SPC webinar coming up

The UK's Chartered Institute of Patent Attorneys (CIPA) is offering a webinar on supplementary protection certificates on 19 July 2011.  The webinar will commence at 12.30pm British Summer Time and is expected to last for one hour.  1 CPD point is available for those who need it and the cost is a very modest £36 for CIPA members, £54 for non-members (though you have to provide your own refreshments!).  The speaker is Duncan Curley (Innovate Legal) and the event is chaired by Andrew Teuten (Sagittarius IP).

Details are available from the CIPA website here.

UK Atorvastatin hearing for 11 July

Chemist and Druggist reported last week that a court order was made in favour of Pfizer, restraining the sale and distribution of generic atorvastatin by AAH Pharmaceuticals, Phoenix Healthcare Distribution and Teva UK. The order states that, until a further hearing scheduled for July 11, the three companies must not advertise, offer for sale, sell or supply any atorvastatin other than that supplied by Pfizer or that agreed in orders placed before the injunction was issued.

The named claimant in the proceedings is Warner-Lambert Co, which Pfizer acquired in 2000. According to Pfizer:

"The patent at issue is covered by a supplementary protection certificate (SPC) that does not expire until November 2011, and Pfizer has applied for a six-month paediatric extension to the SPC. In 2005, the same court had rejected a challenge to the patent by Ranbaxy, finding that a generic atorvastatin product would infringe Pfizer's patent covering atorvastatin, the active ingredient in Lipitor. That decision was affirmed on appeal."

A spokesperson for Teva said the company was disappointed that Pfizer had used the courts to prevent customers receiving further stocks, adding:

"Our view is that the patent protection in place for Lipitor is invalid; and we intend to win the case and resume supply as soon as possible".

The order was made by Patents Court judge Mr Justice Floyd.

SPC is presumed valid in proceedings for injunctive relief, says top Austrian court

This weblog does not often receive news from Austria, but International Law Office has recently posted a note on a ruling of the Austrian Supreme Court on 16 February (17 Ob 5/11a). The ruling arose from an unusual set of facts in which the holder of an SPC challenged the grant of a later SPC which, it alleged, was based on the same active ingredient as its own earlier SPC.  In patent infringement proceedings the holder of the later SPC had secured interim injunctive relief against the holder of the earlier one but, once the patent on which the later SPC was based had expired, the holder of the earlier one sought a discharge of that injunction on the basis that, on the expiry of the admittedly valid patent, the injunction was now based only on the SPC which should not have been granted.

The Supreme Court considered that, for the purposes of interim relief -- where the degree of investigation open to the court is limited -- granted rights such as SPCs must be presumed to be valid unless there was sufficient evidence to the contrary. Interim injunctions are governed by the Austrian Enforcement Act (not the Patent Act) and, while this law provide for the possibility of a stay of enforcement if sufficient monetary security is offered, this option is not available in patent and SPC litigation since the consequences of continuation of an infringement cannot be foreseen with sufficient certainty.

Source: "Court clarifies legal aspects of supplementary protection certificates", by Ferdinand Graf and Tanja Melber, Graf & Pitkowitz Rechtsanwälte GmbH, Austria, International Law Office, 27 June 2011

AG Opinion for C-125/10 - English translation available!

Earlier this month, The SPC Blog posted a short note on the AG's opinion for case C-125/10 (Merck & Co Inc v Deutsches Patent- und Markenamt). No official English translation is available yet on the Curia website. However, Monica Heinemann (Abitz & Partner, Munich) has kindly provided a translation, which you can access here. Thanks Monica!

SPC Seminar 2011

A big thank you to everyone who attended the Third SPC Blog Seminar at Olswang's offices yesterday and made the afternoon such a success. We hope to provide a video of the meeting and copies of the slides on this site shortly.

A theme running through a lot of the presentations is that there is still a good number of questions to entertain the CJEU in relation to this "wretched regulation". This was graphically illustrated by Patricia Cappuyns (Olswang), who noted that even courts in the same territory (the lively jurisdiction of Belgium in this case) can "politely disagree" on the interpretation of the regulation, never mind courts in different jurisdictions.

