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Articles

If ANDA is Silent on Infringement, then Infringement is Assessed Based on the Product Likely to Be Sold; Courts Have Discretion to Consider Post-Trial ANDA Amendments

August 29, 2014

Articles

If ANDA is Silent on Infringement, then Infringement is Assessed Based on the Product Likely to Be Sold; Courts Have Discretion to Consider Post-Trial ANDA Amendments

August 29, 2014

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Ferring B.V. v. Apotex, Inc. et al.,__ F.3d __ (Fed. Cir, Aug. 22, 2014) (Lourie, DYK, Reyna) (D. Nev.: Jones) (3 of 5 stars)

Fed Cir affirmed dismissal of Ferring’s Hatch-Waxman infringement claim as moot after Apotex’s amendment to its ANDA rendered it non-infringing.

The patents covered an extended-release drug and required that less than “about 70%” of the active ingredient dissolve after 45 minutes.  Apotex filed an ANDA in 2010 that did not specify the dissolution rate but amended it in 2014 to require at least 75% dissolution at 45 minutes.  The district court found that, although the 2010 ANDA infringed because its silence on the dissolution rate meant Apotex “could” sell an infringing product, the 2014 amended ANDA no longer infringed and thus dismissed the claim as moot. —Read more on Fish’s Litigation Blog

 

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