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Report Predicts Tough Road Ahead for Some Generics After Federal Circuit Patent Use Code Decisions
3 Sep 2010, 11:42 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
APP Moves Forward With Appeal Notice in ANGIOMAX PTE Litigation in Light of PTO/FDA Indecision
2 Sep 2010, 10:21 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
District Court Denies Apotex Declaratory Judgment Motion on Generic ARICEPT; Does Not Accept “Prompt Launch” and “Indefinite Delay” Jurisdiction Theories
1 Sep 2010, 6:49 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
GAO Issues Report on Non-Inferiority Studies; Finds No Evidence of “Biocreep,” But More Conservative Use of Such Studies to Support Approval
30 Aug 2010, 11:53 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
D.C. District Court Denies Preliminary Injunction in Generic LOVENOX Case; Is the Juice Worth the Squeeze for Sanofi to Appeal?
26 Aug 2010, 10:01 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Patent Expiration, Pediatric Exclusivity, and Generic Drug Approval – Some Interesting Tensions Between the FDC Act and Patent Law
18 Aug 2010, 11:34 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
FDA Issues NOOH Proposing to Withdraw All Midodrine HCl Approvals
16 Aug 2010, 1:25 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
New Analysis Takes Issue with CBO Patent Settlement Legislation Cost Estimate
16 Aug 2010, 8:10 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Another Advocacy Group Asks FDA to Increase Marketed Unapproved Drugs Enforcement Crackdown
12 Aug 2010, 12:25 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Induced patent infringement across the globe – are you ready?
12 Aug 2010, 2:28 am by Duncan
Jenkins, UK Fabrizio Jacobacci, Studio Legale Jacobacci & Associati, Italy Kurt R. [read post]
IP Thinktank - http://duncanbucknell.com/ipthinktank.blog
180-Day Exclusivity – From Abacavir Sulfate to Zolpidem Tartrate
10 Aug 2010, 8:41 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Senator Brownback Introduces the Creating Hope Act of 2010; Bill Would Change the Priority Review Voucher Program and Extend it to Applications for Rare Pediatric Diseases
5 Aug 2010, 11:49 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
UPDATE - Generic Drug Labeling Carve-Out Citizen Petition Scorecard
4 Aug 2010, 3:45 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
MDCO Prevails in ANGIOMAX PTE Case – District Court Grants Summary Judgment; Will the PTO Appeal?
3 Aug 2010, 1:57 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
NRDC Sues FDA for Failing to Take Action on Triclosan and Triclocarban
3 Aug 2010, 10:59 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Up, Up and Away! FDA Sets Fiscal Year 2011 User Fee Rates
3 Aug 2010, 6:57 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Preserve Access to Affordable Generics Act Included in FY 2011 Financial Services and General Government Appropriations Bill
30 Jul 2010, 5:46 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Federal Circuit Denies Rehearing Petition in PRANDIN Patent Use Code Case; Dissents Argue that “Section viii” Carve-Outs Eviscerated
29 Jul 2010, 10:24 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
DC District Court Denies Sanofi Summary Judgment Motion in Generic ELOXATIN Case; Refuses to Reinstate 30-Month Stay on ANDA Approvals
28 Jul 2010, 7:53 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
The Other Shoe Drops . . . . Sanofi Sues FDA Over Generic LOVENOX Approval
27 Jul 2010, 4:55 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/