Post Therasense Cases and Practical Tips  

January 10, 2013

Summarized by Tatsuo YABE


20115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、20124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、20129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) 

1st 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.”  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。 20115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。


従って、Therasense判決以降は、出願審査中における通常のIDS提出忘れでは不公正行為が認定されない、即ち、特許は権利行使不能とはならないということは略間違いないと結論づけられる。 然しながら、地裁レベルでは、出願審査中におけるIDS提出不備を理由に不公正行為の抗弁をするという被疑侵害者側の訴訟実務は継続されているので、ディスカバリーの負荷と費用を軽減するためにも、今後、特許権者は権利行使の前に補充審査(庁費用だけで約22000ドルと高額ではあるが、訴訟における不公正行為の抗弁を封じるという効果は当該費用の数十倍の価値があるだろう)によってIDS提出不備などの問題はできるだけ解決してから訴訟を開始することが望ましいと言えよう。


Table of Contents


Ø  Summary of Therasense Decision (May 2011)

Ø  Post Therasense (Fed Cir) Decisions

Ø  Powel v. Home Depot (Fed Cir: Nov. 2011)

Ø  Aventis Pharma v. Hospira (Fed Cir: April 2012)

Ø  1st Media v. Electronic Arts (Fed Cir: Sep. 2012)

Ø  Summary:

Ø  Practical Tips:


Summary of the Therasense decision: May 25, 2011


  1. To prevail on the defense of IC (inequitable conduct), the accused infringer must prove that the applicant misrepresented or omitted material information with the specific intent to deceive the USPTO.
  2. The accused infringer must prove both elements “intent and materiality” by clear and convincing evidence.



u  For the element of intent to deceive the USPTO: evidence of “deliberate decision” to deceive must be proven by clear and convincing evidence.

u   Proving 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.

u  When circumstantial evidence must be relied on, “intent to deceive” must be the single most reasonable inference.



u  For the element of materiality, Fed Cir demands evidence of “BUT-FOR Materiality”.  The court must find that, but for the deception, the PTO would not have allowed the claim. 

u  However, in making this patentability determination, he court should apply the preponderance evidence STD and give claim a broadest reasonable interpretation.



u  As a major exception, the court holds that in cases involving affirmative egregious misconduct, “but for materiality” needs NOT be proven.

u  Example of Affirmative Egregious Misconduct – unmistakable false affidavid


Post Therasense Decisions

Powell v. Home Depot  (Fed. Cir. Nov. 2011)

Aventis Pharma v. Hospira  (Fed. Cir. April 2012)

1st Media v. Electronic Arts  (Fed. Cir. Sep. 2012)


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).

District Court:

              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 Powell’s failure to inform to the PTO “that the condition which supports a Petition to Make Special no longer exist” does not constitute inequitable conduct.  Because Powell’s 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 misconduct”.



Aventis Pharma v. Hospira  (Fed. Cir. April 2012)


Claimed Invention:

              -- covers Avenis Pharma’s chemotherapy cancer drug Taxotere, which was administered in an aqueous solution called a “perfusion”.

              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.


District Court:

              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 inventor’s withholing the references with the specific intent to deceive the PTO, Fed. Cir. rejected the inventor’s contentions that there was more than one inference that could be drawn from his conduct and found the inventor’s testimony explaining why he withheld the prior art was not credible.


              In view of a totality of inventor’s 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 inventor’s 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  (Fed. 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.


District Court:

              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.


Fed. Cir.

u  Did not decide whether any of the references were but-for material;

u  Because Fed. 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.” 

              In this case, the last element (3) is missing.


AIA--Supplemental Examination


u  Effective: Sep. 16, 2012 with respect to any patent (issued before, on or after that date); 

u  Patent owner 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 found).


u  Once determined that SNQ exists, then ex-parte reexam commences;

u  Immunity (amnesty) to defense of unenforceability based on inequitable conduct will be provided with respect to the issues resolved during the Sup Exam (following Re-exam)

u  Exceptions:

Ø  “Fraud”, if found by PTO, can be reported to Attorney General.

Ø  No immunity given if litigation is commenced before conclusion of Sup Exam.



  1. Therasense (en banc) raised the bar of proving inequitable conduct by Def.
  2. 1st Media even clarified how high the bar raised by Therasense.
  3. However, still defense of unenforceability based on IC (Inequitable Conduct) alive (see Aventis).
  4. Supplemental Exam may cure IDS related problems, especially non-submission of the relevant references cited during the examination.


Practical Tips:

1.               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). 


2.               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.


3.               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.


4.               In particular, since proof of “deliberate intent to deceive” 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 “intent to deceive” factor).



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