The hon’ble IPAB has allowed an appeal filed by the appellant, Pharmacyclics LLC, against the Order dated 04/03/2020 issued under Section 25(2) revoking Indian Patent no. IN 262968. The patent covers, amongst other compounds, a compound having an International Non-Proprietary Name (INN), IBRUTINIB, which is an active pharmaceutical ingredient (API) of the drug IMBRUVICA®, that is useful for the treatment of disease associated with B-cell malignancies.

The appellant made many submissions in the matter in favour of the invention, bit in particular highlighted few facts that showed the strength of the: a) It has been granted over 87 countries. b) The said patent is an “old patent” and 14 years of the term of the said patent are already over. c) The said patent relates to a new chemical entity and has not been invalidated in any of the countries. d) The Opposition Board Recommendation have clearly held that “the present patent be maintained”.  Additionally, Ibrutinib is the first of its kind irreversible BTK inhibitor to be approved by any regulatory agency in the world.

While deciding the appeal hon’ble IPAB provided certain guidelines for post grant opposition and directed the same to be included in the Manual of the Patent Office:-

• Rule 60 brings an end to filing any further evidence without the leave of Controller;
• It is very clear that whatever evidence need to be filed by either party; whether as per Rules 57-59 or with leave of Controller under Rule 60, must be filed prior to the date when the Controller has fixed the hearing under rule 62;
• It is implied that after the date of hearing is fixed no evidence by either party is admissible as per the provisions of the Patents Act and the Rules
• If the hearing is re-fixed to some other date, the new date so rescheduled cannot be taken into account for the purpose of Rule 60.As, when the Controller fixed the first hearing, he/she was already in possession of the recommendation of the opposition board, constituted under the provisions of the Acts and Rules,
• As per Rules, once the procedure of tendering the evidence is complete up to Rule 60, no further/ additional evidence can be brought on record by any party except publication which are in public domain being small window available under Rule 62(4). For the same, 5 days’ notice before the date is necessary. If no notice is given, even publication may not be considered by the Controller once the hearing is fixed under rule 62(1) of the Rules;
• It is mandatory for the Controller to take the recommendation of the opposition board into consideration. In either case of his agreement or disagreement his clear view is required to be annotated. If this is not happening then the whole spirit of the law, having double check (opposition board and controller), is likely to lose its meaning.

The Hon’ble IPAB also relied on Hon’ble High Court of Delhi in W.P.(C) 12105/201910 wherein such guidelines are formulated.

The other factual details of the case are discussed here, where the order of the hon’ble IPAB granting stay to the impugned order is discussed. For the two issues raised in the stay application, the hon’ble IPAB made the following findings:-

1. On the issue of non- presence of members of opposition board during hearing: As per the Hon’ble IPAB the Learned Controller should have taken note of the directives of the Orders of the Hon’ble Court in W.P.(C) 12105/2019, issued on 20/11/2019 while conducting hearing on 22/11/2020.
2. On the issue of that the Learned Controller did not send certain later filed documents to the opposition board: As per the board the Learned Controller couldn’t have sent it as there is no provision in the Rules. At the same time, if these documents were filed in the pretext of “publication” under Rule 62(4) and were found to have evidentiary value, such evidence could not be allowed to be taken on record without scrutiny of the Opposition Board. As per the board this anomaly is, purposefully created by some of the opponents, who chose to take the route of Rule 64(2) for filing additional evidence to avoid the scrutiny of opposition Board, when the statute provides ample opportunity; both through pre-grant opposition and further in post –grant opposition.

The impugned order held that the claimed invention lacks inventive step. The Hon’ble Board disagreed with this finding, based on the following:-

• The compounds of the patent are Btk inhibitors. The Learned Controller held in the impugned order that Lck and Btk are analogous primarily for two reasons i.e. allegedly admitted facts in the Compete specification and the views expressed by the opponents based again on alleged admitted facts of complete specification, prior arts US’851 and one document -Chen et al. the IPAB however held that the complete specification of the impugned patent does not indicate that both Lck and Btk are analogues. Lck does not share homology with Btk as it does not have a cysteine residue at 481 position rather LCK contains Serine at the corresponding 481 position and not the Cysteine amino acid residue. [Fig 1 of complete Specification]. Thus the prior arts that have been considered as analogous are not actually analogous for inventive step.
• For “inventive step” determination, as per the hon’ble board, the prior arts should be analogous. In order for a reference to be proper for use in an obviousness rejection, the reference must be analogous art to the claimed invention. The Hon’ble IPAB held that the prior arts chosen by the opponents are not analogous and any determination of inventive step based upon the non-analogous prior arts is not going to yield proper result.
• The requirement of “a person in India possessing average skill in, and average knowledge of, the art to which the invention relates, to work the invention” is for determining the “sufficiency of disclosure’ by proving “workability” of invention and it is different than that of ascertaining the patentability requirements such as determination of “inventive step” of an invention which requires “person skilled in the art”. In absence of any definition of this term in the Patents Act, 1970, the definition provided in Bishwanath Prasad Vs. Hindustan Metal Industries as “a competent craftsman (or engineer as distinguished from a mere artisan)” is adopted.
• Further, the Board held that the Learned Controller could not have arrived at the findings that the present invention lacks inventive step without the “hindsight analysis”. The “alleged ordinary person skilled in the art” as the Learned Controller conceived, could not have visualised the chemical substitutions as hypothesised by the opponent and agreed by the ld. Controller such as replacing Cyclohexane at position 1 of one of the prior art Andrew’s compound with Piperidine, and/or obtaining the compound of the impugned invention with Michael acceptor.

The hon’ble IPAB therefore, in view of the above, held that the claimed invention does not lack inventive step and the order of the Learned Controller dated 04/03/2020 is void of merit and is being set aside forthwith.