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Orange Book Patent Listing Precipitates DJ Action to Trigger Generic KEPPRA XR 180-Day Exclusivity Forfeiture
28 Mar 2011, 2:42 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Pharmaceutical, Biotechnology and Chemical Inventions - World Protection and Exploitation
24 Mar 2011, 10:12 am by FDABlog HPM
Dormer and Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
New IP resource for Pharma, Biotech and Chem – Compulsory licences, comparing national requirements
21 Mar 2011, 9:14 pm by Duncan
Jenkins, UK Fabrizio Jacobacci, Studio Legale Jacobacci & Associati, Italy Kurt R. [read post]
IP Thinktank - http://duncanbucknell.com/ipthinktank.blog
Sen. Casey Takes Over the Reins for the Creating Hope Act; New Bill Substantially Mirrors Sen. Brownback’s 2010 Version
21 Mar 2011, 1:12 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
FDA Issues New Guidance on PDUFA User Fee Waivers, Reductions, and Refunds; Guidance Represents the Culmination of 18 Years of FDA Experience
21 Mar 2011, 12:00 pm by FDABlog HPM
Butler & Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Judge Snuffs Out Holistic Candlers Lawsuit; Constitutional Challenge Falls on Deaf Ears
20 Mar 2011, 10:10 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Recent Hatch-Waxman Scholarship Suggests Patent Settlement and Product Hopping Create a “Lethal Combination”; Another Article Proposes a “Smith Barney Approach” to 180-Day Exclusivity
15 Mar 2011, 12:46 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Orange Book Patent Delisting Counterclaim Raised in 505(b)(2) Application Patent Infringement Litigation; Decision Could Provide Guidance on Drug Delivery System Patent Listability
8 Mar 2011, 12:40 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
New IP resource for Pharma, Biotech and Chem – Licensing and listing
7 Mar 2011, 9:38 pm by Duncan
Jenkins, UK Fabrizio Jacobacci, Studio Legale Jacobacci & Associati, Italy Kurt R. [read post]
IP Thinktank - http://duncanbucknell.com/ipthinktank.blog
Supreme Court Shuts Another Door on Patent Settlement Agreement Antitrust Challenge – Denies Certiorari in CIPRO Case
7 Mar 2011, 1:45 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
FDA Announces Major Enforcement Action on Marketed Unapproved Prescription Cough, Cold, and Allergy Drug Products
2 Mar 2011, 10:27 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Snowmageddon, a Government Shutdown, and Other Acts of Nature (Mother or Human) – What are the Effects on FDA Approval Decision Deadlines?
1 Mar 2011, 1:32 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Fifth Circuit Vacates District Court “Second Inspection Ruling” in Compounding Pharmacy Case
28 Feb 2011, 3:53 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
The Itch is Scratched – FDA Denies XYZAL Carve-Out Petition; Another Precedent Added to the Generic Drug Labeling Carve-Out Citizen Petition Scorecard
24 Feb 2011, 1:40 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
District Court’s Extension of 30-Month Stay on Generic XYZAL Approval Ends; ANDA Sponsors are Itching for an FDA Decision on “Carved-Out” Urticaria-Only Labeling
23 Feb 2011, 10:58 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Legislation to Ban Authorized Generics During 180-Day Exclusivity Period Makes a Comeback in Congress
21 Feb 2011, 1:04 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
The President’s FY 2012 Budget Would Create New User Fees, Ban Patent Settlements, and Reduce BPCIA Reference Product Exclusivity
15 Feb 2011, 10:05 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Subsequent ANDA Sponsor Says DETROL LA Patent Has Gotta Go; But Would a Final Court Decision Trigger 180-Day Exclusivity?
10 Feb 2011, 5:35 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
The Fat Lady Goes Back to Her Dressing Room; Federal Circuit Denies MDCO Motions in ANGIOMAX PTE Litigation
6 Feb 2011, 10:41 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
OGD Finished 2010 on a High Note – Really High!
3 Feb 2011, 2:01 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/