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Breaking Up Is Hard to Do: Validity Upheld Based on Expert Separation Testimony

by Alexandra Cavazos, PhD | Apr 27, 2023 | Patents

The US Court of Appeals for the Federal Circuit affirmed a district court decision finding that two patents covering enantiomerically pure compositions of the psoriasis drug Otezla® (apremilast) were valid and one patent covering a dosage titration schedule was invalid as obvious. Amgen Inc. v. Sandoz Inc. Case No. 22-1147 (Fed. Cir. Apr. 19, 2023) (Lourie, Cunningham, Stark, JJ.)

Amgen markets apremilast, a phosphodiesterase-4 inhibitor that is used for treating psoriasis and related conditions, under the brand name Otezla®. Amgen has three patents covering Otezla®. Two of the patents are directed to orally administered pharmaceutical compositions of enantiomerically pure apremilast (composition patents), and one of the patents covers a dosage titration schedule for enantiomerically pure apremilast that ranges from a starting dose of 10 mg to a dose of 60 mg by the sixth day (dosage patent). Sandoz submitted an Abbreviated New Drug Application (ANDA) seeking approval from the US Food and Drug Administration (FDA) to market a generic version of apremilast. Amgen filed suit against Sandoz for infringement of its three patents covering Otezla®.

Sandoz asserted that the composition patents were invalid based on prior art that had an example (Example 12) that described a 50%:50% racemic mixture of apremilast but did not disclose the purified apremilast (+) enantiomer recited in the claims. The prior art did state that apremilast could be isolated from this racemic mixture using chiral chromatography, a well-known technique. The district court rejected Sandoz’s argument, finding that there was insufficient evidence to conclude that a skilled artisan would have had reason to believe that the desirable properties of Example 12 derived in whole or in part from the apremilast enantiomer (i.e., the (+) enantiomer). The district court also concluded that Sandoz had not demonstrated that a skilled artisan would have had a reasonable expectation of success in resolving Example 12 into its individual enantiomeric components. Furthermore, the district court looked to objective indicia of non-obviousness, finding that apremilast unexpectedly provided substantial improvement over previously known phosphodiesterase inhibitors in terms of both efficacy and tolerability, and a nexus existed between the unexpected potency and the asserted claims.

Sandoz also argued that the dosage patent was invalid based on prior art that taught various dosage schedules and amounts for apremilast. The district court found that it would have been within the ability of a skilled artisan to titrate apremilast for a patient presenting with psoriasis and that doing so would have been a routine aspect of treating psoriasis with a drug (such as apremilast) that was known in the art to require dose titration to ameliorate side effects. The district court therefore found that the dosage patent was invalid. Sandoz appealed with respect to the composition patents, and Amgen appealed with respect to the dosage patent.

The Federal Circuit affirmed the district court’s decision with respect to the composition patents, finding that Sandoz had not proven that a skilled artisan would have had sufficient motivation to purify apremilast’s (+) enantiomer from the racemic mixture disclosed in Example [...]

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Reaching New Lights: Inherent Upper Limit Enables Open-Ended Range

by Amol Parikh | Apr 27, 2023 | Patents

The US Court of Appeals for the Federal Circuit affirmed an International Trade Commission decision finding a § 337 violation. The Court concluded that the Commission correctly found that an open-ended claim was enabled since there was an inherent upper limit and correctly construed the term “a” to mean “one or more” in finding infringement. FS.com Inc. v. International Trade Commission, Case No. 22-1228 (Fed. Cir. Apr. 20, 2023) (Moore, Prost, Hughes, JJ.)

Corning Optical Communications owns several patents directed to fiber optic technology. Corning alleged that FS violated § 337 by importing high-density fiber optic equipment that infringed the patents. In assessing infringement, the Commission construed the claim term “a front opening” to mean “an opening located in the front side of a fiber optic module (e.g., the opening depicted in Figure 13 of the [asserted] patent as having dimensions H1 and W1”) and further concluded that the term encompassed one or more openings. The Commission found that FS’s products met this requirement and therefore infringed. FS argued that certain claims were invalid because they were not enabled. The claims at issue recited “a fiber optic connection density of at least ninety-eight (98) fiber optic connections per U space” or “a fiber optic connection of at least one hundred forty-four (144) fiber optic connections per U space.” FS argued that these open-ended density ranges were not enabled because the specification only enabled up to 144 fiber optic connections per U space. The Commission rejected FS’s invalidity argument. FS appealed.

