Teva Pharmaceuticals USA, a wholly-owned subsidiary of Teva Pharmaceutical Industries Ltd., is making a full-court press on getting the word out on the need for follow-on biologics.  In its “Year of Affordable Healthcare” campaign, Teva is putting put together videos to argue for generics, just as the White House is making its position known on […]

The American Conference Institute’s Maximizing Pharmaceutical Patent Lifecycles, the 10th Anniversary Edition will be held at the Helmsley Park Lane Hotel, New York, New York, on Wednesday, October 7, 2009 to Thursday, October 8, 2009. Overview This 10th American Conference Institute event on Maximizing Pharmaceutical Patent Life Cycles will bring you the thoughtful and targeted […]

Last week’s book review was on the Annual Review of Intellectual Property Law Developments: 2006-2008, by the American Bar Association (ABA) Section of Intellectual Property Law. This week, we’re giving you a chance to get your own copy for free (reg. price: $149.95). Through various circumstances (yes, my fault), the ABA Section sent me two […]

The Obama Administration sent out a warning shot that seven years is enough time to protect brand-name biotechnology medicines from generic competitors.  In a letter to Representative Henry Waxman (D-CA), the White House set out that seven years “strikes the appropriate balance between innovation and competition by providing for seven years of exclusivity.” In looking […]

Sens. Bill Nelson [D, FL] and Sen. Herbert Kohl [D, WI] have introduced a bill (s. 1315) to amend the Federal Food, Drug, and Cosmetic (Hatch-Waxman) Act to define the term “first applicant” for purposes of filing an abbreviated new drug application (ANDA) in order to give generic drug makers challenging brand-name patents an chance […]

A recent decision of an Australian appeal court concerning a patent for an enantiomer pharmaceutical dealt with matters of patent claim validity and patent term extension. The decision, H Lundbeck A/S v Alphapharm Pty Ltd [2009] FCAFC 70, involves a decision of the Full Federal Court on rehearing an appeal by Alphapharm over an earlier […]

Today’s book review is of the Annual Review of Intellectual Property Law Developments: 2006-2008 put out by the American Bar Association (ABA) Section of Intellectual Property Law. The debut volume covers over 300 recent legal developments including Supreme Court cases, e.g., eBay, MedImmune, KSR, Quanta, and Microsoft v. AT&T; Federal Circuit en banc decisions, e.g., […]

In recent years, the USPTO has been very slow to process papers when moving from the international (PCT) stage to entry into the U.S. national-stage.   It’s common to have a year or more pass before the USPTO gets around to actually looking at the national-stage papers and mailing a Notice of Missing Requirements or […]