Queensland, SPCs based on process claims and third party observations: the UK Fabrazyme SPC application

The attention of The SPC Blog has been caught by a recent decision of the UK Intellectual Property Office (IPO) in Icahn School of Medicine at Mount Sinai's application (Case O/552/14), a decision of Hearing Officer L. Cullen which was given on 14 December last but which has hitherto escaped us. According to the IPO summary:

Application SPC/GB13/069 concerns the product Agalsidase-beta, a glycosylated human a-galactosidase A enzyme which is the active ingredient in the medicinal product Fabrazyme (RTM). This product is used to treat Fabry disease where a deficiency in this enzyme means that those with this disease cannot break down a specific glycolipid leading to renal, cardiovascular and cerebro-vascular problems.

The applicant considered that the application met the requirements of Article 3(a) of the SPC Regulation because the wording of the process claim of EP(UK) 2210947 B1 filed in support of the application identifies the product which is the subject of their SPC application. The applicant argues that this is sufficient to satisfy Article 3(a) in light of the decision of the Court of Justice of the European Union (CJEU) in C-630/10 (University of Queensland, CSL Ltd v Comptroller-General of Patents, Designs and Trade Marks).

After considering the relevant case law, including C-630/10, the hearing officer found that in order to satisfy Article 3(a), the product of the SPC application has to be identified in the wording of the claims of the basic patent as the product deriving from the process in question. The key step is to establish what is the product that is identified in the claim and decide if this is the product for which the SPC is being sought. A further consideration of whether the product for which the SPC is sought is (or could be) produced directly by the process claimed in the basic patent is not relevant to the basis for granting an SPC under Article 3(a).

The hearing officer examined what was the product that was identified in the process claim of the basic patent and was satisfied that this was the same product approved by the marketing authorisation and for which the SPC was sought. As the product of the SPC application was indeed identified in the wording of the claims of the basic patent as the product deriving from the process in question, the hearing officer thus concluded that the application met the requirements of Article 3(a) of the Regulation. The case was remitted back to the examiner.

This decision is also of note in that it considers third party observations made under Section 21 of the Patents Act 1977 -- which can be made in respect of the grant of an SPC. The Hearing Officer confirmed that the examiner correctly took such observations (made in this case by Genzyme Corporation) into account when reaching his decision and reiterated that a third party making such observations does not thereby become a party to the proceedings.

No paediatric extension when conditions are not met before SPC expires

In BL O/098/15 Otsuka Pharmaceuticals Company Limited's application, 4 March 2015, Dr Lawrence Cullen, for the United Kingdom's Intellectual Property Office (UKIPO), held that it was not possible to grant an application for a paediatric extension for patent protection when the conditions for establishing one's entitlement to a paediatric extension -- the completion of investigations relating to paediatric indications and the issue of an updated marketing authorisation  -- had not been fulfilled before the expiry of the SPC.

Otsuka, who had an SPC for ‘aripiprazole or a salt thereof’, used in the treatment of schziphrenia and bipolar affective disorder, was unsuccessful in securing a paediatric extension. In reaching his decision, Dr Cullen distinguished the earlier and authoritative decision of the Court of Appeal for England and Wales in EI du Pont de Nemours & Co v UKIPO [2009] EWCA Civ 966 [on which see The SPC Blog post here and note by Sebastian Moore and Jonathan Turnbull here], on the basis that, in that case, while the requirements for an extension had not been met at the date of application, they had still been met before the date of expiry of the related SPC and it was the case that matters in relation to the extension of an SPC had to be decided before that SPC expired. This was so even if the decision was taken on the last day of the SPC's existence because, once the SPC expired, others were entitled to enter the market and the interest of third parties (i.e. generic pharmaceutical companies) had to be taken into account.

In Dr Cullen's own words:

"55 I accept that the applicant has to carry out the studies in the paediatric population first and get approval from the EMEA. This involves a commitment of time and resources up front. I accept that if the applicant carries out the necessary steps, then they should be entitled to the reward without taking too restrictive a view of how and when the applicant meets the requirements to qualify for an extension to the SPC.

56 However, I do not take this to mean that this should extend beyond the expiry date of the SPC. I think that it is reasonable to expect that matters in relation to an extension to an SPC are decided before the SPC expires, even if this decision is taken on the last day of the SPCs existence! Once the SPC expires, others are entitled to enter the market. Because of this, I think that, after the expiry date of the SPC, one must take account of the interest of third parties. Knowing when the SPC will expire is important for the entry of third parties, such as generic medicine companies, into the market because once the SPC expires; they are free to bring their own versions of the medicines comprising this active ingredient to market. If an application for an extension to a granted SPC was still considered to be capable of rectification after the expiry date of the SPC and the grant of an extension could be back-dated, this would, in my view, introduce uncertainty and, even, the potential for abuse. It would not be clear in such a situation when the paediatric studies would have to be completed by and when the updated MA would be available. There needs to be some clarity as to when matters are complete and others can enter the market. This seems to me to represent an appropriate balance, as referred to in recital 10 of the SPC regulation, to take account of all the interests at stake “in a sector as sensitive and complex as pharmaceuticals” while also making sure that research into paediatric uses of medicines is given the necessary incentive".

