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6 May 2024, 9:43 am by Dennis Crouch
Apotex, Inc., the Federal Circuit affirmed a district court holding that the claimed “kit” with a label instructing once-daily dosing of a budesonide drug was invalid because “the instructions in no way function with the drug to create a new, unobvious product. [read post]
25 Mar 2024, 4:36 am by Dennis Crouch
Teva & Apotex’s Arguments Against Certiorari Vanda forfeited its “predictability” argument by not raising it below. [read post]
19 Feb 2024, 12:55 pm by Dennis Crouch
  Teva and Apotex, filed Abbreviated New Drug Applications (ANDAs) with the FDA seeking to market generic versions of the $100m+ drug. [read post]
4 Feb 2024, 11:54 am by Alastair Clarke
They are then forced to spend the time to review the application history, review the 8-step legal test set out in Apotex and make a decision re the duty to perform. [read post]
19 Jan 2024, 4:00 am by Alan Macek
In other contexts, there have been concerns that double patenting may increase burdens under the Notice of Compliance regime for pharmaceuticals – see for example, Glaxosmithkline Inc. v Apotex Inc, 2003 FCT 687 at 90: “The existence of additional patents allows the patent-holder to bring additional applications, thereby obtaining multiple injunctive periods. [read post]
1 Dec 2023, 4:00 am by Martin Kratz
How far such edits must go is put in doubt by the Federal Court of Appeal decision in Apotex Inc. v. [read post]
27 Oct 2023, 6:17 am by Searcy Law
On March 2, 2023, Apotex Corp. issued a recall due to “cracks that have developed” in some of the bottles used to store its Apotex-brand eye drops. [read post]
27 Oct 2023, 6:17 am by Searcy Law
On March 2, 2023, Apotex Corp. issued a recall due to “cracks that have developed” in some of the bottles used to store its Apotex-brand eye drops. [read post]
27 Oct 2023, 6:17 am by Searcy Law
On March 2, 2023, Apotex Corp. issued a recall due to “cracks that have developed” in some of the bottles used to store its Apotex-brand eye drops. [read post]