Novartis AG v. The Controller General of Patents, Designs and Trade Marks

IMPORTANT ISSUES

  1. Whether the Controller General was wrong revoking the patent based on a post-grant opposition, without appreciating recommendation of the Opposition Board in favour of the Appellant Patentee.
  2. Whether the Controller failed to appreciate the evidence demonstrating novelty of the subject matter of the instant patent.

SUMMARY

Title: Novartis AG v. The Controller General of Patents, Designs and Trade Marks and Ors.

Subject matter of Patent: Novel pyramidine compounds with 2 phenyl rings at 2nd at 4th positions via amine groups. Ceritinib is specifically claimed, in free form or in the form of a pharmaceutically acceptable salt.

FACTUAL MATRIX

Patent bearing no. IN 276026 was granted by the Controller on 28.09.2016. Respondent No.2 namely Natco filed a post grant opposition under Section 25(2) on the grounds of lack of novelty, lack of inventive step and insufficient disclosure.

The Controller vide impugned order dt. 16.08.2019 revoked the patent on all three aforementioned grounds.

SUBMISSIONS BY APPELLANT

  • Patent has been found to lack novelty without citing any prior art which fully discloses or exemplifies subject matter Ceritinib.
  • Controller has examined the opposition based on “hindsight analysis” and “cherry picked” ingredients, substitutes and their arrangements, trying to locate them in Markush claims of prior art citations. Such prior art are subsisting patents of the Appellant and do not disclose Ceritinib.
  • Controller has failed to correctly apply the test of anticipation. It is not the coverage of the subject matter of the patent but its disclosure by way of identification, description or exemplification that is required to be established.

SUBMISSIONS BY RESPONDENT

There is a lack of inventive step and novelty in the patent. Ceritinib is anticipated in prior art and hence a separate patent cannot be granted for the same.

HELD

  • The Court explained the dichotomy between coverage and disclosure and held that coverage cannot go much beyond disclosure as it would negate fundamental principles of the law of patents.
  • Section 5 of the Patents Act, 1970 makes it clear that Complete Specification shall “fully” and particularly describe the invention, its operation and method of performance, and also the best method of its production.
  • To test the novelty of a patent, mosaicking of documents is not permissible. Each prior art that is alleged to anticipate the subject matter in contention should stand on its own. Mosaicking of documents is allowed only to argue obviousness.
  • Subject matter of coted prior arts may have general disclosure of genus but none of them describe Ceritinib in full.
  • In conclusion, the post grant opposition is not maintainable for the following reasons:
    1. Prior art does not contain clear disclosure of elements described in the instant patent, novelty not destroyed. Without the “hindsight analysis” it would not be possible to arrive at the structure of the instant patent and such analysis is not allowed.
    2. Cumulative effect of unclear and ambiguous prior arts disclosures cannot be taken into consideration for destruction of “novelty”.

Therefore, impugned order of revocation of patent is set aside.

COPY OF JUDGEMENT

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