Synflorix: SPC can be based on covalently bound active ingredient -- in principle ...

This morning the Court of Justice of the European Union (CJEU) delivered its judgment in Case C‑631/13, Arne Forsgren v Österreichisches Patentamt, a request for a preliminary ruling under Article 267 TFEU from the Oberster Patent- und Markensenat, Austria. The CJEU obviously didn't consider this a tough case to decide, since it dispensed with an Opinion from Advocate General Bot.

The factual background runs as follows. Forsgren owned a European patent (EP0594610B1, ‘the basic patent’) relating to ‘Protein D ‒ an IgD-binding protein of Haemophilus influenzae’.  Protein D is present in a pneumococcal vaccine for paediatric use, ‘Synflorix’, the marketing of which was authorised by Commission Decision C(2009) 2563 for ‘Synflorix — Pneumococcal polysaccharide conjugate vaccine (adsorbed)’. From the wording of the marketing authorisation (MA) for Synflorix, it appears that Synflorix was composed of 10 pneumococcal polysaccharide serotypes which were conjugated to carrier proteins and adsorbed on to aluminium phosphate. In eight of those serotypes, Protein D was the carrier protein. The therapeutic indications set out in the MA were for

‘Active immunisation against invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae in infants and children from 6 weeks up to 2 years of age’. 

According to the MA, the excipients of that vaccine were sodium chloride and water for injections.

In September 2009 Forsgren applied to the Österreichisches Patentamt for an SPC for Protein D. No, said the office, since Protein D was just an excipient. On appeal, the Board of Appeal of the Österreichisches Patentamt agreed: while Protein D had a therapeutic effect against the Haemophilus influenzae bacterium, it wasn't present as such in Synflorix, being covalently bonded to other active ingredients. Accordingly, Protein D couldn't be authorised as a medicinal product within the meaning of the SPC Regulation. Forsgren appealed further to the Oberster Patent- und Markensenat, which decided to stay proceedings and to refer to the CJEU the following questions for a preliminary ruling:

‘1. Under Article 1(b) and Article 3(a) and (b) of [Regulation 469/2009], provided that the other conditions are met, may [an SPC] be granted for an active ingredient protected by a basic patent (in this case, Protein D) where that active ingredient is present in a medicinal product (in this case, Synflorix) as part of a covalent (molecular) bond with other active ingredients but none the less retains an effect of its own?

2. If Question 1 is answered in the affirmative:

(a) Under Article 3(a) and (b) of [Regulation No 469/2009], may [an SPC] be granted for the substance protected by the basic patent (in this case, Protein D) where that substance has a therapeutic effect of its own (in this case, as a vaccine against the Haemophilus influenzae bacterium) but the marketing authorisation for the medicinal product does not relate to that effect?

(b) Under Article 3(a) and (b) of [Regulation 469/2009], may [an SPC] be granted for the substance protected by the basic patent (in this case, Protein D) where the marketing authorisation describes that substance as a ‘carrier’ for the actual active ingredients (in this case, pneumococcal polysaccharides), where the substance, as an adjuvant, enhances the effect of those substances, but where that effect is not expressly mentioned in the marketing authorisation for the medicinal product?’

This morning the CJEU (Eighth Chamber) ruled:

1. Articles 1(b) and 3(a) of Regulation 469/2009 ...  must be interpreted as not precluding, in principle, the possibility that an active ingredient can give rise to the grant of a supplementary protection certificate where the active ingredient is covalently bound to other active ingredients which are part of a medicinal product.

2. 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, a matter which it is for the referring court to determine, in the light of all the facts of the dispute in the main proceedings.

There may be some further comment from the blog team but, in the meantime your comments are most welcome.

Circadin patent extended in Israel despite opposition

Neurim's conduct was found, on the facts,
not to be a "baa" to patent extension

"Unipharm Challenges Validity of Patent Term Extension for Neurim’s Circadin in Israel" is the title of this blogpost by Israeli patent attorney Michael Factor on his eponymous blog The IP Factor ("Opinionated Intellectual Property News Blog with an Israel Slant").

To cut a long story short (the full tale is there for all to read on Michael's weblog), Unipharm opposed the patent term extension of Neurim's Circadin patent and Commissioner King was required to consider three issues:

• Whether an extension could lawfully be granted on account of Neurim's inequitable behaviour 
• Whether the patent in question was to be considered the “basic patent” under Section 64a of Israel's Patent Law 
• Whether Circadin was the first drug containing the active ingredient as required by 64d of the Israel Law

The Commissioner rejected the opposition and extended the patent till 22 April 2017.  A large part of the IP Factor report deals with inequitable conduct, in particular the allegation that, in its ex parte application for patent extension, the company had behaved improperly and withheld or suppressed relevant information.  The Commissioner confirmed that an applicant was required to behave in an equitable manner, but did not consider that any breach by Neurim of that requirement was sufficient to prevent the extension.

Isoxadifen reference: can you help?

One of our readers has written in to ask:

"Would it be possible to ask the SPC community for a copy of the decision of the German Federal Patent Court (BPatG; file number: 15 W (pat) 14/07 with regard to the corn safener Isoxadifen from Bayer) with regard to the recent referral to the Court of Justice of the European Union in Case C-11/13 Bayer CropScience? The referred question seems to ask whether a "safener" can be a product and an active ingredient according to Article 3(1) and Article 1 No. 8 and No. 3 of Regulation 1610/96. Unfortunately (although the court decided the referral as long ago as July 2012) the decision has not yet been published".

While this weblog is inevitably much more focused on pharma products than on the agrochemical sector, we do have some readers on that side too. Can they, or indeed anyone, help?