Novartis' lawsuit to gain a patent for a new formulation of Gleevec is the first legal challenge to Section 3(d) of the Indian Patent Act, which seeks to bar "evergreening" by restricting patents for minor improvements to old formulations.
Under the provision, derivative formulations must be significantly more efficacious than the original formulation. What constitutes "efficacy," however, is not defined in the statute, leaving room for inconsistencies and subjectivity in the patent controller's decisions.
The Indian Patent Office in January 2006 rejected Novartis' patent for a beta-crystalline form of imatinib mesylate, reasoning that it did not meet the requirements under Section 3(d), since the beta-crystalline formulation did not show sufficient efficacy improvement over the original free base form of the drug filed prior to 1995.
In May, Novartis filed writ petitions in the Madras High Court against the Indian government and generic manufacturers Cipla, Natco, Sun Pharma and Ranbaxy, challenging the patent controller's decision to deny its patent application, and alleging that Section 3(d) of the Indian Patent Act was vague, ambiguous, and contrary to the World Trade Organization's Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement.
Under TRIPS, "any invention" that is new andinvolves an "inventive step" may be patented. Since TRIPS does not define what is an "inventive step," there is disagreement as to how much flexibility WTO member nations have to adjust the regulations to reflect socio-economic realities on the ground.
In 2001, 142 nations, among them the United States, signed the "Declaration on the TRIPS Agreement and Public Health," which stated that intellectual property regulations "can and should be interpreted and implemented in a manner supportive of WTO Member's rights to protect public health, and in particular, to promote access to medicines for all."
Novartis contends that India's interpretation of the law is too strict and violates Article 14 of the Indian Constitution which ensures equality and prohibits discrimination. Meanwhile, Indian generic drug firms contend that India has a right to implement provisions under Section 3(d) in line with its public health needs, and that the provision does not restrict innovation, but simply holds a higher bar for incremental improvements.
However, the patent statute's singular focus on "efficacy" would deny patent rights to changes in modes of administration or formulation that may not improve efficacy but may improve patients' quality of life. For instance, improvements to make insulin heat-stable would have a profound impact in a tropical climate like India's, but would not be protected under India's current patent regime, Novartis' head of corporate research Paul Herrling said.
With regard to the Gleevec patent suit, Novartis has contended that by focusing only on efficacy, the patent examiners have failed to consider that the beta-crystalline formulation of imatinib is 30 percent more bioavailable than the free base form.
"By focusing on increases in efficacy only, it excludes all the other improvements in quality of life and ease of applicability, but it would also prevent people from investing on such improvements for the simple reason that to do such a clinical study needs a major investment," Herrling told "The Pink Sheet" DAILY. "If there is no IP protection, there is no incentive to pursue such innovations."
"Incremental [improvements] doesn't mean minor," he said.
Novartis has been quick to point out that Gleevec has patent protection in 35 countries, including China.
In February, a report by an expert panel convened by India's Parliament highlighted the drug patent regimes in the UK, U.S., China, Japan, Brazil and Australia, calling for formulating and rigorously applying guidelines to "eliminate ... the remotest possibility of granting frivolous patents." Parliament convened the group 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 (1"The Pink Sheet" DAILY, March 14, 2007).
The discrediting of the panel's findings may ultimately delay much-needed guidelines to clear up the still murky areas of India's patent system, Shamnad Basheer, visiting associate professor of IP law at George Washington University Law School and the author of an IP Institute report on TRIPS and India, told "The Pink Sheet" DAILY. Instead of politicizing the issue, the focus should be on developing the guidelines needed to improve India's patent system, he said.
By failing to update its IP system on par with other countries, India will end up "losing a lot of money and the only people who will get rich are lawyers," he said.
The expert panel's report reached a similar conclusion. "Drug discovery research is still finding its feet in India. Though many companies are investing, it will be at least a decade before a critical mass is in place and results start accruing," the withdrawn report said. "Restricting patentability to just NCEs would mean that most of the pharmaceutical product patents would be owned by [multinational companies]."
The panel also looked at the types of patents Indian drug companies were filing overseas, and noted that many had filed for patents based on incremental innovations. Particularly, Natco, one of the generic manufacturers embroiled in the Novartis suit, has filed three such patents outside of India for a controlled-release gastric floating matrix formulation containing imatinib; for polymorphic forms of imatinib mesylate; and for a novel polymorphic form of imatinib mesylate and a process for its preparation.
"It's clear from the fact that Indian drug companies are filing patents based on incremental innovations in other countries that they are ready to innovate," Basheer said.
[Editor's note: This is the second part in a three-part series. Part 3 will be published March 16; Part 1 was published March 14.]
- Turna Ray
This article is reprinted from "The Pink Sheet" DAILY – March 15, 2007
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