Monday, April 11, 2011

Drug Firms break patent norms



In a recent dispute, major pharmaceutical  firms including F. Hoffmann-La Roche, Bayer Corp., Schering Corp.,Pfizer Inc., Bristol Myers Squibb Co., are held guilty of breaching the Indian patent laws. These companies reportedly failed to disclose relevant information regarding the working of the patents within the Indian territories .The RTI disclosure about the working status of these patented drugs and relevant working information on these life saving drugs was reportedly asked by the patent blog Spicy IP under one of their posts. The drugs in question are as follows: Pagasys, Tarceva (Roche's), Sutent (Pfizer), Nexavar (Bayer), Entecavir and Dasatinib (Bristol Myers), ViraferonPeg (Schering). The mentioned drug firms reportedly failed to furnish relevant details until 2009. It is noteworthy as per the Indian patent act, 1970, under section 146, there is a requirement to furnish all details about the working status of the patent ( failing which a penalty of Rs.10 lakh per patent is levied). As per the patent law:

Power of Controller to call for information from patentees: 

1) The controller may, at any time during the continuance of the patent,by notice in writing, require a patentee or a licensee, exclusive or otherwise to furnish to him within two months from the date of such notice or within such further time as the controller may allow, such information or such periodical statements as to the extent to which the patented invention has been commercially worked in India as may be specified in the notice.

2)  Without prejudice to the provisions of subsection (1) every patentee and every licensee shall furnish in such manner and form and at such intervals (not less than 6 months) as may be prescribed statements as to the extent to which the patented invention has been worked on a commercial scale in India.

3)  The controller may be publish the information received by him under sub- section(1) or sub-section(2) in such manner as may be prescribed.

 The working status of the drug patents and updates are required by the patent office to tap undue monopolies by the pharmaceutical firms.The patent office also look into the necessity of providing compulsory licenses (Under section 84 , Indian patent law) in the event of emergency or when the invention is unavailable at an affordable price to the public within the Indian territory.Amidst all this,  in future, the third parties have  probable open options for applying towards the compulsory patents.Well, at last it will  be interesting to observe the future outcomes regarding this matter.

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