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Doctrine of Equivalents Analysis Should Not Be Simple Binary Comparison

The US Court of Appeals for the Federal Circuit remanded a district court’s claim construction and grant of a defendant’s summary judgment motion of non-infringement under the doctrine of equivalents, finding that a reasonable juror could find that the accused products performed substantially the same function in substantially the same way to achieve substantially the same result as the claimed invention. Edgewell Personal Care Brands, LLC v. Munchkin, Inc., Case No. 20-1203 (Fed. Cir. Mar. 9, 2021) (Moore, J.)

Edgewell manufactures and sells the “Diaper Genie,” a diaper pail system with a replaceable cassette placed inside the pail for soiled diaper collection, forming a wrapper around the diapers. Munchkin marketed a refill cassette as compatible with Edgewell’s pails. Edgewell’s two patents at issue relate to improvements in the cassette. After claim construction, Edgewell asserted literal infringement of one patent and infringement under the doctrine of equivalents of the other patent. The district court granted Munchkin’s summary judgment motion of non-infringement against both patents. Edgewell appealed.

Edgewell’s first patent is directed to a cassette with a clearance at its bottom portion. The claim construction dispute turned on whether the claims required a clearance space after the cassette was installed. The district court construed the claim to require a space and to require that the claimed “clearance” cannot be filled by an unclaimed interfering member. The district court granted Munchkin summary judgment because Munchkin’s refill cassette had no space after the cassette was installed. The Federal Circuit reversed, explaining that an “apparatus claim is generally to be construed according to what the apparatus is, not what the apparatus does.” The Court found that without an express limitation, “clearance” should be construed to cover all uses of the claimed cassette. The Court determined that the specification and purpose of the “clearance” supported the notion that the claim does not require a clearance after insertion.

The second patent is directed to a cassette with a cover that includes a “tear-off” section. The district court’s construction of an annular cover was of a single, ring-shaped cover. Munchkin’s cassettes each include a two-part cover, and the district court granted Munchkin’s motion for summary judgment of non-infringement. Although the Federal Circuit agreed with the claim constructions, the Court found that the district court erred in granting summary judgment to Munchkin under the doctrine of equivalents for claim element vitiation on the basis that “annular cover” and “tear-off” limitations §§would be rendered meaningless.

The vitiation doctrine ensures that applying the doctrine of equivalents “does not effectively eliminate a claim element in its entirety.” The Federal Circuit found that the district court erred in evaluating this element as a binary choice—single-component structure versus a multi-component structure. Instead, the Court explained that the district court should have evaluated the evidence to determine whether a reasonable juror could find that the accused products perform substantially the same function, in substantially the same way, achieving substantially the same result as the corresponding claim elements. Edgewell’s expert opined that Munchkin’s products performed the [...]

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Knowledge of Patent, Evidence of Infringement Are Necessary, but Not Sufficient, to Establish Willfulness

Addressing claim construction, enablement, damages and willfulness, the US Court of Appeals for the Federal Circuit found that evidence of a defendant’s knowledge of the asserted patent and proof of infringement were, by themselves, legally insufficient to support a finding of willfulness. Bayer Healthcare LLC v. Baxalta Inc., Case No. 19-2418 (Fed. Cir. Mar. 1, 2021) (Stoll, J.)

Bayer owns a patent on certain recombinant forms of human factor VII (FVIII), a protein that is critical for blood coagulation. Recombinant FVIII is useful as a treatment for coagulation disorders, primarily Hemophilia A. Natural FVIII has a short half-life, making therapeutic administration expensive and inconvenient. Adding polyethylene glycol (a process known as PEGylating) to FVIII at random sites was found to increase the protein’s half-life but reduce its function. Bayer invented FVIII that is PEGylated in a specific region (the B-domain) so that it retains its function and maintains the longer half-life.

