By Kurt R. Karst – There’s no rest for the weary! There certainly hasn’t been much rest for FDA’s litigation team this past week . . . . and it’s not getting any better. The week started off quiet (though clearly anxiety was in the air), …
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Prescription Drugs and Biologics
- It’s Been One of “Those Weeks” in Hatch-Waxman World: Another Two Lawsuits and Two Court DecisionsApril 30th, 2015
- HP&M Attorneys Author Chapters in FDLI’s “Bringing Your Pharmaceutical Drug to Market” GuidebookApril 28th, 2015
In a new guidebook published by the Food and Drug Law Institute, David B. Clissold and James E. Valentine of Hyman, Phelps & McNamara, P.C. co-authored Chapter 3-1, “FDA Regulatory Scheme,” and Alexander J. Varond authored Chapter 3-7, “Orphan Drugs.” Both chapters cover essential elements of …
- You’re Invited . . . To a Dance Party! Will You Dance the Amgen Waltz, or the Sandoz Shuffle?April 27th, 2015
By Kurt R. Karst – As you enter the Courtroom 402 “dance hall” at the U.S. Court of Appeals for the Federal Circuit on Wednesday, June 3, 2015, you’ll have to decide whether to take an initial right step and join the Amgen Inc. …
- CDER Announces Public Compendium of Clinical Outcome Assessments with Hopes of Facilitating Greater Use in Drug DevelopmentApril 20th, 2015
By James E. Valentine* & Josephine M. Torrente – During FDA’s April 1, 2015 public workshop on clinical outcome assessments (COAs), in a presentation on the future of COA development and utilization in drug development programs, officials from CDER’s Study Endpoints and Labeling Development (SEALD) staff …
- Awesome Baby; We Love This Game! An Update on Pending Hatch-Waxman and BPCIA LitigationApril 8th, 2015
By Kurt R. Karst – Some days we feel like the “Dickie V” (Dick Vitale) of the Hatch-Waxman and Biosimilars worlds – enthusiastically calling play-by-play on litigation and other FDA happenings, just like the Basketball Hall of Fame broadcaster does for college basketball games. (And while …
- FDA Revises Formal Meetings Guidance for PDUFA ProductsApril 6th, 2015
By Alexander J. Varond – After six years of operating under its May 2009 “Guidance for Industry: Formal Meetings Between the FDA and Sponsors of Applicants,” FDA refreshed its guidance. On March 11, FDA announced its draft guidance entitled “Formal Meetings Between the Food and Drug Administration and …
- Federal Circuit Rules that a Statutory Patent Disclaimer is Sufficient to Trigger Hatch-Waxman DJ Jurisdiction; Will It Be Enough to Trigger a Forfeiture of 180-Day Exclusivity?April 5th, 2015
By Kurt R. Karst – Last week, the U.S. Court of Appeals for the Federal Circuit ruled in Apotex Inc. v. Daiichi Sankyo, Inc., saying that there is subject matter jurisdiction to hear a declaratory judgment action of non-infringement for a disclaimed Orange Book-listed patent. The …
- Critical Path Innovation Meetings: A New Opportunity to Discuss Drug Development Issues with FDAApril 2nd, 2015
By James E. Valentine*, Josephine M. Torrente & Frank J. Sasinowski – On March 31, 2015, FDA’s Center for Drug Evaluation and Research (“CDER” or the “Center”) finalized its Guidance for Industry: Critical Path Innovation Meetings, establishing an enduring function of the Center to facilitate Critical Path …
- The PATIENT Act’s Proposed Exclusivity-Stacking Two-Year Extension: Is it an Incentive, a Reverse Incentive . . . or Both?March 30th, 2015
By Kurt R. Karst – Over the past few months we’ve seen various pieces of the 21st Century Cures Initiative discussion draft released as stand-alone bills in both the U.S. House of Representatives and the U.S. Senate (see our FDA Legislation Tracker). One section of the …
- Somebody’s Thinking Ahead! New Legislation Seeks Some Clarity as the BPCIA’s March 2020 Transition Deadline Appears on the HorizonMarch 30th, 2015
By Kurt R. Karst – Last week marked the 5th anniversary of the March 23, 2010 enactment of the Affordable Care Act (“ACA”). Title VII of the ACA, the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”), amended the Public Health Service Act (“PHS Act”) …
- Denied Again! Another Obstacle to Biosimilar First Launch Falls with FDA Rejection of Amgen’s Certification Petition; Meanwhile, an Appeal is Filed in the Patent Dance LitigationMarch 26th, 2015
By James C. Shehan – Events keep on coming at a furious pace in the biosimilar world, with two new developments in the battle between Amgen and Sandoz over the latter’s hopes to launch its recently approved Zarxio, a biosimilar version of the former’s Neupogen (filgrastim). On March …
- The Advancing Hope Act of 2015 – A First Shot at Reauthorizing the Rare Pediatric Disease Priority Review Voucher ProgramMarch 26th, 2015
By Alexander J. Varond – On March 23, Representative G.K. Butterfield (D-NC) introduced H.R. 1537, the “Advancing Hope Act of 2015.” The Advancing Hope Act would reauthorize the rare pediatric disease priority review voucher (“Pediatric Voucher”) program, which is slated to sunset in March 2015. Rep. …
- Otsuka Sues FDA Over “Corrected” ABILIFY Approval; Alleges Violation of the Most Fundamental Precept of FDA’s Statutory Drug Approval AuthorityMarch 25th, 2015
By Kurt R. Karst – Does FDA has the authority to approve a new indication for an approved drug when that new indication has not been shown to be safe and effective by adequate and well-controlled studies submitted by the sponsor of the application? And under …
- One, Two, Three . . . and They’re Out! FDA Issues Third Rare Pediatric Disease Priority Review Voucher, Triggering One-Year Sunset ClauseMarch 23rd, 2015
By Alexander J. Varond & Josephine M. Torrente – On March 17, 2015 FDA approved Cholbam (cholic acid) for pediatric and adult patients with bile acid synthesis disorders due to single enzyme defects, and for patients with peroxisomal disorders. In approving Cholbam, FDA also issued the third …
- Denied! District Court Rules in NEUPOGEN Biosimilar Litigation; Says that the BPCIA’s “Patent Dance” Procedures are Optional, and Notice Can Come Before Commercial MarketingMarch 20th, 2015
By Kurt R. Karst – Hopes for a victory were running high among folks in the blossoming biosimilars industry after Judge Richard Seeborg of the U.S. District Court for the Northern District of California indicated at a hearing last Friday (March 13th) that he wasn’t inclined …