Competition Law Patent

Merck – Glenmark to mediate in Januvia (Sitagliptin) patent infringement case


As reported by the TOI, in an interesting turn of events Merck has sought a settlement with Glenmark in the Januvia (Sitagliptin) patent dispute. Earlier this month, Merck applied in court to refer the Sitagliptin patent case to the mediation centre. Since the defendant Glenmark had no objection and was agreeable to engage in mediation, Justice AK Pathak allowed Merck’s application.

According to TOI reports the matter is to be listed before the Delhi high court mediation and conciliation centre on July 14, and be entrusted to two “seasoned and experienced” mediators, in consultation with the counsels for the parties.

Januvia patent dispute: A quick recap

In April last year in a brazen move, Glenmark launched generic version of Merck’s blockbuster anti-diabetes drug Januvia (Sitagliptin phosphate). Shortly thereafter, Merck has filed a patent infringement lawsuit against Glenmark in the Delhi high court. The Delhi High Court (Justice Rajiv Sahai Endlaw) refused to grant interim relief to Merck (plaintiff) seeking to restrain Glenmark (defendant) from launching its products Zita and Zita met. I found the line of reasoning for denying interim relief bizarre. For details please read my previous posts on this here and here.

Merck also initiated another patent infringement law suit against Aprica pharma with regard to launch of generic versions of Sitagliptin. In stark contrast the Delhi High Court (Justice Sanjeev Sachdeva) passed an ex parte injunction order, preventing Aprica pharmaceuticals from launching generic versions of Januvia.

keep-calm-and-choose-mediation

Mediation: trending?

Looks like mediation is in vogue!! After the Roche –Cipla case, this is the second patent case which has reached the mediation stage. In the Roche Cipla case, the parties agreed to engage in mediation pursuant to court orders, whereas in the Merck-Glenmark case, Merck voluntarily initiated the mediation.

It’s rather surprising and interesting and to note that Merck initiated the mediation.The Roche-Cipla case comes as a disappointment because, after a full-fledged trial and several proceedings in the High Court, the appellate court referred the case for mediation!! Many perceive the Roche-Cipla Case as being analogous to the Merck-Glenmark case; therefore expect a similar outcome/judgement. So in order to avoid a long drawn out patent battle,uncertainties and other costs,I believe Merck voluntarily sought a settlement to expedite proceedings .

Patent settlements: Anti- trust?

As Shamnad Basheer aptly states in an exclusive interview to frontlineGiven that a number of MNCs [multinational corporations] and domestic majors are now collaborating on a variety of fronts, it is expected that the number of pharma litigations and adversarial proceedings would anyway come down. This is worrying, as we all expect our generic majors to defend the public health turf and weed out undeserving pharma patents. If the generic majors are going to settle these privately, it presents a worrying trend. And the onus to challenge such undeserving patents falls on civil society and all of us.”

I agree, patent settlements especially settlements in the pharmaceutical sector may prove to be tricky from a competition law perspective. In case of settlements involving patents of questionable quality, it is the society who invariably pays the price for a delay in market entry resulting from such agreements.

Patent settlements,unlike court decisions create an atmosphere of uncertainty for other generic companies waiting to launch their generic versions. In these cases other generic companies will have to fight their own battles with the patent holders.

Mediation’s are usually successful after the counsels of both parties have assessed the relative merits of their respective positions. In this case it appears as though both parties are still maintaining their original stand. In the TOI article a Glenmark spokesman was quoted as saying “the company agreed to refer the matter for mediation, but we continue to believe that our products are non-infringing.”

The Januvia patent dispute is still in nascent stages and whether this mediation will result in a settlement, only time will tell!  Stay tuned.

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.

3 comments.

  1. AvatarAnonymous

    The Question in this case is unanswered. Whether Glenmark Infringes the Sitagliptin Basic patent or not?

    Reply
  2. Avatarvinay

    Patent settlements b/w MNC’s and India’s major drug firms may not be welcomed. These type of settlements mainly in view of money business rather than middle class health interest.

    Reply

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