Additional Evidence and Following the Timeline Mentioned in Patent Rules: Novartis vs. Controller of Patents

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The decision of the Controller of Patent to revoke Novartis’ patent on the anti-cancer drug Ceritinib, was quashed by the Intellectual Property Appellate Board (IPAB). This decision examines several issues concerning the novelty and obviousness, the extent of coverage and disclosure, and timelines for filing the evidence. The IPAB while quashing the decision held that despite not being disclosed, the compound was contained in the broader genus patent.

Patent Application

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Facts

The anti-cancer drug Ceritinib is an ALK inhibitor targeted at non-small lung cancer treatment which was granted the patent in 2016 (IN 276026) claiming the prior art from the year 2007 and selling the drug by the name of ‘Spexib’ in the Indian market. Novartis also has a patent for the same drug in the US (US 8377921). Natco filed the post-grant opposition maintaining the ground of obviousness and lack of inventive steps in 2017. Complying with the opposition, the patent was revoked in August 2019. Novartis appealed to the IPAB which stayed the revocation.

Completely disregarding the Opposition Board’s report on dismissing the opposition and allowing the patent, Novartis contended while appealing the Controller’s revocation. Novartis also contended the violation of the principle of natural justice by relying on the Natco’s additional evidence but rejecting the evidence contended by Novartis which can be easily observed while not relying on the test of novelty and instead on the analyzing few compound's constituents.

Analysis

Several procedural aspects were not followed by the Natco while filing the opposition. The amount paid by Natco was an amount which was payable by a natural person and Natco, being a legal entity was obliged to pay more. Nevertheless, Natco paid the balance after the expiry of the statutory period of filing the opposition to which IPAB pointed to Section 142(2) of the Patent Act. The order of the Controller will not be maintainable since it was passed on to the opposition which was not in existence.  

Various irregularities were being noticed by the IPAB. Taking up the additional evidence long after fixing the hearing was noticed to be not adhered to by the Patent Rules 2003. Moreover, various statements of the Controller were taken into considerations which were found to be contradictory. The Controller states that no further evidence will be considered and further says that considers an important document that was brought to its notice. Not considering the rebuttal evidence filed by Novartis was also bought to notice by the IPAB. The reiteration of following the statutory timelines was also being discussed in a recent case dealing with the Ibrutinib patent where the evidence was admitted after a long gap of fixing the hearing. Due to not following the timeline, IPAB quashed the revocation.

While arguing for the disclosure, Natco contended that the drug Ceritinib was already covered in the Markush Structures of earlier patents, resulting in prior anticipation of the drug. Natco, while proving the obviousness of the drug stated that no technical advances are being made by Ceritinib which can help in proving the non-obviousness in nature. Countering the same, Novartis contended that the generic disclosure of a chemical class did not take away the novelty of a specific compound within the class unless the latter was ‘individualized’.

While observing the case, it was held that the question of claiming prior art, was already being scrutinized at the stage of examination and no such patents were found. In case of objection, the reply of Novartis was adjudged satisfactory. IPAB also observes the Opposition Board’s report which concluded that while a series of compounds had been described by way of a Markush Structure, none of the earlier patents exemplified compounds suggested the modifications required to obtain Ceritinib.

The case provides an important analysis concerning the take of IPAB on the coverage-disclosure issues. Effective disclosure is very important for serving the system of patents. The patent giving the monopoly over the said invention also requires the inventor to disclose the invention. Without effective disclosure, the said system will not have a level playing field. The case emphasizes the need for having an effective disclosure and enablement for determining coverage.

Author: Saransh Chaturvedi (an advocate) currently pursuing LLM from Rajiv Gandhi School of Intellectual Property Law (IIT Kharagpur).  In case of any queries please contact/write back Global Patent Filing us at support@globalpatentfiling.com.

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