anticipation Archives

anticipation

Not even a thread left: Single reference anticipation, missing claim limitation entitle defendant to JMOL

by Tyler Jackson | Aug 6, 2026 | Patents

The US Court of Appeals for the Federal Circuit reversed a judgment of infringement, concluding that the asserted patent claims were anticipated by a single prior art reference and that the accused products did not satisfy a limitation under the district court’s claim construction. As a result, the Court concluded that the defendant was entitled to judgment as a matter of law (JMOL) of both invalidity and noninfringement. Board of Regents of the University of Texas v. Boston Scientific Corp., Case Nos. 24-2062; -2063 (Fed. Cir. July 27, 2026) (Taranto, Bryson, Cunningham, JJ.)

The Board of Regents of the University of Texas (UT) owns a patent directed to a composition containing at least one biodegradable polymer fiber that includes one or more dispersed therapeutic agents. The claimed invention may be used with commercially available stents to deliver drugs at the site where the stent is placed.

In 2017, UT sued Boston Scientific Corporation (BSC), alleging that BSC’s drug-eluting coronary stent systems infringed UT’s patent. Following claim construction, the case proceeded to trial. The jury found that BSC willfully infringed the asserted claims and rejected BSC’s argument in its motion for JMOL that the claims were anticipated by a prior art reference known as Song. The jury awarded damages to UT. The district court subsequently set aside the willfulness finding as legally unsupported but otherwise upheld the verdict. BSC appealed the infringement and validity rulings, and UT cross-appealed the district court’s decision overturning the willfulness verdict.

The Federal Circuit reversed the judgment for UT, finding that BSC was entitled to JMOL that the asserted claims were invalid as anticipated and, independently, that BSC did not infringe.

Addressing anticipation, the Federal Circuit concluded that Song disclosed each limitation of the asserted independent claim. Song taught the claimed biodegradable polymer fiber and disclosed the claimed “second phase” limitation. The Court explained that Song’s noncontiguous drug phases satisfied the requirement for discrete drug-containing regions.

The asserted dependent claims added limitations expressed in Markush-group form. Because Song disclosed at least one member of each claimed Markush group, the Federal Circuit concluded that those claims were also anticipated. The Court further found that Song disclosed the claimed release of a drug at varying rates.

The Federal Circuit separately concluded that BSC was entitled to JMOL of noninfringement. Under the district court’s claim construction, the asserted claims required a “thread-like” structure. The Court determined that UT’s evidence did not establish the presence of such a structure in BSC’s accused stent coatings.

UT’s infringement theory relied on sections of the coating that had been artificially separated for purposes of analysis. The Federal Circuit concluded that no reasonable jury could characterize those artificially isolated portions as the claimed thread-like structure. BSC therefore was entitled to JMOL of noninfringement.

Back on track: Contextual inquiry required before applying § 112(f) to software claim element

by Richard (Rick) Evans | Jul 16, 2026 | Patents

The US Court of Appeals for the Federal Circuit vacated and remanded a district court’s indefiniteness ruling based on an insufficient means-plus-function analysis under 35 U.S.C. § 112(f) while affirming the denial of judgment as a matter of law (JMOL) and a new trial following a jury verdict finding a related patent invalid as anticipated. TrackTime, LLC v. Amazon.com Services LLC, Audible, Inc., Case No. 24-1102 (Fed. Cir. July 2, 2026) (Prost, Taranto, JJ; Kovner, J., sitting by designation.)

TrackTime sued Amazon and Audible for patent infringement, asserting two related patents directed to time-synchronized transcript technology for audio and video files. One patent relates to methods for annotating and sharing time-synchronized transcripts on mobile devices. The other relates to “tap-to-jump” technology, which allows a user to tap a word in a transcript and jump to the corresponding point in the associated audio or video file.

The district court issued a claim construction order finding the annotation-and-sharing patent invalid for indefiniteness. The court concluded that the claim terms “executable program code configured to facilitate annotation” and “executable program code configured to synchronously play multimedia” were means-plus-function terms that recited functions without sufficient corresponding structure. Because the specification did not adequately disclose structure for performing those functions, the district court held the terms indefinite.

