Madras High Court Ruling on Section 59 of the Patents Act

By Aastha Suri and Rashmi

Introduction

In this article, the Hon’ble Madras High Court clarifies the most perplexing questions regarding the scope of claims amendments of originally filed patent application, in light of section 59(1) of the Indian Patents Act. This judgment highlights the importance of considering the substance of patent amendments rather than rejecting them solely based on the amendments from “method claims” to “composition claims” under Section 59 of the Patents Act. This judgment also emphasizes the need for a comprehensive examination of all objections raised during the patent application process.

BRIEF OVERVIEW OF THE MATTER

The applicant filed a national phase patent application bearing application number 201647000423, titled “COMPOSITIONS AND METHODS FOR TREATING ANEMIA” on January 06, 2016, with the Indian Patent Office (IPO). The Indian patent application was published in patent journal dated July 01, 2016. Subsequently, a First Examination Report (FER) was issued by the Assistant Controller on January 08, 2019, citing objections pertaining to lack of novelty, inventive step, and on the ground of non-patentability under Section 3(i) and 3(d) of the Patents Act, 1970. The applicant filed a response to the FER along with an amended set of claims on October 07, 2019. Thereafter, a second extended hearing notice was issued u/s 14 by the Controller of Patents & Designs on October 05, 2021, after filing a request for adjournment of hearing by the applicant under rule 129A on October 04, 2021. The objections under Section 2(i)(j), Section 3(i) and 3(e) and section 59 of the Patents Act were again cited by the Controller in the hearing notice.

The details of the subject patent application are provided herein below:

ORDER PASSED BY THE ASSISTANT CONTROLLER REFUSING THE PATENT APPLICATION

After considering the written submissions filed by the applicant on November 18, 2021, the Learned Controller an order dated November 26, 2021, wherein it was held that the objection of formal requirements cited in the hearing notice was not met as the amendments made in the claims at the time of FER reply including amending the preamble of claim 1 from “A method of treatment anemia” to “a pharmaceutical composition” are not allowable under Section 59 read with Section 57 of the Patents Act. Therefore, the application was refused by the Learned Controller under Section 15 of the Patents Act.

APPEAL FILED BY THE APPLICANT

An appeal was filed by the applicant (hereinafter referred to as Appellant) before the Hon’ble Madras High Court against the order passed by the Learned Controller (hereinafter referred to as Respondent).

SUBMISSIONS MADE BY THE APPELLANT DURING THE COURT’S PROCEEDING

• The Learned senior counsel of the appellant submitted that as per section 138(4) of the Patents, Act, 1970, the appellant was required to file the same specification as in the original PCT application while entering the national phase in India.
• The preamble of originally filed claim 1 was amended from “A method of treatment anemia” to “a pharmaceutical composition” at the time of filing of FER reply.
• The claims amendments fall substantially within the scope of the originally filed claims and completely within the scope of the originally filed complete specification. A comparison table showing the similarities between the originally filed claim 1 and amended claim 1 was also provided in the written submissions filed on November 18, 2021.
• The Learned senior counsel further cited the case law of Allergan Inc. v. The Controller of Patent case, submitting that the principles of this case law decision directly apply to the present case, particularly regarding the interpretation of Section 59 of the Patents Act.

RESPONDENT’S SUBMISSION TO THE APPEAL FILED BY THE APPELLANT

• The respondent submitted that the main objection under Section 59 was that the amended claim 1 claims “a pharmaceutical composition”, in contrast to the originally filed claim 1, which pertained to “a method of treating anemia”.
• The respondent further submitted as per Section 59(1) of the Patents Act amendments are only allowed by way of disclaimer, correction, or explanation, and the amendment from “a method claim” to “a composition claim” falls beyond this scope.

JUDGMENT PASSED BY THE HON’BLE MADRAS HIGH COURT

Upon considering contentions from the Appellant and the Respondent, the Hon’ble High Court examined Section 59(1) of the Indian Patents Act, 1970 and its interpretation in previous judgments, particularly the Allergan case from the Delhi High Court. The Hon’ble High Court noted that in Allergan case law, it was concluded that amended claims cannot be rejected under Section 59 solely on the ground that a method claim is amended by the applicant to a product claim or composition claim.

The Hon’ble High Court states that amendments under section 59 are allowed by way of disclaimer, correction, or explanation, which imply that the amendments cannot modify the specification in a manner that introduces new claims or describes new matter that was not disclosed in the original filed application.

Upon comparing the originally filed claims with the amended claims, the Hon’ble High Court found that while the nature of the claims changed from “a method of treating anaemia” to “a pharmaceutical composition”, which may be used to treat anaemia, the scope remained essentially the same. The Hon’ble High Court determined that this rejection is not tenable under section 59 of the Act, based on the interpretation of Allergan case and its own previous decision in Commonwealth Scientific & Industrial Research Organization and Anr. v. The Assistant Controller of Patents & Designs.

The Hon’ble High Court further noted that other objections raised by the Controller pertaining to lack of inventive step, non-patentability under Sections 3(i) and 3(e) were not discussed in the impugned order, requiring a remand of the matter.

The Hon’ble High Court set aside the Controller’s order dated November 26, 2021, refusing the patent application and the matter was remanded for reconsideration by another Controller other than the Controller who issued the refusal order. The Hon’ble High Court further stated that the appellant should be given a reasonable opportunity to present their case and a decision with proper reasoning should be made within four months from the date of receipt of this order. The Hon’ble High Court clarified that no observations were made on the merits of the patent application itself.[1]

CONCLUSION

The Hon’ble Madras High Court’s judgment in the case of Akebia Therapeutics, INC. vs The Controller of Patents and Designs brings clarity to the scope of allowable claim amendments in light of Section 59(1) of the Patents Act. This ruling considerably broadens the permissible amendments to claims according to Section 59(1) of the Act. The court’s decision emphasizes the importance of considering the substance of patent amendments and clarifying that amendments from one claim type to another claim type such as from method claims to composition or product claims fall within the scope of originally filed claims under 59(1) of the Act. This judgement reflects the court’s balanced approach, addressing the procedural issue while ensuring a fair reconsideration of the patent application on its merits. This judgement sets a precedent for more rigorous and transparent patent examination processes in India leading to more flexible approaches to claim amendments, potentially benefiting both the inventors and the patent system.

[1] https://indiankanoon.org/doc/167707702/