Generic pharma giant Teva Pharma announced (in a press release Here ) that U.S. Court of Appeals for the Federal Circuit has affirmed a ruling by the U.S. District Court for the District of New Jersey (as reported by us Here ) has declared innovator Bayer's orange book listed patent for Drospirenone and Ethinyl estradiol (Yasmin) 3.0 mg+0.03 mg tablets.
The CAFC has declared following key patent covering Yasmin as invalid:
US6787531 (Expiry: AUG 31, 2020): Which covers combination of Drospirenone and Ethinyl estradiol (Micronization technique)
Barr argued that micronization technique is obvious as it increases dissolution of Drospirenone. Bayer argued that micronization without coating to reduce acid degradation in stomach is not obvious. Court decided in the light of KSR V/S Teleflex decision and concluded that person having ordinary skilled in the art would have known to test bioavailability of Drospirenone, and when choosing from finite number of methods for delivering oral contraceptive, micronized tablets without enteric coated would have been obvious to try.
Court also observed that Spirorenone (Drospirenone is a metabolite of Spirorenone) and Spirorenone have similar features and there is reasonable expectation of success on this parameter that both compounds perform similarly if not identically. Further, obviousness does not require absolute predictability of success but all that is required is reasonable expectation of success. The Krause articles rightly obviate Drospirenone micronization technique.
Earlier on June 24, 2008, Barr Laboratories, Inc. (now a wholly owned subsidiary of Teva Pharmaceutical Industries, Ltd.) announced that it had entered into a supply and licensing agreement with Bayer for distribution of a generic version of Yasmin®. Under the terms of that agreement, Bayer supplies Barr with the generic product, which Barr distributes in the U.S. under the Barr Laboratories label, Ocella. Ocella was launched in July, 2008 and had annual sales of approximately $170.2M in the United States for the twelve months that ended December 31, 2008, based on IMS sales data.
Opinion of CAFC Here
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