They opposed Novartis on Glivec, but now seek patent

If you thought only multinational drugmakers were monopolistic and fought fiercely to secure patents for new forms of known molecules, you are so wrong.

Indian pharma companies are just as aggressively chasing patents for their versions of known drugs.

In early 2006, based on the pre-grant opposition filed by Hyderabad-based Natco Pharma, amongst others, the Chennai Patent Office had rejected the patent application for Novartis’ beta crystalline form of blockbuster cancer drug imatinib mesylate
(Glivec). And last month, the Delhi Patent Office, based on the pre-grant opposition by companies like Mumbai-based Sun Pharmaceuticals, rejected the patent application for Novartis’ alpha form of imatinib mesylate.

The rationale offered on both occasions was that since the patent was for a new form of an existing substance, it came under Section 3 (d) of the Indian Patent Act 1970, which states that mere discovery of a new form of a known substance, which does not result in the enhancement of the known efficacy of that substance, shall not be treated as an invention and is thus not patentable.

Fair enough. After all, drug evergreening reduces people’s access to healthcare.
Strangely, however, the very same Indian companies are now looking to do a Novartis themselves. Natco and Sun, among a host of others, which had opposed the patent application of Novartis, are seeking patents for their versions of the same molecule —- imatinib mesylate.

Natco has filed for a polymorphic form of the molecule; Hetero Drugs for a novel form; and Cipla for the stable crystal form. Sun Pharmaceuticals, on its part, has made two applications for crystal and amorphous forms. Each company claims its version of imatinib mesylate is a “novel form.”

“Our invention is not hitherto known and relates to improved processes for the preparation of imatinib mesylate,” says an official from one of these companies.
Imatinib mesylate is used in the treatment of chronic myeloid leukemia (CML), a life threatening type of cancer, characterised by increased and unregulated growth of myeloid cells in the bone marrow and their accumulation in the blood.

There are approximately 2 lakh CML patients in the country at present, with 40,000-50,000 people getting afflicted each year, says YK Sapru, founder chairman and CEO of Cancer Patients Aid Association, the NGO which had locked horns with Novartis over patent grant for Glivec.

“Both MNCs and local drugmakers are just trying to get market monopoly,” says Sapru.

Shamnad Basheer, the ministry of human resources’ chair in intellectual property law at the National University of Judicial Sciences in Kolkata, feels there is a high chance of these applications failing as they come under Section 3 (d).

A New Delhi-based lawyer points out that applying for a patent for a new form of a known substance is a defensive strategy by pharma companies. “Once a patent application is made, that bit of technology goes to the public domain and so no other company can claim rights on it.”

According to Anuradha Salhotra, partner, at New Delhi-based intellectual property firm Lall, Lahiri & Salhotra, if the company can prove that its version of the known salt has greater efficacy and that it therefore doesn’t fall under Section 3 (d), it can get the patent.