Gardasil is a quadrivalent vaccine comprising the proteins HPV18 L1, HPV16 L1, HPV11 L1 and HPV6 L1. Each of the four proteins in the vaccine protects against a separate strain of the Human Papilloma Virus (HPV). Merck's Israeli patent covers the HPV18 L1 protein and a composition comprising the protein. It does not specifically claim the other proteins included in Gardasil.Liad represented the patentee in the proceedings.
Under sections 64D(1) and 64A of the Israeli Patents Act, in order to be eligible for extension, the patent must claim the "material" ("the active ingredient in the medicinal product"). The Israeli PTO initially rejected Merck's PTE petition on the ground that the Israeli patent did not claim all the active ingredients in the product (i.e. there was no "match" between the scope of the patent and the "material").
The office's approach was in line with the approach taken in the past by several Patent Offices in Europe but was rejected by the Court of Justice of the European Union (CJEU) in Medeva and subsequently in Queensland & CSL which also related to Gardasil. It was also opposed to the traditional approach taken by the USPTO.
Merck appealed to Patents Commissioner. On 11 January 2015 the Commissioner overruled the decision and granted the PTE petition. In reaching his decision, the Commissioner noted that each protein in Gardasil was produced in separate fermentation and was a standalone API. Accordingly, the fact that HPV 18 L1 was combined with three other active ingredients in the product did not undermine the eligibility for patent term extension for the patent claiming a single protein.
Significantly, the Commissioner essentially adopted the patentee's approach solely based on analysis of the relevant statutory provisions and related Israeli case law, and completely disregarded the CJEU Medeva ruling. Nevertheless, the Commissioner's decision is an important precedent that brings Israeli law in closer conformity with EU law in connection with SPCs for combination products.
Generally, the Israeli Office is attentive to the legal situation and judicial developments in major jurisdictions. One exception is with respect to the peculiar and rather restrictive PTE system under Israeli law (for a short overview of these peculiarities see earlier SPC Blog post here). The Office has traditionally taken a restrictive approach in interpreting the PTE provisions, often resulting in denial of PTE eligibility. It is yet to be seen whether the recent decision may be a first step in the direction of more balanced decisions on patent term extensions.
The SPC blog
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
Monday, 19 January 2015
Thursday, 15 January 2015
Commission Decision C(2009) 2563 for ‘Synflorix — Pneumococcal polysaccharide conjugate vaccine (adsorbed)’. From the wording of the marketing authorisation (MA) for Synflorix, it appears that Synflorix was composed of 10 pneumococcal polysaccharide serotypes which were conjugated to carrier proteins and adsorbed on to aluminium phosphate. In eight of those serotypes, Protein D was the carrier protein. The therapeutic indications set out in the MA were for
‘Active immunisation against invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae in infants and children from 6 weeks up to 2 years of age’.According to the MA, the excipients of that vaccine were sodium chloride and water for injections.
In September 2009 Forsgren applied to the Österreichisches Patentamt for an SPC for Protein D. No, said the office, since Protein D was just an excipient. On appeal, the Board of Appeal of the Österreichisches Patentamt agreed: while Protein D had a therapeutic effect against the Haemophilus influenzae bacterium, it wasn't present as such in Synflorix, being covalently bonded to other active ingredients. Accordingly, Protein D couldn't be authorised as a medicinal product within the meaning of the SPC Regulation. Forsgren appealed further to the Oberster Patent- und Markensenat, which decided to stay proceedings and to refer to the CJEU the following questions for a preliminary ruling:
‘1. Under Article 1(b) and Article 3(a) and (b) of [Regulation 469/2009], provided that the other conditions are met, may [an SPC] be granted for an active ingredient protected by a basic patent (in this case, Protein D) where that active ingredient is present in a medicinal product (in this case, Synflorix) as part of a covalent (molecular) bond with other active ingredients but none the less retains an effect of its own?This morning the CJEU (Eighth Chamber) ruled:
2. If Question 1 is answered in the affirmative:
(a) Under Article 3(a) and (b) of [Regulation No 469/2009], may [an SPC] be granted for the substance protected by the basic patent (in this case, Protein D) where that substance has a therapeutic effect of its own (in this case, as a vaccine against the Haemophilus influenzae bacterium) but the marketing authorisation for the medicinal product does not relate to that effect?
