Pharmabiz
 

THE PATENT SETTLEMENTS

P A FrancisWednesday, August 13, 2014, 08:00 Hrs  [IST]

A new trend of collusion of multinational drug corporations with large Indian companies is emerging in the Indian pharmaceutical market to overcharge essential drugs which are under patent. After the amendment of Indian Patent Act in 2005 allowing product patents, MNCs started launching a number of ‘patented drugs’ in the Indian market at very high prices. Although many of these patented drugs are actually not new molecules, the MNCs have the exclusive rights to market these products in the Indian market. Large Indian companies realized this game and started challenging the grant of patents to MNCs fully realizing that they can easily get a verdict against the MNCs. In a situation like this, the best option for MNCs is to arrive at a settlement with the challenging Indian company to ensure that there is no judicial intervention. Some such settlements between MNCs and Indian companies have already taken place and many more are likely soon. With this, the Indian companies which came out to fight against profiteering of MNCs in patented drugs have turned into partners to the same MNCs. It is quite possible that these mutually beneficial deals may flourish in the Indian pharmaceutical market at the cost of millions of patients if there is no timely intervention by the government agencies.

One such patent settlement is between Roche and Cipla after six years of legal battle over a patent infringement case over launching of a cheaper version of Roche’s patented cancer drug Tarceva (erlotinib) in the Indian market. In another case, US drug multinational Merck Sharp and Dohme has come to an understanding between two Indian companies over marketing of a new diabetes drug, sitagliptin, in the Indian market. Both the Indian companies and Merck are thus selling sitagliptin – metformin combination at the same price in the Indian market. The Competition Commission of India (CCI) has taken serious note of these growing unethical practices in the Indian drug market and issued notices to some of these companies. CCI’s move to examine these questionable deals follows increased scrutiny of patent settlements between brand companies and generic makers in some of the Western countries. The practice of MNCs paying attractive compensation to generic companies to prevent launching of cheaper versions of patented products has been in existence for some time. Such collusive settlements between the brand and generic companies go against the interest of the patient community as the access to cheaper versions of expensive medicines get restricted. CCI’s intervention is, therefore, justified and should ensure that patient access to critical drugs is not compromised. These out of court patent settlements between the companies also leaves the validity issue of patents undecided in midway. Many MNCs had obtained patents for different forms of the same drugs, like salt, polymorphs, analogues, crystalline and combinations with other drugs.

 
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