In the matter of Arthrogen GMBH (‘Appellant’) v Controller General of Patents, Designs and Trademarks and Anr (‘Respondents’) [C.A.(COMM.IPD-PAT) 415/2022], the Delhi High Court, vide its order dated 05.02.2024, set aside the Respondents impugned order dated 28th November 2019 and remanded the matter to the Respondents for de novo consideration while restoring the patent application for the subject patent to its original number.
The present appeal was directed against the Respondents decision dated 28th November 2019 rejecting the Appellant’s invention as non-patentable under section 3(j) and 3(i) of the Indian Patent Act.
The Appellant contended that for the present patent application the First Examination Report [FER] was issued on 23rd April, 2018 on the basis of originally filed thirty-one claims and objections of non-patentability were raised under Section 3(c), (d), (e), (f) and (j) of the Act in the FER. Further, the Appellant had filed a reply to the same and revised the claims to comply with the objections raised in the FER. Thereafter, a hearing notice was issued and besides other objections, non-patentability objections were raised under Section 3(b) and (i) of the Act. The Appellant attended the hearing and filed its written submissions post hearing but the Respondents refused the said application under section 3(j) and 3(i) of the Indian Patent Act.
The Appellant submitted that while the refusal order cited section 3(j) as one of the grounds for refusing its patent application, but the said section 3(j) was not even included as a ground for objection in the hearing notice. The Appellant further submitted that had such an objection been mentioned in the Hearing Notice, the Appellant would have had a chance to adjust the claims accordingly. Therefore, because of failure to raise this objection in the hearing notice, the Appellant was deprived of the opportunity to properly address and revise the claims in response and hence the impugned order, to that extent, was in violation of the principles of natural justice.
With regard to the objection under section 3(i), the Plaintiff contended that the Respondent No. 2 had failed to take note of the fact that the Appellant had not made any claim to the effect that “then blood or blood serum is used for autologous or homologous blood transfusion”. It was further contended that the Respondent No. 2 had failed to see the difference between “method of treatment” and “method for producing a substance or composition which may have a specific use in a method of surgery, therapy or diagnosis” and the present invention falls under the latter category thereby making the objection of non-patentability clearly a misdirection on the part of Respondent No. 2.
The Court, after considering the above-mentioned contentions, acknowledged that it was not disputed that the said Hearing Notice did not raise any objection under Section 3(j) of the Act but was one of the grounds for rejecting the application. In this regard, the Court was of the opinion that the Appellant was not afforded an opportunity to contest the said ground which is an evident violation of principles of natural justice.
With regard to objection under section 3(i) of the Indian Patent Act, the Court was of the view that the claims of the Appellant’s invention clearly articulate a method for producing a protein-enriched blood serum using gold particles and this process is claimed to be an innovative method that results in a novel composition—protein-enriched blood serum. The Court further observed that “the potential use of this serum could be for autologous or homologous blood transfusion. However, that is an application of the product, rather than the claimed invention itself. Therefore, the invention does not claim a “method of treatment” but rather a “method of producing” a specific substance, which is a significant distinction that affects its patentability. Respondent No. 2 has failed to take note that “the protein enriched blood or blood serum is used for autologous or homologous blood transfusion”1 is not part of the claims. Respondent No. 2’s failure to recognize this distinction has led to an erroneous application of section 3(i) of the Act. It overlooks the fact that the process itself, as claimed, is directed towards the production of a novel composition, and not towards direct treatment of human beings or animals. Therefore, the objection of non-patentability is clearly a misdirection on the part of Respondent No. 2.”
The Court concluded that the objection under section 3(i) of the Act should be reconsidered in light of the clear distinction between a method of treatment and a method of producing a novel substance. The Appellant’s invention falls squarely within the latter category. Thus, in the opinion of the Court, “the impugned order deserves to be set aside with following directions:
- The impugned order dated 28th November 2019 is set-aside and the matter is remanded to the Respondents for de novo consideration.
- The patent application for the subject patent is restored to its original number.
- Prior to deciding the matter afresh, Appellant shall be granted a hearing, and the notice of such hearing must clearly delineate the objection(s), if any.
- After completion of hearing, the decision thereon shall be rendered within a period of four months from the date of conclusion of hearing.
- The Respondent shall decide the application uninfluenced by any observations made in the impugned order and all rights and contentions of the parties are left open.”
The present order helps in better understanding the distinction between a method of treatment and a method of producing a novel substance that may have a specific use in a method of treatment while determining the non-patentability of the applications under section 3(i) of the Indian Patent Act.
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