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

Friday, 20 July 2012

A more “fit for purpose” SPC Regulation?

Apart from the various comments posted at the foot of yesterday's blog item on Case C-130/11 Neurim Pharmaceuticals,  The SPC Blog has also received the following observations from Andrew Hutchinson (Associate Solicitor, Simmons & Simmons LLP)
A more “fit for purpose” SPC Regulation?
The CJEU’s judgment has allowed Neurim to obtain an SPC and so in that sense has followed the Court of Appeal (England and Wales) and the Opinion of Advocate General (AG) Trstenjak of 3 May 2012. However, while the CJEU has allowed Neurim’s application to proceed, as is now a common theme in SPC decisions, it seems to have struggled to formulate a legal test that can be applied generally and simply to all cases.

The CJEU has not applied the same test or gone into the detailed reasoning of the AG’s Opinion, which suggested that an earlier authorisation should be ignored if it did not fall within the scope of the protection of the later basic patent. This test required the assessment of the scope of protection of the basic patent in question and a determination of whether any earlier authorisations fell within it. The clear water between Neurim’s patent and the earlier authorisation was not in dispute. However, the CJEU may have been reluctant to apply this test given that finer distinctions may arise and an assessment of the scope of protection of a basic patent could overburden the SPC-granting authorities. The CJEU may have also been concerned about causing conflicts with its own earlier decisions, in particular Pharmacia (case C-31/03) and Yissum (case C-202/05), which the High Court for England and Wales had already assessed and considered, acte clair, to preclude Neurim’s SPC.

While the CJEU has held that the mere existence of an earlier authorisation can no longer be said to be automatically relevant to (and perhaps preclude) a later SPC application for the same product, the CJEU has provided hardly any test at all. As a result, it is not completely clear how similar to Neurim a subsequent case will need to be to benefit from this decision. In this sense, the decision provides for a specific exception to the stricter, literal interpretation of Articles 3(d) and 13(1), as opposed to applying a wider, more general teleological interpretation.

The requirements for benefiting from Neurim are split into two parts, which are closely connected: (1) is your SPC application for an old product with a “different application" and (2) do you have a “new patent” for that different application as your basic patent (paras 25-27). The central question is therefore: what is covered by "a different application"? A second medical use appears to qualify. There is no mention of the need for there to be a different species (as was the case in Neurim) but, as this is not addressed, it may be argued that this is a further limitation. This also leaves open the issues of any non-active components, new formulations, inventive excipients, etc.

Overall, some will seek to limit the scope of this decision while others will seek to extend it, so the circumstances of the case in question will be paramount. Another common theme in SPC decision continues: more referrals are likely.  It remains to be seen whether, as Jacob LJ commented when referring Neurim to the CJEU, cannot yet be ascertained whether allowing Neurim’s SPC will create a more “fit for purpose” SPC Regulation. It may only be a small step in that direction.


Anonymous said...

How can you say that "The CJEU has not applied the same test" when they say in paragraph 30 "the MA referred to in Article 13(1) of the SPC Regulation is the authorisation of a product which is within the limits of the protection conferred by the basic patent relied upon for the purposes of the application for the SPC"?

Anonymous said...

This means for getting SPC, we have to file seperate patents for each indication or combination.
I have one more question: Is divisonal application can consider as diffent patent for getting SPC

Anonymous said...

Surely in the case of non-active components, new formulations and inventive excipients you apply the test of whether the earlier MA is an authorisation of a product within the limits of protection conferred by the basic patent?

Anonymous said...

Para 25 suggests that the decision is not limited to new uses only when in a different species.

Anonymous said...

Re Anonymous 26 July 2012 13:18

You don't have to file multiple patents but what you do have to use is the same MA for each SPC you file under a patent. The SPC for each product or application will all end on the same date which provides market certainty.

Anonymous said...

Am I alone, or is this the most unclear and least satisfactorily reasoned SPC decision yet from the CJEU? How can it not even comment on Yissum and Pharmacia Italia when the fact situations in those cases were so similar? Presumably, they remain good law, and Answer 1 deliberately is restricted to the earlier authorisation being for a veterinary use and one that does not fall within the limits of the protection conferred by the basic patent. But how does that square with the statements made in paras 25 and 26?

If the earlier authorisation is for a different human use, how is that distinguished from Yissum? Surely it is a matter of form over substance that you can take account of the therapeutic use of the product when considering Article 3(d) (Neurim) but not allow it to form part of the definition of the product in general like in an EPC2000 "Product for therapeutic use" claim (as in Yissum).

So how are you now supposed to construe Article 3(c) in the situation where there is an earlier SPC under a different patent to a different use?

And why are Answers 1 and 2 couched in different terms? Surely, the same considerations of what counts as an earlier authorisation should be the same (setting aside territorial considerations) in Article 3 and Article 13?

The CJEU is supposed to provide clarity. Perhaps the real question is whether the CJEU is fit for the purpose of construing the SPC Regulation?

Anonymous said...

I am Sam (Anonymous 26 July 2012 13:18), For instance the single patent which markushly and as compound claims three drugs i.e. rabeprazole, lansoprazole and omeprazole.
All drugs got Marketing authorisation at different time and in such way that each drug are eligible for SPC.
(Priority Date: 10-Dec-2002; International Filing date: 10Dec-2003; patent Granted date: 05-Feb 2009, Rabeprazole MA Date: 10-Feb-2010; lansoprazole MA Date: 10-Feb-2011; omeprazole MA Date: 10-Feb-2012).
Then it is possible that we get three SPC for each said drug which is claimed in same basic patent. (Please provide your valuable suggestion)

Anonymous said...

Anonymous 26 July 2012 15:01 - you are most definitely not alone. The only thing that this decision has made absolutely clear is that the CJEU has guaranteed its SPC-related work flow for the next few years.

Anonymous said...

Er, what planet is Anonymous 6 Aug 16:08 on....?

You say: "Rabeprazole MA Date: 10-Feb-2010; lansoprazole MA Date: 10-Feb-2011".

Not so fast.

Rabeprazole - first MA in the EU -08 May 1998 (UK)

Lansoprazole - first MA in the EU - 11 Dec 1990 (France)

Anonymous said...

Re: Anonymous 7 August 2012 07:38, Sir I am not giving the exact MA date of rabeprazole, lansoprazole or omeprazole. I am giving MA date for an example to understand the case impact of C-130/11 Neurim Pharmaceuticals.


Anonymous said...

Re 7 August 2012 15:14 (Sam).

You would not be the first person who gave incorrect first EU MA dates in order to get an SPC....

Olorin said...

"You would not be the first person who gave incorrect first EU MA dates in order to get an SPC...."

LOL - They've paid their fine now!

"Para 25 suggests that the decision is not limited to new uses only when in a different species."

Yes, but para 26 suggests otherwise - "only the MA of the first medicinal product, comprising the product and authorised for a therapeutic use corresponding to that protected by the patent relied upon for the purposes of the application for the SPC, may be considered to be the first MA of 'that product' as a medicinal product exploiting that new use within the meaning of [...]"

"and authorised for a therapeutic use corresponding to that protected by the patent relied upon" clearly ties together the therapeutic indication in the basic patent and later MA. So if you have two MAs for the same active ingredient for treating the same disease but with different excipients, say, and you have a patent which reads on to only the product protected by the later MA which is the first MA?!