The Federal Circuit affirmed the Commission’s enablement determination. The Court explained that open-ended claims are not inherently improper and may be enabled “if there is an inherent, albeit not precisely known, upper limit and the specification enables one of skill in the art to approach that limit.” The Court found that there was an inherent upper limit of about 144 connections per U space since skilled artisans would have understood that densities substantially above 144 connections per U space were technologically infeasible. The Court further found that the specification disclosed that the maximum density achievable was 144 connections per U space and expert testimony confirmed that, despite market pressure, no commercial product has achieved a density greater than 144 connections. Considering this evidence, the Court concluded that the Commission properly found that the open-ended claims had an inherent upper limit of about 144 connections per U space and the claimed open-ended range was therefore enabled.

The Federal Circuit also affirmed the Commission’s infringement determination. The Court explained that the terms “a” or “an” in a patent claim generally mean “one or more,” unless the patentee evinces a clear intent to limit “a” or “an” to “one.” FS argued that the recitation of “front openings” in an unasserted claim showed a clear intent to limit “a front opening” in the asserted claim to a single opening. The Court rejected that argument, finding that limiting an unasserted claim to multiple openings did not show an intent to limit the asserted claim to [...]

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No Spark Here: TTAB Refuses to Register Similar Mark for Real Estate Services

by Kathleen Lynch | Apr 27, 2023 | Trademarks

The US Court of Appeals for the Federal Circuit upheld the Trademark Trial & Appeal Board’s refusal to register a mark due to the “close similarity” between the applied-for mark and a previously registered mark. In Re: Charger Ventures LLC, Case No. 22-1094 (Fed. Cir. Apr. 13, 2023) (Prost, Reyna, Stark, JJ.)

Charger Ventures applied to register SPARK LIVING, identifying its services as rental property management and real estate leasing and listing. Based on an existing mark, SPARK, which identified other real estate services such as rental brokerage, commercial property leasing and management, the Examining Attorney ultimately refused to register Charger’s mark, despite Charger twice amending its application and disclaiming the word LIVING. Charger appealed to the Board, which used the 13 DuPont factors to analyze likelihood of confusion. The Board focused on five of the DuPont factors:

Similarity of the marks: SPARK LIVING fully incorporates SPARK, and LIVING is both descriptive and disclaimed, making it “subordinate to SPARK.”
Similarity of the nature of goods/services: While not identical, commercial and residential real estate services may “emanate from a single source under a single mark.”
Similarity of trade channels: There exists “some overlap” between commercial and residential real estate trade channels.
Class of purchasers: Although real estate purchasers exercise a high level of care, “even . . . sophisticated purchasers are not immune from source confusion.”
Strength of the mark: Although SPARK is somewhat commercially weak, “even weak marks are entitled to protection.”

The Board did not announce the weight it afforded to each factor but found that Charger failed to overcome the high similarity between its mark and SPARK. The Board therefore affirmed the Examining Attorney and refused to register SPARK LIVING. Charger appealed to the Federal Circuit.

As to factor 1, Charger argued that the Board erred in finding similarity of the marks. The Federal Circuit disagreed, noting that Charger disclaimed LIVING from its mark. The Court explained that disclaimer has no legal effect on likelihood of confusion because consumers do not know which words have been disclaimed. The Court found that the Board properly considered the full mark and that the marks were clearly similar.

As to factors 2 and 3, Charger argued that the previous SPARK registration could not be newly extended to include residential real estate services. The Federal Circuit rejected Charger’s argument, finding that many marks bridge the commercial and residential gap and that a registration’s listed services do not limit the trade channels in which the mark actually operates.

Regarding factor 4, Charger argued that SPARK and SPARK LIVING appealed to different classes of purchasers. The Federal Circuit disagreed, finding that Charger had failed to show that residential property owners were distinct from commercial owners.

Charger asserted that the Board improperly analyzed factor 5, since a mark’s weakness is “paramount” to likelihood of confusion. However, the Federal Circuit agreed with the Board that Charger failed to overcome the registered mark’s presumption of validity, despite other “spark” marks in the field. The Court [...]

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Same Old Story: Copyright Discovery Rule Still Applies

by Alexander Piala, PhD | Apr 27, 2023 | Copyrights

The US Court of Appeals for the Fifth Circuit affirmed a district court’s infringement determination, finding that the copyright owner’s claims were timely since they were brought within three years of discovering the infringement. Martinelli v. Hearst Newspapers LLC, Case No. 22-20333 (5th Cir. Apr. 13, 2023) (Barksdale, Southwick, Higginson, JJ.)