The tap-to-jump patent proceeded separately to a jury trial. The jury found the asserted claim invalid on multiple grounds, including anticipation by a prior art program called LiveNote, and found no infringement. The district court later denied TrackTime’s post-trial motions for JMOL and a new trial. TrackTime appealed both the indefiniteness ruling on the annotation-and-sharing patent and the denial of JMOL and a new trial on the tap-to-jump patent.

The Federal Circuit vacated and remanded the indefiniteness ruling on the annotation-and-sharing patent, finding the district court’s § 112(f) analysis insufficient considering the Federal Circuit’s intervening decision in Dyfan, LLC v. Target Corp. (2022). In Dyfan, the Court explained that determining whether a limitation should be construed under § 112(f) requires a full contextual analysis, including whether the claim language recites sufficient structure when viewed in light of the specification, the surrounding claim language, and how a person of ordinary skill in the art would understand the term.

The Federal Circuit found that the district court did not conduct the full inquiry required by Dyfan because it failed to consider extrinsic evidence regarding usage in the field and how a skilled artisan would understand the disputed “executable program code” limitations. The Court declined to decide the § 112(f) issue in the first instance, leaving it to the district court on remand to determine whether the disputed limitations, read in context, recited sufficient structure for performing the claimed annotation and synchronous-play functions on a mobile device.

The Federal Circuit reached a different result on the tap-to-jump patent. TrackTime argued that LiveNote failed to disclose three limitations, namely “performing a data lookup,” a “mobile computing device,” and a “touch-sensitive input interface.” The Court rejected each argument. It found that TrackTime [...]

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Dim damages methods can doom bright ideas

by Keval Amin | Aug 7, 2025 | Patents

In a mixed ruling on evidentiary exclusions and damages methodology, the US Court of Appeals for the Federal Circuit affirmed in part, reversed in part, vacated in part, and remanded a district court’s decision that excluded patent validity evidence and granted judgment as a matter of law (JMOL). The Federal Circuit found that the district court erred in blocking the defendant’s invalidity case and directed it to reassess the reliability of the damages expert’s testimony under Rule 702. Jiaxing Super Lighting Co., Ltd. v. CH Lighting Technology Co., Ltd., Case No. 23-1715 (Fed. Cir. July 28, 2025) (Dyk, Chen, Hughes, JJ.)

Jiaxing Super Lighting and its affiliate Obert (collectively, Super Lighting) sued CH Lighting over three patents related to LED tube lamps – two covering structural designs and one addressing electrical safety. CH Lighting admitted infringement but argued that the structural patents were invalid under the America Invents Act’s (AIA) on-sale bar. The district court excluded key evidence, found the remaining expert testimony insufficient, and granted JMOL in Super Lighting’s favor. A jury later found CH Lighting liable and awarded damages, which the district court doubled. CH Lighting’s motions for a new trial and renewed JMOL were denied. CH appealed.

CH Lighting contended that certain 2014 LED tubes met all claim limitations and triggered the on-sale bar. The Federal Circuit disagreed, affirming the district court’s finding that CH Lighting’s expert lacked a proper foundation, having offered no concrete evidence or personal knowledge of the alleged sales. However, the Court found error in the exclusion of two key evidentiary items: testimony authenticating sales documents and an internal presentation showing competitor products predating the patents. The district court excluded the documents for lack of authentication and barred the presentation because of its connection to a dropped inequitable conduct claim, later reasoning that the products shown differed in wattage. The Federal Circuit rejected both rationales, explaining that the relevant inquiry focused on whether the products disclosed patented features, not their wattage. The Federal Circuit deemed these exclusions an abuse of discretion, warranting a retrial on validity.

