Hyman Phelps McNamara

By Kurt R. Karst –       Earlier this year we posted on the effects of the U.S. Court of Appeals for the Federal Circuit’s December 2009 “false marking” decision in Forest Group, Inc. v. Bon Tool Co.  False marking is the act of placing an item in …

By John A. Gilbert & Peter M. Jaensch – On October 6, 2010, the Drug Enforcement Administration (“DEA”) announced a Statement of Policy concerning the procedure by which a registrant-prescriber may use an agent, including a nurse in a long term care facility (“LTCF”), to communicate controlled substances …

Hundreds of you have already signed up for Hyman, Phelps & McNamara, P.C.’s free webinar – The Evolution and Resurgence of Strict Liability Criminal Prosecutions Under the Park Doctrine – scheduled for Friday, October 8, 12:00 p.m. – 1:30 p.m.  For those last minute stragglers, …

By Carrie S. Martin – Yesterday, the Federal Trade Commission (“FTC”) announced the issuance of proposed revisions to its “Green Guides,” last revised in 1998.  The proposed revisions would update industry guidance on how to avoid making misleading environmental claims.  In addition, Julie Brill, Commissioner of …

By Kurt R. Karst –       Earlier this week, the Institute of Medicine (“IOM”) issued a 350-page report, titled “Rare Diseases and Orphan Products: Accelerating Research and Development,” which is intended to help refocus attention on accelerating rare diseases research and product development.  The report is the …

By Kurt R. Karst –       The U.S. Court of Appeals for the Federal Circuit answered “Yes” to this question in an October 6th decision in Teva v. Eisai (2009-1593) that could pave the way for generic versions of Eisai, Inc.s’ ARICEPT (donepezil HCl) Tablets sooner than …

By Kurt R. Karst –       The voice of Michael Corleone – “Just when I thought I was out . . . they pull me back in” – played over and over again in our heads today when we learned that Apotex, Inc. filed a Petition for …

By Kurt R. Karst –       In a short, but scathing opinion piece published in the October 5th Wall Street Journal (“WSJ”), the editors take on the Federal Trade Commission (“FTC”) and those Members of Congress who want to ban patent settlements between brand-name and generic drug …

Hyman, Phelps & McNamara, P.C.’s Kurt R. Karst will be speaking at the Center for Business Intelligence’s (“CBI’s”) 3rd Annual Life Sciences Congress on Paragraph IV Disputes, which is scheduled for October 18-19, 20109 at the Hilton Alexandria Old Town in Alexandria, Virginia.  This popular …

By Ricardo Carvajal – No sooner did FDA hold its advisory committee meeting and public hearing on bioengineered AquAdvantage salmon than Congressional representatives made their displeasure known with the prospect of FDA approval.  In addition to signing on to letters of protest to the Commissioner (here …

Join Hyman, Phelps & McNamara, P.C. attorneys on October 8, 12:00 p.m. – 1:30 p.m. for a free webinar on a very important, timely topic.  You can register for the free webinar here.  The webinar will feature attorneys with decades of experience in FDA’s application of …

By John A. Gilbert & William T. Koustas – The United States Congress passed the Secure and Responsible Drug Disposal Act of 2010 (“the Act”) on September 29, 2010, and it is soon expected to be signed into law by the President.  This Act is intended …

By Ricardo Carvajal – FDA announced the availability of a draft guidance on acidified food intended to help processors determine whether their products are subject to the current good manufacturing practice ("CGMP") requirements in 21 CFR part 114 and the “Specific Requirements and Conditions for Exemption …

By Michelle L. Butler – Yesterday, the Office of the Inspector General (“OIG”) of the Department of Health and Human Services (“HHS”) issued a Special Advisory Bulletin regarding a new enforcement initiative to promote increased compliance by manufacturers with regard to reporting of average manufacturer prices …

By Riëtte van Laack – On September 27, 2010, less than two week after POM Wonderful LLC (“POM”) filed a complaint against the Federal Trade Commission (“FTC”) (see our previous post here), the Agency filed a Complaint against POM, its sister corporation Roll International Corp. and …