Fall Carolina Patent Trademark and Copyright Law Association Meeting Patent Law Developments by Tom Irving Sept. 24, 2011 © Finnegan, 2011 1 The Presenter gratefully acknowledges Stacy Lewis for her assistance in the preparation of these slides. Disclaimer These materials are public information and have been prepared solely for educational and entertainment purposes to contribute to the understanding of American intellectual property law. These materials reflect only the personal views of the authors and are not individualized legal advice. It is understood that each case is fact-specific, and that the appropriate solution in any case will vary. Therefore, these materials may or may not be relevant to any particular situation. Thus, the author and FINNEGAN cannot be bound either philosophically or as representatives of various present and future clients to the comments expressed in these materials. The presentation of these materials does not establish any form of attorney-client relationship with the author or FINNEGAN. While every attempt was made to insure that these materials are accurate, errors or omissions may be contained therein, for which any liability is disclaimed. 2 Patent Reform: Bill Sent to President for Signature: Enacted: Sept. 16, 2011! First-inventor-to-file New definition of prior art Post-grant proceedings Best mode Supplemental examination Inventor’s Oath Tax strategy patents Pre-grant submission of prior art Derivation Joinder Business Method Patents Prior User Rights 3 America Invents Act Effective Dates Effective date of provisions is one year from enactment (Sept. 16, 2012) unless otherwise provided (Sec. 35) Not “otherwise provided”: advice of counsel (Sec. 17), travel expenses (Sec. 21), satellite offices Sec. 23/24), priority examination for important technologies (Sec. 25), Study on implementation (Sec. 26), Study on genetic testing (Sec. 27), Patent Ombudsman (Sec. 28), Study diversity of patent applicants (Sec. 29), Sense of Congress (Sec. 30), Study international patent protections for small businesses (Sec. 31), Budgetary effects (Sec. 36) Effective Date: Oct. 1, 2011 PTO Funding (Sec. 22) Effective Date: Immediate upon enactment: September 16, 2011 Best mode (Sec. 15) (including 119(e)(1) and 120; effective to “proceedings commenced on or after” September 16, 2011. See 35 USC §120 – “proceedings” broad Defense of Prior Commercial Use (Sec. 5) Venue (Sec. 9) Appeals from Board to CAFC (Sec. 7(e)) Marking (Sec. 16) Micro-entity Fees for Patent Services (Sec. 11) Jurisdiction, incl. joinder (Sec. 19) Funding agreements (Sec. 13) Amendment to §306 (changing 145 to 144) PTO Fee Setting Authority (Sec. 10) (7year sunset clause) Limitation on issuance of human organism patents (Sec. 33) Tax Strategies (Sec. 14) Pro bono program (Sec. 32) Patent term extension (Sec. 37) Standard for inter partes reexam changes from SNQP to “reasonable likelihood” of prevailing Effective Date: 10 days after enactment: September 26, 2011 Effective 60 days after enactment: November 16, 2011 Prioritized examination fee and surcharge (Sec. 11(h) and (i)) Fee for paper filing (Sec. 10(h)) Effective Date: 1 year from enactment: Effective September 16, 2012 Inventor’s oath, changes to § 112 (joint inventor) (Sec. 4) Preissuance submission by 3rd parties (Sec. 8) Post-Grant Review and IPR (Sec. 6, except for amendment to §306 (changing 145 to 144), which takes effect on the date of the enactment)(gradual implementation over 4 years). Patent Trial and Appeal Board (Sec. 7), except jurisdiction over appeals of reexam decisions to CAFC take effect upon enactment Business method patents (Sec. 18)(8-year sunset clause) Supplemental examination (Sec. 12)(applies to patents filed before, on, or after effective date) Technical amendments, includes changes to reissue statute (Sec. 20) Study of patent litigation (Sec. 34)(DUE 1 year after enactment) Effective Date: 18 months from enactment: Effective March 16, 2013 First-inventor-to-file, new §102, amended §103, repeal of §104, derivation, Repeal of Statutory Invention Registration (Sec. 3) 4 Road-Map U.S.C. § 100(i)(1) defines “effective filing date” for claimed invention [see page 4 of the statute]. SEC. 3(n)(1) defines effective date of amendments to 35 U.S.C. § § 102 and 103 [see pages 23-24 of the statute]. 35 U.S.C. § 102(a)(1) [see page 5 of the statute] defines prior art/ § 102(b)(1) exceptions [see page 6 of the statute] 35 U.S.C. § 102(d) [see page 8 of the statute] defines prior art under 35 U.S.C. § 102(a)(2) [see pages 5-6 of the statute](earlier-filed, laterdisclosed) (§ 102(b)(2) exceptions [see pages 6-7 of the statute]). 