The questions referred for a preliminary ruling are these:
"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?".Said Advocate General Verica Trstenjak, the questions should be answered as follows:
"(1) Under Article 3(d) of Council Regulation (EEC) No 1768/92 of 18 June 1992 ..., a supplementary protection certificate for a product which is protected by a basic patent in force may be granted only on the basis of the first authorisation which permits that product to be placed on the market as a medicinal product which is within the scope of protection conferred by the basic patent in the Member State for which the application is made. The fact that the same product has previously been authorised as a medicinal product for human use or a veterinary medicinal product in the Member State for which the application is made does not preclude the grant of a supplementary protection certificate based on a later authorisation to place that product on the market as a new medicinal product, provided the first-authorised medicinal product is not within the scope of protection conferred by the patent designated by the applicant as the basic patent.
(2) The first authorisation to place the product on the market in the European Union to which Article 13(1) of Regulation No 1768/92 refers must also be understood as the first authorisation to place a product on the market in the European Union as a medicinal product which is within the scope of protection conferred by the basic patent designated by the applicant.
(3) The answers to the above questions are no different if
The SPC Blog's Rob Stephen hopes to post a comment soon but, in the meantime, readers who wish to post their own thoughts in this advice are, as usual, both welcome and encouraged to do so.– in the Member State for which the application is made, a first authorisation has been granted to place a product on the market as veterinary medicinal product for a particular indication and a second authorisation has been granted to place that product on the market as a medicinal product for human use for a different indication;
– there are two authorisations to place a product on the market as a medicinal product and the later authorisation required a full application under Article 4 of Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products;
– the product covered by an earlier authorisation to place the medicinal product on the market is within the scope of protection of a patent which belongs to a different registered proprietor from the person who applied for a supplementary protection certificate on the basis of a later authorisation to place that product on the market as a new medicinal product and on the basis of a different patent".
22 comments:
Fundamental objective of Regulation No 469/2009 is to ensure sufficient protection to encourage pharmaceutical research and play a decisive role in the continuing improvement in public health.
So animal product for different use doe not reduce much the regulatory review period of the product for human use for different indication. So he should get some benefit.
doesn't that not mean that every 2nd medical use patent, dosage regimen and formulation patent will now be filed on for every single LCM product?
what a complete abuse of the system
just as in Medeva, the same AG demonstrates a monumental and gross misunderstanding of the commercial system and reasoning behind this piece of legislature!
This is a very well-reasoned opinion, and I can only assume that Anonymous at 12:27 has not properly read the opinion.
When a valid patent has been maintained it is only fair that the patent-holder is compensated for any regulatory delay involved in working within the scope of that patent.
We are pleased that the court has the sense to make such pronouncements.
I suspect that the 2 anonymous views above may reflect somewhat different sides of the pharma industry... I hope that both are coming to the SPC blog event, it should be a lively debate on the subject.
This opinion has also got me thinking this evening if it is possible to manipulate the timing and scope of any marketing authorisation applications to manage the overlap between this and the patent scope, and thus optimise SPC duration. I'll be talking with some regulatory contacts tomorrow...
On first reading I agree with anonymous at 12:27, that this opens the floodgates for second tier patents to be eligible for SPCs, such as polymorphs, formulations, method of use etc, but this depends on two things:
1) whether the term Market Authorisation refers to the concept of the 'Global Marketing Authorisation as adopted by the EU to determine data exclusivity pronciples - in this case there are clearly two Global MA's,
2) Whether or not the one SPC per 'product' rule (3c) applies to the particular situation, and how the 'product' is defined. i.e. the recommendation is that it does not preclude, not that it allows the SPC to be granted.
I agree there seems to be a lack of commercial awareness in the AG's recommendations and it is unfortunate that every SPC decision that comes from the CJEU creates more uncertainty and opportunity for disharmony across the Member states.
The regulatory review mainly includes Safety-efficacy data, which includes mainly two studies, Preclinical study and Clinical study.
I) Preclinical study (animal study); mainly contain ED50 and LD50 data. Time required for this study is approximately 2 year.
II) Clinical study (human study); mainly contains Phase I, II and III data. Time required for this study is approximately 5 years.
