Generics v Daiichi note available

The Current Intelligence note by Bratin Roy ((McDermott Will & Emery UK LLP) on the Court of Appeal (England and Wales) decision in Generics (UK) Ltd v Daiichi Pharmaceutical Co Ltd & Another [2009] EWCA Civ 646 (2 July 2009), Court of Appeal, England and Wales (noted here on The SPC Blog), published in this month's Journal of Intellectual Property Law & Practice, is available in full at no charge from that journal's weblog here.

SPC practice in Germany - changes due to the PatModG

Klemens Stratmann (Hoffman-Eitle, Munich) has kindly informed us of some recent developments on SPCs practice in Germany due to the Patentrechtsmodernisierungsgesetz (shortened - PatModG; English translation - The Act to simplify and modernise the Patent Act), which entered into force on 1 October 2009:

"One change concerns requests for the correction of the duration of granted SPCs. Prior to 1 October 2009, the terms of granted SPCs could only be corrected by lodging a request for partial nullification at the Federal Patent Court. The SPC proprietor was barred from filing such request. Although there is no explicit legal basis for requests of this type to be found in Regulation 1768/92, that this can be allowed may be derived from Art. 17(2) and Recital 17 of Regulation 1610/96 (Federal Patent Court decision "Finasterid", 15 March 2007, 3 Ni 2/06).

New Sec. 49a (4) of the German Patent Act allows for the first time the filing of requests for the correction of an SPC at the German Patent and Trademark Office. Further, such requests can be filed by the owner of the SPC, for instance if he was in error regarding the first authorization to place the product on the market in the Community when filing the SPC request.

New Sec. 49a(3) of the German Patent Act implements the provisions of Regulation 1901/2006 on medicinal products for paediatric use.

The German legislators also took the opportunity with this change to introduce fees for extensions of paediatric SPCs. Should an SPC application already be pending, the request to extend the SPC costs 100 € as of October 1, 2009. If the request for SPC extension is lodged after the SPC application, the fee is 200 €."

The SPC Blog would be interested in knowing how corrections are handled in other European countries. Please post your comments below.

Medeva pertussis vaccines fail the Art 3 test as question of appeal remains unresolved

On Monday, in Medeva BV's application, BL O/357/09, Dr Lawrence Cullen was faced with five applications for supplementary protection certificates (SPCs), each of which was based on the same patent, EP (UK) 1 666 057 B1, which was filed on 20 April 1990 with a priority date of 8 May 1989, then granted on 18 February 2009.

The SPCs covered pertussis vaccines, each of which contained the two active ingredients expressly covered by the basic patent, in combination with several other active ingredients [there's a neat tabular representation of the combinations at p.2 of the decision]. Dr Cullen upheld the examiner's view that the basic patent could not be construed as protecting any combination of this type and that an application for an SPC covering only the two claimed active ingredients could not succeed because there was no marketing authorisation for such a product; all the authorisations were for combined products [these are neatly tabulated on p.3]. Since the defects in the application had not been remedied by Medeva within the four-month window for rectifying them, the applications were doomed.

At paragraphs 12 to 13 Dr Cullen mentions a preliminary issue, which remains outstanding since his decision dealt only with the substantive question of whether the applications fulfilled the requirements of Article 3 of Regulation 469/2009:

"12. In correspondence with the examiner, the applicant gave notice that they
considered his report dated 31 July 2009 to be a ‘final decision’ on these
applications and, as a consequence, that they would bring this ‘final decision’ to
refuse these SPC applications as an appeal before the Patent Court. The
examiner wrote back on 1 September 2009 indicating that this examination report
did not constitute a final decision, that a response to the examination report was
awaited and that, if the applicant did not have further arguments or observations
on these applications, they could request a final decision on these applications
from the Office, either at an oral hearing, or if they wished to expedite matters, on
the basis of the papers currently on file. The applicant replied on 9 September
2009 waiving their right to be heard and indicating that they would like a decision
based on the papers currently on file so that the status of these applications
could be resolved before expiry of the basic patent in April 2010.

13. However, this request was made without prejudice to the ongoing question over
whether or not it is appropriate to launch an appeal based on an examination
report. While the Office agreed to the applicant's request for a decision from the
papers, it also indicated that it would reserve its right to seek an order to have
this appeal application struck out on the ground that there was no decision of the
Office to appeal from at that date".

Chewing the fat? Chewy Lipitor goes for paediatric extension

According to Trading Markets, Pfizer Inc said today that it has submitted paediatric data for Lipitor (atorvastatin) to the European Medicines Agency (EMEA), after the EMEA concluded that Pfizer's programme studying the use of Lipitor in children with high cholesterol complied with its criteria. This submission includes a new chewable form of Lipitor, including a paediatric-appropriate 5 mg dose (see also Welt Online, RTT News ).

Just over a week ago, Dr Reddy's filed an application to manufacture a generic version of the drug (see here and here).

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.

Ask the IPO ... at the SPC Seminar 2010

The SPC Blog is pleased to announce that Lawrence Cullen, Deputy Director of the UK Intellectual Property Office, will be joining the panel for the Hot Topics and Questions discussion at the SPC Law and Practice 2010 Seminar.

The SPC Blog's 2010 seminar: you're all invited!

The SPC Blog is delighted to announce SPC Law and Practice 2010, the weblog's second annual seminar. Once again we are fortunate that Olswang LLP has agreed to host the event, which is free, at its London office.

The seminar takes place on Wednesday 13 January 2010. It will run from 1.30pm, when registration commences, till the last drop of wine is sipped and the last peanut ceremonially crunched at 6pm. Last year's seminar was very well attended and, judging by the growth of interest in SPCs, paediatric extensions and patent term prolongation in general over the past year, we expect a capacity crowd of 90 participants or thereabouts.

Highlights of the afternoon include presentations on the current state of SPCs in Spain (Javier Huarte, Grau and Angelo) and the Netherlands (Martijn de Lange, Netherlands Patent Office) as well as patent term extension in the USA (Jeffrey Boone, Covidien). SPC Blog team member Rob Stephen (Olswang) takes the chair. There will also be a celebrity line-up for the Hot Topics and Questions session, which will be full of surprises.

For further details click the invitation here. To tell the SPC Blog that you'll be coming, email Verity here