High Court examines the scope of permissible patent claim amendments in the pre-grant stage in the application 7039/DELNP/2012
In the order dated January 20, 2023, the Hon’ble Delhi High Court (hereinafter referred to as “the Hon’ble High Court”) has reverse an order passed by the learned Controller of Patents (hereinafter referred to as “the Controller”) against a pharmaceutical company Allergan (hereinafter referred to as “the Applicant”) and has scrutinized the scope of the admissibility of claim amendments with respect to the originally filed claims under Section 59(1) of the Indian Patents Act, 1970 (hereinafter referred to as “the Patent Act”).
The Applicant, in its PCT national phase patent application 7039/DELNP/2012 (claiming the priority of its US application) filed before the Indian Patent Office on August 13, 2012. Said patent application comprising 20 claims revealing the methods for treating ocular ailments using intracameral implants. The learned Controller in the First Examination Report (hereinafter referred to as “the Office Action”), objected that the claims as disclosed in the application are related to a method of treatment of human beings or animals and so the claims are non-patentable under Section 3(i) of the Patent Act.
In response to the Office Action, the Applicant has amended the claims and the amended claims are now related to the product claim instead of the method claims (as filed). The amended claims are now disclosing intracameral sustained release implant for ocular ailment. In response to the reply to the office action, the learned Controller on March 30, 2020, refused the patent application under Section 59(1) of the Patent Act, observing that the amended claims are beyond the scope as they don’t have the support from the originally filed claims.
The Applicant justified the claim amendments by pointing out the differences in the patentability rules between the US and India. They explained that, according to Section 138(4) of the Indian Patents Act, when filing a patent application in India through the National phase, the international application’s title, description, claims, and abstracted drawings must be considered as the complete specification, preventing amendments at the time of filing. Rule 20(1) of the Indian Patent Rules further restricts claim amendments at the filing stage to only claim deletions. Therefore, the Applicant argued that they cannot be held responsible for not claiming the amended product claims for the implants during the initial filing in India, as there was no opportunity to amend the original claims filed in the PCT application.
The Controller, reiterating its position, submitted that amendments in the claims were beyond the scope of the originally filed claims and hence not allowable under Section 59(1) of the Patent Act.
There are two major questions over there:
The first question was related to the difference in patent regimes in the US and India. In the priority application which was filed in the US is claiming the method of treatment, as the US patent law allowing such claims. Contrarily, in India invention claiming method of treatment of human beings or animals are not patentable under section 3(i) of the Patent Act. Therefore, the applicant at the time of the examination, amend the claims and claiming the product rather than method.
Another question indicated before the Hon’ble High Court was related to the use of the term “scope of a claim” under Section 59(1) of the Patent Act. The learned Controller was in the opinion that the amended claims don’t have support from the originally filed claims. Further, the amendments were not claimed either in PCT application claims or while entering into the India as national phase application.
Court’s observations
The Hon’ble High Court in its order observed that the Controller’s interpretation of Section 59(1) of the Patent Act was incorrect and if it is accepted, it would result in the Applicant being prevented from seeking a patent in respect of the implants. The order of the Hon’ble High Court read that “In such scenarios, the Court should keep in mind the public benefits, particularly where the patent is pharmaceutical or therapeutic in type.” 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), the Hon’ble High Court was of the opinion that the Controller should 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 ground that the Applicant was not entitled to amend its claims in view of Section 59(1) of the Patent Act.
The Court observed that the patent’s complete specifications disclosed the implants and their composition, emphasizing that separating the claims from the specifications goes against fundamental patent law principles. The claims and complete specifications must be read together as an whole and cannot be treated as separate parts of the document.
The Hon’ble High 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 Patent Act and the principles of natural justice, and following due procedure by providing the Applicant with a fair opportunity to be heard.
This decision rechecks the position of law concerning amendments of claims in the pre-grant stage by giving broader permissibility for the same.
By: Harsh Parikh and Sanjaykumar Patel (Excelon IP)