5 35 U.S.C. § § 100(i)(1) and (j) § 100(i)(1) The term ‘effective filing date’ for a claimed invention in a patent or application for patent means— (B) the filing date of the earliest application for which the patent or application is entitled, as to such invention, to a right of priority under section 119, 365(a), or 365(b) or to the benefit of an earlier filing date under section 120, 121, or 365(c). (A) if subparagraph (B) does not apply, the actual filing date of the patent or the application for the patent containing a claim to the invention; or § 100(j): “The term ‘claimed invention’ means the subject matter defined by a claim in a patent or an application for a patent.’’ Entitlement does not require best mode (SEC. 15(b) amending Sections 119(e)(1) and 120). [page 116 of statute] Effective immediately to “proceedings” commenced on or after September 16, 2011! . [pages 116 117 of statute] Legislatively modifies In re Gosteli (Fed. Cir. 1989). See 35 USC §120 – “proceedings” broad. 6 Effective Date of § § 102/103 Changes SEC. 3(n)(1) Except as otherwise provided in this section, the amendments made by this section shall take effect upon the expiration of the 18-month period beginning on the date of the enactment of this Act, [March 16, 2013] and shall apply to any application for patent …that contains or contained at any time: A. a claim to a claimed invention that has an effective filing date as defined in section 100(i) [remember: “entitled to”] …, that is on or after the effective date described in this paragraph [March 16, 2013]; or B. a specific reference under §§ 120, 121, 365(c) to any patent or application that contains or contained at any time such claim. [antecedent for “such claim” has to be sub.para. (A)] 7 Straddling the Effective Date: Double Trouble First to Invent System Applies PCT Filing Enactment: Sept. 16, 2011 PCT Filing Priority Date “First To Invent” System or “First Inventor to File” System? (see SEC. 3(n)(1)(A)) Scenario 1: no claims entitled to priority date: first-to-file Scenario 2: all claims entitled to priority date: first-to-invent Scenario:3: at least 1 claim not entitled to priority date: first-to-file Enactment: Sept. 16, 2011 Priority PCT Date Filing Enactment: Sept. 16, 2011 Effective Date: March 16, 2013 “First Inventor to File” System Applies Assumes “priority date” is ex-US 8 Filing Strategy Based on Effective Date for Prior Art Provisions File before 18 months after enactment (on or before March 15, 2013) New applications; CIPs; New claims (disclosed but not previously claimed)? 9 35 U.S.C. § 102(a) – Defines Prior Art Under New Law §102 Conditions for patentability (a) NOVELTY; PRIOR ART. A person shall be entitled to a patent unless— (1) the claimed invention was patented [anywhere in the world], described in a printed publication [anywhere in the world], or in public use [anywhere in the world], on sale [anywhere in the world], or otherwise available to the public [anywhere in the world] before the effective filing date of the claimed invention; ~ OR … ~ 10 35 U.S.C. § 102(a) – Cont’d §102 Conditions for patentability (a) NOVELTY; PRIOR ART. A person shall be entitled to a patent unless— … (2) the claimed invention was described in a [US] patent issued under section 151 [US patent], or in an application for [US or PCT application designating the US (§374)] patent published or deemed published under section 122(b) [US application or PCT application designating the US], in which the [US] patent or [US or PCT designating the US] application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. [see §102(d)(next slide): effective filing date can be earliest foreign priority document] [§102(a)(2)somewhat like old §102(e); filed before effective filing date but not disclosed before effective filing date, otherwise would be under §102(a)(1)] 11 §102(a)(2)/§102(d) Earlier-Filed but Later-Published [US] Patent Documents Somewhat like old §102(e) but cannot be antedated by earlier invention. Following publication, the disclosure has retroactive availability as prior art as of effective filing date Available as prior art for novelty and obviousness purposes §102(d) PATENTS AND PUBLISHED APPLICATIONS EFFECTIVE AS PRIOR ART.