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9 Jun 2015, 6:16 am by Curtis Bradley
And the Court distances itself from some of the broad presidential power dicta in United States v. [read post]
26 Jun 2008, 6:31 pm
Section 337(a) preemption is avoided only due to an FDCA provision that's unique to food and has no counterpart in the medical device (or drug) arena. [read post]
22 May 2014, 3:58 pm by Aaron Barkoff
The agenda includes the following presentations: Minimizing the Uncertainty Surrounding the Untested Pathway: Insight Into FDA's Current Position and Initiatives Regarding Biosimilars Predicting Follow-On Entry and Evaluating the Risk and Commercial Opportunity in the Emerging Biosimilar Landscape New Kid No More: Evolution in Biosimilars Science and Regulations The Holy Grail for Biosimilars: Meeting FDA's Requirements for Biosimilarity and the Heightened Standard of Interchangeability… [read post]
27 May 2009, 10:42 pm
Many of the cases reviewed were the ones that have been summarized in previous posts to this blog, such as the excess insurance case of Kropa v. [read post]
27 Dec 2006, 2:39 pm
Responding in part to the Supreme Court's contribution to this mess with its ruling in Hill v. [read post]
9 Nov 2009, 8:05 am
[Read the full article: Business Method Patents_Blog.pdf] Notes: Bilski v. [read post]
28 May 2019, 7:52 am by Benjamin Beaton
In January, a partially divided Sixth Circuit panel (Griffin, White; McKeague dissenting in part) held the case—Guertin v. [read post]
19 Jul 2010, 8:34 am by David Post
The Ninth Circuit gutted the red flag doctrine in Perfect 10 v. [read post]