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2019 IP Law Year in Review: Patents

Executive Summary

2019 was another important year in intellectual property law that resulted in hundreds of decisions by the courts and Patent Trial and Appeal Board (PTAB) that may affect your company’s litigation, patent prosecution or business strategy. This special report on patents discusses some of the most important cases from 2019 from the US Supreme Court, the US Court of Appeal for the Federal Circuit and the PTAB.

On January 22, 2019, the Supreme Court addressed in Helsinn Healthcare S.A. v Teva Pharmaceuticals, USA, Inc. the question of whether, under the America Invents Act (AIA), an inventor’s sale of an invention to a third party that is obligated to keep the invention confidential qualifies as prior art for purposes of determining the patentability of the invention. In a unanimous decision authored by Justice Clarence Thomas, the Supreme Court concluded that such a sale qualifies as prior art.

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Draft Amendment to German Patent Act May Limit Availability of Injunctions

On 14 January 2020, the German Federal Ministry of Justice published a draft act to modernize German patent law. Among other things, the draft addresses the fact that patent infringement trials proceed much quicker than parallel invalidity proceeding (which, under German law, are conducted separately). Hence, an injunction may be issued in first instance infringement proceedings before a decision on the validity of the patent in suit can be obtained; the resulting time gap between infringement and invalidity decision is called the “injunction gap” in German patent litigation. The draft modernization act seeks to improve the coordination between infringement and invalidity proceedings by having the Federal Patent Court provide a preliminary assessment of patent validity quickly. In view of such preliminary assessment, an infringement court may then stay infringement proceedings until a decision in the parallel invalidity proceedings.

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Inherent Claim Limitation Necessarily Present in the Prior Art Invalidates Patent

Addressing the issue of obviousness, the US Court of Appeals for the Federal Circuit affirmed the district court’s finding that a patent was invalid based on inherency because the claim limitation was necessarily present in the prior art. Hospira, Inc. v. Fresenius Kabi USA, LLC, Case Nos. 19-1329, -1367 (Fed. Cir. Jan. 9, 2020) (Lourie, J).

The patent at-issue is directed to premixed pharmaceutical compositions of dexmedetomidine that do not require reconstitution or dilution prior to administration and remains stable and active after prolonged storage. Hospira makes and sells dexmedetomidine products, including a ready-to-use product called Precedex Premix covered by the patent at-issue. Fresenius filed an Abbreviated New Drug Application (ANDA) seeking approval by the Food and Drug Administration (FDA) to market a generic ready-to-use dexmedetomidine product. Hospira brought suit alleging infringement under the Hatch-Waxman Act.

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A Mixed Bag on New Rules – Juggling Copyright Preclusion and Patent Infringement

Addressing issues of copyright and patent infringement, the US Court of Appeals for the Federal Circuit found that the Federal Insecticide, Fungicide, and Rodenticide Act did not preempt copyright protection and that patent infringement under 35 U.S.C. § 271(g) does not require that the claimed process be performed by a single entity. Syngenta Crop Protection, LLC v. Willowood, LLC, Case Nos.18-1614, -2044 (Fed. Cir., Dec. 18, 2019) (Reyna, J.).

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Practicing Product Must Be Essentially Claimed Invention to Link Secondary Considerations to Patent Claims

Raising the hurdle for proving secondary considerations, the US Court of Appeals for the Federal Circuit found that the “coextensiveness” requirement for purposes of nexus requires that the practicing product be “essentially the claimed invention.” FOX Factory, Inc. v. SRAM, LLC, Case No. 18-2024, -2025 (Fed. Cir. Dec. 18, 2019) (Prost, J.).

