【重要美國專利案例評析】

美國聯邦巡迴上訴法院於2011年5月25日，以6-1-4的結果由全院庭審（en banc）作出重要決定，於TheraSense, Inc. v. Becton, Dickinson and Company一案[附註1]中，重新定義了關於「不正當行為」（inequitable conduct）之判斷標準。因此，專利權人、或是其專利代理人於進行專利申請時是否有「不正當行為」之判斷標準日後將被從嚴認定，頗值得大家注意！
 

案件背景事實
1. 專利權人為TheraSense, Inc.、以及Abbott Laboratories（以下合稱為”TheraSense”）。TheraSense, Inc.是一家研發、製造及行銷血糖自我監測設備（blood glucose self-monitoring devices）之供應廠商，後來已經被Abbott集團所收購而成為Abbott Diabetes Care, Inc.。
 
2. 被控侵權人為Becton, Dickinson and Company、Nova Biomedical Corporation、以及Bayer Healthcare LLC為（以下合稱為”Becton, Dickinson”）。Becton, Dickinson and Company（碧迪醫療，簡稱BD）是一家研發、生產和銷售醫療設備，醫療系統和試劑的醫療技術公司，於1897年成立，總部位於新澤西州，生產銷售包括醫用耗材、實驗室儀器、抗體、試劑、診斷等產品[附註2]。
 
3. 於數篇系爭專利中，美國專利5,820,551專利（以下簡稱” ’551專利”）係一種血糖測試片[附註3]，具有一電化學感測器用以測試整體血液（whole blood），且其最大特點是於電極上不需要有一片保護薄膜（membrane）。一些前案技術則是提供保護薄膜以保護電極的設計。
 
4. 時間回到於1984年，專利權人TheraSense, Inc.向美國專利商標局（USPTO）提出’551專利之原始申請案，之後的13年間遭受多次的新穎性以及進步性核駁，其中，最重要的核駁前案為Abbott所擁有之美國4,545,382專利（以下簡稱” ’382專利”）。於1997年，專利申請人之美國專利代理人提出一組新的申請專利範圍揭露一種於測試整體血液時不需要保護薄膜之設計，並指出這點與前案’382專利有區隔，並且依據審查委員的要求下，專利申請人之研發部門Director作出宣誓書（affidavit），指出於該發明時點時，前案若想要測試整體血液就必須要有保護薄膜的設計。因此，’551專利隨後獲准。
 
5. 於2004年3月，原告Becton, Dickinson於聯邦麻塞諸塞州地方法院提起「確認之訴」（declaratory judgment）控告其並未侵害被告專利權人TheraSense之數項美國專利；而專利權人TheraSense即於聯邦加州北區地方法院反訴控告Becton, Dickinson之試紙（test strip）產品侵害該些專利之外，另再加上主張其’551專利。本案移轉至聯邦加州北區地方法院後，TheraSense再追加控告Becton, Dickinson之供應商Nova Biomedical Corporation；並於2005年8月，另行起訴控告Bayer Healthcare LLC之產品亦侵害’551專利等，聯邦加州北區地方法院合併審理該些案件。
 
6. 被控侵權人Becton, Dickinson於訴訟時發現，專利權人TheraSense, Inc.向歐洲專利局（EPO）提出’551專利之對應歐洲專利案EP 0 078 636（以下簡稱”EP ‘636專利”）申請時，曾經分別於1994年1月12日、1995年5月23日由其歐洲專利代理人向歐洲專利局表示過其發明的血糖測試片之保護薄膜僅為選擇性，用以排除德國前案D1。因此，被控侵權人Becton, Dickinson認為專利權人TheraSense就此保護薄膜之說法不一致，而且於申請’551專利時並未提交上述對應歐洲專利案之相關資訊給美國專利商標局，故其行為應為「不正當行為」。最後，聯邦地方法院之判決認為：’551專利因為不具進步性而無效，且專利權人TheraSense未提交這些歐洲專利局表示過資訊的行為已經構成「不正當行為」，故整篇專利為不可實施（unenforceable）。專利權人TheraSense不服提起上訴。
 
