Recent Posts
- Hikma v. Vanda: Oral Argument Recap
- Teva v. Lilly should not be read as creating a new 112 rule for method of use claims
- Should ANDA filers be using the PTAB to mount early challenges to OB patents?
- Switching to WordPress
- Judge Hughes concurrence highlights post grant review appeal standing issue for pharma cases
Category: 30-Month Stay
-
As readers of this blog surely known, parties seeking to launch a generic drug must address the patents listed in the Orange Book for the reference listed drug. Listing of a patent in the Orange Book is a powerful tool for pharmaceutical patent owners, as it gives the right to an automatic 30 month stay…
-
Endo Pharmaceuticals v. Mylan, No. 11-220-GMS (D. Del.) In an opinion filed on Monday, the U.S. District Court for the District of Delaware granted leave to Endo Pharmaceuticals to file an amended complaint to correct a defective initial complaint. In doing so, the court found that Endo's first complaint, while defective, properly triggered a statutory thirty-month…
-
"The MMA generally precludes multiple 30-month stays for those applications to which it applies." That is a statement from the FDA in a draft guidance document entitled "Listed Drugs, 30-Month Stays, and Approval of ANDAs and 505(b)(2) Applications Under Hatch-Waxman, as Amended by the Medicare Prescription Drug, Improvement and Modernization Act of 2003," published in October…
Orange Book Blog 