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22 Mar 2007, 12:50 pm
Pediatric studies submitted in a supplemental application for a drug that has already received one period of pediatric exclusivity may qualify the drug to receive another 6-month period of pediatric exclusivity, however the second 6-month period will attach only to the 3 year exclusivity period (under sections 505(c)(3)(D)(iv)) and 505(j)(5)(D)(iv)) granted to the supplemental application for which the studies were completed. [read post]
16 May 2016, 12:02 pm
Szyba, and Ephraim J. [read post]
4 Jan 2016, 9:01 pm
Thus, the granting of rights to a former stepparent raises serious constitutional concerns. [read post]
5 Apr 2011, 2:35 pm
There are two patents listed in the Orange Book for Warner Chilcott Pharmaceuticals, Inc. [read post]
29 Sep 2016, 2:24 pm
Corp. (98 AD3d 848 [1st Dept 2012] [Acosta, J., concurring]), "I would hold that a plaintiff does not have th[e] burden [of disproving the affirmative defense of comparative negligence]. [read post]
30 Apr 2013, 1:54 pm
The most up-to-date draft version of the ERRB available to the public (a link to which was provided by Andy J here) provided that the Secretary of State might by regulations authorise a subject (to be determined by such secondary legislation) to grant licences in respect of orphan works (also these to be defined by means of secondary legislation). [read post]
3 Jun 2024, 1:48 am
The law, which came into force last year, granted automatic anonymity to individuals suspected of sexual assault prior to charge. [read post]
21 Dec 2010, 11:00 am
FDA granted the petition in October. [read post]
20 Dec 2024, 6:30 am
Although they did not write the book specifically to sober or chasten liberal and progressive aspirations concerning the possibilities for repair, the book has had that effect upon us. [read post]
27 Apr 2022, 7:29 am
Circuit Judge J. [read post]
23 Sep 2010, 12:39 pm
Section 355(j)(2)(A)(vii), with respect to the compound claims in the '937 patent directed to famciclovir; and (ii) as reflected in the FDA's Orange Book, Novartis is entitled to marketing exclusivity with respect to those tablets until March 21, 2011. [read post]
8 Mar 2011, 1:38 am
Huller: Vice President - Legal, Globus Medical, Inc.John J. [read post]
16 Nov 2015, 11:49 am
Michael J. [read post]
15 Feb 2011, 3:01 pm
(see J 5/80 [headnote 1]).Taking of all due care by the representativeGeneral statements on due care[5.2.1] The following statements are extracted from the Case Law Book (Fifth edition). [read post]
19 Apr 2010, 1:34 pm
” INTEGRILIN is covered by five Orange Book-listed patents. [read post]
26 Jan 2022, 6:30 am
J. 785 (1984) (esp 791). [read post]
28 Feb 2025, 9:10 am
J. [read post]
5 Sep 2009, 5:54 am
"--Anthony J. [read post]
23 May 2016, 9:01 pm
Or take notice of the efforts of Oklahoma legislators—at the same time they were passing an unconstitutional bill to ban all abortions (vetoed by their governor)—to pass a law that would grant students a right to avoid sharing a bathroom with a transgender student in the name of religious freedom.Why all the hubbub? [read post]
27 Oct 2012, 12:35 pm
"--Micah J. [read post]
