As part of a push to increase competition and lower drug prices, the U.S. Senate recently passed a bill that limits the number of patents that can be asserted in biosimilar litigation. The Affordable Prescriptions for...more
Since its enactment in 2022, the validity of the Inflation Reduction Act (IRA) and its drug price negotiation program (Program) has been repeatedly challenged in District Court, with little success. Boehringer Ingelheim’s...more
President Biden signed the Inflation Reduction Act (IRA) into law on Aug. 16, 2022, with the goal of reducing health care costs for the government and participants in Medicare and Medicaid programs. The IRA includes a section...more
On the heels of one of the first district court decisions that denied a copyright for AI-generated work that entirely lacked human authorship and left open the question of what level of human intervention will be required in...more
One of the hot-button issues that generative artificial intelligence (AI) has raised is whether works created by AI engines are copyrightable. In one of the first decisions on this issue, the D.C. District Court recently...more
Some of the world’s earliest and most detailed governmental regulations for generative artificial intelligence (AI) just went into effect in China on Aug. 15. These “Generative AI Measures” are intended to balance state...more
On July 28, 2021, the Food and Drug Administration (FDA) approved the first interchangeable biosimilar product, Semglee (insulin glargine-yfgn), as a diabetes treatment. Semglee is both biosimilar to and interchangeable with...more
On June 17, 2021, the Supreme Court of the United States issued its decision in California et al. v. Texas et al. (No. 19-840), upholding the Affordable Care Act (ACA). A bloc of U.S. states, led by Texas, and two individuals...more
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California v Texas ,
Commerce Clause ,
Individual Mandate ,
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SCOTUS ,
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Tax Cuts and Jobs Act
In December 2020, the U.S. District Court for the District of Columbia issued a decision in Teva v. FDA, reviewing FDA’s definition of “protein” in connection with the agency’s determination that Teva’s Copaxone®, a...more