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.<\/p>\n
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.<\/p>\n
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.<\/p>\n
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.<\/p>\n","protected":false},"excerpt":{"rendered":"
Mylan has reached a settlement with Pfizer over patent litigation related to Sildenafil, allowing earlier generic market entry in the US. This agreement is expected to lower drug prices and may signal a trend for further settlements involving Indian pharmaceutical companies.<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"iawp_total_views":48,"footnotes":""},"categories":[6,14],"tags":[1821,1760,553,158,218,3475,518,7129],"class_list":["post-21462","post","type-post","status-publish","format-standard","hentry","category-intellectual-property","category-patents","tag-generic-drugs","tag-indian-pharma","tag-mylan","tag-patent-litigation","tag-patent-settlement","tag-patent-term-extension","tag-pfizer","tag-sildenafil"],"_links":{"self":[{"href":"https:\/\/www.bananaip.com\/intellepedia\/wp-json\/wp\/v2\/posts\/21462","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.bananaip.com\/intellepedia\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.bananaip.com\/intellepedia\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.bananaip.com\/intellepedia\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.bananaip.com\/intellepedia\/wp-json\/wp\/v2\/comments?post=21462"}],"version-history":[{"count":4,"href":"https:\/\/www.bananaip.com\/intellepedia\/wp-json\/wp\/v2\/posts\/21462\/revisions"}],"predecessor-version":[{"id":149856,"href":"https:\/\/www.bananaip.com\/intellepedia\/wp-json\/wp\/v2\/posts\/21462\/revisions\/149856"}],"wp:attachment":[{"href":"https:\/\/www.bananaip.com\/intellepedia\/wp-json\/wp\/v2\/media?parent=21462"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.bananaip.com\/intellepedia\/wp-json\/wp\/v2\/categories?post=21462"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.bananaip.com\/intellepedia\/wp-json\/wp\/v2\/tags?post=21462"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}