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 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…
The Dutch Supreme Court held that Art. 69 EPC in conjunction with art. 1 Protocol for the application of Art. 69 EPC provides a guideline for the determination of the scope of protection. Other “viewpoints” are the essence of the invention and the inventive idea behind the wording of the claims as opposed to the…
On Friday, July 20, 2012, the U.S. Court of Appeals for the Federal Circuit heard oral arguments in Association for Molecular Pathology v. Myriad Genetics, Inc. (the ACLU “gene patenting”/BRCAI case), which is on remand in view of the U.S. Supreme Court decision in Mayo v. Prometheus. Reading the tea leaves from the judges’ questions and…
Practitioners and applicants have been wondering how the USPTO would respond to the July 20, 2012, U.S. Supreme Court decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc., which held that Prometheus’ personalized medicine method claims could not be patented because they were directed to a law of nature, and so excluded from patent-eligibility under 35 USC…
The Paris Court of Appeal clarified the conditions to be assessed by the Court in order to grant an interlocutory injunction pursuant to Article L. 615-3 of the French Intellectual Property Code. A summary of this case will be posted on http://www.KluwerIPCases.com
The Court of Appeal dismissed Pharmaq’s claim that Intervet’s patent claiming deposited virus strains and closely related strains sharing genotypic and phenotypic characteristics was invalid and that its vaccine did not infringe. The court held that the patent only covered the virus in isolated form and that the isolation of the virus strain from nature…
