Citation: C.A.(COMM.IPD-PAT) 415/2022 Arthrogen GmbH vs. Controller of Patents, Design and Trademark, 5 February, 2024
The appeal under Section 117A of the Patents Act, 1970 challenges the rejection of Indian patent application No. 11377/DELNP/2012 by Respondent No. 2, the Controller of Patents, based on Sections 3(j) and 3(i) of the Act.
Appellant’s Details and Patent Application:
Arthrogen GmbH, a German company, filed the patent application for a method involving the production of protein-enriched blood serum using gold particles. The application included several claims, including methods and product claims related to the protein-enriched blood serum.
Claim 1: 1. A method of producing a protein enriched blood serum comprising the steps of: collecting a blood serum; mixing the blood serum and gold particles in a container; incubating the blood serum and gold particles to produce protein-enriched body fluid serum; and removing the gold particles from the protein enriched blood serum.
Initial Objections and Response:
Following the First Examination Report (FER), objections were raised under Sections 3(c), (d), (e), (f), and (j) of the Act. Arthrogen submitted revisions to the claims to address these objections. Subsequently, a hearing was held where additional objections under Sections 3(b) and (i) were raised.
Impugned Order and Grounds of Rejection:
The impugned order, dated 28th November 2019, cited non-patentability under Sections 3(j) and 3(i) of the Act. It focused on the method claims which described the steps of collecting blood serum, mixing it with gold particles, incubating to enrich protein, and removing the particles.
Appellant’s Arguments:
Procedural Issue – Objection Under Section 3(j):
Arthrogen’s counsel argued that objections under Section 3(j) were not included in the hearing notice, depriving them of an opportunity to address these during the hearing. This omission was seen as a violation of natural justice principles.
Nature of Invention – Method of Production vs. Method of Treatment:
Counsel emphasized that the claims did not pertain to methods of treatment but rather described a method for producing protein-enriched blood serum. They asserted that the invention focused on a novel substance and its production method, not direct therapeutic applications on humans.
Comparison with International Standards:
Arthrogen’s counsel pointed out that similar patents were granted in other jurisdictions, including the European Union, where the invention was categorized differently, not falling under methods of treatment. This comparison aimed to illustrate the discrepancy in interpretation between jurisdictions.
Respondent’s Defense:
The Controller of Patents defended the rejection, arguing that the method claims implied uses that could be construed as methods of treatment under Section 3(j) of the Act. They maintained that the application did not strictly adhere to the distinction between methods of production and methods of treatment.
Court’s Analysis and Ruling:
Procedural Irregularity – Failure to Raise Objection:
The court acknowledged the procedural lapse in not including objections under Section 3(j) in the hearing notice. This oversight was deemed a violation of natural justice, as it hindered Arthrogen’s ability to respond effectively.
Interpretation of Section 3(j) – Method of Treatment Clarification:
The court examined the nature of Arthrogen’s invention and distinguished between methods of treatment and methods of production. It clarified that Section 3(j) applies strictly to methods directly involving treatment or diagnostic methods on humans or animals.
The Court stated that the claims relate to a method of preparing protein enriched serum using gold particles. As per the Court, the claims relate to a method of making a composition, and do not relate to a method of treatment. Though the blood serum produced from the method can be used for homologous or autologous blood transfusion, the Court pointed out that transfusion is a subsequent step, which is not covered in the claims. Therefore, the Court stated that the refusal based on Section 3(i) is not valid.
Comparative Jurisdiction Analysis:
Drawing upon decisions from other jurisdictions, the court highlighted that patents were granted where the invention did not fall under methods of treatment. This comparative analysis reinforced the view that the rejection under Section 3(j) in India did not align with international standards.
Court’s Decision and Directions:
Given the procedural lapse and the incorrect application of Section 3(j), the court set aside the impugned order. The case was remanded to the Controller of Patents for fresh consideration, with clear directions to outline all objections in the hearing notice. Arthrogen was granted a fair opportunity to address these objections, and a decision on the patent application was mandated within a specified timeframe.
Conclusion:
The judgment in Arthrogen GmbH vs. Controller of Patents underscores the importance of procedural fairness and the correct interpretation of patentability criteria under the Indian Patents Act. It clarifies that methods of treatment under Section 3(j) must involve direct interaction with human or animal bodies, distinct from methods of producing substances. The court’s decision ensures that patent applicants are given adequate opportunity to respond to objections raised, aligning with principles of natural justice and international standards of patent law.
[Disclaimer: The author provides this information to the best of their understanding and interpretation for public information. Readers are advised to refer to the full order/judgment for their own interpretation.]
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