The Federal Circuit separately upheld the jury’s findings on a different patent where the jury found the patent not invalid for anticipation and infringed. CH Lighting had argued that a prior art reference anticipated the asserted claims and that the accused chips could not infringe if the reference did not. The Court found, based on the conflicting testimony of the parties’ expert witnesses, that the jury was free to credit one expert over the other and therefore had substantial evidence supporting the jury’s no invalidity verdict. Similarly, the parties’ experts presented conflicting evidence on infringement and that Jiaxing’s expert’s theory was not necessarily inconsistent with the validity ruling. The Court thus affirmed the findings of validity and infringement.

Turning to damages, the Federal Circuit emphasized that expert testimony must be based on reliable methodology and sufficient factual grounding, reinforcing standards articulated in the recent EcoFactor, Inc. v. Google en banc decision. Because the jury [...]

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CRISPR Clarity: Enablement Is Analyzed Differently Under §§ 102 and 112

by Peter Marston | Jun 18, 2025 | Life Sciences, Patents

In a decision underscoring the distinct standards governing enablement under §§ 102 and 112, the US Court of Appeals for the Federal Circuit affirmed the Patent Trial & Appeal Board’s finding that a prior art reference was enabling for purposes of anticipation, even in the absence of working examples. Agilent Technologies, Inc. v. Synthego Corp., Case Nos. 23-2186; -2187 (Fed. Cir. June 11, 2025) (Prost, Linn, Reyna, JJ.)

The case centers on CRISPR, the gene-editing technology that has reshaped the frontiers of biology and biotechnology. Agilent owns patents that claim chemically modified guide RNAs (gRNAs) designed to improve stability and performance in CRISPR-Cas systems. Synthego filed an inter partes review (IPR) petition asserting that the patents were unpatentable. The Board found all claims unpatentable, relying on a 2014 publication by Pioneer Hi-Bred that disclosed similar modified gRNAs. Agilent appealed.

Agilent challenged the Board’s finding that the prior art was enabling, arguing that Pioneer Hi-Bred merely proposed a research plan without demonstrating which specific modifications would yield functional gRNAs. Agilent emphasized that the reference lacked working examples and disclosed numerous nonfunctional sequences, contending that a skilled artisan would not have been able to identify a successful embodiment without undue experimentation. It also argued that the nascent state of CRISPR technology in 2014 compounded the unpredictability, making the reference non-enabling. In support, Agilent relied heavily on the Supreme Court’s 2023 decision in Amgen v. Sanofi, where the Supreme Court invalidated a broad genus claim for failing to enable its full scope.

The Federal Circuit was not persuaded. The Court drew a clear distinction between enablement under § 112 (which governs patent validity) and enablement under § 102 (which governs anticipation). The Court explained that the bar is lower for the latter, and that a prior art reference need only enable a single embodiment within the scope of the claim. While Amgen involved § 112, the Court emphasized that this case turned on § 102, where the standard is less demanding.

The Federal Circuit grounded this distinction in both the statutory text and the underlying purpose of the respective provisions. Statutorily, § 112 requires that a patent specification enable a person of ordinary skill in the art to “make and use” the invention. Section 102, by contrast, contains no such requirement. This divergence reflects a difference in purpose: § 112 ensures that the patentee does not claim more than they have taught, thereby preventing overbroad monopolies. As the Supreme Court explained in Amgen, “[t]he more a party claims, the broader the monopoly it demands, the more it must enable.” But the Federal Circuit emphasized that the Supreme Court’s reasoning in Amgen was rooted in the patentee’s burden to support the full scope of a genus claim under § 112. That concern, the Court explained, does not apply in the § 102 context, where the question is not how much the prior art claims, but whether it teaches enough for a skilled artisan to practice at least one embodiment without undue [...]

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Transatlantic Terminology: Skilled Artisan Could Equate UK, US Word Meanings

by Anisa Noorassa | Apr 24, 2025 | Patents

The US Court of Appeals for the Federal Circuit affirmed a Patent Trial & Appeal Board unpatentability determination, finding that a skilled artisan would have found the term “sterile” in a UK publication to mean the same as the term “sterilized” in the United States. Sage Products LLC v. Stewart, Case No. 23-1603 (Fed. Cir. Apr. 15, 2025) (Reyna, Cunningham, Stark, JJ.)

