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.
In my earlier posts (here and here) I reported and commented on the first two phases of the Italian Pfizer antitrust case, in which the Italian Antitrust Authority (IAA) accused Pfizer of having abused of a dominant position by judicially enforcing patent rights against generic latanoprost in the Italian Courts. A small but potentially meaningful…
It could be argued that 2013 is proving to be somewhat unkind to UK patentees when it comes to the issues of sufficiency and priority. On 25 June 2013, in a typically comprehensive judgment running to some 90 pages, Arnold J held that Janssen’s patent was invalid for insufficiency. The relevant facts were as follows:…
According to the law on employee inventions, the inventor is entitled to information about all income generated by the employer from third parties in exploiting the invention. This information is the basis for claims of the employees against the employer for compensation. The Court confirmed the decisions of the lower courts and held that the…
On June 13, 2013, the U.S. Supreme Court issued its long-awaited decision in the “ACLU/Myriad” gene patents case (Association For Molecular Pathology v. Myriad Genetics, Inc.). In a unanimous opinion authored by Justice Thomas, the Court held that “a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been…
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. Click here for the full text of this case. A summary of this case will be posted on http://www.Kluweriplaw.com
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…
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. Click here for the full text of this case. A summary of this case will be…
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…
