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.
Over the last few years, Spanish Courts have struggled to resolve an avalanche of cases where the core of the discussion was the legal effects of TRIPS on the effects of the Reservation made by Spain when it joined the European Patent Convention in 1986. According to this Reservation, patents filed before 7 October 1992…
This long awaited ECJ decision concerns the interpretation of the term “embryo” in the Biotech Directive (98/44/EC). According to the Court Art. 6 (2c) of the Directive excludes the patentability of use of human embryos for commercial or industrial purposes, and only use for therapeutic or diagnostic purposes which is applied to the embryo for…
A recently published decision of the Court of Turin in the case Merck Sharpe & Dohme versus Sandoz (decision of 7 April 2011), concerning dorzolamide hydrochloride timolol maleate eye drops, provides an interesting interpretation of the Italian rules governing territorial jurisdiction in the case of the infringement of pharmaceutical patents. MS&D sued Sandoz before the…
The Federal Institute of Intellectual Property can also issue a supplementary protection certificate to an applicant if a certificate for the same active pharmaceutical ingredients (API) or combination thereof has already been granted to a third person. By interpreting the law in that way – only restricting the grant of a certificate for the same…
To stay, or not to stay, that is the question. But not in the recent Danisco v. Novozymes case before the District Court of The Hague. On the face of the Court’s decision of 22 June 2011, the question whether to stay the national proceedings pending the outcome of opposition proceedings at the EPO on…
Since 2009, French law has allowed patentees to voluntarily limit their granted patent claims. This possibility, which has existed for a long time in a number of European countries, (e.g. Austria, Switzerland, Germany, Denmark, Italy, Norway and the United Kingdom) has recently been introduced into the European patent system through Art. 105bis et seq. of the…
A movement is emerging now among the French courts to stay the proceedings in litigations relating to supplementary protection certificates (SPCs) and more precisely relating to the interpretation of Article 3(a) of Regulation (EC) No. 469/2009 (former Regulation No. 1768/92): “the product is protected by a basic patent in force”. These proceedings are stayed waiting for future decisions…
In the antitrust case initiated by the Italian Competition Authority (AGCM) last October (see my posts here and here), Pfizer have offered a number of commitments in order to settle the case and avoid sanctions. These are the following. Firstly, Pfizer will offer an irrevocable and royalty-free license on EP 1225168 to all interested parties…
The Milan Court revoked a patent on the second medical use of a known drug because excerpts of the protocol of the clinical trials aimed at proving efficacy of the second use had been published before the relevant date in a scientific journal. The Court held that the outcome of the trials – which later…
The Court of Turin held that Article 68 (1 bis) of the Italian IP Code, which was introduced by Legislative Decree 131 of 13 August 2010, establishing that ‘Without prejudice to the provision of paragraph 1, companies intending to manufacture pharmaceutical specialties outside patent protection may commence the procedure of registration of the product containing…
