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17 Aug 2023, 9:00 pm
Vanda requested that FDA revoke the approval of Apotex’s and Teva’s generic versions of Hetlioz on the grounds that the generic tasimelteon products did not meet the statutory “same labeling” requirement for generic drugs found in 21 U.S.C. [read post]
1 Aug 2023, 11:47 am
., 2023 FC 906 at para. 20).[5] Apotex Inc v Wellcome Foundation Ltd, [2001] 1 FC 495 (FCA). by Pablo Tseng and Anica Villamayor (Summer Law Student) A Cautionary Note The foregoing provides only an overview and does not constitute legal advice. [read post]
31 Jul 2023, 1:47 pm
Apotex Corp., 403 F.3d 1331, 1343–44 (Fed. [read post]
31 Jul 2023, 12:48 pm
Apotex (Fed. [read post]
11 Jun 2023, 8:17 pm
Defendants Teva and Apotex filed ANDAs having Paragraph IV certifications that prompted Vanda's assertion of these four claims: • RE46,604 (Claim 3) (wherein the limitations... [read post]
12 Apr 2023, 4:00 am
., 2023 FC 243 at para 6 quoting from the Regulatory Impact Analysis Statement, (2017) Canada Gazette, Part 1, Vol 151, No 28 at 3317. [3] See Section 7(1)(d), Patented Medicines (NOC) Regulations. [4] See Section 6(3), Patented Medicines (Notice of Compliance) Regulations, subsections (a0 and (b) provide for a counterclaim against asserted claims in a patent or in a certificate of supplementary protection respectively. [5] See Janssen Inc v Apotex Inc, 2022 FCA 184, followed in Boehringer… [read post]
11 Apr 2023, 2:44 pm
Apotex Corp., 403 F.3d 1331, 1343–44 (Fed. [read post]
24 Mar 2023, 5:15 pm
This month there were two new recalls for eyedrops distributed by Pharmedica and Apotex. [read post]
10 Feb 2023, 4:44 am
Putting aside the idiosyncratic chapter by the late Professor Berger, most of the third edition of the Reference Manual presented guidance on many important issues. [read post]
19 Jan 2023, 1:46 pm
Apotex Corp., 439 F.3d 1312, 1319 (Fed. [read post]
17 Jan 2023, 6:30 am
., Apotex Corp., and Apotex Inc., the United States District Court for the Southern District of Florida recently granted defendant Apotex, Inc. [read post]
17 Jan 2023, 6:30 am
., Apotex Corp., and Apotex Inc., the United States District Court for the Southern District of Florida recently granted defendant Apotex, Inc. [read post]
17 Jan 2023, 6:30 am
., Apotex Corp., and Apotex Inc., the United States District Court for the Southern District of Florida recently granted defendant Apotex, Inc. [read post]
5 Dec 2022, 6:55 am
Apotex, Inc., 540 F.3d 1353 (Fed. [read post]
5 Dec 2022, 6:55 am
Apotex, Inc., 540 F.3d 1353 (Fed. [read post]
5 Dec 2022, 6:55 am
Apotex, Inc., 540 F.3d 1353 (Fed. [read post]
25 Sep 2022, 6:00 pm
Brandon Heard: Ontario Court of Appeal Affirms Dismissal of Apotex’s Statutes of Monopolies and Trademarks Act Claims Regarding Olanzapine (Source: JD Supra) Samantha Handler: Apple Patent Victories Upheld by Tribunal After Arthrex Remand (Source: Bloomberg Law) Blake Brittain: Ex-Patent Officials, U.S. [read post]
23 Sep 2022, 9:39 am
MYLAN BV and SANDOZ BVOne of the first patent cases decided in 2021 was an SPC case between MSD and Apotex, where the Brussels Enterprise Court had to decide whether an SPC could be granted for the combination of ezetimibe and simvastatin, even if a previous SPC had already been granted for ezetimibe alone based on the same patent. [read post]
5 Sep 2022, 4:58 am
Apotex, Inc., 531 F.3d 1372 (Fed. [read post]
21 Jun 2022, 12:18 am
., Teva, 595 F.3d at 1317-18; see also Apotex, Inc. v. [read post]
