Lost In Bureaucracy? Novartis Gleevec IP Case Held Up By Indian Legal System
Novartis is concerned that the changing intricacies of the Indian legal system will indefinitely delay its court case challenging the Indian Patent Office's denial of the Gleevec (imatinib) patent in the developing country.
On April 3, the Chennai High Court handed Novartis' Gleevec patent case over to a newly-formed Intellectual Property Appellate Board, which will likely tie up the Swiss drug maker in administrative complexity and draw out its decision in the case.
In January 2006, the Indian Patent Office refused Novartis a patent for a beta-crystalline form of imatinib mesylate, reasoning that it did not show sufficient efficacy improvement over the original free base form of the drug as mandated by Section 3(d) of the Patent Amendment Act of 2002 for medicines filed prior to 1995 (1"The Pink Sheet" DAILY, March 15, 2007).
In signing on to the World Trade Organization's Trade Related Intellectual Property Rights (TRIPS) agreements 12 years ago, India instated product patents, and made "reverse engineering" and copying Western drugs illegal for products patented after 1995. In 2002, the Indian government issued the Patents Amendment Act, which required that all appeals to decisions made by the patent office be heard by a newly formed legal body, the so-called Intellectual Property Appellate Board.
The IPAB became operational for patent review on April 2, one day after Novartis concluded arguments for its appeal case before the Chennai High Court. "This is a step forward in creating a fully functioning patent system in India, however we are concerned that this new development may further delay review of the Gleevec patent matter," Novartis spokeswoman Carrie Scott said.
Novartis' Head of Corporate Services Thomas Wellauer told "The Pink Sheet" DAILY that what was holding up the implementation of the two-member IPAB was the nomination of a technical member.
Once the technical member was appointed on April 2, the Indian government "made the appellate board operational, and by the patent amendment act, appeals against a decision by the patent office now have to be heard by the IPAB," Wellauer explained.
"Although the board is formed, they say they need a couple of months to become really operational," he added. "They have to define their procedures. That means it will take some time until the hearing of our appeal will be scheduled."
However, if the IPAB makes a negative decision against Novartis, then the case goes back to the original Chennai High Court. If the court decides against Novartis, the company can take the case to India's Supreme Court.
In another twist, the newly appointed technical member is the former Controller General of the Indian Patent Office, Shri Chandrasekaran, who was initially responsible for the rejection of the Gleevec patent in India. With Chandrasekaran's presence on the board, Wellauer expressed concern regarding bias.
Chandrasekaran "will have to excuse himself because he is prejudiced. So the government will have to appoint an alternative technical member," Wellauer said. "How long that will take is anybody's guess."
While these changes advance India toward a "fully functional" patent system, "it is not a step forward for the timing of our case. ...It certainly will make our case more drawn out than if it had been heard by the court," Wellauer added.
[Editor's note: In March, "The Pink Sheet" DAILY ran a three-part series examining issues surrounding the Gleevec patent fight in India. The first part is available 2here.]
Beyond these administrative delays, Novartis' chances of garnering a favorable decision will ultimately hinge on whether the IPAB finds that the beta-crystalline form of imatinib mesylate is more efficacious than the original free base form of the drug. Novartis has presented data claiming that the new form of the drug is 30 percent more bioavailable than the original composition.
Shamnad Basheer, visiting associate professor of IP law at George Washington University Law School, told "The Pink Sheet" DAILY that the Gleevec patent case can go either way contingent upon the facts.
"If Novartis can show that the new Gleevec form's 30 percent more bioavailability confers an increase in efficacy then it would be pretty hard for the court to rule against Novartis," Basheer said.
In an effort to establish patent rights for Gleevec in India, Novartis is also embroiled in a second case where the Swiss drug giant is challenging that Section 3(d) of violates the TRIPS agreements and is unconstitutional.
According to Basheer, Novartis' chances of success in this second case are tenuous because "a domestic court is not the right venue. This matter should be challenged in the WTO."
Under TRIPS, "any invention" that is new and involves an "inventive step" may be patented. Since TRIPS does not define inventive steps, there is disagreement as to how much flexibility WTO member nations have to adjust the regulations to reflect socio-economic realities on the ground. Novartis claims that India's interpretation of the regulation is too strict.
According to Basheer, however, "salt forms are pretty obvious," as established in Pfizer v. Apotex. In that case, the Court of Appeals for the Federal Circuit found that a new salt form of a composition is obvious in view of the prior art.
Basheer authored an IP Institute report on TRIPS and India, which was included without citation in a government-commissioned report. The report was funded by INTERPAT, an organization of pharma companies whose members include Novartis.
The "citation error" in the Mashelkar Commission's report - which found that limiting patents to new chemical entities would not be TRIPS compliant - incited accusations of plagiarism and industry pandering, forcing the head of the group, R.A. Mashelkar, former director general of India's Council of Scientific and Industrial Research, to withdraw the document (3"The Pink Sheet" DAILY, March 14, 2007).
Novartis had hoped to use the report to defend its challenge of Section 3(d).
-Turna Ray
This article is reprinted from "The Pink Sheet" DAILY – April 24, 2007
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