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

Wednesday, 20 August 2014

Pharmaq AS v Intervet International BV

Of immediate relevance to the blogpost that appeared earlier this afternoon is this announcement from the EFTA Court (reproduced in full below):
EFTA COURT

Request for an Advisory Opinion from the EFTA Court by Oslo tingrett dated 16 June 2014 in the case of Pharmaq AS v Intervet International BV (Case E-16/14)

A request has been made to the EFTA Court by a letter dated 17 July 2014 from Oslo tingrett (Oslo District Court), which was received at the Court Registry on 23 July 2014, for an Advisory Opinion in the case of Pharmaq AS v Intervet International BV, on the following questions:

1. Concerning Article 2 of the SPC Regulation, has a product been placed on the market as a medicinal product in the EEA before it has been granted marketing authorisation in accordance with the procedure for administrative authorisation laid down in Directive 81/851/EEC (or Directive 2001/82 EEC) when delivery of the product has taken place in accordance with
(i) “special approval exemptions” granted by the State Medicines Agency to veterinarians and fish health biologists pursuant to Section 3-6 or 3-7 of the Norwegian Regulation of 22 December 1999, alternatively Sections 2-6 or 2-7 of the Norwegian Regulation of 18 December 2009, or

(ii) what are known as “AR 16 licences” granted by the Irish Department of Agriculture, Food and the Marine pursuant to the Irish Statutory Instrument No 144/2007 European Communities (Animal Remedies) Regulations 2007 part III “Exceptional authorisation”, point 16?
2. If question 1 is answered in the affirmative, is such a product outside the scope of the SPC Regulation and is an SPC granted on the basis of such a product therefore invalid?

3. Concerning the interpretation of Article 2 of the SPC Regulation, should a marketing authorisation granted for a veterinary medicinal product pursuant to Article 26(3) of Directive 2001/82 be deemed to constitute an administrative authorisation pursuant to Directive 81/851 (or Directive 2001/82) within the meaning of Article 2?

4. (a) Do special approval exemptions pursuant to Section 3-6 or 3-7 of the Norwegian Medicines Regulations of 1999 (FOR-199-12-22-1559) or Section 2-6 or 2-7 of the Norwegian Medicines Regulations of 2009 (FOR-2009-12-18-1839) constitute valid authorisation to place the product on the market as a medicinal product within the meaning of Article 3(b)?

(b) Do special approval exemptions pursuant to Section 3-6 or 3-7 of the Norwegian Medicines Regulations of 1999 (FOR-199-12-22-1559) or Section 2-6 or 2-7 of the Norwegian Medicines Regulations of 2009 (FOR-2009-12-18-1839) constitute a first authorisation to place the product on the market as a medicinal product in Norway within the meaning of Article 3(d)?

5. When the medicinal product is a virus vaccine, can the scope of protection under the SPC cover not only the specific strain of the virus that is included in the medicinal product and covered by the basic patent, but also other strains of the virus that are covered by the basic patent?

In answering this question, is it of significance whether
a) such other strains have an equivalent therapeutic effect to the virus strain included in the medicinal product or whether the therapeutic effect is not immediately equivalent?

b) a medicinal product based on such other strain will have to be the subject of a separate marketing authorisation with requirements for documentation of safety and effect?
6. If an SPC has been granted with a product definition that is not strictly limited to the specific strain of the virus authorised to be placed on the market as a medicinal product,
a) will such an SPC be valid, or

b) will the SPC be valid; such, however, that the scope of protection pursuant to Article 4 does not extend beyond the specific virus strain authorised to be placed on the market as a medicinal product?
This request was received from the Oslo District Court on 23 July.  The deadline for written observations from Governments and relevant institutions is Monday, 13 October 2014.