— For purposes of determining whether a patent or application for patent is prior art to a claimed invention under subsection (a)(2), such patent or application shall be considered to have been effectively filed, with respect to any subject matter described in the [US] patent or [US or PCT designating the US] application“(2) if the patent or application for patent is entitled to claim a right of priority under section 119, 365(a), or 365(b), or [entitled] to claim the benefit of an earlier filing date under section 120, 121, or 365(c), based upon 1 or more prior filed applications for patent, as of the filing date of the earliest such application that describes the subject matter.” [“entitlement” trumps “describes”- therefore enablement is required?] ‘‘(1) if paragraph (2) does not apply, as of the actual filing date of the patent or the application for patent” 12 New 35 U.S.C. § 102(b) – Defines Exceptions to Prior Art These exceptions define what is not prior art under §§ 102(a)(1) and (a)(2), respectively, and are generally personal to the inventor: §102 (b) EXCEPTIONS. (1) [twins with (a)(1)]Disclosures [anywhere in the world] made 1 year or less before the effective filing date [anywhere in the world; see §100(i)(1)] of the claimed invention shall not be prior art under (a)(1) if: (A) made by an inventor or by another who obtained the subject matter directly or indirectly from an inventor, or (B) if the subject matter had been previously publicly disclosed by an inventor or one who obtained it from an inventor; 13 New 35 U.S.C. § 102(b) – Cont’d §102 (b) EXCEPTIONS – … (2) [twins with (a)(2)] Disclosures appearing in [US or PCT designating the US] applications and [US] patents are not prior art under (a)(2) [NOTE: NO RECITATION OF “ONE YEAR OR LESS”] if: (A) obtained directly/indirectly from an inventor; (B) the subject matter was publicly disclosed before filing by an inventor or one obtained it directly or indirectly from an inventor; or (C) the subject matter disclosed and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. 14 First-to-Invent vs. First-Inventor-to-File First-to-Invent: X Can Win X CONCEIVED X RTP Y CONCEIVED X FILED Y RTP Y FILED First-Inventor-to-File: Y (Independent Inventor) Wins 15 Definition of Prior Art: Scenario 1 X FILED X PUBLISHED IN US Y FILED Old: Y Could Antedate X with evidence of earlier invention. New: Since X filed first, X is Prior Art to Y (for § § 102 and 103 purposes) Assuming §102(b)(2) exceptions do not apply. 16 Definition of Prior Art: Scenario 2 X SOLD IN EUROPE (Confidential???) Y FILED Old: Sale of X Not Prior Art to Y because not in US. New: Sale of X Is Prior Art to Y. [§102(a)(1) only] Consider if 102(b)(1) exception applies. 17 Definition of Prior Art: Scenario 3 X PUBLICLY USED: ex US > 1 Year Y INVENTED Y FILED Old: Public use outside US was not prior art. New: X’s use outside the 1-year period is prior art to Y wherever it occurred; exception under §102(b)(2) cannot apply because no patent or patent application. 18 Definition of Prior Art: Scenario 4 X PUBLICLY USED < 1 Year Y INVENTED Y FILED Old: Y could antedate X’s use. New: X’s use inside the 1-year period may be prior art to Y wherever it occurred: grace period exception under 102(b)(1) may apply. 19 How the NEW U.S. Grace Period Will Work (§102(b)(1)(A)): Applies to Both Applications Here Disclosure “by or obtained from” an inventor §102(b)(1)(A), but only if effective filing date is the foreign priority date Grace Period! §102(b)(1)(A) Public use Public use U.S. Patent 12 mos. Foreign Priority Filing 12 mos. U.S. Filing Date 20 How the NEW U.S. Grace Period Will Work: §102(b)(1)(A) and (B) Respectively Apply Grace Period! Disclosure “by or obtained from” an INVENTOR Disclosure by ANYONE §102(b)(1)(A) §102(b)(1)(B) Public use Public use U.S. Patent 12 mos. Effective Filing Date 21 How the NEW U.S. Prior Art Provisions Will Work: A Sword and A Shield (A Hat Trick!) Disclosure “by or obtained from” Inventor Barbara Filing by independent inventor Tom §102(b)(1)(A) §102(b)(2)(B) §102(a)(1) Public use 12 mos. Pat. App. Filed Tom’s US application published Barbara’s U.S. Patent Effective Filing Date of Barbara Barbara avoids public use through §102(b)(1)(A); Barbara’s public use avoids Tom’s publication through §102(b)(2)(B) and defeats Tom through § 102(a)(1); First inventor to file loses because other inventor disclosed first. 