More on adjuvants - from the Netherlands and France

Martijn de Lange sends us the following summary of a decision by the Rechtbank ‘s;Gravenhage in the Netherlands on whether an adjuvant is an active ingredient:

"Stallergenes filed an application for an SPC on the basis of a marketing authorization for Grazax which contains as the active ingredient a standardised extract of grass pollen allergen from Timothy grass. However earlier marketing authorizations existed for medicinal products containing the same active ingredient and in addition aluminium hydroxide, which is a well known adjuvant used for boosting the effectiveness of allergen products (and also vaccines). Stallergenes argued that because this adjuvant induces certain physiological responses it should be considered an active ingredient. Therefore the earlier marketing authorizations were issued for a combination of active ingredients, and thus a product different from that of Grazax. The Netherlands Patent Office rejected this interpretation and pointed to the fact that the earlier marketing authorizations clearly list, in accordance with directive 2001/83, the adjuvant aluminium hydroxide under the excipients. The application was therefore refused in view of article 3(d). On appeal the Court of The Hague (Rechtbank ‘s;Gravenhage, 4 november 2009) upheld this decision. The court noted, with reference to ECJ C-431/04 ‘MIT’, that in this particular situation aluminium hydroxide did not have any therapeutic effect on its own. A formal appeal was filed to the appellate court but was withdrawn last week."

A copy of the decision in Dutch is available here.

"In France where the equivalent SPC was granted, ALK-Abelló, the manufacturer of Grazax, challenged the validity of the SPC and the court (Tribunal de Grande Instance, 7 october 2009) came to the same conclusion that a substance cannot be considered to be an active substance if it has no therapeutic effect on its own and for the particular indication. It therefore annulled the SPC. This decision was published last month in Propriété industrielle - Bulletin documentaire (PIBD) No. 909 (2009) III, pages 9-14."

Thanks Martijn!

Breaking news: Medeva appeal dismissed

Earlier this morning the decision of Mr Justice Kitchin in Medeva BV v The Comptroller General of Patents [2010] EWHC 68 (Pat) was released. This is an appeal against the refusal of Lawrence Cullen (see The SPC Blog here) to grant five SPCs for pertussis vaccines.

As of the time of this blogpost (12.56pm), the judgment has not yet been uploaded on to BAILII, but you can read it here. The SPC Blog will discuss it in due course.

Addendum: as of 14.14pm the judgment has been available on BAILII, here.

Records of the 1st, 2nd and 3rd Expert Meetings on SPCs

Thanks to Martijn de Lange for providing copies of the records of the 1st, 2nd and 3rd Expert Meetings on SPCs. Copies of these documents can now be found on the SPC Blog Resources web page, in the side bar.

More IPO decisions on Vaccines - this time on HPV

Gardasil also played a role in the Intellectual Property Office's recent decision on eight applications for SPCs for single active ingredients on different strains of the L1 protein of the Human Papillomavirus (HPV). The applications were in the name of Georgetown University, one in the name of Loyola University of Chicago and one in the name of University of Rochester.

"One application concerned the recombinant L1 protein of Human
Papillomavirus (HPV) strain HPV6; one application concerned the recombinant L1
protein of Human Papillomavirus (HPV) strain HPV11; three applications concerned
the recombinant L1 protein of Human Papillomavirus (HPV) strain HPV16 and three
applications concerned the recombinant L1 protein of Human Papillomavirus (HPV)
strain HPV18. Although in the name of three applicants, these applications all
currently relate to a single licensee.

Two marketing authorisations were filed in support of these eight applications Gardasil (RTM) which comprises the recombinant L1 proteins of Human
Papillomavirus (HPV) strains HPV6, HPV11, HPV16 and HPV18 and Cervarix (RTM) which comprises the recombinant L1 proteins of Human Papillomavirus (HPV) strains HPV16 and HPV18. [...]

The eight SPC applications were found not meet the requirement under Article 3(b), because the marketing authorisations filed in support of each of these applications
comprises a further one or three active ingredients in addition to the active
ingredient listed in the product definition of that SPC application. Thus, in
each case, a valid authorisation has not been supplied to place the product (for
which an SPC has been applied) on the market as a medicinal product.
Since in accordance with Article 10(3) an opportunity to correct the irregularities
with these applications has been given, they were rejected under Article 10(4). "

Read the decision here.

