by Dennis Crouch

This week the Supreme Court granted certiorari in Cox Communications, Inc. v. Sony Music Entertainment, No. 24-171, while denying the competing petition in Sony Music Entertainment v. Cox Communications, No. 24-181. This grant/deny pair follows the Trump Administration’s Solicitor General recommendation and sets up another major Supreme Court battle over the scope of contributory copyright infringement–this one focusing on how internet service providers handle allegations of user piracy.

USDOJ: Contributory Infringement Requires Conscious and Culpable Acts

The case centers on fundamental questions about when companies can be held liable for their users’ copyright infringement—issues that parallel similar debates in patent law regarding inducement under 35 U.S.C. § 271(b) and contributory infringement under 35 U.S.C. § 271(c). Patent and copyright cases share common purposes and a core tension of how to hold those who facilitate infringement accountable without stifling innovation or access.

The Sony v. Cox litigation began when a consortium of record companies and music publishers sued Cox Communications, an internet service provider with millions of customers, for copyright infringement based on actions by Cox’s subscribers during 2013-2014. During this period, anti-piracy company MarkMonitor sent Cox over 160,000 automated notices alleging that specific IP addresses on Cox’s network were being used to share particular copyrighted music via peer-to-peer networks like BitTorrent.

Cox had implemented what it called a “graduated response program” under which repeat infringers would receive escalating consequences: email warnings, temporary suspensions, and ultimately possible termination. However, Cox’s application of this policy was admittedly inconsistent. Over the relevant period, Cox terminated only 33 subscribers for copyright violations while terminating over 600,000 for nonpayment. Internal emails showed Cox employees expressing frustration with the volume of infringement notices and resistance to aggressive termination policies that would cost the company subscriber revenue. (more…)

by Dennis Crouch

In an “informative” decision addressing the limits of multiple IPR petitions, Acting USPTO Director Coke Morgan Stewart granted Director Review and vacated the PTAB’s institution of two IPR proceedings challenging the same patent claims. CrowdStrike, Inc. v. GoSecure, Inc., IPR2025-00068, IPR2025-00070 (USPTO June 25, 2025). The Director found that the Board abused its discretion by allowing CrowdStrike to pursue two separate IPR proceedings against the same claims of Patent 9,954,872 B2, where the primary difference between the petitions was alternative constructions of a single claim term. The Director’s opinion states that allowing multiple petitions based solely on alternative claim constructions “effectively expands the permitted word count and places a substantial and unnecessary burden on the Board and the patent owner.” On remand back to the PTAB, the parties are instructed to submit claim construction briefs in order to allow the Board to consider moving forward with an IPR.

• IPR2025-00068-InformativeDirectorDecision
• IPR2025-00068-PTABInstitutionDecision
• IPR2025-00068-ResponseDirReviewRequest
• IPR2025-00068-DirReviewRequest

Interestingly, this remand may give the petitioner exactly what it wants in this case – room to make the alternative arguments within a single IPR petition. (more…)

A lot has been happening at the USPTO over the past six months! Join me along with an interesting panel of patent law experts for a 1-hour discussion sponsored by the LAIPLA.

• July 1, 2025: 12:00 PM – 1:30 PM (PACIFIC TIME)
• Cost: Free
• Register: https://laipla.wildapricot.org/event-6191982

Patrick Maloney (Cork Maloney) organized the event and the panel includes Jessica Hudak (Edwards Lifesciences); David Bailey (KPPB); and Dennis Crouch (Me).

by Dennis Crouch

The Supreme Court recently issued a Call for the Views of the Solicitor General (CVSG) in the “skinny label” inducement case, Hikma v. Amarin.  I expect the CVSG brief will be filed in late fall by the Trump-appointed Solicitor General (currently D. John Sauer).  Behind the scenes lobbying will be ongoing between  the Republican populists (seeking lower drug prices) and more traditional Republicans (promoting innovator businesses).

At issue is Hikma’s generic version of Amarin’s Vascepa (icosapent ethyl). Initially approved to treat severe hypertriglyceridemia (SH), Amarin subsequently secured FDA approval and patent protection for using Vascepa to reduce cardiovascular (CV) risk, a second indication constituting the majority of sales. Hikma launched its generic with an FDA approved “skinny label” explicitly carving out the patented CV. Doctors have a strong incentive to prescribe the generic version for the patented CV use due to significantly lower costs, leading to broader patient access. Additionally, insurers and pharmacy benefit managers actively encourage or require the use of lower-priced generics whenever available, further motivating physicians to prescribe generic alternatives for patented indications.  We also know the unpatented SH use is closely related to the patented CV use.  Severe hypertriglyceridemia (very high triglyceride levels) typically coincides with increased cardiovascular risk.