(b) Under Article 3(a) and (b) of [Regulation 469/2009], may [an SPC] be granted for the substance protected by the basic patent (in this case, Protein D) where the marketing authorisation describes that substance as a ‘carrier’ for the actual active ingredients (in this case, pneumococcal polysaccharides), where the substance, as an adjuvant, enhances the effect of those substances, but where that effect is not expressly mentioned in the marketing authorisation for the medicinal product?’
1. Articles 1(b) and 3(a) of Regulation 469/2009 ... must be interpreted as not precluding, in principle, the possibility that an active ingredient can give rise to the grant of a supplementary protection certificate where the active ingredient is covalently bound to other active ingredients which are part of a medicinal product.There may be some further comment from the blog team but, in the meantime your comments are most welcome.
2. Article 3(b) of Regulation 469/2009 must be interpreted as precluding the grant of a supplementary protection certificate for an active ingredient whose effect does not fall within the therapeutic indications covered by the wording of the marketing authorisation.
Article 1(b) of Regulation 469/2009 must be interpreted as meaning that a carrier protein conjugated with a polysaccharide antigen by means of a covalent binding may be categorised as an ‘active ingredient’ within the meaning of that provision only if it is established that it produces a pharmacological, immunological or metabolic action of its own which is covered by the therapeutic indications of the marketing authorisation, a matter which it is for the referring court to determine, in the light of all the facts of the dispute in the main proceedings.
Tuesday, 30 December 2014
As regular readers of this blog will know, the questions referred by the Oberlandesgericht Wien in Seattle Genetics relate to the issue of whether longer term should be awarded to certain SPCs by relying upon the date of notification of a “centralised” Marketing Authorisation instead of the (earlier) date of the European Commission’s decision to issue the Authorisation.
Mike’s article discusses and analyses the questions referred to the CJEU and highlights potential problems with regard to the framing of those questions. In an attempt to clear away any confusion that could be caused by the manner in which the questions referred have been framed, Mike presents an alternative question that is more precisely adapted to the facts underlying Seattle Genetics. He concludes by expressing the hope that the CJEU decides to answer such an alternative question, and by outlining reasons why, in his view, that alternative question should be answered in favour of using the date of notification for “centralised” MAs.
Wednesday, 3 December 2014
Monday, 24 November 2014
CJ case: C-471/14: SEATTLE GENETICSThe UKIPO provides further information about its solicitation of comments:
We have received notification of a new case referred to the Court of Justice of the European Union (CJEU): C-471/14: A request for a preliminary ruling concerning the supplementary protection certificate for medicinal products.
The questions referred to the Court of Justice (CJ) for a preliminary ruling are:
1. Is the date for the first authorisation to place the product on the market, pursuant to Article 13(1) of Regulation 469/2009 concerning the supplementary protection certificate for medicinal products determined according to Community law, or does that provision refer to the date on which the authorisation takes effect in the law of the Member State in question?This case and the questions referred to the Court can also be viewed on our website at:
2. If the Court determines that the answer is that the date is determined by Community law, is this the date of authorisation or the date of notification?
If you would like to comment on this case please e-mail firstname.lastname@example.org by 01 December 2014.
We understand how difficult it is to provide detailed comments in the time available. The IPO has tight time limits in which to consider and provide advice to ministers on CJ cases. In order to help us provide the right advice, we just need a short email by the deadline stating whether you think the UK should intervene and some general points about how you think we should answer the questions.
You are welcome to follow this email up with more detailed comments after the deadline, which can be taken into consideration if we have chosen to submit observations or if we decide to attend a hearing.
If you are aware of any references to the Court of Justice that are not currently included on our website, you are also welcome to send us your views. If you choose to do this, please include clear information about the case to help us to identify it.
Further information on intellectual property CJ cases can be found on our website https://www.gov.uk/government/publications/references-to-the-european-court-of-justice.
