Mylan discontinues its pursuit to patent process to prepare anti impotence drug

Company filed application for novel process for preparation of Sildenafil Citrate, the active ingredient of Pfizer's Viagra

Mylan Laboratories has dropped its pursuit to patent a novel process for preparation of Sildenafil Citrate, the active ingredient in Pfizer's erectile dysfunction drug Viagra.

The company, which filed response to the initial objections of the patent office in October, 2015, informed the officials later this year that it do not wish to pursue with the application anymore.

The application for invention titled 'Novel process for the preparation of Silenafil Citrate' was filed on June 5, 2006, by Matrix Laboratories. It was acquired by Mylan in 2007.

The invention it claimed was as an anti impotence drug in a cost effective manner employing a smaller number of steps than that of the methods known till then.

While several previous patent applications discloses processes for the preparation of the drug, there is a need for the industry to provide a novel and alternate process which is commercially useful for its preparation, it said in its patent description.

"The main objective of the invention is to prepare sildenafil citrate by a process which is commercially viable and involves simpler and less number of steps and gives advantage over prior art processes," it said.

The patent examiner issued the First Examination Report on October 31, 2014 and a reply was filed by the company on October 16, 2015, following which a hearing was fixed on October 18, 2016. The company, on September 27, 2016, informed they Patent Office that it do not wish to pursue with the prosecution of the application anymore. Based on this, the Patent Office refused the application, pointing out that the objections remain yet to be complied with.

Last year, Mylan has settled a patent litigation with Pfizer related to Viagra, in US, which would allow the company to launch the generic version of the drug in US by December 2017, or sooner under certain conditions, according to reports.