22 Hilmer Doctrine Abolished by §102(d) §102(d) eliminates need for foreign applicants to file provisional applications by establishing that an application is “effectively filed” on the date an application was filed under §119 or § 365. Hilmer Doctrine evidenced bias of U.S. law against inventions originating outside the U.S. Based on two U.S. litigations (Hilmer I and II) that held that the foreign right of priority of a U.S. patent does not provide a prior art effect under § 102(e) as of that foreign priority date, nor does inventive work outside the U.S. have a prior art effect under § 102(g). Rather, one needed a U.S. filing date to have a prior art effect. Created “shield vs. sword” distinction Foreign applicant needed to file in the U.S. to get a § 102(e) or § 102(g) prior art effect date. Current foreign applicant practice: file U.S. provisional at the same time as foreign priority application to get earliest § 102(e) date. 23 Impact of § 102(d)(2) – Prior Art Date Prior art date U.S. Prov. Appl. Pub. Appl. U.S. Appl. Non-Prov. Prior art date UK Prior art date FR English USPAT Pub. Appl. PCT (U.S.) PCT (U.S.) English USPAT Pub. Appl. French USPAT • NO geographical or language distinction •Assuming entitlement to date benefit of US Prov App., UK app., and FR app. 24 US Patent Reform: Effect on §103 New law modifies §103 to read: would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains… Present §103 reads: would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains Hence, the new US law switches from “at the time the invention was made” to the time “before the effective filing date of the claimed invention” Generally broadens the scope and content of the prior art in the U.S. Effective date March 16, 2013 (same as for § 102). 25 Third-Party Challenges: Current Board of Patent Appeals Interferences Inter Partes Reexam Filing Examining Corps Ex Parte Reexam Issuance 26 Third-Party Challenges: New Patent Trial and Appeal Board Inter Partes Review Post-Grant Review Filing Examining Corps Ex Parte Reexam Issuance 27 Challenges in PTO: Current Regime v. New Regime New and revised procedures that open “windows” for challenges. Current Regime New Regime Preissuance 3rd Party Submissions (citations only) Preissuance 3rd Party Submissions (can provide details) Ex Parte Reexam (post-grant) Ex Parte Reexam (post-grant) Post-Grant Review (PGR) (within 9 months of grant) Inter Partes Reexam (post-grant) Inter Partes Review (IPR) (after 9 months of grant) 28 PGR Features Broad ground: any ground that could be raised under paragraph (2) or (3) of § 282(b) (relating to invalidity of the patent or any claim). Lower burden of proof than litigation. Lower cost than litigation (but increased discovery TBD). Final determination within 1-1½ years. Must identify real parties in interest. Threshold: “more likely than not that 1 or more claims invalid.” Estoppel effect. 29 IPR Features Narrower grounds: § 102 or § 103 but only on basis of prior art patents and printed publications. Lower burden of proof than litigation. Lower cost than litigation (with some discovery). Final determination within 1-1½ years. Must identify real parties in interest. Threshold: “reasonable likelihood would prevail.” Estoppel effect. 30 IPR & PGR – Relation to Infringer’s Lawsuit No IPR/PGR if petitioner had previously filed a civil action challenging validity. (§315(a)(1)) /§325(a)(1)) Civil action challenging validity filed by petitioner on or after date IPR/PGR petition is filed - automatically stayed unless: Patent owner moves to lift the stay; Patent owner files action or counterclaim for infringement; or Petitioner moves to dismiss civil action. §325(a)(2)/§325(a)(2) Counterclaim of invalidity does not qualify as a civil action challenging validity (§325(a)(1)/§325(a)(3)). 31 IPR – Relation to Patentee’s Lawsuit No IPR if petition is filed >1 year after petitioner is served a complaint alleging infringement. (§315(b)). Joinder (§315(c)). Time limit does not apply to request to join as a party to the IPR. Joinder is discretionary. 32 PGR – Relation to Patentee’s Lawsuit If patentee files suit for infringement within 3 months of issuance, court may not stay motion for preliminary injunction on the basis that PGR petition was filed or instituted. (§325(b)). 33 IPR & PGR – Final Decision—Estoppel Petitioner/RPI (“real-party-in-interest”) cannot request or maintain a proceeding before the PTO with respect to the claim at issue on any ground that the petitioner raised or reasonably could have raised during the IPR/PGR. §315(e)(1)/§325(e)(1). Petitioner/RPI cannot assert, in a district court litigation or ITC proceeding, that the claim is invalid on any ground that the petitioner raised or reasonably could have raised during the IPR/PGR. §315(e)(2)/§325(e)(2). Settlement: No estoppel. §317/§327. 