Merck Vs Glenmark Case Study
Merck vs Glenmark Plaintiff: Merck Sharp and Dohme Corporation and ANR. Defendant: Glenmark Pharmaceuticals Limited Since, 2008 Merck has marketed Sitagliptin, a DPP-IV inhibitor which is specifically used in the treatment of Type 2 Diabetes. Merck is marketing Januvia and Janumet containing Sitagliptin Phosphate Monohydrate and Sitagliptin Phosphate Monohydrate along with Metformin as the active moieties and is licensing the same to Sun Pharma who markets it under the names Istavel and Istamet. Merck, as the innovator has two Indian patents: a product patent (IN209816) for Sitagliptin and a process patent (IN219148) for the intermediates formed during the manufacture of Sitagliptin. In April 2013, Glenmark Pharmaceuticals launched Zita …show more content…
Glenmark argued that because Merck had filed for separate patents, Sitagliptin and Sitagliptin Phosphate Monohydrate are chemically different compounds. Glenmark had further argued that Zita and Zita-Met were manufactured without using Sitagliptin free base or Sitagliptin Hydrochloride and that conversion of the phosphate form to the free base occurred within the body due to natural processes and that Zita and Zita-Met did not contain Sitagliptin free …show more content…
Glenmark also claimed that there was no industrial application of Sitagliptin free base as it was unstable and could not be administered as a drug by itself. Glenmark also made a statement that the patent does not disclose the method of preparation of Sitagliptin Phosphate Monohydrate and thus its claims by way of Markush structures do not cover the same. Glenmark requested for revocation by way of section 64 which as per Glenmark’s interpretation mandated the disclosure of other patent applications regarding Sitagliptin and because Merck failed to do so, the patent must be
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