EPLAW Patent Blog

UK - ISCC v Comptroller General of Patents

International Stem Cell Corporation v Comptroller General of Patents, Patents Court, London, UK, 17 April 2013, Case No. [2013] EWHC 807 (Ch)

Following an appeal by International Stem Cell Corporation (“ISCC”) against a decision that the inventions disclosed in two of its patent applications relating to human stem cells were excluded from patentability, the UK High Court (Deputy Judge Carr QC) has made a reference to the Court of Justice of the European Union (“CJEU”), requesting that the term “human embryos” in Article 6(2)(c) of Directive 98/44/EC on the Legal Protection of Biotechnological Inventions (“Biotech Directive”) be clarified.  In particular whether this includes unfertilised human ova whose division and further development have been stimulated by parthenogenesis, and which, in contrast to fertilised ova, contain only pluripotent cells and are incapable of developing into human beings.  

This follows guidance given by the CJEU on the correct interpretation of Article 6(2)(c) in Brüstle (Case C-34/10) in which it ruled inter alia that any non-fertilised human ovum whose division and further development have been stimulated by parthenogenesis constitutes a ‘human embryo” within the meaning of Article 6(2)(c) due to it being capable of commencing the process of development of a human being just as an embryo created by fertilisation of an ovum can do so.

UK- GSK v Comptroller- General

Glaxosmithkline Biological SA v Comptroller-General of Patents Designs and Trade Marks, Patents Court, London, UK, 21 March 2013, Case No. [2013] EWHC 619 (Pat)

The UK Patents Court has made a further reference to the Court of Justice of the European Union, requesting that Article 1(b) of Regulation 469/2009/EC (the SPC Regulation) be clarified, and in particular the meaning of “active ingredient” and “combination of active ingredients”.

Glaxosmithkline Biological SA (“GSK”) filed two Supplementary Protection Certificate (“SPC”) applications, one for an adjuvant known as AS03, and one for a vaccine comprising an antigen and AS03.  In both applications, GSK relied upon a marketing authorisation for a influenza vaccine, sold under the trade mark, Prepandrix.  Acting on behalf of the Comptroller, the Deputy Director of the UK Intellectual Property Office, decided that neither application was allowable since AS03 was not an “active ingredient” of Prepandrix, within the meaning of the SPC Regulation.  GSK appealed this decision.

Both parties agreed that this issue should be referred to the CJEU for a preliminary ruling.  Mr Justice Arnold, hearing the case, agreed that this was necessary for three reasons: (1) the answer in this case was not acte clair; (2) there was a lack of consistent interpretation between different national authorities on this point; and (3) the present case raised a similar issue to the issue in a previous SPC related case, Bayer CropScience.

Accordingly, the following questions have been referred to the Court of Justice:

UK - Population Diagnostics Inc. v The Comptroller General

Population Diagnostics Inc v Comptroller General of Patents, Designs and Trade Marks, High Court of Justice, Patents Court, London, UK, 13 December 2012, Case No. [2012] EWHC 3541 (Ch)

This was an appeal to the High Court of a decision by a UK Intellectual Property Office Hearing Officer not to grant two patent applications (one directed at human subjects, the other to animals).  The invention in this case relates to the field of genetics and was directed towards a screening method for differentiating between copy number variants (“CNV”s- repeated sections of DNA) which are associated with a particular condition or phenotype, and CNVs which are present in the population at large, and do not appear to cause disease.   

Claim 1 referred to the provision of genome-wide CNV frequency data from a control group of at least 1,000 individuals who did not possess the particular phenotype.  The issue was whether there was an inventive step, and whether the invention fell foul of the mental act and the computer program exclusions.  The Hearing Officer held that the contribution of the invention lay solely in excluded fields, and there were no other technical contributions. 

