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IPAB stays revocation of Pharmacyclics’ patent on anti-cancer drug Ibrutinib

Laxmi Yadav, Mumbai
Wednesday, June 24, 2020, 08:00 Hrs  [IST]

The Intellectual Property Appellate Board (IPAB) has granted an interim stay on an order issued by the Indian Patent Office removing a patent of Pharmacyclics for anti-cancer drug Ibrutinib.

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).

NR Meena, Joint Controller of Patents and Designs, in an order issued on March 4, 2020 revoked the patent based on a post-grant opposition filed by Laurus Labs. The patent office observed the claims made by Pharmacyclics are obvious to an ordinary person skilled in the art and that the drug lacks any inventive step that would make it superior to other existing formulations.

According to Pharmacyclics, ibrutinib is a small molecule that works by inhibiting an enzyme called protein kinase, which controls the rate at which certain cells multiply. It claims that the drug works differently from existing chemotherapy and immunotherapy solutions. It is a once-daily, first-in-class Bruton's tyrosine kinase (BTK) inhibitor administered orally, and has been jointly developed and commercialised by Pharmacyclics and Janssen Biotech, Inc.

Pharmacyclics filed a patent application for ibrutinib in 2009 and received a patent on September 25, 2014. Laurus filed a post-grant challenge on September 24, 2015 citing lack of novelty and lack of inventive steps among others.

Natco Pharma launched a generic version of the drug in December 2019 at Rs. 38,000 per month, as opposed to Rs. 4 lakh course for Imbruvica. Natco tied up with Laurus Labs.

On December 18, 2019 Pharmacyclics sued Natco and Laurus Labs before the Delhi High Court for allegedly infringing its patent Ibrutinib.

Based on Patent Office order rejecting patent of Pharmacyclics in March, Natco and Laurus sought dismissal of the patent infringement suit filed by the US drugmaker in Delhi High Court.

Pharmacyclics said it would file an appeal before the IPAB within the next two weeks, and on that basis, asked for adjournment. The High Court passed a conditional order stating that the suit shall be dismissed with liberty to be revived or reinstituted if the IPAB doesn’t pass an interim stay order by the next date of hearing.

The IPAB, which was taking up only urgent matters due to the outbreak of COVID-19, resumed its functioning, via video conferencing from May 26, 2020, and took this matter up on June 12, 2020. There, the IPAB passed the stay order against the Joint Controller of Patents and Designs’ revocation of the patent, on apprehension of “irreparable damage to the petitioner (Pharmacyclics)”, and set the final date of appeal on July 9, 2020.

This also prevented Pharmacyclics’ suit from being dismissed at the Delhi High Court.

The IPAB decision was given by its chairperson (Retd.) Justice Manmohan Singh and the board’s sole technical member Dr Onkar Nath Singh.

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.

The board in the present case decided in favour of granting a stay essentially only on the basis of the applicant’s allegations against the Patent office’s order, since no representation was made on its behalf on the day of the hearing.

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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