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References
1.Takeda Chemical Industries Ltd v Mylan Laboratories, Inc. (S.D.N.Y. September 20, 2006 ) (hereinafter, ‘Takeda’).
2.
See, for example, Yamanouchi Pharmaceutical Co., Ltd v Danbury Pharmacal, Inc. , 231 F.3d 1339, 1347 (Fed. Cir. 2000 ) (affirming holding that ANDA filer's ‘misconduct in filing a wholly unjustified ANDA certification and misconduct during the litigation that followed warranted the district court's finding that this case was exceptional’).
3.Glaxo Group Ltd. v Apotex, Inc. , 376 F.3d 1339, 1350–51 (Fed. Cir. 2004) (‘mere fact that a company has filed an ANDA application or certification cannot support a finding of wilful infringement for purposes of awarding attorney's fees pursuant to 35 U.S.C. § 271(e)(4)’).
4.
In re Wands, 858 F.2d 731, 736–37 (Fed. Cir. 1988) (whether a claim is enabled is a conclusion based on factual considerations, and some of the considerations include ‘(1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.’).
5.Amgen, Inc. v Chugai Pharm. Co. , 927 F.2d 1200, 1213 (Fed. Cir. 1991) (stating that the Wands factors ‘are illustrative, not mandatory’).
6.Knorr-Bremse Systeme Fuer Nutzfahrzeuge GmbH v Dana Corp. , 383 F.3d 1337 (Fed. Cir. 2004 ) (en banc).