MAs and APIs: the Austrian Supreme Court applies Forsgren ruling

Last week our friend Rainer Schultes (Geistwert) posted on his blog this note, which we are happy to reproduce below with his permission, on the Austrian Supreme Court's application of the provisions of the SPC Regulation in the light of a recent ruling of the Court of Justice of the European Union (CJEU) in response to the Austrian court's reference in the Synflorix case.  For the benefit of any first-time readers, API stands for "active pharmaceutical ingredient" and an MA is not a higher degree but a marketing authorisation:

The API of an SPC need not be mentioned in the MA

In Case C-631/13 Forsgren [noted briefly here on The SPC Blog], the CJEU already ruled: 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.

GEISTWERT has blogged already (link).

Now, the Austrian Supreme Court shed further light on the SPC Regulation when applying the CJEU's judgment (Austrian Supreme Court, 4Ob20/15t).

In the matter at stake an SPC was requested for a protein D, which is a carrier protein covalently bonded to other active ingredients. Covalent binding does not exclude an SPC.

The Supreme Court analysed the context between the order for reference, the statement of the European Commission and the CJEU’s judgment: The Supreme Patent- and Trademark Senate, which referred the question to the CJEU had individualized the protein D as a carrier for which no pharmaceutical effect was mentioned in the Marketing Authorisation (MA). With regard to that, the Commission meant that the protein’s activity had to be mentioned in the MA, otherwise the request for SPC was not justified. The CJEU did not follow that but referred to the facts, thus to the effectiveness of the protein within Synflorix.

Upon this analysis, the Supreme Court now held that an own pharmacological, immunological or metabolic action of the protein D within the indications covered by the MA has to be established but it is not necessary that the protein D is explicitly mentioned in the Marketing Authorisation.

To verify that, the matter was referred back to the first instance.

Thanks so much, Rainer, for keeping us informed!

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.

Switzerland, Liechtenstein and the AstraZeneca reference: your chance to comment

Readers of The SPC Blog will be familiar with the UK litigation between AstraZeneca AB and the Comptroller of Patents, Designs and Trade Marks since this blog posted a note on it back in October of last year.  This case has now resurfaced as a reference to the Court of Justice of the European Union with the new designation of Case C-617/12  AstraZeneca.

The UK's Intellectual Property Office reminds us that the referring court has asked the following questions:

"1. Is a Swiss marketing authorisation not granted pursuant to the administrative authorisation procedure laid down in Directive 2001/83/EC, but automatically recognised by Liechtenstein, capable of constituting the 'first authorisation to place the product on the market' for the purposes of Article 13(1) of Regulation 469/2009/EC?

2. Does it make a difference to the answer to the first question if:

(a) the set of clinical data upon which the Swiss authority granted the marketing authorisation was considered by the European Medicines Agency as not satisfying the conditions for the grant of a marketing authorisation pursuant to Regulation 726/2004/EC; and/or

(b) the Swiss marketing authorisation was suspended after grant and was only reinstated following the submission of additional data?

3. If Article 13(1) of Regulation 469/2009 refers solely to marketing authorisations granted pursuant to the administrative authorisation procedure laid down in Directive 2001/83/EC, does the fact that a medicinal product was first placed on the market within the EEA pursuant to a Swiss marketing authorisation automatically recognised in Liechtenstein which was not granted pursuant to Directive 2001/83/EC render that product ineligible for the grant of a supplementary protection certificate pursuant to Article 2 of Regulation 469/2009?".

If you would like to comment on this case and, by doing so, encourage the UK government to take a position on whether to make observations to the CJEU, please email policy@ipo.gsi.gov.uk by 28 February 2013.  We know there's not much time, but ...

SPCs and Directive 2001/83-compliant authorisations: a comment on AstraZeneca

AstraZeneca AB v Comptroller-General of Patents, Designs and Trade Marks [2012] EWHC 2840 (Pat), decided by Mr Justice Arnold last week, was briefly recorded by this weblog as breaking news.  The SPC Blog is now pleased to host a more substantial comment by Andrew Hutchinson and Marjan Noor (Simmons & Simmons LLP)

AstraZeneca: SPCs, marketing authorisations and Directive 2001/83 -- what's the safest bet?

The latest decision of the Patents Court for England and Wales refers another series of questions (three in total) on SPCs to the CJEU: AstraZeneca AB v Comptroller-General. This time the Court is revisiting the position where a "first authorisation" may be deemed to be a Swiss MA by virtue of its automatic recognition in Liechtenstein, following the CJEU's decision in Novartis (Cases C-207/03 and C-252/03).

It is important to note that the facts occurred before the introduction of the negative-list in Liechtenstein in 2006, which sought to prevent the automatic recognition of Swiss authorisations in Lichtenstein, but that is not to say the case is not relevant to products with SPCs where the first authorisation was in Switzerland and the negative-list was used.

