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(Cite as: 356 F.3d 1357)
168(2.1)
SMITHKLINE BEECHAM CORP. (doing business as Narrowing amendment made by patent applicant to satisfy any requirement of Patent Act may give rise to estoppel when patentee subsequently asserting infringement under 168(2.1)
Nos. 02-1581, 02-1612, 03-1011.
presumption that patentee surrendered territory betweenoriginal claim and amended claim; such presumption may be rebutted by showing that allegedly infringing equivalent Background: Owner of patent for sustained release version
of brand name anti- depressant drug brought separate infringement actions against manufacturer of generic tangential to purpose of amendment, or that equivalent was version. The United States District Court for the Eastern not foreseeable at time of amendment.
Smith, J., granted summary judgment of noninfringement, and the United States District Court for the District of NewJersey, William H. Walls, J., consequently dismissed.
invention if it recites essential structure or steps, or if it isnecessary to give life, meaning, and vitality to claim.
The Court of Appeals, Rader, Circuit Judge, heldthat fact issue existed as to whether owner was estopped from asserting equivalent infringement.
"New matter doctrine" prevents patent applicant fromadding new subject matter to claims unless specification shows that inventor had support for addition at time of 324.55(5)
168(2.1)
Court of Appeals reviews patent infringement, either literal or by equivalents, as question of fact.
amendment surrendered equivalents by invoking its own failure to include known equivalent in its originaldisclosure.
Prosecution history estoppel, as limit on doctrine ofequivalents, presents question of law.
323.2(3)
Question as to whether sustained release agent used ingeneric version of sustained release antidepressant drug was Addition of named sustained release agent to patent claim known alternative at time drug patentee filed narrowing for sustained release version of antidepressant drug, in order amendment, claiming use of different agent, precluded summary judgment on issue of whether patentee was "narrowing amendment," for purpose of determining estopped from asserting equivalent infringement.
whether patentee was thereafter estopped from assertingequivalent infringement by drug which used different agent.
Copr. West 2004 No Claim to Orig. U.S. Govt. Works (Cite as: 356 F.3d 1357)
methylcellulose (HPMC), which is a partly O-methylatedand preparations, HPMC extends drug release by transforming into a gel that swells upon ingestion. The hydrogel state of of New York, NY, argued for plaintiff-appellant. With him HPMC releases bupropion hydrochloride from an ingested The claims a sustained release tablet containingan admixture of bupropion hydrochloride and HPMC.
However, many of the claims as originally filed did not CA, argued for defendant-appellee. With him on the brief recite HPMC as a limitation. During prosecution on the merits in the United States Patent and Trademark Office (Patent Office), the examiner rejected the claims that did notrecite HPMC for lack of enablement under . Glaxo amended those claims to overcome the rejection.
The exemplary independent claims of the state: Independent claims 15 and 19 mirror claims14 and 18, respectively, but recite 150 mg of On summary judgment, the United States District Court for the Eastern District of Virginia determined that ExcelPharmaceuticals, Inc. and ABC Co. (collectively Excel) did *1360 1. A controlled release tablet comprising 25 to 500
not infringe Smithkline Beecham Corporation's (Glaxo's) mg of bupropion hydrochloride and hydroxypropyl patent on a controlled sustained release formulation of methylcellulose to one part bupropion hydrochloride being 0.19 to 1.1 and said tablet having a surface to Because an issue of material fact remains unresolved, this volume ratio of 3:1 to 25:1 cm -1 and said tablet having a court vacates the judgment of the trial court and remands.
shelf life of at least one year at 59 to 77 F. and 35 to 60%relative humidity, said tablet releasing between about 20 and 60 percent of bupropion hydrochloride in water in 1hour, between about 50 and 90 percent in 4 hours and not less than about 75 percent less in 8 hours.
directed to controlled sustained release tablets containing 14. A controlled sustained release tablet comprising an bupropion hydrochloride. Pharmacologically, bupropion admixture of 100 mg of bupropion hydrochloride and (m-chloro-?-t-butylaminopropiophenone) is a monocyclic administration of a single one of said tablets in adult men produces plasma levels of bupropion as free base ranging treat depression and inebriation. In addition, they facilitate between the minimum and maximum levels as shown in the cessation of smoking by producing neural stimulation in Fig. 5 over twenty four hours.
mammalian systems. See 'col. 1, ll. 5-10; ' 18. A sustained release tablet containing a mixture of (a) col. 1, ll. 29-39; U.S. Patent No. 3,819,706 (issued 100 mg of bupropion hydrochloride and (b) means for June 23, 1974). Due to this action as a stimulant, a spike in releasing between about 25 and 45% of bupropion bupropion concentrations can have the side effect of causing hydrochloride in one hour, between 60 and 85% in 4 hours and not less than 80% in eight hours in distilledwater To avoid the need for multiple dosages with the attendant fluctuations in plasma bupropion concentrations, Glaxo , col. 11, l. 40--col. 12, l. 60 (emphases added).
invented a sustained release formulation of the compound.