7. 而本案上訴到聯邦巡迴上訴法院後，於2010年1月25日，合議庭作出判決[附註4]維持聯邦地方法院之專利無效、不侵害專利等判決結果，但稍後同意了專利權人TheraSense之請求就「不正當行為」部分進行全案庭審。
 
案件爭點
本案件的主要爭點即在於：「不正當行為」的判斷標準究竟為何？

由於聯邦巡迴上訴法院觀察到過去數年來「不正當行為」的擴大解釋與適用已經導致許多不樂見的後果，且該「不正當行為」積極抗辯於專利訴訟策略中也已經有被濫用的趨勢，甚至於在專利申請時，亦對美國專利商標局於進行專利申請案的審查時造成很嚴重的負擔。最顯著地影響，例如：(1) 被控侵權人輕易地可擴張訴訟時的證據揭示（discovery）之範圍到系爭專利申請前，且想辦法使該專利代理人因為不符合資格（disqualified）而被除排於訴訟團隊之外；(2) 由於擔心日後會造成道德上的問題，該專利代理人會希望由法院判決來回覆名譽，將導致訴訟不易和解，且專利侵權之本質失焦；(3) 並且造成訴訟的複雜度、時間及成本等大幅增加。
A charge of inequitable conduct conveniently expands discovery into corporate practices before patent filing and disqualifies the prosecuting attorney from the patentee's litigation team.  . . .  Because the doctrine focuses on the moral turpitude of the patentee with ruinous consequences for the reputation of his patent attorney, it discourages settlement and deflects attention from the merits of validity and infringement issues.  . . .  Inequitable conduct disputes also "increas[e] the complexity, duration and cost of patent infringement litigation that is already notorious for its complexity and high cost."
TheraSense, Inc. v. Becton, Dickinson and Company, 649 F.3d 1276, 1288 (Fed. Cir. 2011) (en banc).
 
"Applicants disclose too much prior art for the PTO to meaningfully consider, and do not explain its significance, all out of fear that to do otherwise risks a claim of inequitable conduct."
TheraSense, Inc. v. Becton, Dickinson and Company, 649 F.3d 1276, 1289 (Fed. Cir. 2011) (en banc).
 
相關法律規定
1. 美國專利法施行細則37 C.F.R. 1.56（以下簡稱”Rule 56”），係關於專利申請人有義務需要揭露與該申請中專利的相關資訊（information disclosure statement，簡稱IDS）之規定，其中：
(1) 於第(a)項表明了，專利是要基於公共利益（public interest）之本質，因此，專利申請人有此義務需主動提供與該申請中專利的重要性（material）資訊給美國專利商標局；另外，最後也提到，專利申請人不可惡意（bad faith）、或是以故意不正當行為（intentional misconduct）來詐欺美國專利商標局。這就是主觀上的「意圖」欺騙之要件。
(2) 於第(b)項則是針對客觀上的「重要性」要件亦列出了一些供參考的判斷原則。

37 C.F.R. 1.56－DUTY TO DISCLOSE INFORMATION MATERIAL TO PATENTABILITY

(a) A patent by its very nature is affected with a public interest.  …  There is no duty to submit information which is not material to the patentability of any existing claim.  …  However, no patent will be granted on an application in connection with which fraud on the Office was practiced or attempted or the duty of disclosure was violated through bad faith or intentional misconduct.  … 
(b) Under this section, information is material to patentability when it is not cumulative to information already of record or being made of record in the application, and
(1) It establishes, by itself or in combination with other information, a prima facie case of unpatentability of a claim; or
(2) It refutes, or is inconsistent with, a position the applicant takes in:
(i) Opposing an argument of unpatentability relied on by the Office, or
(ii) Asserting an argument of patentability.
 
2. 本案判決如教科書般地列出了三件相關的美國聯邦最高法院於先前所作出的判決並加以引用，包括：Keystone Driller Co. v. General Excavator Co., 290 U.S. 240, 54 S.Ct. 146, 78 L.Ed. 293 (1933)；Hazel-Atlas Glass Co. v. Hartford-Empire Co., 322 U.S. 238, 64 S.Ct. 997, 88 L.Ed. 1250 (1944)；以及Precision Instruments Machinery Co. v. Automotive Maintenance Machinery Co., 324 U.S. 806, 65 S.Ct. 993, 89 L.Ed. 1381 (1945)等三案件，有興趣的讀者可加以參考。
 
