Novartis Case Against India’s Patent Law Resumes This Week

By Tatum Anderson for Intellectual Property Watch
The latest chapter in the Swiss pharmaceutical company Novartis’ challenge to the Indian intellectual property system begins on 18 June when the Indian Patent and Trademark Appellate Board (IPAB) is scheduled to hold its first hearing.

However, lawyers expect “teething” problems to delay the proceedings.

Although the IPAB has existed in law since 2003, a fully-functioning board that could hear such appeals did not exist in reality before the Novartis case. This group actually became operational on 2 April, 2007 and made public on 3 April.

Anand Grover, an opposition lawyer, said of the proceedings, “It is uncertain whether it will go on, so most people will treat the 18th as a date of directions.”

The case was originally heard exclusively in the Indian High Court since Novartis filed a writ petition objecting to a decision made by the Indian Patent Controller last year. The controller had rejected a patent application filed by Novartis for its anti-cancer drug Glivec.

Novartis actually filed two separate challenges, but both were heard at the High Court in Chennai concurrently by the same judges.

The first challenges the very decision made by the Chennai Patent office to reject the patent application.

The Patent Controller had concluded that Glivec was merely a new form of an existing patented substance rather than a new invention that merited a patent, as defined in Indian patent law.

Novartis disagreed, however, on the basis that Indian patent law states that a patent cannot be granted for “the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance.”

Novartis has said the Glivec patent application was rejected despite the fact that it demonstrated a 30 percent increase in bioavailability, the amount of drug absorbed in the body, over the original substance.

The appellate board is therefore expected to deliberate over exactly what measure of efficacy would demonstrate that substance was a new chemical entity that merits a patent, rather than just a new form of a known substance.

The second, and most controversial, case challenged Indian law itself. Specifically, Novartis claimed that section 3(d) of the 2005 Indian Patents Act, which defines exactly what a new invention should consist of, is not in compliance with the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and is therefore unconstitutional.

After weeks of arguments the constitutional challenge was left in the High Court, while the challenge to the Patent Controller was moved to the IPAB in May.

Therefore, as arguments on the constitutional challenge had been completed by the time the split happened, a decision on whether Indian law is TRIPS-compliant appears to be imminent.

Conversely, the move to the IPAB threatens to delay a ruling on the Patent Controller’s decision for a number of reasons.

For one thing, the board is likely to require the case to be heard again from the beginning. When the decision to split the case was made, Novartis had only just finished its arguments and other parties had yet to put their counter arguments, said Novartis.

However, experts say Novartis will not be able to submit further evidence to support its case. Some say that, like the High Court, the parties will only be allowed to present the evidence that was originally used by the Patent Controller to reach his decision in 2005.

There are also practical limitations to holding the case on Monday. The IPAB is so new that it needs a bigger office, and is believed to be office-hunting. One source said, “When there are thirty lawyers, the tiny cubicle that the IPAB is operating from will not be sufficient.”

And, crucially, there has been controversy over the make-up of the board. That is because the appellate board decided to appoint as its new technical member, Dr. Chandrashekran, the former Patent Controller himself. As head of the Indian Patent Office, he was ultimately responsible for the original decision to reject the Glivec patent in 2006. He also has been an active member of the case at the High Court. Indeed, Chandrashekran filed an affidavit related to the constitutional challenge case in the Chennai High Court.

It is unclear how Novartis plans to deal with the appointment. It was unavailable for comment.

However, Novartis has made no secret of its concerns in the past. When the referral to the IPAB was announced in April, a spokesperson for Novartis said: “We have confidence in the Indian court system, and we hope we can have the same confidence in the appellate board. We look to the Ministry of Commerce and Industry to quickly develop procedures that allow us to explain our case clearly to an impartial board and in a manner that ensures transparency in the decision-making process.”

Tatum Anderson may be reached at info@ip-watch.ch.