Special approval exemptions in a nutshell: a request for help

This blog has recently received a request for assistance from an enthusiastic young student who writes:
"I am doing research concerning SPCs and, in particular, on the implications of special approval exemptions for medicine (to be sold on the market, at the request of a doctor/vet, prior to marketing authorisation) for SPC applications. In a nutshell, I am looking for case law and articles that may have touched on this issue: does a special approval exemption under Directive 2001/82 [on the Community Code Relating to Veterinary Medicinal Products] or Directive 2001/83 [on the Community Code Relating to Medicinal Products for Human Use], granted for many consecutive years, constitute a de facto marketing authorisation, thereby disqualifying the product in question from applying for a SPC? 
If you happen to have information on this topic, I would greatly appreciate it if you could share it with me".
Well, readers -- this is your chance! Do please post any useful reading suggestions below and let's see what we can come up with.

Monday, 18 August 2014

Patent term extension in Israel: a recent ruling

It's always good to keep an eye on other weblogs, since they do feature patent term extension news from time to time. One such blog is Michael Factor's IP Factor blog, which has just posted a piece, "Israel Patent Number 94634, Extending and Shortening Patent Term Extensions", here, on The Association of Israeli Pharmacists v Sir Roy Calne and Wyeth, Ruling Asa Kling 13, July 2014.

The post is quite long and a bit complex, so we thank Michael for getting this case online while packing for his holiday.  That's enthusiasm for you!

Friday, 8 August 2014

Medical Devices Directive authorisation no good for SPC

In Leibniz-Institut für Neue Materialien Gemeinnützige GmbH, BL O/328/14, a UK Intellectual Property Office decision of 29 July, hearing officer Lawrence Cullen held that a medical device, the marketing authorisation for which was governed by Directive 93/42 -- the Medical Devices Directive -- was not a basis for granting an application for an SPC under Regulation 469/2009 in respect of the “aqueous dispersion of iron oxide nanoparticles” . According to the Institute the authorisation procedure under the Medical Devices Directive was the equivalent of an authorisation to place the product on the market as a medicinal product, granted under the administrative procedure laid down in Directive 2001/83 (the Medicinal Products Directive). Following a careful examination of all the relevant legislation and case law, the hearing officer held that a product which had not been subject to the administrative procedure in the Medicinal Products Directive is actually excluded by Article 2 of the SPC Regulation from being granted an SPC.

The 45 page ruling can be read in its entirety here.

Thursday, 7 August 2014

A Bulgarian milestone as Supreme Court rules on Atripla application

From our friend Dimitar Batakliev (IP Attorney, Bulgaria) comes the following news:
"I would like to report a recent case before the Supreme Administrative Court of Bulgaria regarding an SPC application for Atripla, a drug for treatment of HIV infection.

In a decision of 8 June 2014 the Court held that the claimed product, consisting of efavirenz, emtricitabine and tenofovir disoproxil fumarate, was not protected by the basic patent BG 62612 and therefore did not meet the requirements of Article 3 of the SPC Regulation. According to the court, this combination was outside the scope of claim 8 which protected 
“a combination of a compound of Formula I or Formula II according to claim 2 with a nucleoside analog having biological activity against HIV reverse transcriptase”. 
Although efavirenz was found to be a compound of Formula I and emtizitabine -- a nucleoside analogue -- the court held that the claim envisaged only combinations of two active ingredients, while the applied product consisted of three. Further, the court confirmed that the third ingredient, tenofovir disoproxil fumarate, was also outside the scope of the claim as it was a nucleotide rather than a nucleoside analogue. Although after its intake it was transformed in the human body into a nucleoside, at the time of composing the claimed product it lacked such characteristics. As a result the Supreme Court reversed the decision of the court of first instance and instead upheld the decision of the Patent Office to reject the application of Merck Sharp & Dohme Inc.

In its detailed analysis the Supreme Court touched on a number of important topics of the SPC domain. It provided guidance on the methods of interpretation of patent claims, on the applicability of the infringement test and the significance of the Medeva and Eli Lilly decisions. It also commented on decisions of other jurisdictions which had been put forward by the parties in support of their arguments. Therefore, in my opinion the Atripla case resulted in a milestone decision of the Bulgarian case law with respect to the application of the SPC Regulation.
If you can cope with the original Bulgarian text of the judgment, Dimitar has kindly provided a link to it here.

