Biologics

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.

Biologics, Chemical Engineering, EPC, Exceptions to patentability, France, Second Medical Use, Validity

(Véron & Associés)/

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.

Biologics, Case Law, Extent of Protection, Italy

(Trevisan & Cuonzo)/

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…

(Indirect) infringement, Amendments, Biologics, EPC, Equivalents, France, Scope of protection

(Véron & Associés)/

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.

(Compulsory) license, (Indirect) infringement, Biologics, EPC, France

(Véron & Associés)/

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.

Biologics, Italy

(Trevisan & Cuonzo)/

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…

Biologics, Exceptions to patentability, Italy

(Trevisan & Cuonzo)/

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…

Antibodies, Biologics, Netherlands, Scope of protection, SPC

(Brinkhof)/

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…

(Indirect) infringement, Biologics, Extent of Protection, Italy, SPC

(Trevisan & Cuonzo)/

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,…

(Indirect) infringement, Amendments, Biologics, EPC, Equivalents, Extent of Protection, France

(Véron & Associés)/

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.