ACI’s Eighth National Advanced Forum on Litigating Patent Disputes
Festo In Litigation
What Festo and Its Progeny Mean for Litigation Today . . . and Tomorrow
Richard S. Meyer Mary T. Huser
February 2003
The Bold Agenda
Let‟s Get Grounded -- Festo II review
When Festo applies
Impact of Festo Precedent in District Courts
Greater Burden on Patentees Rebutting the Festo presumption
Federal Circuit Insights
Amendment v. argument-based estoppel Festo II on Remand in the Federal Circuit
Tips, Takeaways & Strategies
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The Supreme Court’s May 28, 2002 Decision
Festo forecloses use of Doctrine of Equivalents (DOE) for amended claim elements due to Prosecution History Estoppel (PHE)
Applies when:
Any narrowing claim amendment
Including voluntary and involuntary amendments
Is made for any statutory requirement of patentability
Avoid prior art Comply with 35 U.S.C. 112
Unless the amendment is “truly cosmetic”
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Effect of Festo
Amendment is presumed to be a “general disclaimer of territory between the original claim and amended claim”
Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., Ltd., 535 U.S. 722 (2002)
Creates rebuttable presumption that the patentee surrendered the particular equivalent in question
Burden of proof now on patentee to prove no PHE where amended claim element not literally present
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How to Rebut the Presumption
Subject matter surrendered unless Patentee shows:
Equivalent unforeseeable at time of amendment/application; Reason for amendment bears no more than a tangential relation to the equivalent; or
Any other reason patentee could not have reasonably been expected to describe the insubstantial substitute in question
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How Have the District Courts Been Applying the Presumption?
Procedural Issues How to Measure Foreseeability
Objective evidence from skilled artisan? Subjective evidence from inventor and/or patent attorney?
What is tangential?
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When Does the Festo Presumption Apply?
Not when determining literal scope of claims
Court should determine ordinary meaning of claim language as understood by skilled artisans. Burden on party seeking to alter plain meaning.
Middleton, Inc. v. 3M Co., 311 F.3d 1384 (Fed. Cir.
2002)
Only to DOE analyses
Burden on patentee as tries to extend protection beyond literal scope of claims.
Gentile v. Franklin Sports, Inc., 211 F. Supp. 2nd 334
(D. Mass 2002)
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Case Law Applying Festo II Rebuttable Presumption
Tangential Argument Succeeded
Vardon -- First reported case (N.D. Ill.)
Foreseeability Arguments Failed
Glaxo Wellbutrin SR® Drug Cases EDVA, SDNY, ND Cal. Bosch Cordless Drill (C.D. Cal.)
Soundtube Dome Loudspeakers (D. Mass.)
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Vardon Golf Co. v. Karsten Mfg. Corp.
2002 U.S. Dist. LEXIS 11802 (N.D. Ill. 2002)
Vardon‟s „021 patent directed to golf clubs with enlarged faces and reinforced cavity Vardon: Karsten‟s PING ISI golf clubs, with “ring and dot” in cavity, infringe under DOE
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Vardon
Claim 7, relating to structural reinforcements, was amended to avoid prior art:
“...said head having a face wall, and means to reinforce the face wall and enlarge the effective hitting area of the golf club including an integral perimeter wall extending rearwardly from and surrounding the face wall defining a cavity in the rear of the head, and a progressive face wall reinforcing [weighting] element in the cavity extending from the approximate center of the rear of the face wall outwardly in the cavity to the perimeter wall, said element being integral with both the face wall and perimeter wall, said reinforcing element incrementally increasing [in weight] in height [at least one direction] from the approximate center of the rear of the face wall to the perimeter wall...”
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Vardon
Prior art reference disclosed iron with dot in center Defendant Karsten:
By distinguishing „021 invention from prior art with a “dot in rear cavity” Vardon surrendered subject matter PING ISI irons – with ring and dot in center of cavity – are part of surrendered territory
Prior Art
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Vardon
Vardon:
Could not reasonably be expected to draft claim literally encompassing clubs with ring and dot. Ring and dot only tangentially related to reinforcing function of the ribs in accused ISI clubs.