Wednesday, 19 November 2014
According to the abstract
Patent term extensions are the most important instrument for securing rights to innovative medicines after expiry of the regular patent term. The new manual comments on all relevant provisions including the relevant case law in the U.S., Japan and Europe. In addition, it presents corresponding extension opportunities in Australia, Israel, Korea, Russia, Switzerland, Singapore, Taiwan and in the free trade agreement between the U.S. and the Central American countries. It also comments on the current state of negotiations on the Free Trade Agreement between the European Union and Canada. So the manual covers all important markets, which offer the possibility of a patent term extension. It is aimed at lawyers from pharmaceutical companies and international law firms.Many of the contributors of chapters will be known to readers of this blog. Apart from the editor himself you will encounter the efforts of
Its bilingual German/English synoptic structure is tailored to support the global development of innovative medicines. It facilitates the decision-making in international project teams through a rapid and easy access to all relevant information. It also assists to find uniform argumentation during grant or revocation proceedings across borders.
- Cheol-Gyoon Ahn, Senior Korean Patent Attorney, Seoul, Korea
- Eran Bareket, Attorney at law, Tel-Aviv, Israel
- Chen Ben Dori-Alkan, Attorney at Law, Tel-Aviv, Israel
- Ronnie Benshafrut, Patent Attorney, Tel-Aviv, Israel
- Ruth Fang, Attorney at law, Taipei, Taiwan
- Dr. Nicolai von Füner, Patent Attorney, Munich, Germany
- Dr. Siegfried Grimm, Patent Attorney, Zürich, Switzerland
- Brion P. Heaney, Patent Attorney, Arlington, USA
- In-Hwan Kim, Senior Foreign Legal Counsel, Seoul, Korea
- Peter Maddigan, Barrister, Sydney, Australia
- Dr. Arne Markgraf, Attorney at law, Berlin, Germany
- Dr. Olaf Meiselmann, Munich, Germany
- Kristian Robinson, Patent Attorney, Singapore
- Dr. Regula Rüedi, Patent Attorney, Zürich, Switzerland
- Harry B. Shubin, Patent Attorney, Arlington, USA
- Damian Slizys, Patent Attorney, Melbourne, Australia
- Yoichi Watanabe, Patent Attorney, Tokyo, Japan
- Paul Whenman, Patent Attorney, Sydney, Australia
Monday, 17 November 2014
Review and analysis of pending CJEU referrals and recent CJEU decisions (Dr Robert Stephen, Olswang LLP) here
Amending and attacking SPCs (Dr Dorothea von Renesse, König Szynka Tilmann von Renesse) here
What’s up?” from the perspective of the IPOs
- Patrick Purcell, UK IPO here
- Dr Oliver Werner, German Patent Office here
SPCs involving medical devices (Charlotte Teall, Forresters) here
- Dr Martijn de Lange, Dutch Patent Office here
SPCs for biologics (Mike Snodin, ParkGrove IP) hereThe PowerPoints for the various sessions, together with the speakers' biographical details, have already been uploaded for your delectation and can be accessed here.
The seminar's SPC Law and Practice 2014 - Q&A session can be viewed here
Thursday, 13 November 2014
Michael's post contains all the details.
Friday, 7 November 2014
WARNING! It's a big 2.56 MB file, running to some 143 pages, so think twice before printing it in full -- particularly if your ink cartridge is coming up for replacement.
Thursday, 6 November 2014
|SPCs for fish vaccines? Or is this|
the dawning of the Age of Aquarium ...?
- the speakers' PowerPoints and notes will all be made available on this weblog in the near future;
- the seminar has been recorded on video, which should be processed and published more swiftly than on previous occasions, on the basis that Olswang LLP (the host firm -- thanks!) has had more practice at video-recording seminars than it did when last an SPC seminar was held there.
This year a variety of topics were discussed, with a first-ever mention of the phenomenon of SPC for fish vaccines and the prospects of shoal immunity. But that's another matter and, if you want to know what was said about this and other issues, you shouldn't have long to wait.
Apart from Olswang (whose London office staff also provided the logistics and processed the refreshments), gratitude is also expressed to all of the speakers and participants for giving of their time and effort, and to the Court of Justice of the European Union for their possibly inadvertent contribution by providing so much content for us to analyse and discuss -- a contribution that shows no signs of abating.
Do please be patient: all items will be made available as soon as possible, so there's no need to chase!