In the oral proceedings held in the EPO appeal case T 1760/11 the Board of Appeal (BoA) 3.3.01 selected one single closest prior art (CPA) document for the inventive step assessment and then denied the opponents the opportunity to present inventive step attacks starting from other CPAs. Petitions for review under Article 112a EPC were filed. The BoA’s denial did not constitute a violation of the right to be heard, said the Enlarged Board of Appeal (EBA) in the decisions R 5/13 and (identical) R 9/13 to R13/13.
The underlying Case of T 1760/11
The issue under discussion was the assessment of inventive step. The Opposition Division had earlier revoked the patent inter alia for lack of inventiv [...]
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).