Nicola Jadeja (Rouse), discussed the recent CJEU hearing on Medeva and highlighted the potential differences between one-pot (e.g. Medeva) versus co-administration combinations (e.g, Takeda). Nicole vividly described the CJEU as a bit like Eurovision - flags, crowds, interpreters...

After an epic 18-month trek (involving, snow and diverted flights to random British airports nowhere near London) Javier Huarte (Grau & Angulo) was eventually able to give his delayed presentation on SPCs in Spain. Javier reminded us of the fact that it was not possible to obtain SPCs for products that obtained approval before 2 July 1997, meaning that SPCs in Spain for a number of products was sadly not possible. However, if approval was obtained after this date on a patent filed before mid-1986 (when ES patents had 20 year term from grant), the 5 year SPC that could be obtained provides these lucky products with significantly longer protection in Spain than in most other EU states.

Hugh Goodfellow and Ed Oates (Carpmaels & Ransford) provoked a lot of debate following their presentation of the Neurim questions and the possibility that this could lead to SPCs being obtainable more generally for the second medical use of a substance that has previously obtained a Marketing authorisation.

From SPC blog to SPC textbook

The SPC blog is pleased to pass on the following information from Christopher Brückner, a man brave enough to take on the task of writing a book on SPCs. We imagine that Christopher is now recovering with a cold towel firmly pressed to his forehead, and we congratulate him on his efforts.

Christopher says:

Navigating the Bermuda-triangle between patent, marketing authorisation and product? Scared of getting lost?

We are pleased to draw your attention to the first SPC-commentary, a textbook which hopefully will answer most of your questions related to SPCs.

The SPC-commentary, written by Christopher Brückner, a German Patent Attorney at the law firm Bardehle Pagenberg in Munich, is drafted in German and English, to give users in all European Countries access to this source of SPC-information.

The commentary will be on the market in September. We will notify you when it is available. If you want to get your copy as one of the first readers, you can order it now.

For more details please see the attached official advertisement of the Carl Heymanns Publishing House and the following link:

http://shop.wolterskluwer.de/wkd/shop/deutsches-und-europaeisches-patentrecht,203/ergaenzende-schutzzertifikate%0Asupplementary-protection-certificates,978-3-452-27566-0,carl-heymanns-verlag,51269/viral/

This commentary will be presented officially on 7. July 2011 in Munich. For this event, a limited number of seats have been reserved for members of the SPC-blog. Therefore, please register now (for free) if you want to participate in this event. You can register at: event@bardehle.deand we will inform you as soon as we receive your reservation.

Talks and speeches at the event will be held in German, however, if you are not from Germany, you might not be the only one and we will be happy to accommodate you and answer any questions you may have.

AG's Opinion in Merck: what's your opinion?

Last week's Opinion of the Advocate General in Case C-125/10 Merck (noted briefly here on The SPC Blog) is still not available in English, but that does not mean that the English have not been commenting on it.  Via media releases this blog has received two opinions from the local profession:

* Maria Isabel Manley (Head of Bristows’ Regulatory Practice)

“So far the approach to negative/zero SPCs has been very fragmented across the EU and, in this sense, the AG’s opinion is to be welcomed by the innovative pharmaceutical industry. For the first time, the CJEU will have the opportunity to look into this crucial area of negative SPCs and to harmonise the contradictory national interpretations. It will be great news for the industry if the CJEU decides to follow the AG’s opinion (which is usually the case) and rules in favour of the grant of SPCs with a negative term.

This outcome will also be beneficial to the paediatric population as there is no doubt that it will encourage bio/pharma companies to invest in the conduct of paediatric studies. Indeed, the reward consisting of a 6-month extension to the SPC is an absolutely necessary incentive, as it will assist in partially recouping the investment made by the industry in generating the paediatric data which is so important to the paediatric population.”

