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1 Sep 2015, 9:59 pm by Patent Docs
Patent No. 7,772,209, owned by Lilly, would be infringed by the ANDA products for which Defendants Teva Parenteral Medicines, Inc.; Teva Pharmaceuticals USA, Inc.; APP Pharmaceuticals, LLC; Barr Laboratories, Inc.; and Pliva Hrvatska D.O.O. sought approval to market (opinion).... [read post]
28 Jul 2015, 11:52 am by Schachtman
Merrell Dow Pharmaceuticals Inc., 43 F.3d 1311, 1320 (9th Cir.), cert. denied 516 U.S. 869 (1995) [Daubert II]. [read post]
26 Jun 2015, 11:30 am
Xanodyne Pharmaceuticals, Inc., 771 F.3d 1218 (9th Cir. 2014), here. [read post]
16 Jun 2015, 7:22 am by Schachtman
Sandoz Pharmaceuticals Corp., 244 F. [read post]
26 May 2015, 7:42 am
  Claims such as in Mills, which are at loggerheads with FDA criteria for drug development, are precisely those with the most potential for making pharmaceutical manufacturers into “sitting ducks” for litigation, in this instance litigation based on extraneous genetic factors.It may well be that the coming (and to some extent existing) revolution in genetically individualized medical therapy will require changes in how drugs are evaluated, labeled, etc., but this is a… [read post]
25 Apr 2015, 11:03 am by Schachtman
The first edition of the Reference Manual on Scientific Evidence [Manual] was published in 1994, a year after the Supreme Court delivered its opinion in Daubert. [read post]
9 Apr 2015, 5:00 am
Medicis Pharmaceutical Corp., 342 P.3d 847 (Ariz App. 2015), once, here. [read post]
28 Mar 2015, 9:24 am by Schachtman
Plaintiffs’ lawyers in pharmaceutical cases routinely file Medwatch adverse event reports, which thus inflate the “signal,” they claim supports the signal of harm from medication use. [read post]