On 5th Feb, a Single Bench (SB) of the Delhi High Court (DHC) overturned a previous order by the Controller General of Patents that had classified the “method of producing ‘protein enriched blood serum’” as a method of treatment under Section 3(i) in The Patents Act, 1970. This decision was made in the case of Arthrogen Gmbh vs Controller General Of Patents. The SB determined that the controller had erroneously equated the method of producing a novel substance with a method of treatment. Consequently, the SB revoked the refusal of a patent to Arthrogen GMBH for their technique of producing protein-enriched blood serum using gold particles. (For a deeper discussion of what constitutes a ‘method of treatment,’ refer to Amit Tailor’s post here). Moreover, the SB found that the Controller of Patents had breached principles of natural justice by citing Section 3(j) as a ground for refusal without raising it as an objection during the hearing notice. This post will analyse the SB’s insights and how they fare in light of Madras High Court’s decision in the Chinese University of Hong Kong case.
Factual Basis of the Matter
Arthrogen GMBH submitted a patent application for a method involving the use of gold particles to produce protein-enriched blood serum. Initially, the Controller of Patents raised objections during the first examination report, citing Sections 3(c) (mere discovery of a scientific principle), 3(d) (mere discovery of a new form of a known substance), 3(e) (substance obtained by a mere admixture), 3(f) (mere arrangement/re-arrangement/duplication of known devices), and 3(j) (discover of plants and animals). In response, the applicant adjusted the claims to address these objections.
However, during the subsequent hearing, the Controller of Patents introduced new objections under Sections 3(b) (inventions posing risks to public order, morality, or the well-being of humans, animals, plants, or the environment) and 3(i) (processes related to medical treatment for humans or animals, including diagnosis, therapy, or disease prevention), which were not part of the original examination report. Despite the applicant’s participation in the hearing and submission of written arguments, the Controller of Patents ultimately rejected the patent application, citing an objection from the examination report under Section 3(j) and a new objection from the hearing notice under Section 3(i). Dissatisfied with this decision, the patent applicant appealed to the DHC, primarily arguing that the refusal order violated principles of natural justice concerning Section 3(j) and contending that Section 3(i) was not applicable to the claimed invention.
Analysing the Decision
The patent application put forth by the party outlined a method for producing protein-enriched blood serum, involving steps such as collecting blood serum, mixing it with gold particles, incubating the mixture, and removing the gold particles. In the legal analysis put forth by the SB, the analysis was two-fettered:
- With respect to Section 3(j):
Upon review of the claims and the refusal order, the SB found that the Controller of Patents had violated principles of natural justice by invoking Section 3(j) as a ground for refusal without including it in the objections during the hearing notice. This omission deprived the applicant of the opportunity to address the objection, constituting a breach of natural justice.
- With respect to Section 3(i):
The SB determined that the claims pertained to a method of preparing protein-enriched serum using gold particles, emphasizing that they focused on the process of creating a composition rather than a method of treatment. While acknowledging that the resulting blood serum could potentially be used for transfusions, the SB noted that such transfusions were subsequent steps not covered in the claims. Consequently, the refusal based on Section 3(i) was deemed invalid.
In light of these findings, the SB overturned the refusal order and directed the patent office to reevaluate the application afresh. It instructed the Controller to grant the applicant a hearing and make a decision on the patent application within four months from the date of the hearing.
Comparing the Ideologies of the DHC and MHC for Section 3(i)
The Madras High Court (MHC) had recently issued a comprehensive order concerning Section 3(i) in the case of The Chinese University of Hong Kong and SEQUENOM, INC. versus The Assistant Controller of Patents & Designs. The Appellants challenged the rejection of their patent application for a proposed method of “Fetal Genomic Analysis from a Maternal Biological Sample” by the Respondent at the Patent Office in Chennai.
The respondent argued that this method could identify genetic irregularities in a fetus, classifying it as diagnostic under Section 3(i) and thus not eligible for a patent under the Patents Act, 1970. The appellants contested this, asserting that their method solely identifies the fetal fraction in a maternal sample and is not inherently diagnostic. The invention itself did not directly diagnose diseases or conditions but provided a valuable indicator, the fetal fraction, essential for subsequent diagnostic processes.
The MHC stressed that a process’s ‘diagnostic’ classification is determined by its inherent capability to detect diseases, regardless of its label. The court differentiated between screening and diagnostic tests, clarifying that while the appellants’ method was related to diagnostics, it was not explicitly diagnostic, thus nullifying objections based on Section 3(i) grounds.
Before concluding, the MHC also suggested the refinement of Section 3(i), highlighting potential improvements for treatments and leaving the final decision on such amendments to the competent authorities. The court’s comment was as follows: “My conclusions in this matter are founded on an interpretation of Section 3(i) by examining the text thereof in context. I notice that the Patent Office has granted patents to in vitro processes and there is inconsistency. I also recognise that several technological advancements have been made in diagnosis, especially by using genomic tools With a view to incentivise inventors in these cutting-edge areas, albeit without compromising on the public policy exclusion from patent eligibility of methods of diagnosis and treatment adopted by medical doctors, there is a case to consider options such as restricting the scope of the expression ‘diagnostic’ in Section 3(i) to in vivo processes and counter balancing by providing for compulsory licensing. Since this is squarely within the province of law makers, I stop with urging such reconsideration.”
In light of this case, the DHC’s decision comes out as a step furthering the same ideology of adopting a broader scope for accepting and ensuring that inventions for diagnostic tools lie within the strict confines of Section 3(i). A more liberal interpretation of that provision is likely to disincentivize the patents of such technologies, hampering innovations and medical feats in this domain.