After Baxalta developed a PEGylated FVIII therapeutic, Adynovate®, Bayer sued Baxalta for infringement of its patent. During claim construction, the district court construed the claim preamble “an isolated polypeptide conjugate” to mean “a polypeptide conjugate where conjugation was not random,” finding that Bayer had disclaimed conjugates with random PEGylation. The district court also construed “at the B-domain” to mean “attachment at the B-domain such that the resulting conjugate retains functional FVIII activity,” rejecting Baxalta’s proposal of “at a site that is not any amine or carboxy site in FVIII and is in the B-domain” because Bayer had not disclaimed PEGylation at amine or carboxy sites. Before trial, Baxalta moved for clarification of the term “random” in the construction of the preamble, but the district court “again” rejected Baxalta’s argument that Bayer defined “random” conjugation as “any conjugation at amines or carboxy sites.”

Before trial, Baxalta moved to exclude the testimony of Bayer’s damages expert regarding his proposed reasonable-royalty rate. The expert had defined a bargaining range and proposed to testify that the royalty rate should be the midpoint of the range based on the Nash Bargaining Solution. The district court permitted the expert to testify as to the bargaining range but excluded the opinions regarding the midpoint as insufficiently tied to the facts of the case.

After trial, the district court granted Baxalta’s pre-verdict motion for judgment as a matter of law (JMOL) of no willful infringement. Subsequently, the jury returned a verdict that the claims were infringed and not invalid for non-enablement, and awarded damages based on an approximately 18% royalty rate for the period for which the parties had presented sales information. Baxalta moved for JMOL or a new trial on infringement, enablement and damages. Bayer moved for pre-verdict supplemental damages for the period between the presented sales data and the date of judgment, and for a new trial on the issue of willfulness. The district court denied all of Baxalta’s motions and Bayer’s motion for new trial, but granted Bayer’s motion for supplemental damages, applying the jury’s ~18% rate to sales data for the later period. [...]

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Corresponding Structure Necessary to Support ‘Module’ Claim Element

In determining whether a claim element invoked 35 USC § 112, ¶ 6, the US Court of Appeals for the Federal Circuit concluded that “module” was a nonce term and required sufficient corresponding structure in the patent specification to avoid indefiniteness under 35 USC § 112, ¶ 2. Rain Computing, Inc. v. Samsung Electronics Co., Ltd., Case Nos. 20-1646, -1656 (Fed. Cir. Mar. 2, 2021) (Moore, J.)

Rain sued Samsung for infringement of a patent directed to a method for delivering software application packages to user terminals over a network. The claims at issue included an element that recited a “user identification module configured to control access [to] software application packages.” The district court determined that the “user identification module” was a means-plus-function term subject to 35 USC § 112, ¶ 6, but that the specification disclosed sufficient corresponding structure such that the term was not indefinite. Rain appealed the judgment of non-infringement.

Reviewing de novo, the Federal Circuit first addressed whether the claim language invoked § 112, ¶ 6. While there is a rebuttable presumption that ¶ 6 does not apply to claims lacking “means” language, the Court noted that “module” does not provide any indication of structure and is a well-known substitute for “means.” No other claim language, including the “user identification” prefix, imparted any structure onto the term. For purposes of claim construction, the specification also did not impart any structure to the claimed user identification module. Rain argued that amendments and examiner arguments during prosecution were proof of sufficient structure, and that, as the examiner noted, a means-plus-function term cannot be nested within a method claim. The Federal Circuit disagreed, noting that the examiner’s statement that a means-plus-function claim element cannot be nested within a method step was simply incorrect as a matter of law. Thus the Court found that “user identification module” was a means-plus-function claim term.

Citing to its 2015 en banc ruling in Williamson v. Citrix Online, the Court turned to the term’s construction under §112, ¶ 6, applying the same two-step process it used just a few weeks earlier in Synchronoss Technologies v. Dropbox. In the first step, the Court simply used the district court’s undisputed finding that the function was “to control access to . . . software packages to which the user has a subscription.” In the second step, the Court attempted to identify corresponding structure in the specification. Here the Court noted that structure in a specification corresponds only if there is a clear link or association, and that the specification must also disclose an actual algorithm when the function is performed by a general-purpose computer.