While Excel Pharmaceuticals, Inc. is a subsidiary of Alpharma, patented, Glaxo obtained the 'protect its Inc. that licenses generic pharmaceuticals for sale by other sustained release formulation of the drug. Glaxo markets companies. Excel filed two Abbreviated New Drug Applications (ANDAs) with the United States Food and Wellbutrin®SR for treatment of depression and as Zyban® Drug Administration, one proposing a generic substitute for for smoking cessation. The key ingredient for achieving Wellbutrin®SR and the other a generic substitute for sustained release in this invention is hydroxypropyl Copr. West 2004 No Claim to Orig. U.S. Govt. Works (Cite as: 356 F.3d 1357)
Zyban®. In both ANDAs, Excel made a paragraph IV certification that its proposed sustained release bupropion hydrochloride tablets do not infringe Glaxo's ' The sustained release agent in Excel's generic composition literal or by equivalents, as a question of fact. is polyvinyl alcohol (PVA), a hydrogel-forming polymer.
Glaxo, upon receiving notice of Excel's ANDA filings, Prosecution history estoppel as a limit on commenced infringement actions in Virginia and New the doctrine of equivalents presents a question of law. Jersey, alleging infringement of claims 14-15 and 18-19 of the . The Eastern District of Virginia assigned Glaxo's case on the anti-depressant formula to the Norfolk judgment only if the facts and inferences, when viewed in division and assigned the case on the smoking cessation the light most favorable to Glaxo, would not persuade a reasonable jury to return a verdict for Glaxo, the nonmoving.
During litigation, Excel moved for summary judgment ofnoninfringement because its formulation does not contain HPMC. Excel contended that prosecution history estoppelprecludes infringement under the doctrine of equivalents.
Glaxo opposed and filed a cross-motion for an extension of HPMC, a recited claim limitation, is not present in its time to conduct discovery. The district court determined: sustained release bupropion formulation. Instead, Glaxo "When the patentee rewrote the claims to include HPMC, seeks a judgment of infringement under the doctrine of the amendment narrowed the scope of these claims from equivalents. Therefore, infringement depends on whether claiming a generic concept, sustained release of bupropion the prosecution history of the forecloses Glaxo's hydrochloride into the bloodstream, to a 'single species' of reliance on the doctrine of equivalents. Specifically this polymer to accomplish this property: HPMC." court must examine whether Glaxo narrowed claims 14-15 amendment was made to satisfy the requirements of 35 , and, therefore, the amendment was 'made for a reason related to patentability.' " districtcourt therefore granted Excel's motion for summary According to the Supreme Court in Festo, judgment because the ANDA does not literally infringe the narrowing amendment made to satisfy any requirement of and because prosecution history estoppel bars the Patent Act may give rise to an estoppel." Glaxo from invoking the doctrine of equivalents. The same day that the Norfolk division issued its opinion in a narrowing amendment, whether made to avoid prior art or the antidepressant case, the Alexandria division reassigned to comply with § creates a presumption that the its *1361 smoking cessation case to Norfolk. Excel then
patentee surrendered the territory between the original invoked res judicata in its motion for summary judgment in the smoking cessation case. The trial court also granted that The patentee may rebut that presumption by showing that motion. Likewise, the presiding judge in the District of New the alleged equivalent could not reasonably have been Jersey dismissed that case sua sponte due to the res judicata described at the time the amendment was made, or that the effect of the summary judgment in the identical Virginia alleged equivalent was tangential to the purpose of the amendment, or that the equivalent was not foreseeable (andthus not claimable) at the time of the amendment. Id. Glaxo timely appealed these judgments to this court, which consolidated these appeals into this single appeal. Glaxo acknowledged and applied these rebutting criteria. argues the district court erred in granting summary judgment to Excel, because PVA is an equivalent to HPMC which Glaxo did not surrender during prosecution of the'798 claims. This court has exclusive jurisdiction under Glaxo amended claims 14-15 and 18-19 of the to recite HPMC. Glaxo's application did not disclose any othersustained release mechanism. Therefore, Glaxo's disclosure of HPMC alone could not support a broad generic claim toother sustained release mechanisms. Nonetheless Glaxo This court reviews summary judgment without contends that this amendment *1362 did not surrender other
deference, drawing all reasonable factual inferences in favor hydrogels equivalent to HPMC. Rather, Glaxo contends that Copr. West 2004 No Claim to Orig. U.S. Govt. Works (Cite as: 356 F.3d 1357)
it only added HPMC to the claims to distinguish the it was added while a completely unrelated limitation was sustained release agent in its invention from other disclosed (affirming thedistrict court's finding that prosecution history estoppel The examiner rejected originally filed claims 14-15 and barred the application of the doctrine of equivalents), application claimed controlled sustained release tablets with particular plasma concentration profiles over twenty-fourhours and specific bupropion release rates. The application, To the contrary, the examiner explained that the original however, did not recite the release mechanism responsible claims broadly embraced a genus of sustained release for these profiles. The disclosed rate of release, according to compounds. Because the claims did not enable use of that the examiner, distinguished the claimed "unique tablet" broader genus, the examiner required an amendment. The from instant release tablets known in the art. The examiner "sustained release tablet" phrase recited in the preamble stated that bupropion's rate of release is "directly related to gives life and meaning to the claims, because sustained release is an essential*1363 feature of the invention.
