Source: http://thespcblog.blogspot.com/2012/11/
Timestamp: 2019-04-20 05:04:10+00:00

Document:
"Verica is is the AG who caused all the confusion over “one SPC per patent” and “subject matter of the invention” in Medeva. If she is off the scene, then perhaps these ideas will have fewer supporters in the referrals on these points in Actavis v Sanofi, Lilly v HGS etc. Credit where credit is due, though - she got Neurim absolutely right!"
The SPC Blog has been closely watching developments in Australia, where a serious no-holds-barred review of pharmaceutical patent protection, taking in patent term extension is in full swing.
Recently, the Pharmaceutical Patents Review Panel released a Background and Suggested Issues Paper in regard to patent extension of term provisions. We are aware that your blog has contained posts relating to pharmaceutical patents in the past and thought you may be interested in the issues under review and the views posted on the Pharmaceutical Patents Review blog.
At present the Pharmaceutical Patents Review blog has just two items posted on it, but it may be a good idea to watch it closely and see what sort of responses are posted -- and from whom.
The Pharmaceutical Patents Review Panel has released an Issues Paper, inviting the public to make submissions by 21 January 2013. The Panel conducting the review will submit a final report to Government in April 2013.
The review will evaluate whether the system for pharmaceutical patents is effectively balancing the objectives of securing timely access to competitively priced pharmaceuticals, while fostering innovation and supporting research. In particular, the extension of term provisions will be reviewed.
The public are also invited to contribute to the review by commenting on the review's blog. The Review Panel will be posting topics and papers on the blog for further discussion during the review.
See the Background and Suggested Issues paper.
The Background and Special Issues paper is 72 pages long; patent term extension is dealt with on pages 4 to 14.
This blogger is not certain how inclusively the word "public" is understood within the context of the review, but suspects that its intention is to encourage a wide range of responses rather than merely those from the various sectors of the pharma industry.
The SPC Blog thanks Anna Feros (Shepherd and Wedderburn LLP) for the link.
A few weeks ago The SPC Blog posted this item on Actavis Group PTC EHF & another v Sanofi Pharma Bristol-Myers Squibb SNC  EWHC 2545 (Pat), another case in which the Patents Court, England and Wales, decided to make a reference to the Court of Justice for a preliminary ruling.
"1. What are the criteria for deciding whether "the product is protected by a basic patent in force" in Article 3(a) of Regulation 469/2009/EC ("the Regulation")?
2. In a situation in which multiple products are protected by a basic patent in force, does the Regulation, and in particular Article 3(c), preclude the proprietor of the patent being issued a certificate for each of the products protected?"
If you would like to send a comment to the UK Intellectual Property Office on this case, which might result in the UK making representations to the court, please email policy@ipo.gsi.gov.uk by 16 November 2012.
Patent linkage: has it returned to Italy?
"Only very recently, the Italian Parliament had abolished a provision contained in the Italian IP Code and corresponding to a form of patent linkage. This provision indicated that an application for a generic marketing authorization could be filed only within the last year of life of the patent or SPC protecting the originator product, also taking into account any paediatric extension filed with respect to the SPC. The abolition of this provision followed from an infringement procedure started by the EU Commission against Italy.
Now, on 8 November 2012, the Italian Parliament has passed a law entitled "Urgent measures for promoting the development of the [Italian] State by way of a higher level of health protection". Among other things, this law provides that the Italian Regulatory Authority (Agenzia Italiana del Farmaco, AIFA) shall carry out an extraordinary review of the national list of authorized pharmaceutical products, so as to more clearly identify any therapeutically obsolete medicinal products.
"the medicinal products which are equivalent, according to the law, to medicinal products whose patent or SPCs is yet to expire/about to expire [translator's note: the Italian terms of the law are not clear on this point!] cannot be classified as reimbursed by the Italian national health service prior to the patent or SPC expiry date published by the Ministry of Economic Development [translator's note: this is the Ministry encompassing the Italian PTO] according to the provisions of law."
The new law therefore does not appear to introduce a patent linkage regarding when a generic marketing authorization should be filed or when it should be granted; nevertheless, the language of Art. 11(1) appears to introduce a patent linkage regarding when a generic product can be reimbursed by the national health service.
While the law was under discussion at the Italian Parliament, the Italian Antitrust Authority had sent a formal communication to the Parliament proposing that the provision of Art. 11(1) be abolished given that, in the Authority's own words, such provision "introduces ... a clear form of 'patent linkage'". Despite this comment by the Authority, the provision was maintained and is still part of the new law.
The full text of the new law as published in the Italian OJ of November 8, 2012 can be found here.
Art. 11(1) of the new law should be read and assessed also in the context of Art. 14 of the current version of the Proposal for a Directive of the European Parliament and of the Council relating to the transparency of measures regulating the prices of medicinal products for human use and their inclusion in the scope of public health insurance systems, which can be found here.
Interestingly enough, Art. 14 is entitled "Non interference of intellectual property rights...". It will be watching carefully to see how Art. 11(1) of the new Italian law will be reconciled with the text of Art. 14 of this draft directive.
Surely this will not be the last we hear regarding Italy and patent linkage!"

References: Art. 11
 Art. 11

Art. 11
 Art. 14
 Art. 14
 Art. 11
 Art. 14