The Deputy Controller of Patents, Dr. Kavita Taunk vide an order dated 16th August 2019 has revoked patent numbered IN276026 granted to Novartis.

 IN276026 was granted to Novartis AG on their Application No. 3951/DELNP/2009. Natco Pharma Limited filed notice of opposition. On completion of pleadings and on receiving the recommendation of the opposition board under Section 25(4) of the Act, a hearing under Rule 62(1) was fixed on April 9, 2019.

The Controller has refused the patent on grounds of lack of novelty, lack of inventive step and invention not patentable under section 3(d) of the Act.

As per the controller if the compounds claimed in the impugned patent IN276026 (3951/DELNP/2009) and prior art IN 232653 (2241/CHENP/2005) are compared then both Patents disclose substituted pyrimidine compounds.

The structure I is a structure claimed in claim-1 of impugned Patent IN276026 (3951/DELNP/2009). The structure II is the representative of the compounds claimed in IN232653 (2241/CHENP/2005). The controller from various substitutions provided for Structure II, held that Structure I is nothing but narrower Markush structure of Structure II. A similar reasoning was applied by the Controller for prior art IN240560 (553/CHENP/2006). The substituents as defined in IN240560 when substituted in markush structure of claim 1 of IN240560 as per the controller results compound claimed in IN276026. Based on the above analysis the Controller held that impugned Patent IN276026 (3951/DELNP/2009) lacks novelty with respect to IN232653 and IN240560.

Since the compounds lack novelty, the controller also held that the same are obvious and not patentable under Section 3(d) of The Patent Act, 1970. The Patentee as per the controller has also not provided any in vivo efficacy data in comparison to compounds disclosed in IN232653 (2241/CHENP/2005) and IN240560 (553/CHENP/2006).

The Controller also referred to the document relied upon by the Opponent relating to Patent term extension in USA by Patentee and Orange book to show the relationship of the impugned Patent 276026 (corresponding US patent no. 8377921) with cited documents IN 232653( corresponding US patent no. 7964592); IN240560 (corresponding US patent no. 7893074) and WO2001/64654 (corresponding US patent no. 7153964) and essentially that all said patents cover the commercial drug product of Novartis, Ceritinib.

An infringement suit was also pending in respect of Ceritinib before the Delhi High Court, however, taking note of the revocation of the patent, the court held that the infringement action is not maintainable.