Glenmark an Indian generic drug manufacturer launched the drug “Zita/Zita-met” in the market in 2013. The drug is composed of Sitagliptin, a phosphate salt which is used in the treatment of diabetes. The salt is sold under the tradename Januvia by Merck Sharp and Dohme. After the subsequent launch of “Zita/Zita-met” by Glenmark, an infringement proceeding was initiated by Merck Sharp and Dohme.
Point of Contention :
Before going any further it would be better for you’ll to understand if the point of contention is explained. Basically sitagliptin is a phosphate salt and questions has been raised against its efficacy and hence it is often combined with another agent (for example metformin). The patented product of MSD is Sitagliptin free base. The patent does not mention any agent along with which it has been combined.
Monohydrate version can be prepared :
In the proceeding it was cited by MSD that this was a reckless act by Glenmark to release a product which clearly infringes the patent. They have raised the point that the drug “Zita” comprises of Sitagliptin phosphate monohydrate which can be obtained only from the sitagliptin free base. They have cited the reason that Sitagliptin phosphate monohydrate cannot be prepared without the free base.
Defense :
In response to this Glenmark have pointed out that the patented product is anticipated by prior art and they have suggested that the patent application is just a “copy paste” from the prior art. Glenmark have further pointed that the patent should not have been granted in the first place and it lacks an inventive step.
An inventive step is basically a feature of the application which is an improvement from the existing product in terms of technical advancement or economic significance.
The following example
Components Product Quantity Time required Cost of production
a+b -> Ice cream Ice cream 100 litres 4 hours Rs. 5000/-
a+b -> Ice cream in presence of catalyst Ice cream 130 litres 2 and ½ hours Rs. 3500/-
Assume the above mentioned data and notice the difference that a catalyst has been added to the process and it is basically improving the quantity of production in lesser time and at a lower cost. mobdro for pc So this is an inventive step which Glenmark stated that MSD’s patent lacked.
Glenmark also further stated that MSD did not disclose the details pertaining to foreign application made for the same invention under Section 8, which according to the law is required.
Among the other reasons cited by Glenmark was that the invention does not possess industrial application.
The Verdict :
So coming to the point why an injunction was granted against Glenmark :
The patent sufficiently discloses the details pertaining to Sitagliptin free base and hence the argument proves null in case of disclosure.
The ruling explained that Sitagliptin was not known before and the compound has plenty of application even though it has to be coupled with another agent. The court has explained that regarding the patent applications made for the same application has to be disclosed, it is required in case of foreign applications only and the details for the foreign applications have been disclosed by MSD in a modified form ( in Form – 3 – Statement and undertaking, which requires the patentee to convey all the related information). The court was able to establish that sitagliptin free base was used by Glenmark.
A generic manufacturer can be promoted if the affordability of the drug was a problem, but in this circumstance the prices of the drugs was not considered an issue due to similar price of the products.
The Judge had ruled in favor of MSD and granted an injunction against Glenmark. The court had stated that they were disappointed with the arguments of Glenmark and considered this a reckless act.
