In a landmark case, Gilead Pharmasset, LLC v Sankalp Rehabilitation Trust and Ors., the Indian Patent Office (IPO) in Kolkata granted a patent to Gilead Pharmasset, LLC (Gilead), covering the prodrug molecule of anti-HCV drug Sofosbuvir. The IPO rejected all the 13 pre-grant oppositions, filed by various opponents including pharma companies, advocacy groups, and individuals against the patent application. The case spanned a decade.
The patent application was opposed primarily on the grounds of lack of novelty, lack of inventive step, non-patentability under section 3(d), and insufficiency of disclosure and failure to disclose information under section 8 of the Indian Patent Act, 1970. Since these multiple oppositions were filed at varying intervals, the grant proceedings were substantially delayed.
After considering all the materials on record, the Controller of Patents (Controller), held as follows: made the following key findings:
In Kuraray Co. Ltd. and Mebiol Inc. v The Assistant Controller of Patents & Designs, The Patent Office, the Madras High Court ruled in September that the Assistant Controller of Patents & Designs' (Controller) refusal order lacked merit due to insufficient reasoning.
An appeal filed by Raytheon Company (Raytheon) challenged an impugned order dated Oct 17, 2019, issued against its Indian patent application for a method of scheduling in a high-performance computing system. The impugned order refused the grant of Raytheon’s patent application on the grounds of “lack of inventive step” and “non-patentability” under section 3(k) of the Indian Patents Act, 1970.
The Assistant Controller of Patents and Designs (Controller) relied on the following test indicators while deciding on the ground of non-patentability under section 3(k) of the Act:
Based on these test indicators, Raytheon’s patent application was declared solely as software, without having any novel hardware, and that the processor executed programme/algorithm in a conventional manner. Hence, the contribution of Raytheon’s patent application was declared as a non-patentable subject matter, and a grant of patent was refused.
Dissatisfied with the Controller’s decision, Raytheon appealed before the erstwhile Intellectual Property Appellate Board (IPAB). However, with IPAB’s dissolution in April 2021, the case was transferred to the Intellectual Property Division (IPD) of the Delhi High Court.
The appeal contended that:
Based on Raytheon’s contention, the Court analyzed the impugned order and observed that the Controller had indeed tested patentability based on the presence of novel hardware but not on the technical contribution of the invention disclosed in Raytheon’s patent application.
Referring to the updated CRI guidelines of 2017 that stated “Claims which are directed towards computer programme per se are excluded from patentability” [Section 4.5.4], the Court reaffirmed that the to ensure that only computer programmes “as such” are not granted but genuine inventions which are developed based on computer programmes should not be refused patents if they contain certain other things, ancillary thereto or developed thereon. Further, the court ruled that the Controller’s focus should be on the substance of the claims and not on form or presentation. The Court further referred to the interpretation of section 3(k) in the judgments from Ferid Allani v Union of India (Ferid Allani) and Microsoft Technology Licensing v Assistant Controller of Patents and Designs (Microsoft) and clarified that in the case of CRIs, the technical effect of the invention is what needs to be examined and not to insist on a novel hardware requirement.
Relying mainly on the updated CRI guidelines of 2017 and well-settled interpretation of 3(k) in the cases of Ferid Allani and Microsoft, the Court declared that the Indian Patent Office (IPO) was in error as it failed to examine the patentability of the invention based on the underlying subject matter and the technical contribution of the invention, and thereby set aside the impugned order. Keeping in mind the time elapsed since the filing date of Raytheon’s patent application, the Court directed the IPO to re-examine and dispose the Raytheon’s patent application within three months from the date of the Court’s order.
By emphasizing the significance of an invention’s technical contribution or technical effect over the mere presence of novel hardware, the Court has provided clearer guidance for CRI-related patent evaluations. This reaffirmation of focus is likely to have a profound impact on software-centric innovations, ensuring that genuine technical advancements receive the patent protection they deserve, without insisting upon the requirement of novel hardware. As a result, applicants’ can now approach the IPO with greater clarity and confidence, knowing that their software inventions will be assessed based on technical merits by following the latest CRI guidelines rather than expecting innovation on hardware systems which is nothing but a higher standard that has no basis in the patent law.
In August, the Delhi High Court underscored the importance of adhering to patent opposition procedures outlined in the Patent Rules,2003, particularly Rules 55A to 62, setting a significant precedent for forthcoming patent disputes. The case at the centre of this development is Akebia Therapeutics Inc. (Akebia) v Controller General of Patents, Design, Trademark and Geographical Indications, & Ors.
The case revolved around a post-grant opposition filed by an opponent against Akebia’s patent pertaining to specific compounds used in medical research and treatments. The said post-grant opposition was filed under Rule 57 with contentions and documents, but no affidavit to support the contentions. Akebia responded under Rule 58, refraining from providing evidence due to the absence of an affidavit in the opponent’s filing. Subsequently, the opponent submitted a rejoinder under Rule 59, seeking to substantiate their Rule 57 contentions. Akebia objected, contending that Rule 59 did not permit new evidence in responses, and urged the Opposition Board not to assess the opponent’s challenges unless Akebia had an opportunity to present evidence. However, the Controller rejected these objections wherein arose the instant writ petition before the Delhi High Court.
The Court carefully examined the legal framework governing post-grant patent oppositions as defined by the Patents Act, 1970, and Patent Rules. In its ruling, the Court sided with Akebia and emphasized the need for practitioners, especially opponents, to strictly adhere to the following statutory provisions:
(a) Affidavit Requirement (Rule 57): The Court clarified that documents submitted as part of a post-grant opposition under Rule 57 cannot be considered as evidence, as defined under section 79, unless supported by an affidavit. Without such supporting affidavits, these documents cannot be considered by the Opposition Board.
(b) No Late Affidavits (Rule 59): The Court ruled that the opponent cannot rectify the absence of an affidavit by filing a supporting rejoinder affidavit under Rule 59 subsequent to the submission of the patentee’s reply.
(c) Limited Additional Evidence (Rule 59): The Court clarified that the opponent can only introduce further evidence strictly confining to the matter submitted by the patentee in their reply statement filed under Rule 58.
Recommendations of the Opposition Board: The Court, referring to the Supreme Court’s judgement in Cipla Ltd v Union of India, also highlighted the recommendations of the Opposition Board have “great persuasive value” and are “crucial” in the Controller’s decision-making process. Further, the Court directed a fresh decision by the Opposition Board to ensure a fair and just decision-making process.
The Court also called upon the Controller General to ensure strict compliance with the provisions of the Patents Rules, particularly Rule 57, when handling post-grant oppositions, highlighting the pivotal role of the Opposition Board’s recommendations in shaping judgment outcomes.
This ruling serves as a notable precedent, emphasizing the critical nature of meticulous adherence to patent opposition procedure under the existing legal framework.