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Antitrust Liability Risk When Listing Patents in Orange Book

The US Court of Appeals for the First Circuit held that pharmaceutical companies that wrongly list patents in FDA’s Orange Book must prove they acted in good faith to avoid antitrust liability. In re Lantus Direct Purchaser Antitrust Litigation, Case No. 18-2086 (1st Cir. Feb. 13, 2020) (Kayatta, J).

In applying for FDA approval to market new drugs, drug manufacturers must list all patents that “claim” the drug or the method of using the drug in FDA’s “Orange Book.” Listing a patent in the “Orange Book” allows the drug manufacture to trigger an automatic 30-month stay of FDA approval of any application for a competing drug product.

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All in the Family: Prior Patent License Implicitly Grants License to Asserted Patent

The US Court of Appeals for the Federal Circuit affirmed a district court dismissal, finding that a patent license implicitly licensed all parents and continuations that disclosed the same invention as the explicitly licensed patent. Cheetah Omni LLC v. AT&T Services, Inc., Case No. 19-1264 (Fed. Cir. Feb. 6, 2020) (Lourie, J).

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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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Tree-mendous award: Damages expert royalty opinions are lit

The US Court of Appeals for the Federal Circuit affirmed a damages verdict amounting to tens of millions of dollars. The Court found that the patentee’s damages expert correctly apportioned value to the patented feature and rejected challenges to her methodology. Willis Electric Co., Ltd. v. Polygroup Ltd., Case No. 24-2118 (Fed. Cir. Feb. 17, 2026) (Moore, Stark, Oetken, JJ.)

Willis sued Polygroup for infringing its patent related to pre-lit artificial trees with decorative lighting. In response, Polygroup filed multiple inter partes review (IPR) petitions challenging the asserted claims. Following extensive IPR proceedings, only a dependent claim that required coaxial trunk connectors remained for trial.

A jury found the claim infringed and not obvious, and awarded about $42.5 million in damages, equating to a $4-per-tree royalty. Polygroup moved for judgment as a matter of law of obviousness or, alternatively, for a new trial on damages. The district court denied both motions. Polygroup appealed.

Effect of prior IPR ruling

Polygroup argued that because the independent claim from which the asserted claim depended was held unpatentable, damages should be limited to only the incremental value of the coaxial connectors recited in the asserted dependent claim. The Federal Circuit rejected that argument, explaining that the IPR applied the broadest reasonable interpretation standard, while the district court construed the independent claim under the Phillips standard. Under the district court’s construction, the independent claim required forming simultaneous mechanical and electrical connections regardless of rotational orientation, a feature that was not required under the IPR construction. Because the independent claim had not been held unpatentable under the district court’s construction, the Federal Circuit reasoned that the IPR ruling did not preclude Willis from relying on that one-step functionality in calculating the value attributable to the coaxial connectors recited in the dependent claim.

The Federal Circuit emphasized that what value was attributable to the claimed coaxial connectors was a question of fact for the jury. Substantial evidence supported the jury’s finding that the value included rotationally independent, simultaneous connection functionality, not merely the physical presence of coaxial connectors.

Rule 702 and damages methodology

Willis’ damages expert presented two independent apportionment analyses.

Under an income-based approach, the expert compared profit margins for Willis’ “One Plug” trees and Polygroup’s Quick Set trees against comparable noninfringing trees to derive a royalty range. Under a market-based approach, she analyzed several license agreements to establish a reasonable royalty range, which she combined with her income approach to arrive at an expanded reasonable royalty range. She then applied the Georgia-Pacific factors to select a $5-per-tree royalty, resulting in a jury award of $4 per tree.

Polygroup argued that the expert failed to adequately apportion value and relied on non-comparable licenses and improper averaging methods. The Federal Circuit disagreed, emphasizing the district court’s gatekeeping role under Federal Rule of Evidence 702 while reinforcing the distinction between admissibility and weight.

The Federal Circuit explained that reasonable royalty determinations inherently involve approximation and uncertainty. Where an expert’s methodology is grounded in record evidence, including internal sales [...]

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Did you account for the entire corresponding disclosed structure?

The US Court of Appeals for the Federal Circuit affirmed the district court’s grant of summary judgment of noninfringement of a means-plus-function claim element, emphasizing that a patentee must compare the accused product to the entire disclosed structure, not just a selected subset. Genuine Enabling Tech. v. Sony Group Corp., et al., Case No. 24-1686 (Fed. Cir. Feb. 19, 2026) (Dyk, Taranto, Chen, JJ.)

Genuine Enabling Technology (GET) sued Sony for patent infringement, alleging that Sony’s PlayStation 3 and 4 infringed its patent related to synchronizing data streams from multiple input devices. The district court ruled in favor of Sony, granting summary judgment of noninfringement and excluding the infringement conclusion of GET’s expert. GET appealed.

The Federal Circuit affirmed. The parties agreed that the term “encoding means” for synchronizing two separate streams, present in each asserted claim, was a means-plus-function limitation under 35 U.S.C. § 112(f). Neither party disputed that the corresponding structure consisted of the entirety of a logic block disclosed in the patent specification.

GET’s expert focused solely on the bit-rate clock appearing in the logic block, neglecting most of the other disclosed components, and did not provide an explanation for these omissions in his “way” analysis. The Federal Circuit explained that this approach failed to satisfy the function-way-result test for structural equivalence, which requires demonstrating that the accused product is equivalent to the disclosed structure by showing that both the accused and corresponding disclosed structures perform the identical function in substantially the same way to achieve substantially the same result. The Court clarified that while a component-by-component examination is not necessary, the analysis must consider all components of the identified structure or justify any omissions. GET’s expert did not meet the burden of describing the “way” the “encoding means” structure in the patent performed its function.

GET’s expert attempted to simplify structural equivalence to “anything that synchronizes to a clock.” The Federal Circuit explained that this approach improperly reduced the function-way-result test to function-result alone, contradicting the patent’s specific synchronization scheme. Because of the lack of analytical support for the expert’s structural-equivalence conclusion, the Federal Circuit upheld the district court’s exclusion of the expert’s opinion.

Since GET did not seek discovery of the accused product’s Bluetooth schematics until the end of fact discovery, GET’s expert never examined the internal design of the accused Bluetooth modules. Instead, his infringement theory relied solely on assumptions about generic Bluetooth behavior, which the Federal Circuit found to be conclusory, legally insufficient, and inconsistent with the patent’s detailed circuitry disclosed in the specification. The Federal Circuit affirmed the district court’s partial exclusion of GET’s expert’s testimony.

Practice note: When litigating means-plus-function claims under 35 U.S.C. § 112(f), an opining expert must address the entirety of the corresponding structure disclosed in the specification. Selectively focusing on only one or two elements without explaining omissions can be fatal.




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