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The best things in life are unexpected because there were no expectations (Eli Khamarov)

Apart from the enthralling Lyrica saga which began in earnest back in January, and the main trial of which recently began before Arnold J, 2015 has not witnessed many significant pharmaceutical patent decisions from the UK patents courts. Thus, three cases in this field which, rather like London buses, arrived almost simultaneously, have provided welcome food for thought to life sciences patent enthusiasts.

The three cases were Smith & Nephew v Convatec (24 June 2015) and Eli Lilly v Actavis (25 June 2015) from the Court of Appeal and a decision from Arnold J in Hospira v Genentech (24 June 2015), part of the on-going campaign to clear the way in respect of certain Genentech patents relatin [...]

Swiss Form Claims and Skinny Labelling – the Lyrica Appeal

On 28 May 2015, the English Court of Appeal issued a ruling in the on-going Lyrica saga which, although almost certainly not representing the last word on the topic, took a markedly different approach to the correct construction of Swiss form claims to the first instance judge, Arnold J. One thing there does appears to be agreement on at least is that this an important, yet difficult, subject matter.

The Lyrica litigation is active in several European countries (as well as further afield, e.g. Australia) and so the background will be familiar to many readers. In short, towards the end of January this year, Arnold J refused to grant interim relief against Actavis in respect of Warner Lamber [...]

Pre-action Disclosure: Transparency is a virtue

On 28 April 2015, Mr Justice Arnold handed down judgment in relation to an unprecedented application for Pre-Action Disclosure from a patentee. The applicant, The Big Bus Company Limited (“Big Bus”) had applied for disclosure of all licence agreements which the respondent, Ticketogo Limited (“Ticketogo”), had granted under patent UK 2 391 101 (“the Patent”). The Patent claims a method of issuing a ticket over the internet which contains a barcode as an image file. Big Bus made the application following several years of sporadic correspondence with Ticketogo, in which Ticketogo outlined that it considered Big Bus required a licence under the Patent. The latest correspondence inden [...]

Swiss-Form Claims, Skinny Labelling and the duty of the National Health Service – the Lyrica case continues

By Claire Phipps-Jones and Brian Cordery

At the end of January, we reported the Warner-Lambert v Actavis decision of 21 January 2015, in which Arnold J refused to grant Warner-Lambert interim relief in relation to an apprehension of patent infringement by Actavis of Warner-Lambert’s patent comprising Swiss-form claims directed to the use of pregabalin in the preparation of a medicament for the treatment of pain. The apprehended patent infringement pertained to Actavis’ generic pregabalin medicine. Actavis had carved-out pain indications from the label for its medicine but it was nevertheless foreseeable that some of these medicines would be dispensed and used for pain in the UK.

The ju [...]

Swiss Form Claims and Skinny Labelling – the Lyrica Case

Most readers will know that so-called Swiss form claims (“Use of drug X in the manufacture of a medicament for the treatment of disease Y”) were first proposed by the Enlarged Board of Appeal of the EPO in the EISAI case back in December 1984 to allow new uses for known drugs to be patented. This area is of considerable importance, because, as was set out in the resolution of AIPPI on this issue passed at the Toronto congress in September 2014: “Second medical uses may provide solutions to unmet medical needs and provide significant benefits to patients. They may require significant investment in research and development and represent socially, medically and economically valuable [...]

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 [...]

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