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, 16 January 2017

More questions for the CJEU from the High Court

In two separate decisions handed down last Friday, Teva UK Limited & Ors v Gilead Sciences Inc [2017] EWHC 13 (Pat) and Abraxis Bioscience LLC v The Comptroller-General of Patents [2017] EWHC 14 (Pat), Mr Justice Arnold has decided to send more questions to the CJEU for a preliminary ruling.

In Teva UK Limited & Ors v Gilead Sciences Inc, at [95], Mr Justice Arnold repeats question 1 of the Actavis v Sanofi case:
"What are the criteria for deciding whether 'the product is protected by a basic patent in force' in Article 3(a) of the SPC Regulation?"
In Abraxis Bioscience LLC v The Comptroller-General of Patents, the question is (at [62]):
"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?"

Taxol eluting stent decision from the Swiss Federal Administrative Court

The SPC Blog has received news from Tarik Kapic of Bovard of a decision from the Swiss Federal Administrative Court that will force the Swiss Institute of Intellectual Property to decide whether an SPC can be granted on a stent eluting an active ingredient.  An application was filed in 2014 but the Institute refused completely to enter into the matter and the Court has now accepted the appeal based on a “denial of justice” (Rechtsverweigerung). 

A copy of the decision can be found here.  Unfortunately no English translation is available at the moment.

Many thanks to Tarik for passing this on!

Friday, 13 January 2017

New CJEU Reference and Comments for the UKIPO - C-492-16 - Incyte Corporation

Case C-492/16 (Incyte Corporation) appears to be the latest SPC dispute to be referred to the CJEU for a preliminary ruling.  According to the Curia website, the following questions have been referred:
1.  Must Article 17(2) of Regulation (EC) No 1610/96 of the European Parliament and of the Council of 23 July 1996 concerning the creation of a supplementary protection certificate for plant protection products 1 be interpreted as meaning that ‘the date of the first authorization to place the product on the market in the Community’ is incorrect in an application for a supplementary protection certificate, within the meaning of that regulation and of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products, 2 where that date was determined without taking account of the Court of Justice’s interpretation of the law in the judgment in Seattle Genetics (Case C-471/14), with the result that it is appropriate to rectify the date of expiry of the supplementary protection certificate even if the decision to grant that certificate was made prior to that judgment and the time limit for appealing against that decision has already expired?

2.  Is the industrial property authority of a Member State which is entitled to grant a supplementary protection certificate required to rectify, of its own motion, the date of expiry of that certificate in order to ensure that that certificate complies with the interpretation of the law set out in Case C-471/14?
____________1 OJ 1996, L 198, p. 30.
2 OJ 2009, L 152, p. 1.

In addition, the UKIPO is seeking comments on this case.  Comments must be emailed to policy@ipo.gov.uk by 25 January 2017.

Thursday, 5 January 2017

UKIPO seeks comments on C-567/16

The UKIPO is seeking comments on CJEU case C-567/16 (Merck Sharp and Dohme Corporation) with a view to advising the UK government as to whether it wishes to make representations in this reference.  The deadline for filing submissions is coming up very soon - 6 January 2017.

The questions referred to the CJEU are:
  1. Is an End of Procedure Notice issued by the reference member state under Article 28(4) of European Parliament and Council Directive 2001l83/EC of 6 November 2001 on the Community code relating to medicinal products for human use before expiry of the basic patent to be treated as equivalent to a granted marketing authorisation for the purposes of Article 3(b) of European Parliament and Council Regulation 469/2009/EC of 6 May 2009 concerning the supplementary protection certificate for medicinal products (codified version) (the “SPC Regulation”), such that an applicant for an SPC in the Member State in question is entitled to apply for and be granted an SPC on the basis of the End of Procedure Notice?
  2. If the answer to question (1) is no; in the circumstances in question 1, is the absence of a granted marketing authorisation in the Member State in question at the date of the application for an SPC in that member state an irregularity that can be cured under Article 10(3) of the SPC Regulation once the marketing authorisation has been granted?
Many thanks to Andrew Hutchinson (Simmons & Simmons) for pointing this out!

Wednesday, 16 November 2016

The SPC Blog once again thanks Alice de Pastors for sharing her excellent and informative SPC News (no.30) with readers of this weblog.  Unfortunately, it looks like this will be the last issue.  Thanks Alice for all your efforts!

Readers can access the SPC News here.

