Fine-tuning the SPC Regulation; a never-ending story?

During the past ten years, numerous decisions of the Court of Justice have contributed to the interpretation and application of Supplementary Protection Certificate Regulations  469/2009 and 1610/96   In fact, one of the last rulings of the Court of Justice for 2017 was the  Incyte case (C-492/16, EU:C:2017:995), which concerned the calculation of the term of the Supplementary Protection Certificate (“SPC") and the mandate that national administrative authorities have as to its rectification.

The background to this case can be understood as follows. The calculation of the term of an SPC is based on the date of the first marketing authorisation ("MA"), the question being whether that means the date that the decision of the first marketing authorisation was reached or  the date the decision was communicated to the applicant. In the case of Seattle Genetics (C‑471/14, EU:C:2015:659), given on 6 October 2015, the Court of Justice ruled in favour of the second approach, namely the date the decision was communicated to the applicant. This decision initiated a process of reviewing and revising decisions of national administrative authorities in order to acquire a prolongation of the term of protection.

Incyte applied for an SPC, and the application was granted on the basis of the basic patent (for the pharmaceutical product ‘Jakavi’, used in the treatment of myelofibrosis) the first MA granted on 24th of August, communicated to the applicant on the 28th of August. The   National Intellectual Property Office, Hungary("the Office")  communicated to  Incyte the grant of the  SPC on  7 October 2014,  with  a notice  that an appeal to the administrative decision could be filed to the Fővárosi Törvényszék (Budapest High Court, Hungary)  within 30 days of the communication of the decision.

Following the decision by the Court in  the Seattle Genetics decision, Incyte requested a revision of the administrative decision and asked for the SPC term to expire on the 28th (rather than the 24th) of August 2027. The Office declined such a revision, taking into consideration that the change  was not  due to a clerical mistake or miscalculation and that the deadline for appeal had already expired.

The Budapest High Court, ruling on the case, decided to stay the proceedings and  refer the following questions to the Court of Justice for a preliminary ruling on the following questions:
“(1) Must Article 17(2) of Regulation … No 1610/96 … be interpreted as meaning that “the date of the first [MA] in the [European Union]” is incorrect in an application for a[n] [SPC], within the meaning of that regulation and of Regulation … No 469/2009, where that date was determined without taking account of the Court of Justice’s interpretation of the law in the judgment of 6 October 2015, Seattle Genetics (C‑471/14, EU:C:2015:659), with the result that it is appropriate to rectify the date of expiry of the [SPC] even if the decision to grant that certificate was made prior to that judgment and the time limit for appealing against that decision has already expired?

(2)      Is the industrial property authority of a Member State which is entitled to grant a[n] [SPC] required to rectify, of its own motion, the date of expiry of that [SPC] in order to ensure that that certificate complies with the interpretation of the law set out in the judgment of 6 October 2015, Seattle Genetics (C‑471/14, EU:C:2015:659)?”
The Court concluded that
“As regards its scheme, it is clear from Article 13(1) of Regulation No 469/2009 that the certificate is to take effect for a period equal to the period which elapsed between the date on which the application for a basic patent was lodged and the date of the first MA in the European Union, reduced by a period of five years. It therefore follows from that provision that the duration during which the SPC granted ‘shall take effect’ is wholly determined by the application of the detailed criteria laid down by that provision and the authority responsible for granting the SPC enjoys no degree of discretion in that regard.”
Taking into consideration  that Incyte was the one to initiate proceedings for  rectification of the date of the first MA and thus also of the term of the SPC, the Court chose not to answer  the question whether the administrative authority should  ex officio reopen and review administrative proceedings concerning the term of the SPC.
Some hope in the horizon for a 
harmonized interpretation of the SPC Regulation?

Apart from following on the decision in the Seattle Genetics case, confirming  that questions concerning the term of SPC are not  yet settled, the Incyte case offers  an  interesting insight into how the Court approaches  the balance between legal certainty and legality under EU law. The principle of legal certainty requires a restrictive review of administrative decisions that are no longer subject to appeal, while legality of EU law dictates the need of the administrative authorities to follow and apply the interpretation of EU law even with regard to decisions that were reached  before the specific EU law provision has been interpreted on the relevant point. In the Incyte case, the decision of the Office was not even considered to be a review of the case but rather a rectification of an erroneous date.

The SPC Regulation has not been easy to interpret and apply. The lack of clarity of its legal provisions has given rise to extensive case law, both  at the national and EU levels. It has also given rise to alternative approaches at the level of national implementation, such as in the case at hand. Although the various judicial clarifications  by  the Court of Justice do seem to be bringing  the SPC system closer to  harmonisation, several provisions remain unclear and their national application continues to diverge. The need to provide for a solution  at a Unitary Patent level has become more important than ever.
Fine-tuning the SPC Regulation; a never-ending story? Fine-tuning the SPC Regulation; a never-ending story? Reviewed by Frantzeska Papadopoulou on Sunday, January 28, 2018 Rating: 5

5 comments:

Anonymous said...

Who is responsible for the granting of SPCs for a unitary patent, and under what specific laws is this determined?

Proof of the pudding said...

SPC law is governed by Regulations and therefore ought to already be harmonised. Providing a "unitary" solution is therefore not the answer.

The only way in which a "unitary" solution would increase harmonisation is by decreasing the number of courts that provide opinions on how the Regulations should be interpreted. Whether this is desirable or not will depend upon the quality of the judgements of the "unitary" court. If that quality is anything like that provided by the CJEU (with regard to judgements on SPCs), then this would only make the situation worse.

What would be more welcome is the provision (by the Commission) of a guidance document to "fill in the blanks" with regard to procedure, which is where most instances of divergence are to be found. There is little that can be done about the unpredictable ways in which the Regulations can be interpreted by the courts. This is because that unpredictability has a lot to do with the fact new medicaments (and the manner in which they are authorised) do not always fall into neat categories... which means that regulatory law and practice is always evolving, and not necessarily in predictable ways.

Mr Blobby-Obvious said...

could do with a better comment-approval process so that comments actually get posted an discussions can be had.

Impossible said...

I agree with Proof of the Pudding. We could have had a very certain clear SPC regulation which simply said that the subject matter of any type of invention that can be defined by a medical use claim can be subject to an SPC. That would have meant that use of a new dosage regime for a drug would have got an SPC even there was a previous SPC for the drug. Or the SPC could have said any invention that needs its own separate marketing authorisation can have an SPC. However when the SPC regulation was written the EU was not ready for the philosophy behind SPCs to be so defined, and so it has needed to be done by case law with the constant asking of what SPCs are really meant to be about. One can see how even now writing a comprehensive SPC regulation would be difficult because of the need to decide beforehand what can and cannot be protected in an area where so much money is at stake and parties are very willing to defend or attack SPC rights.

Proof of the pudding said...

I would also add that one only needs to look at what has happened with the Community trade mark Regulation (no. 207/2009) to understand that providing a "unitary" law and a "unitary" court system (EU IPO plus the General Court and then the CJEU) does not necessarily help to remove uncertainty.

For example, a quick check on the CURIA database for references to the (now defunct) Regulation 207/2009 reveals a total of 1,853 cases. That's not bad for a Regulation that was in force for less than 9 years. Indeed, it makes the total number of CJEU cases on SPCs (which, over a period of two and a half decades, average out at less than 2 cases per year) look decidedly puny by comparison.

This suggests that it might be more appropriate to view the SPC Regulations as paragon of clarity and precision ... at least compared to the "norm" for EU Regulations!

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