General disadvantages of fixed-dose combinations cannot reduce the reasonable expectation of success derivable from the prior art with respect to the formulation of a pharmaceutical composition containing two specific active pharmaceutical ingredients. A synergistic effect is not suitable to establish inventive step of a fixed-dose combination of two active pharmaceutical ingredients, where the synergistic effect was already observed for the simultaneous but separate administration of the same active ingredients.
The later finding of the biological relationships underlying the activity of a drug does not constitute a new teaching for technical action if the indication, the dosage and the way of using the drug coincide with an the prior disclosed use of a drug for the treatment of a disease (confirmed by FCJ 9 June 2011 – X ZR 68/08, GRUR 2011, 999 – “Memantine”). The selection of a value within a known range does not render an invention patentable, unless for special circumstances (e.g. the dosage instruction achieves a particular technical effect vis à vis the prior art).
The Court of Appeal of Burgos dismissed the appeal against the Judgment of the Provincial Court of Burgos, which upheld a patent for a pharmaceutical composition and its use, despite the fact that clinical trials regarding the patented composition and the patented use were mentioned in the prior art.
In my previous post of 2 August 2013 I made passing reference to the recent decision of the English Court of Appeal in the Copaxone litigation. This case was an appeal of the decision of Arnold J (previously reported here) where he found Yeda’s patent valid and infringed. With permission of the court, Mylan appealed that decision.
Yeda is the registered proprietor (and Teva is the exclusive licensee) of EP (UK) 0 762 888 (the “Patent”) relating to a synthetic copolymer known as copolymer-1. Teva markets a product containing copolymer-1 under the brand name Copaxone, which is used for the treatment of relapsing-remitting multiple sclerosis (the most common [...]
It could be argued that 2013 is proving to be somewhat unkind to UK patentees when it comes to the issues of sufficiency and priority. On 25 June 2013, in a typically comprehensive judgment running to some 90 pages, Arnold J held that Janssen’s patent was invalid for insufficiency.
The relevant facts were as follows: Janssen is the owner of EP (UK) 1 994 937 (the “Patent”) entitled “Prevention and treatment of amyloidogenic disease”. The Patent discloses and claims pharmaceutical compositions comprising an antibody to β-amyloid peptide (a type of protein plaque that builds up in Alzheimer’s disease patients’ brains – the theory being that an antibody to β-amyloid peptide mi [...]
and Bernd Kröger.
A combination of two pharmaceutical ingredients, i.e. leflunomide and teriflunomide is to be considered obvious if the person skilled in the art uses an obvious process to obtain leflunomide that automatically results in – even with a certain delay – both components due to a chemical reaction.
Click here for the full text of this case.
A summary of this case will be posted on http://www.Kluweriplaw.com[...]