Latest News on Medicinal Product SPCs: Alice de Pastors' report

With The SPC Blog's seminar almost upon us, here's a link to "Latest News on Medicinal Product SPCs in Europe", this being the 26th issue of Alice de Pastors' SPC News. It contains nine pages of fascinating data, enriched with colourful tables.

Thanks, Alice, for sharing all your hard work with us!

Pharma summer school covers SPCs, extensions

"Pharmaceutical Law and Policy -- Hot Topics shaping the Future of the European Pharmaceutical Industry" is the title of a five-day course, from 13 to 17 August, in the University of Copenhagen's 'Copenhagen Summer University'.  

What are the most significant current issues shaking and shaping today's pharmaceutical industry? The business environment and legal framework pertaining to the pharmaceutical industry continue to change rapidly as they are constantly challenged by competition, politics and new technological possibilities. Considering the highly lucrative and competitive nature of the industry, it is more important than ever for professionals working with legal and regulatory aspects of drug development to stay abreast of the most recent developments. 

This course provides a broad and practical understanding of the "hot topics", and will present and analyse these topics from a scientific, legal and policy perspectives. The hot topics are:

• Scientific trends - Scientific breakthroughs that impact the pharmaceutical industry and create new business opportunities

• Biosimilars & Antibodies - New approval pathways, guidelines & regulatory requirements

• Data & market exclusivities - Legislation and political debates

• Individualized medicine - Threats, challenges and opportunities

• New markets - How to deal with the emerging Asian markets?

• Clinical trials - New challenges posed by increasing international competition

• Patents & competition law - Recent pharma-related case law

• Paediatric extensions & SPCs - New developments & case law

• Public Private Partnerships (PPPs) - An increasingly important model of co-operation

• Counterfeit Medicines - Buying and selling pharmaceuticals in cyberspace beyond established quality control systems?

Full details of the programme and registration are available here. The deadline for registration is 29 May.

Medeva: the final chapter in the UK

First, thanks to all those kind readers who sent copies of the final judgment of Medeva to us yesterday; we now have the link, too: it's here and the citation is Medeva BV v Comptroller General of Patents [2012] EWCA Civ 523. In this ruling the Court of Appeal for England and Wales (the Chancellor -- Sir Andrew Morritt, Lords Justices Etherton and Elias) applied the now-familiar preliminary ruling of the Court of Justice of the European Union (CJEU) in Case C-322/10 Medeva and dismissed the appeal.

To recap for new readers of The SPC Blog, Medeva had filed five SPC applications. Three related to vaccines against five diseases (diphtheria, tetanus, meningitis, polio and whooping cough), while the other two omitted the vaccine against meningitis (Hib). The UK IPO's hearing officer rejected all five applications. In the case of four of them, the active ingredients included some which were not protected by Medeva's patent (ie the vaccines against diseases other than whooping cough); as to the fifth, while the active ingredients were limited to those protected by Medeva's patent, the market authorisation covered a combination vaccine which included vaccines against the other four diseases. Thus in all five there was a mismatch between the active ingredients protected by the patent and the active ingredients in the vaccine or medicinal product for which the relevant market authorisations had been given.

Medeva appealed unsuccessfully to the Patents Court and then again to the Court of Appeal, which stayed the proceedings and referred a number of questions concerning art.3(a) of the SPC Regulation to the CJEU for a preliminary ruling. In its ruling, the CJEU held that art.3(a) had to be interpreted as precluding the competent industrial property office of a Member State from granting an SPC relating to active ingredients which were not specified in the wording of the claims of the basic patent relied on in support of the application for such a certificate.

Medeva put quite a positive spin on this ruling.  The way they saw it, the CJEU's explanation of the law still entitled them to the grant of SPCs on the first four of their applications --  or, if this was not so, that the EU's senior court had insufficiently answered the questions referred , so that another reference was needed.

The Court of Appeal dismissed Medeva's further arguments and, with it, the appeal. It held that, since both the Advocate General and the CJEU had rejected any test based on infringement or on the protective effect of the basic patent, all that was left for the national court to do was to determine which active ingredients were specified in the wording of the patent's claims. In this context, "specified" is an interesting word: it could mean anything between expressly naming, actually describing, effectively implying something, or this could be the result of a reasonable construction of the claims. Medeva's problem was that, wherever the dividing line was to be drawn, the active ingredients relating to vaccines against diphtheria, tetanus, meningitis and polio were excluded, while the CJEU's ruling required that the other elements or active ingredients be specified in the wording of the claims. Here was no such wording to indicate that the active ingredients of the vaccines against diphtheria, tetanus, meningitis and polio were included.

