Therasense, Inc. v. Becton, Dickinson & Co., 374 Fed. Appx. 35, CPLRG 0058 (Fed. Cir. 2010) (En Banc). TherasenseEnBancOrder
MAJOR ISSUES: inequitable conduct; unenforceability of patents; fraud.
COMMENT: In this order, the Federal Circuit vacates the panel decision, Therasense, Inc. v. Becton, Dickinson & Co., 593 F.3d 1289 (Fed. Cir. 2010), which upheld an inequitable conduct charge. In the order, the court indicates that it intends to review the inequitable conduct defense to patent enforceability.
The court requested the parties to “file new briefs addressing the following issues:
“1. Should the materiality-intent-balancing framework for inequitable conduct be modified or replaced?
“2. 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?
“3. 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?
“4. 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).
“5. Should the balancing inquiry (balancing materiality and intent) be abandoned?
“6. 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.”
CROSS REFERENCES. On inequitable conduct generally, see Chisum Patent Law Digest 4000; Chisum on Patents 19.03.