The U.S. Court of Appeals for the Federal Circuit, in SmithKline Beecham Corp. and GlaxoSmithKline v. Apotex Corp (04-1522), held that once a product is fully disclosed in the art, future claims to that same product are precluded, even if that product is claimed as made by a new process. Earlier, SmithKline sued Apotex for […]

The University of California won a $100 million plus settlement from Monsanto for patent claims that had been pending for over 24 years – a patent covering the growth hormone used to make cows produce more milk. Monsanto reached a deal with the university just as the case was set to begin a jury trial. […]

Allergies are second only to the weather in hot conversation topics around here in the Midwest. So, there was a collective groan when sales of generic Flonase were halted by a judge’s temporary restraining order. This comes two days after the U.S. Food and Drug Administration approved a generic nasal spray for the active ingredient […]

The European Union decided against allowing a protein drug derived from the milk of genetically-engineered goats. In a press release, the European Medicines Agency (EMEA) in London said it had rejected the application to license a natural human protein extracted from the milk of goats. EMEA recommended against approval of ATryn (recombinant antithrombin alpha), which […]

On January 17, 2006 Judge Rodney Sippel of the U.S. District Court for the eastern district of Missouri has ruled under summary judgment in favor of the generic challengers, clearing their way to launch generic versions of Toprol-XL in U.S. market. This is, however, a pyrrhic victory for generic manufactures after successive para IV defeats […]

The Supreme Court agreed to consider allowing a lawsuit by MedImmune Inc. that seeks to end royalties the company pays on its drug Synagis to go forward. The Court agreed to review a Federal Circuit decision that a licensee may not use a declaratory judgment action to challenge the validity of the licensed patent where […]

In Ferring B.V., and Aventis v. Barr Labs, (05-1284), the Court of Appeals for the Federal Circuit, deemed a patent unenforceable due to inequitable conduct where the inventors submitted declarations to the examiner in order to define the term “peroral” but did not disclose to the examiner that some of the declarants had been employed […]

The European Medicines Agency recommended approval of Omnitrope, which copies an existing growth hormone prescribed for undersized children. If given final OK by the European Commission, Omnitrope could be on the market later this year and would be the first-ever generic biotechnology drug. Omnitrope marks the first real threat to the near monopoly enjoyed by […]