The inventive step reflects a general patentability requirement in most patent laws, according to which an invention should be sufficiently inventive (not obvious in view of the prior art using the skilled person’s common general knowledge) in order to be patented / the patent to be held valid. In the United States, rather than ‘inventive step’, the expression ‘non-obviousness’ is used: is the invention an adequate distance beyond or above the state of the art? The assessment of the inventive step varies from one country to another. The European Patent Office uses the so-called problem-and-solution approach to assess inventive step, an instrument also used by several national European courts.
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. The full summary of this case has been…
Suppose you have an invention that resides in using a known substance in a known dosage for a known purpose, and your only distinguishing feature is that you apply a particular therapeutic measure after the administration of your substance. Can such a post-administration therapeutic measure, which is in essence a method of treatment, establish patentability…
The development of Herceptin (trastuzumab) in the late 1980s and 1990s is one of the most remarkable advances in the treatment of breast cancer. The story of the drug and its pioneer, the “velvet jackhammer”, Dennis Slamon, is neatly summarised in Siddhartha Mukherjee’s award winning novel: “The Emperor of All Maladies – a Biography of…
The board held that a document of speculative nature could not objectively be considered as a realistic starting point or the most promising springboard towards the claimed invention: the document was no more than a speculative review of what might be potentially feasible in the future and no concrete realization of the claimed type of…
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…
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…
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. The full summary of this case…
Introduction 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…
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:…
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…
