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

Thursday, 14 September 2017

Tenofovir - High Court Decision in France

Those following the tenofovir SPC litigation in Europe will be pleased to hear that the High Court of Paris has recently handed down a decision in relation to Gilead's SPC based on EP0915894.  Denis Schertenleib, who acted for Mylan in these proceedings, has kindly provided a short summary of the case, along with a copy of the decision and an English translation.

"Recently, the High Court of Paris had to opine on the validity of the Gilead SPC on Truvada covering tenofovir and emtricitabine. The SPC was based on the basic patent for tenofovir.  One of its claims covered a combination of tenofovir with another optional therapeutic ingredient.  
In the context of preliminary injunction proceedings, the Presiding judge of the Paris High Court had to decide whether this SPC was likely to be held invalid on the merits. The Court held in a ruling dated 5 September 2017, that the SPC was likely to be invalid.
The reasoning of the Court was based on the finding that the reference to another “therapeutic ingredient” could not be deemed to constitute a functional definition of any compound under the Eli Lilly v HGS doctrine of CJEU case C-493/12. In addition, the Court held that nothing in the description or the prior art could be held to point to Emtricitabine as being this optional therapeutic ingredient. Finally, the Court noted that the combination of tenofovir and emtricitabine could not constitute the core invention of the basic patent under the Actavis v Sanofi doctrine of CJEU case C-443/12. The Court thus held that the SPC was likely to be invalid and that no preliminary injunction could be granted.

The Judgment in French and translated in English can be downloaded here.

The ruling can be appealed and a case on the merits is ongoing.”
Many thanks to Denis for this!

Thursday, 31 August 2017

Call for comments for C-443/17 (Abraxis Bioscience)

The UK IPO is seeking comments on CJEU case C-443/17 (Abraxis Bioscience) with a view to advising the UK government as to whether it wishes to make representations in this reference.  Comments should be sent by email to policy@ipo.gov.uk by 6 September 2017.

As a refresher, the question referred to the CJEU in this case is as follows:
Is Article 3(d) of the SPC Regulation to be interpreted as permitting the grant of an SPC where the marketing authorisation referred to in Article 3(b) is the first authorisation within the scope of the basic patent to place the product on the market as a medicinal product and where the product is a new formulation of an old active ingredient?

Wednesday, 26 July 2017

Canadian Government proposes Certificate of Supplementary Protection Regulation


Canada appears to be moving closer towards having system for patent term extension. On 15 July 2017, the Government of Canada published a proposed Certificate of Supplementary Protection Regulations in the Canada Gazette (here).  In addition, the Government is seeking comments on the proposed Regulation by 30 July 2017.

The background section of the Regulatory Impact Analysis Statement is reproduced here:

"In order to meet Canada’s CETA obligations, the Patent Act (the Act) was amended to create a framework for the issuance and administration of certificates of supplementary protection (CSP), for which patentees with patents relating to human and veterinary drugs may apply. As set out in the Act, the new CSP regime, which will be administered by the Minister of Health (Minister), will provide additional protection from the date of the expiry of the eligible pharmaceutical patent based on the first authorization for sale of a drug containing a new medicinal ingredient or combination of medicinal ingredients in Canada. This new protection, which is intended to partly compensate for time spent in research and obtaining marketing authorization, provides patent-like rights in respect of drugs containing the same medicinal ingredient or combination. The scope of protection can be no broader than the scope of protection afforded by the patent set out in the CSP, and is subject to the same limitations and exceptions as the patent.

The term of a CSP is the difference between the date of the filing of the application for the patent and the date of issuance of the authorization for sale, reduced by five years, and capped at two years [i.e. CSP term = (Notice of Compliance date – Patent filing date) – five years, with a cap of two years].

The Act allows CSP applications to be submitted within a prescribed timeframe from (i) the authorization for sale of a drug, or (ii) the subsequent grant of an eligible patent that occurs after the authorization for sale of the drug. To be eligible, the application for authorization to sell a drug containing a medicinal ingredient or combination must be filed with the Minister before, or within a reasonable amount of time from, when the approval of a drug containing the same medicinal ingredient or combination was first sought in any comparable jurisdictions (the timely submission requirement). For a medicinal ingredient or combination to be eligible for a CSP, a drug containing it must not have been previously authorized for sale (as that phrase is defined) in Canada.