In 2015, Sotheby’s International Realty commissioned Antonio Martinelli to photograph an Irish estate owned by the Guinness family. Martinelli took seven photographs of the property, and the property was subsequently listed for sale. On March 7, 2017, Hearst Newspapers used those commissioned photographs in news articles discussing the sale in various Hearst publications. Over the next few years, Martinelli learned about Hearst’s use of the photographs. For instance, on November 17, 2018, Martinelli learned about the use of the photographs in the Houston Chronicle, and between September 2019 and May 2020, Martinelli learned about further use of the photographs in the San Francisco Chronicle, the Times Union, the Greenwich Time, the Middletown Press and the Elle Décor website. Based on these uses, Martinelli sued for copyright infringement on October 18, 2021—more than three years after the initial publication but less than three years after Martinelli discovered the publication.

Hearst stipulated both to infringement and that Martinelli could not have discovered the use of the copyrighted photographs at an earlier time. Instead, Hearst argued that Martinelli was too slow in bringing his infringement action since, under 17 U.S.C. § 507(b), the action must be brought within three years of the infringement, regardless of a plaintiff’s knowledge or diligence. The district court disagreed, holding that § 507(b) follows the discovery rule, which means the limitations period only begins when the plaintiff knows or has reason to know of the injury. Hearst appealed.

Hearst argued that the district court’s decision ran afoul of the Supreme Court’s 2019 decisions in Petrella v. MGM and Rotkiske v. Klemm. According to Hearst, under Petrella and Rotkiske, the discovery rule cannot apply to § 507(b) and the limitations period starts “when the plaintiff has a complete and present cause of action.” The Fifth Circuit disagreed.

The Fifth Circuit began by explaining that unless unequivocally overruled by a Supreme Court decision, an en banc court or a change in law, it was bound by its 2014 decision in Graper v. Mid-Continent Casualty, which held that the limitations period starts running “once the plaintiff knows or has reason to know of the injury upon which the claim is based.” Since neither party asserted that there had been an en banc decision or a change in the law, the only question was whether Petrella or Rotkiske overruled Granger.

Since the Supreme Court explicitly refused to address whether the discovery rule applied to § 507(b) in Petrella, the Fifth Circuit refused to read Petrella as overruling Graper. Turning to Rotkiske, the Fifth Circuit noted the Supreme Court’s statement that “[i]f there are two plausible constructions of a statute of limitations, we generally adopt the construction that starts the time limit running when the [...]

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PTO Requests Comments on Revisions to AIA Trial Proceedings

by Amol Parikh | Apr 27, 2023 | America Invents Act, Patents

On April 21, 2023, the US Patent & Trademark Office (PTO) announced that it is seeking public input on proposed modifications to the rules of practice for inter partes reviews (IPRs) and post grant reviews (PGRs) before the Patent Trial & Appeal Board to better align the practices with the PTO’s mission to promote and protect innovation and investment in the same and to provide a less expensive alternative to district court litigation to resolve certain patentability issues while also protecting against patentee harassment.

The PTO is considering promulgating rules that the Director—and, by delegation, the Board—will use to do the following:

Exercise the Director’s discretion to institute IPRs and PGRs
Provide a procedure for separate briefing on discretionary denial that will allow parties to address relevant issues for discretionary denial without encroaching on the page limit to address the merits of a case
Give petitioners the ability to pay additional fees for a higher word-count limit
Clarify that all settlement agreements, including pre-institution settlement agreements, are required to be filed with the Board.

To create clear, predictable rules where possible, as opposed to balancing tests that decrease certainty, the PTO is considering changes that would provide for discretionary denials of petitions in the following categories, subject to certain conditions and circumstances as discussed further in the Official Notice:

Petitions filed by certain for-profit entities
Petitions challenging under-resourced patent owner patents where the patentee has brought or is attempting to bring products to market
Petitions challenging patent claims previously subject to a final adjudication upholding the patent claims against patentability challenges in district court or in post-grant proceedings before the PTO
Serial petitions
Petitions raising previously addressed prior art or arguments
Parallel petitions
Petitions challenging patents subject to ongoing parallel litigation in district court.

The PTO also seeks comments on proposed threshold definitions that apply to one or more of these categories of petitions subject to discretionary denials. Those definitions set forth the criteria used to determine the following:

What constitutes a “substantial relationship” between entities sufficient to trigger or avoid discretionary denial
When claim sets are deemed to have “substantial overlap” with challenged claims
What constitutes “compelling merits” sufficient to trigger an exception to discretionary denial.