* Gareth Williams (Partner, Marks & Clerk LLP)

“This is a slightly surprising Opinion, given that the notion of a negative term right goes against legal convention in general. However the Advocate General’s logic makes good sense, and this solution is in both the commercial and public interest in this particular case. The whole point of the Paediatric Extension is to incentivise R&D into drugs for use with children. This aim is compromised if we punish companies for marketing to children simply because the adult version of their drug went through marketing approval quickly, which is what would happen if we were to insist that SPCs should have a positive term. On the other hand, the Advocate General is right to reject zero term SPCs as compromising the public interest, as this approach incentivises companies to delay marketing approval for their products in order to get the extra six months protection, effectively encouraging companies to withhold treatments from the needy. 

Importantly, Europe needs a harmonious approach, and the ECJ ruling – if it follows today’s Opinion – will provide the basis for that. 

However, the concept of a negative term SPC is still rather odd, and one wonders whether this whole issue wouldn’t be better dealt with by simply separating the two rights, so that Paediatric Extensions can be applied for separately without having to be bolted onto an existing SPC.”

This weblog would be delighted to hear what other comments have been received, including from different countries and industrial sectors around Europe and beyond.  Do let us know.

Incidentally, voting was close in the opinion poll: 26 respondents said "yes", there could be negative term SPCs; 25 said "no" and a very small number answered "it all depends".

Independent consultant sought: could it be you?

A reader has asked The SPC Blog to draw the attention of fellow readers to the following rather unusual opportunity.  He writes

"We are looking for an independent consultant who can work with us in certain projects -- either on an hourly basis or on the basis of some other arrangement. Regarding location and language, we are based in Sweden but need not restrict ourselves just to someone based in Sweden (though it's always simpler and cheaper to work together with someone in your own country).

As yet there is no formal date of commencement for the consultancy, since that is something which depends on our projects.

We need a person who understand and can support the development of business strategies for drug projects in smaller companies, including the optimisation of opportunities for gaining maximum exclusivity of future products: this means the lifetime of patents by SPC, data exclusivity etc. Bearing this in mind, it is likely that the person appointed preferably would have experience from a commercial company".

Any interested candidate should forward his or her CV to me here with the subject line "Consultancy SPC" and it will be forwarded in confidence.

Monaco, France and SPCs

A friend of the SPC Blog has posed the following question for our readers, based upon the fact that Monaco does not appear to have made any provision for SPCs in its law.

Does a French SPC have any effect in Monaco? More specifically, can a French SPC produce a direct or indirect effect in Monaco?

A direct effect may simply result from the French SPC having a legal effect in Monaco, while an indirect effect could be that the existence of a French SPC effectively renders the lack of an SPC in Monaco irrelevant by governing the sales and price of the product in Monaco.

Our friend suspects that there is no direct effect of a French SPC in Monaco, but they are less sure about whether or not there is an indirect effect.

As always, any comments on this tricky issue will be gratefully received.

Opinion of the AG for C-125/10 is out!

The opinion is out and is available here (but not in English yet). In short, the AG is in favour of granting a 'negative' SPC even if the period between the date on which the application for a basic patent was lodged and the date of the first authorisation to place the product on the market in the community is less than five years.

Many thanks to Monika Heinemann (Abitz & Partner) and Andreas von Falck and Miriam Gundt (Hogan Lovells LLP) for passing this on.

Merck ECJ reference: Opinion due this Thursday

Here's a quick reminder: this coming Thursday will see the publication of the Opinion of the Advocate General in Case C-125/10 Merck & Co Inc v Deutsches Patent- und Markenamt, a reference for a preliminary ruling from the Bundespatentgericht (Germany) lodged back in March 2010.

The question referred to the Court of Justice of the European Union is this:

"Can a supplementary protection certificate for medicinal products be granted if the period of time between the filing of the application for the basic patent and the date of first authorisation for marketing in the Community is shorter than five years?"

This weblog looks forward to bringing you news of the Opinion, together with comment if appropriate.

The SPC Blog is conducting a poll, which closes at 9:30am on Thursday. You will find this located at the top of the side bar on the right of the blog's front page. Is the answer "yes" -- or is it "no"? This is your big chance to vote!