3. The Law Before Therasense:
Two Prongs with Balancing
Applicants for patents have a duty to prosecute patents in the PTO with candor and
good faith, including a duty to disclose information known to the applicants to be
material to patentability. 37 C.F.R. § 1.56(a) (2004); see also Molins PLC v. Textron, Inc.,
48 F.3d 1172, 1178 (Fed. Cir. 1995). A breach of this duty may constitute inequitable
conduct, which can arise from an affirmative misrepresentation of a material fact,
failure to disclose material information, or submission of false material information,
coupled with an intent to deceive or mislead the PTO. Molins, 48 F.3d at 1178. A
party asserting that a patent is unenforceable due to inequitable conduct must
prove materiality and intent by clear and convincing evidence. Kingsdown Med.
Consultants, Ltd. v. Hollister, Inc., 863 F.2d 867, 872 (Fed. Cir. 1988). Once threshold
findings of materiality and intent are established, the trial court must weigh them
to determine whether the equities warrant a conclusion that inequitable conduct
occurred. Molins, 48 F.3d at 1178. This requires a careful balancing: when the
misrepresentation or withheld information is highly material, a lesser quantum of
proof is needed to establish the requisite intent. See N.V. Akzo v. E.I. DuPont de
Nemours, 810 F.2d 1148, 1153 (Fed. Cir. 1987). In contrast, the less material the
information, the greater the proof must be. See id.
Purdue Pharma L.P. v. Endo Pharm. Inc., 438 F.3d 1123 (Fed. Cir. 2006)
5. The Law After Therasense:
a 6‐1‐4 Split en banc Decision
•
Majority opinion by Chief Judge Rader, joined in full by Circuit Judges
Newman, Lourie, Linn, Moore, and Reyna, and joined in part (part V) by
Circuit Judge OʹMalley (“This court holds that, as a general matter, the
materiality required to establish inequitable conduct is but‐for materiality.” “A
district court should not use a ‘sliding scale,’ … [and] may not infer intent
solely from materiality.”)
•
Concurring‐in‐part and dissenting‐in‐part opinion by Circuit Judge OʹMalley
(“I respectfully dissent from those portions of the majority opinion which
describe the test it directs lower courts to apply in assessing materiality and
which vacates and remands for further inquiry the materiality determinations
made by the district court in this case.” “[B]oth the majority and dissent strain
too hard to impose hard and fast rules.”)
•
Dissenting opinion by Circuit Judge Bryson, joined by Circuit Judges Gajarsa,
Dyk, and Prost (“I would adhere to the materiality standard set forth in the
PTO’s disclosure rule[ Rule 56.]”)
8. The Law After Therasense:
If Petition for Cert Is Denied by the SC
• Case will be remanded to the District Court
(Judge Alsup at the NDCA) under the majority
opinion in Therasense en banc for further
proceedings.
• Would inequitable conduct be found for the
patent‐in‐suit by applying Therasense en banc?
Probably Yes.
• Let’s look at the facts in Therasense.
10. What Abbott Should Have Done During
the Prosecution of the European Patent
•
It may be true that words such as “optionally, but preferably” are mere
“patent phraseology” commonly used by patent prosecutors. But at the
outset it’s a hard battle to win insisting “optionally” actually means
“always” in the context of patents. However, the chance of avoiding the
finding of inequitable conduct could have been slightly improved by
paying attention to arguments made during the prosecution.
•
In hindsight, Abbott unnecessarily gave away too much while making
arguments during the prosecution of the European counterpart to the ‘382
patent.
•
To distinguish the German reference (labeled D1), which required a
diffusion‐limiting membrane, Abbott could have simply argued that no
diffusion‐limiting membrane is required, and said nothing more. Abbott
could have further stated that a protective membrane for keeping away
coarse particles in whole blood is required, which was probably the state‐
of‐the‐art at that time. There would have been less contradictions.