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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Hatch-Waxman
- It’s Been One of “Those Weeks” in Hatch-Waxman World: Another Two Lawsuits and Two Court DecisionsApril 30th, 2015
- 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 …
- No Beginning and No End: A Moment of Zen in the Patent Term Extension WorldApril 7th, 2015
By Kurt R. Karst – It’s not all that often that we see the Patent and Trademark Office (“PTO”) dismiss or deny a request to extend the term of a patent covering a medical device, though such actions on a Patent Term Extension (“PTE”) request do …
- 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 …
- 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”) …
- 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 …
- Protecting Patent Exclusivity: House Passes Bill to Ensure that Drug Scheduling Does Not Adversely Effect Marketing of NCEsMarch 17th, 2015
By John A. Gilbert – On March 16th, the U.S. House of Representatives passed by voice vote H.R. 639, the Improving Regulatory Transparency for New Medical Therapies Act, which would amend the Federal Food, Drug & Cosmetic Act (FD&C Act) and the Controlled Substances Act (CSA) …
- The Everlasting Patent: Is it Hiding in Plain Sight in the 21st Century Cures Act?March 16th, 2015
By Kurt R. Karst – Nothing lasts forever in our mortal world, though some things try to come close: Wonka’s Everlasting Gobstoppers, The NeverEnding Story, Doctor Who, the Energizer Bunny . . . . and perhaps one day in the not too distant future, the Everlasting …
- FDA’s Anti-Franchising Policy: What Is It and Where Did It Come From?March 4th, 2015
By Kurt R. Karst – Every once in a while FDA gets asked a question along the lines of: “Can my company submit two ANDAs to FDA – from two different subsidiaries – each containing the same bioequivalence data?” . . . or “Can my company …
- A New Variation on an Old Theme: FDA Refuses PTE Regulatory Review Period Revision Based on Filing Refusal DecisionFebruary 24th, 2015
By Kurt R. Karst – It’s been a long time since we last posted on a Patent Term Extension (“PTE”) controversy – a little more than a year it seems (see here) – but that doesn’t mean we’re not keeping an eye on decisions coming out …
- Would You Balk at Disclosing Confidential Information to Your Competitors?February 18th, 2015
By Kurt R. Karst – Without even knowing what we’re talking about, it’s probably safe to say that any company would immediately answer “Yes!” to the question posed in the title to this post. But that’s exactly what FDA is asking some ANDA applicants to do …
- Can the AIA’s New IPR and PGR Post-Grant Proceedings Trigger a Forfeiture of 180-Day Exclusivity Under the Failure-to-Market Provisions?February 17th, 2015
By Kurt R. Karst – Last year we posted on the possible effect of Inter Partes Review (“IPR”) on the forfeiture of 180-day exclusivity eligibility under the so-called failure-to-market forfeiture provisions at FDC Act § 505(j)(5)(D)(i)(I) added by the 2003 Medicare Modernization Act. With no decision …
- We Need to Move the Freight and Not be Late, Says OGD’s Uhl in GDUFA Update; But for Many in Industry, “Seeing is Believing”February 13th, 2015
By Kurt R. Karst – For those in the generic drug industry who attended the Generic Pharmaceutical Association’s (“GPhA’s”) annual meeting in Miami, Florida earlier this week, the message from Office of Generic Drugs (“OGD”) Director Dr. Kathleen “Cook” Uhl in her Generic Drug User Fee …
- FINALLY! Multiple Generic Companies Receive FDA Final Approval to Market Generic Versions of Celebrex®February 12th, 2015
By Douglas B. Farquhar, Jennifer M. Thomas & Kurt Karst – We can’t help celebrating a recent court victory in which Hyman, Phelps & McNamara, P.C. represented Mylan Pharmaceuticals, Inc. (“Mylan”), and which yesterday resulted in Final Approvals for Mylan and one other generic drug company …