There is insufficiency of disclosure if the skilled person must deliberately ignore a feature of the claim which is perfectly understandable per se in order to work the invention.
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[...]In an earlier post, I reported the news that a new piece of legislation (the so called “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) introduced a rule which some have already labelled as “reimbursement price linkage”. In substance, according to Article 11 of the Balduzzi Decree, the Italian regulatory Authority will refrain from granting a reimbursable price to approved generic drugs when the reference product is still covered by a patent or SPC.
Last week, AIFA officially confirmed that it will apply such a rule, by issuing a communication to all pharmaceutical compan [...]
In order to determine whether the features that distinguish the patent claims over the prior art can be considered when assessing inventive ste p and novelty, the Board must consider whether these features make a technical contribution to the invention.
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[...]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 oral arguments, the questions the Justices ask (or don’t ask) and the parties’ responses may at least provide an indication of the issues that the Court will focus on when it renders its decision.
Are Human Genes Patentable?
The Supreme Court granted certiorari to address the fundamental, threshold question of the patent-eligibility of human g [...]
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 than the particular wording of the claims despite the ruling in Medeva. In addition, the Court sought clarification on whether it is possible to obtain more than one SPC per patent, given the differing interpretations of the Biogen decision in light of Medeva.
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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 a process failing within the claim.
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