This regime is substantially defined in the amendments to the Act. The proposed Regulations specify the various timelines and requirements necessary for the purpose of the regime."

Friday, 23 June 2017

Paediatric Extensions in Norway

The SPC Blog is grateful to Arne Lund Kverneheim at Bryn Aaflot for the following news on paediatric extensions in Norway:
"Paediatric extensions in Norway will be implemented and available from 1 September 2017. This means that SPCs with expiry dates later than 1 March 2017 will be entitled to extensions provided that the application for the extension is submitted according to the requirement in the regulation or in the transitional regulations. 
The background for the amendments in the Norwegian Medicines Act and the Patent Law is in the EEA committee decision of 5 May 2017 (92/2017) adapting the SPC regulation 1768/92 - 469/2009 to include the EEA states. 
The implication is that any SPC in Norway with expiry date later than 1 March 2017 is entitled to paediatric extensions. The maximum duration of the protection will however be no longer than 6 months after the expiry of the SPC. 
RequirementsThe requirement in Norway will be the same as in EU member states.  Application forms in Norwegian and English will be provided by NIPO. 
NIPO will allow receipt of applications for paediatric extensions from 1 August 2017. The extension will be in force when the application is made public and after implementation of the regulation. 
DeadlinesThe normal deadline to apply for a paediatric extension is 2 years prior to expiry of the SPC. However, in a transition period of 5 years after implementation, which is until 1 September 2022, the deadline is 6 months prior to expiry of the SPC. 
Please note that an application for an extension will not prevent any third party who, between the expiry of the certificate and the publication of the application for an extension, in good faith has commercially used the invention or made serious preparation for such use, to continue such use. 
ExamplesThe transition regulations for SPC with an expiry close to the implementation can be interpreted with the following examples and timeline:
  • SPC expiry 1 April 2017
entitled to a 1 month extension from 1 September 2017 (until 1 October 2017)
applicable from 1 August 2017
  • SPC expiry 1 June 2017
entitled to a 3 months extension from 1 September 2017 (until 1 December 2017)
applicable from 1 August 2017
  • SPC expiry 1 November 2017
entitled to a 6 months extension (until 1 May 2018)
apply by 1 October 2017
  • SPC expiry 1 June 2018
entitled to a 6 months extension (until 1 December 2018)
apply by 1 December 2017"

Many thanks to Arne again!

Monday, 19 June 2017

Max Planck Institute SPC Survey - deadline for participating - 23 June 2017

As many readers of this Blog will be aware, the Max Planck Institute for Innovation and Competition is currently conducting a study on supplementary protection certificates in the European Union on behalf of the European Commission.  The study aims to include the views and opinions of a wide range of stakeholders including pharmaceutical companies, professional and industry associations as well lawyers, patent attorneys and other interest groups.

As part of the study, a survey is being conducted which includes questions on the past experience with the system, general policy considerations, assessment of the present legal rules, as well as some proposals on the potential amendment of the current SPC Regulations. The answers will be collected on an anonymous basis.  The deadline for participating in the survey is this Friday, 23 June 2017

If you are interested in participating in the survey, please contact Victoria Rivas at the Max Planck Institute at victoria.rivas@ip.mpg.de

Friday, 5 May 2017

Darunavir and the interpretation of Article 3(a) by Mr Justice Arnold

darunavir
Earlier this week, Mr Justice Arnold handed down a decision (here, [2017] EWHC 987 (Pat)) relating to the validity of Searle’s SPC to darunavir  in view of Article 3(a) of the SPC Regulation.

The facts of the case are as follows: G.D. Searle LLC hold SPC/GB07/038 (“the SPC”) to darunavir.  Janssen Sciences Ireland UC is the exclusive licensee. The SPC is based on EP 0 810 209, to which claim 1 is directed to a compound presented by Formula I


wherein the substituents P1, P2, R2, R3, and R4 are listed.

Sandoz and Hexal challenged the validity of the SPC on the basis that it does not comply with Article 3(a) of the SPC Regulation because darunavir is not specified or identified in any of the claims of the patent.  In particular, they argued that although darunavir falls within the scope of the claims, it is not specifically identified by name or structure in the claims or in the specification, nor is there any teaching in the patent which points to darunavir.