Sage owns two patents related to a sterilized chlorhexidine product in a package, such as an applicator filled with an antiseptic composition for disinfecting skin. Becton, Dickinson and Company petitioned for inter partes review (IPR) of both patents. The Board relied on four key pieces of prior art, including one that was a UK publication, to find the challenged claims unpatentable. In instituting the IPR and evaluating the petition, the Board construed the term “sterilized” to mean that “the component or composition has been subjected to a suitable sterilization process such that sterility can be validated.” In the final written decision, the Board found that a skilled artisan at the time of the invention would have known, through education and experience, that the term “sterile,” as used in the UK prior art publication, is equivalent to the term “sterilized,” as used in the US and particularly in the Sage patents. Reviewing the totality of the evidence before it, including both parties’ experts’ reports and testimony, the Board determined the challenged claims were unpatentable. Sage appealed.

The Federal Circuit declined to overturn the Board’s findings, affirming the Board’s definition of a person of ordinary skill in the art and their understanding of the term “sterilized” at the time of the invention. The Court found that the Board did not ignore or disregard evidence but properly weighed the evidence before it, concluding that a skilled artisan having the education and experience required by the Board’s definition would know the differences between the US and UK regulatory standards for “sterile” and therefore would know that UK references to “sterile” items would satisfy the challenged claims’ requirement for “sterilized” items.

Construing Unambiguous Claim Language and Qualifying Challenged Expert as POSITA

by Taylor MacDonald | Mar 20, 2025 | Patents

Addressing the issues of claim construction and the requisite expert qualifications to testify on obviousness and anticipation, the US Court of Appeals for the Federal Circuit vacated a Patent Trial & Appeal Board decision invalidating half of the challenged patent’s claims and instructed the Board to clarify whether the patent owner’s expert was indeed qualified as a person of ordinary skill in the art (POSITA). Sierra Wireless, ULC v. Sisvel S.P.A., Case Nos. 23-1059; -1085; -1089; -1125 (Fed. Cir. Mar. 10, 2025) (Moore, CJ: Schall, Taranto, JJ.)

Sisvel owns a patent directed to methods for retrieving data lost during wireless transmission. The prior art taught methods for flagging lost protocol data units (PDUs) so that the data transmitter could retry the transmission. Sisvel’s patent includes a timer that prescribes a period of time to elapse before alerting a transmitter of a missing PDU, allowing the transmission to be completed without notification. The patent has 10 claims, two of which are independent. The primary independent claim has four limitations, including one related to stopping the timer before a status report issues if the missing PDU is located and another related to issuing a status report upon the timer’s expiration. The limitations are linked by the word “and.”

Sierra Wireless initiated inter partes review (IPR), arguing that all 10 of the claims were both anticipated and obvious in light of the “Sachs” prior art patent. The Board found that half of the claims, including both independent claims, were anticipated and obvious. In finding that the other claims were not unpatentable, the Board relied on the testimony of Sisvel’s expert. Both parties appealed.

Sisvel raised two arguments in support of the claims the Board found unpatentable. First, Sisvel argued that the Board misconstrued the two above-noted limitations as mutually exclusive. Sisvel argued that the prior art had to teach both limitations to invalidate the claim. Second, Sisvel argued that the Board’s interpretation of Sachs’ teachings to include the first of the two limitations was unsupported by substantial evidence.

The Federal Circuit agreed. On the claim construction issue, the Court found that the two limitations in issue could not be mutually exclusive because the claim language linked them using the word “and.” To construe the limitations as mutually exclusive would be inconsistent with the unambiguous claim language. With regard to the prior art, the Court looked to Sachs Figure 5, which the Board relied upon in determining that the prior patent had taught the first limitation. Both the figure and the patent’s surrounding language made clear that the time referenced therein was dependent upon reordering of PDUs, not upon receiving missing ones. The Court thus vacated the Board’s invalidity determination as not supported by substantial evidence.

