In a latest development in the Indian patenting scene, according to a news report, the Madras High Court has set aside the patent relating to Valganciclovir granted to F.Hoffman-La Roche.

F.Hoffmann-La Roche AG had filed a Patent Application titled 2 -(2-Amino-1, 6-Dihydro-6-oxopurin-9-yl)-methoxy-1,3-propanediol Derivative for a patent relating to Valganciclovir, a drug used to treat CMC retinitis. The said application was published in the Official Journal of the Patent Office, which triggered a representation from patient groups by way of opposition at the pre-grant stage.

According to the news report, the Madras High Court, after hearing the writ petition filed by patient groups, mentioned the failure of the Chennai patent office to comply with the statutory requirements under Patents Act 1970 (as amended by Patents (Amendment) Act 2005) and Patents Rules 2003 (as amended by Patents (Amendment) Rules 2006). The Court while setting aside the grant of patent, directed the Patent Office to assign the consideration of the petitioner’s pre-grant opposition to any other officer in the rank of Assistant Controller of Patents, Designs & Trade Marks in the Intellectual Property Office, other than the officer who granted the patent.

Meanwhile, Roche is also embroiled in a patent infringement suit on this drug against Cipla as the latter had launched a generic version of this drug in India early this year. Madras High Court, on the apprehended frustration of the patent infringement suit filed by Roche, while distinguishing between the two causes of action ruled that the petitioner’s role in seeking a remedy against the invalid action of the Patent Office cannot be defeated on that consideration as the suit filed by Roche is not against the petitioner.

Under the Patents Act, 1970, an examination of a patent application with respect to any lawful ground of objection to the grant of the patent and an investigation for the purposes of ascertaining whether the invention is anticipated by a prior art does not warrant, in any way, validity of any patent. A pre-grant opposition or a re-evaluation of a patent by the Patent office acting later in time, very much alike in a post-grant opposition, gives an opportunity to overcome limitations of the Patent office’s initial review.

The Madras High Court’s decision amply reflects on patent review. The instant decision based itself on procedural norms to be followed but in cases where the court is satisfied with the defence of patent invalidity, it may adjourn the proceedings for a specified time period so as to enable a review of the invention on patent eligibility, novelty, non-obviousness and industrial applicability. The stay of the suit for the infringement of a patent shall not preclude the court from making any interlocutory order.

A reliable patent evaluation procedure in the context of litigation makes available a presumption of validity or rather helps the patentee to earn the presumption. Significant evaluation of a patent as a result of challenges in an information-rich environment, accords to them an earned presumption of validity.