Mike and Michael acknowledge that, on the face of it, the opinion appears to be good news for the innovative pharmaceutical industry. However, their analysis of the opinion highlights some potentially serious side-effects that may throw the SPC system out of balance in a way that is detrimental to the long-term interests of the industry. In particular, they point to the fact that the solution proposed by the Advocate General would inadvertently sever an important link in the legislation (a link between a high regulatory hurdle and the award of an SPC) and lead to not only inconsistencies with certain statements of principle from the authors of the original legislation but also to a proliferation of SPCs based upon almost any kind of marketing authorisation (and therefore almost any degree of regulatory hurdle).
Mike and Michael therefore question whether, when reaching their judgment later this year, the Court of Justice of the EU may wish to consider alternative "cures" that have fewer side-effects but that still avoid the harsh result for Neurim that is reached through strict application of the prior case law of that court.
You can read Mike and Michael's article in full here.
10 comments:
What happened to the earlier comment disagreeing with this post? Why was it taken down? I fully concur with the views expressed in that comment, that the paper linked is not a fair representation of the purpose of the SPC regulation, as no doubt does the rest of the innovator indusry.
To Anonymous: I deleted the earlier comment on the basis that it was unworthy of this weblog. It consisted of a number of unsupported and unsubstantiated abusive assertions masquerading as a comment but hiding behind the skirt of anonymity.
If you are also the author of the deleted post, and have any objective justification for what you say, I suggest that you do so openly, rather than snipe at respected members of the SPC community who are not ashamed or afraid to say who they are.
This article seems to rather miss the point of the Neurim test. If a new treatment, needing a new MA, is clever enough to get a patent (despite earlier medical uses of the same drug which led to the “first” MA) then the innovator should also get an SPC based on their patent.
Given the difficulties of getting “follow on” patents granted, most of the patents involved will relate to therapies that will require a full MA. In the rare cases where a full MA is not required for the new treatment (which seem to cause the authors of this article so much concern), then the therapy will be particularly clever in order to be both inventive over the prior art and yet not require a full MA.
As far as I can see, SPCs are not designed to be a reward for doing clinical trials but instead they are designed to compensate innovators for the lost sales caused by the delay between filing a patent and getting a MA. Therefore, I see no problems with the Neurim test – maybe the authors of this article would like to suggest a hypothetical scenario to illustrate their concerns?
The 2 x Mikes have a point. If Neurium is right, then we start to see some perverse results.
Let's assume that there is a generic company who develops a generic product and then, after data exclusivity expiry, relies on the data of the branded company (quite rightly so, in the light of the Helsinki declaration). In parallel, that company applies for and gets granted for a patent relating to an aspect of their generic medicinal product (such as new polymorph, new formulation etc). Uner Neurium, that generic company should be entitled to an SPC, no?
If not, why not? All you need is a granted MA and a patent, and then you should be entitled to an SPC.
As for the specific comments of Anonymous at 10.32:
(1) "...If a new treatment, needing a new MA, is clever enough to get a patent (despite earlier medical uses of the same drug which led to the “first” MA) then the innovator should also get an SPC based on their patent...."
As far as the patent offices are concerned, a generic company that files for and is granted a patent on a formulation is as much entitled to a patent as the branded pharma company that files for and is granted a patent on a new NCE / new dosage regime / new polymorph / etc. Surely you would agree therefore that the generic company is entitled to an SPC? The generic company is as much an "innovator" as the "innovator".
(2) "...Given the difficulties of getting “follow on” patents granted, most of the patents involved will relate to therapies that will require a full MA. In the rare cases where a full MA is not required for the new treatment (which seem to cause the authors of this article so much concern), then the therapy will be particularly clever in order to be both inventive over the prior art and yet not require a full MA...."
(a) What's a "full" MA? One for which clinical trials are required? Full, de novo, trials for a new NCE are one thing. But what about hybrid applications (stand up escitalopram, where there was merely a bridging study to link to the old citalopram data), or trials for new dosage regimes (again, which rely heavily on old data)...? If we are going to start distinguishing between MAs, where do we draw the line?