34 IPR Effective Date, Exception, Limit (A) Effective date: amendments effective 1 year after the date of the enactment of this Act and shall apply to all patents issued before, on, or after such date [Sept. 16, 2012] SEC. 6(c)(2)(A) (B) EXCEPTION: inter partes reexam request under old law if filed after date of enactment [Sept. 16, 2011] but prior to effective date of new IPR [Sept. 16, 2012]. SEC. 6(c)(3)(C). [lower standard for getting old inter partes reexam] (C) GRADUATED IMPLEMENTATION.—The Director may impose a limit on the number of inter partes reviews that may be instituted during each of the first 4 years following the effective date of subsection (a), provided that such number shall in each year be equivalent to or greater than the number of inter partes reexaminations that are ordered in the last full fiscal year prior to the effective date of subsection (a). SEC. 6(c)(2)(B) 35 PGR Effective Date, Exception, Limit (A) Effective date: amendments effective 1 year after the date of the enactment of this Act. SEC. 6 (f)(2) and, “except as provided in section 18 [transitional program for business method patents] and in paragraph (3) [pending interferences], shall apply only to patents described in section 3(n)(1) [slide 5, effective filing date after one year from enactment (Sept. 16, 2012)].” [out of phase with IPR effective date; compare slide 34] (B) EXCEPTION: interferences may be dismissed without prejudice to the filing of a PGR petition. SEC. 6 (f)(3). (C) GRADUATED IMPLEMENTATION.—The Director may impose a limit on the number of post grant reviews that may be instituted during each of the first 4 years in which the amendments are in effect. SEC. 6(f)(2)(B). 36 Comparison Preissuance Submissions When? Limited time before allowance Ex Parte Reexam Inter Partes Reexam Post-Grant Review Inter Partes Review After grant After grant (being replaced) Within 9 months of grant After 9 months of grant More likely than not or important novel/unsettled legal question Reasonable likelihood of success No No Threshold Showing N/A SNQ Substantial new question of patentability Anonymity Yes Yes No 37 Comparison Preissuance Submissions Ex Parte Reexam Inter Partes Reexam Post-Grant Review Inter Partes Review Issues raised Issues raised or could have or could have been raised: been raised: PTO, district PTO, district court, and ITC court, and ITC Estoppel None None Issues raised or could have been raised Before Whom? Examiner CRU CRU Board Board Declaration Declaration and discovery Declaration and discovery Discovery/ Evidence? N/A Declaration 38 Comparison Speed within PTO Appeal Preissuance Submissions Ex Parte Reexam Inter Partes Reexam Post-Grant Review Inter Partes Review Case dependent Many Years Many Years 1 to 1½ years 1 to 1½ years Only patentee Only Both parties Both parties can appeal to patentee can can appeal to can appeal to Board and appeal to Board and Federal then Federal Board and then Federal Circuit Circuit then Federal Circuit Circuit Both parties can appeal to Federal Circuit 39 Impact and Strategy Considerations Consider the following in choosing a mechanism: Windows of time Threshold requirements Available grounds: PGR broader than IPR Estoppel effect Decision maker (Examiner, Board) Discovery opportunities Speed Limits on numbers to be considered by PTO Oral hearing and appeal 40 Best Mode Still required to disclose best mode in §112, ¶1. But failure to disclose best mode no longer a ground for invalidity or unenforceability. See SEC. 15(a) amending 35 U.S.C. § 282. Effective on enactment. §§ 119(e)(1) and 120: best mode compliance gone? [But see slide 6 and pages 116-117 of the statute] Is it really that simple? 41 Supplemental Examination and Interface with en banc Therasense Allows submission of prior art in your own patents §257(c): But SE effect does not apply against allegations already raised in district court or ANDA notice para. IV before date of filing request (§257(c)(2)(A)), or SE effect shall not apply to any defenses raised in ITC litigation/district court litigation unless SE and any reexam ordered therefrom is finished before the date on which the action is brought (§257(c)(2)(B)). For PTO “to consider, reconsider, or correct information believed relevant to the patent” Prior art? Inconsistent positions? Errors? Therasense: Rule 56? 