After briefly reviewing the CJEU’s  “guidance” in the Medeva and Lilly cases in relation to whether a product satisfies the requirement of Article 3(a) of the SPC regulation, Mr Justice Arnold came to the conclusion that it is sufficient for the claim to specify the product by means of a Markush formula which covers it.  Not entirely happy with the CJEU’s unclear tests, he also referred to what he considered as a better test, and as he advanced in Teva v Gilead, which would require that the product falls within the claim and that it embodies the inventive advance (or technical contribution) of the claim.

Kristina Cornish and Dayle Callaghan of Kilburn & Strode LLP were part of the team acting for the defendant in this successful matter.

Thursday, 23 March 2017

Atripla - a combination of issues

Mr Justice Arnold gave his ruling earlier this week in Teva UK Limited & Ors v Merck Sharp & Dohme Corporation [2017] EWHC 539 (Pat).

In brief, Merck Sharp & Dohme (MSD) was granted an SPC for a combination product of  efavirenz, emtricitabine and tenofovir disoproxil fumarate based on EP (UK) 0 582 455 (the product is marketed as Atripla by Bristol-Myers Squibb Co. and Gilead Sciences Inc).  At trial, MSD relied on claim 16 as protecting the product.  Claim 16 reads:
“A combination of the compound of claim 12 or a pharmaceutically acceptable salt thereof with a nucleoside analog having biological activity against HIV reverse transcriptase.”
MSD also previously obtained an SPC for efavirenz based on the same patent.  Teva, Accord and Mylan challenged the validity of the SPC.

Mr Justice Arnold found that the SPC was invalid because it did not comply with either Article 3(a) or Article 3(c) of the SPC Regulation.  More specifically, he found that the scope of protection of claim 16 extended to a combination of efavirenz and tenofovir or a combination of efavirenz and emtricitabine, but not to a combination of all three actives.  He also found that the SPC does not comply with Article 3(c) because claim 16 does not represent a distinct invention from the invention protected by the claims for efavirenz.

Friday, 3 March 2017

Forum Institut SPC Seminar

From Rechtassessor Jean-Claude Alexandre Ho (IP conference manager at FORUM Institut für Management GmbH) comes news of an SPC-related seminar which he is organising:

'Quo vadis, SPC?', the update seminar in which Dr Christopher Brückner, the author of the SPC commentary noted here (participants will receive the second edition on top of course documentation), will speak on the CJEU's referrals from 2011 to 2017 and on how to understand the decisions and which practical consequences we may expect for the future.  

Date: 31 May 2016; venue: Amsterdam.

More information is available here.  

To register, just forward this blogpost to Jean-Claude himself at jc.alexandreho@forum-institut.de or click here.

Tuesday, 7 February 2017

A new CJEU referral - C-681/16

In case C-681/16 (Pfizer Ireland Pharmaceuticals, Operations Support Group), the Landgericht Düsseldorf  has referred questions to the CJEU relating to SPCs and the specific mechanism.  According to the UKIPO's website, the questions are:
1.Can the holder of a supplementary protection certificate that was issued to it for the Federal Republic of Germany rely on the specific mechanism to prevent the importation of products into the Federal Republic of Germany from the accession States the Czech Republic, Estonia, Latvia, Lithuania, Hungary, Poland, Slovenia, Slovakia, Bulgaria, Romania … and Croatia (Annex IV to the 2003 Act of Accession, OJ 2003 L 236, p. 797, as amended in OJ 2004 L 126, p. 4, for Estonia, Latvia, Lithuania, Poland, Slovenia, Hungary, Slovakia, the Czech Republic; Part I of Annex V to the 2005 Act of Accession, OJ 2005 L 157, p. 268, for Romania and Bulgaria; Annex IV to the 2011 Act of Accession, OJ 2012 L 112, p. 60, for Croatia) if the supplementary protection certificate was applied for in the Federal Republic of Germany at a point in time at which the laws for obtaining such a supplementary protection certificate already existed in the respective accession States but could not be applied for by, or issued to, the holder of the supplementary protection certificate issued for the Federal Republic of Germany because the basic patent required for the issuing of the supplementary protection certificate did not exist in the accession State?
2.Does it make any difference to the answer to Question 1 if it was merely at the time of the filing of the application for the basic patent issued for the Federal Republic of Germany that such protection through a basic patent could not be obtained in the accession State but, by the time of publication of the application on which the basic patent issued for the Federal Republic of Germany was based, it could be so obtained?
3.Can the holder of a supplementary protection certificate that was issued to it for the Federal Republic of Germany rely on the specific mechanism to prevent the importation of products into the Federal Republic of Germany from the accession States the Czech Republic, Estonia, Latvia, Lithuania, Hungary, Poland, Slovenia, Slovakia, Bulgaria, Romania… and Croatia if those products are imported after the expiry of the term of the supplementary protection certificate stipulated in the original decision to grant the patent but before the expiry of the six-month extension of the term of the supplementary protection certificate that was granted to it on the basis of Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004?
4.Does it make any difference to the answer to Question 3, in the case of Croatia, that, on account of the accession of Croatia in 2013, the specific mechanism did not come into force until after the entry into force of Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 on 26 January 2007 – unlike in the other Member States which acceded prior to 26 January 2007, namely the Czech Republic, Estonia, Latvia, Lithuania, Hungary, Poland, Slovenia, Slovakia, Bulgaria [and] Romania …?

