Therasense Cases and
January 10, 2013
Summarized by Tatsuo YABE
2011年5月のTherasense大法廷判決後の不公正行為に関わるCAFC判決を３つピックアップしています。CAFCの判決としては、2012年4月のAventis判決のみが唯一不公正行為が認定され、権利行使不能と判断されたと理解されます。 その後、2012年9月の1st Media判決においては、Therasense大法廷判決における騙す意図の立証責任の困難さをより明白に説示した判決と考えます(以下参照)。
Media v. Electronic Arts判決文において、被告が「騙す意図の証明」ができていないということに対してCAFCが説示した内容。
Ultimately, for all of the
references, the evidence supports only that Lewis & Sawyer (1) knew of
the references, (2) may have known they were material, and (3) did not
inform the PTO of them. But
that is not enough. As Therasense
made clear, defendant must prove that an applicant (1) knew of the
reference, (2) knew it was material, and (3) made a deliberate
decision to withhold it.Espan style="mso-spacerun:yes"> 649
F.3d at 1290 (Emphasis added)
In this case, the last element (3) is missing.
結局のところ、全ての証拠を集積しても、Lewis氏とSawyer氏（出願人と代理人）が（１）それら先行技術を周知していた、（２）それらの重要性(クレームとの関連性)を知っていたかもしれない、及び、（３）米国特許庁にはIDSしなかったということを示すのみである。 これら3点を証明したところで騙す意図の証明には不十分である。 2011年5月のTherasense大法廷判決で明白に判示されたようい、騙す意図を立証するには、被告は（１）先行技術を周知していた、（２）その重要性を周知していた、及び、（３）意図的にその情報を隠匿すると決断した、ということを証明しなければならない。 本事件においては（３）の証明が欠落している。
Table of Contents
Summary of Therasense
Decision (May 2011)
(Fed Cir) Decisions
Powel v. Home
Depot (Fed Cir: Nov. 2011)
v. Hospira (Fed Cir: April 2012)
Media v. Electronic Arts (Fed Cir: Sep. 2012)
Summary of the
Therasense decision: May
For the element of intent to deceive the USPTO: evidence of Eu>deliberate
decisionE to deceive must be proven by clear and convincing evidence.
applicant knew of a reference, should have known of its materiality, and decided
not to submit it to the PTO does not prove specific intent to deceive.
When circumstantial evidence must be relied on, Eu>intent to deceiveEmust
be the single most reasonable inference.
For the element of materiality, Fed Cir demands evidence of Eb>BUT-FOR MaterialityE
The court must find that, but for the deception, the PTO would not have
allowed the claim.
making this patentability determination, he court should apply the preponderance
evidence STD and give claim a broadest reasonable interpretation.
As a major
exception, the court holds that in cases involving affirmative egregious
misconduct, Eu>but for materialityEneeds NOT be proven.
Example of Affirmative
Egregious Misconduct Eunmistakable false affidavid
Post Therasense Decisions
Powell v. Home Depot (Fed. Cir.
Aventis Pharma v. Hospira (Fed. Cir.
1st Media v. Electronic Arts
Powell v. Home Depot
(Fed. Cir. Nov. 2011)
During the prosecution, Powell filed a Petition to Make Special on
ground that he was obligated to manufacture and supply devices covered by the
claims to Home Depot. However, the
negotiations with Home Depot had failed before the USPTO granted the petition.
Powell did not inform the USPTO that he was no longer qualified for the
Special status under the prospective manufacture (MPEP708.02).
The district court (before Therasense en banc decision) held that
the failure to inform the PTO was done with intent to deceive the PTO, but the
intentionally non-informing information to the PTO was not material.
Fed. Cir. Affirmed the district court decision:
Held that Powells failure to inform to the PTO that the condition
which supports a Petition to Make Special no longer existEdoes not constitute
inequitable conduct. Because
Powells conduct (improper omission) fails the but-for materiality
standard of Therasense and is not the type of act which rises to
the level of affirmative egregious misconductE
Aventis Pharma v. Hospira
Cir. April 2012)
-- covers Avenis Pharmas chemotherapy cancer drug Taxotere, which was
administered in an aqueous solution called a perfusionE
The prior art surfactant used to form the solution triggered allergic
reactions, including anaphylactic shock. To
overcome the problems, the patented formulation uses a different surfactant and
limits the amount of ethanol, as compared to prior art formulation.
