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.
After Teva, Mylan has recently settled its patent litigation with Pfizer. After the settlement, a generic version of the drug is expected to hit the market in 2017, instead of 2020, the year of patent expiry in USA. The early release of the drug is expected to reduce the cost of the drug, benefiting millions of users as it happened in Europe and Canada in 2013/2014.
The drug, Sildenafil, expired in Europe in 2013, and was the subject of patent term extension in USA by 8 years. Two patents protect its release in the USA, one expiring in 2019, and another in 2020. The patents were intensely litigated on grounds of inequitable conduct and inadequate disclosure, and Pfizer managed to scrape through in several cases. Today, Pfizer makes more than a billion dollars every year on the drug.
The terms of the settlement have not been disclosed, and are yet to be approved by the DOJ. Pfizer had in fact sued an Indian company, Torrent Pharma, as well for patent infringement. With the beginning of pre-patent expiry deals, one wonders how many Indian companies are in the queue, and if Pfizer’s strategy involves multiple-licensees.
References: Here
Image Source/Attribution: from here (All rights belong to respective authors)