According to the Convention on Biological Diversity (CBD), ‘biologics’ means ‘any technological application that uses biological systems, living organisms, or derivatives thereof, to make or modify products or processes for specific use’. Related fields are bioengineering, biomedical engineering, biomanufacturing, molecular engineering. The application of patent law to biotechnological inventions has to deal with a number of particularities. Are biological materials mere ‘discoveries’, and therefore not patentable or man-made ‘inventions’? Limitations to patent rights, in particular a research and experimental use exception, have been considered important for innovation.
Sufficiency of disclosure is one of the requirements for the grant of a European patent (Art. 83 EPC). The disclosure in a patent specification shall enable the skilled person to apply the invention, i.e. to make the claimed product or apply the claimed process. A claimed product or process is often defined in general terms…
By decision no. 6967/2009 of 14 May 2009, the IP Chamber of the Court of Milan found for the invalidity of a patent claiming the second medical use of a known pharmaceutical product for lack of inventive step. This decision is remarkable for at least two reasons. Firstly, the Court departed from the findings of…
On 18 June 2009 the IP Chamber of the Milan Court issued its official interpretation on whether the filing of an MA application for a generic drug when the patent is still in force results an act of infringement. This subject that had already been dealt with, with a different outcome, almost three years earlier…
According to the Advocate General Article 9 of the Biotechnology Directive does not limit the scope of protection of patents for biotechnology inventions. Nonetheless protection for DNA sequences as such is excluded.
In its decision rendered on 19 March 2008 the District Court of The Hague referred questions to the European Court of Justice on the interpretation of article 9 of Directive 98/44/EC 0f the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions (“Biotechnology Directive”). In particular the Dutch court wished to know whether article 9 of the Biotechnology Directive should be interpreted as extending the rights conferred by a patent covering a biotechnological invention, or, on the contrary, whether it should be interpreted to limit the proprietor’s right to prevent the exploitation of material containing the patented product (DNA sequence), on the condition that such product still performs its function. The Advocate General in his opinion comes to the conclusion that it is irrefutable that article 9 of the Biotechnology Directive is a rule for the extension of patent protection. However, in his opinion the system put in place by the Biotechnology Directive excludes protection for DNA sequences as such. Such protection is limited “to the situations in which the genetic information is currently performing the functions described in the patent.” But how does this relate to the obligations under the European Patent Convention (EPC)?
Whether patent holders marketing branded drugs may assume that the very act of filing of an MA application by generic companies result in patent infringement is one of the hottest issues at the moment being tackled by the IP Chambers of Italian district courts. The IP Chamber of the Milan Court and the IP Chamber…
The Enlarged Board of Appeal answers three questions of law as follows: Question 1: Where it is already known to use a medicament to treat an illness, Article 54(5) EPC does not exclude that this medicament be patented for use in a different treatment by therapy of the same illness. Question 2: Such patenting is…
The Court of Appeal upheld the High Court’s judgment that HGS’ patent relating to a new protein called Neutrokine-α was invalid for lack of industrial application. The Court of Appeal agreed with the High Court’s determination that uses for Neutrokine-α disclosed in the patent were not plausible at the time the patent was filed as…
The case concerned the validity of a ‘selection patent’. The Court of Appeal held that there is no special approach to be adopted in determining the validity of selection patents and that UK law should be consistent with EPO jurisprudence. For novelty, a prior disclosure of a large class of compounds does not take away…
The Federal Court of Justice presented the following questions to the European Court of Justice: 1. How should the term ‘human embryos’ in Article 6 para. 2 lit. c Directive 98/44 EC be understood? a) Are all development stages of human life from the fertilisation of an egg cell included or are additional conditions required…
Correction of a letter of withdrawal under Rule 139 EPC is only possible if the public has not yet been officially informed about the withdrawal. A full summary of this case has been published on Kluwer IP Law.
