by Jan Pot and Ruprecht Hermans
MSD’s European Patent for treating baldness, EP 0 724 444 (‘EP 444’), has been the subject of a number of (in)validity decisions throughout Europe, with differing outcomes. The Dutch chapter in this saga is a decision of the District Court The Hague, which holds that – contrary to the German, French and Italian courts –the patent is valid and infringed.
Claim 1 of EP 444 is a Swiss-type claim for the use of finasteride for the preparation of a medicament for oral administration useful for the treatment of androgenic alopecia in a person and wherein the dosage amount is about 0.05 to 1.0 mg. Androgenic alopecia is a type of baldness occurring in men a [...]
The doctrine of equivalence has seen some kind of renaissance in German case law recently. In short words, there are three questions to be asked to decide for equivalent infringement if there is no literal infringement. The first one being the question about the effect of the different solution. Do the means used to solve the problem underlying the invention objectively have the same effect? If so, would this different solution have been discovered by the man skilled in the art at the time of the priority date? The objective of this second question to be asked is whether it was kind of obvious to use the different approach instead even though it does not fall under the literal meaning of the [...]
The FCJ held that the priority of an earlier application may be rightfully claimed if the technical information described for a specific embodiment or otherwise in in the application is seen by the skilled person as an example for the more general invention disclosed in the later application and if this more general teaching was disclosed in the prior application as part of the invention.
The FCJ held that legal provisions in force at the priority date must be taken into consideration when assessing novelty and inventive step of an invention. These legal provisions may incite the skilled person to work in a certain direction so that this makes the invention obvious.
Just recently, the judgement of the German Federal Court of Justice (Bun-desgerichtshof, BGH) in re X ZR 31/11 concerning a tyre removal machine has been published. This judgement is of relevance as the Federal Court of Justice had to answer a question of claim construction relevant in infringement and nullity proceedings likewise. The relevant question was whether a claim referring back to a multitude of preceding claims necessarily requires that all features of the multitude of claims re-ferred back to are fulfilled or not.
In this particular case about EP 1 177 920 there have been two independent subclaims (claims 1 and 13) and eleven subclaims dependent on claim 1 (claims 2–12). Wherea [...]
The Bolar exemption must be interpreted narrowly in order not to affect the patent holder’s exclusive rights. The privilege of the generic drug manufacturers who are allowed to conduct clinical trials in order to seek regulatory approval for their therapeutic products based on patented inventions does not apply to their third-party suppliers. Thus, manufacturing of patented pharmaceutical ingredients and offering them to generic drug companies constitutes patent infringement.