In April of 2005, India implemented some of its TRIPS obligations by amending its patent laws to include pharmaceutical product patent protection. According to the Office of the Controller General of Patents, Designs and Trademarks, this amendment triggered a significant increase in patent application filing in the field of organic chemistry and biotechnology.
This amendment will allow India to develop a domestic, innovative pharmaceutical industry. Indian companies like Ranbaxy, Nicholas Piramal and Biocon have reported drugs in the pipeline at this time. It will also increase foreign direct investment. In July 2005, for example, Merck announced its return to India, bringing new products, sales, marketing and research. Merck moved out of India when the Indian Patents Act of 1970 abolished pharmaceutical product patent protection.
Incremental innovation
India's 2005 patent amendments also include a provision that limits the patenting of pharmaceutical products, especially those with incremental innovation, in India. The new law prevents the patenting of salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substances, as well as new uses for known compounds, absent a showing no enhanced efficacy.
Novartis has appealed a rejection by the Office of the Controller General of Patents, Designs and Trademarks (OCGPDT) of its patent application covering a beta crystal form of Glivec (an anti-cancer drug) based upon section 3(d) of the Indian Patent Act. The appeal, which is now pending at the Appellate Board, may help to clarify the meaning of enhanced efficacy under the Indian patent act. The Indian High Court has previously upheld the constitutionality of Section 3(d).
On April 5, 2005, the Ministry of Commerce and Industry established a technical expert group on patent law issues, chaired by Dr. R. A Mashelkar, to consider two aspects of the Indian patent law. First, they considered whether TRIPS would be compatible to limit the patentability of pharmaceuticals to new chemical entities or new medical entities. Second, they considered whether TRIPS would be compatible to exclude microorganisms from patentability. In December 2006, the group released a report that found TRIPS incompatible for both. The report also explained how the protection of incremental innovation would help to build an innovative pharmaceutical industry in India. However, amid subsequent personal attacks on Dr. Mashelkar and accusations of plagiarism, Dr. Mashelkar was asked to withdraw the report. The Indian government may be willing to consider the report, after any technical inaccuracies are corrected.
Data protection
TRIPS Article 39.3 requires India to protect undisclosed pharmaceutical and agricultural chemical test data against disclosure and unfair commercial use when it is required as a condition for marketing approval. In February 2004, an inter-ministerial committee headed by Union Chemicals and Petrochemicals Secretary Satwant Reddy began to consider the issue of data protection and any legislative changes that would be required in India. The report was released on May 31, 2007. It recommends a three-year term of protection for agricultural chemical products, a five-year term of protection for traditional medicine and an indefinite transition period for pharmaceutical products, followed by a five-year term of protection. It also recommends a number of "safeguards" that would significantly reduce protection. However, these recommendations fall short of international standards.
The Ministry of Commerce and Industry, the Ministry of Health and Family Welfare and the Ministry of Agriculture have considered these recommendations. The Ministry of Health will take the lead to draft amendments to the Drugs and Cosmetics Act that will be forwarded to Parliament, in order to address the pharmaceutical and traditional medicine-related issues raised in the report. The Ministry of Health will also draft any regulatory amendments under the Act. Through this process, the Indian government will have the opportunity to revisit the recommendations of the report and implement a modern system of data protection that will allow new drugs to enter the Indian market. A modern system of data protection will also promote growth of the domestic pharmaceutical industry, increase foreign direct investment and the amount of clinical trials in India.
Customs
In order to strengthen the enforcement of intellectual property laws in India and stop the import of infringing goods, the Department of Revenue has recently promulgated the Intellectual Property Rights (Imported Goods) Enforcement Rules, 2007, authorizing customs officials to seize counterfeit and pirated goods at the border without an order from the court. These rules will help to safeguard consumers by preventing the import of ineffective or harmful counterfeit pharmaceuticals, among other harmful products.
USPTO OCGPDT MoU
On December 6, 2006, Jon W. Dudas, Under Secretary of Commerce for Intellectual Property and Ajay Dua, Secretary of the Department of Industrial Policy and Promotion, Ministry of Commerce and Industry, signed a Memorandum of Understanding (MOU) on bilateral cooperation between United States Patent and Trademark Office (USPTO) and OCGPDT. The MOU promotes USPTO-OCGPDT cooperation on capacity building, human resource development and public outreach in the field of intellectual property. An Action Plan under the MOU was also signed. The Action Plan details how work under the MOU will be carried forwarded. Three Indian patent examiners are currently involved in an eight-month training program at USPTO on patent examination in the field of biotechnology. Cooperative efforts are currently under way to promote additional technical exchanges with patent examiners and other government officials on intellectual property matters.
(The author is first secretary for Intellectual Property Embassy of the United States of America)