Forthcoming attractions in Luxembourg

Not everything in the Grand Duchy is so quite and sedate:
have you tried the Luxembourg Grand Prix ...?

The Curia diary for the coming term has now published the first couple of weeks of impending cases before the Court of Justice of the European Union.  The SPC Blog has been tipped off by one of his anonymous but greatly respected regulars (thanks!) that, if anyone were thinking of taking a holiday in Luxembourg next month, he could do no better than to arrange to be there on Thursday 12 September, in time to enjoy the following fare:

Thursday 12/09/2013 09:30	Hearing C-443/12	Approximation of laws Actavis Group and Actavis Court of Justice - Third Chamber	EN
Thursday 12/09/2013 09:30	Hearing C-484/12	Approximation of laws Georgetown University Court of Justice - Third Chamber	NL
Thursday 12/09/2013 09:30	Hearing C-493/12	Approximation of laws Eli Lilly and Company Court of Justice - Third Chamber	EN

If any SPC Blog devotees happen to be there and feel tempted to let us have a report on how these hearings go, we'd be thrilled to share it with our readers.

Just for the record: details of Croatia's new SPC law

From AG-IP News ("The Only Specialized Global Intellectual Property News Agency") comes a short item by Anamarija Stancic Petrovic which confirms that the Croatian Parliament passed a new Patent Act and Act on Amending the Patent Act (Official Gazette No. 76/2013) on an urgent basis, even ahead of Croatia’s EU accession on 1 July 2013, on 29 June 2013. As the piece explains:

The amendments were made with respect to the provisions on supplementary protection certificates and compulsory licensing. The amending Act establishes a competent body and its tasks relating to the implementation of:

Regulation (EC) No. 469/09 of the European Parliament and of the Council of 6 May 2009, concerning the supplementary protection certificate for medicinal products intended for humans or animals, as amended (Official Journal of the EU (OJ) L 152, 16.6.2009, containing all the amendments);

Regulation (EC) No. 1610/96 of the European Parliament and of the Council of 23 July 1996, concerning the creation of a supplementary protection certificate for plant protection products, as amended (OJ L 198, 8.8.1996, containing all the amendments); and

Regulation (EC) No. 816/2006 of the European Parliament and of the Council of 17 May 2006, on compulsory licensing of patents relating to the manufacture of pharmaceutical products for export to countries with public health problems, as amended (OJ L 157, 9.6.2006, containing all the amendments).

The new law came into force in Croatia on 4 July 2013.

Vaccines and SPCs: a fork in the road - now you can read it

Yesterday The SPC Blog mentioned the recent publication of a piece by Simon Cohen and Paul England and expressed the hope that we would be able to host it for the edification of our readers. Well, not only have Lawtext Publishing kindly sent us a pdf, which you can read here, but we received a comment from Anonymous Steve, who wrote:

"I believe that the full text of this article is available from Taylor Wessing using the following link: https://www.taylorwessing.com/fileadmin/files/docs/Vaccines_and_spcs_law_review.pdf".

He's quite right, it is! Thanks, Steve.

Vaccines and SPCs: a fork in the road

The latest issue of the Bio-Science Law Review, published every so often by Lawtext Publishing Ltd, "Vaccines and SPCs: The CJEU Reaches a fork in the Road". The authors are Simon Cohen and Paul England, from the London office of international law and IP practice Taylor Wessing LLP, London. According to the abstract:

"The use of vaccines in the prevention of disease is nothing new and they are often protected by patents and supplementary protection certificates ("SPCs"). However, in more recent times, two developments have taken place: 

(i) guidance has come from regulators that treatment of populations with vaccine combinations is preferred to single vaccines, and  

(ii) there has been an increased need to use adjuvants with vaccines to improve their efficacy. 

Both of these developments have placed strain on the legislative regime governing SPC protection (the "SPC Regulation"), which whilst intended to supplement patents for the protection of investment in medicinal products, was not drafted with such combinations in mind. 

Deciding whether certain classes of medicinal products should be protected by SPCs and, at the same time, maintaining a clear and consistent application of the SPC Regulation has been difficult for the courts. One UK Court of Appeal judge was forced to state that the SPC regime risks failing large areas of pharmaceutical research, making it 'not fit for purpose'. In addition, a UK High Court judge has said that it is "dysfunctonal'. However, until very recently, the interpretation of the SPC Regulation on the subject of SPC protection for combination, including vaccines, had achieved a measure of clarity for makers of combination products. However, an apprent attempt by the Court of Justice of the European Union in Nurim to respond to the commercial argument for wider protection by SPCs expressed by the Court of Appeal judge, has now caused disarray. In that case the court used a so-called teleological approach to theinterpretation of the SPC Regulation that appears to contradict earlier case that were thought to have settled on a strict approach. It is this disarray that caused the frustration expressed by the latter High Court judge and a further reference the the CJEU. 

The case referred, GlaxoSmithKline Biologicals v Comptroller-General of Patents, is where these issues have now come to a head. It concerns vaccines again - adjuvant and vaccine combinations - and takes the SPC regime to a fork in the road: the CJEU can choose to go the new teleological route, or stick to the strict approach. Whichever way the CJEU chooses to go it is likely to have far-reaching commercial consequences for certain medicinal products, such as vaccines, and the pharmaceutical industry in general".

This blog will use its good services to see if it can persuade the publisher -- who has been kind to us in the past -- to let us host the entire text of this piece.