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

Thursday 25 August 2011

Post-Medeva analysis: the dialogue continues

A fortnight ago, Dorothea von Renesse and Norbert Schwenk (König, Syznka, Tilman, von Renesse, Düsseldorf) wrote a thoughtful article (here) in response to The SPC Blog's call for comments on Paul Inman's and Herwig von Morze's comments the previous week on Medeva and the interpretation of EU lawDorothea's and Norbert's article is to be published in the September issue of the Mitteilung der deutschen Patentanwälte.

Herwig con Morze has now kindly produced a detailed response to Dorothea's and Norbert's article, which we reproduce here:
"While I agree with a number of statements in the article written by Dorothea von Renesse and Norbert Schwenk, some statements relating to the abuse of the SPC system must be challenged. In addition, the AG’s Opinion is rather problematic. 
Fundamentally, Article 1(b) of Regulation 469/2009 treats a combination of active ingredients of a medicinal product as a product different from a single active ingredient of a medicinal product (this is a clear difference to the law in the United States). To make it even clearer: the combination A + B is a product different from single active ingredient A or single active ingredient B. Therefore, their fates of supporting an SPC should not be tied to each other, unless special circumstances apply. The AG does not appear to grasp when special circumstances apply requiring tying of SPC eligibility of the active ingredient with that of a combination and when not. In other words, one has to distinguish two scenarios: 
1. The basic patent is limited to active ingredient A, but the first approved product is A + B. According to the AG in Medeva an SPC could issue for the product A. Later on, a second product obtains approval directed to the single active ingredient A. Because previously an SPC already issued for A on the basis of the marketing authorization for A + B, no further SPC can issue for A (Art. 3(c) of the Regulation), but the SPC already issued for A covers also A as single active ingredient (Art. 4 of Regulation 469/2009). Beyond the bar of Art. 3(c), the further extension of A’s exclusivity could result in an abuse of the SPC system, as the duration of its exclusivity could exceed the 15-year maximum term. 
2. The basic patent has two claims, one directed to A, the other one directed to A + B. Assume again, the first approved product is A + B. Here, the SPC does not require any adjustment like in Medeva. The subject of the marketing authorization is identical with the product A + B, the subject of a patent claim. Later on, a second product obtains approval directed to the single active ingredient A. Because A + B is a product different from single active ingredient A, an SPC directed to A can issue. In other words, in this situation the possibility of securing an SPC for A has not been consumed by the earlier marketing authorization for A + B or the earlier SPC directed to A + B. Articles 3(c) and 3(d) do not apply. Because of the clear distinction between a combination of active ingredients and a single active ingredient from this combination pursuant to Art. 1(b), SPCs with different duration may result. A legitimate extension beyond the 15-year exclusivity maximum may result not for a single active ingredient but for the totality of products containing this ingredient in accordance with current practice. This outcome does not amount to an abuse of the SPC system. 
3. This legitimate extension beyond the 15-year term cannot be limited to the situation where the combination of active ingredients is the subject matter of a separate patent in which the combination is specifically claimed, and this combination patent is the basic patent of the SPC request, as argued by Dorothea von Renesse and Norbert Schwenk (No. 17). Otherwise, the existence of an additional basic patent would create a legitimate use of the SPC system, which in the absence of this additional patent would be considered an abuse of the SPC system. Both situations could have the same effect of producing an extension beyond the 15-year exclusivity for the totality of products A and A + B. 
4. In summary, the prevention of abuse of the SPC system has to be tied to a scenario where the facts of Medeva prevail: the product authorized for marketing includes more active ingredients than what is the subject of the patent. The AG failed to recognize the distinction between a set of circumstances akin to Medeva and the more common circumstance where the active ingredients of the approved product coincide with the product claimed in the patent. On a fundamental level the AG did not understand the mandate of Art. 1(b) to distinguish between individual active ingredients and a combination of these individual active ingredients. In sum, you cannot have a second SPC for the same active ingredient (Article 3(c)) but you can have two SPCs for two different products even if the two products have an active ingredient in common but are different with respect to their other active ingredient(s). 
5. The AG’s Opinion would be acceptable to the extent it is directed to the Medeva scenario, albeit the infringement test would have been much cleaner and less tortuous and achieve the same result. However, as the AG ventures outside the boundary conditions of Medeva, her views are rather troublesome for the biochemical and pharmaceutical industry. She appears to sweep a number of previously accepted practices under the “abuse of the SPC system” carpet. Let’s hope that her carpet will not fly at the ECJ".


Anonymous said...

I agree that a distinction should not be drawn on the basis of whether there is a separate patent (point 3 above), particularly as applicants could file parallel patent applications or divisional applications based on the same original invention so that they have one patent for the "single active ingredient SPC" and one for the "combination SPC". The AG is naive about such procedural tricks, which would certainly be worthwhile for a blockbuster drug with follow-on combinations.

Note another reference in this post to "the infringement test" (point 5), but sill no explanation of how this test (if indeed there is only one form of it) works in practice. How does it apply to second medical use claims - how can the "product" (i.e. the active ingredient per se or combination per se, not the complete medicinal product) infringe a use claim? The same goes for pharmaceutical composition claims and other “applications” of the product in the Article 1(c) sense. Perhaps you only need to look for "infringement" of the part of the claim that defines the active ingredient, but not many people would call this a true “infringement test”. And if you only look at part of the claim , then this approach leads to "zero scope" SPCs where the medicinal product does not infringe the patent (because the ignored features of the claims are not present in the medicinal product) – is that what the legislators intended? SPCs for inventions that have nothing to do with the authorised medicinal product? These are complicated issues that supporters of “the infringement test” tend to over-simplify.

Anonymous said...

Re 3: The point about a separate patent, as I understood it, was not simply a formalistic one about the combination being claimed in a separate document.

I believe the implication was that the 'separate patent' was a later one - i.e. that the combination was itself inventive. It's no abuse of the system to obtain a second SPC for this new invention.

That is very different to the scenario where the combination is just the same invention as before, but with some other (known) active thrown in.

Anonymous said...

OK. Then how about a "later application" for the combination that is filed the day before the first application is published but is essentially identical to that application except for saying the active ingredient can be used in a combination? The combination is novel and inventive because the ealier application is not prior art....it is a new invention under the EPC. Is that an abuse?

And of course the AG dodged the bullet of explaining in how much detail the later application would need to define the combination in order to support the SPC. Are Gilead-style claims enough? It's a good job there are later references to mop up these thorny issues - let's hope the CJ takes the opportunity to do this.

Anonymous said...

A more common situation would be a first patent that generically covers the active and a later patent for the specific compound (or a specific formulation etc). The first patent could be used to get an SPC for the active, but could the later patent be used to get an SPC for the combo? We still need an answer to this basic question of how Article 3(a) applies to combos.