Bicycle chainrings are the toothed disks to which bicycle chains engage. SRAM owns a patent directed to an improved chainring structure that better maintains the chain, obviating the need for extraneous structures. The independent claims of the patent recite a chainring with alternating narrow and wide tooth tips and teeth offset from the center of the chainring. Some of the claims recite tooth tips offset toward the body of the bicycle (inboard offsets) and other claims recite teeth offset away from the body of the bicycle (outboard offsets). The specification discloses additional chainring features that are not recited in the claims. Each of the disclosed but unclaimed features contribute to improving chain retention. For example, the specification discloses forwardly protruding tip portions that function to engage a chain link earlier than a chain lacking the tip portion, a hook feature formed on the rear flank of each tooth to provide better guiding of the chain, and also that the narrow and wide teeth preferably fill at least 80% of the axial distance of the corresponding space in the chain link (>80% gap filling). SRAM sells 13 different versions of its “X-Sync” chainrings, 12 of which embody the inboard offset claims and one of which embodies the outboard offset claims. The X-Sync chains also embody the unclaimed features disclosed in the specification.

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Data Processing Software Checks Out as Patent Eligible

PATENTS / SUBJECT MATTER ELIGIBILITY / ABSTRACT IDEA

Addressing an issue of software subject matter eligibility, the US Court of Appeals for the Federal Circuit reversed the district court’s judgment on the pleadings under 35 USC § 101, finding claims related to error checking patent eligible. Koninklijke KPN N.V. v. Gemalto M2M GMBH et al., Case Nos. 18-1862, -1864, -1865 (Fed. Cir. Nov. 15, 2019) (Chen, J).
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Appeal is too late to raise percolating claim construction dispute

The US Court of Appeals for the Federal Circuit affirmed a district court’s finding of noninfringement, concluding that the patent owner had improperly raised a claim construction issue for the first time on appeal – an argument not preserved at the district court level. Egenera, Inc. v. Cisco Systems, Inc., Case No. 23-1428 (Fed. Cir. July 7, 2025) (Prost, Taranto, Stark, JJ.)

Egenera owns a patent that enhances traditional server systems by enabling a one-time physical setup followed by flexible virtual reconfiguration. The company alleged that Cisco infringed specific claims of the patent.

During claim construction, the parties disputed the interpretation of two terms: “computer processor/processor” and “emulate Ethernet functionality over the internal communication network.” The district court adopted the ordinary meaning of “computer processor,” which excluded Cisco’s unified computing system from its scope. Regarding the term “emulate,” the district court considered whether it implied an absence from the internal communication network but made no further determinations as the parties did not explicitly raise a dispute regarding the remainder of the claim term. Based on its construction of “computer processor/processor,” the district court granted Cisco’s motion for summary judgment on certain claims. Later, at trial, a jury found no infringement of other asserted claims. Egenera moved for judgment as a matter of law (JMOL) or alternatively for a new trial, both of which the district court denied. Egenera appealed the post-trial rulings and the earlier summary judgment ruling.

The Federal Circuit affirmed the district court’s grant of summary judgment. It concluded that the record lacked sufficient evidence to show that Cisco’s system “emulated” Ethernet functionality as required by the asserted claims. The Court emphasized that Egenera’s argument focused narrowly on the construction of the term “emulate,” rather than on the evidentiary record. Moreover, neither party clearly indicated that the dispute centered on unresolved claim construction rather than factual issues. The Court noted that it will not address claim construction on appeal where the issue was not preserved in the district court and was inadequately presented on appeal. As a result, the Court confined its analysis to the sufficiency of the evidence and upheld the district court’s finding of noninfringement.

The Federal Circuit also affirmed the district court’s denial of JMOL. The Court emphasized that it needed to address only one of Cisco’s proposed noninfringement grounds to determine whether substantial evidence supported the jury’s verdict. It concluded that the jury had a sufficient evidentiary basis to find that Egenera failed to prove infringement.

Finally, the Federal Circuit upheld the district court’s denial of Egenera’s motion for a new trial. It rejected all of Egenera’s arguments, which alleged errors related to jury selection, jury instructions, expert testimony, closing arguments, and a verdict contrary to the weight of the evidence.