42 Supplemental Examination 3 months for PTO to indicate whether or not submitted information raises a SNQP. If no SNQP, subject to exceptions on previous slide, patent cannot be held unenforceable on considered information ; isn’t that “but-for” materiality? If yes, can trigger reexam But patentee cannot make submissions regarding the art or claims before first Office Action. Assuming the patentee establishes patentability of the claim (either in original or amended form) in the reexamination over the SNQ raised by the information reviewed, the patentee is insulated in subsequent litigation from a charge of inequitable conduct based on that information, subject to exceptions noted on previous slide ((§257(c)(1)). 43 Supplemental Examination Is this the holy grail of a purge of inequitable conduct under a “but-for” materiality standard? IN GENERAL.—A patent shall not be held unenforceable on the basis of conduct relating to information that had not been considered, was inadequately considered, or was incorrect in a prior examination of the patent if the information was considered, reconsidered, or corrected during a supplemental examination of the patent. The making of a request under subsection (a), or the absence thereof, shall not be relevant to enforceability of the patent under section 282. (§257(c)(1)). 44 Supplemental Examination Exceptions: see above and next bullet. (§257(f)). Nothing in this section shall be construed— (1) to preclude the imposition of sanctions based upon criminal or antitrust laws (including section 1001(a) of title 18, the first section of the Clayton Act, and section 5 of the Federal Trade Commission Act to the extent that section relates to unfair methods of competition); (2) to limit the authority of the Director to investigate issues of possible misconduct and impose sanctions for misconduct in connection with matters or proceedings before the Office; or (3) to limit the authority of the Director to promulgate regulations under chapter 3 relating to sanctions for misconduct by representatives practicing before the Office. Do (1)-(3) compel full disclosure as discussed in Therasense majority and dissent? Are they adequate brakes on “affirmative egregious misconduct”? 45 Supplemental Examination Fraud exception (§257(e)) [pp. 112-113]. What is “fraud” and what investigation needed? (e) FRAUD.—If the Director becomes aware, during the course of a supplemental examination or reexamination proceeding ordered under this section, that a material fraud on the Office may have been committed in connection with the patent that is the subject of the supplemental examination, then in addition to any other actions the Director is authorized to take, including the cancellation of any claims found to be invalid under section 307 as a result of a reexamination ordered under this section, the Director shall also refer the matter to the Attorney General for such further action as the Attorney General may deem appropriate. Is that an attempt to compel full disclosure? 46 Reissue Amendment ▪ Another purge opportunity? Amendment to §§251, 253: – Whenever any patent is , through error without any deceptive intention, deemed wholly or partly inoperative or invalid, by reason of a defective specification or drawing, or by reason of the patentee claiming more or less than he had a right to claim in the patent, the Director shall, on the surrender of such patent and the payment of the fee required by law, reissue the patent…. (American Invents Act Sec. 20(d) and (e)). – Would one use a combination of Reissue and Supplemental Examination to insulate reissued claims from allegation of inequitable conduct? 47 Inequitable Conduct: Standards for Intent and Materiality Therasense, Inc. v. Becton, Dickinson & Co., 593 F.3d 1289 (Fed. Cir. 2010), reh’g en banc granted, --F.3d– (Fed. Cir. May 25, 2011) Abbott’s statements in US prosecution found to be inconsistent with statements made to the EPO. Statements made to the EPO found to be not disclosed to USPTO examiner. District court: Unenforceable for inequitable conduct. Withheld information was material, and “neither Pope nor Dr. Sanghera provided a credible explanation for failing to submit the EPO documents to the PTO” 48 Inequitable Conduct Therasense Majority on Rehearing En Banc: “but for” materiality = if the PTO would not have allowed a claim had it been aware of the undisclosed prior art. “affirmative egregious misconduct” exception = no “but-for” materiality but it would otherwise be unjust to allow the patentee to enforce the patent. Example: