Sun, Merck sign patent licensing agreement for Januvia

In a bid to strengthen their case, US drug firm Merck Sharp & Dhome and Indian drug-maker Sun Pharma, who have a co-marketing tie up for Merck's diabetes drug Januvia, have now included a patent licensing agreement in their arrangement.

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CNBC TV18’s Archana Shukla reports, quoting sources, that though this was a procedural requirement, it has larger implications on the ongoing case. Merck and Sun are together fighting a patent infringement suit against Glenmark after it launched generic versions of Merck’s diabetes drugs Januvia & Janumet in India.

Merck has now licensed its patents on Januvia to Sun Pharma in India. This was a mandatory procedural requirement, which was missing when Merck and Sun Pharma filed a patent infringement suit against Glenmark on April 1. Now, any company filing a patent suit or becoming party to a patent case needs to have a license for that patent.

But here, Sun Pharma, which was a co-plaintiff in the Januvia patent case, did not have any license for Januvia’s patent.

This error was highlighted by Glenmark’s attorneys in their arguments in the Delhi HC and could have weakened Merck and Sun’s position in this case. Sources say the two companies formalised the licensing agreement, signed it on May 16 and registered it in the Patent Office on May 21.

This agreement will not have any impact on the existing marketing tie-up that Merck and  Sun had signed in 2011, under which Sun sells Merck’s diabetes drugs in India under the brand names of Istavel and Istamet

On seeking official comments, while Merck said it was not willing to discuss the matter, Sun Pharma responded by saying that it was not true.

The patent case where Glenmark claims its generic versions do not infringe Merck’s patent on Januvia has taken an interesting turn. Last week, Merck got a vacation court to grant an injunction against Aprica Pharma and stopped the firm from launching generic versions of Januvia and Janumet.

Now, while this is a positive development for Merck, patent experts say this may not really benefit, as the same Delhi HC has denied an injunction against Glenmark and it continues to sell generic versions.

And secondly, the verdict was given without any arguments, since Aprica Pharma was not present even after two notices were served. Now both Merck and Glenmark are strengthening their cases for the next hearing in the Delhi High Court on July 15.