By Kurt R. Karst – In music, “coda” is a term used primarily to designate a passage that brings a piece (or a movement, which may be part of a symphony – an extended musical composition) to an end – the “fine.” A coda can be …
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Hatch-Waxman
- The Coda in the ANGIOMAX Symphony; Approaching Fine (the End)February 9th, 2012
- DC District Court Grants FDA Summary Judgment in Generic LOVENOX DisputeFebruary 7th, 2012
By Kurt R. Karst – On February 7, 2012, Judge Amy Berman Jackson of the U.S. District Court for the District of Columbia issued her decision in the long-running dispute concerning FDA’s July 23, 2010 approval of Sandoz Inc.’s (“Sandoz’s”) ANDA No. 077857 for a generic version …
- PTO Challenged After Denying a Patent Term Extension Based on First Commercial Marketing or Use GroundsJanuary 31st, 2012
By Kurt R. Karst – The U.S. Patent and Trademark Office (“PTO”) has been sued once again after denying a Patent Term Extension (“PTE”) request. The latest case in a long line of lawsuits concerns U.S. Patent No. 5,206,248 (“the ‘248 patent”), which is listed in …
- A New Hatch-Waxman DJ Jurisdiction Decision . . . . And an Added TwistJanuary 24th, 2012
By Kurt R. Karst – In a recent Hatch-Waxman decision from the U.S. District Court for the Northern District of Illinois (Eastern Division), the court denied Plaintiffs’ Seattle Children’s Hospital, Novartis Vaccines and Diagnostics, Inc., and Novartis Pharmaceuticals Corporation (collectively “Novartis”) Motion to Dismiss the lawsuit …
- Leap Year and Hatch-Waxman – An Unusual Conundrum Years in the MakingJanuary 23rd, 2012
By Kurt R. Karst – It’s absolutely amazing how, after nearly 28 years, the 1984 Hatch-Waxman Amendments continue to provide surprises. Consider the latest example we came upon recently (with a little help) involving PRISTIQ (desvenlafaxine) Extended-Release Tablets. FDA approved PRISTIQ under NDA No. 021992 in a …
- ACI’s FDA Boot Camp ConferenceJanuary 19th, 2012
The American Conference Institute will be holding its FDA Boot Camp conference in New York City from Tuesday, March 20 to Wednesday, March 21, 2012. A copy of the conference program can be obtained here. Hyman, Phelps & McNamara, P.C.’s Kurt R. Karst will be …
- FDA Sends User Fee Pacts to Congress; Proposed Generic Drug User Fee Statute Includes Some Unique ProvisionsJanuary 18th, 2012
By Kurt R. Karst – Last week, FDA Commissioner Margaret A. Hamburg, M.D. announced that the Agency sent to Congress packages for three user fee programs, including proposed statutory language for the fifth iteration of the Prescription Drug User Fee Act (“PDUFA V”), and two new …
- FDA Denies Petition Seeking to Add Application Information to Drug LabelsJanuary 12th, 2012
By Kurt R. Karst – FDA recently denied a 2008 citizen petition (Docket No. FDA-2008-P-0291) requesting that the Agency amend its drug label regulations to require that product labels include the Orange Book-listed NDA number under which the product is approved. According to the petition, “[i]ncreasingly, …
- A Federal Court Win on the RLD Theory of Liability; More of Moore Will Likely be Called ForJanuary 9th, 2012
By Kurt R. Karst – In what appears to be the first federal court decision on the so-called Reference Listed Drug (“RLD”) theory of liability, Judge Marvin H. Shoob of the U.S. District Court for the Northern District of Georgia (Atlanta Division) recently ruled in Moore …
- “Size Matters,” Says FDA, When it Comes to Generic Drug-RLD SamenessJanuary 4th, 2012
By Kurt R. Karst – In what appears to be a further sign of FDA’s efforts to clamp down on differences between brand-name Reference Listed Drugs (“RLDs”) and their proposed generic counterparts, FDA’s Office of Generic Drugs (“OGD”) is now looking more closely at tablet size …
- FDA Proposes Generic Drug User Fee System and Performance GoalsDecember 7th, 2011
By Kurt R. Karst – Just one day after FDA announced a December 16th public meeting and comment period to discuss the Agency’s proposed recommendations for a user fee program for biosimilar biological products for Fiscal Years (“FYs”) 2013 through 2017 (see our post here), the …
- FDA Proposes to Depart From Conventional Bioequivalence Metrics; Draft Guidance Proposes Partial AUC for Generic RITALIN LANovember 30th, 2011
By Kurt R. Karst – In what appears to be the second guidance of its kind, FDA proposed in a draft bioequivalence guidance document issued earlier this week that companies seeking approval to market generic versions of RITALIN LA (methylphenidate HCl) Extended-Release Capsules must, in addition …
- NJ District Court Dismisses Patent Use Code Counterclaim as Not Valid Under Current Law; All Eyes Move to the Supreme Court PRANDIN Use Code CaseNovember 21st, 2011
By Kurt R. Karst – Less than a month before the U.S. Supreme Court is scheduled to hear Oral Argument in Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S, Docket No. No. 10-844 (see here and here), concerning whether the patent delisting counterclaim provisions at FDC …
- The FAIR Generics Act Makes its Debut; the Bill Takes a New Tack in Addressing Patent Settlement AgreementsNovember 16th, 2011
By Kurt R. Karst – On November 16th, Senators Jeff Bingaman (D-NM), David Vitter (R-LA), Sherrod Brown (D-OH), and Jeff Merkley (D-OR) announced the introduction of the Fair And Immediate Release of Generic Drugs Act, or the “FAIR GENERxICS Act,” a draft version of which is …
- FDA is Sued After Approving Generic Topical Corticosteroid Drug Products; Lawsuit Seeks Withdrawal or Suspension of ANDA ApprovalsNovember 16th, 2011
By Kurt R. Karst – In a lawsuit filed in the U.S. District Court for the District of Columbia, Florida-based Hill Dermaceuticals, Inc. (“Hill”) is seeking declaratory and injunctive relief after FDA approved, on October 17, 2011, three ANDAs submitted by Identi Pharmaceuticals Inc. (“Identi”) – …