In pre-Therasense, the district court made separate and distinct
findings on intent and materiality.
The district court found that the inventors had cited a prior art
reference which identified the problem they sought to solve, but did not cite
other two references which revealed the solution to the problem.
The withheld references were material to patentability and that the
inventor intentionally withheld them in order to deceive the USPTO.
Fed. Cir. :
Affirmed a Pre-Therasense
judgment of inequitable conduct given after a bench trial.
The references were but-for-material because the district
court properly found that the claims were invalid over the references.
Regarding the inventors withholing the references with the specific
intent to deceive the PTO, Fed. Cir. rejected the inventors
contentions that there was more than one inference that could be drawn from his
conduct and found the inventors testimony explaining why he withheld
the prior art was not credible.
In view of a totality of inventors testimony, which includes his
testimony that his prior experiments (recorded in the withheld reference) was
one of the main factors that shaped his thinking in choosing a surfactant for
the claimed invention, Fed. Cir. concluded that the district court was justified
in finding the inventors explanation none-credible, especially because the
inventor disclosed to the PTO other prior art that shows the problem to be
solved (without disclosing a possible solution).
1st Media v. Electronic Arts
Cir. Sep. 2012)
Field of Invention:
The patent at issue relates to an entertainment system for use in
purchasing and storing songs, videos and karaoke information.
After Notice of Allowance but before payment of the issue fee, Sawyer and
Lewis received a Search Report of the counterpart EP application with Y-reference
(particularly relevant if combined with another reference) and Office Actions
for related US Applications with two additional references (allegedly
discloses similar features as those in the patent at issue).
None of these 3 references had been submitted to the PTO as IDS.
The district court found that their (Sawyer and Lewis) explanations
(did not recognize the materiality of any of these references and the
failure to disclose these references was due to an oversight) for non-disclosure
were not credible and that it was appropriate to infer that they intended to
deceive the PTO.
The district court, before the Therasense decision (en banc),
concluded that the patent was unenforceable because Sawyer and Lewis had
committed inequitable conduct.
Did not decide
whether any of the references were but-for material;
Cir. concluded that Def (Elec. Arts) failed to prove that Sawyer and Lewis made a
deliberate decision to withhold references from the PTO.
Says the Fed. Cir., that ultimately, for all of the references, the
evidence supports only that Lewis & Sawyer (1) knew of the references, (2)
may have known they were material, and (3) did not inform the PTO of them.
That is not enough!
As Therasense (en banc) made clear, Def. must prove that an
applicant (1) knew of the reference, (2) knew it was material, and (3) made a
deliberate decision to withhold it.Espan style="mso-spacerun:yes">
In this case, the last element (3) is missing.
Sep. 16, 2012 with respect to any patent (issued before, on or after that date);
may request Sup Exam to consider, reconsider, or correct information believed to
be relevant to the patent. Request
must be made with fee $21,260 (possible refund $16,120 available if no SNQ is
determined that SNQ exists, then ex-parte reexam commences;
(amnesty) to defense of unenforceability based on inequitable conduct will be
provided with respect to the issues resolved during the Sup Exam (following
if found by PTO, can be reported to Attorney General.
given if litigation is commenced before conclusion of Sup Exam.
Do not immediately loosen up the existing IDS submission rules in
view of Therasense (en banc) and 1st media because
defense based on IC (Inequitable Conduct) has still often been asserted during
the trial court. In other words, the
proof of IC by Def may eventually fail at appeal court (Fed Cir), but dealing
with the IC related defense at trial court and appeal court will be burdensome
(time and cost).
It is, thus, clever to reduce the possible issues that may likely
be the subject of IC defense. For
this purpose, complete Sup Exam to cure as many IDS related problems as
possible (up to 12) before enforcing your patent.
If existing IDS submission rules appear too burdensome or too
costly, then in consultation with experienced U.S. Patent Attorney, it should be
possible to relax some segments of the rules.
In particular, since proof of Eu>deliberate intent to deceiveE the PTO
becomes very tough for the accused infringer (see 1st
Media), formation of the IDS submission Rules and following the rules as routine
practice are very important (because having the rules & following the
rules as routine practice almost eliminates Eu>intent to deceiveE factor).