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
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