In its appeal, Sierra argued that the Board’s reliance on Sisvel’s expert’s testimony to find certain claims not unpatentable was an abuse of discretion. The Federal Circuit agreed, finding that the Board abused its discretion by not finding that the proposed expert qualified as a POSITA before relying [...]

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No Two Ways About It: No Disparagement ≠ Teaching Away, Free Samples ≠ Commercial Success

by Mike Baldwin | Aug 31, 2023 | Patents

The US Court of Appeals for the Federal Circuit affirmed the Patent Trial & Appeal Board invalidating two patents: one as anticipated because disclosure of a genus anticipated the claimed species, and the other as obvious because the prior art did not disparage the claimed invention and therefore was not a “teaching away.” The Court also found that free samples cannot be used to show commercial success. Incept LLC v. Palette Life Sciences, Inc., Case Nos. 21-2063; -2065 (Fed. Cir. Aug. 16, 2023) (Schall, Taranto, JJ.) (Newman, J., concurring in part, dissenting in part).

Incept owns two patents related to improved methods for treating cancer, particularly prostate cancer, using radiation. The patents describe methods of introducing a filler between a radiation-targeted tissue and other tissue to increase the distance between the two and thereby decrease the amount of radiation received by the non-targeted tissue. Palette filed inter partes review petitions against each patent, asserting that the claims of one patent were anticipated and the claims of the other were obvious. Both theories of invalidity relied on the same prior art reference, Wallace. The Board instituted review and ultimately found both patents unpatentable. Incept appealed.

As to the patent that the Board found anticipated, Incept argued that the Board erred legally by “picking and choosing” from the teachings of Wallace to piece together elements. Incept argued that Wallace teaches a genus of millions to billions of possible compositions while its patent claims a species. Thus, according to Incept, the genus had to be defined well enough that a person of ordinary skill could have envisioned each member of the genus.

The Federal Circuit found no legal error in the Board’s anticipation analysis. The Court rejected Incept’s assertion that its patent claimed a species, finding that the patent described a method to inject a composition that had the same general properties as the composition described in Wallace. The Court also found that the Board’s conclusion that Wallace taught biodegradable compositions (where Wallace stated that “a portion of the polymer may be biodegradable”) was supported by substantial evidence and noted that it was not the Court’s duty to reweigh factual determinations.

As to the Board’s obviousness finding of the other patent, Incept alleged that the Board improperly reiterated its anticipation analysis, disregarded statements in Wallace that teach away, did not separately analyze the dependent claims and disregarded evidence of commercial success. The Court was unpersuaded by any of these arguments.

First, the Federal Circuit noted that since the anticipation analysis had no error, it was not improper for the Board to rely upon that analysis for its obviousness determination. The Court noted that the Board relied on the teachings of another piece of prior art concerning the challenged patent’s displacement limitation. The Court also dismissed Incept’s allegation that the motivation to combine analysis was conclusory.

The Federal Circuit rejected Incept’s assertion that Wallace taught away from biodegradable compositions, noting that Wallace provided a preference for an alternative but did not criticize, discredit or [...]

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Holy Pulmonary Hypertension, Batman: Method of Treatment Not Constrained by Safety and Efficacy

by Nitya Anand | Aug 3, 2023 | Patents

The US Court of Appeals for the Federal Circuit affirmed a district court’s holding that the asserted method of treatment patent was valid and infringed because safety and efficacy are not patent concerns. The Federal Circuit also affirmed the district court’s holding that certain claims of the product-by-process patent were invalid because the claimed product was in the prior art, regardless of the process by which it was made. United Therapeutics Corporation v. Liquidia Technologies, Inc., Case Nos. 22-2217; 23-1021 (Fed. Cir. July 24, 2023) (Lourie, Dyk, Stoll, JJ.)

