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IPAB maintains Interim Stay over Revocation of Pharmacyclics Anti-Cancer Drug Patent Ibrutinib
IPAB maintains Interim Stay over Revocation of Pharmacyclics Anti-Cancer Drug Patent Ibrutinib
The Hon’ble Intellectual Property Appellate Board (IPAB) vide order has granted an interim stay on order issued by the Joint Controller of Patents and Designs, Patent Office which had revoked a patent Ibrutinib, an anti-cancer drug owned by Pharmacyclics LLC (AbbVie) on the grounds of lack of inventive step.
Ibrutinib sold by Pharmacyclics Inc, a Silicon Valley-based biopharmaceutical company and part of AbbVie under the brand name ‘Imbruvica’ is used to treat adults with mantle cell lymphoma (MCL), chronic lymphocytic leukaemia (CLL)/small lymphocytic lymphoma (SLL), Waldenström’s macroglobulinemia (WM), marginal zone lymphoma (MZL), and chronic graft versus host disease (cGVHD).
Pharmacyclics LLC had been granted the patent for Ibrutinib in 2014 in India, against which Laurus Labs Pvt. Ltd filed a post-grant challenge in 2015 on the grounds of “obviousness and lack of inventive step.” On 4/3/2020 the Joint Controller of Patents and Designs revoked the patent based on the post-grant opposition.
Pharmacyclics appealed to IPAB under Section 117-A of the Indian Patents Act, 1970 and obtained an interim stay on 12/6/2020 against the revocation order of the patent, since the balance of convenience was in favor of Pharmacyclics (appellant), and also on the apprehension that it would cause irreparable loss and injury to the appellant. Consequently, the interim stay order of 12/6/2020 was passed again on 7/8/2020 and is to be maintained until the appeal is finally decided.
The IPAB stated that the appellants have made a strong prima facie case in its favour by arguing that (i) the Delhi High Court case would be dismissed, (ii) that the Patent Office did not submit additional evidence filed by the parties to the opposition board, as instructed by the High Court in the order dated November 20, 2019, and (iii) that the Patent Office decided on obviousness without application of mind.
This has opened the doors for generic companies to approach the IPAB for an interim stay on similar grounds, on Patent Office upholding of a patent, said patent experts.
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