India’s Pre-Grant Opposition Leads to TRIPs Compliance Suit
As Congress considers establishing post-grant opposition in the United States and the USPTO aims to pilot the pre-examination Community Patent Review Project as a way to conduct “open examinations” and to get pertinent prior art into the hands of those who need it the most, namely, patent examiners, a few other countries such as India have pre-grant opposition proceedings. In India, pre-grant oppositions also function to provide prior art to patent examiners, but go well beyond that as they are opposition proceedings.
Most recently in the news, many multinational pioneer pharmaceutical companies have had their patent applications opposed by Indian generic pharmaceutical companies and by advocacy groups. Some have criticized this as merely a delay tactic. We here at Maier & Maier are inclined to agree and that is why we support post-grant proceedings which are by their nature unable to delay the prosecution of a patent (India also has post-grant opposition).
The recent pre-grant oppositions of applications on pharmaceuticals are the result of India’s move towards TRIPs compliance in 2005, which was a condition of India joining the WTO. Simply put, TRIPs requires that pharmaceutical substances be patentable. From 1995 to 2005, India was also required to maintain a mailbox for receiving pharmaceutical and agricultural chemical patents applications that were published in 2005 and are now subject to examination. Because India is a leading producer of generic drugs, it was no surprise that a few thousand “mailbox” applications were filed by pioneer pharmaceutical companies.
For example, Novartis was not granted a patent on a 1998 application for its cancer drug, Gliveec / Glivec, after it was opposed by the Cancer Patients Aid Association. In response, during May 2006, Novartis filed two suits, one challenging the rejection and, more importantly, one challenging Section 3(d) of the Indian Patents Act, on which the application was rejected, as not being compliant with TRIPS. Recently, a panel appointed by the Indian Ministry of Commerce comprised of IP specialists has concluded that Section 3(d) does not comply with TRIPs (report at http://www.ipindia.nic.in/ipr/patent/mashelkar_committee_report.doc ). Section 3(d) is an exception to patentability that excludes “the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of the substance, the mere discovery of any new property or new use for a known substance, and the mere use of a known process, machine or apparatus – unless the process results in a new product or employs at least one new reactant.”
The next hearing before the Chennai High Court in the Novartis case is scheduled for today, January 29, 2007. We here at Maier & Maier are interested in your thoughts on pre-grant opposition, Section 3(d) and the Novartis case as well as any other comments on Indian patent law.
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