Search for: "United States v. Karst" Results 1 - 20 of 38
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21 Jun 2010, 12:47 pm by FDABlog HPM
Solvay Pharms, Inc., 588 F.3d 1318 (11th Cir. 2009) and United States, ex rel. [read post]
21 Mar 2011, 1:12 pm by FDABlog HPM
  Specifically, the bill states that “[i]f the Secretary requires sponsors seeking a [PRV] to demonstrate a good faith intent to market the rare pediatric disease product in the United States, the Secretary shall first issue a guidance document setting forth the required evidentiary support necessary to demonstrate such a good faith intent. [read post]
28 Feb 2011, 3:53 pm by FDABlog HPM
  Under the so-called “waiver doctrine” of the “law-of-the-case doctrine,” an issue that a party could have raised in an earlier appeal in the case, but that was not raised, is barred from consideration (see United States v. [read post]
2 Nov 2010, 11:11 pm by FDABlog HPM
Department of Justice (Solicitor General of the United States) filed its highly anticipated amicus brief in response to the U.S. [read post]
17 Jul 2013, 1:34 pm by WIMS
Appealed from the United States District Court for the Southern District of Indiana, Indianapolis Division. [read post]
26 Sep 2011, 12:30 pm by FDABlog HPM
—The amendment made by subsection (a) shall apply to any application for extension of a patent term under section 156 of title 35, United States  Code, that is pending on, that is filed after, or as to which a decision regarding the application is subject to judicial review on, the date of the enactment of this Act. [read post]
19 Sep 2023, 3:34 am by Kurt R. Karst
Karst —Listing patent information in the Orange Book is a matter of judgment, but that judgment call is about to get a bit more scrutiny. [read post]
6 Sep 2012, 5:25 pm by FDABlog HPM
Karst –       In a decision handed down late in the day on Thursday, September 6th, Judge Amy Berman Jackson of the U.S. [read post]
2 Jun 2010, 12:42 pm by FDABlog HPM
Supreme Court recently invited the Solicitor General to express the views of the United States on the topic (see our previous post here). [read post]