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Salt limitation leads to sweet and sour Court of Appeal judgment

by Gregory Bacon and Brian Cordery

The Actavis v Eli Lilly UK litigation concerning pemetrexed (sold by Eli Lilly under the brand Alimta(®) has already been widely reported in light of Actavis’ innovative application to the English court for declarations of non-infringement (DNIs) of national designations of a European Patent in addition to the UK designation. The latest instalment concerns the Court of Appeal’s judgment in the appeal on the merits. In summary, the Court of Appeal refused to grant the declarations sought by Actavis. This overturned the decision of Mr Justice Arnold in the Patents Court, who had held that each of the UK, French, Italian and Spanish national designatio [...]

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 [...]

UK: Actavis Group PTC EHF v. Pharmacia LLC, High Court of England and Wales, Chancery Division, Patents Court, HP14A01503, 11 July 2014

The English High Court (Arnold J.) has granted an application for a stay of the UK High Court proceedings to revoke the UK designation of an EP patent pending the outcome of opposition proceedings at the EPO. The decision is unusual as Arnold J had previously refused to stay the validity proceedings in this case on several grounds including the lengthy duration of the EPO proceedings. Following Arnold’s first decision dated 11 July 2014, Pharmacia offered two additional undertakings, which led Arnold J. to tip the balance in favour of a stay.

A full summary of this case has been published on Kluwer IP Law.

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Fordham Conference 2015 – Biosimilars

Penny Gilbert from Powell Gilbert LLP explains the position of biosimilars in the pharmaceutical industry. Biosimilars are essentially generic versions of biologics. Traditional generic compounds are  chemical reproductions of the patented compound which makes regulatory approval more straightforward. Biological compounds (proteins or antibodies which are produced from genes) are not identical with one another and have higher hurdles in terms of achieving regulatory approval. The cost of bringing it to market is significant. Doctors may be less willing to prescribe biosimilars as compared to generic chemical compounds when considering the alternatives to the originator’s product. Undertakin [...]

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