Wait 'n watch: Exclusive marketing rights won't be granted soon

NEW DELHI: There will be no more exclusive marketing right grants in a hurry. The Controller General of Patents and Trademarks has decided to wait for fresh guidelines from the ministry of commerce and industry before it takes any fresh decision on pending EMR applications.
The charge against the drafters of the Patent Act that they allowed an undue lot of discretionary power to rest with the Controller General of Patents and Trademarks seems valid.
The office of the Controller-General has to grapple with a spate of petitions in various courts in the country, challenging its decisions on EMR applications and will now deliver the verdicts on pending applications only in consultation with the ministry of commerce and industry.
“We will write to the ministry soon, asking for a policy direction on EMR applications. Until and unless the policy has been made clear, we will not take decisions on the EMR applications at hand,� a source from the office of the controller-general said.
The decision of the controller-general will impact the EMR pleas of Bayer, Eli Lilly and FulFord India, among others. The sources said these pending applications will now be considered only after the ministry and the controller make a joint policy decision on interpretation of allegedly grey areas in the Patent Act that could be source of litigation.
The controller-general’s office wants to stick to the Act and refrain from discretionary interpretation to the extent possible. As it is, the Patent Act is allegedly ambiguous on definitions of patentability, with terms like “novelty�, “industrial application� and “prior art� left for the patent-giving authority to draw conclusions on, with regard to their applicability to individual applications.
The controller has already got a feel of the difficult task of deconstructing these terms, as it examined the EMR applications. For instance, the first EMR in the pharma sector granted to multinational Novartis produced a row, which, in addition to the date of grant of original patent for the product, brought to fore the question of grant of patent for derivative of a new molecule, on grounds of novelty.
The question is whether beta crystalline version of the molecule imatinib mesylate will qualify for EMR. Novartis says the version being an allotropic form of the molecule, it will satisfy the novelty test, while generic producer of the drug Natco Pharma says there are various judgements by the US courts to the effect that salts that do not materially alter the nature of the product do not qualify for EMR.
Sources said it is being recognised that the controller might lack the technical competence to appraise the novelty of a product for which an EMR is sought. Given the fact that the decisions on a few EMR applications have given risen to a flurry of litigation, it is now apprehended that absence of a foolproof system will be more obvious when the product patents are introduced in pharmaceuticals from January 1 ’05.
It may be noted that GlaxoSmithKline had challenged the denial of EMR to Rosiglitazone (Avandia) in Delhi High Court and a writ petition of Hoffmann La Roche against denial of EMR to Saquinavir mesylate is pending disposal in Kolkata High Court.