The present drug is used in veterinary for different purpose, i.e. use in sheep to initiate an early breeding season. And applicant wants to use same drug in human for treatment of deficiency in the plasma melatonin profile. So there is no doubt that, one have to have spent minimum 5 years for Clinical study. But even preclinical data is not that much useful in such cases. One has to regenerate ED50 data. And one has to develop a different animal model for that particular indication and which needs to validate, so preclinical study also required around 1.5 years.
If you compare the human to human indication shift, it does not require that much time and data for regulatory review period (example, Sildenafil).
If you check the Japanese system, then you come to know that they are providing Patent term extension for human to human indication shift; moreover they also provide patent term extension for IR to ER shift. That’s why Japan’s contribution in branded drug is accountable.
Good point, Prashant Navale, that it brings the system into line with Japan. My US colleagues also tell me that Neurim would have got their SPC over there too, so I am glad to see that Europe is raising its incentives in line with those other countries.
I find it surprising and unsatisfactory that the AG has not even mentioned Yissum: either to say that it is wrong or to explain why it does not apply in this case.
For political and/or commercial reasons, the AG and most of the bloggers here seem to argue that if a new market authorization is required to use the subject matter of a further "basic patent", the patentee deserves an extension of the patent's term. However, obviously the SPC-regulation does not provide any basis for such a conclusion.
Actually, the law (Art. 3d) stipulates that "the authorization referred to in point (b) is the first authorization to place the product on the market as a medicinal product". Hence, to refer to another authorization, the "product" must be different or a "new one".
According to the case law, neither the use on humans (vs. veterinary use, ECJ C-31/03) nor a new indication (ECJ C-202/05) renders the product novel and it remains absolutely incomprehensible how the AG came to her conclusion; I do not see anything that is well-reasoned. Possibly, it is just another one of her pointless “one SPC per patent”-statements.
But the CJEU is entitled to do what it wants. If it doesn't feel the need to comment on Yissum (which is harmful law) then it does not have to do so.
Full credit for the AG for finally delivering an opinion which makes commercial sense and from which Europe as a whole will benefit.
Recitals 13 and 14 of the plant regln would be ineffective had the AG come to any other conclusiIons that are existing in reality. It's a perfectly sensible and thought-through opinion.
The court is right to have avoided going into detail on Yissum because Yissum dealt only with a specific point - on the meaning of product - which is different from the points in the Neurim reference.
The Advocate General seems to argue that if the patentee has to go through a complete authorisation process (e.g., including major clinical trials) before he can profit from his patented invention, he deserves an SPC. I do not see where (in the law) such an independent authorisation is defined as the point of origin for granting an SPC and if an independent and complete authorisation is regarded as pivotal, I wonder why SPCs are granted for simple combinations of known agents, the authorisations of which are regularly based solely on the two mono-authorisations with only some minor in-vitro studies.
If we leave the political desires out of the discussion and stick to the written law and the pertinent case law, I do not see any possible line of argumentation that could allow for granting an SPC in the present case. In particular, point (1) of the reasoning of the Advocate General clearly contradicts Pharmacia Italia and point (2) is diametric to the Yissum. At least, this time we did not have to read anything like “one SPC per authorisation”.
Speaking as an executive at a research-orientated pharma company, I have to say that this is a very solid and justifiable AG opinion. Without rewards for discovering new uses of old actives, people like us simply will not do the research. It's as simple as that.
The concerns about the perceived lack of SPC protection for such research have worried me and my colleagues, so the AG's statements are a welcome relief to us.
The AG perfectly mirrors the commercial reality that such research needs rewarding through the SPC system. The readers who claim that the AG opinion does not reflect commercial reality could not be more wrong:- they are clearly posting with a vested interest and are not concerned with encouraging valuable research.
Having finally (!) read the opinion, I think the answer to the anonymous poster at 4 May 18:23 & 5 May 20:16 is that none of the earlier cases looked at the meaning of 'authorisation', for example Yissum looked at 'product'. Consequentially there appears to me to be a big difference in Neurim over the earlier cases.
The AG's Neurim opinion is based not just on the presence of a new MA but also the presence of a patent which is so narrow in scope that it does not cover the first MA. It makes perfect sense that delays in implementing such innovations should be rewarded. A surprisingly sound conclusion was reached by the AG I say. More of the same please!
