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Roche’s Valganciclovir Patent Dispute

Issued: February 01 2009
In a recent judgement – and perhaps the first judgement of its kind – the Madras High Court passed an order dated December 2, 2008 setting aside the Patent Office’s decision to grant a patent to Hoffmann-La Roche and directed the Patent Office to first offer a hearing to the petitioners for a pre-grant opposition for Valganciclovir, a drug used for the treatment of HIV/AIDS. The patent application is 959/MAS/1995 and was filed in July 1995. A patent for the same was issued with number IN 207232 in April 2007. The petitioners, Indian Network For People Living With HIV/AIDS and Tamil Nadu Networking People With HIV/AIDS, had filed a pre-grant opposition for the patent application in question; the Patent Office disposed of the matter without hearing the petitioners and proceeded to grant the patent. The petitioners filed a writ petition at the Madras High Court.

The Indian Patents Act allows for pregrant and post-grant opposition. Section 25(1) and Rule 55 of the Patents Act, 1970 provide conditions and procedure for pre-grant opposition, which formed the basis for the judgement. Section 25(1) lays down a provision that “the Controller shall, if requested by such person for being heard, hear him and dispose of such representation in such manner and within such period as may be prescribed.”

Rule 55(6) says: “After considering the representation and submission made during the hearing, if so requested, the Controller shall proceed further simultaneously either rejecting the representation and granting the patent or accepting the representation and refusing the grant of patent on that application, ordinarily, within one month from the completion of above proceedings.”

The Madras High Court held that giving a hearing to the pre-grant opponent or the petitioner is mandatory and that the rights of the petitioner were prejudiced by not hearing them and granting the patent in favour of Roche. The Patent Office’s decision to grant the patent was set aside by the Madras High Court and it further directed the Controller of Patents to hear the Petitioners by January 31, 2009. The relevant portion of the order setting aside Roche’s patent is:

“The grant of patent in patent No. 207232 by the office of the respondents 2 and 3 in Patent Application No. 959/MAS/1995 filed by the fourth respondent is set aside. The third respondent must hear only the petitioners and the fourth respondent on the petitioner’s representation at the stage of pre-grant opposition filed under Section 25 (1) of the Act. The third respondent need not consider any other pre-grant objection pursuant to this judgement. Such hearing should be completed by 31st January, 2009.”

Thereafter, Roche filed a plea with the Supreme Court to set aside the Madras High Court order setting aside its patent for Valganciclovir. The Supreme Court refused to stay the decision of Madras High Court that set aside Roche’s patent for Valganciclovir and passed a modified order stating:

“The Assistant Controller of Patents, Designs and Trademarks in the Intellectual Property Office shall decide the patent application no. 959/MAS/1995 on or before 31st January 2009, to the extent the impugned order is modified. We once again clarify that the matter shall be disposed of by 31st January, 2009. Needless to add, while deciding the above application, the Assistant Controller shall take into account the pre-grant opposition filed in this case.”

In view of the order, the Chennai Patent Office took up the pre-grant opposition matter and a hearing was offered to the opponents and applicant on January 21, 2009. The Chennai Patent Office passed an order dated January 30, 2009 in Roche’s favour dismissing the pre-grant opposition.

On another note, Roche has initiated infringement proceedings against Cipla at the Bombay High Court for the same drug. The Supreme Court stated that the Madras ruling should not have any impact on the infringement proceedings pending before the Bombay High Court. It will be interesting to see whether the Bombay High Court dismisses or accepts Roche’s plea for infringement against Cipla.

Bristol-Myers Squibb Initiates Proceedings Against Hetero Drugs

The Delhi High Court issued an order restraining Hyderabad-based Hetero Drugs from manufacturing, selling, distributing, advertising, exporting, offering for sale or in any manner dealing directly or indirectly in any product infringing Bristol-Myers Squibb’s patented drug Dasatinib.

The order gave Bristol-Myers Squibb one week to make a representation to the Drug Controller General of India making out a case for the drug. The Drug And Cosmetics Act expects the DCGI to examine the safety and efficacy of a drug. It does not lay down any provision wherein the DCGI has to check on the patent coverage of a drug and then grant the approval.

The order brings up the question that whether it is right to expect the DCGI to keep a check on the patent coverage of the drug, the approval of which is pending before the DCGI. The other question is even if the DCGI has to keep a check on the patent then how is he going to do it? The Patent Office does not provide much details of a patent online. Mostly, the bibliographic details along with the abstract of a patent are available. It is cumbersome even for a regular practising patent attorney to get the details of a patent easily from the Indian Patent Office. In such a scenario, isn’t the expectation from DCGI to keep a check on the patent a bit over stretched?

Krishna & Saurastri
K.K. Chambers, 1st Floor,
Sir P.T. Marg, Fort,
Mumbai 400 001, India
T: +91 22 2200 6322
F: +91 22 2200 6326

About the Author

Saima Ansari is a Patent Associate and Patent Agent at Krishna & Saurastri. She holds a Master degree in Organic Chemistry from Mumbai University and she is associated with the Chemical and Life Sciences Department of the firm


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