(b) Since when did being "clever" have anything to do with patents. Patents are only granted for novel non-obvious inventions that are sufficiently disclosed. Further, it certainly has nothing to do with data exclusivity. You peform some trials, and then the data is protected - that's it.
RE: the comments at 13:13 - what is "perverse" about a patented product receiving an SPC to compensate its inventors for a delay in getting marketing authorisation?
The "perverse result" suggested by 13:13 seems to be a perfectly sensible result. Wouldn't it be more perverse if an SPC was NOT granted to the "generic" company in 13:13's situation?
So authors think that Neurim should be granted SPC based on the 4th question referrred to court of justice. That seems just, but authors have not persuaded me that AG's views are wrong. in other word, I think questions 1 and 2 referred to court of justice provide better answer and should be used to grant neurim's spc.
Reg 469 should reward any delay irrespective of regulatory burden. I do not follow author's argument that a full marketing application is required for SPC. In contrast, the Explanatory Memorandum states that ALL RESEARCH is intended to be capable of SPC receipt. Reg 469 is intended to reward delays in exploiting patented INNOVATION. Anyways, if regulatory hurdle small then delay is little and SPC would have no term under art. 13.
I think previous poster at 1356 makes good point.
Answering question 4 in the affirmative is one alternative solution that could still lead to Neurim being granted an SPC. However, it is certainly not the only alternative solution that it is possible to envisage.
The reference in the article to a (relatively) high regulatory hurdle is merely an observation on what seems to be an important characteristic of the SPC system as originally described in the Explanatory Memorandum (a characteristic that seems to be reflected in many decisions of the Court of Justice).
Given the opinion held by the AG (and many posting on this blog), it is clearly a debatable point whether a high regulatory hurdle can be viewed as an essential characteristic of the SPC system. I understand why some would want to argue that it is not, but cannot help but wonder whether the long-term interests of the industry would be better served by an alternative solution that avoids the side-effects highlighted in the article.
But, Mike S, Recital 14 of 1610/96 proves conclusively that a high regulatory hurdle is not a prerequisite for an SPC. It tells you explicitly that a salt (of all things!), i.e. something that certainly can be the subject of a generic MA, can get its own separate SPC.
Also, what are these “side effects” or this “unbalancing” that you refer to? I can’t see any. If Neurim enhances SPC availability then so what? Any Neurim-type SPCs will necessarily be sufficiently narrow in scope to avoid evergreening the earlier MA.
So it’s an opinion that’s good for everyone: generics and innovatives. I can’t understand what you don’t like about it.
Anonymous: as far as I am aware, there is nothing in the legislative background to the PPP Regulation that explains why Recital (14) is there. However, the timing of the introduction of that Recital seems to coincide with Farmitalia, and therefore could be viewed as an attempt to ensure that a separately patented salt is always considered to be a different "product" to the active principle (even if it falls within the scope of an earlier SPC to that active principle).
As there do not seem to be any clear flags in the background to the PPP Regulation that signal a fundamental change of principles from those set out in the Explanatory Memorandum of the MP Regulation, is there any reason to view the exception created by Recital (14) of the PPP Regulation as being of direct relevance to anything other than defining a "derivative" that may be encompassed by an earlier SPC but that should nevertheless be considerer to be a separate "product"?
I have no prejudice against the concept of SPCs based upon varied or even generic MAs. However, my concern about the possible effects of the AG's opinion goes back to the careful balance that the legislators tried to introduce into the original SPC legislation. If this balance is changed in such a way as to enable SPCs in situations that seem to be ruled out in the Explanatory Memorandum, what will be the long-term reaction of the legislators (and/or the payors)?
The answer is coming soon according to curia!
Case Language of the case Courtroom
Thursday 19/07/2012
09:30 Judgment
C-130/11
Intellectual propertyNeurim Pharmaceuticals
Court of Justice - Fourth Chamber EN Courtroom III - Level 6
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