By Kurt R. Karst – Earlier this week FDA finally released its Manual of Policies and Procedures (“MAPP”) on NDA Classification Codes (MAPP 5018.2) – formerly called “Chemistry Classification Codes.” The MAPP has been under development for quite some time . . . . and there’s …
By Kurt R. Karst – Hatch-Waxman Patent Term Extension (“PTE”) disputes never get old for this blogger. There’s often some new twist for FDA or the U.S. Patent and Trademark Office (“PTO”) to consider, as shown in a recent PTE denial for a patent concerning the …
By Kurt R. Karst – Predicting the future is a tricky business. Predictions don’t often pan out, even when most or all of the indicators prognosticators use say something will (or will not) happen. We have a pretty decent track record of guessing how a case …
By Kurt R. Karst – Hatch-Waxman controversies are often like trains barreling down railroad tracks. They first appear in the distance as small objects, seemingly moving at a slow velocity. But with each passing moment, the object grows larger and more distinct, and appears to pick …
By Kurt R. Karst – On September 30, 2015, Judge Randolph D. Moss of the U.S. District Court for the District of Columbia issued his highly-anticipated decision in a lawsuit lodged by Eisai Inc. (“Eisai”) last August challenging FDA's April 2014 denial of a Citizen Petition (Docket No. FDA-2013-P-0884) requesting that the Agency conclude that the …
By Kurt R. Karst – FDA recently released the Agency’s Seventh Annual Report to Congress, required by FDC Act § 505(q)(3), on FDA’s experience during Fiscal Year 2014 (“FY 2014”) with citizen petitions subject to FDC Act § 505(q). Other than some updated numbers fo FY …
By Kurt R. Karst – Finding new ways to incentivize and reward drug development for particular therapeutic needs is all the rage these days. Over the past few years we’ve seen several new incentives incorporated (and proposed for incorporation) into the FDC Act. These new incentives …
By Kurt R. Karst – Last week, Senators Amy Klobuchar (D-MN) and Charles Grassley (R-IA) announced the introduction of S. 2019, the Preserve Access to Affordable Generics Act. The bill is the latest attempt to pass legislation to address pharmaceutical patent settlement agreements (aka “reverse payment …
By Kurt R. Karst – It’s been a while since we peeked in on the appeals Takeda Pharmaceuticals U.S.A., Inc. (“Takeda”) and Elliott Associates, L.P., Elliott International, L.P. and Knollwood Investments, L.P. (collectively “Elliott”) filed with the U.S. Court of Appeals for the District of Columbia …
By Kurt R. Karst – Finger through the “Discontinued Drug Product List” section of the Orange Book and youl’ll quickly realize that there are a lot of drug products no longer marketed. The “Discontinued Drug Product List” spans 337 pages in the current annual edition of …
By Kurt R. Karst – Back in September 2013, when FDA’s Office of Generic Drugs (“OGD”) was gearing up for significant implementation of the Generic Drug User Fee Amendments of 2012 (“GDUFA”) (and the associated Performance Goals and Procedures), the Office issued a Manual of Policies …
By Kurt R. Karst – It seems that hardly a week passes (and sometimes, hardly a day or two) without news of a new merger or acquisition in the pharmaceutical or biotechnology industries. Indeed, 2015 may be a record-breaking year for such deals (see here, here, …
By Kurt R. Karst – Earlier this week, the U.S. District Court for the District of Maryland unsealed a 73-page Opinion handed down on July 29, 2015, along with an Order, in a challenge brought by Mallinckrodt Inc. (“Mallinckrodt”) last November after FDA downgraded from “AB” …
By Kurt R. Karst – There are few things this blogger relishes more in his practice than getting his hands on FDA exclusivity decisions. (It’s like being given and then unwrapping a holiday gift.) We don’t mean the “decisions” that most people see in ANDA approval letters …
By Kurt R. Karst – It’s been almost seven weeks since the U.S. District Court for the District of Columbia issued its Opinion in Veloxis Pharmaceuticals. Inc. v. FDA, ___ F.Supp.3d ___, 2015 WL 3750672 (June 12, 2015), a challenge concerning the scope of 3-year new …
