Therasense Inc. (now Abbott) v. Becton, Dickinson and Co. (Fed. Cir. 2010)
The Federal Circuit has granted Abbott’s request for an en banc rehearing on the issue of inequitable conduct.
The rehearing will focus on six questions of law:
- Should the materiality-intent-balancing framework for inequitable conduct be modified or replaced?
- If so, how? In particular, should the standard be tied directly to fraud or unclean hands? See Precision Instrument Mfg. Co. v. Auto. Maint. Mach. Co., 324 U.S. 806 (1945); Hazel-Atlas Glass Co. v. Hartford-Empire Co., 322 U.S. 238 (1944), overruled on other grounds by Standard Oil Co. v. United States, 429 U.S. 17 (1976); Keystone Driller Co. v. Gen. Excavator Co., 290 U.S. 240 (1933). If so, what is the appropriate standard for fraud or unclean hands?
- What is the proper standard for materiality? What role should the United States Patent and Trademark Office’s rules play in defining materiality? Should a finding of materiality require that but for the alleged misconduct, one or more claims would not have issued?
- Under what circumstances is it proper to infer intent from materiality? See Kingsdown Med. Consultants, Ltd. v. Hollister Inc., 863 F.2d 867 (Fed. Cir. 1988) (en banc).
- Should the balancing inquiry (balancing materiality and intent) be abandoned?
- Whether the standards for materiality and intent in other federal agency contexts or at common law shed light on the appropriate standards to be applied in the patent context.
Abbott’s en banc brief is due in 45 days from today. The response is due within 30 days of service of Abbot’s brief. Briefs of amici curiae will be entertained and may be filed without leave of court. Under Fed. R. App. Proc. 29, the amicus curiae brief must be filed within 7–days of the filing of the principle brief of the party being supported. If the amicus curiae does not support either party then the brief must be field within 7–days of the petitioner’s principal brief.
Comment: The correct answers to these questions depend upon the purposes of the inequitable conduct doctrine. Namely, is the doctrine intended to the behavior of patent prosecutors is is it intended to catch perpetrators. The major empirical issue is that the doctrine pushes patent prosecutors to over-compensate in ways that potentially harm the system and certainly raise the costs of patent protection.