An applicant for a paediatric extension has 28 days in which to appeal.

IPO consults on extending 'Appointed Person' facility to SPC appeals

The United Kingdom Intellectual Property Office (IPO) has published a consultation paper on whether to extend the use of Appointed Persons from trade mark law to to patents. At present, trade mark appeals from the decisions of IPO hearing officers may be made to the High Court (of which the Patents Court forms part) or to a specially designated Appointed Person. In the former case, further appeals may be made to the Court of Appeal and Supreme Court, while in the latter case -- as a means of preventing the costs of an appeal from spiralling upwards -- the decision of the Appointed Person is final and no appeal may be made on substantive legal grounds. According to the IPO:

"This discussion document takes a look at the issues surrounding introducing an Appointed Person appeal route for patents matters (and, by extension, matters relating to supplementary protection certificates)".

It is difficult to imagine why proprietary pharma companies and their generic counterparts would wish to opt for an appeal against which there is no appeal in an area of law which is so complex and uncertain -- but we won't know for a while what the outcome of this consultation will be, since the closing date for the submission of responses is 21 May 2013.

Click here for a little more background
Click here for the consultation paper

Late renewal: when the computer can't be blamed

In Tulane Education Fund v Comptroller General of Patents [2012] EWHC 932 (Pat) Roger Wyand QC, sitting on 17 April as a Deputy Judge of the Patents Court, England and Wales, heard an appeal against the refusal of a UK Intellectual Property Office hearing officer to reinstate a supplementary protection certificate following the applicant's failure to pay the prescribed fees in time.

Tulane's basic patent for Cetrorelix expired on 10 July 2008 and the SPC was due to come into effect the next day. Dennemeyer & Co had been instructed to pay Tulane's SPC fees. Having failed to pay the prescribed fee within the prescribed period, Dennemeyer sought to pay it within the six months immediately following the prescribed period in reliance on the Patents Act 1977 Sch.4A para.5, using the electronic patent, design and trade marks renewal system at the same time as it made 3,075 other payments for various other patent renewals. Unfortunately the SPC number was converted into a patent number by the IPO's computer system, which did not recognise it as a valid patent number, with the result that the payment was rejected. Dennemeyer did not realise which application had been rejected because the reference number had been changed, and the error was realised only after the period for late payment for the prescribed fee had expired.

Tulane then applied to the Intellectual Property Office for a correction of an irregularity under the Patents Rules 2007 r.107 or for the SPC to be brought into effect under s.28(1) of the Act ("Where a patent has ceased to have effect by reason of a failure to pay any renewal fee, an application for the restoration of the patent may be made to the comptroller within the prescribed period"). The hearing officer rejected Tulane's applications and the company appealed.

In its appeal Tulane submitted that (1) the IPO erred in relying on a computer system which erroneously changed the reference number of the SPC and rejected it, and in failing to send an adequate response in relation to the rejection of the payment; (2) the hearing officer should have restored the lapsed certificate under s.28 since that provision applied to SPCs as well as patents; (3) Sch.4A para.5 was ultra vires as it was intended to implement Regulation 1768/92 and a requirement for a single payment could not fall within the provision in Art.12 of the Regulation allowing "annual fees".

Roger Wyand QC dismissed the appeal. In his view the electronic payment system used by Dennemeyer was intended for patent payments and not for SPC payments. A computer program's attempt to interpret a reference number by converting it into a format appropriate for the payments for which the system was intended could not therefore be described as an error. The IPO was obliged to send a rejection, quoting the number used in the payment application, when it rejected that payment and that failure did contribute to the failure to pay the appropriate fee in time. However, the failure to identify the payment that was rejected accurately did not actively bring about Dennemeyer's failure to pay the fee: Dennemeyer had not followed the Rules and paid via the appropriate system for a SPC -- and it could have worked out the change in reference number. In terms of causation Roger Wyand QC added that, even if the error had not occurred, it was doubtful that the correct fee would have been paid in time. Accordingly, the IPO's error was not sufficiently causative to enable the application of r.107(3). For the avoidance of all doubt, he added that s. 28 had no application in the case of SPCs.


Source: note published on the Lawtel subscription-only service

No further UK appeal over levofloxacin

According to a news item this morning on the UKSCblog, which focuses on the activities of the new Supreme Court for the United Kingdom which took over the appellate functions of the House of Lords this autumn, the Supreme Court has refused permission to appeal in Generics (UK) Ltd v Daiichi Pharmaceuticals [2009] EWCA Civ 646 (noted here on The SPC Blog). Generics (now known as Mylan) wanted to appeal against the decision of the Court of Appeal that that Daiichi's by then expired patent antibacterial levofloxacin and the supplementary protection certificate based upon it were valid.

This news item has been picked up by Zenopa here. It does not however appear on the Supreme Court's own website or on any of the usual internet news channels.