The Federal Circuit concluded that the district court erred in finding that the disclosure of a storage device provided sufficient structure, explaining that such devices are nothing more than general purpose computers not capable of performing the access control function without specialized software—an algorithm. Rain’s patent specification disclosed no such algorithm, without which the “user identification module” lacked sufficient structure. Thus [...]

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Impossible; Cloud Storage Patent Claims Invalid for Indefiniteness or Not Infringed

The US Court of Appeals for the Federal Circuit affirmed a district court’s determination that three patents directed to data synchronization were indefinite as lacking sufficient disclosed structure to support a means plus function claim element, as impossible in terms of claim scope or not infringed. Synchronoss Technologies, Inc. v. Dropbox. Inc., Case Nos. 19-2196, -2199 (Fed. Cir. Feb. 12, 2021) (Reyna, J.)

Synchronoss filed suit against Dropbox for infringement of three patents relating to synchronizing data across multiple devices connected via internet, a synchronization agent management server, and transferring media data to a network coupled device. As to the first patent, the district court found that Dropbox did not infringe because the claims, as construed, required hardware, whereas Dropbox’s accused product existed entirely in software. The district court then found that all of the claims of the second patent were invalid as indefinite under § 112, paragraph 6, since various claim terms, including “user identifier module,” did not correspond to adequate structure in the specification. Finally, the district court found that the third patent was invalid under § 112 for including within its scope an impossibility, namely, “generating a [single] media file” that “compris[es] a directory of digital media files.” Synchronoss appealed all three findings.

The Federal Circuit first addressed the claim that the district court found to include impossible scope. The Court agreed with the district court, noting that Synchronoss’s expert admitted that it was impossible for a media file to contain a directory of media files. The Court rejected Synchronoss’s argument that a person of ordinary skill in the art would understand that the invention actually meant something different, and noted that Synchronoss’s proposal would result in re-writing the claims to preserve their validity.

The Federal Circuit next addressed the claim including the means plus function element found to contain terms lacking adequate structure antecedent in the specification. The Court applied a two-step process to construe the “user identifier module” term, first identifying the claimed function and then determining whether the specification disclosed sufficient structure for performing the claimed function. Adopting Synchronoss’s position that the claimed function was “identifying a user,” the Court found that the specification did not disclose sufficient structure corresponding to the claimed user identifier module. The Court noted that although Dropbox’s expert identified more than 20 different possible structures that could perform the claimed function, “it is not enough that a means-plus-function claim term correspond to every known way of achieving the claimed function; instead, the term must correspond to ‘adequate’ structure disclosed in the specification such that a person of ordinary skill in the art would be able to recognize and associate the structure with the claimed function.”

Finally, the Federal Circuit addressed the district court’s finding of non-infringement. At the district court, Synchronoss proposed a construction of the claim term “device” to include “software . . . residing on . . . hardware” and conceded that its claims could not cover “software completely detached from hardware.” The Court concluded that the [...]

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Stick to the Fax: Conflicting Statements Made During Prosecution Lead to Indefiniteness

In deciding whether use of the term “passive link” to define a connection between a computer terminal and a fax machine rendered a patent claim indefinite, the US Court of Appeals for the Federal Circuit affirmed the district court’s finding of invalidity based on conflicting statements made by the patent owner during prosecution. Infinity Computer Products, Inc. v. Oki Data Americas, Inc., Case No. 20-1189 (Fed. Cir. Feb. 10, 2021) (Prost, C.J.)

Infinity owns a patent directed to providing a circuit for interfacing a personal computer with a facsimile machine to enable the facsimile to be used as a scanner or a printer for a personal computer. The patent seeks to accomplish all of the objectives of a scanner or a printer in a simple, straightforward manner through the use of a circuit of highly simplified design and low cost. The patent claims recite that this functionality is accomplished “through a bi-directional direct connection via a passive link between the facsimile machine and the computer.” Infinity asserted the patent against Oki in district court.

