Seattle Genetics and the question of dates: the Advocate General opines

Congratulations to JA Kemp for so speedily posting this news item on yesterday's Advocate General's Opinion in the Court of Justice of the European Union (CJEU) SPC reference in Case C-471/14 Seattle Genetics. This was a request for a preliminary ruling from the Oberlandesgericht Wien. According to this note:

Both the term of an SPC and the deadline for applying for an SPC may be set by the date of the first Marketing Authorisation for a product. An issue has arisen since many Marketing Authorisations have two dates associated with them: the date of the Marketing Authorisation itself and the (later) date on which the Marketing Authorisation is notified in the EU’s Official Journal. Practice across Europe has begun to diverge as to which of these dates should be used. The UK Intellectual Property Office, for instance, uses the date of notification, as do the Belgian, Slovenian and Portuguese Patent Offices. In many other EU territories, however, the earlier date of the Marketing Authorisation is used. In practical terms this has resulted in SPCs being granted in EU territories with different terms, albeit only differing by a few days in length.

This issue came before the Oberlandesgericht Wien after Seattle Genetics appealed a decision of the Austrian Patent Office to use the date of Marketing Authorisation to calculate the term of an SPC. Given the divergent practice across the EU territories, and the fact that it was not clear whether Community law or local law should apply, the Oberlandesgericht Wien referred two questions to the CJEU. The questions referred were:

Is the date of the first authorisation to place the product on the market in the Community pursuant to Article 13(1) of Regulation 469/2009 concerning the supplementary protection certificate for medicinal products determined according to Community law or does that provision refer to the date on which the authorisation takes effect under the law of the Member State in question? If the Court’s answer is that the date referred to in Question 1 is determined by Community law, which date must be taken into account — the date of authorisation or the date of notification? The Advocate General (AG) has now issued his preliminary Opinion, answering the first question by confirming that it is Community law which applies. The AG has answered the second question by confirming it is the date of notification which should be used. The AG’s Opinion is therefore in conformity with the approach currently adopted by the UK Intellectual Property Office, and Belgian, Slovenian and Portuguese Patent Offices.

The questions referred by the Oberlandesgericht Wien and the AG’s Opinion deal only with Article 13 of the SPC Regulation, which sets the term of an SPC. It is nonetheless slightly disappointing that the AG did not see fit also to comment upon other Articles in the SPC Regulation which are affected by the date of the first Marketing Authorisation. In particular, Articles 3(d) and 7, which concern the requirement for an SPC to be based on the earliest Marketing Authorisation in an EU member state, and the deadline for applying for an SPC, respectively. However, it seems likely that the same reasoning would apply to those Articles.

The AG’s opinion is not binding on the CJEU, but does set out the key points which will be taken into account by the CJEU when coming to their decision. The CJEU’s final decision is not expected for another 12 months or so.

Seattle "Relevant date" reference: UKIPO seeks comments

Back in October The SPC Blog posted a this item from Daniel J. Wise (Carpmaels & Ransford), "Austria refers Seattle Genetics to CJEU: is "relevant date" for EU or national law?". The UK Intellectual Property Office is now seeking comments on this reference, with a view to advising the UK government as to whether it wishes to make representations in this reference. According to the UKIPO's media release:

CJ case: C-471/14: SEATTLE GENETICS

We have received notification of a new case referred to the Court of Justice of the European Union (CJEU): C-471/14: A request for a preliminary ruling concerning the supplementary protection certificate for medicinal products.

The questions referred to the Court of Justice (CJ) for a preliminary ruling are:

1. Is the date for the first authorisation to place the product on the market, pursuant to Article 13(1) of Regulation 469/2009 concerning the supplementary protection certificate for medicinal products determined according to Community law, or does that provision refer to the date on which the authorisation takes effect in the law of the Member State in question?

2. If the Court determines that the answer is that the date is determined by Community law, is this the date of authorisation or the date of notification?

This case and the questions referred to the Court can also be viewed on our website at:

https://www.gov.uk/government/publications/references-to-the-european-court-of-justice/references-to-the-european-court-of-justice-2014

If you would like to comment on this case please e-mail policy@ipo.gov.uk by 01 December 2014.

The UKIPO provides further information about its solicitation of comments:

We understand how difficult it is to provide detailed comments in the time available. The IPO has tight time limits in which to consider and provide advice to ministers on CJ cases. In order to help us provide the right advice, we just need a short email by the deadline stating whether you think the UK should intervene and some general points about how you think we should answer the questions.