In this case, AZ obtained a Swiss MA for gefitinib in March 2004 (when every Swiss MA was automatically recognised in Liechtenstein), which was suspended in October 2005 and not reinstated until December 2010. By December 2010, AZ had (in June 2009) obtained an MA via the centralised procedure and claimed that this should be the "first authorisation" from which to calculate its SPC term. To achieve this outcome, AZ argued that Novartis should be overturned or confined to its own facts.

Arnold J agreed that the law was not acte clair and referred two questions to the CJEU (which both AZ and the UK's Intellectual Property Office agreed were necessary):

1. Is a Swiss marketing authorisation not granted pursuant to the administrative authorisation procedure laid down in Directive 2001/83, but automatically recognised by Liechtenstein, capable of constituting the ‘first authorisation to place the product on the market’ for the purposes of Article 13(1) of Regulation 469/2009?

2. Does it make a difference to the answer to the first question if:

(a) the set of clinical data upon which the Swiss authority granted the marketing authorisation was considered by the European Medicines Agency as not satisfying the conditions for the grant of a marketing authorisation pursuant to Regulation 726/2004 and/or

(b) the Swiss marketing authorisation was suspended after grant and was only reinstated following the submission of additional data?

The Court also addressed the more fundamental issue raised by the CJEU in Merz v Synthon and Generics v Synaptech (Joined Cases C-195/09 and C-427/09), whereby products authorised not in accordance with Directive 2001/83 were deemed outside the scope of the SPC regime altogether under Article 2.

Arnold J's third question deals with the consequences of the Swiss authorisation not counting as the "first authorisation" for the purposes of calculating duration (i.e. a 'no' to the first question) because it is deemed not to be compliant with Directive 2001/83:

3. If Article 13(1) of Regulation 469/2009 refers solely to marketing authorisations granted pursuant to the administrative authorisation procedure laid down in Directive 2001/83, does the fact that a medicinal product was first placed on the market within the EEA pursuant to a Swiss marketing authorisation automatically recognised in Liechtenstein which was not granted pursuant to Directive 2001/83 render that product ineligible for the grant of a supplementary protection certificate pursuant to Article 2 of Regulation 469/2009?

Arnold J offers his thoughts on the answers to both issues. He considers that the earlier Swiss/Liechtenstein MA should be the "first authorisation" for the purposes of Article 13 because the factual scenarios set out in question 2 do not provide a cogent basis for distinguishing Novartis. However, Arnold J considers that, if the Liechtenstein MA does not count as the first authorisation because it is not Directive 2001/83-compliant, for the same reasons the product should fall outside the scope of the SPC regime and not be entitled to an SPC at all as it would have been placed on the market in Europe before the grant of a Directive 2001/83 complaint MA (i.e. following Merz and Generics).

If the CJEU's answer does not maintain the Novartis position as proposed by Arnold J, then the impact of a knock on affirmative answer to Q3 (following Merz) would be significant. SPCs granted before the negative-list would be vulnerable to revocation. Since 2006, although the negative-list procedure in Liechtenstein has provided a mechanism for companies to delay the automatic recognition of MAs between Switzerland and Liechtenstein, this procedure will need to be carefully assessed and managed pending CJEU clarification on this issue. At the very least companies will need to ensure their products remain on the negative-list pending a Directive 2001/83-compliant authorisation. The safest bet would be to ensure that the Swiss MA is delayed until after a Directive 2001/83-compliant European authorisation but this may not be commercially desirable or practical. 

Brave New World post-Neurim?

"A brave new world for supplementary protection certificates?” is the title of an article by Mike Snodin and Michael Pears (both of Potter Clarkson) that has been published in the most recent edition of Life Sciences IP Review.  The article discusses the opinion of Advocate General Verica Trstenjak in Neurim Pharmaceuticals (C-130/11), which it notes has the potential to greatly increase the number of medical innovations that will qualify for supplementary protection in Europe .

Mike and Michael acknowledge that, on the face of it, the opinion appears to be good news for the innovative pharmaceutical industry. However, their analysis of the opinion highlights some potentially serious side-effects that may throw the SPC system out of balance in a way that is detrimental to the long-term interests of the industry. In particular, they point to the fact that the solution proposed by the Advocate General would inadvertently sever an important link in the legislation (a link between a high regulatory hurdle and the award of an SPC) and lead to not only inconsistencies with certain statements of principle from the authors of the original legislation but also to a proliferation of SPCs based upon almost any kind of marketing authorisation (and therefore almost any degree of regulatory hurdle).

Mike and Michael therefore question whether, when reaching their judgment later this year, the Court of Justice of the EU may wish to consider alternative "cures" that have fewer side-effects but that still avoid the harsh result for Neurim that is reached through strict application of the prior case law of that court.