Court: Vardon rebutted Festo presumption
Amendments focused on structural -- not cosmetic -distinctions. Ring and dot are primarily aesthetic. No mention of ring and dot in Vardon‟s amendment. PTO considered “dot” insubstantial distinction as it granted patent despite presence in prior art.
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GlaxoSmithKline (“GSK”) HPMC Cases
GSK basic patent on active ingredient for antidepressant drug Wellbutrin SR® expired in „91.
GSK obtained another patent for a sustained release version of the drug.
Claims originally recited functional features of sustained release and shelf life of over a year.
Claims were rejected under 35 U.S.C. § 112 for lack of enablement
Hydroxypropylmethylcelluslose (“HPMC”) is “considered critical for controlled and/or sustained release and should be incorporated into the independent claims.”
Claims were amended, adding HPMC as sustained release agent and dropping the shelf life feature.
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GSK HPMC Cases
Four generic drug companies filed ANDA‟s/¶ IV certs.
Andrx used HPMC but not as sustained release agent. Excel used polyvinyl alcohol (PVA). Eon and Impax used hydroxypropyl cellulose (HPC).
GSK filed 4 patent infringement suits
SDFla, EDVA, SDNY, and NDCal.
Andrx obtained SJ of non-infringement pre-Festo II. In August 2002, courts ruled on other defendant‟s motions for summary judgment of non-infringement, based on the foreseeability test outlined Festo II.
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SmithKline Beecham v. Excel
214 F. Supp.2d 581 (E.D.V.A. 2002)
GSK argued claim Festo did not apply
Alleged claim not narrowed because substituted HPMC for unrelated shelf life feature. Court ruled claims narrowed from generic, controlled release concept to single species, HPMC.
GSK had “burden to demonstrate that the amendment did not surrender the alleged equivalent…PVA.” GSK submitted affidavit from expert that PVA was unforeseeable and skilled artisan could not have drafted claim to literally cover.
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SmithKline Beecham v. Excel
214 F. Supp.2d 581 (E.D.V.A. 2002)
Court, assuming truth of non-movant‟s affidavit, still granted SJ of non-infringement to Excel.
GSK, preparing for usual pre-Festo DOE case, had to admit numerous mechanisms like HPMC were known. Court found that scientific knowledge of this “category of polymers” existed at the time the claims were amended. Therefore, even if PVA unforeseeable, equivalents from that family of polymers were foreseeable.
Court concedes patentee could not have successfully redrafted the claims in PTO, but issue is whether patentee had “scientific ability” to draft literal claims.
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Glaxo Wellcome v. Eon Labs
220 F. Supp.2d 1089 (S.D.N.Y. 2002), 2003 U.S. Dist LEXIS 2074 (2003)
On SJ, GSK only had to “come forward with evidence to establish a triable issue of fact as the foreseeability of HPC as a sustained release agent.”
Glaxo argued
No teaching in prior art of sustained release version. Inventors tested and only knew of HPMC. Expert affidavit shows HPC could not have been foreseen.
Eon submitted a listing from prior art catalogue disclosing that HPC was a “well-known” sustained release agent.
Court held Glaxo created a triable issue of fact Per Eon court, foreseeability is subjective/question of fact. 2.13 Motion for Reconsideration/Claim Preclusion denied.
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Glaxo Wellcome v. Impax Labs
2002 U.S. Dist. LEXIS 15966 (N.D. Cal. 2002)
Court grants SJ of Non-Infringement to Impax
Addressed earlier decisions, but did not finding the same ambiguity as Eon court.
Court held, PHE, including foreseeability of equivalents, is question of law for court. Two-part test for Festo II PHE:
(1) if the amendment narrowed the claim for reasons related to patentability; and
(2) skilled artisan could have foreseen a less restrictive alternative.
