Drug Regulation Patent

Novartis sues Biocon over anti-diabetes drug vildagliptin: Bitter pill?


A year after the Glivec saga and looks like Novartis is leaving no stone unturned to protect its blockbuster anti-diabetic vildagliptin. According to news reports, Novartis filed a suit seeking an injunction against Biocon Ltd. at the Delhi High Court for infringement of the vildagliptin product patent. During the hearing on March 28, 2014, the court recorded a statement according to which Biocon will not manufacture, sell or export Vildagliptin for commercial purposes till the next court hearing. Details of the order can be accessed here (CS (OS) 891/2014). This is for the second time that Novartis has been embroiled in a patent litigation issue over Vildagliptin in India. On March 5, 2014, Novartis was granted a preliminary injunction by the Delhi High Court against the generic Wockhardt for infringement product patent. Our post regarding the Novartis-Wockhardt issue can be accessed here.

Image from here

Image from here

Factual matrix and Quia-timet suits:

It all started when Novartis received a notice from IPAB informing them about a revocation petition filed by Wockhardt. Shortly thereafter Novartis filed an RTI with the DCGI (Drug Controller General of India) seeking information regarding regulatory approvals issued for Vildagliptin. The RTI response provided them with a list of manufacturers to whom approval was issued (Wockhardt and presumably Biocon).

Subsequently Novartis filed a suit against Wockhardt and Biocon alleging patent infringement. Vildagliptin is protected by Indian patent no. 212815(mail-box application no. IN/PCT/2001/779/CHE-subsequently matured into product patent).

Quia timet suits aimed at preventing possible future injury are nothing new. Previously in an excellent post, Shamnad had blogged about quia-timet actions and big Pharma’s strategic use of RTI information to sue, given that there is no other credible way of knowing if a generic manufacturer intends to launch a patented drug.

Parallel proceedings:

In the patent infringement suit initiated by Novartis, at a later stage if the generics counterclaim and allege invalidity of the patent in the high court, an interesting scenario would arise wherein the validity of the same patent will be challenged at two separate forums i.e. IPAB and high court.

In Dr. Aloys Wobben vs Yogesh Mehra & Ors, the courts respondents considered the question of whether defendants can be permitted to continue the prosecution of proceedings for revocation of patents instituted by them, before the IPAB when they have elected to prosecute their counter claims for revocation of the very same patents, in the suits for infringement, filed by the appellant, who is the original plaintiff. In this case the court made some interesting observations:

  • Parallel proceedings in two separate forums for revocation of the very same patents could not proceed if, they were found to be inconsistent with each other.
  • Where the nature of the challenge in the two forums was materially different, it was quite possible to contend that proceedings could continue concurrently both before the IPAB and the High Court.
  • The mere fact that proceedings which are concurrent in nature are instituted before two separate and distinct forums would not trigger in, the doctrine of election unless, they are also inconsistent with each other.

In the US, however if validity of a patent is contested at two separate forums via ex-parte reexamination at PTAB and high court, the Director of the USPTO shall determine whether or not to suspend the reexamination.

Anti-diabetic drugs: trending?

Recently there has been a spike in litigation involving anti-diabetic drugs especially gliptins/ dipeptidyl peptidase-4 inhibitors (DPP-4). I am not surprised though, since in India the gliptins market share is estimated at about 500 crore! Also owing to obesity and lifestyle changes, India has acquired the dubious distinction of becoming world’s diabetic capital followed closely by China. Emerging markets like India offer huge untapped potential and opportunity for anti-diabetic drug launches. No wonder everyone wants a piece of the gliptin pie.

Interesting times ahead!

Picture1

Madhulika Vishwanathan

Madhulika Vishwanathan

Madhulika is a registered Indian patent agent and has completed her Master’s in Pharmacology from the Institute of Chemical Technology (ICT), Mumbai. Her interests include issues involving pharmaceutical and biotechnology patent law, regulatory aspects like Hatch Waxman litigation and antitrust law.She is currently working at law firm based out of Memphis, TN.

2 comments.

  1. AvatarZRS

    I believe that the Suit was recently decreed with Biocon agreeing to a permanent injunction with 107A flexibility.

    Reply

Leave a Reply

Your email address will not be published.