By Kurt R. Karst – Late last week, Par Pharmaceutical, Inc. (“Par”) filed a Complaint in the U.S. District Court for the Eastern District of Pennsylvania seeking a declaration that two recently issued patents – U.S. Patent Nos. 7,858,122 (“the ‘122 patent”) and 7,863,316 (“the ‘316 …
By Alan M. Kirschenbaum – Today drug and device manufacturers and other stakeholders had an opportunity to provide comments to CMS during an Open Door Forum teleconference on how the physician payment sunshine provisions of the Patient Protection and Affordable Care Act ("ACA") should be …
Have you been looking for that one, comprehensive publication that covers intellectual property and patent law issues in the pharmaceutical, biotechnology and chemical industries from around the world’s key jurisdictions? Well, it’s finally here – or will be in the next month or so when …
By Ricardo Carvajal – The Supreme Court affirmed a 9th Circuit Court of Appeals decision that allows a securities fraud class action to go forward against Matrixx Initiatives, Inc. ("Matrixx") for allegedly violating § 10(b) of the Securities Exchange Act and Exchange Commission Rule 10b-5. As …
Hyman, Phelps & McNamara, P.C. (“HP&M”) and VirginiaTech are pleased to announce the availability of the first two DVD’s of the VERSUS series that is being sponsored by VirginiaTech. They provide an overview of the processes a prescription drug must follow to be FDA-approved and …
By Kurt R. Karst – Last week, Senator Robert Casey (D-PA), along with co-sponsors Sens. Scott Brown (R-MA), Sherrod Brown (D-OH), Al Franken (D-MN), and Johnny Isakson (R-GA), formally introduced S. 606, the Creating Hope Act of 2011. The bill, which, according to Sen. Casey “has …
By Michelle L. Butler & Kurt R. Karst – FDA recently published in the Federal Register notice of a long-awaited revision to its draft interim guidance on user fee waivers, reductions, and refunds. See 76 Fed. Reg. 13629 (Mar. 14, 2011); FDA, Draft Guidance for Industry, …
By Jennifer D. Newberger – One of the tasks of the Office of Inspector General (“OIG”) of the Department of Health and Human Services (“HHS”) is to make recommendations that will result in cost savings and/or improvements in program efficiency and effectiveness. Unfortunately, as we are …
By Nisha P. Shah – Effective March 28, 2011, sponsors and investigators of human drug and biological products subject to either an investigational new drug application ("IND") or bioavailability ("BA") or bioequivalence ("BE") studies exempt from IND requirements will have revised safety reporting requirements under the …
By Kurt R. Karst – Each year, thousands – indeed, tens of thousands – of pages are written concerning the Hatch-Waxman Amendments. As we were clearing out our in-box this past weekend, we came across two scholarly articles from some Hatch-Waxman “regulars” that we think merit …
By Kurt R. Karst – In what is, to our knowledge, the first instance in which a company has asserted the patent delisting counterclaim provisions added by the Medicare Modernization Act (“MMA”) in the context of a 505(b)(2) application – and even in the context of …
By Kurt R. Karst – On March 7th, the U.S. Supreme Court denied yet another Petition for Writ of Certiorari concerning whether patent settlement agreements (what opponents call “pay-for-delay” agreements or “reverse payments”) are unlawful and violate the antitrust laws. As we previously reported, the case, …
By Kurt R. Karst – FDA’s Unapproved Drugs Initiative, which began in June 2006 when the Agency issued its final version of “Marketed Unapproved Drugs – Compliance Policy Guide Sec. 440.100,” took a major step with the Agency’s March 2, 2011 announcement that FDA plans to …
By Kurt R. Karst – Midnight, March 4, 2011 – that’s the time and date on which the federal government will close for business if Congress fails to approve a spending bill, or a short-term/stopgap funding measure that would likely just delay a shutdown for a …
By Susan J. Matthees – In an interesting twist in a developing story on the importation of thiopental, a drug used to administer the death penalty by lethal injection, the attorney for Georgia death row inmate Andrew Grant DeYoung sent Attorney General Eric Holder a …