For example, one proposal with respect to the “substantial relationship” is a requirement that a patent owner and petitioner disclose anyone with an ownership interest in the patent owner or petitioner, any government funding related to the patent, any third-party litigation funding support, and any stake any party has in the outcome of the America Invents Act (AIA) proceeding or any parallel proceedings on the challenged claims.

Additional changes being considered by the PTO include the following:

Absent exceptional circumstances, requiring petitioners to file a stipulation that neither they nor their privy or real parties in interest have filed prior post-grant proceedings (PGRs, IPRs, covered business methods or ex parte reexaminations) on the challenged claims
If petitioners’ post-grant proceeding is instituted, requiring that [...]

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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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Branding Function Patent Yet Another 1[01] to Bite the Dust

by Thomas DaMario | Apr 20, 2023 | Patents

Addressing the patentability of claims directed to digital image branding functions, the US Court of Appeals for the Federal Circuit affirmed a district court’s determination that claims across three related patents were invalid under 35 U.S.C. § 101 for lacking patent-eligible subject matter. Sanderling Mgmt. Ltd. v. Snap Inc., Case No. 21-2173 (Fed. Cir. Apr. 12, 2023) (Chen, Cunningham, Stark, JJ.)

Sanderling owns three patents, each titled “Dynamic Promotional Layout Management and Distribution Rules.” The three patents share a common specification and are generally directed to a method using distribution rules to load digital imaging branding functions to users when certain conditions are met. The specification explains that a distribution rule is “a rule used in determining how to target a group of end users, for instance, a rule that determines that only a group of end users having certain characteristics and/or match a certain requirement.”

Sanderling asserted each of the three patents against Snap in the Northern District of Illinois. Snap moved to transfer venue to the Central District of California and to dismiss the case under Fed. R. Civ. P. 12(b)(6) for failure to state a claim based on the allegation that the asserted patents’ claimed ineligible subject matter under § 101. After the case was transferred, the Central District of California found the claims patent ineligible and granted Snap’s motion to dismiss. Sanderling appealed.

The Federal Circuit reviewed the decision by engaging in the two-step Alice framework for subject matter eligibility. Under step one, the Court determined that the claims were directed to the abstract idea of providing information—in this case, a processing function—based on meeting a condition (e.g., matching a GPS location indication with a geographic location). The Court explained that for computer-related inventions, the relevant question is whether the claims are directed to an improvement to computer functionality or to an abstract idea. The Court found that the claims in issue were not directed to an improvement in computer functionality, but instead to the use of computers as a tool—specifically, a tool to identify when a condition is met and then to distribute information based on satisfaction of that condition.

Even if directed to an abstract idea, patent claims may still be eligible under step two of the Alice framework if there are additional features that constitute an inventive concept. The Federal Circuit, however, found that the claims failed this step also. The Court explained that if a claim’s only inventive concept is the application of an abstract idea using conventional and well-understood techniques, the claim has not been transformed into a patent-eligible application of an abstract idea. The distribution rule of the asserted claims was just that: the application of the abstract idea using common computer components. Accordingly, the Court affirmed the district court’s decision that the patent claims were invalid under § 101.

Practice Note: On appeal, Sanderling argued that the district court erred at step one of the Alice analyses by failing to construe certain claim terms that were allegedly crucial to the determination. [...]

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Context Is Key in Claim Construction

by Brennen Baylor | Apr 20, 2023 | Patents

The US Court of Appeals for the Federal Circuit reiterated that intrinsic evidence trumps extrinsic evidence in determining the meaning of claim terms. Sequoia Technology, LLC v. Dell, Inc. et al., Case Nos. 21-2263; -2264; -2265; -2266 (Fed. Cir. Apr. 12, 2023) (Stoll, Lourie, Dyk, JJ.)

Sequoia Technology owns a patent directed to data storage methods involving storing the same data across multiple physical disk drives to make up a virtual disk drive. Sequoia asserted the patent against several companies, all based on a product sold by Red Hat. During litigation, the parties disputed the construction of the terms “computer-readable recording medium,” “disk partition” and “logical volume.” Related to the latter two claim construction issues, the parties construed the term “used or not used” in the context of an extent’s usage in an “extent allocation table.”