聯邦巡迴上訴法院全院庭審見解
1. 針對本案聯邦巡迴上訴法院的全院庭審結果，法官們作出了6-1-4之認定結果，多數意見書由大名鼎鼎的首席法官Judge Rader主筆，有另外五位法官加入，另外，O’Malley法官僅同意多數意見書中Part V部分、其他部分不同意，而Bryson法官，則是提出了不同意見書，且有另外三位法官加入，可說是意見也相當分歧。

2. 於多數意見書中，首先，Rader法官指出了本爭點核心的一個關鍵，就是若系爭專利被判斷為涉及「不正當行為」時，其後續救濟會是像原子彈一樣的效果，因此有必要謹慎看待，例如：(1) 若僅是其中單一申請專利範圍有涉及該行為時，仍然會造成整篇專利不可實施（unenforceable）的結果、(2) 若涉及「不正當行為」時，該專利並不能藉由再發證專利（reissue）、或是再審查專利（reexamination）等程序所治癒、(3) 若被認定為「不正當行為」後，可能會一同汙染、並擴散到其他相同技術之專利家族的專利案或是專利申請案，因此可能會危及一間公司的專利組合（patent portfolio）、(4) 也因此可能會產生反托拉斯（antitrust）、或是不正當競爭（unfair competition）的訴訟、(5) 再者，還可能導致訴訟的另一方會主張這是「特別案件」（exceptional case）而要求專利權人依據35 U.S.C. § 285之規定來賠償律師費用等、(6) 也還可能會構成「律師-當事人保護特權」（attorney-client privilege）之例外而可證明刑事犯罪或是詐欺行為等。筆者認為這內容真得是一篇很好的整理啊~~！

Perhaps most importantly, the remedy for inequitable conduct is the "atomic bomb" of patent law.  Aventis Pharma S.A. v. Amphastar Pharm., Inc., 525 F.3d 1334, 1349 (Fed.Cir.2008) (Rader, J.,dissenting).  Unlike validity defenses, which are claim specific, see 35 U.S.C. § 288, inequitable conduct regarding any single claim renders the entire patent unenforceable.  Kingsdown Med. Consultants, Ltd. v. Hollister Inc., 863 F.2d 867, 877 (Fed.Cir.1988).  Unlike other deficiencies, inequitable conduct cannot be cured by reissue, Aventis, 525 F.3d at 1341, n. 6, or reexamination, Molins PLC v. Textron, Inc., 48 F.3d 1172, 1182 (Fed.Cir.1995).  Moreover, the taint of a finding of inequitable conduct can spread from a single patent to render unenforceable other related patents and applications in the same technology family.  See, e.g., Consol. Aluminum Corp. v. Foseco Int'l Ltd., 910 F.2d 804, 808-12 (Fed.Cir.1990).  Thus, a finding of inequitable conduct may endanger a substantial portion of a company's patent portfolio.
A finding of inequitable conduct may also spawn antitrust and unfair competition claims.  See Dow Chemical Co. v. Exxon Corp., 139 F.3d 1470, 1471 (Fed.Cir. 1998) (unfair competition claim); Walker Process Equip., Inc. v. Food Mach. & Chem. Corp., 382 U.S. 172, 178, 86 S.Ct. 347, 15 L.Ed.2d 247 (1965) (antitrust action for treble damages).  Further, prevailing on a claim of inequitable conduct often makes a case "exceptional," leading potentially to an award of attorneys' fees under 35 U.S.C. § 285.  Brasseler, U.S.A. I, L.P. v. Stryker Sales Corp., 267 F.3d 1370, 1380 (Fed.Cir.2001).  A finding of inequitable conduct may also prove the crime or fraud exception to the attorney-client privilege.  See Inre Spalding Sports Worldwide, Inc., 203 F.3d 800, 807 (Fed.Cir.2000).
TheraSense, Inc. v. Becton, Dickinson and Company, 649 F.3d 1276, 1288-1289 (Fed. Cir. 2011) (en banc).

