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The Use of Mandated Public Disclosures of Clinical Trials as Prior Art Against Study Sponsors

Patently-O

11, 2024) Human clinical trials play an essential role in the discovery, development, and regulatory approval of innovative drugs, and federal law mandates the public disclosure of these trials. In its brief, Vanda argues that: clinical trials are far from a sure thing – indeed, most drug trials fail. [M]erely Norwich Pharms.

Art 75
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The Carrot and Stick Approach to Innovation

Patently-O

.” In particular, the appellate panel agreed that Gilead could be held liable for for delaying the development of an alternative HIV/AIDS drug (TAF) that it expected would be safer and equally effective compared to its existing drug (TDF) in order to maximize profits from TDF. The court relies on Mexicali Rose v.

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HOW INTELLECTUAL PROPERTY LAW CAN SOLVE LITIGATION SURROUNDING THE HATCH-WAXMAN ACT BROUGHT BY THE COURT’S DECISION IN BRAEBURN V. FOOD & DRUG ADMINISTRATION

JIPL Online

[i] This confusion has a direct impact on the willingness to invent, drug pricing, the recovery of research and development (R&D), and other basic purposes of the Act. [ii]. However, the FDA may not approve the new clinical investigation if it deems that the differences between the existing and the new drugs to beinsignificant. [iv]

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Supreme Court on Patent Law: November 2023

Patently-O

by Dennis Crouch The Supreme Court is set to consider several significant patent law petitions addressing a range of issues from the application of obviousness standards, challenges to PTAB procedures, interpretation of joinder time limits IPR, to the proper scope patent eligibility doctrine. Traxcell Techs. AT&T (No. Fortinet, No.

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Developing IP Strategy for FDA-Regulated Drug Products Requires Special Considerations

More Than Your Mark

Despite the widely diverging needs of the different industries that make use of the US patent system, US patent law applies essentially the same rules to innovations from all technology fields. This means that drug and biotechnology-based inventions are treated no differently by the U.S. Food & Drug Administration (FDA).

IP 52
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Seeing Clearly: Article III Standing of IPR Judicial Review

Patently-O

Jordan is a third-year law student at the University of Missouri and a registered patent agent. He has an extensive background in chemistry, food science, and viticulture. Article III standing remains a hot topic at all levels of federal litigation and across many different areas of law. Guest Post by Jordan Duenckel.

Art 48
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SpicyIP Weekly Review (November 8-November 15)

SpicyIP

Call for Papers: NALSAR’s Indian Journal of Intellectual Property Law (IJIPL) Vol. M/s Prataap Snacks Limited vs Chaudhary Food Products on 5 November, 2022 (Delhi District Court). Lt Foods Limited vs Saraswati Trading Company on 11 November, 2022 (Delhi High Court). Call for Papers/ Submissions . Cases in Indian Courts.

Trademark 105