In a recent, very intensely contested litigation between Merck
Sharp and Glenmark Pharmaceuticals Ltd., the Hon'ble Delhi High
Court delivered a much awaited judgement. In the suit Merck
contended infringement of its Anti-diabetic drug Sitagliptin
[protected by Indian Patent No. 209816 (IN'816); marketed under
trade names - Januvia and Janumet or
(Istavel or Istamet of Merck's Licensee-Sun
Pharma] by Glenmark. Whereas Glenmark contended that its product on
Sitagliptin, which is Sitagliptin phosphate monohydrate (marketed
under trade names Zita and Zitamet) did not
infringe Merck's patent IN'816 considering the said patent
only covered the basic free form Sitagliptin i.e. Sitagliptin
hydrochloride and not Sitagliptin phosphate monohydrate. Glenmark
also contended that Merck had abandoned its Indian Application No.
5948/DELNP/2005 pertaining to Sitagliptin Phosphate Monohydrate
which attributed to the fact that both molecules namely Sitagliptin
Phosphate monohydrate and Sitagliptin Hydrochloride were separate
The Hon'ble Delhi High Court was of the opinion that
Merck's patent IN'816 generically covered Sitagliptin
Phosphate monohydrate. To arrive at its opinion, the Hon'ble
High Court relied on the facts that (a) the free base Sitagliptin
Form was the active biological ingredient having therapeutic
efficacy as DPP-IV inhibitor and; (b) the monohydrate phosphate
salt of Sitagliptin (contested by Glenmark) only had improved
chemical and physical properties for delivering Sitagliptin to the
body, wherein its therapeutic efficacy was due to the free base
Sitagliptin whereas phosphate had no role to play in the
Moreover the Hon'ble Delhi High Court also opined that in
the Sitagliptin Phosphate monohydrate salt, the Sitagliptin existed
in Sitagliptin –H+ form and phosphate as an anion form along
with water molecule; and that in a tablet form of 128.5 mg
Sitagliptin Phosphate Monohydrate, 100 mg was the Sitagliptin free
base which in fact is the biologically active moiety responsible
for therapeutic efficacy. The Hon'ble Court in this matter
relied on the Judgement by the Hon'ble Supreme Court of India
in Novartis AG vs. Union of India &Ors. (2013 (54) PTC
1), wherein it was held that, that therapeutic efficacy cannot be
attributed to more beneficial flow properties; better thermodynamic
stability and lower hygroscopicity as these properties do not
contribute to therapeutic efficacy. Thus in view of the aforesaid
the Hon'ble court held that use of Sitagliptin free base by
Glenmark in its product Sitagliptin Phosphate Monohydrate amounts
to infringement of Merck's patent IN'816.
This judgement may be regarded by pharmaceutical experts in
various perspectives, as some may consider it to be pro-innovators.
Whatever may be the opinion of the experts, but the essentials of
this judgement lies in looking at the innovations, patents and
Indian patent law in a more structured manner so as to ensure that
legitimate protection to innovations can be given within the ambit
of Patent Law.
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
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