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.
In a recent post of mine I have reported that by decision of 29 July 2010, the Italian Supreme Administrative Court (Consiglio di Stato) had tackled the issue of whether the Italian drugs regulatory authority (Agenzia Italiana del Farmaco – AIFA) should or should not consider the existence of a patent when adopting decisions relating…
Along with a number of other relevant innovations to the Italian IP Code, last August the Italian legislator eventually passed the long awaited implementation into Italian law of Directive 44/1998/EC on biotechnological inventions (see legislative decree no. 131/2010 of 13 August 2010 here). Those who are familiar with the Italian political scene will know that…
In a decision of 7 September 2010, the Dutch Patent Office (NL Octrooicentrum) on appeal confirmed its earlier decision to not grant a supplementary protection certificate (SPC) for the medicinal product tocilizumab, a humanized monoclonal antibody against the human interleukin-6 receptor, which is approved as a human rheumatoid arthritis drug. The applicant had requested an…
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…
