The global pharmaceutical firm was also suing a number of national companies for the infringement of patents covering the drug. The HC order paves the way for more affordable versions by national companies of the successful antidiabetic drug Dapagliflozin on the market.
In a July 20 ruling, a Delhi high court divisional court dismissed AstraZeneca’s appeal, saying it found no reason to interfere with previous orders from last year on two patents. In November, the court had rejected AstraZeneca’s request seeking a restraining order against the marketing of the diabetes drug by generic companies, including Intas, Alkem, Zydus, Eris LifeSciences, USV, Torrent, MSN, Micro Labs and Ajanta.
With nearly a dozen companies releasing competitively priced generic versions, the stage is set for a price war between players to grab a slice of the growing Rs 15 billion diabetes market, experts said.
AstraZeneca holds two patents for Dapagliflozin in the country: the first (IN 147) expired in October last year, while the second (IN 625) will expire in May 2023. Simply put, the second patent was not found to have merit. inventive over what already existed in the state of the art (prior patent), legal experts told TOI.
Dapagliflozin from AstraZeneca is sold under the brand name Forxiga and is part of a popular class of drugs called SGLT2 inhibitors, valued at around Rs 5,000 crore.
S Majumdar, representing generic companies, said: “It is a landmark decision in patent law, recognizing the need to avoid double patenting. In this case, it has a direct impact on diabetic patients, since, after the expiration of the term of the first Astra patent for Dapagliflozin, several generic companies can also make the drug available at competitive prices ”.
The court said: “We, at least at this stage, cannot, in the face of the aforementioned allegations of the appellants / plaintiffs themselves, find any difference between IN 147 and IN 625.” The request, to which TOI had access, said:
“In our opinion, with respect to an invention, there can only be one patent. The appellants / plaintiffs in this document, however, while claiming a single invention, that is, DAPA, are claiming two patents with respect to it, with infringement of both, by the defendant (s) / defendant (s). The same alone, in our view, attacks the very root of the appellants / plaintiffs’ claim and strips the appellants / plaintiffs of any interim measure. ”
In imposing a fine on AstraZeneca, the order read: “Therefore, there is no merit in the appeals, which are dismissed, with costs assessed at Rs 5 lakh for the defendant (s) / defendant (s) in each one of the lawsuits. ”
The total fine will be Rs 45 lakh. Significantly, the bank noted: “To maintain that an inventor, simply on the basis of his work, research, discovery and state of the art, but who has not produced any product capable of commercial exploitation, has the right, by obtaining the patent of the same, to prevent others from investigating in the same field, in our opinion it would not be conducive to research and development and would also violate the fundamental duties of the citizens of this country, enshrined in article 51A of the Constitution of India, to develop the scientific temperament and the spirit of inquiry. The same will allow busy people, by walking only part of the mile, to prevent others from completing the mile as well. ”
“We are also of the prima facie opinion that once the appellants / plaintiffs, before the USPTO, requested and agreed to the validity period of the US patent equivalent to IN 625 which ends on the same day as the validity period of the US patent. equivalent to IN 147, the appellants / plaintiffs in this country do not have the right to claim different periods of validity of the two patents ”, he added.