The ECP, epi and Business Europe have collaborated to produce a downloadable, fifty page guide to practice before the EPO. While not binding on Examiners, it was issued under the authority of the EPO and is a sort of mini-MPEP, intended for use by both applicants and Examiners. A copy is provided at the end of this post. You can read more about it here.
Archive for the ‘EP and UK Practice’ Category
In the last few months, the European Court of Justice (ECJ) has handed down several decisions relating to the grant and validity of supplementary protection certificates (SPCs; i.e. patent term extensions). Thereof, the following rulings are generally considered to have significant impact on IP strategies in the pharmaceutical industry.
By Paul Cole, European Patent Attorney, Lucas & Co – Warlingham, UK
The above proceedings relate to European Patent (UK) 0,939,804 concerning a new human protein called Neutrokine-α. The specification explained (i) the existence and amino acid sequence of Neutrokine-α, (ii) the nucleotide sequence of the gene encoding for Neutrokine-α, (iii) the tissue distribution of Neutrokine-α, (iv) the expression of Neutrokine-α by its mRNA (the encoding gene) in T-cell and B-cell lymphomas, and (v) that Neutrokine-α is a member of the TNF ligand superfamily. The specification described the invention as potentially useful for the diagnosis, prevention, or treatment of a large number of disorders of the immune system, either through Neutrokine-α itself or through its antagonists. However, nowhere in the Patent was there any data or any suggestion of in vitro or in vivo studies, so there was no experimental evidence to support any of those suggestions.
Thank you to Dr. Stefan Danner, a German and European Patent Attorney at DHS Patentanwaltsgesellschaft mbH in Munich for letting us post the current issue of the biotech IP newsletter dealing with the recent EPO decision concerning the patentability of drug polymorphs. A PDF of the entire newsletter is attached at the end of this post.
On May 24, 2011, the EPO Technical Board of Appeal (TBA) 3.3.01 handed down decision T777/08 concerning the inventiveness of (specific) polymorphic forms of a drug previously only known in solid amorphous form. This decision caused considerable attention in the pharmaceutical industry.
The relevant claimed subject matter of European Patent EP 1 148 049 relates to crystalline forms II and IV of the statin drug atorvastatin hydrate that are characterized by an X-ray powder diffraction pattern expressed in terms of 20 angles, d spacings, and relative intensities with a relative intensity of >15% determined using CuKα radiation.
The full document can be found here 10.11. Inventive Polymorphs.