Portuguese tribunal rules on Gardasil SPC

Thank you, Alice de Pastors, for letting us know some news from the Far West of the European Union. Today, 21 January, the Portuguese Patent Gazette (at pages 7-17) published the decision of the Tribunal do Commercio de Lisboa relating to the cancellation of Portuguese SPC 260 for Gardasil and Silgard, referring to Merck & Co's patent EP0817851.

Alice has also kindly provided us with this link to the issue of the Patent Gazette in which the decision appears.

The Patent Term Extension Debate: a conference paper

New Spaces, New Actors and the Institutional Turn in Contemporary Intellectual Property Law is the grand title of a conference held on 13-14 February at the Kyushu University, Fukuoka City, Japan. One of the papers may be of interest to readers of this weblog. It's "Pharmaceutical Innovation and Patent Law and Policy Making - focusing on Patent Term Extension Debates in Japan and in Europe" by Professor Nari Lee. According to the abstract:

"Patent law often is said to be modelled for the type of industry where the path technological innovation is centripetal and unidirectional, following a common technological trajectory. A sunk cost of investment in the initial phase justifies the legal monopoly of exclusive right granted at the end of this path to recoup the cost of invention.

Pharmaceutical industry is said to be the paradigm example of this case, where research and development including clinical trial period leading to innovative medicine and pharmaceutical products justify a strong exclusive right not only as an incentive to innovate but also as a means to coordinate the innovation process. Pharmaceutical industry arguably is the example where an early grant of right working toward an identified patent prospect leads to an economic efficiency, as it would reduce the wasteful duplicative research efforts.

Pharmaceutical products are regulated heavily, out of concern for the safety of the public without expert medical knowledge. However, technologically sophisticated consumer products increase this regulation necessity, such as the products with genetically modified organism, subject to Cartegena Protocol on Biosafety. Furthermore, a modern administrative State also concerns itself not only with the public safety but also with public health, aiming to provide access to crucial medicines at a lowest possible cost to the widest public. To complicate the policy choices further, certain pharmaceutical innovations have also become less cost intensive and more subject to various innovation that enhances or improves the efficacy of the existing or even known medical products, by focusing on new delivery system, or secondary medical indications.

This paper examines these conflicting policy choices through patent term extension where the several policy decisions at different level have to be made between the public safety, the public health and the promotion of technological progress. Given this complex factors, using the examples of the recent case law development and debates in Japan and Europe on patent term extension and supplementary protection certificate, this paper highlights the cases which institution of law (market, law, court, and the administration) would be at a least imperfect position to make policy decisions concerning what aspect of the patent term extension. In conclusion, this paper argues that patent term extension is not uniformly treatable, as it affects
actors in the value chain of pharmaceutical innovation differently both as the producers as well as the users of the pharmaceutical innovation. The crucial policy question is not whether the patent term extension should be introduced in comparison with the practices of other countries, but its impact on the broader scope of stake holders including competing producers, consumers and to provide them with a countervailing means of redress against the abuse. The institutional comparison thus need to take this question of redress into consideration and the institution that have the best situated to address the question of abuse may be entrusted with the competence to make the policy decision".

The seminar: an afternoon to remember

Here are a couple of photos from Wednesday's seminar that were not so bad that they had to destroyed on sight. Above are Martijn de Lange (Netherlands Patent Office) and Jeffrey S. Boone (Covidien), both smiling despite the length of the queue for coffee during their well-earned break.

This is Judith Caldwell (Keltie, right), who was just in the process of taking possession of a newly innominate bear-mouse. The story behind this moving (still?) picture is as follows: IBC Informa conference organiser Catherine Watson, together with her friends Sarah Haynes and Katie Thorne, had decided to ascend Mont Blanc this August in order to raise funds for three charities: Breast Cancer Campaign, White Ribbon Alliance and Action for Children. To assist them in their fund-raising (their target is £15,000, with a little over £4,000 promised so far), the SPC Blog agreed to auction the cuddly toy depicted above.

The toy in question was provisionally named Monty the Mountain Bear (Monty being an allusion to 'Mont', the French word for a mountain), but after some consideration the trio felt that the toy might be a mouse rather an a bear. Noting the alliterative quality of Monty the Mountain Mouse they decided to rename him there and then.