The term “passive link” does not appear in the patent specification. Infinity introduced this term during prosecution to overcome rejections based on a prior art patent to Perkins. During prosecution, Infinity unsuccessfully argued that unlike Perkins, the claimed invention permits uninterrupted transfer of signals between the facsimile and the computer without the use of intervening circuitry. Infinity engaged in multiple rounds of amendment and response with the examiner before finally overcoming the rejections based on Perkins by arguing that the invention “creates a passive link between the facsimile machine and the computer [and] therefore does not require any intervening apparatus as does Perkins.” Perkins used a modem, characterized by Infinity as the “intervening apparatus,” internal to the computer. Infinity argued that the modem “should be regarded as a peripheral device to the computer which processes data before it is transmitted to the I/O bus of the computer,” effectively drawing the boundary of the “passive link” at the I/O bus of the computer.

After allowance, the patent was the subject of three ex parte re-examination proceedings. The patent was a continuation-in-part of a parent application, and in order to overcome a prior art reference asserted in the re-examination proceeding, Infinity argued that the claimed “passive link” element was entitled to the priority date of an earlier parent application. Infinity specifically noted that the patent’s description of “the RJ11 telephone cable and use thereof in communicating data between the fax machine 30 and the PC computer 40 meets the definition of ‘passive link.'” In doing so, Infinity pointed to certain figures in the parent application specification that disclosed fax modem circuitry internal to the computer, effectively drawing the boundary of the “passive link” at the computer’s external port—before the I/O bus.

The district court found that there was a discrepancy on the boundary of the “passive link” because during prosecution it was defined as at the I/O bus of the computer, but during the ex parte re-examination it [...]

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PTO: Board to Align Indefiniteness Approach in AIA and District Court Proceedings

On January 6, 2021, US Patent and Trademark Office (PTO) Director Andrei Iancu, Commissioner for Patents Andrew Hirshfeld and Chief Administrative Patent Judge Scott Boalick issued a memorandum to the members of the Patent Trial and Appeal Board to align the Board’s approach when deciding indefiniteness issues under 35 USC § 112 in America Invents Act (AIA) post-grant proceedings more closely with district court proceedings. The memo was issued under the PTO director’s authority to set forth binding agency guidance to govern the Board’s interpretation of statutory provisions. The memo cited to similar recent changes to the approach to claim construction in such proceedings, and stated that aligning “the indefiniteness approach [used] in AIA post-grant proceedings [to district court proceedings] will promote consistency and efficient decision making among coordinate branches of government that decide similar issues in co-pending proceedings.” The instructed approach, per the Supreme Court of the United States’ 2014 decision in Nautilus, applies to post grant review (PGR) and inter partes review (IPR) proceedings, but not to indefiniteness (or claim construction) issues decided outside the context of AIA reviews.

Post-AIA 35 USC § 112(b) (and pre-AIA § 112, second paragraph) require that “[t]he specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.” Claims not meeting this requirement are invalid for indefiniteness and may be determined indefinite during PTO examination, on appeal from examination and during AIA post-grant proceedings. In 2014 the US Court of Appeals for the Federal Circuit approved the PTO’s long-standing approach to assessing indefiniteness during patent prosecution in its per curiam In re Packard decision that “[a] claim is indefinite when it contains words or phrases whose meaning is unclear.” At the time, this approach was used agency-wide to analyze questions of indefiniteness, in complement with the office’s broadest reasonable interpretation approach to claim construction.