3. 緊接著，於本案判決中針對數項要件一一進行討論，認為：
(1) 針對主觀上「意圖」（intent）要件的部分：認為於專利申請中，單純的因為「重大過失」（Gross Negligence）、或是「普通過失」（Negligence）而錯誤表示、或是忽略未提供相關資訊給美國專利商標局的情況，並不符合該要件。在此，本判決認為於判斷是否具有「意圖」要件時，需要看其行為是否具有「特定的意圖」（specific intent）來欺騙美國專利商標局，並指出「不正當行為」之抗辯係源起於前述的三件聯邦最高法院Keystone、Hazel-Atlas、及Precision判決，故應該要回歸該些判決的精神來加以判斷。因此，被控侵權人需要提出相關證據來證明：(i) 專利權人已經明知該資訊（knew of the reference）；(ii) 且已經明知該資訊是具有重要性（knew that it was material）；(iii) 而且決定故意扣留（made a deliberate decision to withhold）該資訊時，以證明該專利權人符合「意圖」要件。
另外，附帶一提，判斷是否具有「意圖」要件的判斷標準為較高程度的「清楚明白且令人信服的證明」（clear and convincing evidence）之舉證責任。
To prevail on a claim of inequitable conduct, the accused infringer must prove that the patentee acted with the specific intent to deceive the PTO.  Star, 537 F.3d at 1366 (citing Kingsdown, 863 F.2d at 876).  A finding that the misrepresentation or omission amounts to gross negligence or negligence under a “should have known” standard does not satisfy this intent requirement.  Kingsdown, 863 F.2d at 876.  “In a case involving nondisclosure of information, clear and convincing evidence must show that the applicant made a deliberate decision to withhold a known material reference.”  Molins, 48 F.3d at 1181 (emphases added).  In other words, the accused infringer must prove by clear and convincing evidence that the applicant knew of the reference, knew that it was material, and made a deliberate decision to withhold it.
TheraSense, Inc. v. Becton, Dickinson and Company, 649 F.3d 1276, 1290 (Fed. Cir. 2011) (en banc).
 
此外，因為被控侵權人提起該「不正當行為」之積極抗辯時必須負擔起舉證之責任，專利權人不需要主動提出自己行為是善意的解釋（good faith explanation），除非被控侵權人已經證明了專利權人滿足該「意圖」要件。
Because the party alleging inequitable conduct bears the burden of proof, the “patentee need not offer any good faith explanation unless the accused infringer first . . . prove[s] a threshold level of intent to deceive by clear and convincing evidence.”  Star, 537 F.3d at 1368.  The absence of a good faith explanation for withholding a material reference does not, by itself, prove intent to deceive.
TheraSense, Inc. v. Becton, Dickinson and Company, 649 F.3d 1276, 1291 (Fed. Cir. 2011) (en banc).
 
(2) 針對客觀上「重要性」（materiality）要件的部分：採取所謂的「若非測試」（but-for test），亦即，僅有當專利權人於申請時所未提出的相關資訊一旦揭露給美國專利商標局時，專利審查委員就會依此否決系爭專利之核准的情況下才為具有重要性。
然而，此時如何來判斷其可專利性呢？就需要採取較低程度的「優勢證據」（preponderance of the evidence）標準來對申請專利範圍做出合理的最寬廣解釋範圍（reasonable broadest construction）下，看有此相關資訊時是否還會具有可專利性。
另外，附帶一提，判斷是否具有「重要性」要件的判斷標準亦為較高程度的「清楚明白且令人信服的證明」之舉證責任。
This court holds that, as a general matter, the materiality required to establish inequitable conduct is but-for materiality.  When an applicant fails to disclose prior art to the PTO, that prior art is but-for material if the PTO would not have allowed a claim had it been aware of the undisclosed prior art.  Hence, in assessing the materiality of a withheld reference, the court must determine whether the PTO would have allowed the claim if it had been aware of the undisclosed reference.  In making this patentability determination, the court should apply the preponderance of the evidence standard and give claims their broadest reasonable construction.  . . .  However, even if a district court does not invalidate a claim based on a deliberately withheld reference, the reference may be material if it would have blocked patent issuance under the PTO’s different evidentiary standards.
TheraSense, Inc. v. Becton, Dickinson and Company, 649 F.3d 1276, 1291-1292 (Fed. Cir. 2011) (en banc).
 
