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

Wednesday 13 July 2011

Medeva and Georgetown: AG's Opinion published today

The Curia website has just posted a 124-paragraph Advocate General's Opinion in Joined Cases C‑322/10 Medeva BV v Comptroller-General of Patents, Designs and Trade Marks and C‑422/10 Georgetown University, University of Rochester and Loyola University of Chicago v Comptroller-General of Patents, Designs and Trade Marks, both of which are references from England and Wales. You can read the Opinion in full here.

The SPC Blog plans to post some comments on the Opinion. In the meantime, the Advocate General recommends the Court of Justice to rule as follows:
"A – Questions 1 to 5 of the Court of Appeal (England and Wales) (Civil Division) (Case C-322/10)

(1) The condition for the classification of an active ingredient or combination of active ingredients of a medicinal product as a product within the meaning of Article 3(a) of Regulation ... 469/2009 ...  concerning the supplementary protection certificate for medicinal products is that that active ingredient or combination of active ingredients forms the subject‑matter of a basic patent within the meaning of Article 1(c) of that regulation. Whether an active ingredient or combination of active ingredients of a medicinal product forms the subject‑matter of a basic patent within the meaning of Article 1(c) and whether that active ingredient or combination of active ingredients is protected by a basic patent in force in accordance with the requirement of Article 3(a) are determined, in principle, according to the rules governing the basic patent. However, the definition of the basic patent laid down in Article 1(c) of the regulation precludes use of the protective effect of the basic patent from being invoked as a criterion for the purpose of answering the question whether an active ingredient or combination of active ingredients of a medicinal product forms the subject‑matter of a basic patent.

(2) In the context of the assessment of a supplementary protection certificate application relating to a medicinal product with multiple active ingredients or to a multi‑disease vaccine, there are no further or different criteria for determining whether a product within the meaning of Article 3(a) of Regulation No 469/2009 exists and whether that product is protected by a basic patent in force.

(3) The questions whether a multi‑disease vaccine can be classified as a product within the meaning of Article 3(a) of Regulation No 469/2009 and whether that product is protected by a basic patent in force where only one of its active ingredients or each of its active ingredients against one of the diseases is protected by a basic patent in force must, in principle, be answered according to the rules governing the basic patent. However, the protective effect of the basic patent must not be used as a criterion for the purpose of answering the question whether a product within the meaning of Article 3(a) of the regulation exists.

B – Sixth question of the Court of Appeal (England and Wales) (Civil Division) (Case C-322/10) and sole question of the High Court of Justice of England and Wales Chancery Division (Patents Court) (Case C-422/10)

(4) A valid authorisation to place the product on the market as a medicinal product within the meaning of Article 3(b) of Regulation No 469/2009 exists for a single active ingredient or combination of active ingredients where that active ingredient or combination of active ingredients is contained together with one or more other active ingredients in a medicinal product which was the subject of a valid marketing authorisation granted in accordance with Directive 2001/83/EC or Directive 2001/82/EC".

14 comments:

Anonymous said...

Wow, explosive stuff.
The one SPC per patent rule (par.102) is a real shocker. I don't think the AG realized this as she hardly argues this point. Plenty of antibody SPCs out there based on just a few process patents.

Anonymous said...

I think you can go further than that, Anonymous. The one SPC per patent rule is quite clearly WRONG. She's plucked that out of nowhere: it certainly doesn't come from Biogen as she argues.

The 3(a) question will still be relevant, e.g. to the question of whether a generic claim can be used as the basis for an SPC based on an MA for something more specific. The AG's approach to the 3(a) question (determined "according to the rules governing the basic patent") is going to lead to a mess. If we're to apply the Gilead test in the UK, why can Gilead get their SPC whereas Astellas can not? And what (divergent) approaches are other countries going to take?

Anonymous said...

At least she was sensible enough to ignore the literal wording and go with a teleological approach instead. That's the only sensible way of reading the regulation...

