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Recent news in the Italian Pfizer antitrust case

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 development now has to be reported while the case is being heard in the last instance by the Supreme Administrative Court, after appeal by the IAA against the decision of the Regional Administrative Court.

The story commenced in October 2010 and concerned the fact that Pfizer had obtained an SPC over latanoprost on the basis of the grant in 2009 of [...]

Biotech patent fails for insufficiency – Eli Lilly and Company v Janssen Alzheimer Immunotherapy – 25 June [2013] EWHC 1737

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: Janssen is the owner of EP (UK) 1 994 937 (the “Patent”) entitled “Prevention and treatment of amyloidogenic disease”. The Patent discloses and claims pharmaceutical compositions comprising an antibody to β-amyloid peptide (a type of protein plaque that builds up in Alzheimer’s disease patients’ brains – the theory being that an antibody to β-amyloid peptide mi [...]

Genveraenderungen, Federal Court of Justice (Bundesgerichtshof), 5 February 2013

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 income of the employer comprises all financial benefits related to the employees’ invention and its exploitation. This includes not only payments made to the employer but also other benefits such as patent protection.

Click here for the full text of this case.

A summary of this case will be posted on

U.S. Supreme Court Holds Isolated Human Genes May Not Be Patented

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 isolated, but that cDNA is patent eligible because it is not naturally occurring.” Thus, the Court held that human genes may not be patented.


This case stems from a declaratory judgment action brought to challenge certain claims in seven patents related to Myriad’s discovery of the BRCA1 and BRCA2 genes, and t [...]

Process for improving glucose metabolism, European Patent Office (Appeals Court), 19 December 2012

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

AIFA officially to apply the “reimbursement price linkage” provisions

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 [...]

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