值得注意的是，聯邦巡迴上訴法院拒絕採用美國專利商標局所制定的Rule 56之定義來進行「重要性」要件之認定，認為該規定經過多年來的不斷變更已經使公眾難以遵循，又依照該定義則會繼續造成現今專利申請人提出太多無關緊要的資訊給美國專利商標局、而且於訴訟中則是仍然會造成幾乎每一個案件都提起「不正當行為」積極抗辯之情況。雖然，不同意見書對於此點並不表示認同，認為法院應當尊重行政機關所制定之Rule 56定義。
Because Rule 56 sets such a low bar for materiality, adopting this standard would inevitably result in patent prosecutors continuing the existing practice of disclosing too much prior art of marginal relevance and patent litigators continuing to charge inequitable conduct in nearly every case as a litigation strategy.
TheraSense, Inc. v. Becton, Dickinson and Company, 649 F.3d 1276, 1295 (Fed. Cir. 2011) (en banc).
 
(3) 例外：於前述利用「若非測試」來判斷「重要性」要件時，法院認為具有一例外，即當專利申請人係存心地計畫且小心地執行該謀略（deliberately planned and carefully executed scheme）來欺騙美國專利商標局或是法院時，則該行為是「極其嚴重的不正當行為」（egregious misconduct），例如：並非錯誤地提出虛假之宣誓書（the filing of an unmistakably false affidavit）等行為，此時，就不需要再透過「若非」測試即可來進行判斷。
Although but-for materiality generally must be proved to satisfy the materiality prong of inequitable conduct, this court recognizes an exception in cases of affirmative egregious misconduct.  This exception to the general rule requiring but-for proof incorporates elements of the early unclean hands cases before the Supreme Court, which dealt with “deliberately planned and carefully executed scheme[s]” to defraud the PTO and the courts.  Hazel-Atlas, 322 U.S. at 245, 64 S.Ct. 997.  When the patentee has engaged in affirmative acts of egregious misconduct, such as the filing of an unmistakably false affidavit, the misconduct is material.  . . .  After all, a patentee is unlikely to go to great lengths to deceive the PTO with a falsehood unless it believes that the falsehood will affect issuance of the patent.  . . .  Because neither mere nondisclosure of prior art references to the PTO nor failure to mention prior art references in an affidavit constitutes affirmative egregious misconduct, claims of inequitable conduct that are based on such omissions require proof of but-for materiality.
TheraSense, Inc. v. Becton, Dickinson and Company, 649 F.3d 1276, 1292-1293 (Fed. Cir. 2011) (en banc).
 
(4) 二者要件須獨立判斷：由於主觀上的「意圖」欺騙與客觀上的「重要性」兩者為分別獨立的要件，法院不可適用所謂的「滑動衡量」（sliding scale）方法來進行綜合判斷以斷定是否具有「不正當行為」，而是需要兩者要件獨立來進行判斷，例如不可因為具有「重要性」要件而推論亦滿足「意圖」要件。糾正了在此之前的一些法院判決所做出的觀念！
Intent and materiality are separate requirements.  Hoffmann-La Roche, Inc. v. Promega Corp., 323 F.3d 1354, 1359 (Fed. Cir. 2003).  A district court should not use a “sliding scale,” where a weak showing of intent may be found sufficient based on a strong showing of materiality, and vice versa.  Moreover, a district court may not infer intent solely from materiality.  Instead, a court must weigh the evidence of intent to deceive independent of its analysis of materiality.
TheraSense, Inc. v. Becton, Dickinson and Company, 649 F.3d 1276, 1290 (Fed. Cir. 2011) (en banc).
 
(5) 衡平法則下之裁量：由於這些都是涉及衡平法則下的抗辯，因此，法院仍可於判斷前述兩個要件後，在有可能涉及「不正當行為」之情況下，再看看專利權人是否透過該行為以取得不公平的利益，依據裁量權來認定其是否為「不正當行為」而需要造成系爭專利或其專利家族為不可實施的結果。
As an equitable doctrine, inequitable conduct hinges on basic fairness.  . . .  Because inequitable conduct renders an entire patent (or even a patent family) unenforceable, as a general rule, this doctrine should only be applied in instances where the patentee’s misconduct resulted in the unfair benefit of receiving an unwarranted claim.  . . .  After all, the patentee obtains no advantage from misconduct if the patent would have issued anyway.  . . .  Moreover, enforcement of an otherwise valid patent does not injure the public merely because of misconduct, lurking somewhere in patent prosecution, that was immaterial to the patent’s issuance.
TheraSense, Inc. v. Becton, Dickinson and Company, 649 F.3d 1276, 1292 (Fed. Cir. 2011) (en banc).
 
