Infringement Analysis Under §271(e) Focuses On The Product That Is Likely To Be Sold Following ANDA Approval, Not

Ferring B.V. v. Watson Labs, Inc. et al.,__ F.3d __ (Fed. Cir, Aug. 22, 2014) (LOURIE, Dyk, Reyna) (D. Nev. Jones) (2 of 5 stars)

Federal Circuit affirmed non-obviousness but reversed infringement finding, and vacated the injunction and order preventing FDA approval of a generic product until patent expiration. This is a companion appeal to Ferring, B.V. v. Apotex, Inc., involving the same patents but a different ANDA defendant.

Non-obviousness: Watson failed to prove obviousness because "the cited prior art references neither set forth the limitations required by the asserted claims, nor provided any reason or motivation to combine those teachings to derive the claimed formulations with specific dissolution profiles." Slip. op. at 10. Moreover, FDA's granting of "fast track" status to Ferring's embodying product "demonstrated that there was a long-felt and unmet need for a treatment for menorrhagia that avoided adverse events." Id. at 11.

Non-infringement: The claims required a product that dissolves at particular rates, and the district court found infringement because Watson's ANDA was silent on the dissolution rate, even though Watson's data on batches of its product and expert testing on samples produced during discovery did not have those rates. The Federal Circuit reversed because, where the ANDA is silent on infringement, it is proper to consider that other evidence. Although "the ANDA itself dominates the infringement analysis," and "[i]n some cases, the ANDA specification directly resolves the infringement question because it defines a proposed generic product in a manner that either meets the limitations of an asserted patent claim or is outside the scope of such as claim," as in Sunovion and Bayer, in other cases, the ANDA does not resolve infringement and "we have endorsed the district court's reference to relevant evidence, including biobatch data and actual samples," as in Glaxo. Slip op. at 13-14. Here, the ANDA's "silence does not answer the question of infringement." Id. at 14. Moreover, dissolution data on the "uncoated cores" of Watson's product was irrelevant because infringement had to be based on the final, coated tablet as sold. Likewise, data showing four sample tables out of hundreds was insufficient to show infringement where Watson's expert testified "these outliers were not representative of Watson's ANDA product." Id. at 15. Finally, Ferring did not show that Watson's product met another claim limitation since "just because a certain material can modify [something], does not necessary mean that it actually does." Id. at 17 (emphasis in original). Testing was required, and no such evidence was presented.