act, 1970:

The core issue revolves around whether the claimed invention qualifies as a diagnostic method under Section 3(i) of the Patents Act, which excludes certain methods from patent eligibility. The Assistant Controller of Patents concluded that the claimed invention, which involves a method for measuring sequence imbalance in a biological sample, constitutes a diagnostic method and is therefore not patentable. The judgment elaborates that Section 3(i) includes processes for "diagnostic, therapeutic or other treatment of human beings," and the interpretation of "diagnostic" is central to determining patent eligibility.

2. Interpretation of "Diagnostic" Methods in Patent Law:

The judgment delves into the interpretation of "diagnostic" in the context of patent law. The appellant argued that the term should be limited to in vivo diagnostic methods, citing manuals and international practices. However, the court concluded that the term "diagnostic" under Section 3(i) is not confined to in vivo methods and can include in vitro processes if they are capable of identifying a disease or condition for treatment. The court emphasized that the word "diagnostic" should be interpreted in association with forms of treatment and should include processes that disclose pathology for treatment.

3. Applicability of Prior Art and Inventive Step:

The Assistant Controller found that the claimed invention lacked an inventive step in view of prior art documents, D1 and D2. The court did not delve deeply into this issue as it concluded that the claims were patent ineligible under Section 3(i). However, it is noted that the lack of inventive step was one of the grounds for rejecting the patent application.

4. Consideration of Amended Claims and Their Impact on Patent Eligibility:

The appellant submitted amended claims to address objections, including disclaimers that the method is non-diagnostic and performed in vitro. The court, however, determined that the amended claims still fell within the scope of a diagnostic method as per Section 3(i). The judgment highlights that while the claims delimit the scope of the invention, the complete specification and its embodiments can be examined to assess whether the process is inherently diagnostic.

5. Examination of In Vitro versus In Vivo Diagnostic Methods:

The appellant contended that the claimed invention should not be considered diagnostic as it involves in vitro analysis. The court rejected this contention, stating that Section 3(i) does not limit "diagnostic" to in vivo methods. The judgment references international treaties and patent office manuals but concludes that the term "diagnostic" should be broadly construed to include any process capable of identifying a disease or condition for treatment, regardless of whether it is performed in vitro or in vivo.

In conclusion, the court dismissed the appeal, upholding the decision that the claimed invention is not patentable under Section 3(i) of the Patents Act. The judgment underscores the need for legislative reconsideration to address technological advancements in diagnostic methods while maintaining public policy exclusions from patent eligibility.