Health Care Legislative and Regulatory Update

India Supreme Court determined to protect nation’s generic manufacturing sector

From international law firm Arnold & Porter LLP comes timely views on current regulatory and legislative topics that weigh on the minds of today’s physicians and health care executives.

India has an arguably higher bar to get a patent covering a pharmaceutical than any other country. Before 2005, Indian legislation prohibited patenting pharmaceuticals. Only patents to methods of manufacturing a drug could be issued until recently. Under that system, a highly profitable pharmaceutical sector developed in India that continues to this day to supply generic drugs to the world.

 

Last month, the Indian Supreme Court essentially ensured that Indian generic drug companies would continue to thrive when Novartis was denied a patent for Glivec (a cancer drug with the active ingredient imatinib mesylate). Glivec reportedly costs about $70,000 a year in the United States while a generic version from India costs only about $2,500 a year.

Novartis had been awarded patents for this drug in nearly 40 other countries and filed the case in India, at least in part, to get clarity on what Indian law considers patentable. Novartis also wanted to determine whether investing in the development of better medicines for patients in developing nations is a viable and sustainable long-term option. If India had granted Novartis a patent, Novartis and its licensees would have been the only ones that could legally produce and sell Glivec in India until the patent term expired. This denial by the Indian Supreme Court removes any barrier to Indian drug companies copying, in particular, Glivec and is one of many signals that the Indian patent and court systems will continue to legitimize Indian companies copying medicines under any circumstances.

Kristan Lansbery

The Indian Court denied Novartis a patent because it found that the form of the drug molecule as it is sold commercially was obvious over the initial synthesis of that molecule. Novartis argued that without changing the form of the drug, it would not have passed the regulatory requirements of consistency, safety, and effectiveness for a medicine. In addition, how to create different forms of a molecule (polymorph) and what the properties of any particular form will be are almost impossible to predict, especially for large, flexible molecules like pharmaceuticals.

Regardless, the Indian Supreme Court found that all of the forms of a molecule are inherent in any form of that molecule, and the commercial drug form of Glivec was not sufficiently more efficacious than any precursor form of the same molecule to justify granting a patent.

This decision sent a strong signal that the Indian Courts and Patent Office will protect the Indian generic drug manufacturing sector and that they are willing to sacrifice their country’s ability to support research-based organizations to do so.

Many will view the Indian Supreme Court decision as a victory for millions of patients in developing countries that purchase the generic drugs produced in India. Others will see this decision as an impediment to investment in innovation, particularly for or in emerging markets. Either way, it is a strong signal that the status quo in India will be maintained for some time to come.

Kristan Lansbery, PhD, JD, can be reached at Arnold & Porter LLP, 555 12th Street NW, Washington, DC 20004-1206; 202-942-5186; email: Kristan.Lansbery@aporter.com.

From international law firm Arnold & Porter LLP comes timely views on current regulatory and legislative topics that weigh on the minds of today’s physicians and health care executives.

India has an arguably higher bar to get a patent covering a pharmaceutical than any other country. Before 2005, Indian legislation prohibited patenting pharmaceuticals. Only patents to methods of manufacturing a drug could be issued until recently. Under that system, a highly profitable pharmaceutical sector developed in India that continues to this day to supply generic drugs to the world.

 

Last month, the Indian Supreme Court essentially ensured that Indian generic drug companies would continue to thrive when Novartis was denied a patent for Glivec (a cancer drug with the active ingredient imatinib mesylate). Glivec reportedly costs about $70,000 a year in the United States while a generic version from India costs only about $2,500 a year.

Novartis had been awarded patents for this drug in nearly 40 other countries and filed the case in India, at least in part, to get clarity on what Indian law considers patentable. Novartis also wanted to determine whether investing in the development of better medicines for patients in developing nations is a viable and sustainable long-term option. If India had granted Novartis a patent, Novartis and its licensees would have been the only ones that could legally produce and sell Glivec in India until the patent term expired. This denial by the Indian Supreme Court removes any barrier to Indian drug companies copying, in particular, Glivec and is one of many signals that the Indian patent and court systems will continue to legitimize Indian companies copying medicines under any circumstances.

Kristan Lansbery

The Indian Court denied Novartis a patent because it found that the form of the drug molecule as it is sold commercially was obvious over the initial synthesis of that molecule. Novartis argued that without changing the form of the drug, it would not have passed the regulatory requirements of consistency, safety, and effectiveness for a medicine. In addition, how to create different forms of a molecule (polymorph) and what the properties of any particular form will be are almost impossible to predict, especially for large, flexible molecules like pharmaceuticals.

Regardless, the Indian Supreme Court found that all of the forms of a molecule are inherent in any form of that molecule, and the commercial drug form of Glivec was not sufficiently more efficacious than any precursor form of the same molecule to justify granting a patent.

This decision sent a strong signal that the Indian Courts and Patent Office will protect the Indian generic drug manufacturing sector and that they are willing to sacrifice their country’s ability to support research-based organizations to do so.

Many will view the Indian Supreme Court decision as a victory for millions of patients in developing countries that purchase the generic drugs produced in India. Others will see this decision as an impediment to investment in innovation, particularly for or in emerging markets. Either way, it is a strong signal that the status quo in India will be maintained for some time to come.

Kristan Lansbery, PhD, JD, can be reached at Arnold & Porter LLP, 555 12th Street NW, Washington, DC 20004-1206; 202-942-5186; email: Kristan.Lansbery@aporter.com.

    See more from Health Law News From Arnold & Porter