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Pharmacyclics, LLC v. Controller General of Patents, Designs Trademarks and Geographical Indications and Ors.

Pharmacyclics, LLC v. Controller General of Patents, Designs Trademarks and Geographical Indications and Ors.

IMPORTANT ISSUE

Whether the Controller General erred in accepting additional evidence after the date of hearing is fixed in post grant opposition proceedings. Whether the Controller was correct in determining lack of inventive step for the subject matter of instant patent

SUMMARY

Short description of Patent: The patent claims an irreversible BTK Kinase Inhibitor Ibrutinib that is an active pharmaceutical ingredient (API) of the drug IMBRUVICA®, that is useful for the treatment of disease associated with B-cell malignancies. Ibrutinib is a pyrazolo pyrimidine scaffold consisting of piperidine ring, phenoxy phenyl group, amino group and michael acceptor in substituted in their respective position.

FACTUAL MATRIX

  1. The Appellant was granted Patent no. IN 262968 on 25/09/2014.
  2. The post-grant opposition was filed by respondent No. 3 under Section 25(2) of the Indian Patents Act in respect of IN ‘968 on 24/09/2015. The Controller vide impugned order dated 04/03/2020 revoked the patent.
  3. Aggrieved by this order of the Controller General, this appeal was filed

SUBMISSION BY APPELLANTS

  1. The Controller erred in not sending the new documents and fresh evidence to the Opposition Board for fresh Opposition Board recommendations.
  2. It is submitted by Appellants that the Controller ignored the well settled principle for obviousness determination which is a mixed question of law and fact.

SUBMISSION BY RESPONDENTS

  1. The Respondents recorded that the subject matter in the instant patent lacks inventive step because that after having arrived at a certain structure, a person skilled in the art would only seek to make minimum changes to that structure so as to maintain the effect; and furthermore, compounds in the prior art are analogous to the claimed compound.
  2. The Respondent mentioned that the claimed invention is merely a combination of known features, which does not give rise to an inventive technical advance.

HELD

  • The court opined that it should always be ensured that the provisions of Rules 60 and 62 be followed strictly and no one should be allowed to file additional evidence(s) in the guise of “publication” to avoid the scrutiny of their documents/evidences by the members of opposition Boards.
  • The court explained that determination of “inventive step’ is mixed question of law and facts depending largely on the circumstances of the case. Therefore, ignoring the legal aspects from the determination of the “inventive step” is ignoring the teachings of the judicial pronouncements, ignoring the methodology of determination of inventive steps in the Manual.
  • On the issue of inventive ingenuity of the invention, the court opined that the Learned Controller could not have arrived at the present findings on chemical substitution without the “hindsight analysis” and prior art documents considered for the inventive step analysis were non analogous to the claimed compound.

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

Copy of judgement

Citation OA/46/2020/PT/DEL

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