Anonymous said...

I may be missing something here, but doesn't point 4) effectively say that the first marketing authorisation for a combination product is actually the first marketing authorisation of any product containing any of the active ingredients of the combination product? If this is the case, there are a great many SPCs based on the first EU MA date of the combination product (where the single active MA is earlier) which would be invalid.

Peter Norman said...

The one SPC per patent could indeed cause consternation

PDL Biopharma's EP0451216 has been the basis of eight SPCs granted between 1999 and 2009.

The antibodies covered are:-
Daclizumab
palivizumab
Trastuzumab
Bevacizumab
Omalizumab
Natalizumab
ranibizumab

and Certolizumab pegol (but this SPC has been surrended)

Anonymous said...

To Anonymous nr. 2:
With the one SPC per patent rule it is quite obvious that an applicant will want an SPC for the single ingredient and not a combination. Because an SPC for A according to this AG also protects (via art.4&5) A+B, but not vice versa.
So Gilead will settle for Tenofovir and Astellas for emodepside. Whether there are additional claims in the basic patent for the combinations and how such claims should be interpreted according to national law is no longer of any significance.
The only SPCs for combinations will be the ones based on patents for combinations.

Anonymous said...

Not sure I agree with the last post - a later authorisation of a combo may provide an SPC with a longer term than an earlier authorisation of a mono. There will therefore be situations when applicants will want these combo SPCs (even if they are narrower in scope than mono SPCs), particularly if the combo product is worth a lot more money than the mono. Thus, we will still face the same old Gilead/Astellas problems. I guess it will just be slightly less often (assuming, of course, the CJ follows this opinion).

Anonymous said...

I think you're right. I did not realise that.

But if the first authorisation is for the mono you must at that point in time decide not to pursue an SPC for the mono and wait for the combo.
You do not have the luxury to wait for the combo authorization and then decide if you want a mono or a combo SPC, because the combo authorization is the second authorization for the mono.
When you bring your first mono product to the market you may not know if the market for the combo in the future will be that much more profitable.

Anonymous said...

Or maybe you file a divisional application for the possible combo SPC and use the parent patent to get the mono SPC! I guess Queensland's patent family question ties in to that strategy. Does the AG mean one SPC per patent, or one SPC per patent family?

Anonymous said...

This is anonymous number #2 again, replying to the anonymous who posted at 13:53 and 15:54 who thought that "it is quite obvious that an applicant [will only apply for a mono SPC and not a combo]".

You are wrong for the reasons explained by the anonymous who posted at 14:39 and 17:45. Also, there is (under current law - i.e. a world without a "one SPC per patent rule") nothing to stop you from applying for the combo SPC after you've applied for the mono SPC.

Any "one SPC per patent rule" would also cause unfair problems for those bona fide cases where a patent covers two (or more) active ingredients, each of which should be rewarded with an SPC. E.g. a Markush claim which covers two unrelated authorised actives; in such a case it would be wrong to limit the patent holder to one SPC on one of the products alone.

Don't mess with anonymous #2 when it comes to SPCs.

Anonymous said...

Don't get me wrong.
I don't agree with the one SPC per patent rule either. But if the ECJ makes it the law of the land, then it must be obeyed.

Anonymous said...

Well let's hope for the sake of the land that a one SPC per patent rule is not thoughtlessly and unnecessarily introduced by the CJEU.

Anonymous said...

I have struggled in the past with the statement in Biogen that “Under Article 3(c) of the Regulation, however, only one certificate may be granted for each basic patent.”. Perhaps now the Court will clarify whether this statement/interpretation should be taken at face value, as the AG seems to have done. If so, and as others have already indicated, we have been getting it wrong for some considerable time. Out of the frying pan into the fire?

Anonymous said...

Unlike in the US and Japan, EU SPC does not allow a full extension of the patent. One SPC per patent seems fair since an SPC for A protects all medecines including A...