A niche blog dedicated to the issues that arise when supplementary protection certificates (SPCs) extend patents beyond their normal life -- and to the respective positions of patent owners, investors, competitors and consumers. The blog also addresses wider issues that may be of interest or use to those involved in the extension of patent rights. You can email The SPC Blog here

Friday 29 May 2015

Reliable information on non-EU and non-US patent term extension: can you help?

I have been approached by a correspondent who has posed the following question:
Can you recommend a reference work or website that can provide reliable information as to the availability and rules surrounding Patent Term Extensions or Supplementary Patent Protection in countries other than the US or Europe?
Offhand, I couldn't think of one, though I'm sure that one must exist somewhere -- and one certainly should if none has yet been compiled.

Can readers of this weblog make any recommendations or point our correspondent to an appropriate source -- in English or in any other language?

Monday 25 May 2015

MAs and APIs: the Austrian Supreme Court applies Forsgren ruling

Last week our friend Rainer Schultes (Geistwert) posted on his blog this note, which we are happy to reproduce below with his permission, on the Austrian Supreme Court's application of the provisions of the SPC Regulation in the light of a recent ruling of the Court of Justice of the European Union (CJEU) in response to the Austrian court's reference in the Synflorix case.  For the benefit of any first-time readers, API stands for "active pharmaceutical ingredient" and an MA is not a higher degree but a marketing authorisation:
The API of an SPC need not be mentioned in the MA

In Case C-631/13 Forsgren [noted briefly here on The SPC Blog], the CJEU already ruled: Article 3(b) of Regulation 469/2009 must be interpreted as precluding the grant of a supplementary protection certificate for an active ingredient whose effect does not fall within the therapeutic indications covered by the wording of the marketing authorisation.

Article 1(b) of Regulation 469/2009 must be interpreted as meaning that a carrier protein conjugated with a polysaccharide antigen by means of a covalent binding may be categorised as an ‘active ingredient’ within the meaning of that provision only if it is established that it produces a pharmacological, immunological or metabolic action of its own which is covered by the therapeutic indications of the marketing authorisation.

GEISTWERT has blogged already (link).

Now, the Austrian Supreme Court shed further light on the SPC Regulation when applying the CJEU's judgment (Austrian Supreme Court, 4Ob20/15t).

In the matter at stake an SPC was requested for a protein D, which is a carrier protein covalently bonded to other active ingredients. Covalent binding does not exclude an SPC.

The Supreme Court analysed the context between the order for reference, the statement of the European Commission and the CJEU’s judgment: The Supreme Patent- and Trademark Senate, which referred the question to the CJEU had individualized the protein D as a carrier for which no pharmaceutical effect was mentioned in the Marketing Authorisation (MA). With regard to that, the Commission meant that the protein’s activity had to be mentioned in the MA, otherwise the request for SPC was not justified. The CJEU did not follow that but referred to the facts, thus to the effectiveness of the protein within Synflorix.

Upon this analysis, the Supreme Court now held that an own pharmacological, immunological or metabolic action of the protein D within the indications covered by the MA has to be established but it is not necessary that the protein D is explicitly mentioned in the Marketing Authorisation.

To verify that, the matter was referred back to the first instance.
Thanks so much, Rainer, for keeping us informed!

Wednesday 20 May 2015

SPCs for Beginners and a touch of Rembrandt

Room service has definitely improved
since the days of Rembrandt himself
The SPC blog earlier this year, in "SPCS for beginners", drew the attention of readers that, on Tuesday 16 June, a seminar is being arranged on the subject of (yes, you've guessed it) SPCs for Beginners. Speaking in this event is Paul Brady (Abel & Imray), who has just contacted The SPC Blog to tell us that the event's organiser (Sarah Packham at Management Forum) has aske The SPC blog to tell its readers that -- in keeping what seems to be a most agreeable trend* towards more affordable registration fees -- Management Forum is offering a 15% discount for SPC blog readers.

For the mathematically minded, this is effectively the 15% early bird reduction, which has now been extended for SPC Blog readers beyond its original deadline date. It works out at (£508.30 + VAT rather than £598.00+VAT). £508.30 is just a couple of pounds short of three times the price this blogger paid for his first car ...

For the record, the seminar takes place at The Rembrandt Hotel, London (if you're staying there, do check out the attic ...). Paul Inman (Wragge Lawrence Graham LLP) is either in the chair or is actually the chair (everything is so politically correct these days), and the other speakers are Oliver Kingsbury (Elkington & Fife LLP), Andrew Rudge (Pfizer) and regular SPC Blog contributor Mike Snodin (Park Grove IP). For further details and registration, just click here.

* For another instance of this trend see the 25% registration fee reduction offered by CIPA for everyone, even non-blog-readers, for this year's Congress.

Tuesday 19 May 2015

Pharma Law Academy: a Tale of Downing and Discounts ...

The Pharmaceutical Law Academy 2015 is running from 25 to 27 August 2015, the venue being the very pleasant facilities of Downing College, Cambridge, UK (right). While the programme, as the name suggests, runs a good deal more widely than coverage of SPCs, both patent term extensions and marketing authorisations are among the topics addressed in the first day's programme, chaired by Matthieu Guérineau (Director of the Contract Department, Les Laboratoires Servier). Developments concerning the Paediatric Medicines Regulation are dealt with on day two, while the third day investigates -- among other things -- recent SPC case law.

For further information, you can view the latest agenda and register at the event website here. Readers of The SPC Blog who quote VIP code FKW82574SPC can save 10% on their registration fee.