CAFC discusses enablement in Cephalon v. Watson

The outcome of Cephalon v. Watson

After a bench trial, the district court found that Watson’s ANDA products did not infringe and held the asserted patents invalid for lack of enablement. Cephalon, Inc. v. Watson Pharms., Inc., 769 F. Supp. 2d 729, 761 (D. Del. 2011). We reverse on the issue of enablement because Watson failed as a matter of law to show with clear and convincing evidence that Cephalon’s patents require undue experimentation to practice the invention. As to the noninfringement finding, the district court did not clearly err. Thus, we reverse– in–part and affirm–in–part.

As to the law of enablement:

Enablement is a question of law that we review with- out deference, based on underlying factual inquiries that we review for clear error. MagSil Corp. v. Hitachi Global Storage Techs., Inc., 687 F.3d 1377, 1380 (Fed. Cir. 2012). (...)

This requirement is met when at the time of filing the application one skilled in the art, having read the specification, could practice the invention without “undue experimenta- tion.” In re Wands, 858 F.2d 731, 736–37 (Fed. Cir. 1988). Whether undue experimentation is required “is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations.” ALZA Corp. v. Andrx Pharms., LLC, 603 F.3d 935, 940 (Fed. Cir. 2010) (citing Wands, 858 F.2d at 737).
The following factors may be considered when deter- mining if a disclosure requires undue experimentation:
(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.
Wands, 858 F.2d at 737 (“Wands factors”); Enzo Biochem, Inc. v. Calgene, Inc., 188 F.3d 1362, 1372 (Fed. Cir. 1999) (“The Wands factors, when applied from the proper tem- poral perspective . . . are a useful methodology for deter- mining enablement . . . .”). These factors while illustrative are not mandatory. Enzo Biochem, Inc., 188 F.3d at 1371. (...)

The burden of proof here is on Watson to show that the Khankari patents are invalid for lack of enablement by clear and convincing evidence. See Auto. Tech. Int’l, Inc. v. BMW of N. Am., Inc., 501 F.3d 1274, 1281 (Fed. Cir. 2007).(...)

As an initial matter, the district court determined that Watson established a “prima facie” case of lack of enablement and that Cephalon failed to “rebut” Watson’s prima facie case. Cephalon, 769 F. Supp. 2d at 751, 754. Actually, the burden of proof was Watson’s alone. Be- cause we must presume a patent enabled, the challenger bears the burden, throughout the litigation, of proving lack of enablement by clear and convincing evidence. Morton Int’l, Inc. v. Cardinal Chem. Co., 5 F.3d 1464, 1469–70 (Fed. Cir. 1993). Hence, there is no formal burden-shifting framework when addressing the issue of enablement. Accordingly, we examine whether Watson met its burden of proof and determine that it did not.

Of the evidence:

Dr. Mumper’s ipse dixit statements that co-administration would be “difficult” and “complicated,” however, cannot be enough to constitute clear and convincing evidence. See Ashland Oil, Inc. v. Delta Resins & Refractories, Inc., 776 F.2d 281, 294 (Fed. Cir. 1985) (“Lack of factual support for expert opinion going to factual determinations, however, may render the testimony of little probative value in a validity determina- tion.”). Despite the district court’s finding according credibility to Dr. Mumper, his testimony is largely unsup- ported, and therefore, carries little weight in this analysis.

Of amount of experimentation:

In addition, exten- sive experimentation does not necessarily render the experiments unduly extensive where the experiments involve repetition of known or commonly used techniques. See Johns Hopkins Univ. v. CellPro, Inc., 152 F.3d 1342, 1360 (Fed. Cir. 1998) (finding that the difficulty in pro- ducing certain antibodies could not be attributed to the shortcomings in the disclosure of the patent at issue, but rather, the difficulty was attributed to the technique commonly used during experimentation that generally required repetition). Thus, the focus “is not merely quan- titative, since a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance . . . .” PPG Indus., Inc., 75 F.3d at 1564 (citation and quotation omitted).

AND

See United States v. Telec- tronics, Inc., 857 F.2d 778, 786 (Fed. Cir. 1988) (“Since one embodiment is admittedly disclosed in the specifica- tion, along with the general manner in which its current range was ascertained, we are convinced that other per- mutations of the invention could be practiced by those skilled in the art without undue experimentation.”). Nor does Watson show that the resulting experimentation in this case would be excessive, e.g., that it would involve testing for an unreasonable length of time. See White Consol. Indus., Inc., 713 F.2d at 791. Unsubstantiated statements indicating that experimentation would be “difficult” and “complicated” are not sufficient. In light of the lack of evidence on the record of undue experimenta- tion, the district court erred as a matter of law in holding that Watson proved its case on enablement by clear and convincing evidence.