Drug firms may have breached patent norms

Drug firms may have breached patent norms

Mumbai: Aright to information or RTI disclosure indicates that the world’s top drug makers, including Pfizer Inc., Bristol Myers Squibb Co., F. Hoffmann-La Roche AG, Bayer Corp. and Schering Corp. (currently owned by Merck and Co. Inc.), may not have been in compliance with some Indian patent norms.

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These companies, which sell high-value drugs under patent protection, failed to disclose mandatory data about the working status of their patents in the local market for several years since the grant of patents and continued imports.

While this violation carries a fine of at least 10 lakh per patent per year, the patent office cites practical difficulties in taking action against the firms.

A patent attorney for Roche in India said the firm has filed Form 27 (which deals with the requirement) for its drugs Tarceva and Pegasys for all the years including 2007 and 2008, but did not share the details for these years.

Merck and Co.’s India spokeswoman said in an email statement, “MSD (which includes legacy Schering Plough companies) has followed, and continues to follow, all local laws and regulations for all our products in the country."

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

Bayer said it hadn’t violated any Indian laws.

“Considering that the matter is sub judice before Delhi high court, it would not be appropriate to comment," said a Bayer spokesperson. “However, we wish to place on record that Bayer is a law-abiding company and is in full compliance with the requirements as mandated under the Indian Patent law."

At least one-third of 38,000 Indian patent holders have been ignoring a key provision in the country’s patent law by not disclosing the working status of these patents. The data on the working of a patent is key to the patent office deciding whether the market and consumers are actually benefiting in terms of availability of the product.

If the patent office is not convinced about consumers’ interest being served, it can issue a compulsory licence to a third party. Such data is to be filed by March every year.

An RTI disclosure sought from the patent office by patent blog Spicy IP and a follow-up investigation by Mint among drug firms and other stakeholders have revealed that many large firms who hold several patents in the local market, especially those drug makers with patents for life-saving drugs, have not been filing the information for years.

Some of them have been giving information but not all that’s required by Form 27.

The RTI query sought by Spicy IP with reference to seven life-saving drugs currently sold by foreign firms including Pfizer, Bristol Myers, Roche, Bayer and Schering has revealed that these firms haven’t made the full disclosure for all these years since the grant of their patent rights in the local market. Some of these drug patents are also facing law suits in various Indian courts challenging their validity.

“We received about 24,000 filings (Form 27) in 2010 when some 33,000 patents were in force," India’s controller general of patents P.H. Kurian said on Tuesday. “In 2011, about 40,000 patents were in force. Since the compilation is not yet over, we don’t have the exact number of filings."

A patent-wise disclosure from the patent office on seven important medicines—including cancer drugs such as Pfizer’s Sutent, Roche’s Tarceva, Bristol Myers Squibb’s Dasatinib and Bayer’s Nexavar, besides hepatitis drugs such as Bristol Myers’ Entecavir, Roche’s Pagasys and Schering’s ViraferonPeg—shows most of the companies have not furnished the details till 2009 to the patent office.

India has allowed product patents for drugs under the TRIPS (Trade Related Intellectual Property Rights) provision since 2005 and a majority of these, except Nexavar and Entecavir, were granted in 2006 and 2007, indicating the need for filing the working status from 2008 onwards.

The patent office had in 2009 insisted on the need for filing the details through a key notification, although India’s Patent Act mandates this from the beginning.

Form 27, to be filed by all patent holders yearly, seeks details including whether the patent is working in the local market; the quantity and value of product sold; manufacturing base, and a statement on whether the public requirement has been met partly, adequately or to the fullest extent at reasonable price.

All the firms mentioned in this story currently import the drugs from their plants abroad, according to their own filings in the years 2010 and 2011. The update on the working status is required by the government to ensure that any patent-induced monopoly hasn’t blocked access of the product to the public and to make it accessible through a compulsory licence route (if needed). Working of a patent essentially means that a patented technology or invention is available for use of society to the required quantity and satisfaction, and that it meets needs in terms of production, sales and final use.

Also, a locally patented product cannot be continuously imported from overseas.

Section 84 of India’s patent law mandates that patents cannot be granted for “mere importation".

The access issue, especially for diseases such as cancer, hepatitis and HIV, is critical in India as most of the drugs are not affordable to much of the population.

“A vast majority of all registered drug patents in India are potentially subject to the risk of a compulsory licence, since they belong to multinational firms that merely import the drug," said Shamnad Basheer, human resource development ministry chair in intellectual property law at the National University of Juridical Sciences in Kolkata and the promoter of Spicy IP.

The patent authority cited several practical difficulties in penalizing the defaulters.

Kurian said the department is proposing to make all the data related to the working of patents public from this year, thereby alerting third parties interested in applying for compulsory licensing.