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State court action doesn’t create reasonable apprehension of related federal claims

Addressing whether a federal district court had jurisdiction over an action for declaratory relief that certain trade secrets and trademarks were invalid and not infringed, the US Court of Appeals for the Eighth Circuit concluded that state law claims for breach of contract, trade secret misappropriation, and trademark infringement did not create a reasonable apprehension of federal litigation sufficient to give rise to federal jurisdiction. Thunderhead of Ankeny, Inc. v. Chicken Bones of Kearney, Inc., Case No. 24-2741 (8th Cir. July 8, 2025) (Colloton, Arnold, Gruender, JJ.)

Nearly 20 years ago, David Anders sold his equity in Chicken Bones of Kearney, Inc., which ran a bar and grill called the Chicken Coop. Anders subsequently opened a new Chicken Coop restaurant. Chicken Bones sued Anders for misappropriating Chicken Bones’ trade secrets, trademarks, and trade dress. The parties settled, and Anders received a limited license to the Chicken Coop intellectual property. Anders then opened several other Chicken Coop locations under that license.

Believing that Anders had not complied with the license in opening the new restaurants, Chicken Bones sued Anders in state court for breach of the settlement agreement, misappropriation of trade secret recipes, and infringement of the Chicken Coop trademarks and trade dress. In response, Anders sued Chicken Bones in federal court, seeking declarations of noninfringement and invalidity. The district court dismissed the suit for lack of jurisdiction. Anders appealed.

The parties and the Eighth Circuit assumed that the district court would have jurisdiction only if the suit presented a federal question. The Eighth Circuit explained that to assess federal question jurisdiction in the case of a declaratory action, the Court must imagine a traditional action that presents the same controversy and determine whether a federal claim would appear on the face of the resulting complaint. “If, but for the availability of the declaratory judgment procedure, the federal claim would arise only as a defense to a state created action, jurisdiction is lacking.”

Applying this principle, the Eighth Circuit concluded that the district court did not have jurisdiction over Anders’ declaratory action because he primarily sought vindication of his defenses to Chicken Bones’ pending state law claims. While the Court recognized that Anders also sought declaratory relief in anticipation of potential federal trade secret, trademark, and trade dress claims, the Court reasoned that any federal law controversy between the parties was too speculative to support jurisdiction. While a threat of litigation can give rise to a justiciable controversy, there was no evidence that Chicken Bones would assert overlapping and duplicative federal law claims against Anders. The Eighth Circuit further found that Chicken Bones’ petition to cancel Anders’ federal trademark registration of a Chicken Coop logo did not change its analysis, because the petition merely confirmed the existence of a trademark infringement dispute between the parties, which Chicken Coop elected to adjudicate in state court.

The Eighth Circuit distinguished cases involving state law trade secret claims concerning a patented invention. Because there is no state patent system, such trade secret claims can [...]

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Motivation, expectation of success negate obviousness presumption in overlapping range case

The US Court of Appeals for the Federal Circuit affirmed (on its second review) a district court’s ruling upholding the validity of patent claims related to a long-acting injectable dosing regimen, finding that the presumption of obviousness does not apply automatically and must be grounded in specific factual findings, particularly regarding a skilled artisan’s motivation and expectations. Janssen Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc., Case No. 25-1228 (Fed. Cir. July 8, 2025) (Prost, Reyna, Taranto, JJ.)

Janssen sued Teva under the Hatch-Waxman Act in 2018 after Teva filed an abbreviated new drug application (ANDA) seeking approval for a generic version of Janssen’s drug. Teva stipulated infringement but challenged the patent’s validity, arguing that all claims were obvious in light of prior art. The patent at issue covered a dosing regimen involving two “loading doses” spaced about a week apart, followed by monthly maintenance injections, designed to improve patient compliance compared to traditional oral dosing.

In 2021, the district court rejected Teva’s obviousness arguments, citing key differences between the claims and prior art, including the specific dosage amounts, the sequence of administration, and the requirement for deltoid injections. In 2024, the Federal Circuit initially vacated that decision and remanded for further analysis. On remand, the district court again found the claims nonobvious, and Teva appealed again.