The district court adopted Red Hat’s construction of “computer-readable recording medium” to include transitory media (i.e., signals or waves). The district court found no clear language in the specification that excluded transitory media and found Red Hat’s extrinsic evidence to be persuasive, “particularly given the lack of any substantive rebuttal from Sequoia’s expert.” For “disk partition” and “logical volume,” the district court agreed with Red Hat and construed “disk partition” to mean a “section of a disk that is a minimum unit of a logical volume” and “logical volume” to mean an “extensible union of more than one disk partition, the size of which is resized in disk partition units.” These constructions require that a logical volume is constructed by whole disk partitions, not subparts of disk partitions such as extents. The district court also construed the phrase “used or not used” in the limitation “extent allocation table for indicating whether each extent in the disk partition is used or not used,” adopting Red Hat’s construction that “used or not used” means that an extent “is or is not storing information.”

Following claim construction, the parties stipulated that under the district court’s claim construction of “logical volume” and “disk partition,” the accused products did not infringe the asserted claims. The parties also stipulated that under the district court’s construction of “computer-readable recording medium,” certain claims were subject matter ineligible under 35 U.S.C. § 101 as including transitory media. Sequoia appealed.

The Federal Circuit concluded that the district court erred in construing “computer-readable recording medium.” Starting with the claim language, the Court noted that the claim recited a “computer-readable recording medium storing instructions” and not simply a “computer-readable medium.” The Court reasoned that an ordinarily skilled artisan would understand transitory signals to be incompatible with the claimed invention because such fleeting signals would not persist for sufficient time to store instructions. Turning to the specification, the Court explained that although the specification did use open-ended “including” language to describe a computer-readable medium, the relevant portion of the specification defined computer-readable media as “including compact disc read only memory (CDROM), random access memory (RAM), floppy disk, hard disk, and magneto-optical disk,” all of which are non-transient [...]

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Allegations in Complaint Prevail over Statements in Exhibit

by Mike Baldwin | Apr 20, 2023 | Patents

The US Court of Appeals for the Federal Circuit, prioritizing specific allegations in the complaint over disclosures in exhibits to the complaint, reversed and remanded a district court decision dismissing an original complaint, denying leave to file an amended complaint. Healthier Choices Management Corp. v. Philip Morris USA, Inc.; Philip Morris Products S.A., Case Nos. 22-1268; -1563 (Fed. Cir. Apr. 12, 2023) (Taranto, Cunningham, Stoll, JJ.)

Healthier Choices Management (HCM) filed a complaint for patent infringement against two Philip Morris defendants in the Northern District of Georgia. The infringement allegation involved a patent for a nicotine delivery device. The relevant language from the claims focused on a heating element in the device “initiating . . . a combustion reaction . . . [with] the combustion reaction at least partially combusting the combustible material.” In its complaint, HCM alleged that the heating in the accused product resulted in at least partial combustion.

Philip Morris defended the claim by arguing that its accused product aerosolized the nicotine at a low temperature and, therefore, never combusted the tobacco. Philip Morris filed a motion under Fed. R. Civ. Pro. 12(b)(6) against HCM arguing that an exhibit to the complaint “conclusively demonstrated” that the accused product did not initiate a combustion reaction. The district court agreed and granted the motion to dismiss, prompting HCM to file a motion for leave to amend its complaint to more definitively allege infringement. The district court denied the motion and granted Philip Morris’s subsequent motion for attorneys’ fees under 35 U.S.C. § 285. HCM appealed.

Since the issues raised were not unique to patent law, the Federal Circuit addressed HCM’s appeal under the law of the relevant regional circuit, the Eleventh Circuit. The Court noted that in the Eleventh Circuit, exhibits attached to a complaint can be considered and the exhibit controls in the event of any conflict with allegations pertaining to the exhibit. However, when an exhibit is alleged to be factually false in some way and the allegations in a complaint are specific and well pleaded, then the allegations in the complaint control. The exhibit regarding the accused product in this case was alleged to be incorrect, as far as it stated that there was no combustion initiated by the “heat-not-burn” method described in the exhibit. HCM contended that combustion occurred despite the assertions in that document. Relying on several cases disavowing the truth of the exhibit, the Federal Circuit found Eleventh Circuit law to be both clear and in alignment with HCM. The Court concluded that in light of the detailed allegations as to the basis underlying HCM’s disagreement with the facts asserted in the exhibit, the complaint should not have been dismissed based on the exhibit.

The Federal Circuit next turned to HCM’s amended complaint. Noting that the amended complaint “superseded” the earlier complaint, the Court found that the amended complaint removed the offending exhibit and any references to the offending exhibit and included a declaration of a technical expert to further support HCM’s allegations. [...]

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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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