Despite the Supreme Court’s decision in Nautilus that a claim is unpatentable for indefiniteness if the claim, read in light of the specification delineating the patent and the prosecution history, fails to inform, with reasonable certainty, those skilled in the art about the scope of the invention, the PTO reaffirmed its intent to follow Packard in examination (whether original, appeals or reexamination). In 2018, in the interest of consistency and efficiency, the PTO changed its claim construction standard for post-grant trial proceedings to review a claim of a patent, or a claim proposed in a motion to amend, from the broadest reasonable interpretation to the same Phillips standard that would be used to construe the claim in a district court action.

The memorandum noted that there has been some confusion as to whether the Packard or Nautilus standard should apply in AIA proceedings. While parties to such proceedings argued for one or the other, neither the Board nor the Federal Circuit ruled as to which standard applied. Now, in the interest of clarity, consistency and efficiency, and to “lead to greater [...]

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Apportionment Unnecessary When Royalty Is Based on Comparable License

Rejecting a defendant’s request for a new trial on a variety of grounds, the US Court of Appeals for the Federal Circuit affirmed a damages award and explained that apportionment was unnecessary because a sufficiently comparable license was used to determine the appropriate royalty. Vectura Ltd. v. GlaxoSmithKline LLC et al., Case No. 20-1054 (Fed. Cir. Nov. 19, 2020) (Prost, C.J.)

Vectura owns a patent directed to the production of composite active particles for use in pulmonary administration, such as in dry-powder inhalers. Vectura filed a lawsuit against GlaxoSmithKline (GSK) alleging infringement of the patent by GSK’s Ellipta-brand inhalers. At trial, a jury found the patent valid and infringed, and awarded $90 million in damages. After GSK’s motion for judgment as a matter of law (JMOL) on infringement was denied, GSK appealed.

The Federal Circuit affirmed, rejecting all of GSK’s arguments. The Court rejected GSK’s argument that, based on a claim construction issue, it was entitled to JMOL of non-infringement. The asserted claims of the patent related to “composite active particles” made up of particulate additive material (magnesium stearate) on the surface of a particle of active material, used to promote the dispersion of these particles (in, e.g., inhalers). GSK argued that there was no substantial evidence of improved dispersion because Vectura’s scientific test was technically defective. The Court concluded that this test “generally supported” Vectura’s view and that, in any event, Vectura had provided other evidence—including GSK’s own documents—that the accused inhalers demonstrated improved dispersion.

The Federal Circuit also rejected GSK’s argument that the district court had erroneously construed the claim term “composite active particles” to mean “[a] single particulate entit[y/ies] made up of a particle of active material to which one or more particles of additive material are fixed such that the active and additive particles do not separate in the airstream.” GSK argued that this term required use of the “high energy milling” process referred to in the specification of the patent, but the Federal Circuit disagreed, stating that “[a]lthough the [asserted] patent contains a few statements suggesting that its high-energy milling is required . . . those statements are outweighed by the numerous statements indicating that high-energy milling is merely a preferred process.”

The Federal Circuit further rejected GSK’s argument that Vectura’s damages theory was deficient. Vectura’s damages theory was based on a 2010 license between the parties relating to highly comparable technology. GSK argued that Vectura’s damages theory simply adopted the royalty rate from this prior license wholesale and failed to “show that the patented . . . mixtures drove consumer demand for the accused inhalers before presenting a damages theory based on the entire market value of the accused inhalers.” The Court noted that the case presented a “rather unusual circumstance” in that, while apportionment is ordinarily required where an entire-market-value royalty base is inappropriate, “when a sufficiently comparable license is used as the basis for determining the appropriate royalty, further apportionment may not necessarily be required.” The Court concluded that this was “one [...]

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“Gradual” and “Continuous” Includes Step-Wise

The US Court of Appeals for the Federal Circuit affirmed a priority decision in favor of the senior party, upholding a claim construction that was based upon a verbatim definition set forth in the patent specification of the application from which the count in interference was copied. Chevron U.S.A. Inc. v. University of Wyoming Research Corp., Case No. 19-1530 (Fed. Cir. Nov. 4, 2020) (Schall, J.) (Newman, J., dissenting).

