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 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 Cancer” – a fascinating if not necessarily uplifting read.
In short, unlike traditional chemotherapy, trastuzumab is a monoclonal antibody which specifically targets a receptor known as HER-2 which is involved in the development of breast cancer. No-one disputes that the development of Herceptin was a landmark advance in the field of oncology – [...]
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 product was described therein.
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.