Ceritinib – India

On Sep 29, 2020, Intellectual Property Appellate Board (IPAB) set aside the order of Learned Controller finding compound patent invalid.

Brief background of the case is like this. Appellant, Novartis filed patent application - IN 3951/DELNP/2009 on Jun. 16, 2009. This application claims compound, Ceritinib as tyrosine kinase receptor inhibitor. This application was granted as IN 276062 on Sep 28, 2016. Post grant opposition was filed by Natco Ltd. on Sep 26, 2017. Patentee & opponent then filed their respective written submissions.  Hearing was rescheduled few times & finally it was held on Apr. 09-10, 2019. During this period additional documents were also filed after the announcement of date of hearing. Parties filed post hearing submissions & on Aug. 16, 2019, the Learned Controller by its order revoked the patent under lack of novelty, inventive step, section 3(d) & lack of sufficiency.

Appellant filed appeal to IPAB on violation of principle of natural justice. IPAB came heavily on the reasoning of Learned Controller & found that Learned Controller did not follow the proper procedure of law. IPAB said that the Learned Controller disregarded the recommendation of the Opposition Board which found patent valid. Second, the Learned Controller considered the evidence filed by the Opponent in relation to patent term extension and orange book listing but has disregarded the rebuttal evidence filed by the Appellant. Third, the Learned Controller has failed to consider the arguments on novelty given by the Appellant and has also failed to rely upon the expert affidavit submitted along with it.

With respect to novelty, IPAB said that the entire finding of invalidity is based without any prior art cited which discloses or exemplifies Ceritinib, the compound subject matter of IN 276026. The Controller has engaged in prohibited act of “cherry picking” of the constituents, substituents, their arrangement, their positioning, their linkage and interplay from the subject patent IN 276026 and tried to locate them in the vast pool of possible substituents contained in markush claims of prior art citations. It is also settled practice that in order to demonstrate lack of novelty, the anticipatory disclosure must be entirely contained within a single document. However, if a cited document refers to a disclosure in another document in such a way as to indicate that, that disclosure is intended to be included in that of the cited document, then the two are read together as though they were a single document. Here, Learned Controller took help of two cited prior arts to attack “novelty’ of the subject patent by picking suitable equivalent substitutions, keeping inventive structure of the subject patent IN’026 in sight.

IPAB also said that the opposition was filed by M/s Natco Pharma Limited on 26/09/2017. At the time of filing of opposition, opponent paid fees as a natural person. So, filing the opposition by a legal entity and paying the prescribed fee of filing opposition with the fee which is applicable to natural person (INR 2400) is not justifiable. If the balance fee of (INR 9600) was paid on 08/11/2017 – a date much later than the last date of filing opposition, the opposition was not maintainable as per the provisions of the Patents Act and the Rules made there under. The post-grant opposition was not maintainable ab initio for lack of filing proper prescribed fee.

IPAB finally found that the impugned order is void of merit & thus set aside the order.