India: High Court examines the scope of permissible patent claim amendments in the pre-grant stage

In the order dated January 20, 2023, the Hon’ble Delhi High Court (hereinafter referred to as “the Hon’ble Court”) has overturned an order by the Controller of Patents (hereinafter referred to as “the Controller”) against a US-based pharmaceutical company Allergan (hereinafter referred to as “the Applicant”) and has scrutinized the ambit of the permissibility of claim amendments with respect to the originally filed claims under Section 59(1) of the Indian Patents Act (hereinafter referred to as “the Act”).

The Applicant, in its patent application 7039/DELNP/2012 dated August 13, 2012, submitted 20 claims owing to methods for treating ocular ailments using intracameral implants in India, as filed in the US. The Controller in the First Examination Report (hereinafter referred to as “the Office Action”), objected to the claims, holding them non-patentable under Section 3(i) of the Act, as they related to a method of treatment of human beings/animals. Pursuant to the Office Action, the Applicant amended the claims from method claims to product claims related to intracameral sustained release implant for ocular ailment. Thereafter, in the order dated March 30, 2020, the Controller refused the patent application under Section 59(1) of the Act, observing that the amended claims did have any support in the originally filed claims and the claimed intracameral implants in the amended set of claims were not claimed either in Applicant’s PCT or in the Indian application.

According to Section 59(1) of the Act, “No amendment of an application for a patent or a complete specification or any document related thereto shall be made except by way of disclaimer, correction or explanation, and no amendment thereof shall be allowed, except for the purpose of incorporation of actual fact, and no amendment of a complete specification shall be allowed, the effect of which would be that the specification as amended would claim or describe matter not in substance disclosed or shown in the specification before the amendment, or that any claim of the specification as amended would not fall wholly within the scope of a claim of the specification before the amendment.”

The Applicant justified the claim amendments by shedding light on the difference in the patentability regime in the US and in India. Further, the Applicant argued that under Section 138(4) of the Act, while filing a patent application via the National phase in India, it is a prerequisite that the “title, description, claim and abstracted drawings filed in the international application to be taken as the complete specification for the purposes of the Patents Act,” hence barring them from making any amendments at the time of filing. Under Rule 20(1) of the Indian Patent Rules, claim amendments at the stage of filing are only restricted to claim deletions and no other amendments. Therefore, the Applicant submitted that it cannot be faulted for not claiming the amended product claims for the implants at the time of filing the application in India, as there could be no occasion for the Applicant to amend the claims as originally filed in the PCT application in the US.

The Controller, reiterating its position, submitted that amendments sought by the Applicant were beyond the scope of the original claims as filed and hence were not permissible under Section 59(1) of the Act.

Accordingly, the following issues are of note:

The first issue in question was with regard to the difference in patent regimes in the US and India. The Applicant, emphasizing the same, defended the claim amendments, seeking a product patent for the implants instead of claiming the method with respect to the same as originally filed, and in its explanation asserted that the method claims are patentable in the US, whereas they are not patentable in India, by virtue of Section 3(i) of the Act.

As per Section 3(i) of the Act, inventions claiming a method of treatment of human beings or animals are not patentable. The Controller, taking this ground, objected to the method as claimed in the amended claims.

Another pertinent issue contended before the Hon’ble Court was with respect to the use of the expression “scope of a claim” under Section 59(1) of the Act. The Controller was of the view that the amended claims which claimed the “composition of Intracameral Implants” did not have any support in the originally filed claims, and that they had not been claimed either in the PCT claims or while entering the National phase in India.

Court’s observations

The Hon’ble Court in its order observed that the Controller’s interpretation of Section 59(1) of the Act was incorrect and if it is accepted, it would result in the Applicant being foreclosed from seeking a patent in respect of the implants. The order of the Hon’ble Court read that “In such circumstances, the Court is also required to keep in mind public interest, being one of the cardinal aims of patent law, especially where the patent is pharmaceutical or therapeutic in nature.” Relying on the decision of the Co-ordinate Bench of this Hon’ble Court in Nippon A and L Inc v. Controller of Patents (2022 SCC OnLine Del 1909), which highlighted that, “So long as the invention is disclosed in the specification and the claims are being restricted to the disclosures already made in the specification, the amendment ought not be rejected, especially, at the stage of examination prior to grant”, the Hon’ble Court was of the opinion that the Controller ought to have allowed the amendments sought by the Applicant and to have examined the claims as so amended, and their patentability, on merits, and should not have dismissed the amendments merely on the ‘somewhat tenuous’ ground that the Applicant was not entitled to amend its claims in view of Section 59(1) of the Act.

The Hon’ble Court further noted that a large part of the complete specifications in the subject patent dealt with the implants, and their peculiar compositional constitution. Hence, “Dichotomizing the claims and the accompanying specifications is, therefore, contrary to the most fundamental canons of patent law,” and that “the claims and complete specifications in a patent have to be read together and as a whole. The claims have to be understood in light of the complete specifications. They form an integrated whole, and cannot be treated as two distinct parts of one document.”

The Hon’ble Court, setting aside the Controller’s decision, allowed the Applicant to amend the originally filed claims and directed the Controller to conduct a fresh examination with respect to the patentability of the amended claims, taking into account the Act and the principles of natural justice, and following due procedure by providing the Applicant with a fair opportunity to be heard.

This decision reaffirms the position of law with regard to amendments of claims in the pre-grant stage by giving wider and broader permissibility for the same.