Monday, 4 August 2014

EU Association Agreements with Ukraine, Georgia and Moldova: impact on patent term

A recent Petosevic News & Resources post contains an item, "Ukraine, Georgia, Moldova Sign EU Association Agreements" which mentions, among other things, the amendments to domestic intellectual property law which those three countries will be expected to make in return for closer trading ties with the European Union. One such requirement is that
"the term for patent protection of medicinal and plant products (which are subjects of marketing authorizations), can be prolonged up to 5 years depending on the time spent on completing the marketing authorization process (equivalent to SPC)".
This is unlikely to be done before all current EU Member States have approved the Association Agreements, but it's at least a step in the right direction.

Wednesday, 30 July 2014

SPC Blog Seminar 2014: save the date!

Save the date! Thursday 6 November has now been fixed for this year's SPC Blog seminar. Following readers' suggestions we look forward to having presentations on medical device SPCs, some Intellectual Property Office input -- at least from the UK and ideally from the Netherlands too -- plus biotech SPC considerations, a general case review, and probably a few short topics.

More details, and registration instructions, will be posted as soon as possible.

Monday, 21 July 2014

SPCs based on functional claims, tabalumab and Neutrokine-α

The decision of Mr Justice Warren in Eli Lilly v Human Genome Sciences Ltd [2014] 2404 EWHC (Pat) in the Patents Court, England and Wales, was handed down on Friday. While it's still not available on BAILII, this judgment is currently being kindly hosted by our friends at Powell Gilbert LLP who represented HGS (now part of GSK) in these proceedings. Powell Gilbert have also furnished us with the following note on this ruling which, with minor edits, we reproduce in full:

Lilly v HGS – Article 3(a) SPC Regulation – Guidance on obtaining SPCs based on functional claims

Summary

Article 3(a) of Regulation 469/2009 requires that a product which is the subject of an application for an SPC must be “protected by a basic patent in force”. This was held by the Court of Justice of the European Union (the “CJEU”) in Medeva (Case C-322/10 [noted on this weblog here]) to mean that the active ingredient must be “specified” in the wording of the claims.

In October 2012 the Patents Court for England and Wales (Warren J) in Eli Lilly and Company Ltd v Human Genome Sciences, Inc. referred further questions to the CJEU regarding the interpretation of Article 3(a). In December 2013 the CJEU handed down its judgment in the Lilly case (C-493/12), holding that it is not necessary for the active ingredient to be identified in the claims of the patent by a structural formula. Article 3(a) does not, in principle, preclude the grant of an SPC where the active ingredient is covered by a functional claim provided that “the claims relate, implicitly but necessarily and specifically” to the active ingredient in question.

The case returned to the Patents Court (Warren J) in May and June 2014. The judgment provides important guidance as to the interpretation of the CJEU’s decision and the circumstances in which SPCs may be obtained for products based on claims defined in functional terms.

Background

Human Genome Sciences, Inc. (“HGS” – now owned by GlaxoSmithKline) is the proprietor of European Patent (UK) No 0 939 804 which relates to and claims a novel protein called Neutrokine-α and antibodies which bind specifically to it. The patent has been held to be valid by the UK Courts (including the Court of Appeal and Supreme Court) and the Technical Board of Appeal of the European Patent Office. Of particular importance is the wording of claim 13 which claims:
“An isolated antibody or portion thereof that binds specifically to (a) the full length Neutrokine-α polypeptide … or (b) the extracellular domain of the Neutrokine-α polypeptide …”.
Eli Lilly and Company Ltd (“Lilly”) wishes to market, in due course, a product containing an antibody (known as tabalumab) that binds specifically to Neutrokine-α. Lilly has not yet received a marketing authorisation (“MA”) for tabalumab.

Lilly issued a claim against HGS seeking a declaration from the Patents Court that any SPC granted to HGS in respect of the patent and based upon any MA for tabalumab would be invalid.

Lilly’s case was that tabalumab is not “protected by” the patent for the purposes of Article 3(a) as tabalumab is not specified in the wording of the claims. That, Lilly submitted, would require a structural definition of the active ingredient in the claims of the patent. 
Lilly had originally sought to argue a further ground on which any SPC would be invalid, namely that HGS would not be able to obtain an SPC based on the HGS Patent and an MA held by a third party (Lilly) – the “Third Party Issue”. Lilly discontinued this aspect of the claim before the CJEU hearing in September 2013.