UK - AstraZeneca v. Comptroller General / SPC referral to CJEU

AstraZeneca AB v. Comptroller General of Patents, High Court of Justice, Chancery Division, Patents Court, London, UK, 19 October 2012, Case No. [2012] EWHC 2840 (Pat)

AstraZeneca applied for a supplementary protection certificate (SPC) on 11 December 2009 for the product gefitinib. This is the active ingredient in a medicinal product marketed by AstraZeneca as Iressa. Iressa is used to treat non-small-cell lung cancer. The basis for the SPC is EP (UK) 0 832 900 (“the Patent”), which will expire on 22 April 2016. The SPC was granted with an expiry date of 1 March 2019, being calculated by reference to a marketing authorisation granted by the Swiss regulatory authority on 2 March 2004 (“the Swiss MA”). AstraZeneca appealed this, contending that the correct expiry date is 22 April 2021 because the duration of the SPC should be calculated by reference to a marketing authorisation granted by the European Medicines Agency (“EMA”) on 24 June 2009 (“the European MA”).

Stating that the resolution of the appeal depends on two issues of interpretation of Regulation 469/2009/EC of 6 May 2009 (“the SPC Regulation”) Arnold J has referred the following questions to the Court of Justice of the European Union:

1.         Is a Swiss marketing authorisation not granted pursuant to the administrative authorisation procedure laid down in Directive 2001/83/EC, but automatically recognised by Liechtenstein, capable of constituting the ‘first authorisation to place the product on the market’ for the purposes of Article 13(1) of Regulation 469/2009/EC?

2.         Does it make a difference to the answer to the first question if:

(a)        the set of clinical data upon which the Swiss authority granted the marketing authorisation was considered by the European Medicines Agency as not satisfying the conditions for the grant of a marketing authorisation pursuant to Regulation 726/2004/EC; and/or

 (b)         the Swiss marketing authorisation was suspended after grant and was only reinstated following the submission of additional data?

 

3.            If Article 13(1) of Regulation 469/2009 refers solely to marketing authorisations granted pursuant to the administrative authorisation procedure laid down in Directive 2001/83/EC, does the fact that a medicinal product was first placed on the market within the EEA pursuant to a Swiss marketing authorisation automatically recognised in Liechtenstein which was not granted pursuant to Directive 2001/83/EC render that product ineligible for the grant of a supplementary protection certificate pursuant to Article 2 of Regulation 469/2009?

 
Read the decision (in English) here.

Head note: Paul England

UK - Medeva v. Comptroller General of Patents

Medeva BV -v- Comptroller General of Patents, UK Court of Appeal [2012] EWCA Civ 523
 
In this decision, the Court of Appeal applied the much anticipated ruling of the Court of Justice made on 24 November 2011 to Medeva's applications for supplementary protection certificates relating to combination vaccines.  In brief, the Court of Justice had ruled that Article 3(a) of Regulation (EC) No. 469/2009 precluded the patent offices of EU member states from granting an SPC relating to active ingredients "which are not specified in the wording of the claims of the basic patent relied on in support of the application". The relevant patent claim referred to a method of preparing a vaccine which "comprises" the preparation of two specified active ingredients. The claim made no express reference to the other active ingredients of the combination vaccine in respect of which the SPC applications had been made.  Medeva sought to argue that because the word "comprises" or "comprising" in patent claims permits the inclusion of additional elements in addition to those elements expressly referred to, it followed that those additional elements were to be taken as being "specified" in the wording of the claim - a more narrow interpretation would mean that the SPC would fail to provide the same rights in relation to infringement as the underlying patent. The Court of Appeal rejected this argument.  Medeva's approach would have the effect of apply the "infringement test" to the interpretation of Article 3(a), something which the Advocate General and the Court of Justice had themselves rejected. The test propounded by the Advocate General was "the subject matter of the patent" or "the scope of protection" test.  It was for the national court to determine which active ingredients were specified in the wording of the claims.  Where the line was to be drawn was something that would require further references to the Court of Justice, depending on the facts of future cases, but in this case it was clear that, wherever the line was drawn, the active ingredients relating to vaccines against diphtheria, tetanus, meningitis and polio were excluded.  It followed that the UK Intellectual Property Office hearing officer and the first instance judge (Kitchin J) had correctly applied the provisions of Article 3(a) to the facts of this case and the appeal was dismissed.

Read the judgment in English here.

