By Kurt R. Karst – Each year around this time, some of us at our firm participate in a version of The Price Is Right Showcase Showdown in which folks “bid” on what they think the PDUFA application user fee rate will be set at for …
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Prescription Drugs and Biologics
- PDUFA IV User Fees End With a Bang, Not a Whimper! Application Fee Increases by a Whopping 19.4% (or Almost $300K)July 31st, 2011
- District Court Says “Shall” Means “Must” in Challenge to PTO Denial of Interim Patent Term ExtensionJuly 25th, 2011
By Kurt R. Karst – Late last week, the U.S. District Court for the Eastern District of Virginia granted the U.S. Patent and Trademark Office’s (“PTO’s”) Motion for Summary Judgment in a challenge mounted by the Genetics & IVF Institute (“GIVF”) to the PTO’s August 2010 …
- Will the Fourth Time be the Charm? FDA is Once Again Asked for Guidance on Drug Delivery Device Patent Orange Book ListingJuly 21st, 2011
By Kurt R. Karst – FDA has been asked for a fourth time to provide an advisory opinion on compliance with the Hatch-Waxman Orange Book patent listing requirements for a patent that claims a drug delivery device integral to the administration of the active ingredient, but …
- The Scope of New Chemical Entity Exclusivity and FDA’s “Umbrella” Exclusivity PolicyJuly 20th, 2011
By Kurt R. Karst – Suppose FDA approves a New Drug Application (“NDA”) – NDA No. 1 – and grants a period of 5-year New Chemical Entity (“NCE”) exclusivity, but there are no patents listed in FDA’s Orange Book for the NDA, and therefore, there is …
- Court Dismisses, on Ripeness Grounds, Cephalon Challenge to Generic FENTORA ApprovalJuly 18th, 2011
By Kurt R. Karst – Last week, Judge Ellen S. Huvelle of the U.S. District Court for the District of Columbia dismissed without prejudice for lack of subject matter jurisdiction a Complaint filed by Cephalon, Inc. (“Cephalon”) on March 15, 2011 challenging FDA’s January 7, 2011 …
- Priority Review Vouchers – Not Much Bang for the BuckJuly 11th, 2011
By Kurt R. Karst – A recent article in The RPM Report concerning the apparent fate of the only Priority Review Voucher (“PRV”) issued to date by FDA caught our attention. Kudos to The RPM Report team, which took note of some statements made during a …
- Will the Dog Days of Summer Offer a Reprieve to FDA and the Regulated Industry (and Your Bleary-Eyed Bloggers)? DoubtfulJuly 6th, 2011
By Kurt R. Karst – Over the Independence Day holiday, in between the family BBQ and fireworks, we had a few minutes to reflect on what a hectic month June was for FDA and the regulated industry. There were the decisions handed down by the U.S. …
- Is Information Contained in a Paragraph IV Certification Notice Letter Accompanied by an Offer of Confidential Access Subject to Public Disclosure? One District Court has an AnswerJune 29th, 2011
By Kurt R. Karst – A recent unpublished decision out of the U.S. District Court for the District of New Jersey presented an interesting public disclosure issue that we think will be of interest to the Hatch-Waxman community. The case, like so many Hatch-Waxman cases, is …
- Efforts to Obtain a PTE for ANGIOMAX Patent Continue as the U.S. House Passes an Amendment to the America Invents Act in “After Business Hours” VoteJune 28th, 2011
By Kurt R. Karst – The continuing court battle over a Patent Term Extension (“PTE”) for U.S. Patent No. 5,196,404 (“the ‘404 patent”) covering The Medicines Company’s (“MDCO’s”) ANGIOMAX (bivalirudin) could be derailed if a recent amendment added to the House version of the America Invents …
- DDMAC – When Two Well-Controlled Studies Do Not Equal Substantial EvidenceJune 27th, 2011
By Dara Katcher Levy – Last week, FDA’s Division of Drug Marketing, Advertising, and Communications (“DDMAC”) released an Untitled Letter issued to Novartis on May 31st, which alleges the company made unsubstantiated superiority claims in a detail aid for its ADHD drug, Focalin XR. Unlike most …
- Freedom and Unity to Use IMS Prescribing Data in VermontJune 24th, 2011
By Ben Wolf* and Jeff Wasserstein – Justice Kennedy delivered the opinion of the Supreme Court in today’s 6-3 decision in Sorrell v. IMS Healthcare Inc. (Docket No. 10-779). This decision strikes down a Vermont law prohibiting the sale, disclosure, and use of pharmacy records that reveal …
- Supreme Court Issues Decision on Generic Drug Preemption; To Borrow From Harry Caray – “Holy Cow! Generics Win! Generics Win!”June 23rd, 2011
By Kurt R. Karst – Like a young attorney (full of angst) waiting for Bar Exam results to be posted on the Internet, we sat in front of our computer this morning constantly hitting the “refresh” button to update the U.S. Supreme Court’s “2010 Term Opinions …
- Tentatively, FDA Hones In On A Working Definition of NanotechnologyJune 19th, 2011
By Ricardo Carvajal & Riëtte van Laack – When the FDA Nanotechnology Task Force issued its report in 2007, it declined to adopt precise definitions of the terms "nanoscale materials" or "nanotechnology," opting instead to take an inclusive approach. FDA has now issued draft guidance on nanotechnology …
- HP&M Director Named to ACTION Board of AdvisorsJune 15th, 2011
Hyman, Phelps & McNamara, P.C.’s David B. Clissold has been named to the Board of Advisors of Analgesic Clinical Trial Innovations, Opportunities, and Networks (“ACTION”). ACTION is a public-private partnership aligned with FDA’s recently launched Initiative for the Advancement of Regulatory Science. ACTION is designed …
- Smarter than the Average Bear? Two Recent Lifecycle Management Strategies of NoteJune 13th, 2011
By Kurt R. Karst – Like Yogi Bear, who is always on the lookout for a better way to procure pic-i-nic baskets, we are always on the lookout for innovative strategies companies come up with to protect their market exclusivity. Two strategies have recently come by …