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
Thursday, 30 June 2011
Wednesday, 29 June 2011
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.
Tuesday, 28 June 2011
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
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!
Wednesday, 22 June 2011
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.
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.
Saturday, 18 June 2011
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:
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: email@example.com 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.
Wednesday, 15 June 2011
* 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.* Gareth Williams (Partner, Marks & Clerk LLP)
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.”
“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".
Tuesday, 14 June 2011
"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).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.
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".
Thursday, 9 June 2011
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.
Friday, 3 June 2011
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!