Government

Supreme Court Oral Arguments

1

Supreme Court Oral Arguments

scotusstats.com
Today’s Local Environment—The Compliance Podcast

2

Today’s Local Environment—The Compliance Podcast

Local Government Environmental Assistance Network (LGEAN)
Portside Conversations

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Portside Conversations

BVI Ports Authority

29 Apr

1

[24-889] Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc.

Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc. Justia · Docket · oyez.org Argued on Apr 29, 2026. Petitioner: Hikma Pharmaceuticals USA Inc.Respondent: Amarin Pharma, Inc. Advocates: Charles B. Klein (for the Petitioners) Malcolm L. Stewart (for the United States, as amicus curiae, supporting the Petitioners) Michael R. Huston (for the Respondents) Facts of the case (from oyez.org) Amarin Pharma markets icosapent ethyl under the brand name Vascepa. In 2012, the FDA approved Vascepa for treating severe hypertriglyceridemia (the SH indication), which affects patients with blood triglyceride levels of at least 500 mg/dL. In 2019, following additional research and clinical trials, the FDA approved Vascepa for a second use: reducing cardiovascular risk in patients with triglyceride levels of at least 150 mg/dL (the CV indication). Amarin listed two patents covering the CV indication in the FDA’s Orange Book. In 2016, Hikma Pharmaceuticals submitted an Abbreviated New Drug Application seeking approval for a generic version of icosapent ethyl. When the CV indication was approved in 2019, Hikma filed a “section viii statement” seeking FDA approval only for the SH indication by “carving out” the patented CV indication from its label—creating a “skinny label.” The FDA approved Hikma’s ANDA in May 2020. Throughout 2020, Hikma issued press releases referring to its product as the “generic version” or “generic equivalent” of Vascepa, describing Vascepa as indicated “in part” for the SH indication, and citing Vascepa sales figures (over $1 billion annually) that were attributable primarily to the CV indication. Hikma also marketed its product on its website under the therapeutic category “Hypertriglyceridemia” and as “AB” rated, though with a disclaimer that it was approved for fewer indications than Vascepa. In November 2020, Amarin sued Hikma for induced infringement of its CV indication patents. The U.S. District Court for the District of Delaware granted Hikma’s motion to dismiss. The U.S. Court of Appeals for the Federal Circuit reversed, finding that Amarin’s allegations—based on Hikma’s skinny label combined with its press releases and marketing materials—plausibly stated a claim for induced infringement. Question 1. When a generic drug manufacturer excludes a patented use from its label, can it still be liable for inducing infringement if it calls its product a “generic version” of the brand-name drug and cites publicly available information about the brand-name drug’s sales? 2. Can a patent infringement complaint survive dismissal if it does not allege that the defendant made any statement specifically instructing or encouraging the patented use?

29 Apr

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1 hr
22 Apr

2

[25-429] Blanche v. Lau

Blanche v. Lau Justia · Docket · oyez.org Argued on Apr 22, 2026. Petitioner: Todd Blanche, Acting Attorney General.Respondent: Muk Choi Lau. Advocates: Sopan Joshi (for the Petitioner) Shay Dvoretzky (for the Respondent) Facts of the case (from oyez.org) Muk Choi Lau, a native and citizen of China, was admitted to the United States as a lawful permanent resident on September 7, 2007, after several years of traveling to the country as a nonimmigrant. On May 7, 2012, Lau was charged in New Jersey with third-degree trademark counterfeiting. While awaiting trial, he left the United States for a brief period. Upon returning on June 15, 2012, he presented himself at John F. Kennedy International Airport as a returning lawful permanent resident. However, because of his pending charge, immigration authorities declined to admit him outright and instead paroled him into the country pursuant to 8 U.S.C. § 1182(d)(5)(A). Over a year later, in June 2013, Lau pleaded guilty to the counterfeiting charge and was sentenced to two years’ probation. The Department of Homeland Security initiated removal proceedings against Lau in March 2014, charging him with inadmissibility under 8 U.S.C. § 1182(a)(2)(A)(i)(I) for having been convicted of a crime involving moral turpitude (CIMT). Lau argued that he should not have been treated as an arriving alien at the time of reentry and that he was eligible for a discretionary waiver under 8 U.S.C. § 1182(h). The immigration judge rejected both claims, and the Board of Immigration Appeals affirmed. Lau petitioned for review, arguing primarily that DHS lacked clear and convincing evidence to treat him as an applicant for admission on reentry merely due to a then-pending charge. The U.S. Court of Appeals for the Second Circuit agreed, holding that DHS erred in treating Lau as inadmissible based solely on unproven allegations at the time of reentry and granted his petition. The immigration judge ordered removal in 2018, and the Board of Immigration Appeals upheld that decision in 2021. The Second Circuit vacated the removal order in 2025 and remanded the case to terminate proceedings under the inadmissibility ground, reserving the possibility of future removal under a deportability provision. Question To remove a lawful permanent resident who committed an offense listed in Section 1182(a)(2) and was subsequently paroled into the United States, must the government prove that it possessed clear and convincing evidence of the offense at the time of the lawful permanent resident’s last reentry into the United States?

22 Apr

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1hr 30min
20/07/2023

3

Sensing a Change in the Air: How Local Governments Can Respond and Adapt to Shifts in Air Quality Monitoring Technology

Recent wildfire smoke events have highlighted the value of air quality measurement. But how does it really work, anyways? From the latest technologies and regulations to the unique challenges faced by local governments and Tribes, this week's guests discuss the transforming landscape of air quality monitoring. Join hosts Georgia Ray and Ella Stack and guests Chet Wayland from the EPA, Christopher Lee from Tribal Air Monitoring Support Center, and Miles Keogh from the National Association of Clean Air Agencies for the discussion. This episode was completed in partnership with ELI's People Places Planet Podcast. In This Episode We Cover: · How the onset of new monitoring and data technologies is shifting the air monitoring paradigm · What the surge in air quality participatory science means for rulemaking · Why local governments and Tribes are so well situated to address air pollution Hosts: Georgia Ray and Ella Stack, Environmental Law Institute Guests: Chet Wayland, EPA, Christopher Lee, Tribal Air Monitoring Support Center, and Miles Keogh, National Association of Clean Air Agencies

20/07/2023

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40 min

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