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, 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."

Tuesday, 24 January 2017

Plant Protection Product SPCs - an article

News comes from Velautha-Cumaran Arunasalam and Filip de Corte who report the publication of their recent article "Supplementary protection certificates for plant protection products: the story of 'The Ugly Duckling'" in the Journal of Intellectual Property Law & Practice (JIPLP).  They write:
The paper was put forward to celebrate the upcoming 20th anniversary of the PPP (plant protection product) SPC Regulation coming into effect and to confirm the continued importance of the SPC Regulation for the plant protection sector.
Importantly, the paper considers briefly the social as well as economic factors behind the SPC Regulations and puts forward reasons why not all the case law on medicinal product SPCs, especially those concerning combination products, should be directly applicable to the plant protection sector.  The Regulations can be said to be sisters but not twins.
The article can be accessed here.

Thursday, 19 January 2017

Another EC tender on SPCs - this time on the economic impact

Via this post on the IPKat comes news of a recently published tender entitled "Study on the economic impact of supplementary protection certificates, pharmaceutical incentives and rewards in Europe." This study will complement the ongoing legal study on SPCs (reported on the SPC Blog here).

According to the press release:
"The study will provide an economic evaluation of the incentives and rewards for pharmaceutical innovation in Europe, and its functioning within the Internal Market. 
The study will in particular analyse the effects of supplementary protection certificates (SPCs) for pharmaceutical uses (human and veterinary), and plant protection, data protection and market exclusivity for medicinal products for human use.
Evidence on the overall impact on availability and accessibility of pharmaceutical care for patients and the pressure on health systems across the European Union will be examined. The evidence and analysis provided by this study will hence support the policy making in those areas."
More detailed information on the tender can be obtained in the technical specifications, here. The deadline to apply is 8 February 2017.

Tuesday, 17 January 2017

The return of SPC referrals…

Following previous posts on this case (here, here and here), the UKIPO will now be preparing its submission in the recent CJEU referral in Merck (Case C-567/16).

Marking the return of SPC referrals, of which a number have now followed, Simmons & Simmons (Andrew Hutchinson, Machteld Hiemstra and Nicholas Fischer) has published an article on this case – kindly available here.

As well as considering the referral and issues raised by Arnold J’s decision in respect of Article 3(b), this article analyses the UK IPO’s original decision under Article 3(c) and reviews the parallel Dutch Patent Office decision, which interestingly comes to a contrasting outcome under both grounds.

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!