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A Little German Christmas Present and some Year’s End Reflections

Thanks to Miquel Montaña’s brilliant Christmas post, we have learnt a lot about the lucina sine (aut cum) concubitu and the legal impact her involvement may have had for the application of Directive 98/44/EC to the event leading to the holidays that we have just been celebrating. While I must admit that even after having read Miquel’s lucid post, I am still not a hundred percent clear on whether Jesus in statu embryonis would have fallen under article 6(2) of Directive 98/44/EC, I can at least confidently say that I am satisfied with the fact that certain questions are probably unanswerable and that the CJEU has generously left this one for the national courts to decide.

Which brings us [...]

Herceptin Round 2: Hospira enjoys the sweet smell of success once more

By Brian Cordery and Steven Willis

Regular readers of the Kluwer patent blog may recall that in April 2014, the English Patents Court revoked two patents relating to trastuzumab, the active ingredient in Herceptin, which is marketed outside of the US by Roche. One patent was for a dosage regimen and the other related to a composition of trastuzumab containing certain levels of impurities. The SPC for trastuzumab itself subsequently expired in July 2014, but as yet, Hospira has not launched its competing medicine in the UK. As part of its campaign to clear the way for launch, Hospira challenged two further related divisional patents – this time relating to lyophilised formulations of tra [...]

Patentability of biotechnology inventions: “O time thou must untangle this, not I. It is too hard a knot for me to untie”

Although Brian Cordery will try to have you believe that the title of this blog is borrowed from William Shakespeare’s Twelfth Night, it may well have been taken from the Report from the Commission to the Council and the European Parliament dated 14 July 2005 on Development and implications of patent law in the field of biotechnology and genetic engineering, where the Commission wrote that:

There is no immediate answer to the question of the patentability of embryonic pluripotent stem cells and indeed at this stage it would appear premature to come to a definitive conclusion. The Commission will continue to monitor developments in this area.”

No additional progress appears to have been made [...]

Cloned Sheep And Other Patent Eligibility Issues In The U.S.

Last week, in In Re Roslin Institute, the U.S. Court of Appeals for the Federal Circuit held that cloned cattle, sheep, pigs and goats are non-patent eligible subject matter under 35 USC § 101. While the result that these cloned animals cannot be patented may not be surprising, the basis for the court’s finding–that the claimed subject matter was ineligible under the “product of nature” doctrine, has some scratching their heads. A more logical way to understand the decision is to read the court’s holding as finding that the cloned animals are non-patent eligible subject matter because they cannot be distinguished from naturally occurring animals.

The patent application at iss [...]

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 [...]

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