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.
By Legislative Decree no. 131 of 13 August 2010, which became effective on 2 September 2010, the Italian legislator passed a number of amendments to the Italian IP Code. One of these is new Art. 68 (1bis) on the statutory limitations to patent rights (which in paragraph 1 already included, and still includes, personal use,…
The Tribunal de Grande Instance of Paris in its 28 May 2010 decision, Institut Pasteur v Société Siemens Healthcare Diagnostics, illustrates the specificity of the French doctrine of equivalents, rejecting the “file wrapper estoppel” theory as it is known in the US. However, since it applies the doctrine of equivalents although the function of the claimed means is not novel, this decision does not seem to be in line with the majority of decisions rendered on that item.
The torrent of UK cases concerning applications for supplementary protection certificates (SPCs) shows no sign of abating. Following the reference from the Court of Appeal in June to the CJEU in Medeva’s SPC Applications regarding the scope of the SPC Regulation (see previous post), the issue of SPCs for combination products has arisen again in…
The European Court of Justice held that Article 9 of the Biotech Directive (98/44/EC) does not confer patent protection to genetic information that does not (anymore) perform its function for which it is patented (in the case at hand the DNA present in soy meal). In addition, the Court held that Article 9 Directive provides…
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…