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Glaxo Wellcome v. Impax Labs
2002 U.S. Dist. LEXIS 15966 (N.D. Cal. 2002)
Court found “anyone skilled in the art would have known that HPC and HPMC were substantially equivalent”
HPC listed in Handbook of Pharmaceutical Excipients
as popular stabilizing and suspending agent in drugs Earlier GSK patents disclose both as release agents
GSK argued HPC not foreseeable because it was not tested with Wellbutrin SR® Court responded by noting GSK had known for years HPC and HPMC similar, and its failure to perform analysis or expand claims was “unreasonable.”
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Soundtube Entertainment v. Brown Innovations
233 F.Supp.2d 188 (D. Mass. 2002)
Brown „438 patent:
“Spherical” dome loudspeakers Speaker with “substantially spherical” interior rejected as indefinite under § 112
Amendment: “substantially spherical”
Prior art disclosed speaker with elliptical cross section
Amendment: a spherical interior having “a constant radius”
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Soundtube Entertainment v. Brown Innovations
233 F.Supp.2d 188 (D. Mass. 2002)
Accused infringer Soundtube used 30-inch dome speaker that was almost spherical:
Upper portion of dome varied from best fit sphere by 0.16 inches, lower portion varied by over 0.11
Brown argued that Soundtube speaker fell within “allowable tolerances for spheres”
Soundtube‟s slight variance not foreseeable „438 amendments only “tangentially related” to infringing aspects of Soundtube speaker
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Soundtube Entertainment v. Brown Innovations
233 F.Supp.2d 188 (D. Mass. 2002)
Court: Brown did not rebut Festo presumption
Substantially-spherical speakers (like Soundtube‟s) were foreseeable
Patentee originally claimed them
Tangential argument rejected
Patentee made arguments about the benefits of a
constant radius to avoid prior art
Brown estopped from asserting DOE
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Federal Circuit Insights
Amendment v. Argument-based Estoppel Post-Festo II
Riles v. Shell Exploration & Production Co., 298 F.3d
1302 (Fed. Cir. 2002) Eagle Comtronics, Inc. v. Arrow Comm. Labs., Inc., 64 U.S.P.Q.2d 1481 (Fed. Cir. 2002)
Arguments give more leeway to patentees
Festo II on Remand in the Federal Circuit
En banc Rehearing Held on Feb. 6, 2003
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Eagle Comtronics v. Arrow Comm. Labs
64 USPQ2d 1481 (Fed. Cir. 2002)
Eagle „494 patent: Electrical signal filters to unscramble protected TV signals
Improved cable filter with sealed collet assembly to prevent moisture and other contamination
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Eagle Comtronics v. Arrow Comm. Labs
64 USPQ2d 1481 (Fed. Cir. 2002)
Examiner rejected claims for collet assembly as being obvious in view of prior art
Eagle: Argued that prior art did not teach use of
O-ring seal between front cap and rear insert body
Prior art used sealant at rear of collet assembly
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Eagle Comtronics v. Arrow Comm. Labs
64 USPQ2d 1481 (Fed. Cir. 2002)
Accused device also has collet assembly to prevent moisture and contamination in filter One-piece block – no front cap and rear insert body Eagle alleged DOE infringement Defendant asserted argument-based estoppel as to location of O-ring seal
Accused Device
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Eagle Comtronics v. Arrow Comm. Labs
64 USPQ2d 1481 (Fed. Cir. 2002)
Federal Circuit
While claim amended, amended-based estoppel not alleged
A filter structure comprising:
» » » » ... a rear insert body including a rear end portion, ... and a region of the housing that surrounds the rear end portion is not covered by sealant material
Court analyzed for argument-based estoppel
Requires “clear and unmistakable surrender of subject matter”
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Eagle Comtronics v. Arrow Comm. Labs
64 USPQ2d 1481 (Fed. Cir. 2002)
Traditional PHE analysis applied to argument
What was given up and why No Festo presumption of surrender
Eagle‟s arguments not based on whether claimed collet was made of separable pieces or integral
Argued prior art did not suggest use of seal at interface between collet assembly and filter housing Did not surrender location of seal elsewhere along interface
Patentee has more leeway with arguments
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Festo II on Remand in CAFC
Supreme Court left rebuttal issues unresolved On remand, CAFC asked parties in Festo II:
Whether rebuttal of presumption of surrender is a question of law for judge or a question of fact for jury
Festo brief, amicus brief by research organizations, argue that rebuttal is factual matter for jury Defendant SMC, majority of amici, relied on Markman in arguing that rebuttal is legal matter for judge
What factors are encompassed by Supreme Court‟s criteria?