Wyoming Research provoked a patent interference proceeding by copying into its pending application a claim from Chevron’s pending patent application. Under the now-discontinued interference statute, the patent for an invention claimed by more than one party was awarded to the first-to-invent party. If the Patent Trial and Appeal Board (Board)determined there was an interference in fact—that is, two patent applications claimed the same subject matter—then the Board could proceed to determine priority of inventorship. A finding of interference in fact required the copying party’s patent specification to contain adequate written description and enablement to support the copied claim.

The copied claim was directed to a method of fractioning asphaltenes from crude oil. The technology used a mobile phase into which an alkane solvent was introduced and its concentration “gradually and continuously” changed over time, and the resulting eluted fractions were analyzed. The disputed claim limitation was: “gradually and continuously changing the alkane mobile phase solvent to a final mobile phase solvent.”

Chevron argued that “gradually and continuously changing” referred to the act of feeding alkane mobile phase solvent into the inlet of the column. Relying on intrinsic evidence, the Board instead adopted Wyoming’s construction, concluding that the limitation’s “gradually and continuously changing” referred to the change of solvents in the column and not to changes at the inlet to the column. The distinction was important because at the inlet, the Wyoming invention introduced solvent in a step-wise manner. The parties agreed that Wyoming’s specification supported only the construction adopted by Board, and Wyoming was declared to be the senior party for the priority contest.

Because Chevron had filed a priority statement that indicated that its earliest corroborated conception coupled with diligence date was later than Wyoming’s priority date, the Board determined that Chevron was unable to prevail on priority and entered judgment in favor of Wyoming. Chevron appealed.

On appeal, Chevron argued that the Board’s construction was inconsistent with Chevron’s patent specification. Chevron contended that its application disclosed that the solvent was “gradually and continuously” changed at the column’s inlet and that the Board’s construction rendered the limitation meaningless because it encompassed even “sudden, abrupt immediate solvent switches.”

The Court affirmed the Board’s construction, holding that the broadest reasonable construction of “gradually and continuously changing” did not require a change of solvents at the column inlet. The Court reasoned that the Board’s construction was consistent, and indeed tracked verbatim, with the Chevron application’s express definition of “gradually.” While the Court acknowledged that certain examples in the Chevron application illustrated that one way to implement a “gradual and continuous change” of the [...]

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Size Matters in Obviousness Analysis

The US Court of Appeals for the Federal Circuit affirmed in part and reversed in part two Patent Trial and Appeal Board (Board) decisions, finding that the Board erred in its construction of certain claim terms relating to an artificial heart valve that does not require removal of the damaged native heart valve. St. Jude Medical, LLC v. Snyders Heart Valve LLC, Case Nos. 19-2108, -2109, -2140 (Fed. Cir. Oct. 15, 2020) (Taranto, J.).

St. Jude filed two petitions for inter partes review (IPR) of a patent for an artificial heart valve and a system for inserting the valve. Both petitions were instituted by the Board and resulted in final written decisions. In the first decision, the Board found that St. Jude failed to establish unpatentability of the challenged claims, rejecting St. Jude’s contention that all challenged claims were anticipated by and obvious over the Leonhardt prior art reference. In the second decision, the Board found that certain claims were anticipated by the Bessler prior art reference, but rejected St. Jude’s contentions as to all other claims. St. Jude appealed, arguing that the Board erred in the first decision by erroneously construing the term “band” and erred in the second decision by finding that St. Jude failed to prove that a skilled artisan would have made a particular combination of Bessler and the Johnson prior art. Snyders cross-appealed in the second decision as to the claims the Board found were anticipated by Bessler.

