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.
On 10 March, the Court of Justice of the European Union (“CJEU”) issued its long-awaited opinion on the patentability of human embryonic stem cells in Brüstle v Greenpeace C-34/10. Biotechnological inventions are subject to Directive 98/44/EC of the European Parliament and of the Council on the legal protection of biotechnological inventions (the “Directive”). Article 6(1)…
The company governed by the laws of Switzerland, Novartis AG, is the holder of patent EP 0 443 983 entitled “Acyl compounds”, whose subject-matter is a group of antihypertensive compounds, including valsartan, pharmaceutical preparations containing them and processes for the preparation of these compounds. , This patent, filed on 12 February 1991, was to have expired on 12 February 2011. However, Novartis…
As many readers of this blog already know, last October the Italian Antitrust Authority (Autorità garante della concorrenza e del mercato – AGCM), following a complaint filed by Ratiopharm, started investigations against Pfizer aimed at ascertaining whether Pfizer’s behaviour in the enforcement of its patent rights on the drug Xalatan amounts to abuse of a…
H. Lundbeck A/S (hereinafter referred to as Lundbeck) is the holder of European patent EP 0 347 066 entitled “new enantiomers and their isolation”, which designates France and was filed on 1 June 1989; it claims priority of a British patent dated 14 June 1988. The invention relates to the two new enantiomers of the antidepressant drug Citalopram and the use of…
By a judgement dated 28 September 2010, the Tribunal de Grande Instance of Paris held that claims 1, 2 and 3 of the French designation of Merck & Co. Ltd’s Patent EP 0 724 444 were invalid for being excluded from the scope of patentability in accordance with the provisions of Article 53(c) EPC 2000 (former Article 52 (4) EPC 1973). The court held that the invention the subject-matter of main claim 1 was only a new dosage regime ranging from 0.05 to 1 mg) of an already known compound (finasteride) in an already known therapeutic application (the treatment of hyperandrogenic conditions and especially the treatment of androgenic alopecia). A mere new dosage regime is not a second medical use but a therapeutic method excluded from patentability pursuant to Article 53 (c) EPC 2000.
The mere filing of an application for marketing authorization of a generic drug does not constitute an infringing activity., although of a preparatory nature as, aAlthough it is true that the filing of such an application may constitute the basis for the marketing of the drug, there still is the possibility that the eventual act…
On 27 October 2010 the Court of Rome issued a decision in the Janssen – Menarini v. EG case concerning the active substance nebivolol. This is one of the few reported cases on enantiomer patents in Italy. In more detail, the basic patent inter alia disclosed an AB compound (so called compound 84) formed of…
On the occasion of a dispute opposing the Institut Pasteur and two Chiron companies, the French Cour de Cassation rendered on 14 December 2010 an interesting decision which confirms the existing case law on three points : the “file wrapper estoppel” theory, the contributory infringement and the infringement by equivalence.
On 8 October 2010, the Cour d’Appel of Paris rendered a interesting decision about the interpretation of the wording of one of the settlement agreements which have been concluded between Institut Pasteur and the American health authority (DHHS/NIH) in order to put an end to the various disputes which opposed them concerning the paternity of the HIV-1/VIH retrovirus’ discovery and the patents relating thereto. The question at stake was to determine if a gp 110 protein was the subject-matter of the said settlement agreement so that Abbott, as a sublicensee of the NIH, could validly exploit in France that gp 110 protein in its detecting kits. Otherwise Abbott would have been an infringer of the Institut Pasteur’s European patents.
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…
