The court is right
ON THE 1ST of April, the Supreme Court of India threw out of the window, the Swiss drug maker Novartis’ attempt to win a patent protection for its landmark drug Glivec. This decision sets a benchmark not only for patenting standards but also serves as a guidance document around the world in balancing pa tent rights to that of public health.
The Apex Court dismissed the case on the grounds that the patent does not qualify the standards set by Section 3(d) of the Indian Patents Act, 1970.
Section 3 (d) that barred the patent states that the mere discovery of a new form of an old drug is not an invention. No patents will be granted to such inventions, unless the patentee demonstrates enhanced efficacy for the modified compound. For example, when a drug such as aspirin is already patented, a new salt of aspirin, say aspirin hydrochloride, will not be patentable unless the said salt has better effect to the already known effect of aspirin.
Evolution of Indian patent law
Till 2005, only process patents were granted in India and it was not possible to obtain pro duct patents for food and drugs. In 1995, India ratified TRIPS agreement and was provided a period of 10 years till 2005 to implement product patent regime in three stages. In order to comply, the Indian Patent’s Act was amended in the years 1999, 2002 and 2005. Any product applications filed in this period were processed as “black box applications,” which meant that these applications would be examined when the product patent regime would come into force. Novartis filed patent application No. 1602/MAS/1998 for grant of patent for beta crystal of imatinib mesylate in 1998.
Rs 120,000 vs. Rs 8000 per month
In mid 2002, Novartis introduced the product Glivec in India as its beta crystal form covered by Indian patent application at a price of Rs 120,000 per month. Natco, an Indian generic manufacturer, also introduced the same pro duct branded veenat, also in its beta crystal form just at Rs 8000 per month.
Meanwhile, the 2002 amendment, introduced provisions for exclusive marketing rights (EMR). Novartis promptly applied and obtained exclusive marketing rights in respect of imatinib mesylate from Calcutta Patent Office even while its product patent application was pending under the then existing patent regime before Chennai Patent Office in 2003. Natco filed a writ in the Delhi High Court challenging the validity of EMR provisions on the ground that it did not provide for hearing any member of public. Unfortunately, this matter was dismissed on the ground of lack of jurisdiction. Natco promptly filed a Special Leave Petition(SLP) in the Supreme Court of India.
In 2004, Novartis filed a suit for infringement of patent against Hetero, Cipla and Ranbaxy at Chennai High Court alleging that the respondents have infringed their EMR. An ex-parte interim injunction was granted, against the respondents, but it was vacated after hearing. In the same year, Novartis also filed a suit for infringement of patent against Natco at the Mumbai High Court alleging infringement of the product veenat sold by Natco. By means of a chemical analysis Natco submitted that the product veenat is identical in chemical composition to Glivec.
On 25 May, 2005, Natco filed a pre-grant opposition against the said patent application of Novartis on the grounds of lack of novelty, lack of inventive step, non-patentability and also that the crystal is inherently formed while practising the 1993 US patent (the original patent, which is a prior art, ie known before the date of the said application), and substantiated the same by tests conducted by reputed Institutes. The Indian Patent Office, allowed Natco’s opposition and rejected the application of Novartis.
Aggrieved, Novartis filed writ petitions before the Madras High Court. The Central government issued a notification providing that all appeals against orders or decisions of the Controller of Patents pending before any High Court as on 2 April 2007 should be transferred to the Intellectual Property Appellate Board (IPAB).