The Federal Circuit affirmed the Board’s conclusions in the first decision, finding that not only was the Board’s construction of the term “band” proper, but that it was actually broader than St. Jude’s proposed construction—and that St. Jude expressly accepted the Board’s construction. The Board construed the heart valve band to mean “a structure generally in the shape of a closed strip or ring” (replacing St. Jude’s “circular” with “closed”). In the prior art, Leonhardt discloses a graft material which extends the length of the entire structure. The Federal Circuit agreed with the Board’s finding that Leonhardt’s graft material was “like a sleeve” as opposed to “a closed strip or ring.” St. Jude argued that an ordinary skilled artisan’s understanding of the term “band” does not include a length restriction, that a Leonhardt’s material was just a long band, and that the Board effectively changed its construction of the term. The Federal Circuit, however, was not persuaded by St. Jude’s unlimited-length definition of “band,” instead turning to dictionary definitions that included terms like “thin” and “narrow,” and looking to the patent specification that did not explicitly disclaim any length restrictions. The Court ultimately rejected St. Jude’s arguments, finding that St. Jude should have proposed a claim construction that precluded any limitations on length if it wished to argue such. The Federal Circuit affirmed the Board’s findings as to first decision.

The Federal Circuit next addressed Snyder’s cross-appeal. Snyder disputed the board’s construction of the “size[] and shape[]” of a frame that the patent requires must be inserted [...]

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Only Human: Broadest Reasonable Interpretation Standard Applies to Intentionally Expired Patent

Affirming an invalidity finding by the Patent and Trial Appeal Board (PTAB), the US Court of Appeals for the Federal Circuit found that the claims of the now-expired patent should be construed under the broadest reasonable interpretation (BRI) standard, and not under the Phillips standard, because the patent owner intentionally gave up the remainder of the patent term only after the appeal was fully briefed. Immunex Corp. v. Sanofi-Aventis U.S. LLC, Case Nos. 19-1749, -1777 (Fed. Cir. Oct. 13, 2020) (Prost, C.J.).

Immunex owns a patent directed to human antibodies that inhabit certain receptors to treat inflammatory diseases such as arthritis. After being sued for infringement, Sanofi and Regeneron (collectively, Sanofi) requested inter partes review (IPR) of the patent, which the PTAB instituted. Based on the IPR filing date and because the patent was unexpired during the pendency of the IPR proceeding, the PTAB used the BRI standard to construe various claim terms. Had the patent been expired, the PTAB would have used the more stringent Phillips standard to construe the claims. Ultimately, the PTAB found all of the challenged claims unpatentable. Immunex appealed.

After appellate briefing was complete, Immunex filed a terminal disclaimer of its patent. The US Patent and Trademark Office accepted the terminal disclaimer, and as a result the patent term expired approximately two months before oral argument. Immunex then filed a citation of supplemental authority informing the Federal Circuit of the terminal disclaimer and asking the Court to change the applicable claim construction standard from BRI to Phillips.

The Federal Circuit found that the application of the BRI standard to Immunex’s patent was appropriate. Although the PTAB currently applies the Phillips claim construction standard in all newly filed IPRs, at the time that Sanofi filed its IPRs, the PTAB applied the Phillips standard only to expired patents. For unexpired patents, it applied the BRI standard. The Court noted that the use of the Phillips standard in cases where the patent expired during the appellate process should not be an absolute, particularly when the patent term expired at an unexpected early date, such as through the filing of a terminal disclaimer.

The Federal Circuit further affirmed the PTAB’s claim construction under the BRI standard and the invalidity finding predicated on that claim construction. The issue on appeal was whether a “human antibody” must be entirely human (as asserted by Immunex) or whether it may also be “partially human,” including “humanized” (as asserted by Sanofi and construed by the PTAB). The Court agreed with the PTAB and found that the patent’s specification supported the conclusion that the BRI of “human antibody” “includes both fully human and partially human antibodies.” The Court also found that “human antibodies” in the context of the patent-in-suit is a broad category that encompasses both partially and completely human antibodies. The Court therefore affirmed the PTAB’s finding.

The Federal Circuit also commented on the PTAB’s departure from an earlier claim construction ruling by a district court in which “human” was construed to mean “fully [...]

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