A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art. Teva argued that a presumption of obviousness should apply because the prior art disclosed equal loading doses (150 or 100 mg-eq) within the claimed range. The Federal Circuit disagreed, emphasizing that the presumption depends on factual premises (such as a skilled artisan’s motivation to optimize and expectations from routine experimentation), which were not met here. The Court noted that Janssen’s specific choice of a higher first dose followed by a lower second dose did not clearly fall within the presumption’s scope.

Turning to the obviousness analysis, the Federal Circuit found that the three primary prior art references did not disclose a loading-dose regimen. Teva’s additional references, which it claimed taught dose reduction strategies, were also deemed insufficient. The Court found that one expert cited a reference recommending a high first dose for acutely ill patients while another noted that long-acting injectables were not typically used for such patients. The Court found that the prior art taken as a whole undermined Teva’s position.

Teva further contended that the district court improperly considered safety and efficacy (factors not recited in the claims) and erred in finding that the multidose regimen added complexity that would discourage a skilled artisan. The Federal Circuit rejected these arguments, affirming that the district court appropriately considered the motivation to develop a safe and effective regimen and correctly found that the prior art lacked relevant safety or efficacy data for multidose approaches.




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Prosecution history primacy: “Consisting essentially of” means what applicant said it meant

In a decision that underscores the primacy of prosecution history to determine claim scope, the US Court of Appeals for the Federal Circuit reversed the Patent Trial & Appeal Board’s interpretation of the transitional phrase “consisting essentially of,” holding that the patentee’s actions during prosecution narrowed the claims beyond the conventional construction. Eye Therapies, LLC v. Slayback Pharma, LLC, Case No. 23-2173 (Fed. Cir. June 30, 2025) (Scarsi, Dist. J., by designation; Taranto, Stoll, JJ.)

The case involved a method for reducing eye redness using low concentrations of brimonidine, a vasoconstrictive compound. Eye Therapies owns a patent that claims methods of administering brimonidine “consisting essentially of” the active ingredient. During inter partes review (IPR), the Board applied the typical construction of that transitional phrase, allowing for the presence of other active agents as long as they did not materially affect the invention’s basic and novel properties. Based on that reading, the Board found the claims obvious over prior art references that disclosed brimonidine in combination with other drugs. On appeal, Eye Therapies argued that the Board’s construction was too broad and inconsistent with the prosecution history.

The Federal Circuit agreed. Although “consisting essentially of” is generally understood to permit unlisted ingredients that don’t materially affect the invention, the Court emphasized that this meaning can be overridden by the intrinsic record. In this case, the applicant amended the claims to avoid prior art and repeatedly argued that the invention involved only brimonidine, with no other active agents. During the original prosecution, the examiner allowed the claims on that basis. The Court found these statements to be definitional, particularly in light of the applicant’s use of “i.e.” to equate the claim language with a brimonidine-only method. Given the clarity and consistency of the applicant’s position, the Court concluded that the prosecution history required a narrower reading than the one the Board used based on the phrase’s conventional meaning.

The Federal Circuit acknowledged that the patent specification disclosed embodiments containing additional active agents. That alone, however, did not justify a broader construction. The narrowing amendment came after the specification was drafted, and the Court reiterated that not every embodiment must fall within the scope of the claims, particularly when the claims have been narrowed during prosecution. The Court also noted that other embodiments in the specification were fully consistent with the narrower interpretation. Taken together, these factors reinforced the conclusion that the applicant’s prosecution statements – not the broader illustrative disclosures – defined the proper scope of the claims.

The Federal Circuit distinguished its 2009 decision in Ecolab v. FMC, where it declined to apply prosecution history disclaimer despite similar language. In Ecolab, the patentee initially stated that peracetic acid was the “sole antimicrobial agent,” but the examiner clarified that “consisting essentially of” did not mean “solely.” The applicant never repeated the statement and secured allowance on other grounds. The specification in Ecolab also described compositions that included other known antimicrobial agents, which supported the broader interpretation. In contrast, the applicant here amended the claims, consistently [...]

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