Ferring v. Watson: Hatch-Waxman and "Artificial" Infringement

Category: Infringement 
 By: Christian Hannon, Contributor  
TitleFerring B.V., v. Watson Labs., No. 2014-1416 (Fed. Cir. Aug. 22, 2014).
IssueThis appeal raises questions of validity and infrignement[.]
Ferring B.V. at *8.
HoldingWe conclude that the district court did not err in holiding that Watson failed to prove by clear and convincing evidence that the asserted claims are invalid as obvious [...] [and] conclude that the district court's finding that Watson's generic tranexamic acid product infringes Ferring's asserted claims was not in accordance with law and therefore reverse that judgment. Id. at *2.
Procedural History[Watson appealed a district court's] final judgment permanently enjoining the manufacture, use, sale or offer for sale of Watson's generic tranexamic acid product.
Ferring B.V., at *8.
Legal Reasoning (LOURIE, Dyk, Reyna)
Watson's Abbreviated New Drug Application (ANDA)In 2011, Watson submitted to Ferring a notice of certification [. . .] regarding its proposed generic tranexamic acid product as specified in its ANDA. Ferring then initiated the instant suit, asserting that Watson's ANDA submission consituted an act of infringement [...] of the '739 patent [...] the '106 pagent; and [...] the '795 patent. [...] After reeiving FDA approval of its ANDA on December 27, 2012, Watson launched its generic tranexamic acid product at risk, which Ferring did not move to enjoin.
Ferring B.V., at *6.
Specifics of Watson's ANDAWatson's initially-filed ANDA specified that the hardness of the cores was 13-20kp; "kp" is an abbreviation for kiloponds, which is a measure of hardness compression. [...] Watson modified its ANDA specification to require a core hardness of 13-17kp.
Id. at *5.
Analysis: Obviousness
ObviousnessA claim is invalid for obviousness if, to one of ordinary skill in the pertinent art, "the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invetion was made."
Ferring B.V., at *10.
Claims Are Not ObviousIn this case, the cited prior art references neither set forth the limitations required by the asserted claims, nor provided any reasons or motivation to combien those teachings to derive the claimed formulations with specific dissolution profiles. Accordingly the asserted claims have not been shown to be invalid under § 103.
Id. at *10.
Analysis: Hatch-Waxman
Hatch-Waxman Act and "Artificial" InfringementInfringement is a question of fact that we review for clear error. Under the Hatch-Waxman framework, the filing of an ANDA constitutes an "artificial" act of infringement for purposes of creating case or controversy jurisdiction. The district court here thus erred to the extent that it read § 271(e) to mean that Watson's act of filing an ANDA, by iteslf, established infringemnt sufficient to preclude consideration of the ANDA specification and any amendments before the FDA. The filing only consitiuted a technical act of infringement for jurisdictional purposes
Ferring B.V., at *12-13.
Infringement Burden Remains the Same
Once jurisdiction is established, the ultimate infringement inquiry provoked by such filing is focused on a comparison of the asserted patent claims against the product that is likely to be sold following ANDA approval and determined by traditional patent law principles. The plain language of [§ 271(e)(2)(A)] does not alter a patentee's burden of proving infrignement by a preponderance of the evidence, and we have rejected shifting that burden to the accused infringer to disprove infringement.
Id. at *13.
When all materials are considered, including amendments, there is no support for the district court's inconsistent finding of infringtetment under either § 271(e) or § 271(a) because there was no evidence that Watson either did or will manufacture, use or sell any commercial products with a core hardness of 17 kp or greater. Pursuant to the amendment suggested by the district court at the close of trial, Watson's FDA-approved ANDA specification now only permits it to make, use, and sell tablets with cores that have a hardness of 13-16.5 kp.
Id. at *16.
[W]e vacate the district court's order resetting the FDA approval date of Watson's ANDA 20-2093 and vacate the district court's permanent injunction of the manufacture, use, sale, or offer for sale of Watson's generic tranexamic acid product. Affirmed in part, reversed in part, and vacated in part.
Id. at *18-19.
Image Attribution Statement: Altairisfar, “Hatch Plantation at Arcola,” available as a public domain image released by author, http://commons.wikimedia.org/wiki/File:Hatch_Plantation_at_Arcola_006.jpg (image edited) (last visited Oct. 29, 2014).
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