Madras High Court sets aside patent on valganciclovir

Madras High Court sets aside patent on valganciclovir

3 December 2008, Mumbai

In a landmark judgment, a bench of the Madras High Court comprising Chief Justice A. K. Ganguly and Justice Ibrahim Kalifulla yesterday set aside the patent granted to F. Hoffman-La Roche AG (Roche) for valganciclovir (Patent No. 207232) for failure of the Indian patent office to comply with the patent law and remanded the matter back to the Patent Controller. The judgment setting aside the patent was delivered in a petition filed by two Indian patients’ groups—Indian Network for People Living with HIV/AIDS (INP+) and Tamilnadu Networking People with HIV/AIDS (TNNP+)—who challenged the Indian Patent Office’s decision to grant a patent without hearing the pre-grant opposition filed by them.

As you know, Indian patients’ groups have been filing pre-grant oppositions against patent applications relating to crucial HIV and cancer drugs. Aware that a patent holder can set high, monopolistic prices once a patent is granted to a drug, patients’ groups are filing pre-grant oppositions to ensure that patents are granted only if the applications comply with India’s strict patentability criteria. One such opposition filed by INP+ and TNNP+ was against Roche’s patent application for valganciclovir.

At the centre of the dispute is the drug called valganciclovir, which is a prodrug of an already known drug ganciclovir. This drug is crucial for treatment of cytomegalovirus (CMV) retinitis, an opportunistic infection that affects persons living with HIV, and to prevent CMV infection in patients who have received organ transplants. At Roche’s maximum retail price of over Rs. 1000 (approx USD 20; 1 USD = approx Rs. 50) per tablet, a patient who has to take a treatment course of approximately four months for CMV retinitis would have to pay about Rs. 250,000 (approx USD 5000). This puts the treatment out of reach for those who need them.

In July 2006, INP+ and TNNP+ filed a pre-grant opposition before the Patent Office at Chennai objecting to the grant of a patent to Roche for valganciclovir and requested the Patent Office for a hearing. Under the Indian law, if an Opponent requests a hearing, the Patent Office is required to hear the Opponent. The Patent Office sent the pre-grant opposition to Roche and received a reply from Roche. Satisfied that the objections raised by INP+ and TNNP+ had been met by Roche, the Patent Office went ahead and granted a patent without hearing INP+ and TNNP+. The grant of the patent was published in June 2007. After correspondence with the Patent Office failed to yield any result, INP+ and TNNP+ filed a petition in the Madras High Court in October 2008. They alleged that failure to grant them a hearing amounted to violation of the mandatory requirements of the patent and also a violation of the principles of natural justice. The Assistant Controller, who had granted the patent, filed a reply justifying the grant. Roche objected to the petition on the ground that INP+ and TNNP+ could take recourse to mechanisms such as post-grant opposition or revocation available under the patent law to challenge the grant of the patent.

The final hearings in the case took place in the third and fourth weeks of November 2008.

Advocate Anand Grover, Director of Lawyers Collective HIV/AIDS Unit, appeared on behalf of INP+ and TNNP+. He argued that the failure of the Indian patent office to hear the opponents amounted to a failure to comply with the mandatory provisions of the patent law and also violated the principles of natural justice. Reading from the affidavit filed by the Assistant Controller and other documents, he showed how the Patent Office had considered the reply filed by Roche to the opposition before deciding to grant a patent. He informed the court that no order had been passed disposing off the pre-grant opposition. He then referred the judges to the provisions of the patent law to show that even if an order was passed rejecting a pre-grant opposition, no appeal could be filed against such an order. He pointed out that were INP+ and TNNP+ to file a post-grant opposition or a revocation proceeding, it would amount to an admission of the grant of the patent. These proceedings, he argued, were separate causes of action and did not afford a remedy to INP+ and TNNP+ in this situation. He also pointed out that as the action of the Patent Office was illegal, the patent granted was void and without any legal effect. He therefore asked that the patent be set aside and the matter be sent back the Patent Office for a hearing.

Senior Advocate A. L. Somayaji, senior counsel appearing for Roche, argued that it was open to INP+ and TNNP+ to file a post-grant opposition or revocation proceeding. He said that a pre-grant opposition was in the nature of an administrative procedure and does not give rise to a dispute between the parties. He further argued that there was no need for the Controller to pass an order in a pre-grant opposition proceeding. Referring to an alleged delay in challenging the grant of the patent, he said that Roche would be prejudiced if the patent granted were set aside by the High Court and it would impact the infringement suit filed by Roche against Cipla before the Bombay High Court.

Advocate R. Vaigai, counsel appearing on behalf of INP+ and TNNP+, rebutted these arguments. She said that a pre-grant opposition proceeding was a quasi-judicial proceeding (like a judicial proceeding) and it was a dispute between two parties. She said that when the grant of the patent itself was illegal from the outset, it was a continuing cause of action and there was no question of delay in approaching the court to set it aside. She pointed out that if the patent was not set aside and the opposition filed by INP+ and TNNP+ was merely sent back to the Patent Office for a hearing, the proceeding would be akin to a post-grant opposition. She further brought to the notice of the court that Roche could continue to import valganciclovir into India and sell it even if the patent were set aside.

In its decision delivered on 2 December 2008, the High Court set aside the grant of the patent and remanded the matter back to the Patent Office. The Court held that since the Petitioners represented public interest, there is no question of waiver of the principles of natural justice. Observing a bias in the affidavit filed by the Assistant Patent Controller, the High Court has directed that the opposition be heard by another patent official before 31 January 2009. The High Court also declined Roche’s counsel’s plea to stay the operative part of the order setting aside the patent until a certified copy of the order was issued to them to enable them to file an appeal.

This decision is likely to have an impact on the infringement suit filed by Roche against Cipla in the Bombay High Court. Roche has alleged that Cipla’s generic version of valganciclovir infringes its patent. The infringement suit will come up for hearing before the Bombay High Court on 10 December 2008.

A soft copy of the decision accessed from the Madras High Court website can be downloaded here.