By Kurt R. Karst – Recently we reported on the “other battle” going on concerning patents listed in the Orange Book for The Medicines Company’s (“MDCO’s”) ANGIOMAX (bivalirudin) Injection. With patent reform reportedly high on President Obama’s agenda, and with the fast approaching September 6th return of …
By Kurt R. Karst – The court battle over the “new drug” status of Cody Laboratories, Inc.’s and Lannett Co., Inc.’s (collectively “Cody/Lannett’s”) Morphine Sulfate Oral Solution 20mg/mL drug product has taken a new turn. FDA’s Motion to Dismiss the case on mootness grounds has been …
By Kurt R. Karst – With all of the hullabaloo that has been going on in court and on Capitol Hill in the continuing 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) …
By Kurt R. Karst – FDA recently denied (here and here) two citizen petitions (here and here) submitted on behalf of ECR Pharmaceuticals (“ECR”) and Laser Pharmaceuticals, LLC (“Laser”) requesting that FDA, among other things, reconsider its determinations that certain marketed unapproved drug products containing brompheniramine …
By Kurt R. Karst – The latest battleground over the period of exclusivity that should apply to biological products is the Trans-Pacific Partnership (“TPP”) trade agreement. As you might recall, earlier this year there was quite a hubbub over whether the 12-year reference product exclusivity period provided …
The American Conference Institute will be holding its 12th annual “Maximizing Pharmaceutical Patent Life Cycles” conference in New York City from October 3-5, 2011. A copy of the conference program is available here. Hyman, Phelps & McNamara, P.C.’s Kurt R. Karst will be presenting at …
By Cassandra A. Soltis & Anne Marie Murphy – The Department of Health and Human Services, Office of the Secretary, along with the Office of Science and Technology Policy, has issued an advance notice of proposed rulemaking (“ANPRM”) requesting comments on how to update current regulations on …
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 …
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 …
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 …
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 …
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 …
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 …
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. …
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 …