Background Materials:

• Dennis Crouch, Amarin v. Hikma: Federal Circuit Reverses Inducement Dismissal in Skinny-Label Case, Patently-O (June 25, 2024);
• Dennis Crouch, Rehearing Requested: Hikma Challenges Federal Circuit’s Skinny Label Ruling, Patently-O (Aug. 26, 2024);
• Dennis Crouch, Generic Drugs, Skinny Labels, and Liability for Off Label (Infringing) Use, Patently-O (Feb. 18, 2025).
• Jacob Sherkow and Paul Gugliuzza, Infringement by Drug Label, 78 Stanford Law Review ___ (forthcoming 2026).

Amarin’s infringement lawsuit was initially dismissed by the district court, but the Federal Circuit reversed, holding that Amarin plausibly alleged induced infringement by Hikma. Despite the skinny label, the court pointed to Hikma’s statements describing its product as a “generic version” of Vascepa, press releases citing total sales dominated by the patented use, and removal of certain disclaimers in its label, concluding that collectively these actions could actively encourage infringement by healthcare providers.

This scenario exemplifies the “label-plus” theory of inducement, wherein a generic drug’s label alone, even if it suggests infringing use, cannot constitute infringement because it falls within a congressionally authorized regulatory scheme. However, when a generic label closely aligns with an infringing use and is combined with additional active steps, inducement liability may arise. In my view, the label itself is not part of the active step, but instead creates the underlying fragile conditions that make it easy to induce infringement. In Hikma’s case, Federal Circuit concluded these active steps involved explicitly highlighting parallels to the branded drug Vascepa—such as marketing it as a “generic version” and emphasizing sales data strongly associated with the patented cardiovascular use—while omitting any explicit mention of the label’s carve-out.  Note here that this was all at the motion-to-dismiss stage of the case; Amarin has not yet proven infringement but has alleged enough to allow the case to proceed into discovery. (more…)

by Dennis Crouch

The USPTO is discontinuing its Accelerated Examination program on July 10, 2025.  The program has received fewer than 100 petitions in recent years, compared with 10,000+ Track One prioritized examination requests.  The USPTO anticipates further raising the annual limit on Track One requests in 2025.  The USPTO also recently terminated the Climate Change Mitigation Pilot Program on January 28, 2025. See Discontinuation of the Accelerated Examination Program for Utility Applications, 90 Fed. Reg. 24324 (June 10, 2025).

The Accelerated Examination program allowed applicants to advance their applications out of turn by filing a petition to make special along with a pre-examination search and examination support document.  The program was designed to provide expedited examination for applicants willing to invest significant effort in preparing detailed examination support materials, including prior art searches and claim charts mapping the prior art to each pending claim.  However, the program’s popularity plummeted following the introduction of Track One prioritized examination in 2011.  Unlike Accelerated Examination, Track One requires only payment of a fee—currently $4,200 for large entities—without the burden of preparing examination support documents or conducting pre-examination searches. (more…)

by Dennis Crouch

The United States Court of Appeals for the Federal Circuit stands today with a dramatically different judicial composition than at any point in its 43-year history. As of June 2025, the court comprises eleven active judges—only three appointed by Republican presidents and eight by Democratic presidents, representing a 73% Democratic majority. This represents a complete reversal from the court’s peak Republican era in the early 1990s, when Republican appointees held ten of eleven active seats. The court’s current composition has taken on heightened significance as it confronts one of the most politically charged cases in its history: V.O.S. Selections v. Trump, challenging President Trump’s global tariff program under the International Emergency Economic Powers Act (IEEPA). The Federal Circuit’s response so far has been as a collective institution—proceeding en banc from the outset and issuing unanimous per curiam orders—reflects institutional awareness of political vulnerabilities that historically patent-focused courts rarely confront.

The chart above illustrates the evolution of the Federal Circuit’s composition since its inception. The court began in October 1982 with a modest Democratic edge of six to five active judges. However, the subsequent span of Reagan and Bush administrations rapidly transformed the court’s ideological balance.  This culminated in an extraordinary 10-1 Republican majority by 1990—the most lopsided partisan composition in the court’s history. Republican dominance persisted throughout the 1990s, with the court maintaining between seven and ten Republican appointees against only one to four Democratic appointees. The turning point came in the early 2000s as senior status and retirements began reshuffling the court’s composition. Democratic appointees steadily increased from 2000 onward, reaching parity around 2010 and achieving majority status by 2015. The trend has continued unabated, with the current 8-3 Democratic majority representing the inverse of the court’s 1990s Republican dominance. Notably, none of the three remaining Republican appointees were named by President Trump, leaving the court without any judges appointed by the current president whose policies it must now review.  The court’s partisan balance has been further complicated by the ongoing suspension of Judge Pauline Newman, the longest-serving non-senior federal appellate judge, who was suspended by her colleagues in September 2023.