Roche pushes for corrective statement from Indian Patent Office
This article was originally published in Scrip
Roche wants the Indian Patent Office to clarify that it has not flouted patent data disclosure norms, with specific reference to the 'working' of its patented products in India as required under Form 27 of the Indian Patent Act.
The company told Scrip that it had, through its patent attorneys in India, written a letter to the Controller General of Patents "to issue a corrective statement by furnishing information that all working statements were filed. We are yet to hear back from them. Roche has complied with the filing of the working statements for all its granted patents in India," the firm said.
Roche's apparent efforts to restore its compliance record in India comes after a recent right to information (RTI) disclosure claimed that leading multinationals including Roche, Merck & Co, Bayer and Pfizer may have flouted Indian patent data disclosure norms. All the companies have claimed to have complied with Indian laws (scripintelligence.com, 8 April 2011).
The RTI requests for Form 27s, filed by Shamnad Basheer, a professor in intellectual property law at the National University of Juridical Sciences in India, essentially covered Roche's products, Pegasys (pegylated interferon) and Tarceva (erlotinib).
Mr Basheer had contended that the drugs that were studied (seven in all) were only being "imported" into India and not manufactured within the Indian sub-continent, making them liable to compulsory licensing under section 84 of the Patents Act. He claims that "local working" implies that the patented product has been manufactured to some extent in India, and the fact that the Patent Act uses the terms "working" and "importation" distinctly means that "working" as used in the Act cannot include "importation".
The issue of what constitutes working of a patent has been controversial and complex, with Indian and multinational firms having their own polarised interpretations. Roche had earlier told Scrip that its products are being worked on a commercial scale to the "full extent" in India and that importation of a patented product constitutes working of the patented product in India.
correct information
Meanwhile, Roche also said that it expects India's controller general of patents to publish all working statements (under Form 27) and not just those specific to the pharmaceutical industry, and also called for industry to be given an opportunity to rectify any gaps.
Data provided under Form 27 is considered critical, especially in the area of medicines, given that Indian laws stipulate that non-working of a patented invention is one of the criteria to attract compulsory licensing provisions. The Patent Controller can fine parties who fail to provide details under Form 27 up to Rs1,000,000 ($22,645) under Section 122 of the Patents Act.
"The requirement of the filing statement is imposed on all patentees irrespective of the industry. Therefore, Roche expects that when the Controller publishes such information, it would relate to all working statements and not just to working statements in the pharmaceutical industry," the company said.
It added that it expects the Patent Office to publish the "complete and accurate" information and if the information is not accurate or complete, the office should give an opportunity to the patentee to correct the information. "As the patented drugs are sold in India, we believe it would erase any doubts on the availability of the new patented drugs," Roche stated.
India's controller general of patents, designs and trademarks, PH Kurian, was recently reported in local media as saying that working details (as provided in Form 27) provided by patentees would be available on the Patent Office website from June.