Novartis challenges Gleevec patent rejection in the Supreme Court

Novartis challenges Gleevec patent rejection in the Supreme Court

28 August 2009, New Delhi

In a case that could have far-reaching implications on access to drugs, Novartis AG (Novartis) has challenged the rejection of its appeal relating to a patent application for imatinib mesylate by the Intellectual Property Appellate Board (IPAB) directly before the Supreme Court. Novartis has urged that the IPAB has wrongly relied on the interpretation of section 3(d) by the Madras High Court-that a patent applicant has to show an increase in therapeutic efficacy.

At the centre of the issue is the beta-crystalline form of imatinib mesylate, a drug used to treat chronic myeloid leukemia (CML), a type of blood cancer.  In 1998, Novartis filed a patent application in India for a product patent on the beta-crystalline form of imatinib mesylate (imatinib mesylate) in 1998.  As India did not recognise product patents for pharmaceuticals this patent application was to be examined only after 2005.  In 2003, Novartis obtained exclusive marketing right (EMR) for imatinib mesylate based on this patent application. Based on the EMR, Novartis obtained orders from the Madras High Court to stop several generic pharmaceutical companies from manufacturing generic versions of imatinib mesylate. While generic versions were available at a cost of around Rs. 8,000 (USD 160) to Rs. 12,000/- (USD 240) per month, Novartis sold its version at Rs. 120,000/- (USD 2400) per month.  The court order resulted in the reduction of the supply of generic versions, and consequently impacted patients suffering from CML.

In 2005, the Chennai Patent office heard patent oppositions filed by CPAA, represented by Lawyers Collective HIV/AIDS Unit, and Indian generic pharmaceutical companies. In 2006, it rejected Novartis' patent application for the beta-crystalline form of imatinib mesylate (brand name Gleevec) on several grounds, including section 3(d). The Patent Office had held that the product claimed by Novartis lacked novelty and inventive step, and also failed to show an increased efficacy over the known substance.

Subsequently, Novartis filed multiple challenges in the Madras High Court. It challenged not only the decision of Patent Office rejecting its patent application, but also section 3(d) of the Patents Act-a crucial public health safeguard introduced in the law by Parliament to prevent evergreening. Novartis urged that not only was section 3(d) was vague and not compatible with the Constitution of India, but also that it was not compliant with the TRIPS Agreement.

In 2007, the Madras High Court rejected Novartis' challenge to section 3(d) and held that it had no jurisdiction to determine the issue of TRIPS compatibility.  In determining the issue of constitutional validity, the court held that the word "efficacy" used in section 3(d) had a definite meaning in the pharmaceutical field.

Due to changes in the law, the set of appeals filed by Novartis challenging the Chennai Patent Office's decision was transferred from the Madras High Court to the IPAB.  After hearings conducted before the IPAB intermittently over two months concluded in December 2009, the IPAB finally passed its order in June 2009. 

The IPAB held that Novartis was not entitled to a patent on imatinib mesylate as its claimed product did not meet the requirement of increased therapeutic efficacy. The IPAB, however, reversed the findings of the Patent Controller on novelty and inventive step. It held that imatinib mesylate was novel and not obvious to a person skilled in the art. It also allowed Novartis to proceed with certain process claims.

Ordinarily, a challenge from an order of the IPAB lies to the High Court. However, Novartis has approached the Supreme Court directly.

The matter is likely to come up before the Supreme Court on 31August 2009 ( Refer here for a copy of the Special Leave petition).

Contact Information:

Anand Grover: 09820184788             Julie George: 09820209736

Dr. Shubha Mudgal (Cancer Patient Aid Association): 09820037718

For the complete text of the Special Leave Petition , view the attachment below.