Neurim and "first authorisation": the Advocate General speaks

The Advocate General rendered his Opinion this morning in Case C-130/11 Neurim Pharmaceuticals, a reference from the United Kingdom in which the facts were as follows. In December 2009 a hearing officer at the UK's Intellectual Property Office refused Neurim's application for a supplementary protection certificate for the use of melatonin to correct a distortion or deficiency in the plasma melatonin profile of a human subject. The basis of the refusal was the fact that the cited marketing authorisation was not the first authorisation to place melatonin on the market as a medicinal product: there was an earlier authorisation to another company for a composition comprising melatonin for use in sheep to initiate an early breeding season -- an authorisation that had nothing whatever to do with Neurim's research or its resulting patent.

The questions referred for a preliminary ruling are these:

"1. In interpreting Article 3 of Regulation EEC No. 1768/92 [now Regulation (EC) No. 469/2009] (“the SPC Regulation”), when a marketing authorisation (A) has been granted for a medicinal product comprising an active ingredient, is Article 3(d) to be construed as precluding the grant of an SPC based on a later marketing authorisation (B) which is for a different medicinal product comprising the same active ingredient where the limits of the protection conferred by the basic patent do not extend to placing the product the subject of the earlier MA on the market within the meaning of Article 4? 

2. If the grant of the SPC is not precluded, does it follow that in interpreting Article 13(1) of the SPC Regulation, “the first authorisation to place the product on the market in the Community” needs to be an authorisation to place a medicinal product on the market within the limits of the protection conferred by the basic patent within the meaning of Article 4? 

3. Are the answers to the above questions different if the earlier marketing authorisation has been granted for a veterinary medicinal product for a particular indication and the later marketing authorisation has been granted for a medicinal product for human use for a different indication? 

4. Are the answers to the above questions different if the later marketing authorisation required a full application for marketing approval in accordance with Article 8(3) of Directive 2001/83/EC (formerly a full application under Article 4 of Directive 65/65/EEC)? 

5. Are the answers to the above questions different if the product covered by authorisation (A) to place the corresponding medicinal product on the market is within the scope of protection of a different patent which belongs to a different registered proprietor from the SPC applicant?".

Said Advocate General Verica Trstenjak, the questions should be answered as follows:

"(1) Under Article 3(d) of Council Regulation (EEC) No 1768/92 of 18 June 1992 ..., a supplementary protection certificate for a product which is protected by a basic patent in force may be granted only on the basis of the first authorisation which permits that product to be placed on the market as a medicinal product which is within the scope of protection conferred by the basic patent in the Member State for which the application is made. The fact that the same product has previously been authorised as a medicinal product for human use or a veterinary medicinal product in the Member State for which the application is made does not preclude the grant of a supplementary protection certificate based on a later authorisation to place that product on the market as a new medicinal product, provided the first-authorised medicinal product is not within the scope of protection conferred by the patent designated by the applicant as the basic patent. 

(2) The first authorisation to place the product on the market in the European Union to which Article 13(1) of Regulation No 1768/92 refers must also be understood as the first authorisation to place a product on the market in the European Union as a medicinal product which is within the scope of protection conferred by the basic patent designated by the applicant. 

(3) The answers to the above questions are no different if 

– in the Member State for which the application is made, a first authorisation has been granted to place a product on the market as veterinary medicinal product for a particular indication and a second authorisation has been granted to place that product on the market as a medicinal product for human use for a different indication;
– there are two authorisations to place a product on the market as a medicinal product and the later authorisation required a full application under Article 4 of Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products;
– the product covered by an earlier authorisation to place the medicinal product on the market is within the scope of protection of a patent which belongs to a different registered proprietor from the person who applied for a supplementary protection certificate on the basis of a later authorisation to place that product on the market as a new medicinal product and on the basis of a different patent".

The SPC Blog's Rob Stephen hopes to post a comment soon but, in the meantime, readers who wish to post their own thoughts in this advice are, as usual, both welcome and encouraged to do so.