Head note: Graham Burnett-Hall

UK - Neurim Pharmaceuticals (1991) Ltd v Comptroller General of Patents / Referral CJEU

Neurim Pharmaceuticals (1991) Ltd v Comptroller General of Patents, Court of Appeal, London, UK, 8 March 2011, Case no. [2011] EWCA Civ 228

Facts
This case concerns Neurim’s application for an SPC on “melatonin”. Further to the requirements of Council Regulation 1768/92/EEC  Article 3(b) and (d) (the “SPC Regulations”), the application cited a first marketing authorisation. In this case it was for “Circadin-melatonin”, relating to the use of melatonin and excipients as a monotherapy for the short-term treatment of primary insomnia in over 55 year olds.

However, an earlier authorisation to place melatonin on the market exists. This is for the veterinary product Regulin that comprises melatonin and excipients. Regulin is used to improve the reproductive importance of pure bred and cross bred lowland sheep that are to be mated before the usual peak of reproductive activity. Both the Regulin product and the Circadin product were protected by patents. However, Circadin did not fall within the protection of the Regulin patent and vice versa.

 

UK - Yeda v. The Comptroller General of Patents

Yeda Research and Development Company Ltd v. The Comptroller General of Patents, Patents Court, Chancery Division, High Court of Justice, London, UK, 12 July 2010, EWHC 1733 (Pat)

The Patents Court has dismissed Yeda’s appeal of the decision of the UK Intellectual Property Office (UKIPO) to refuse two applications for SPCs relating to a combination treatment for cancer.

Yeda’s patent EP (UK) 667 165 B1 was filed in 1989 and claimed a therapeutic composition comprising a monoclonal antibody and an anti-neoplastic agent. A Marketing Authorization was granted by the European Commission on 26 June 2004 for the monoclonal antibody cetuximab and mention was made in passing to its use in combination with the anti-neoplastic agent, irinotecan.

Yeda subsequently file two SPC applications. The first specified the product to be protected as “cetuximab in combination with irinotecan” and the second specified the product as “cetuximab”. UKIPO rejected the first application as the Marketing Authorization relied on was for cetuximab alone and rejected the second application because cetuximab (as opposed to the combination of cetuximab and irinotecan) was not protected by the patent.

UK - Neurim Pharmaceuticals (1991) Limited v. Comptroller-General of Patents

Neurim Pharmaceuticals (1991) Limited v. Comptroller-General of Patents, High Court of Justice, Chancery Division, Patents Court, London, UK, 6 May 2010, Case No. [2010] EWHC 976 (Pat)

On 6 May 2010, the English High Court handed down its judgment in Neurim Pharmaceuticals (1991) Limited v. Comptroller-General of Patents upholding a decision of the UK Intellectual Property Office not to grant a supplementary protection certificate for a product containing the active ingredient melatonin, on the basis that the condition set out in Article 3(d) of regulation 1768/92/EEC was not satisfied. 

Article 3(d) provides that an SPC will only be granted if the authorisation granted to market the product as a medicinal product under article 3(b) is the first authorisation to that effect.

UK - Betson Medical (Ireland) Limited v. Comptroller General of Patents

Betson Medical (Ireland) Limited v. Comptroller General of Patents, High Court of Justice, Patents Court, London, UK, 31 March 2010, Case No. [2010] EWHC 687 (Pat)

The Patents Court has rejected Betson Medical’s appeal of the decision of the UK Intellectual Property Office (IPO) to reject Betson Medical’s application to restore EP (UK) 0 957 878 following non-payment of a renewal fee.

Betson Medical argued that the UK IPO had applied too strict test and ought to have concluded that Mr Betson and Betson Medical did take reasonable care to see that the renewal fee was paid on time. Mr Betson had made strenuous efforts to secure funding from investors and the only funds he did have were used to cover his living expenses.

Mr Justice Kitchin had no doubt that Mr Betson was indeed facing severe financial difficulties at the time the renewal fee was due and he did make strenuous efforts to secure funding in order to exploit his invention commercially and pay the relevant renewal fee. However, the evidence did not establish that Mr Betson took reasonable care to see that the limited sum necessary to secure the renewal of the patent was paid on time and so the appeal had to be dismissed.

Read the judgment (in English) here.