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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 [...]

Very Late Request for Long Extension of Time Allowed by UK Patent Office

In a recent decision of the UK Intellectual Property Office, an applicant for a UK patent was allowed to file a response to an examination report (“office action”) more than 18 months after the due date for response originally set in the examination report. This is an extraordinary effective extension of time, obtained well after the initial due date for response had passed, but serves as a reminder that a UK patent application is not normally treated as formally lapsed until the end of the normal acceptance period of 4½ years from the priority/filing date. The applicant appears to have been representing himself throughout.

The initial due date for response set in the examination repo [...]

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 [...]

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