Source: The Economic Times
MUMBAI: The Delhi High Court has dismissed AstraZeneca’s plea to block Hyderabad based Lee Pharma from making copies of its anti-diabetes drug Onglyza and left it for the patent office to decide whether to grant a compulsory licence for the medicine.
Last month, Hyderabadbased Lee Pharma had filed for grant of compulsory license for saxagliptin, chemical name of Onglyza, at Indian Patent Office, claiming that the British-Swedish drug maker was not making it available to Indian patients at an affordable price. AstraZenecaBSE -0.20 % then filed an injunction petition before HC to stay Lee Pharma’s move.
Striking down claims made by AstraZeneca, Justice Manmohan Singh of the Delhi HC on Wednesday passed an order that the patent suit and the application for the compulsory license will move ahead without being influenced by its decision.
“The Controller General of Patents has to decide the case on the merits of the applicadetertion,” a person aware of the development told ET.
Compulsory licensing is a part of the World Trade Organisation’s TRIPS (TradeRelated Aspects of Intellectual Property Rights) Agreement whereby a government can allow production of a patented product without the consent of the patent holder.
Lee Pharma has assured the HC that it has no intention to violate the patents and make or distribute the product until the patents office granted compulsory licence for the drug.
In its application to the Indian Patent Office, Lee alleged that AstraZeneca has been importing the drug at less than a rupee but charged as much as Rs 45 for each tablet, driving up the cost of therapy beyond the reach of most Indian patients. Lee also contended that AstraZeneca had not made sufficient efforts to make the drug in India, running in contravention to the existing patent laws of the country.
Experts are divided over the strength of Lee’s application.
While a few said the case will put to test how India deterapplicamines public health concerns around an antidiabetes drug that may be substituted in contrast to drugs that treat critical diseases such as cancer, some others felt disparity between import cost of Onglyza and its price may sway the opinion of the authorities against AstraZeneca.
India granted the first ever compulsory licence in 2012 when it allowed Natco Pharma to make a generic version of Bayer’s cancer drug Sorafenib tosylate. International pressure has been building on the country to provide a predictable policy framework, while India has maintained that its local patent laws are within the framework of the WTO provisions.