Wednesday, 12 October 2016

Nab paclitaxel - the UKIPO decision

Not a direction to steal some drug, but rather the full name of the active in this UKIPO decision, considering inter alia the requirements of Article 3d.

The UKIPO's summary is below and the link to the case here

The product for which a Supplementary Protection Certificate (SPC) was sought is defined in the application as “paclitaxel formulated as albumin bound nanoparticles” - referred to as “nab paclitaxel”. Article 3(d) requires that the supporting marketing authorization is the first authorization for the product in the EU. Article 1(b) defines a product as “the active ingredient or combination of active ingredients of a medicinal product”. The examiner considered that paclitaxel, a well-known anti-cancer drug, was the sole active ingredient in the product and therefore the application did not comply with Article 3(d) as it had been previously received marketing authorisations in the EU.
The hearing officer considered that the application was in line with the purpose of the Regulation and had circumstantial and consequential parallels with the SPC held to be valid by the Court of Appeal in Re. Generics UK Ltd v Daiichi Pharmaceutical Co Ltd; Daiichi Sankyo Co Ltd EWCA Civ 646 [2009].

The applicant submitted that nab-paclitaxel represented a new single active ingredient. The hearing officer accepted a range of clinical and in vitro evidence showing that nab-paclitaxel is more effective and safer than paclitaxel, for example in treating breast tumours and in treating non-small cell lung cancer and pancreatic cancer in combination with other drugs. He also accepted that nab-paclitaxel is transported across cell membranes and remains intact inside tumour cells. However, he considered on the basis of the evidence before him that albumin did not play an active role in killing tumour cells but that it functioned as a carrier, which is regarded as a conventional function of albumin. He held that nab-paclitaxel was not a new single active ingredient but a combination of two ingredients and that the albumin component of nab-paclitaxel did not have a therapeutic effect on its own. Consequently, he held that nab-paclitaxel did not qualify as a combination of active ingredients, having regard to the ruling of the Court of Justice of the European Union (CJEU) in Massachusetts Institute of Technology (C-431/04). Several other authorities relating to this subject are also referred to in the decision.

The applicant contended that nab-paclitaxel was a new application of paclitaxel and therefore should be granted an SPC in light of the CJEU ruling in Neurim Pharmaceuticals (1991) Ltd v Comptroller-General of Patents (C-130/11). The hearing officer interpreted the judgment in Re. Neurim as requiring that the new application of a product should be limited to a new therapeutic application and held that nab-paclitaxel did not represent a new therapeutic application of paclitaxel. The application was refused as the hearing officer held it did not comply with Article 3(d) of the SPC Regulation having regard to the definition of a product pursuant to Article 1(b). 

C572/15 (Xeloda) - SPC term calculation and EU accession


The facts in this case (link here ) are as follows.

Roche markets a medicinal product called "Xeloda" in Estonia.  The active substance is capecitabine.  Roche has a basic patent granted on 15 April 1998.  Xeloda was registered for the first time in Estonia on 8 June 2001 and was granted an SPC by the Estonian Patent Office.  

Accord obtained an Estonian marketing authorisation (MA) for a generic version of the product. Roche brought an action before the Estonian district court seeking an injunction against Accord to prevent infringement of their rights until SPC expiry, which Roche calculated to be 8 June 2016.   

Accord considered that the SPC was not valid because the first MA for Xeloda had been  granted in Switzerland in 1998, so they said the maximum 15 years of protection actually expired in 2013. 

Roche countered that the SPC duration should be 15 years from the date of the Estonian MA.  They argued that, as the SPC was issued at a time when Estonia was not a member of the European Union, then only Estonian law applied, according to which the duration of validity of the SPC depended not on the grant of the first MA in the European Union, but the grant of that authorisation in Estonia.

The Estonian Supreme Court then referred the following questions to the ECJ:


"(1) Must Article 21(2) of Regulation No 469/2009 … be interpreted as shortening the duration of [an SPC] issued in a Member State which was issued under national law before the accession of the State in question to the European Union and whose duration in relation to an active substance, as stated in the [SPC], would be longer than 15 years from the time when the first [MA] in the Union was granted for a medicinal product consisting of the active substance or containing it?
(2) If the answer to the first question is in the affirmative, is Article 21(2) of Regulation No 469/2009 … compatible with European Union law, in particular the general principles of European Union law on the protection of acquired rights, the principle of the prohibition of retroactive effect of law, and the Charter …?"
The CJEU held that, for the purpose of calculating the duration of the SPC, the relevant marketing authorisation was to be that first granted in the EU or, in the EEA, even though this was granted before Estonian accession.  
This was not considered to be a retrospective application of EU rules because an SPC took effect only at expiry of the patent, which was after the date of accession. 
The court also ruled that it had no jurisdiction to rule on the validity of Article 21(2) of the SPC Regulation.
The CJEU conclusion was as follows:

1.      The Court of Justice of the European Union does not have jurisdiction to rule on the validity of Article 21(2) of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products, as amended by the Act concerning the conditions of accession of the Republic of Croatia and the adjustments to the Treaty on European Union, the Treaty on the Functioning of the European Union and the Treaty establishing the European Atomic Energy Community.

2.      Article 21(2) of Regulation No 469/2009, as amended, must be interpreted as meaning that it applies to a supplementary protection certificate, relating to a given medicinal product, granted by a Member State prior to its accession to the European Union. To the extent that that medicinal product was the subject, within the European Economic Area, of a marketing authorisation before that granted in that Member State, and, as the case may be, before its accession to the European Union, only the first marketing authorisation must be taken into account for the purposes of determining the duration of validity of the supplementary protection certificate.

Monday, 1 August 2016

New referral to the CJEU

In Merck Shark & Dohme v Comptroller-General of Patents [2016] EWHC 1896 (an appeal to BL O/117/16), Mr Justice Arnold has referred the following questions to the CJEU for a preliminary ruling:

(1) Is an end of procedure notice issued by the reference member state under Article 28(4) of the Medicinal Products Directive equivalent to a granted marketing authorisation for the purposes of Article 3(b) of the SPC Regulation?

(2) If the answer to question (1) is no, is the absence of a granted marketing authorisation at the date of the application for a certificate an irregularity which can be cured under Article 10(3) of the SPC Regulation once the marketing authorisation has been granted?

This case arose because Merck Sharp & Dohme filed an SPC application one day before patent expiry but only had the "End of Procedure Communication" but not a marketing authorisation.

Tuesday, 5 July 2016

Brexit: what does Boris Johnson have to say about SPCs?

Fortunately nothing at all,  but after the UK's exit from normality we've been asked what impact there will be on SPCs in the UK?

As SPCs are granted in the UK under an EU regulation, which will no longer apply after Brexit, in the future it will be necessary for the UK to enact legislation to create some form of equivalent protection. Presumably this will not be at the top of the list of priorities for our new PM, and possibly we will adopt the current EU legislation into UK law, but without appeal to the CJEU for obvious reasons.  The possibility remains that any new protection could be of a different scope, but this seems an unlikely outcome given that there will apparently be some other things to do as well.  After Brexit the UK courts will not be bound by the existing CJEU decisions, or be able to refer questions on SPCs to the CJEU, and we may have divergent opinions on similar legal issues between the UK and EU as we move forward.  Given the view of some of the UK judges on the opinions of the CJEU, this could be rather interesting.

There will also need to be a new mechanism for extending the SPC term after appropriate paediatric studies, assuming the UK looks to maintain equivalent protection with the rest of the EU.

SPCs already granted by the UKIPO should be unaffected, but could potentially have a different validity if the law that applies to them is interpreted differently by a court free from the constraints of CJEU decisions.

Finally, this will all have to be subject to any new or transitional approval regime, given that the EMA may cease to have any jurisdiction in the UK.

All in all, Brexit has placed the UK in a position that arguably is more complex than SPC case law….and that's saying something.

Rob and Catherine

Thursday, 30 June 2016

SPC Seminar coming up soon!

Daniel Wise of Carpmaels & Ransford has written in to the Blog to say that there are a few last places available for Carpmaels’ annual “SPC Summer Review” event taking place next Thursday, 7th July 2016, from 17:30 (for a 18:00 start) at their offices in central London (One Southampton Row, WC1B 5HA).  The seminar will focus on recent CJEU and national guidance for combination product SPCs, including Actavis v Boehringer (C-577/13) and Merck Sharp & Dohme (BL O/117/16), the current approach to Neurim-style SPCs, and will provide a timely opportunity to discuss the implications for SPCs of Brexit and the Unitary Patent & Unified Patent Court.  Drinks and canap├ęs will be served afterwards.  If you would like to join, please send an email to kmm@carpmaels.com, with the subject line “I would like to attend the SPC Summer Review 2016”.  Attendance is free of charge.