Sugen’s desperate attempt to save its Sunitinib patent

Seven years after the enactment of the Patent (Amendment) Act, 2005, India continues to struggle with the absolute basics of its post-grant opposition mechanism. As our readers may already be aware, the Patent Office recently revoked the patent for Sunitinib. 

Although the patent has been identified in the media as a Pfizer patent, Pfizer is only the licensee. The patent is actually owned by Sugen Inc & Pharmacia & Upjohn. In its Form 27 filing with the patent office in the year 2010, Sugen did not disclose the patent was licensed to Pfizer, despite the same being a requirement. Sunitinib is supposed to cover several different types of cancer including some which are resistant to other treatments such as imatinib. Yet, despite these tall claims, Sugen imported only a mere ‘7000 units’ in 2009 into India, a country which loses more than 500,000 people to cancer every year. The relevant Form 27 can be accessed over here (last page). 

After this patent has finally been revoked more than 5 years after it was first granted in the year 2007, Law et. al. reports that the patentees have filed a writ petition before the Delhi High Court asking for the decision of the Controller to be set aside on the grounds that they were not given a copy of the report of the Board of Oppositions (This is a three member board that is set up under Section 25 of the Patents Act, to scrutinize the evidence and the arguments of both parties before submitting a report on the same to the Controller). 

This is an absolutely astonishing argument for the patentees to be making after the Controller has already passed her order revoking the patent. ‘Astonishing’ because the patentees should not have even argued the matter until they had a copy of the report of the Opposition Board. Who in their right minds would proceed to the stage of final arguments without being fully prepared with all the relevant information including the most important piece of information – the report of the Opposition Board. Anybody who has read a Controller’s decision in post-grant opposition matter must be aware of the importance of this document. It is a critical document and has a profound impact on the decision of the Controller in a post-grant opposition. 

It isn’t like the patentee was not aware of this report of the Board of Opposition. The Delhi HC’s order, available over here, records in detail how the patentee claims to have applied for a copy of the report of the Board of Opposition via a letter and also through a RTI application. Apparently some genius in the Patent Office turned down the request on the grounds that the same could not be shared because the matter was sub-judice – there is no provision anywhere in the Patent Act or Rules which allows the patent office to withhold the report of the opposition board on the grounds of ‘sub-judice’. 

Faced with this rejection, the patentee should have immediately appealed the order of rejection of the Patent Office to either the IPAB or the High Court depending on which forum would have had jurisdiction. Instead, according to the narration of facts in the order of the Delhi HC, the patentee just went ahead and argued the matter on merits before the Controller and now after losing the post-grant opposition, the patentees are crying foul over the non-disclosure of the report of the opposition board, an act which they never challenged in the first place. 

What is even more utterly baffling is the fact that the Delhi High Court then proceeded to restrain Cipla from releasing its generic drug in the market – this in a writ proceeding against the order of the Controller! Effectively an interim injunction against a private party, through a writ petition! 

Cipla appealed this order almost instantaneously and the Division Bench which delivered its order on the 12th of October, 2012 makes it clear that the interim arrangement suggested by the Single Judge appeared to be only an interim one till the next date of hearing. The implied suggestion being that Cipla was free to market the drug after the 15th of October unless of course the Single Judge extended his initial arrangement. had this to say about the decision of the Single Judge: “In the absence of any prayer for direction to the appellant herein not to take any steps for marketing its drugs, the learned Single Judge should not have granted such an order.” The case has been remanded to the Single Judge, who on the 15th of October, 2012 adjourned the case to the 6th of December, 2012.