Search for: "Mylan Pharmaceuticals v. FDA" Results 21 - 40 of 233
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10 Sep 2018, 10:17 am by Lawrence B. Ebert
Roxane was that Acorda lost:Roxane Laboratories, Inc.; Mylan Pharmaceuticals,Inc.; and Teva Pharmaceuticals USA, Inc., have submittedAbbreviated New Drug Applications seeking FDAapproval to market generic versions of Ampyra. [read post]
25 Feb 2018, 11:45 am
   Because the claims of the patents are directed to pharmaceutical compositions and methods used to treat human medical conditions, it was not shown that there could be any other commercially relevant ways to practice the invention without FDA approval. [read post]
6 Apr 2017, 1:35 pm by Lawrence B. Ebert
This improved “efficientmixing” process resulted in batches that consistentlysatisfied the FDA’s 1.5 percent limit on the level of Asp9-bivalirudin. [read post]
12 Mar 2017, 9:28 am
 On the 26 April 2017, the US Supreme Court will hear arguments on this issue in Sandoz v Amgen. [read post]
8 Feb 2017, 3:09 am by Dennis Crouch
Alfonso Cioffi, No. 16-200 (holding prosecution history against the patentee) Civil Procedure – Personal Jurisdiction: Mylan Pharmaceuticals, et al. v. [read post]
16 Jan 2017, 5:44 pm by Dennis Crouch
Alfonso Cioffi, No. 16-200 (holding prosecution history against the patentee) Civil Procedure – Personal Jurisdiction: Mylan Pharmaceuticals, et al. v. [read post]
14 Nov 2016, 9:16 am by Dennis Crouch
 Kraft Food Brands Group LLC, No 16-341 (Does the general and broad definition of “residence” found in 28 U.S.C. 1391(c) apply to the patent venue statute 1400(b)) Civil Procedure – Personal Jurisdiction: Mylan Pharmaceuticals, et al. v. [read post]
13 Oct 2016, 6:50 am by Dennis Crouch
Lee, No. 16-446 (Eligibility of new use of old manufacture – blackjack game) Personal Jurisdiction: Mylan Pharmaceuticals, et al. v. [read post]
28 Sep 2016, 8:39 am by Dennis Crouch
Amgen Inc., et al., No. 16-332 (effectively extending exclusivity to 12 1/2 years; complement to the Sandoz petition) Mylan Pharmaceuticals, et al. v. [read post]
26 Aug 2016, 7:25 am by Lawrence B. Ebert
That leaves Mylan alone in the market, with the power to raise prices, which is what it did.A different issue with the FDA, not mentioned by Holbrook, can be found in recent litigations overcolchicine.See http://ipbiz.blogspot.bg/2015/05/takeda-v-hikma-tour-of-hatch-waxman.htmlhttp://ipbiz.blogspot.com/2011/05/colchicine-patent-wars.html [read post]
28 Jun 2016, 6:41 am by Dennis Crouch
Cordis Corporation, et al., No. 15-998 (follow-on to SCA) Safe Harbor: Amphastar Pharmaceuticals, Inc., et al. v. [read post]