Generally, "a preamble limits the [claimed] invention if it considered the recitation of HPMC "critical" for the recites essential structure or steps, or if it is 'necessary to controlled or sustained release aspect of the claims. The give life, meaning, and vitality' to the claim." examiner also noted that the application's disclosure of a single species (HPMC) does not support claims to a Thus, the amendment did not simply replace the shelf life limitation with an entirely new HPMClimitation. Rather, the amendment limited the sustained The examiner did not require the recitation of HPMC to release feature to HPMC, thereby narrowing the claims. The distinguish the claims from other disclosed excipients.
elimination of the shelf life limitation did not affect the Those excipients had no bearing on the patentability of the question of equivalents and the question of whether the claimed sustained release tablets over conventional instant claims embrace sustained release agents beyond HPMC.
release tablets. Rather, the examiner required Glaxo torestrict the claims to a particular controlled drug release agent, i.e., HPMC. The claims as originally writtenembraced all controlled sustained release tablets comprising In its decision, the Supreme Court explained that not bupropion hydrochloride. The application did not enable all narrowing amendments surrender subject matter that the any sustained release agents other than HPMC, however, doctrine of equivalents cannot later recapture. The Court because it only disclosed HPMC's time release and plasma profiles. Indeed the original claims recited those profiles.
The equivalent may have been unforeseeable at the time The examiner expressly stated that only HPMC enabled claims with these profiles. The application did not enable amendment may bear no more than a tangential relation to one of skill in the art to make and use a broader genus of the equivalent in question; or there may be some other sustained release agents. Thus, the examiner's enablement reason suggesting that the patentee could not reasonably argument, which Glaxo did not rebut, shows that Glaxo be expected to have described the insubstantial substitute surrendered other controlled sustained release agents known in question. In those cases the patentee can overcome the presumption that prosecution history estoppel bars a ("A rejection indicates that the patent examiner does not believe the original claim could be patented. While the patentee has the right to appeal, his decision to forgo anappeal and submit an amended claim is taken as a This court recently gave more guidance on factors concession that the invention as patented does not reach as This criterion presents an objective inquiry, askingwhether Glaxo also contends that claims 14-15 were not narrowed unforeseeable to one of ordinary skill in the art at the time upon amendment because the amendment consisted of of the amendment. Usually, if the alleged equivalent removing the originally recited "shelf life" limitation and represents later-developed technology (e.g., transistors in replacing it with the sustained release HPMC limitation.
relation to vacuum tubes, or Velcro® in relation to Glaxo, relying on that while the "overall fasteners) or technology that was not known in the scope" of these claims was "surely narrowed," the HPMC relevant art, then it would not have been foreseeable. In limitation itself was never narrowed by amendment because contrast, old technology, while not always foreseeable, Copr. West 2004 No Claim to Orig. U.S. Govt. Works (Cite as: 356 F.3d 1357)
would more likely have been foreseeable. Indeed, if the equivalent at the time of amendment. The Supreme Court's alleged equivalent were known in the prior art in the field passage addresses the time of amendment only and does not of the invention, it certainly should have been foreseeable address the instance where the applicant could not properly at the time of the amendment. By its very nature, claim a known equivalent because it had purposely left that objective unforeseeability depends on underlying factual known substitute out of its disclosure at the time of filing. In issues relating to, for example, the state of the art and the such an instance, the applicant should have foreseen and understanding of a hypothetical person of ordinary skill in included the proposed equivalent in its claims at the time of the art at the time of the amendment. Therefore, in filing. The Supreme Court states clearly in determining whether an alleged equivalent would have patentee, as the author of the claim language, may be been unforeseeable, a district court may hear expert expected to draft claims encompassing readily known testimony and consider other extrinsic evidence relating Court excuses an applicant from failure to claim a proposed equivalent in the event "[t]he equivalent may have beenunforeseeable at the time of application," id., as this In this case, Glaxo could not have added PVA as an court has explained, at the time of the amendment. amendment in 1994 without drawing a new matter rejection; Glaxo had not recited in its application any reference to amendment was made . is the relevant time for evaluating PVA or other sustained release agents beyond HPMC.