Friday, 27 January 2017

An update on the Pharmaq v Intervet case

In December 2016, the Borgarting Court of Appeal handed down its decision on the validity of Intervet's Norwegian SPC relating to a fish vaccine against pancreatic disease.

The SPC Blog is grateful to Lars Erik Steinkjer at Wikborg Rein for providing a copy of the Court of Appeal judgement (here), a translation of the decision (here) as well as a summary of the facts of this case and of the Court of Appeal decision for readers of the SPC Blog.  Lars Erik Steinkjer and Gunnar Meyer from Wikborg Rein and Ida Gjessing from Grette represented Pharmaq in these proceedings.

Lars writes:
"In the MA for Intervet's vaccine, Norvax Compact PD, the active ingredient is identified as “Inactivated Salmon Pancreatic Disease Virus Strain F93-125”. However, to the Norwegian Industrial Property Office Intervet applied for, and was granted, an SPC with a broader product definition, i.e. “Salmonid pancreatic disease virus that, when injected intraperitoneally at a titre of 103.5 TCID50 into Atlantic salmon post-smolts held in sea water at 14°C causes the fish to develop symptoms of pancreatic disease, wherein
                a) said virus is the virus strain as deposited at ECACC under Deposit number V94090731 or closely related strains which share similar genotypic and/or phenotypic characteristics to said deposited virus strain and
                b) said virus reacts serologically with convalescent anti-FPDV antiserum or antiserum raised against    the deposited virus strain V94090731 and
                c) said virus is in an inactive form.”
Before the Norwegian courts Pharmaq challenged the validity of Intervet’s SPC on the basis of Article 2, 3 and 4 of the SPC Regulation. The Oslo District Court decided to make a referral to the EFTA-court on the interpretation of said articles and the EFTA-court issued its advisory opinion on the 9th of April 2015 (reported earlier here). 
In its subsequent judgment, the Oslo District Court held the SPC valid and infringed by Pharmaq's vaccine (reported earlier on the Blog here). The Court of Appeal, however, overturned the District Court's decision and revoked the SPC as it was held invalid on the basis of article 4 of the SPC regulation. 
Although the Court of Appeal agreed with the District Court's opinion that if the SPC scheme shall fulfill its objectives for biological medicinal products, the scope of protection cannot be limited to a strict interpretation of the wording of the active ingredient in the marketing authorisation, the Court of Appeal also stressed that this consideration must be weighed against the other objectives of the SPC regulation and that SPCs should not be given a wide scope of protection such that improved medicinal products are kept off the market to the detriment of human or veterinary health. 
In the Court of Appeal's opinion it was not clear how the limits on the scope of protection from biological medicinal products ought to be established. The court assumed however that the difference between the products must at least be expressed in such a manner that it has a practical and appreciable effect on the quality, safety and efficacy for the products to constitute two different "active ingredients" according to the SPC regulation. 
On the evidence, the Court of Appeal held that Pharmaq's vaccine, which is based on a different strain than the strain used in Intervet's vaccine, is "systematically, consistently and significantly more efficient against SAV 3 infection than Intervet's vaccine". Thus, the two strains could not be considered the same active ingredient in the meaning of the SPC regulation.  In line with the guidance given by the EFTA-court, the consequence was that the SPC was found invalid.
The judgment is not final as the time limit for appeal to the Norwegian Supreme Court is still running."