United Therapeutics is the maker of Tyvaso®, a treprostinil formulation approved for treating pulmonary hypertension. United Therapeutics asserted two patents covering Tyvaso® against Liquidia’s § 505(b)(2) new drug application (NDA) on Yutrepia™. One patent was a method of treatment patent claiming to treat pulmonary hypertension by administering a “therapeutically effective” dose of a treprostinil formulation, and the other was a product-by-process patent claiming a treprostinil composition with lowered levels of impurities made by a specific salt formation process.

The district court found that United Therapeutics showed that a single administration of treprostinil improves a patient’s hemodynamics, establishing that administration of Liquidia’s Yutrepia, comprising treprostinil, would directly infringe the method of treatment claims. The district court also concluded that even though Yutrepia’s label did not provide hemodynamic data, the label’s instructions would inevitably lead to the administration of a therapeutically effective single event dose. The court thus concluded that Liquidia would induce infringement of the method of treatment claims.

The district court further found that the asserted claims were not invalid for lack of enablement or written description. The court reasoned that a skilled artisan would not need to engage in undue experimentation to practice the full scope of the claimed treatment of pulmonary hypertension, despite potential safety concerns in treating certain patients, since the claims did not require safety and efficacy. The court found that the claims were not invalid for lack of written description, finding that a skilled artisan would, based on the specification, understand that treprostinil would effectively vasodilate the pulmonary vasculature, improve hemodynamics and treat a patient’s elevated pulmonary blood pressure.

Liquidia appealed on five issues: claim construction of the term “treating pulmonary hypertension,” enablement, written description, induced infringement and infringement of the product by process claims. United Therapeutics cross-appealed on anticipation of the product by process claims and non-infringement of those claims.

First, regarding the construction of “treating pulmonary hypertension,” the Federal Circuit affirmed that the term encompassed all recognized groups of pulmonary hypertension but noted that the claim language “treating pulmonary hypertension” did not import any additional efficacy limitations or safety limitations, even those in a group that would not benefit from the treatment. The Court declined to read any safety or efficacy requirements into the claims, explaining that absent incorporation into the claims, the safety and efficacy of a claimed treatment are the purview of the US Food & Drug Administration (FDA), not patent law.

Regarding enablement and written description, Liquidia argued that the method [...]

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If Prior Art Discloses Ingredients and How to Mix Them, the “Cake” Is Anticipated

by Kyle Sorenson, PhD | Apr 20, 2023 | Patents

The US Court of Appeals for the Federal Circuit affirmed that challenged claims were invalid as anticipated based on principles of inherency where the disclosed prior art formulations and processes necessarily met a disputed claim limitation. Arbutus Biopharma Corp. v. ModernaTx, Inc., Case No. 20-1183 (Fed. Cir. April 11, 2023) (Reyna, Schall, Chen, JJ.)

Arbutus Biopharma owns a patent that matured from an application filed on March 9, 2015, that claims priority to a provisional application filed on June 30, 2010. The claimed invention provides stable nucleic acid-lipid particle (SNALP) formulations with a non-lamellar structure that function to increase the efficiency of nucleic acid entry into cells to promote the downregulation of gene expression. The non-lamellar morphology of a SNALP formulation was known to depend on two factors: the lipids incorporated into the SNALP formulation, and the process used to form the SNALPs. The patent disclosed five SNALP formulations of various compositions that can be used and incorporated by reference two US patent publications, which describe two methods that can be used to make SNALP formulations: the Direct Dilution Method (DDM) and the Stepwise Dilution Method (SDM). The representative independent claim recites a composition of SNALPs, wherein each particle in the plurality of SNALP particles comprises a nucleic acid and various lipid types. The claim also requires that at least 95% of the particles in the plurality of particles have a non-lamellar morphology (the Morphology Limitation).