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Feb. 6, 2003 En Banc Rehearing
13 Judge panel presided over packed courtroom
Transcript available from BADC
Predictions from exchange of Judges
Rebuttal is mixed Q of fact of law for judge Analogous to other equitable doctrines like inequitable conduct as DOE is equitable PHE is legal limitation on DOE Mixed standard of review Deferential “clear error” for underlying facts De novo for legal issues and interpretations
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En Banc Rehearing Predictions
Minimal discussion on rebuttal factors
Festo argued for “subjective” foreseeability test
Knowledge and intent of inventors and attorneys relevant
SMC argued for “objective” standard
No remand is necessary as language to literally claim was
available » Original claims encompassed accused SMC device
Festo will probably get remand to develop factual record and make arguments before trial court
CAFC Likely to give some guidance short of treatise
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Significant Issues Remain Re Festo Rebuttal Factors
Is foreseeability objective or subjective test?
Knowledge of inventors and attorneys relevant as in Eon Labs.?
What is foreseeability measured against?
Scientifically available data like Excel Pharm. Case?
Result is narrow exception akin to absolute bar
Actual disclosure in patent specification?
Argued by BIO in its amicus brief
What is or should have been disclosed in specification?
Eli Lily argued in its amicus brief that Festo II creates duty
to draft a reasonably complete and enabling specification
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Significant Issues Remain Re Festo Rebuttal Factors
When is foreseeability measured?
At time of application?
» Would capture after-arising technology as equivalents, consistent with current DOE law.
At time of amendment?
» More equivalents likely foreseeable, so less DOE.
Is unforeseeability limited to new technology?
Unexpected uses of known technology?
Should standard be different based on technology?
Combination of strict §112, 1st ¶ law and a scientifically
based foreseeability test eviscerates DOE in bio/chem. fields. ACI's Eighth National Advanced Forum On Litigating Patent Disputes
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Tips/Takeaways
Pre-litigation
Strategies For Patentees
Premium on high quality patent prosecution
Festo policy requires literally claiming Argue/Traverse/Appeal -- Don‟t amend Spend more $/time on prosecution to avoid DOE
Festo DOE analysis during investigation phase
Identify amended claim elements subject to Festo
Is narrowing amendment unexplained or for patentability? Was accused product known before filing of
application/amendment? » Then, DOE protection harder to obtain.
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Tips/Takeaways
Litigation
Strategies For Patentees
Defer DOE until literal resolved to obviate Festo Force Defendant to link amendments to accused product distinctions In Vardon, claim amended exhaustively, but not related to
distinctions with accused product Break claims into small components, limitation by limitation
Be creative Even if foreseeability turns out to be strict, objective test “Tangential” and “Other” factors wide open
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ACI's Eighth National Advanced Forum On Litigating Patent Disputes
Tips/Takeaways
Litigation Strategies For Defendants
ID limitations not literally present to position case for early resolution based upon Festo Can combine Festo into Markman
Avoid improper burden shift
Burden on party seeking to alter plain meaning on literal
construction of claims Burden on patentee under Festo to show narrowing amendment did not surrender equivalent
Consider waiving reliance on presumption If have strong PHE/DOE case, may avoid need for
factual evidence on foreseeability
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ACI’s Eighth National Advanced Forum on Litigating Patent Disputes
Festo In Litigation
What Festo and Its Progeny Mean for Litigation Today . . . and Tomorrow
Richard S. Meyer Morgan, Lewis & Bockius LLP 202.739.5751 rmeyer@morganlewis.com Mary T. Huser Bingham McCutcheon 650.849.4914 mary.huser@bingham.com