HGS’s case was that tabalumab fell within the scope of protection of claim 13 (as interpreted by section 125 of the UK Patents Act, Article 69 of the European Patent Convention (“EPC”) and the Protocol on the Interpretation of Article 69) and that that claim related “implicitly but necessarily and specifically” to tabalumab, as required by the CJEU.  
The judgment of Warren J

As with other decisions of the CJEU in relation to the SPC Regulation, regrettably the guidance given is not clear. This is reflected by the fact that both Lilly and HGS had applied to the Patents Court for judgment in their favour on the basis of the CJEU’s decision. The Court also observed that “one thing the [CJEU decision] does not give is the clear guidance which the reference was designed to obtain” (paragraph 4).

In dismissing Lilly’s claim for declaratory relief, the Court explains (paragraph 67) that the CJEU has clearly held that functional definitions can, in principle, be sufficient to bring an active ingredient within the protection of a basic patent. This is on the condition that the “claims relate implicitly but necessarily and specifically” to the active ingredient.

The Court held at paragraph 70 that the correct reading of the CJEU’s judgment required an application of the relevant rules (i.e. Article 69 EPC or Section 125 Patents Act 1977) to ascertain the extent of the invention and what the claims relate to. If the active ingredient in question is covered by the claims, it is protected for the purposes of Article 3(a) – subject to a proviso.

This proviso is explained at paragraph 66 of the Judgment and is necessary to reflect the approach of the CJEU in Medeva in relation to products containing combinations of active ingredients. A product is not protected within the meaning of Article 3(a) solely by virtue of a claim containing general wording that extends the claim beyond its principle scope (such as “comprises”). However, in the absence of such extending words, the Court held that “the claims have a focused scope and the question is simply whether the product falls within the scope of the claims” (paragraph 66). Lilly had conceded during the course of these proceedings that tabalumab falls within the scope of claim 13 of the patent, and the proviso did not apply since there were no extending words. Tabalumab was therefore “protected by” the patent within the meaning of Article 3(a).

Finally, the Court considered (at paragraphs 44-54 of the judgment) that paragraph 43 of the CJEU’s decision, which relates to whether a patent owner has made any investment in the research leading to the MA, is more relevant to the discontinued Third Party Issue than to the test under Article 3(a). However, the Court made clear that SPCs are intended to be available without discrimination for the type, or stage, of research leading to the grant of the basic patent. 
What next?

The judgment provides welcome guidance on the interpretation of Article 3(a) and confirms the availability of SPCs for products based on functional claim language (such as for antibodies defined by their binding target). On Friday Lilly was been granted leave to appeal, so the issues will be reviewed further in due course. 

Sunday, 20 July 2014

Recent developments: a new article from an old friend

"Recent developments in the area of supplementary protection certificates" is the title of a new article by our friend and reader Ulrich M. Gassner (Faculty of Law, University of Augsburg, Augsburg, Germany). This 28-page piece appears in Pharmaceuticals Policy and Law 16 (2014) at pages 45 to 72 (DOI 10.3233/PPL-140375). According to the abstract:
"The purpose of this paper is to set out and discuss the recent jurisdictional developments in the European Court of Justice (ECJ) with respect to supplementary protection certificates (SPCs) including paediatric extensions. During the past five years the ECJ has been particularly active and has clarified a number of highly controversial legal ambiguities, such as the availability of negative term SPCs".
You can check out the contents of the issue in which this article appears here, where you will spot the names and contributions of quite a few of our friends and blog-readers.

Monday, 14 July 2014

The 2014 SPC Blog seminar: early announcement

As readers will know, we've not yet been able to sort out a date for this year's SPC Blog Seminar but we are aiming for late October, a rather lovely time of year to be in London, in all its autumnal splendour.  Further details will be posted as soon as available.

Meanwhile, blog team member Robert Stephen is amenable to suggestions for topics and speakers. If you have suggestions for either, can you please email Rob at Robert.Stephen@olswang.com and let him know.