Accusations from India's generic drug makers that a government commission report used the same wording as a research paper funded by brand-name drug manufacturers have thrown a wrench in Novartis' plans to use the report's findings to strengthen its court case challenging the Indian government's denial of a patent for a beta-crystalline form of Gleevec, known as Glivec in India.
In an effort to establish patent rights for its chronic myeloid leukemia drug imatinib mesylate in India, Swiss drug giant Novartis has taken on the Indian government and several generic drug manufacturers, challenging that an amendment to the Indian Patent Act of 1970 violates the World Trade Organization's Trade-Related Aspects of Intellectual Property Rights TRIPS agreements. The particular amendment to the patent law, Section 3(d), forbids the patenting of derivative forms of known substances, unless the new product shows it is substantially more efficacious than the original formulation.
The case is pending before the Madras High Court, with hearings scheduled to resume March 26.
The report Novartis had hoped to use in support of its suit was created in response to a debate in the Indian Parliament regarding amendments to existing patent laws.
In becoming TRIPS compliant in June 2005, India reinstated product patents, making "reverse engineering" and copying Western drugs illegal for products patented after 1995. That same year, Parliament convened an expert panel to examine whether granting intellectual property protection only to new chemical entities or to new medical entities "involving one or more inventive steps" and denying patents for microorganisms would be compatible with TRIPS. In February, the committee, headed by R.A. Mashelkar, former director general of India's Council of Scientific and Industrial Research, issued its report, which found limiting patents to NCEs would not be TRIPS compliant.
Following the report's release, Paul Herrling, head of corporate research at Novartis, told "The Pink Sheet" DAILY that "the report of the commission, the way we read it, actually supports our view, that the amendments were not compatible with the TRIPS agreement."
However, India's left-leaning parties and generic drug manufacturers questioned the integrity of the expert panel's 56-page 1report. They charged that a critical paragraph in the document on the importance of differentiating between "incremental innovations" and "evergreening" was copied verbatim from a report submitted to the committee by the London-based research firm IP Institute and funded by INTERPAT, an organization of pharma companies whose members include Novartis.
Since accusations of "plagiarism" emerged in the Indian media, Novartis has distanced itself from the Mashelkar Commission's findings. "It would be inappropriate for us to comment on this action or on any potential impact it may or may not have on the legal case challenging the denial of our patent application for Glivec or Section 3(d) [amendments] of the Indian patent law," the company said in a statement.
The portion under fire for being "plagiarized" from the IP Institute's report is section 5.10 under the subhead titled "National Interest Perspective," which differentiates "evergreening" or making "insignificant changes" to an existing patent from "incremental innovations," which are "sequential developments that build on the original patented product."
Incremental innovations "may be of tremendous value in a country like India," and "such incremental developments ought to be encouraged by the Indian patent regime," the reports from the IP Institute and the commission both state.
Mashelkar withdrew the report in February, citing errors in attributions. Mashelkar has said he still stands behind the conclusions in the report and plans to submit a new, better drafted report in the coming months. Although Mashelkar will resubmit the report, the Madras High Court will likely not consider it in the Novartis case.
[Editor's note: This is the first part in a three-part series. Part 2 will be published March 15 and Part 3 on March 16.]
- Turna Ray
This article is reprinted from "The Pink Sheet" DAILY – March 14, 2007
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