Moderna filed a petition for inter partes review (IPR) asserting that all the claims of the Arbutus patent were anticipated by a prior art patent. The Patent Trial & Appeal Board found that although the Morphology Limitation was not expressly found in the prior art, the claims were anticipated. The Board determined that the Morphology Limitation was an inherent property (or natural result) of the prior art disclosures. On appeal, Arbutus challenged the Board’s inherent and express anticipation findings for many of the challenged claims, including for the Morphology Limitation.

A limitation is inherent if it is the natural result flowing from the prior art’s explicit disclosure. In other words, a limitation is inherent when the limitation is a property necessarily present in the invention and not actually an additional requirement imposed by the claims. In the IPR proceeding, Moderna argued that the Morphology Limitation was inherent because one skilled in the art would necessarily obtain formulations meeting this limitation by making formulations using the five formulations disclosed by the patent and using the DDM method (from the incorporated-by-reference disclosures) to prepare the formulations.

Both the challenged patent and the prior art disclosed five formulations that can be used to obtain the SNALP formulations. Evidence showed that any differences between the formulations disclosed in these patents would not impact the Morphology Limitation. The Federal Circuit found that substantial evidence supported a finding that the formulations disclosed in both the challenged patent and the prior art were the same or essentially the same.

The Federal Circuit further explained that both the challenged patent and the [...]

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Overlapping Ranges in Prior Art Put Burden on Patentee to Show Criticality

by Alexandra Cavazos, PhD | Apr 20, 2023 | Patents

The US Court of Appeals for the Federal Circuit found that the challenged patents were invalid as anticipated and obvious in a case involving claimed ranges and prior art that included teachings with overlapping ranges. UCB, Inc. v. Actavis Laboratories UT, Inc., Case No. 21-1924 (Fed. Cir. Apr. 12, 2023) (Moore, C.J.; Chen, Stoll, JJ.)

UCB owns two prior art patents (the Mueller patents), one directed to methods for stabilizing rotigotine that covers a drug used in UCB’s Neupro® transdermal patches to treat Parkinson’s disease, and the other directed to the stable dispersions of rotigotine used in Neupro® transdermal patches.

Soon after UCB began marketing its original Neupro® transdermal patch in 2007, it discovered that rotigotine crystallized when the patch was kept at room temperature, which lowered the amount of rotigotine available to cross the skin/blood barrier and enter the patient’s circulation and reduced the product’s effectiveness. UCB recalled Neupro® from the market in the United States. In Europe, it marketed Neupro® only under “cold chain” conditions, which reduced the rotigotine crystallization.

The challenged patent in this case solved the problem of room temperature crystallization using dispersions in which the ratio of rotigotine to the stabilizer polyvinylpyrrolidone (PVP) ranged from “about 9.4 to about 9.6.” The original Neupro® formulation had a rotigotine to PVP ratio of 9:2, and the Mueller patents disclosed a partially overlapping range of 9:1.5 to 9:5, as shown in the following graphic from the Federal Circuit’s opinion:

The reformulated Neupro had a ratio of 9:4 rotigotine to PVP and exhibited stability for up to two years at room temperature.

The district court held that the Mueller patents anticipated all asserted claims because a person of ordinary skill in the art (POSA) would “readily envisage” a combination of 9% rotigotine with 4% to 5% of PVP. The district court also determined that all claims were obvious in light of the Mueller patents and other prior art.

Anticipation/Overlapping Ranges

The Federal Circuit first noted that although the prior art that discloses a point within a claimed range generally anticipates that claim, such was not the case here, and the district court committed legal error treating it thus.

Instead, the Federal Circuit treated this case as one of overlapping ranges. Under that legal rubric, once a patent challenger establishes a prima facie case of anticipation by showing that the claimed range partially overlaps with the cited art, the burden shifts to the patentee to show that the “claimed range is critical to the operability of the claimed invention.” The Court stopped short of ruling that UCB had not met its burden of showing the criticality of the range because it concluded that the two patents in question were obvious in light of the overlap between the claimed ranges and those of the Mueller patents.

Teaching Away

The Federal Circuit affirmed the district court’s rejection of UCB’s arguments that Tang, another [...]

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