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

Gardasil: Israel draws closer to EU practice on combination products

Liad Whatstein (now practising as Liad Whatstein & Co) has just sent The SPC Blog the following report on an decision recently handed down by the Israeli Patent Office in connection with a patent term extension (PTE) for combination products. In essence the Israeli Patents Commissioner held that a patent claiming a single active ingredient was eligible for a PTE in connection with a combination product that comprised additional active ingredients. This decision, adds Liad, brings Israeli law in closer conformity with EU law in connection with SPCs for combination products. Writes Liad:
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.

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.
Liad represented the patentee in the proceedings.

Thursday, 15 January 2015

Synflorix: SPC can be based on covalently bound active ingredient -- in principle ...

This morning the Court of Justice of the European Union (CJEU) delivered its judgment in Case C‑631/13, Arne Forsgren v Österreichisches Patentamt, a request for a preliminary ruling under Article 267 TFEU from the Oberster Patent- und Markensenat, Austria. The CJEU obviously didn't consider this a tough case to decide, since it dispensed with an Opinion from Advocate General Bot.

The factual background runs as follows. Forsgren owned a European patent (EP0594610B1, ‘the basic patent’) relating to ‘Protein D ‒ an IgD-binding protein of Haemophilus influenzae’.  Protein D is present in a pneumococcal vaccine for paediatric use, ‘Synflorix’, the marketing of which was authorised by 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?

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?’
This morning the CJEU (Eighth Chamber) ruled:
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.

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.
There may be some further comment from the blog team but, in the meantime your comments are most welcome.

Tuesday, 30 December 2014

Seattle Genetics and an alternative question -- but will the CJEU answer it?

The SPC Blog has received further news from our friend Mike Snodin (Park Grove IP) that he has published another article in Scrip Regulatory Affairs. This latest article, entitled “Supplementary Protection Certificates: the Court of Justice of the EU will have its day after all” (a copy of which can be obtained here), relates to the questions referred to the Court of Justice of the European Union (CJEU) in Case C-471/14 Seattle Genetics [on which see earlier SPC Blogpost here].

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

Compliance with Article 3(a): will Eli Lilly help? Here's a new article


News has reached us that a regular contributor to this blog -- and one of the speakers at the recent SPC Blog seminar (Mike Snodin, Park Grove IP) -- has published a new article in Scrip Regulatory Affairs. A copy of the article, entitled “Supplementary Protection Certificates: the never-ending saga of Article 3(a)”, which was first published online by Scrip Regulatory Affairs on 1 December 2014, can be viewed via this link.

Mike’s article explains why the ruling of the High Court, England and Wales, of July 2014 in Eli Lilly v HGS may well provide what the SPC community has sought for years, namely a test for compliance with Article 3(a) of Regulation 469/2009 that is not only simple and robust but which is also relatively straightforward to apply in a wide variety of cases.  However he also explains why, in his view, this is unlikely to be the end of the saga relating to Article 3(a). In this respect, Mike’s article discusses two alternative interpretations of Article 3(a) that have been proposed by some commentators and that could muddy the waters for a number of years to come.  While one of those alternative interpretations is perhaps not fundamentally inconsistent with the extent of protection test used by the High Court, Mike’s view is that the same cannot be said for the other -- which is based upon an unusual reading of the CJEU’s ruling in Queensland and which appears to be impossible to reconcile with the conclusions reached by the High Court.  Fortunately, however, Mike also outlines in his article the reasons why he believes that more challenging interpretation must be wrong and why the High Court’s extent of protection test must prevail –- at least for now.

Monday, 24 November 2014

Seattle "Relevant date" reference: UKIPO seeks comments

Back in October The SPC Blog posted a this item from Daniel J. Wise (Carpmaels & Ransford), "Austria refers Seattle Genetics to CJEU: is "relevant date" for EU or national law?". The UK Intellectual Property Office is now seeking comments on this reference, with a view to advising the UK government as to whether it wishes to make representations in this reference. According to the UKIPO's media release:
CJ case: C-471/14: SEATTLE GENETICS

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?

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?
This case and the questions referred to the Court can also be viewed on our website at:

https://www.gov.uk/government/publications/references-to-the-european-court-of-justice/references-to-the-european-court-of-justice-2014

If you would like to comment on this case please e-mail policy@ipo.gov.uk by 01 December 2014.
The UKIPO provides further information about its solicitation of comments:
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

Patent term extensions: a new book, hot off the press

Let no-one accuse The SPC Blog of being slow to being you the news. Only a few minutes ago a new publication was launched, which may be of great interest and relevance to most of this blog's readers. It's titled Ergänzende Schutzzertifikate - Patent Term Extensions: USA, Japan, EU, Germany, Korea, Taiwan, Switzerland, Australia, Israel, Russia and Singapore and it's a bilingual text put together for our benefit by Dr Arne Markgraf. It's published for the very modest sum -- for a specialist law book -- of 134 euro. Oh, yes, and you can order it from the website of publishers Nomos here.

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.

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.
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

  • 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
The SPC Blog looks forward to reviewing this book in due course.

Monday, 17 November 2014

SPC Blog Seminar presentations: now available online

Here, in record time thanks to the efficiency of our friends at Olswang LLP, are the video links to the seven speaker presentations from ""SPC Law and Practice: All You Need to Know", this year's SPC Blog Seminar:
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
  • Dr Martijn de Lange, Dutch Patent Office here
SPCs involving medical devices (Charlotte Teall, Forresters) here 
SPCs for biologics (Mike Snodin, ParkGrove IP) here 
The 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

Israel's Commissioner acts on "wrongfully given bureaucratic decision" on Bazedoxifene

Michael Factor (of the IP Factor weblog) has drawn our attention to a recent blogpost of his own, here, on in Ruling Concerning Patent term extension to IL 120701 to Wyeth, 3 November 2014.  This is a somewhat strange tale involving Israel's recently amended patent law. In short, Wyeth filed a request to correct an error in the patent extension order for Bazedoxifene. The Commissioner for Patents did not allow the amendment but cancelled the patent term extension altogether as a "wrongfully given bureaucratic decision". Having established that it was null and void, he ordered that the patent term extension application be subjected to accelerated re-examination under the amended law.

Michael's post contains all the details.

Friday, 7 November 2014

SPC Blog PowerPoints and biographies now available

The PowerPoints and speakers' biographical details for yesterday's seminar, "SPC Law and Practice 2014: All you need to know" are now available for your delectation. You can read them online by clicking here or download them by clicking here.

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

The SPC Bog seminar 2014

SPCs for fish vaccines? Or is this
the dawning of the Age of Aquarium ...?
This is just a quick note to let readers know that

  • 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!