This is a quick note about one of the items in this year’s Special 301 Report, released by USTR this morning. The report attacks the recent Indian Novartis ruling in unusually direct language. The ruling upheld the denial of a patent on Glivec for failing to meet patentability requirements under Section 3(d) of the Indian Patents Act, (a longer explanation is here). The Special 301 report has this to say on the matter:
The United States is concerned that the recent decision by India’s Supreme Court with respect to India’s prohibition on patents for certain chemical forms absent a showing of “enhanced efficacy” may have the effect of limiting the patentability of potentially beneficial innovations. Such innovations would include drugs with fewer side effects, decreased toxicity, or improved delivery systems. Moreover, the decision appears to confirm that India’s law creates a special, additional criterion for select technologies, like pharmaceuticals, which could preclude issuance of a patent even if the applicant demonstrates that the invention is new, involves an inventive step, and is capable of industrial application.
In contrast, WTO Director Pascal Lamy was quoted in the Hindu Business Line this week discussing TRIPS flexibilities and access to medicines. Regarding the Novartis case, he noted that “Recent decisions by the courts in India have led to a lot of protest by pharmaceutical companies. But decisions made by an independent judiciary have to be respected as such.”
We at PIJIP are just starting to read the report now. More to come later.