(6) 「不潔淨之手原則」：「不正當行為」之積極抗辯係源自「不潔淨之手原則」（unclean hands doctrine），但判定是否涉及「不潔淨之手」時，並不需要具有任何「重要性」要件，而於特定狀況下如「極其嚴重的不正當行為」時仍然有「不潔淨之手原則」適用的餘地。
This court recognizes that the early unclean hands cases do not present any standard for materiality.  Needless to say, this court’s development of a materiality requirement for inequitable conduct does not (and cannot) supplant Supreme Court precedent.  Though inequitable conduct developed from these cases, the unclean hands doctrine remains available to supply a remedy for egregious misconduct like that in the Supreme Court cases.
TheraSense, Inc. v. Becton, Dickinson and Company, 649 F.3d 1276, 1287 (Fed. Cir. 2011) (en banc).
 
小結
1. 於本TheraSense案全院庭審判決後，重新定義了「不正當行為」之判斷標準，上級法院並且認為聯邦地方法院於判斷「不正當行為」部分的認定事實之標準有誤，因而針對該部分撤銷了聯邦地方法院之原判決並發回重新審理。
2. 因此，日後對於專利權人、或是其專利代理人於進行專利申請時是否有「不正當行為」之判斷標準將被從嚴認定，頗值得讀者特別注意！
3. 於本案判決後，美國專利商標局針對與此「不正當行為」相關的專利申請人之注意義務有作出一些相關規定及措施，還請有興趣的讀者再另行參閱。
 

本文章之專業內容，僅為提供資訊參考，非作為法律諮詢之用，亦純屬作者個人之意見，不代表本所或作者任何曾任職過單位之立場。

 
相關參考資料
附註1. 聯邦巡迴上訴法院全院庭審：TheraSense, Inc. v. Becton, Dickinson and Company, 649 F.3d 1276 (Fed. Cir., May 25, 2011) (en banc) 案判決原文（網址：http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/08-1511.pdf）（最後瀏覽日期：2019年9月18日）。
附註2. 「美國BD公司」，Wikipedia網站，網址：https://zh.wikipedia.org/wiki/%E7%BE%8E%E5%9B%BDBD%E5%85%AC%E5%8F%B8（最後瀏覽日期：2019年10月9日）。
附註3. 系爭‘551專利，申請專利範圍1的部分文字內容：
1. A single use disposable electrode strip for attachment to the signal readout circuitry of a sensor to detect a current representative of the concentration of a compound in a drop of a whole blood sample comprising:
a) an elongated support having a substantially flat, planar surface, adapted for releasable attachment to said readout circuitry;
b) a first conductor extending along said surface and comprising a conductive element for connection to said readout circuitry;
c) an active electrode on said strip in electrical contact with said first conductor and positioned to contact said whole blood sample;
d) a second conductor extending along said surface comprising a conductive element for connection to said read out circuitry; and
e) a reference counterelectrode in electrical contact with said second conductor and positioned to contact said whole blood sample,
wherein said active electrode is configured to be exposed to said whole blood sample without an intervening membrane or other whole blood filtering member... .
'551 patent col. 13 l.29-col. 14 l.3 (emphasis added).
附註4. 聯邦巡迴上訴法院合議庭判決：TheraSense, Inc. v. Becton, Dickinson and Co., 593 F.3d 1289 (Fed. Cir., January 25, 2010) 案判決原文。
附註5. Gregory A. Castanias, Jose L. Patiño, “Therasense v. Becton, Dickinson: The Federal Circuit Heightens the Standard for Proving Inequitable Conduct in Patent Litigation,” 2011/6, Website: https://www.jonesday.com/en/insights/2011/06/itherasense-v-becton-dickinsoni-the-federal-circuit-heightens-the-standard-for-proving-inequitable-conduct-in-patent-litigation（最後瀏覽日期：2019年9月18日）。