Drug Regulation Patent

It’s raining injunctions: Novartis granted injunctions against four other generic makers over Galvus.


It seems like Novartis is jealously safeguarding anti-diabetic drug Galvus against competition. In an interesting turn of events Novartis filed quia timet suits against against four other pharmaceutical generics: Glenmark generics, Bajaj healthcare, Cadila healthcare and Alembic pharmaceuticals over alleged patent infringement of Galvus (Vildagliptin).

In the Bajaj healthcare case and Alembic pharmaceutical case the court  granted ex-parte ad-interim injunctions and observed that that plaintiff (Novartis) 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.Time and again, we have reiterated the dangers of granting ex-parte injunctions in highly technical patent cases like these.Please read Shamnad’s and Prashant’s incisive posts on this.

In the Glenmark case as well as the Cadila case the defendants undertook that till the next date of hearing, the defendant shall not manufacture for marketing purposes and shall not market in India or abroad any product, that infringes the patented product of the plaintiffs.  Since the defendants are bound down by their statements this is more or less like an injunction.

Image from here

Around last month, Novartis had obtained similar quia-timet injunctions from the Delhi High Court against two other drug-makers Novartis and Biocon over the alleged infringement of Vildagliptin. We had blogged about this here and here.

After Wockhardt filed a revocation petition in the IPAB, 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 and this probably triggered the flurry of infringement suits.

With so many generic majors seeking regulatory approvals for manufacture of Vildagliptin, the anti-diabetic drug market surely is heating up.

PS: A big thanks to Sai Vinod for bringing this news to my attention.

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.

5 comments.

  1. AvatarAnon again

    Madhulika, hope you would read the orders and clarify that injunctions were not granted in all the cases. Injunctions were granted only in ex-parte cases. In the remaining, the defendants made an undertaking, which is not an injunction.

    It would be interesting if you could comment whether seasoned IP judges of the same Court would grant these injunctions!

    Reply
  2. AvatarAntara Kapoor

    The only injunction appears to be on the Wockhardt csae. The order of the Court in the Biocon case records an undertaking by Biocon that they will not infringe except for the Section 107A exempt activities. Other orders on Alembic, Cadila, Bajaj etc. reflect this same exemption.

    It is interesting that the RTI route is being used – wonder when the respective PIO’s will realise that releasing information qua third party approvals may well violate the RTI Act.

    Reply
  3. AvatarAntara Kapoor

    An addition to my earlier comment – only the Glenmark and Cadila orders do not contain an injunction. Bajaj is injuncted like Wockhardt.

    Mixup of order interpretation there !! 🙁

    Reply
  4. Madhulika VishwanathanMadhulika Vishwanathan Post author

    Hi Anon and Antara:
    Thank you for your comments.
    In both the Glenmark and Cadila cases they essentially made an undertaking that till the next date of hearing, shall not launch the drug in the Indian market. The defendants are bound down by their statement. You may employ numerous euphemisms; but this is essentially an injunction/restraining order.

    Also if you look at the Natco Dasatinib case, Natco undertook in its pleadings that it does not intend to sell and a judge bound them to that undertaking, the order then effectively acted as an injunction.

    Anyway I have updated the post to reflect changes.

    Reply
  5. AvatarAnon again

    Madhulika..

    Please admit a mistake if it’s made. There is a world of difference between an undertaking made by a defendant and an injunction order passed against a defendant. The legal ramifications, consequences and further course of action can hardly be said to be the same except myopically. Do not be so stubborn as not to accept it . Your so called corrective changes in the article is he he he !

    And oh!Euphemisms ..this is a legal thing, may be techno legal thing at best not prose..U guys @ spicy IP really need to reflect at the quality you put up.. and this is not only about you.

    Accept this as constructive criticism. All the best.

    Reply

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