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Healthy Skepticism Library item: 19491

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.


Publication type: news

Mukherjee R
Drug MNCs violating patent law?
The Times of India 2011 Apr 7

Full text:

Five pharma MNCs, including Pfizer, Bayer, Roche, Schering and Bristol Myers Squibb, have been accused of violating patent laws with regard to top-selling patented anti-cancer and hepatitis drugs sold in the country.

A RTI application filed before the Patent Office reveals that since the medicines are being imported, and not manufactured domestically, the drugs are liable for compulsory licensing. Simply put, some quantity of the patented drug sold has to be manufactured in the country, otherwise, it throws open the doors of generic and affordable versions (manufactured by domestic companies) through a licence (compulsory licensing).

RTI applications filed by professor Shamnad Basheer ( National University of Juridical Sciences, Kolkata) to determine the extent of compliance of disclosure norms on patented drugs (as per the patent act) by MNCs

studied disclosure norms of seven top selling MNC drugs (anti-cancer and hepatitis), including Tarceva (Roche), Sutent (Pfizer), Nexavar (Bayer), Dastinib (BMS), Pegasus (Roche), Viraferonpeg (Schering) and Entecavir (BMS) over a period of three-four years. Interestingly, most of these drugs are also involved in patent litigations in the country.

The Patents Act stipulates that each patentee should file regular information to show how a patent has been ‘worked’ in India, through a certain form (Form 27) containing information like whether the patented product is manufactured in India or imported, if so the quantity and value, and whether the reasonable requirements of the public are being met through the patent.

The information contained in the Form 27 is critical to determine whether the patentee is adequately ‘working’ the patent on Indian territory, failing which the patent may be liable for compulsory licensing. If the company’s patent has not been ‘worked’, the Act penalizes the patentee by subjecting the patentee to a compulsory license.

According to Basheer, “None of the firms that we studied complied fully with the disclosure norms under Form 27 and section 146. In some cases, firms did not file Form 27 at all for some years. In others, such as with Sugen’s Sutent & Schering’s Viraferonpeg the information provided was woefully inadequate. This indicates that firms are not taking this disclosure requirement seriously.”

The application, a copy of which is available with TOI, mentions an important caveat, “In places where the patent office did not provide us with any Form 27 (as filed for a certain year for a certain drug), we assume that the said Form 27 was not filed by the patentee for that year”.

Companies like Roche, when contacted by TOI, said that the information was “incorrect” and they had been filing the information as per law.

Another company, Pfizer, which sells Sutent for kidney cancer, said it has consistently fulfilled all legal requirements, including filing of working statements for all patents it was granted in India since the introduction of the rules by Office of the Controller General of Patents, Designs and Trademarks in 2009. “For the year 2010, Pfizer has filed all the relevant statements to Indian Patent Office before the March 31st deadline, providing all the data as required by the authorities under Form 27.”

Bayer, which is embroiled in a dispute over its cancer drug nexavar, said considering that the matter is sub judice it would not be appropriate to comment at this stage. “However, Bayer is a law abiding company and is committed to be in full compliance with the requirements as mandated under the Indian Patent law.”

Significantly, the RTI application reveals since all the drugs are being “imported” into India and not manufactured within the Indian subcontinent, they can be subject to compulsory licensing under section 84 of the Patents Act.

“Section 83 of the Act makes clear that patents are not granted only for the purpose of “importation” of the patented product. And yet it is clear from the Form 27’s that all the drugs in question are merely being “imported” and not worked,” the application adds.

Also, Section 122 of the Patents Act, 1970 permits the Patent Controller to slap a fine of up to Rs 10 lakh on erring parties (those who do not file Form 27 or those who file incomplete information).


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