unforeseeability, for that is when the patentee presumptively Glaxo also notes that the Supreme Court emphasized an surrendered the subject matter in question and it is at that applicant's ability to claim an alleged equivalent as a time that foreseeability is relevant."). In any event, read in hallmark of the unforeseeability excuse: "The patentee must show that at the time of the amendment one skilled in the art applicant from failing to claim "readily known equivalents" could not reasonably be expected to have drafted a claim at the time of application nor allows a patentee to rebut the presumption by invoking its own failure to include a known equivalent in its original disclosure. Instead, the Because it could not have added PVA to its claims at the critical inquiry is whether Glaxo could have foreseen time of amendment (without drawing a new matter sustained release agents for bupropion other than HPMC at rejection), Glaxo contends that it has on that basis alone sufficiently rebutted *1364 the and
justified its invocation of the doctrine of equivalents. For
several reasons, Glaxo is incorrect.
equivalent at the time of the amendment but not atthe time of the application, Glaxo could have filed In the first place, new matter prohibitions are not a continuation-in-part application to disclose and directly germane to the doctrine of equivalents or the claim the additional subject matter.
patentee's proof to overcome the Thenew matter doctrine prevents an applicant from adding new On this point, the record shows that at the time the subject matter to the claims unless the specification shows amendments were made, no known hydrogels other than that the inventor had support for the addition at the time of HPMC had been tested with bupropion hydrochloride to achieve sustained release. Thus, with respect to bupropion alone, a portion of the record might suggest that PVA was doctrine ensures the temporal integrity of the amendment not a known sustained release agent at the time of the process in the Patent Office and does not apply to amendment. PVA later proved to work as a sustained release agent for bupropion, suggesting a undeniable ground for unforeseeability, namely that PVA perhaps may qualify as a later- *1365 developed technology. Because the parties
developed this record before the Supreme Court's equivalent, after-arising technology, would always be opinion with its doctrines for rebuttal of the presumption, unclaimable new matter. In that sense, the doctrine of this court cannot ascertain whether Glaxo should have equivalents compensates for the patentee's inability to claim foreseen PVA as a sustained release agent for bupropion and included it within its literal claims.
Glaxo also removes the Supreme Court's passage in This undeveloped record simply does not show whether from its proper context. The Supreme Court ties ordinarily skilled artisans in this field at this time had foreseeability to whether the applicant would have been verifiable scientific reasons to regard PVA as a foreseeable expected to know of, and thus properly claim, the proposed and claimable sustained release compound for bupropion or Copr. West 2004 No Claim to Orig. U.S. Govt. Works (Cite as: 356 F.3d 1357)
similar formulations. Glaxo relies on the declaration of its expert, Dr. Lowman, to support its contention that PVA and Each party shall bear its own costs.
HPMC are functional equivalents in retarding the release ofbupropion hydrochloride from an ingested tablet. However, the record does not disclose whether HPMC and PVA wererecognized pharmaceutical formulation at the time the claims were amended. On this incomplete record, this court cannotdiscern whether the prior art disclosed PVA as an alternativeto HPMC as a sustained release agent so that Glaxo couldrationally foresee that a competitor might substitute PVAfor HPMC in designing around the amended 'claims or whether PVA was not a foreseeable sustainedrelease agent for bupropion or similar formulations.
In Glaxo Wellcome, Inc. v. Impax Laboratories, Inc., No.
03-1013, a companion case issued today, this courtdiscredited a foreseeability rebuttal for HPC in this exactfield compound's use as a release agent at the relevant time. Incontrast, this record for PVA does not permit a similarfinding. Because foreseeability "depends on underlyingfactual issues," this courtremands to facilitate development of the record on this keypoint. On remand, the trial court may inquire into thespecific use of PVA in the prior art of sustained drug releasecompositions to ascertain whether artisans of ordinary skillin this art would have foreseen the potential substitution ofPVA for HPMC at the time the 'wereamended.
Record evidence shows that Glaxo narrowed the scope ofclaims 14-15 and 18-19 by amendment during prosecutionof the to recite the critical term HPMC. Thereason for making these narrowing amendments was toovercome a rejection for lack of enablement because theclaims improperly embraced a genus of sustained releaseagents. However, the present record does not address theforeseeability of PVA at the time of the narrowingamendment. Thus, this record does not address whetherGlaxo equivalents. Upon remand, the trial court may addresswhether PVA constitutes a foreseeable sustained releaseagent or an unforeseeable technology. Because a materialissue of fact remains to be resolved, Excel was not entitledto summary judgment of noninfringement as a matter oflaw.
The district court's grant of summary judgment ofnoninfringement to Excel is vacated, and the case isremanded for further adjudication on the merits.
Copr. West 2004 No Claim to Orig. U.S. Govt. Works

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