Introduction

This article examines the decision made by Hon’ble High Court of Delhi (‘High Court’) on an appeal[1] filed under Section 117A of the Patents Act, 1970 (‘Act’). The appeal was filed by Societe Des Produits Nestle Sa (‘Appellant’) seeking to set aside an order passed by the Controller of Patents and Design (‘Respondent’) refusing the grant of the Appellant’s Patent Application for lacking inventive step and for not being patentable under Section 3(i), Section 3(e), and Section 59 of the Act. The High Court after considering the facts of the case, decided that the assessment of the claimed invention by the Respondent was erroneous and directed that the Patent Application may proceed for a grant. The High Court has redefined the boundaries of permissible claim amendments for overcoming the objections on non-patentability especially Section 3(i) of the Act without jeopardizing the requirements of Section 59 of the Act. Therefore, the primary focus of this article is on the interpretation of Section 3(i) and Section 59 of the Act provided by the High Court.

Facts of the case

The Appellant filed a Patent Application titled ‘Composition for use in the Prophylaxis of Allergic Disease’ bearing an application number 201817040811 (‘Application’), which is a National Phase Application arising out of PCT international Application No. PCT/EP2017/055680. A First Examination Report (‘FER’) was issued, wherein the Respondent objected to the lack of novelty and inventive step under Sections 2(1)(j) and 2(1)(ja) and non-patentability under Sections 3(e) and 3(i) of the Patents Act. The Appellant filed a response to the FER along with the amended claims, post which the Respondent issued a Hearing Notice, reiterating the objections raised in the FER. A hearing was conducted, and thereafter written submissions were filed by the Appellant.

The Respondent after reviewing the Appellant’s written submission and claim amendments refused to grant the Application under Sections 2(1)(ja) and Section 3 of the Act. In addition, the Respondent cited Section 59 of the Act as a ground for refusing the application. With respect to the objection under Section 3(i) of the Act, the explanation provided by the Respondent was that the Appellant defined a method for ‘treatment of human body’ and the claims were therefore, not patentable, specifically stating that subject-matter protected by the original claim was a ‘composition, when used in treatment’ and therefore contained both ‘composition’ and ‘method features’. With respect to Section 59 of the Act, the Respondent alleged that the amended claims filed by the Appellant were not permissible as they sought to confer greater scope of protection, in comparison to the originally filed claims, which Section 59 of the Act prohibits. The Respondent further alleged that the claims as originally filed conferred protection upon the compound only when it was in use so as to carry out the method of treatment, whereas the proposed amended claims would confer protection upon the composition whether or not it was in use and would therefore confer additional protection compared to the claims as originally filed. Thus, the Respondent asserted that the objection under Section 3(i) of the Act was maintained in view of the objection raised under Section 59 of the Act.

Aggrieved by the decision of the Respondent, the Appellant filed the appeal, seeking to set aside the refusal order issued by the respondent.

The intersection between Section 59 and Section 3(i) of the Act

While arguing the matter, the Appellant’s counsel expressed that the as-filed claim 4, was directed towards a ‘composition’ and not towards a ‘method of treatment’, thus there was no change in the scope of the claims and the description. Secondly, the Appellant submitted that the amendments in the claims were carried out to overcome the objections raised by the Patent Office in the FER and the Hearing Notice and the same were within the scope of the originally filed claims and therefore, permissible under Section 59 of the Act.

The counter arguments provided by the counsel for the Respondents were that the body of the claims filed in response to the FER recited: ‘for use in the prophylaxis of allergic disease in an offspring of a mammalian subject, comprising administration of the composition to said subject pre-pregnancy and/or during pregnancy and/or during lactation’ thereby, defining medicinal use in terms of the method of treatment/prophylaxis, which is a non-patentable as per Section 3(i) of the Act.

With respect to the objection on claim amendments, the Respondents’ counsel submitted that the claims were amended from being ‘purpose-limited’ product claims to ‘pure composition’, expanding the scope of the original claims and thus, contravened Section 59 of the Act. The Respondent alleged that the claims submitted along the written submission after attending the hearing, were amended by the Appellant to omit the phrase ‘for use…’ to overcome the objection under Section 3(i) of the Act raised in the Hearing Notice. The High Court examined the facts of the case and provided an independent analysis of Section 3(i) and Section 59 of the Patents Act.

The High Court’s analysis of Section 3(i) of the Act

At the outset, the High Court established that as per Section 3(i) of the Act any claim directed towards a process for the prophylaxis or prophylactic treatment is not patentable. The High Court then referred to the judicial order passed in University of Miami v. Controller of Patents[2] and pointed out that in said case also, while dealing with the ground of rejection under Section 3(i) of the Act, the erstwhile Intellectual Property Appellate Board (IPAB) clarified that the mere use of expression ‘treatment’ in the claim does not render a claim falling under Section 3(i) of the Act. Similarly, the expression ‘composition for the treatment’ is only a way of defining the composition and in no way the claimed composition can be a method performed by a physician for treatment of disease. The High Court also relied on the road map laid down by Manual of Patent Office Practice and Procedure (‘Manual’)[3], which gives guidance for examination with respect to exclusion of medical, surgical, curative, prophylactic, diagnostic, therapeutic or other treatment.

