The European Medicines Agency (EMEA) published a set of five final guidelines on similar biological medicinal products. They are intended to give guidance to industry in the development of this new type of applications for marketing authorisation. They give guidance on quality, non-clinical and clinical issues. The product class specific annexes to the guideline on […]

As the hosts the 48th Edition of Blawg Review with “unfettered discretion,” the Rethink(ip) guys hate carnivals. At least the ones they have become, in their words, “bloated, link-whore-optimized versions of the original vision for what a carnival should be – an edited review of relevant blog posts presented in a manner that contributes to […]

Recently, I had a client that was about to license a biotech invention for development as a therapeutic. In the course of discussions, we found that in order to bring the product to market, the licensee may need to obtain rights from various other rights holders. As a result, the licensee may be faced with […]

Recently, Philip Brooks sent me a note from one of the readers of his excellent Patent Infringement Updates site. The note was regarding the generic challenge where a brand-name drug has recently gone generic and the drug manufacturer wishes to launch the product in a new indication. The reader asked if the manufacturer would be […]

There are a lot of blogs in the world so I tend to cringe when I see another one (I don’t want to have to keep up with yet more information). But, I’ll just mention a new collaborative law blog, named Blawgr, that was set loose last month as the brainchild of Stephen Nipper, Doug […]

Matt Buchanan, at Promote the Progress, has written about an op-ed piece in today’s edition of the Wall Street Journal. You can view the article here (subscription required). The piece is labeled with the very unoriginal title “Patently Absurd” – just like a lot of other tired articles – and appears to be another in […]

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. […]