 "IPAB to take up Wockhardt plea against Novartis")
The dispute is on the patent of anti-diabetes drug vildagliptin, an oral anti-hyperglycemic agent which is also marketed in combination with Metformin Hydrochloride, owned by Novartis in India. According to information available, the patent was challenged by Wockhardt in September, 2013 through a revocation petition before the IPAB.
Following this, attaining information that the Indian drug manufacturer has received the drug regulator's permission for manufacture and sale of the product on May, 2013, Novartis filed a petition with the Delhi High Court, and received an interim injunction on March 5, till next hearing.
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Wockhardt approached the IPAB for early hearing of the revocation petition. S Majumdar, learned counsel for Wockhardt has requested for early hearing of the revocation petition as his licence for manufacturing is a temporary one and would be expiring soon. He also argued that the matter pending with the High Court is related to the alleged infringement of Novartis' patent and there is no bar on IPAB hearing the petition on revocation of patent.
The IPAB bench comprising of Chairman Justice K N Basha and Technical Member (Patents) DPS Parmar ordered, "Considering the request of the applicant (Wockhardt), we are of the view that no prejudices will be caused to the 1st respondent (Novartis) by fixing an early date for revocation petition."
The learned counsel appeared for Novartis AG submitted that the issue in the civil suit filed by them before the High Court is in respect for the validity of the patent and its infringement. Such be the position, the revocation petition may be taken up after completion of Delhi High Court in order to avoid multiple view and to avoid conflicting decision by the IPAB and the Delhi High Court, he argued.
According to the interim injunction order issued by Justice Sanjeev Sachdeva, Delhi High Court, Novartis is the patent holder of the drug containing the active pharmaceutical ingredient (API) vildagliptin and vildagliptin in combination with Metformin Hydrochloride and has been selling the same under the brands Vysov and Vysov-M in India since 2008 and internationally since 2007. The patent was registered in 1999 and is valid till 2019.
Novartis has a co-marketing agreement with Emcure Pharma and the products Vysov and Vysov-M are marketed by these companies across India.
The company became aware of the revocation petition filed by Wockhardt in IPAB, on receipt of the notice from the Board on January 13, 2014 later collected information from the State Drug Controller that the permission for the manufacture and sale of the product was issued to Wockhardt on May 24, 2013. It argued that while the Indian firm has not yet launched the product in India or abroad, they are in the process of launching the product and this would be a violation of the patent of the the company, they argued.
The Single Judge ordered, “I am satisfied that plaintiff has made out a strong prima facie case for grant of ad-interim injunction. The balance of convenience is also in favour of plaintiff and in case, the ad-interim injunction is not granted, the plaintiff shall suffer and irreparable loss and injury.”
"It is, accordingly, directed that till the next date of hearing, the defendants are restrained from manufacturing, importing, selling, offering for sale, export directly or indirectly dealing in pharmaceutical products, compound or formulation or combination containing Vildagliptin alone or Vildagliptin with Metformin Hydrochloride in combination or Vildagliptin in any other combination in contravention to the Indian Patent No 212815 of plaintiff No.1. Compliance of Order 39 Rule 3 CPC within three days," said the order.
Gliptins are fast growing segment in the anti-diabetes drug market in the country, and the patent owners have been trying to reduce the competition by tying up with one of the generic firms in the country to come up with a lower cost product, according to industry sources.