You can read Mike and Michael's article in full here.

Sumitomo CJEU reference: some further information

The EU Law Radar weblog carries a helpful note on Case C-210/12 Sumitomo Chermical, which has recently been referred to the Court of Justice of the European Union.  An extract of this note is reproduced here, with permission.

Case C-210/12, Sumitomo Chemical – insecticide and an SPC application 

Posted on 21 June 2012 

Can a supplementary protection certificate for a plant protection product be issued to a company when the application is made after an earlier marketing authorisation has expired?

Facts
In this case involving Sumitomo Chemical, the claimant holds patents for an insecticide with Clothianidine as an active substance (European Patent EP 0 376 279 covering Guanidine derivatives, their production and insecticides; and German patent DE 689 06 668). The claimant had applied for its European Patent on 27 December 1989 so the claimant was now seeking to gain a supplementary protection certificate for the plant protection products known as ‘Poncho Pro’, which contains Clothianidine.

The dispute relates to the fact that on 14 May 2004 the claimant’s legal predecessor sought a plant protection product certificate from the German Patent and Trade Mark Office. The application was supported by reference to a decision of Germany’s Federal Office of Consumer Protection and Food Safety. The authority had issued an authorisation in December 2003 to Bayer CropScience for the latter’s product ‘Poncho Pro’, that contains Clothianidine as an active substance.

Whilst the German Patent and Trade Mark Office was reaching its decision in respect of the claimant’s application, other events were taking place. On 8 September 2004, Germany’s Federal Office of Consumer Protection and Food Safety granted Bayer a provisional authorisation valid for the active substance of Clothianidine – its decision being based on Article 8(1) of Directive 91/414. This provisional authorisation was valid for 3 years until 7 September 2007, an authorisation which later became definitive by dint of a decision taken in June 2007.

Learning of the initial provisional authorisation granted in 2004, the claimant’s legal predecessor informed the German Patent and Trade Mark Office of this development. Time passed. In January 2006, a year and a half after the claimant’s legal predecessor had applied for a plant protection product certificate, the German Patent and Trade Mark Office decided to turn down the application. The reason given for the refusal was that the authorisation which enabled Poncho Pro to be put on the German market had been rather a special one. It had been an emergency authorisation granted in accordance with Article 8(4) of Directive 91/414. The Directive’s provision allows for a limited use of a plant protection substance where this appears necessary because of an unforeseeable danger that cannot be contained by other means. As such, the authorisation had run for only 120 days covering the period from 15 January 2004 until 13 May 2004. Since the claimant’s application had been made on the 14 May 2004, the day after the expiry, a plant protection product certificate could not be granted because the phytosanitary certificate could not be considered to be ‘in force’ for the purposes of Article 3(1)(b) of EC Regulation 1610/96.

The claimant’s legal predecessor launched an appeal against the decision of the German Patent and Trade Mark Office. And it sought to revoke the Office’s decision to grant an emergency certificate to Bayer. In turn, Bayer launched two appeals against the German Patent and Trade Mark Office’s decisions which refused to grant subsequent certificates – even though the company had been granted both provisional and definitive authorisations from Germany’s Federal Office of Consumer Protection and Food Safety.

Questions Referred 

According to the UK IPO website, the German Federal Patent Court asked: 

1. Is Article 3(1)(b) 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 to be interpreted as not precluding the grant of a supplementary protection certificate for a plant protection product if a valid marketing authorisation was granted in accordance with Article 8(4) of Directive 91/414/EEC? 

2. If Question 1 is answered in the affirmative: is it necessary under Article 3(1)(b) of Regulation (EC) No 1610/96 for the marketing authorisation to be still in force at the time of application for the Certificate? 

3. If the answer to Question 1 is in the negative: is Article 7(1) of Regulation (EC) No 1610/96 to be interpreted as meaning that an application can be lodged even before the period mentioned in that provision starts to run?

Sumitomo plant protection reference: it's all a question of timing

Case C-210/12 Sumitomo Chemical is a reference for a preliminary ruling from the Court of Justice of the European Union. The referring court is the German Bundespatentgericht, which wishes to obtain the guidance of the CJEU on the following questions relating to SPCs for plant protection products:

"1. Is Article 3(1)(b) of Regulation (EC) No 1610/96 ... concerning the creation of a supplementary protection certificate for plant protection products to be interpreted as not precluding the grant of a supplementary protection certificate for a plant protection product if a valid marketing authorisation was granted in accordance with Article 8(4) of Directive 91/414/EEC?

2. If Question 1 is answered in the affirmative:

Is it necessary under Article 3(1)(b) of Regulation (EC) No 1610/96 for the marketing authorisation to be still in force at the time of application for the Certificate?

