The recent ruling by the Madras High Court upholding section 3(d) of the Patents Act is not going to be the end of the running battle between patent holders and generics manufacturers
A bit of history first.
On July 17,1998, Novartis AG of Switzerland filed a routine patent application in Chennai (1602/MAS/98). The invention for which they filed the application related to a new crystalline form of a salt that already existed and was being used in Glivec, a blockbuster drug for the treatment of a form of Leukemia and Gastro-Intestinal Stronlal Tumours. At that time no one would have thought that this patent application would become the touchstone for testing India’s new patent regime.Acting on the application, on November 10 2003, the Controller General of Patents & Trademarks granted exclusive marketing rights (EMR) to Novartis for Glivec for five years. This was the first ever EMR granted in India under the Patents Act (amended to conform to WTO and TRIPs requirements) and was promptly challenged in various courts by generic drug manufacturers. Novartis also approached the courts to enforce the EMR against nine generic manufacturers.
In September 2004, the Controller General of Patents, S N Maiti was removed from his position by the government, apparently for among other things, the grant of this EMR.
| DARE/the protagonists |
| Novartis AG, Switzerland Novartis India Ltd Vs Union of India through the Secretary, Department of Industry Controller General of Patents & Designs Natco Pharma Cipla Hetro Drugs Cancer Patient Aid Association Ranbaxy Indian Pharmaceutical Alliance Sun Pharmaceutical Industries |
On January 25, 2005, the Asst. Controller of Patents and Designs, Chennai rejected the patent application citing section 3(d) of the Patents Act (Amendment) of 2005, and in August, Novartis filed suit in the Chennai High Court asking that section 3(d) be declared unconstitutional, violating Article 14 of the Indian constitution and article 27 of the TRIPS agreement under WTO.
Section 3(d) defines what are not inventions.
Let’s take a break from this recitation of history and law and understand what the issue at stake was.
More than what is patentable and what is not, at the heart of the legal push and pull was the very future of the generics drugs industry in India.
According to the US Food and Drug Administration (FDA), a generic is “identical, or bioequivalent to a brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use. Although generic drugs are chemically identical to their branded counterparts, they are typically sold at substantial discounts from the branded price. When patents or other periods of exclusivity for a drug expire, manufacturers can apply to the FDA to sell generic versions.”
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Generics can be produced when the original drug was not patented, the patent has expired, the producer of the generic certifies that the patents are invalid, unenforceable or will not be infringed, or in countries where the specific patents are not in force. Generics are present not only in human medicines, but also in a host other areas involving chemicals like fertilizers and agrochemicals.
The global business in pharma generics is huge. The US market for prescription generics alone was estimated to be $18 billion in 2004. Major European markets added another $11 billions. The market for hospital orders is over and above this. Africa and Asia are also huge markets for generic drugs. India is the leading manufacturer of generics in the world.
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While a manufacturer wanting to get a new drug certified by the US FDA goes through the new drug application (NDA) process, a generics manufacturer goes through the NADA, the Abbreviated New Drug Application. It is termed “abbreviated” because generic applicants are generally not required to include animal (preclinical) and human (clinical) data . Instead, they must scientifically demonstrate that their product is bioequivalent (performs in the same manner). One way for this is to measure the time taken by the generic drug to reach the bloodstream in 24 to 36 healthy volunteers. This gives the rate of absorption or bioavailability of the generic, which is compare to that of the original. The generic must deliver the same amount of active ingredients into the bloodstream in the same amount of time.
Under TRIPS, the duration of a patent is 20 years. Most generics enter the market immediately at the end of the patent period. Patent holders may attempt to increase the duration of the patent when it is about to expire. Such attempts to extend the duration of a patent beyond the initial patent period are collectively called evergreening.
Section 3(d) is aimed at preventing evergreening. It specifically states that there has to be an enhancement of efficacy for a patent to be granted for an existing product, and this was at the core of the Novartis writ. Novartis claimed that the decision on whether efficacy was improved by the patent office was likely to be subjective and liable to be misused.
The two Novartis entities had filed separate suits, which were similar, with the Novartis Switzerland suit also asking for the patent to be granted. Later on, the plea for granting the patent was dropped and the court treated both suits as the same. The single bench directed the case to be heard by a division bench, as it involved substantial points of law.
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