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 April 15, 2013, the U.S. Supreme Court will hear oral arguments in one of the most controversial and publicized biotech patent cases, the “ACLU/Myriad” gene patenting case (formally, The Association For Molecular Pathology, et al. v. USPTO et al.). While it is nearly impossible to predict the outcome of a Supreme Court case from…
The High Court (Arnold J.) decided to refer further questions on the interpretation of Article 3 of the SPC Regulation to the CJEU,, particularly in relation to the Article 3(a) requirement that “the product is protected by a basic patent in force”, suggesting an interpretation which focuses on the “inventive concept” of the patent rather…
The Court of Appeal held that while structural approaches for determining obviousness (with reference to the Pozzoli test), are useful, the importance of the statutory test cannot be undermined. The ultimate question that the Court must address is whether it was obvious to the skilled but unimaginative addressee to make a product or carry out…
The German Federal Patent Court (FPC) has recently published its first decision (3 Ni 28/11 of 2 May 2012 “Ranibizumab”, GRUR 2013, 58) dealing with the interpretation of related CJEU Judgments “Medeva” (C-322/10) of 24 November 2011 and “University of Queensland” (C-630/10) of 25 November 2011. In the view of the FPC, the infringement test, which had been utilized by the German Federal Court of Justice in examining the condition of Art. 3(a) of the Regulation, can thus no longer be relied upon. Further, the FPC ruled that the requirement that an SPC can only be granted for active ingredients which are specified or identified in the wording of the claims of the basic patent, applies likewise to products of single active ingredients and combinations of active ingredients.
by Miriam Büttner On 27 November 2012 the German Federal Supreme Court (BGH) decided on the ethical problematical question, if neural precursor cells which origin from human stem cells are patentable or not (case no. X ZR 58/07). Background of the decision: Subject of this BGH decision is the validity of German patent no. 197…
On November 30, 2012, the U.S. Supreme Court granted certiorari in the “ACLU/Myriad” gene patenting case (Association for Molecular Pathology v. Genetics, Inc.), taking on the debate over the patent-eligibility of human genes. The Court will review the August 16, 2012 Federal Circuit decision that held for the second time that Myriad’s claims directed to isolated DNA…
Recently approved “Balduzzi Decree” (Law No. 189/12 of 8 November 2012 (confirming Law Decree 158/12 of 13 September 2012 – a consolidated version of the Decree is available here) seems to have changed quite a lot in terms of the protection of pharmaceutical patents in Italy, making it totally Inconvenient for generics to launch at…
On 3 September 2012, the Adminstrative Court decision in the Italian antitrust case involving Pfizer was published. This decision completely reversed the ruling of the Italian Antitrust Authority which had initially found Pfizer guilty of abuse of dominant position and applied a 10.6 million euro fine (see my earlier post here). In substance, the Administrative…
The UK IPO has applied the decision of the CJEU in Brüstle on stem cells in a recent case that is likely to lead to more judicial comment on the patentability of stem cell inventions. In International Stem Cell Corporation*, the applicant appealed the Examiner’s rejection of two patents, relating to methods of producing human…
By ruling of 10 July 2012, the Court of Turin decided in the first instance an infringement action filed by Italian company Novamont against German and French companies Biotec and Biosphère, for the alleged infringement of three Novamont patents concerning starch based plastic materials used in the production of biodegradable shoppers. The Court denied the…