filing of an unmistakably false affidavit. Does not include mere nondisclosure of prior art references. specific intent to deceive = single most reasonable inference that one with a Rule 56 duty "knew of the reference, knew that it was material, and made a deliberate decision to withhold it.” No more “should have known” standard for intent (no disagreement from dissent or concurring opinions). Absence of a good faith explanation for failure to disclose a material reference (which was the case in Therasense) does not, by itself, constitute intent to deceive. Explicitly forbade inferring intent solely from materiality and abandoned the “sliding scale”. (No disagreement in the dissenting or concurring opinions). 49 Federal Circuit Decision Is Final 6-5 disagreement within Federal Circuit on fundamental principle of materiality. Becton Dickinson counsel publicly stated on Sept. 13, 2011, at IPO meeting that petition for certiorari was not and will not be filed. 50 First Post-Therasense Federal Circuit Decision American Calcar v. American Honda Motor Co., Inc., -F.3d___(Fed. Cir. June 27, 2011) District Court: Inequitable conduct based on failure to disclose material information to the USPTO. Explicitly used “sliding scale”: the court held that, given that the withheld information was highly material, less evidence of intent was required to reach a finding of inequitable conduct. Federal Circuit: Vacated and remanded Inappropriate to use “sliding scale,” and district court used incorrect standards for determining materiality and intent. Some of withheld information was material (found to invalidate the patent claims), but other undisclosed information was evaluated for materiality under current Rule 56 standard and the “reasonable examiner” standard, both rejected in Therasense. District court “failed to make a finding …that the withheld information would have blocked issuance of the claims ….” 51 First Post-Therasense Federal Circuit Decision American Honda (con’t) Federal Circuit: Specific findings on intent required. Lack of credibility of witness alone is insufficient to find specific intent to deceive under the knowing and deliberate standard. “On remand the court should make a specific finding on whether any of the three inventors knew that withheld information was material and whether they made a deliberate decision to withhold it.” 52 Post-Therasense District Court Decisions Ameranth, Inc. v. Menusoft Systems Corp., --F.Supp.2d___ (E.D.Tex. May 26, 2011) Undisclosed prior art was material -> jury found that the withheld references invalidated the claims. Applicant stubbornly, while incorrectly, believed that omitted reference was simply different from the invention and need not be submitted = alternative reasonable inference No inequitable conduct. 53 Post-Therasense District Court Decisions Light Guard Systems, Inc. v. Spot Devices, Inc., --F.Supp.2d ____ (D.Nev. July 22, 2011) Undisclosed prior art reference was found “but-for” material Patentee submitted evidence that he considered the undisclosed reference cumulative and that he (and his patent attorney) believed that the prior art reference was different from the claimed design. No inequitable conduct -> more than one reasonable inference for why the patentee failed to disclose the prior art reference, and therefore no “single most reasonable inference. 54 Post-Therasense District Court Decisions Generac Power Systems Inc. v. Kohler Co., --- F.Supp.2d __, (E.D.Wis. July 5, 2011) “[U]nder the ‘tightened standards’ for materiality and intent, the patentee showed that the defendant’s ‘inequitable conduct defense lack[ed] substantial merit.’” Defendant “erred in arguing a ‘reasonable examiner’ standard for materiality, and did not show a “a reasonable likelihood that the PTO would not have allowed the claims of the '345 patent if it knew of the undisclosed references.” Defendant also erred in relying on a “sliding scale” analysis to infer intent. Patentee did not dispute that the reference was intentionally withheld, but: “Generac is not required to provide a good faith explanation for its failure to disclose, ‘unless the accused infringer first ... prove[s][the] threshold level of intent to deceive,’ which Kohler has not proved. … Therefore, Generac has shown that the '345 patent will likely withstand Kohler's enforceability challenge.” 55 56 57 Thank You! Contact Information: Tom Irving 202.408.4082 [email protected] 58
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