Considering the above, the High Court stated that the previously filed claims were in respect of a composition and not towards a process of prophylactic treatment. The High Court specified that the expression ‘composition comprising …. directed towards treatment‟ was used only for defining the composition and not directed towards a method of treatment. The High Court thus concluded that since the claims on record were directed to a composition for use in treatment, the same did not fall under the ambit of Section 3(i) of the Act. Thus, there was no merit in the decision of the Respondent to refuse the application under Section 3(i) of the Act.

The High Court’s analysis of claim amendments.

The High Court primarily acknowledged that the Appellant filed amended claims on account of an objection raised by the respondent under Section 3(i) of the Act, in the Hearing Notice, whereby the original scope of the claims stood expanded, as instead of being a purpose-related claim, it became a general claim over the composition, which became the basis for the Respondent to reject the patent Application under Section 59 of the Act. The Respondent had further taken issue to the fact that during the proceedings, the Appellant had resorted back to the purpose-limited composition claims similar to the claims submitted in response to the FER, citing that there is no provision in the Act which permits the courts to allow any amendment at the stage of appellate proceedings.

The High Court relied on the Act and several judicial orders to point of some fundamental aspect related to amendments of a Patent specification and carved out some important points while considering the instant case:

1. A request for amendment can be made even after the grant of patent.

The High Court stressed upon the fact that there is no provision in the Act, which specifically bars the amendment of a patent specification at the appellate stage. Sub-section 3 of Section 57 of the Act clearly indicated that an amendment can be made even after the grant of patent.

2. An amendment to the specification can be allowed in the proceedings before the High Court.

The High Court relied on sub-section (1) of Section 58 of the Act and stated that the High Court can allow an amendment to the specification in a matter before the High Court at the stage of revocation of a patent. Accordingly, there is no specific bar for the amendment even at a subsequent stage. The only requirement under the Act is that the amendment has to fulfil the requirements under Section 59 of the Act and the amended claims are consistent with the earlier claims in the original specification.

3. The High Court has similar powers as those granted by Section 15 of the Act to the Controller.

The High Court mentioned that as per Section 15 of the Act, a Controller has been given the power to require an application to be amended to his satisfaction. Therefore, it is understood that if the Controller has been given the power to direct an amendment to the patent Application, the High Court, which is sitting in appeal over the decision of the Controller, should also have similar powers to direct the patent Applicant to amend claims to its satisfaction. The High Court also made a reference to the recent judgement of the Supreme Court in Ramnath Exports Pvt. Ltd. v. Vinita Mehta & Anr, (2022)[4] which clarified that an appeal is a continuation of the proceedings of the original court. A similar position was also held in the matter of AGC Flat Glass Europe SA v. Anand Mahajan and Ors.[5], where a Single Judge of the High Court allowed amendments to the claims of a patent specification when an interim injunction application was being considered, so long as the amendment was in conformity with Section 58 and 59 of the Act.

In this view, the High Court stated that in an appeal considering the issue of the grant of a patent, the High Court is entitled to the same powers as those of the Controller, which includes the power to amend the patent application. Further, since the appellate proceedings are challenging the refusal of grant of a patent, questions of facts need to be re-examined comprehensively and therefore, a liberal view has to be taken with regard to amendment of claims. Therefore, the Appellant resorting back to the previously filed claims is fully covered under Section 59 of the Act. Moreover, as the objection because of which the amendment was filed had been set aside, it was in the interest of justice to allow the amendment at appellate stage.

Conclusion

Considering the High Court’s decision, it is now clear that the Applicants can file claim amendments to overcome the non-patentability objections, such as Section 3(i) of the Act per the Indian Patent Law, keeping in view the boundaries of Section 58 and 59 of the Act. Further, this decision also clarifies that product claims cannot and must not be objected under Section 3(i) of the Act, since the said Section only refers to claims directed to a process.

[The authors are Patent Analyst, Senior Patent Analyst, Director and Executive Director, respectively, in IPR practice at Lakshmikumaran & Sridharan Attorneys]

1. [1] C.A.(COMM.IPD-PAT) 22/2022, I.A. 5588/2022 (stay), I.A. 5589/2022 (O-XI R-1(4) of CPC) and I.A. 16487/2022 (of waiver of costs)
2. [2] OA/33/2015/PT/KOL - University of Miami v. Controller of Patents
3. [3] Manual of Patent Office Practice and Procedure (‘Manual’) issued by the office of the CGPDTM on 26th November 2019
4. [4] Ramnath Exports Pvt. Ltd. v. Vinita Mehta & Anr, (2022) 7 SCC 678
5. [5] Order dated 10th September 2009, in CS(OS) 593/2007 titled AGC Flat Glass Europe SA v. Anand Mahajan and Ors