Share on LinkedInShare on LinkedIn

ARTICLE · 21 OCTOBER 2016

Ethinylestradiol/Drospirenone Formulation Patent Valid And Infringed

On September 7, 2016, Justice Fothergill released his public Reasons and Judgement in consolidated patent infringement/impeachment actions brought by Bayer against Apotex and Cobalt in relation to their various drospirenone/ethinylestradiol products.

CanadaIntellectual Property

On September 7, 2016, Justice Fothergill released his public Reasons and Judgement in consolidated patent infringement/impeachment actions brought by Bayer against Apotex and Cobalt in relation to their various drospirenone/ethinylestradiol products.The patent at issue, Canadian Patent No. 2,382,426, relates to an oral formulation comprising ethinylestradiol and drospirenone particles having a specific dissolution profile. The only asserted independent claim reads:

31. A pharmaceutical composition comprising:

from about 2 mg to about 4 mg of drospirenone particles, wherein the drospirenone is in a form, which when provided in a tablet containing 3 mg of drospirenone, has a dissolution such that at least 70% of said drospirenone is dissolved in 900 ml of water at 37° C. (±0.5° C) within 30 minutes, as determined by USP XXIII Paddle Method using a USP dissolution test apparatus 2 at a stirring rate of 50 rpm, including 6 covered glass vessels and 6 paddles;

We operate a free-to-view policy, asking only that you register in order to read all of our content. Please login or register to view the rest of this article.

See more popular content from