I could just about live with this opinion if it specifically distinguished between veterinary and human uses. Although as 18:23 & 20:16 excellently point out, there is clearly no basis for this in either the Regulation or the case law, it would at least address the concerns of those bloggers who identify the differing safety/efficacy data required (and time/money associated thereto) for medicines intended for either animal or human use. Unfortunately, the opinion is clearly not so focussed and when read detached from the facts of the Neurim case, it contradicts some of the fundamental principles set out in the Regulation (and discussed above). In addition, maybe I have missed something but how can Article 2 be completely overlooked in this case?
Legislative basis for the AG's conclusion can be identified in recital 14 of the plant SPC regulation.
I don't understand why the poster at 7 May 2012 08:34 thinks that Article 2 is relevant. The sheep authorisation was from 2001...
Whilst the result for Neurim seems to be fair, if the ECJ follows the AG, this decision will be highly detrimental to legal certainty in the field of SPCs. I want to avoid hyperbole, so I will simply say that the decision is wrong on a number of grounds.
Most SPC cases which reach the ECJ are difficult cases which fall within grey areas. The Neurim case was not a difficult case; the conditions of Article 3(d) of the Regulation were clearly not satisfied by Neurim's application. From a policy perspective, there is a good argument in favour of amending the regulation so that authorisations for animal and human uses are treated separately under the Regulation, but as the Regulation stands, the definition of 'medicinal product' requires that they are viewed together.
The AG first goes wrong in paragraph 34, where he relies on the fact that a product may be covered by several different patents as the basis for finding "It must therefore be assumed that, in principle, Article 3(a) permits the grant of more than one supplementary protection certificate for a product." This certainly does not follow. Article 3(c) expressly states that it is a condition for granting an SPC that "the product has not already been the subject of a certificate". A Regulation of general applicability could not reasonably get any clearer than this, yet the AG has used a so-called 'teleological approach' to ignore the clear wording of the Regulation.
The same mistake has been made in paragraph 35 of the AG's opinion.
Re: para 36, my recollection of these cases is that they do not say exactly what the AG says they do - I will have to check though, and I may need to eat my hat. As I read the Regulation, however, there is no basis for limiting Art 3(c) in the way the AG has done - it is not even a question of interpretation; neither the operative parts of the Regulation nor the recitals contain such a limitation.
It seems that the purpose of the arguments relating to Art 3(c) (which is not relevant to the facts of Neurim) was to then apply the erroneous limitation of Art 3(c) to Art 3(d) by analogy, i.e. to say that the only relevant authorisations for the purpose of Art 3(d) are those falling within the protection of the basic patent. This is in no way supported by the Regulation, and the AG has created entirely new law, which is also unsupported by any previous cases.
Well done to Neurim's patent attorneys/lawyers!
"When a valid patent has been maintained it is only fair that the patent-holder is compensated for any regulatory delay involved in working within the scope of that patent" said Anonymous at 3 May 2012 13:29
However there are several patents for natural hormon Melatonin and there is not basic patent. And the delay in this case is due probably of establishment of some medicine effect. Melatonin is indicated as monotherapy for the short-term treatment of primary insomnia characterised by poor quality of sleep in patients who are aged 55 or over. Obviously the youngish patients are synthesizing the hormone without using anyone patent or anyone eforts of patent-holder.
Melatonin was employed in several human volunteer studies and clinical trials. These included studies designed to examine its possible value in the treatment of jet lag, psychiatric disorders, cancer and Parkinsonism.
Is it means that SPC will be granted for everyone new patent formulation of Melatonin and for everyone medicine indication that obtained marketing authorisation?
I personally feel that, we are discussing here SPC regarding Animal to Human indication shift, and not Patentability. And also that Neurim is just an example which will decide the path and direction.
I return from my travels to find the most sensible AG opinion I have ever read. I think the ECJ are at long last starting to understand what the SPC system is about, dare I say it.
This opinion is CLEARLY in line with the purpose of the regn, as even the most negative readers must admit. I have been reading the comments above and have not heard a single good reason justifying why the AG is wrong.
I also cannot really see what the fuss above is about. The opinion isn't really that significant because art 3(2) of the plant regn still prohibits more than one SPC/company for a given active ingredient. So, if the ECJ does the right thing and follows the AG, courtesy of Article 3(2), it would not be opening the floodgates. Let's hope the ECJ follows the opinion.
I was in attendance at the very informative SPC blog event where this case was discussed. In various conversations, I was not surprised to hear that there is great support for this decision (not withstanding the negative comments above). Good luck Neurim!
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