Glenmark restrained from manufacturing and selling its anti-diabetes drugs

High Court: In granting permanent
injunction to US
drug company Merck Sharp and Dohme (MSD), the Court restrained Indian firm
Glenmark Pharmaceuticals from manufacturing and selling its anti-diabetes drugs
“Zita” and “Zita-Met”, saying it has infringed patent of the plaintiff. The US drug maker
in its plea had sought injunction against Glenmark alleging it of violating its
patent rights. The plaintiff sells its anti-diabetic product in India under the
brand name “Januvia” and “Janumeta”.

The patent dispute
arose in the year 2013 when the plaintiff moved against the defendant, alleging
patent infringement. The invention of plaintiffs (MSD), that is, Sitagliptin
improves the efficient management of the condition of a patient suffering from
type II diabetes by inhibiting the DPP-IV enzyme According to the plaintiff, Sitagliptin
phosphate monohydrate, the main component of defendant’s drugs, could not be
made without manufacturing the active molecule Sitagliptin, “invented and
patented” by the US drug maker.  In reply
to this the defendant said, “Sitagliptin 
is not the only DPP-IV inhibitor (oral anti-diabetes drug) for treatment
of type II diabetes in the market and there are several other DPP-IV
inhibitors, including the one manufactured and marketed by the defendant, that
is, Teneligliptin”. Further, they argued that Sitagliptin Phosphate Monohydrate
as also the combination of Sitagliptin Phosphate Monohydrate and Metformin
Hydrochloride are totally different than the Sitagliptin Hydrochloride salt. It
was also contended that the process followed by the defendant for production of
Zita and Zita-met is completely different than the process of manufacturing
followed by the plaintiff.

A K Pathak, J. while permanently injuncting the
defendant from making and selling the two drugs said, “it
emerges from the comparison of the product inserts of the plaintiffs’ product
and that of the defendant that they are the same and contain the same compound,
that is, sitagliptin phosphate monohydrate.”  The court remarked that, there was no public
interest in the matter as there were other chemical compounds, other than the
one invented by the plaintiff, which were used in anti-diabetes drugs.  However, on defendant’s oral
plea to allow it to sell its goods already in the market, clarified that it
“may sell such of the products which are already in the market i.e in
possession of its distributors and retailers”. [Merck Sharp and Dohme Corpn. v. Glenmark
Pharmaceuticals Ltd., Decided on 7-10-2015]
Source: Legal news India

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