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Tuesday, 8 March 2011

Are Sheep Relevant? Questions on SPCs for the Court of Justice.

Hot on the heels of the Court of Justice's opinion on the envisaged creation of a Unified Patent Litigation System and Community Patents Court (reported by the IPKat here - a monumental grand 'Non', in case you were wondering), comes a judgment of the Court of Appeal in Neurim Pharmaceuticals v The Comptroller-General of Patents [2011] EWCA Civ 228. The case concerns the interpretation of one of the few patent-related topic to currently fall within the CJEU's (oh for those pre-Lisbon days when we could happily refer to the ECJ and save ourselves that extra letter) remit: Supplementary Protection Certificates (SPCs to their friends).


The case concerns Neurim’s European Patent (EP (UK) No. 0 518 468) on the use of the natural hormone melatonin as a medicine to treat insomnia. As Lord Justice Jacob (giving a judgment with which Smith and Patten LJJ agreed) explains: “Before Neurim could be allowed to sell their patented formulation (for which they use the trade mark Circadin) they of course had to get regulatory approval. They had applied for their patent on 23rd April 1992, but it took over 15 years before they got a marketing authorisation.” It was finally approved for marketing in June 2007 (the “June 2007 MA”).

Understandably, given the time that had elapsed, Neurim applied for a SPC, basing their application on their June 2007 MA. This, they said, was the “first authorization to place the product on the market as a medicinal product” within the meaning of Art. 3(d) of the SPC Regulation EEC 1768/92 (now EC 469/2009). The IPO objected on the basis that this was not the correct MA – they had identified an earlier authorisation for melatonin… for use in sheep. This had been granted between January and March 2001 by the UK Veterinary Medicines Directorate under Directive 81/851/EEC. The sheep product was sold under the trade mark “Regulin.”

The Court of Appeal was therefore faced with the task of interpreting Art 3 of the SPC Regulation. Cutting to the core of the issue, this essentially required the Court to determine whether a valid authorisation had been given for “the product” in question. The IPO argued that melatonin was “the product” and therefore authorisation had been given when it was approved for use in sheep. Neurim argued that sheep were irrelevant – an SPC is just that: protection supplementing the protection of the basic patent. Therefore, as each patent can have its own SPC (but only one), the relevant MA for that patent is an MA for a product falling within the scope of that patent.

So which way to fall? At first instance Mr Justice Arnold was of the opinion that the Regulation was acte clair, and upheld the IPO’s assessment of the relevancy of the sheep. The Court of Appeal was not so convinced:
[28] “We consider that Neurim’s arguments are not only tenable: in our view they are right. Many kinds of valuable pharmaceutical research will not get the encouragement or reward they deserve if they are not. Pharmaceutical research is not confined to looking for new active compounds. New formulations of old active substances are often sought. Most are unpatentable but from time to time a real invention is made and patented.
[29] Moreover there is much endeavour to find new uses for known active ingredients. The European Patent Convention 2000 has indeed made the patenting of inventions in this area clearer. Its effect is that a patent for a known substance or composition for use in a method of treatment is not to be regarded as old (and hence unpatentable) unless use for that method is known. It would be most unfortunate if second medical use patents could not get the benefit of an SPC.”
Concluding that if Neurim were wrong then the Regulation "will not have achieved its key objects for large areas of pharmaceutical research: it will not be fit for purpose." The Court considered that the question of whether this was the case or not was one for "EU’s highest court".

The following questions were therefore referred:
  1. In interpreting Article 3 of Regulation EEC No. 1768/92 [now Regulation (EC) No. 469/2009] (“the SPC Regulation”), when a marketing authorisation (A) has been granted for a medicinal product comprising an active ingredient, is Article 3(d) to be construed as precluding the grant of an SPC based on a later marketing authorisation (B) which is for a different medicinal product comprising the same active ingredient where the limits of the protection conferred by the basic patent do not extend to placing the product the subject of the earlier MA on the market within the meaning of Article 4?
  2. If the grant of the SPC is not precluded, does it follow that in interpreting Article 13(1) of the SPC Regulation, “the first authorisation to place the product on the market in the Community” needs to be an authorisation to place a medicinal product on the market within the limits of the protection conferred by the basic patent within the meaning of Article 4?
  3. Are the answers to the above questions different if the earlier marketing authorisation has been granted for a veterinary medicinal product for a particular indication and the later marketing authorisation has been granted for a medicinal product for human use for a different indication?
  4. Are the answers to the above questions different if the later marketing authorisation required a full application for marketing approval in accordance with Article 8(3) of Directive 2001/83/EC (formerly a full application under Article 4 of Directive 65/65/EEC)?
  5. Are the answers to the above questions different if the product covered by authorisation (A) to place the corresponding medicinal product on the market is within the scope of protection of a different patent which belongs to a different registered proprietor from the SPC applicant?
More on this on the SPC Blog here and here

4 comments:

Peter Smith said...

Why would sheep need treatment for insomnia ... can't they just count one another?

Anonymous said...

So there we have it: the Court of Appeal doesn't count sheep for insomnia cures.

Golden Fleece said...

It's not the fault of the Court of Appeal. I blame the Patent Baaa ...

Michael Factor said...

As my late partner Dr Davis drafted the application and our firm handles Neurim's portfolio internationally it is with trepidation that I contribute this flippant remark, nevertheless I hate anonymous comments, so here goes:

If giving birth to lambs in the spring is a possible side effect that cannot be ignored, one can understand why regulatory approval could take so long...

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