Find below biotech IP newsletters recently provided by Dr. Stefan Danner.
Find below biotech IP newsletters recently provided by Dr. Stefan Danner.
By Paul Cole, European Patent Attorney, Lucas & Co – Warlingham, UK
Judgement – Human Genome Sciences Inc (Appellant) v Eli Lilly
and Company (Respondent)
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.
The following is a contribution from Verena Simpson PhD of Zacco Denmark A/S.
The core of the Decision
1. A non-microbiological process for the production of plants which contains or consists of the steps of sexually crossing the whole genomes of plants and of subsequently selecting plants is in principle excluded from patentability as being “essentially biological” within the meaning of Article 53(b) EPC.
2. Such a process does not escape the exclusion of Article 53(b) EPC merely because it contains, as a further step or as part of any of the steps of crossing and selection, a step of a technical nature which serves to enable or assist the performance of the steps of sexually crossing the whole genome of plants or of subsequently selecting plants.
What triggered the Enlarged Board of Appeal [EBoA] Decision?
The Technical Board of Appeal [TBoA] were faced with the task of deciding whether an opposed patent EP1 069 816 should be maintained in amended form. The claims were directed to “a method of producing Brassica oleracea with elevated levels of glucosinolates” comprising steps of crossing selected wild Brassica oleracea species with broccoli breeding lines; selecting hybrids with elevated of glucosinolate levels; backcrossing the selected line; and finally selecting a broccoli line with elevated of glucosinolate levels, where molecular markers are employed to select the desired hybrids.
The sole question faced by the TBoA (T 83/05) was whether the claimed “method” was excluded from patentability under Art 53b EPC and Rule 26(5) EPC2000.
Bad Behavior has blocked 552 access attempts in the last 7 days.
The commentary presented herein represents the opinions of the author and not of Schwegman Lundberg & Woessner, P.A. or any other employee thereof. This commentary is provided for general informational and discussion purposes and should not be considered to be, or used as, legal advice to address any particular situation.
Minnesota Web Development Company - First Scribe