India’s IPAB Denies Access To A Leukemia Medication In An Unsubstantiated IPAB Order And Creates Uncertainty

By June 19, 2020 July 17th, 2020 IPAB

An interim order of the IPAB from Justice Manmohan Singh & Dr Onkar Nath ensures that an order to make a generic leukemia drug is stayed to DENY ACCESS TO THE MEDICATION TO LEUKEMIA PATIENTS IN India. The unreasoned order of 10/06/2020 dishes Indians out with the disfavor of making the generic version illegal WITHOUT EXPLAINING THE REASON. Thus, it denies access to Indian Leukemia patients to Imbruvica, a drug that will now be sold at INR 4,00,000 ($ 5,000) for a month’s supply as opposed to INR 38,000 ($ 500). A co-authored piece by Swaraj Barooah and Praharsh Gaur captures it all in this SpicyIP post.

The Ibrutinib patent, Indian Patent IN262968, was revoked March, 2020 thus making the generic version available at lower cost for Indian leukemia patients.

As it turns out, the patent holder Pharmacyclics Inc, is a Silicon Valley-based biopharmaceutical company and part of AbbVie.  Interestingly, Abbvie, is the patent holder that sells the other leukemia drug, Venetoclax at $ 5,000 in India for a month’s supply about which I had posted here

Sandeep Rathod, a lawyer from India focusing on the pharmaceutical sector said that such curt interim stay decisions issued by the IPAB, especially after a prior-reasoned order, leads to confusion. In the future, this order opens the possibility wherein a party filing for patent revocation should consider asking for a stay/injunction on the continued use of the patent.  As such, the law that allows such stay of existing orders for patent owners is unclear.

A leading patent litigator and prosecution specialist in Delhi who did not wish to be named stated that the legality of such an order would be questionable. The ideal remedy would have been to go to the Court and ask that the infringement suit be kept in abeyance until the revocation petition is disposed. Instead, what has happened is the creation of uncertainty. First, it is not clear whether the IPAB has the jurisdiction to restore a patent at interim stage. Second, does this apply only between the parties in the IPAB appeal or will it apply against all entities who may have commenced commercial operations due to the patent cancellation?

It is sad to see that India is on a path of systematically let its patients down with no coherent policies from this Government.

About the Author

  • TradeRx Report Coordinator & Advisor
    Professor of Law and Director of India Programs, Texas A&M University School of Law.