At the seminar, Judith won a hard-fought auction battle and walked off with the bear, together with the large and handsome John Lewis plastic carrier bag which would enable her to carry it through the streets of Holborn without attracting too much attention. At a second auction, Rob Stephen (Olswang) acquired the renaming rights to the bear -- though he hasn't yet gone public with the creature's new identity.

If you'd like to know more about this effort, and/or wish to make a donation, you can do so via their website 3birds1mountain.com (GiftAid available for UK taxpayers).

SPC Seminar 2010 - Short Overview

Considering that snow blanketed London yesterday, there was quite a turnout for the SPC Blog's 2nd Seminar on SPC Law and Practice in 2010. We had a few excellent presentations and a lively debate on hot topics. Unfortunately, one of our speakers, Javier Huarte (Grau & Angulo) was not able to join us due to snow-related travel complications.

Here's a short summary for readers who were not able to make it:


Jeffrey Boone (Covidien) provided an overview of patent term extensions in the United States under the Hatch-Waxman Act, including information on the application process, extension period allowed, which products are covered as well as some recent case law.


Martijn de Lange (Netherlands Patent Office) touched on the recent ECJ decision C-482/07 (AHP) and its implications, problems related to paediatric term extensions based on national marketing authorisations, zero/negative term SPCs and that the infringement test was rejected by the Dutch Court of Appeal.


On the hot topics front, issues around SPC infringement stimulated a heated debate. The Blog will post other questions/issues raised during the seminar along with some comments in the next couple of weeks.

SPC Seminar: breaking news

Since the United Kingdom has just been deluged with more snow, a number of registrants for this afternoon's seminar have phoned in to say they're stuck at home or in transit and can't attend.

If you're in the London area and would like to attend -- whether you're on the waiting list or not -- just email Verity Pike here and let her know.

The SPC Blog Seminar: Martijn de Lange's presentation

For the benefit both of (i) those people who are attending the SPC Blog seminar and want to think about some of the issues ahead of time and (ii) those people who cannot attend or applied too late but want to know more about the subjects of discussion, Martijn de Lange (Netherlands Patent Office) has agreed to let this blog post his presentation (here). Thanks, Martijn, for your thoughtfulness.

Paediatric exclusivities: a new article

Pediatric Exclusivities in Europe -- a Quest for the Grail?' is the title of an article by Geneviève Michaux (of Counsel. Covington & Burling LLC, Brussels, Belgium), which has recently been published in 64 Food and Drug Law Journal, 631-662 (2009). According to the abstract,

"This article examines the rules applicable to pediatric rewards and their interpretation by the competent European authorities, i.e. the European Commission and the EMEA, and national authorities, i.e. the national Medicines Agencies and patent offices, in particular in relation to medicinal products that are approved at the national level. Depending on the patent protection of the active substance or status of the medicinal product, the reward for pediatric development is an extension of the term of the supplementary protection certificate (“SPC,” the EU equivalent of the patent term extension) or, where the medicinal product has been designated as an orphan, an extension of the term of the market exclusivity (the EU equivalent of the orphan exclusivity). Where the active substance is not or no longer protected by a patent or an SPC, the pediatric obligation is optional and the pediatric research is rewarded by data exclusivity (the EU equivalent of market exclusivity) for the new pediatric data through the grant of a pediatric use marketing authorization (PUMA). Except for the PUMA, the pediatric rewards are subject to stringent substantive requirements, in particular the approval of the medicinal product in all the EU Member States and the so-called “PIP compliance,” i.e., the implementation of the agreed PIP".

To obtain a full text version of the article, or a copy of an entire issue, you must contact FDLI’s Customer Service Department by email at CSDept@fdli.org which says: "Your purchase will be processed quickly, and at reasonable rates".

SPC Resources

The SPC Blog: Resources web page lists a variety of judicial decisions and legislative materials relating to supplementary protection certificates and paediatric extensions. Regularly pdated by the team, this page was visited 1,932 times since its launch at the beginning of July last year.

If you spot useful materials that should be listed on the SPC Blog: Resources facility, please let any member of the team know and we will endeavour to add it. Just email us individually or via the SPC Blog here.