3. If the answer to Question 1 is in the negative:

Is Article 7(1) of Regulation (EC) No 1610/96 to be interpreted as meaning that an application can be lodged even before the period mentioned in that provision starts to run?"

If you have any comments on this reference which you would like to share with the British government, you are invited to email policy@ipo.gsi.gov.uk before 22 June 2012 -- that's this Friday.

If you have any interesting background information concerning this reference, do feel free to share it with us!

Court of Justice rules on Hus(s)ar SPC

Napoleonic Hussar: an early
experiment in European unity?

The Court of Justice gave its ruling earlier today in Case C‑229/09, Hogan Lovells International LLP, formerly Rechtsanwaltssozietät Lovells v Bayer CropScience AG.  This was a reference for a preliminary ruling under Article 234 EC from the Bundespatentgericht.

Bayer owned a European patent covering, inter alia, a herbicide known as iodosulfuron. The application for this patent was filed on 12 February 1992; the patent issued on 11 November 1998 with an expiry date of 13 February 2012.  On 13 December 1998, an application to have iodosulfuron included in Annex I to Directive 91/414 [concerning the placing of plant protection products on the market] was lodged with the German authorities by an undertaking the rights of which were subsequently acquired by Bayer.  On 9 March 2000 the German authority issued a marketing authorisation to Bayer for a herbicide based on that substance, sold under the name ‘Husar’.  This was a provisional MA, issued on the basis of a provision of national law designed to transpose Article 8(1) of Directive 91/414. In order to take account of Commission Decision 2003/370 [allowing Member States to extend provisional authorisations granted for the new active substances iodosulfuron-methyl-sodium, indoxacarb, S-metolachlor, Spodoptera exigua nuclear polyhedrosis virus, tepraloxydim and dimethenamid‑P], the expiry date of that provisional MA, initially fixed at 8 March 2003, was put back to 21 May 2005.

On 17 July 2003 the Bundespatentgericht granted Bayer an SPC for iodosulfuron and some of its salts and esters for the period between 13 February 2012, the expiry date of the European patent and 9 March 2015. In calculating the duration of the certificate, the Bundespatentgericht took the view that the provisional MA of 9 March 2000 was the first MA.  On 25 September 2003 the Commission included iodosulfuron in Annex I to Directive 91/414 by means of Commission Directive 2003/84.

On 13 January 2005 the German authority issued a definitive MA to Bayer for Husar on the basis of the national provisions transposing Article 4 of Directive 91/414. Its expiry date was fixed at 31 December 2015.

The word is spelled 'Husar'
but an image search reveals
use of 'Hussar' only

Lovells brought an action before the Bundespatentgericht for annulment of the SPC of 17 July 2003, arguing that it was invalid in the light of Regulation 1610/96 [concerning the creation of a supplementary protection certificate for plant protection products].  Under Article 3(1)(b) of that regulation an SPC may be issued only after a definitive MA has been issued under the conditions laid down in Article 4 of Directive 91/414. In this case, however, the MA of 9 March 2000 was a provisional MA coming under Article 8(1) of that directive.

Bayer challenged that interpretation of Article 3(1)(b), which it considered contrary to the general scheme of that regulation and to the practice of the competent national authorities. The Bundespatentgericht decided to stay proceedings and to refer the following question to the Court for a preliminary ruling:

‘For the purpose of the application of Article 3(1)(b) of Regulation No 1610/96, must account be taken exclusively of [a MA] under Article 4 of Directive 91/414 … or can a certificate also be issued pursuant to [a MA] which has been granted on the basis of Article 8(1) of Directive 91/414 …?’

Today the court ruled as follows:

"Article 3(1)(b) of Regulation ... 1610/96 ... must be interpreted as not precluding a supplementary protection certificate from being issued for a plant protection product in respect of which a valid marketing authorisation has been granted pursuant to Article 8(1) of Council Directive 91/414 ..., as amended by Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005".

Dutch speaking readers can note this decision on the excellent Boek9.nl blog here

Almirall vs. Mylan -Belgian Court of Appeal Decision

Benito Boone of Crowell & Moring (Brussels) has kindly provided us with the recent Belgian decision on the calculation of the duration of an SPC in the case Almirall vs. Mylan (aceclofenac). In short,

"the Brussels Court of Appeal confirmed an earlier judgement, which stated that the starting point of the calculation of the duration of the SPC (article 13 of the Regulation), is not the first MA granted in accordance with Dir. 65/65/EEC (now 2001/83/EC), but a national MA which dates from before the entry into force
of Dir. 65/65/EEC (even if the national MA was granted without a full assessment: see p. 33, § 22 in fine of the judgment).

The court also refuses to refer the case to the ECJ for a preliminary ruling. "

For a copy of the judgement in Dutch, here. Let us know if you would be interested in a more detailed summary by emailing us here.