Indian Court Rejects Novartis’ Patent Law Challenge

A court in India dismissed Novartis’ petition challenging a section of the country’s patent law, the company announced Aug. 6. Novartis initiated the challenge in 2006 after the Indian Patent Office denied its patent application for Glivec.

Novartis also appealed the patent office’s decision, but the Intellectual Property Appellate Board’s (IPAB) review is still pending, the company said. To date, Glivec (imatinib mesylate) is patented in nearly 40 countries, including China, Russia and Taiwan, according to Novartis.

In January 2006, Novartis was denied a patent for the cancer drug Glivec — called Gleevec in the U.S. — under Section 3(d) of the Indian Patents Act of 2005, which introduced an “improved efficacy” hurdle for patentability of new forms of known compounds, according to Novartis. Creating new forms of known compounds is sometimes referred to as “incremental innovation.”

Novartis brought its challenge of Section 3(d) to the High Court in Chennai, India, asking the court to declare it unconstitutional and in breach of India’s obligation under the World Trade Organization’s (WTO) Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement. According to Novartis, India had enacted new patent laws in 2005 to comply with the WTO’s requirements for pharmaceutical patents — in May, the WTO advised India to improve its intellectual property system.

Though the High Court dismissed Novartis’ challenge, it has deferred to the WTO to resolve the question of TRIPS compliance, Novartis said.

When hearings began in February, many nongovernmental organizations declared that changes to Indian patent law could restrict access to affordable generic drugs produced in India.

Médecins Sans Frontières (MSF) said the High Court’s decision to dismiss Novartis’ challenge preserves India’s status as the “pharmacy of the world.”

“This is a huge relief for millions of patients and doctors in developing countries who depend on affordable medicines from India,” Tido von Schoen-Angerer, director of the MSF Campaign for Access to Essential Medicines, said. “We call upon multinational drug companies and wealthy countries to leave the Indian Patents Act alone and stop pushing for ever-stricter patent regimes in developing countries.”

Novartis, however, said the ruling will have long-term negative consequences for R&D of better medicines for patients in India and abroad.

“Some groups have speculated that changing India’s patent law will impact access to medicine. However, eliminating Section 3(d) will not hinder the supply of medicines from India to poor countries, given the safeguards in international agreements,” Paul Herrling, head of corporate research at Novartis, said. “In addition, medicines are made available through tiered pricing solutions, public-private partnerships, shared contribution models and donation programs.”

Novartis pointed out that 99 percent of Indian patients being treated with Glivec receive it for free through the company’s patient-assistance program.

Ranjit Shahani, vice chairman and managing director of Novartis India, said the company likely will not appeal the High Court’s ruling and is still waiting for the full text of the court’s decision to be released.

As for the ongoing Glivec patent appeal, Novartis is petitioning the High Court for a new IPAB technical member, because the current technical member is the former controller general of the Indian Patent Office and is responsible for rejecting the Glivec patent. — Breda Lund