Pharma In Brief - Federal Court Addresses The Relationship Between Prohibition Applications And Infringement/Impeachment Actions

Case: Bayer Inc. v Cobalt Pharmaceuticals Company, 2016 FC 1013 (Court Files No. T-1379-13, T-1468-13, and T-1368-14)

Drug: By Bayer Inc.: YAZ (3.0 mg drospirenone and 0.020 mg ethinyl estradiol tablets) and YASMIN (3.0 mg drospirenone and 0.030 mg ethinyl estradiol tablets)

By Apotex Inc. (Apotex): MYA (3.0 mg drospirenone and 0.020 mg ethinyl estradiol tablets) and ZAMINE 21 & ZAMINE 28 (ZAMINE) (3.0 mg drospirenone and 0.030 mg ethinyl estradiol tablets)

By Cobalt Pharmaceuticals Company (Cobalt): ZARAH 21 & ZARAH 28 (ZARAH) (3.0 mg drospirenone and 0.030 mg ethinyl estradiol tablets)

Nature of case: Liability phase of bifurcated action for patent infringement and impeachment pursuant to the Patent Act, RSC 1985, c P-4

Successful party: Bayer Inc. & Bayer Pharma Aktiengesellschaft (collectively Bayer)

Date of decision: September 7, 2016

Summary

This action concerns Bayer's Canadian Patent No. 2,382,426 (the '426 Patent) and generic versions of two combination oral contraceptives marketed in Canada by Bayer: YAZ and YASMIN, both of which contain drospirenone and ethinyl estradiol.

The court found that the '426 Patent was valid, rejecting attacks on the bases of obviousness, anticipation, overbreadth, insufficiency, ambiguity, and inutility. The court also found that all of the alleged generic products infringed the asserted claims of the '426 Patent. Quantification will be determined in a subsequent proceeding.

Background

Both Apotex and Cobalt (now Actavis, itself recently acquired by Teva) market generic versions of YASMIN, known respectively as ZAMINE and ZARAH. Apotex also markets a generic version of YAZ, known as MYA. As we reported here and here, in proceedings under the Patented Medicines (Notice of Compliance) Regulations (the Regulations), Bayer succeeded in preventing Cobalt from marketing a proposed generic version of YAZ. It failed to do so in respect of Apotex's generic YAZ product, which is marketed as MYA. Bayer sued Apotex and Cobalt for infringement; Apotex and Cobalt counterclaimed for a declaration of invalidity.

The '426 Patent is not listed against YASMIN; both Apotex and Cobalt were able to obtain NOCs for their generic versions of this product.

The court held that the claimed invention of asserted claims of the '426 Patent is rapidly dissolving oral formulations of drospirenone particles and ethinyl estradiol. These formulations exhibit surprisingly good bioavailability as a contraceptive despite being exposed...