Adhere to the patent rules or else

Delhi High Court stressed the importance of following the Patent Rules, 2003 (rules), and the significance of compliance in the recent case of Akebia Therapeutics Inc v the Controller General of Patents, Design, Trademark and Geographical Indications and Ors.

The case concerned a patent granted in 2017. The opponent, a respondent in the case, submitted documents in September 2018. The patentee petitioner provided their reply statement in January 2019. The opponent then submitted a rejoinder and an expert affidavit in February 2019. In April 2019, the patentee lodged miscellaneous petition 1, raising objections regarding the opponent’s affidavit. The patentee, in February 2020, applied in miscellaneous petition 2 to introduce additional evidence. The patentee contended that the post-grant opposition was based on insufficient evidence. The post-grant opposition introduced specific documents but lacked supportive evidence.

The petitioner contended that the documents were not produced by affidavit, a requirement of rule 57 of the rules. They argued that this deprived them of the opportunity to respond with evidence, as allowed by rule 58. The procedural deficiencies compromised a fair assessment of the opposition.

The respondent accepted that the opposition documents were not produced by affidavit and did not meet the requirements of rule 57. However, they pointed out that the petitioner could have sought to adduce additional evidence under rule 60 but chose not to do so. The respondent submitted a rejoinder to the petitioner’s reply statement, supported by an expert affidavit. They argued that the procedural irregularities did not prejudice the petitioner and that remedies were available to address these concerns.

Rule 57 details the submission of evidence in a post-grant opposition. Section 79 of the Patents Act, 1970 sets out the requirements for filing evidence. Evidence must be adduced by affidavit. Documents submitted other than by affidavit are not evidence under rule 57. The court relied on authorities such as Taylor v Taylor and State of U.P. v Singhara Singh to emphasise that when the law prescribes a procedure, it must be followed precisely or not at all. The court also analysed rule 61, distinguishing between evidence submitted under rules 57 to 60 and documents referred to by that evidence.

Rule 58 requires the patentee to submit a reply statement accompanied by evidence, if any, to support their case. Rule 59 allows the opponent to provide further evidence strictly limited to the matters presented in the patentee’s evidence. The court held that rule 59 cannot be interpreted as the filing of a rejoinder.

The Court held that the opponent had to provide evidence with their opposition document. Subsequently, the patentee submitted no evidence with their reply statement. The petitioner argued that the opponent should not have been allowed to submit the expert affidavit as evidence in response to the reply, let alone a rejoinder. The patentee applied to present additional evidence under rule 60.

The Opposition Board in considering the matters raised by the respondents had taken into account their documents and the reply statement. The court quashed the board’s recommendations, holding that the prescribed evidence had not been submitted.

The court stressed the importance of strictly following the rules, especially rule 57, in both pre- and post-grant oppositions. However, the court followed the Supreme Court case of Cipla Ltd v Union of India in accepting the relevance and persuasive value of the board’s recommendations. The Supreme Court confirmed the pivotal role these recommendations play in the final decision. The high court emphasised that the legislation ensures fairness and procedural integrity. Strict adherence to the procedure is necessary, to prevent bias and ensure an impartial and equitable process.

The court ordered that the expert affidavit, the opposition documents and the petitioners’ reply statement be considered by the board. The patentee was also allowed to submit further evidence to the board.

This decision has resulted in much-needed clarity regarding the rules and procedures for patent oppositions. This and other judgments have simplified the patent landscape and ensured consistency, allowing accountability and transparency for all parties, including the Patent Office.

Manisha Singh is a partner and Shilpa Priyadarsini is a managing associate at LexOrbis.