Summary
Mylan recently settled its patent litigation with Pfizer regarding the drug Sildenafil, paving the way for a generic version to enter the US market in 2017, earlier than the original 2020 patent expiry. This development is likely to reduce drug costs, as previously seen in Europe and Canada. The patents covering Sildenafil in the US faced extensive litigation on grounds of inequitable conduct and inadequate disclosure, with Pfizer prevailing in multiple cases. Details of the Mylan-Pfizer settlement remain undisclosed and await Department of Justice approval. The case also raises questions about Pfizer's broader licensing strategy with Indian pharmaceutical companies.
Overview
Following a similar settlement concluded by Teva, Mylan has settled its patent litigation with Pfizer. Under the terms of the settlement, a generic version of Sildenafil is expected to be made available in the United States market in 2017, three years ahead of the 2020 patent expiry date in the United States. The early entry of the generic is anticipated to reduce the cost of the drug substantially, in the manner seen in Europe and Canada in 2013 and 2014 respectively.
Background: Sildenafil Patents in the United States
Sildenafil’s patent protection in Europe expired in 2013. In the United States, the drug benefited from a patent term extension of eight years. Two patents protect its release in the United States market: one expiring in 2019 and another in 2020. The patents were litigated intensely on grounds of inequitable conduct and inadequate disclosure, and Pfizer prevailed in several of those proceedings. Pfizer currently earns more than a billion dollars annually from the drug.
Settlement Terms and Pending Proceedings
The financial terms of the settlement have not been disclosed and remain subject to approval by the Department of Justice. Pfizer had also initiated a patent infringement suit against Torrent Pharma, an Indian company. With the commencement of pre-patent expiry licensing arrangements, the question arises as to how many Indian pharmaceutical companies may follow suit and whether Pfizer’s strategy contemplates multiple licensees.
Disclaimer
This article is for general information and does not constitute legal advice. Readers should consult a qualified attorney before acting on any matter discussed here.