You are welcome to follow this email up with more detailed comments after the deadline, which can be taken into consideration if we have chosen to submit observations or if we decide to attend a hearing.

If you are aware of any references to the Court of Justice that are not currently included on our website, you are also welcome to send us your views. If you choose to do this, please include clear information about the case to help us to identify it.

Further information on intellectual property CJ cases can be found on our website https://www.gov.uk/government/publications/references-to-the-european-court-of-justice. 

Austria refers Seattle Genetics to CJEU: is "relevant date" for EU or national law?

From our friend Daniel J. Wise (Partner, Carpmaels & Ransford LLP ) comes the following information about a development from Austria:

On 15 October 2014 the Oberlandesgericht Österreich referred questions to the CJEU on a preliminary ruling regarding the calculation of the SPC term under Article 13 of the SPC regulation.  The case has been assigned the reference number C-471/14 (Seattle Genetics).    The referral not only asks whether under Community law the authorisation’s notification or the decision date should be used to calculate the SPC term, but crucially first asks whether Community law even applies, or whether instead the relevant date should be determined under national law.  The referred questions are (translated from the original German-language decision):  

1.     Is the date of the first authorisation to place the product on the market in the Community under Article 13(1) of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6th May 2009 concerning the supplementary protection certificate for medicinal products determined under Community law, or does the Regulation refer to the date on which the authorisation takes effect according to the law of the respective member state?      

2.     If the CJEU affirms that the date under question 1 is determined under Community law: which is the relevant date – that of the authorisation or that of the notification?    

The need for a referral in this area has been clear, particularly since the UKIPO’s change of practice a year ago to use the date of notification rather than the date of the decision to calculate the SPC term based on centralised authorisations (BL O/418/13 – GENZYME).  This approach typically results in a few extra days of term, which can be very valuable.  Belgium, Slovenia and most recently Portugal use a similar approach, but other national patent offices have resisted, arguing either that the SPC regulations make it clear that the date of the decision is the relevant date, or that in the absence of a CJEU ruling on the matter there is no need for them to change their practice.   

The referral is based on Austrian SPC application no. SZ 39/2012 (“Brentuximab vedotin or pharmaceutically acceptable salts thereof”).  The applicant (Seattle Genetics) applied for the SPC based on EP 1 545 613 and Takeda’s authorisation EU/1/12/794/001 for Adcetris (Brentuximab vedotin).  The authorisation is dated 25th October 2012, but was notified 5 days later, on 30th October 2012.  In calculating the SPC term, the Austrian patent office used the decision date of the authorisation, but Seattle Genetics argued that the notification date should be used, resulting in 5 additional days of SPC term bringing the SPC’s term to 30th October 2027.  In its reasoning, Seattle Genetics referred to the practice in the UK, Belgium, Slovenia and Portugal, as well as Art. 13 and Recital 9 of the Regulation, and the authorisation itself which states that the authorisation is valid from the date of notification.  The Austrian Oberlandesgericht seems to think that if Community law applies, then the relevant date should be the date of the decision, but if national law applies then in Austria it is likely that the relevant date is the notification date.  

It will be interesting to see what the CJEU says.  It would be short-sighted if the CJEU only answered these questions with reference to Article 13, though.  Whatever the answers, SPC applicants will want to know if the same logic applies to Articles 3(d) and 7 as well ... 

Thanks so much, Daniel, for taking the trouble to share this with us.

Valid MAs, Centralised MAs and the date of notification: extra days up for grabs?

The SPC Blog has received a cheerful note from Mike Snodin (who now heads Pharma & Nutrition at Avidity IP). What brings such good cheer? Mike has been working hard to talk the UK Intellectual Property Office round to his point of view, with some success.  Writes Mike:

By way of a decision issued on 22 October 2013 (BL O/418/13), the hearing officer, Dr Lawrence Cullen, essentially agreed with Mike’s arguments that:

(i)         Article 3(b) of Regulation 469/2009 requires there to be a valid Marketing Authorisation (MA) in force;

(ii)         following the CJEU’s decision in Case C-127/00 (Hässle AB), Article 13(1) must be interpreted as referring to the same type of MA as Article 3(b) (i.e. a valid MA); and

(iii)        for a “centralised” MA (from the European Commission / EMA) the earliest date that the MA becomes valid is the date of notification of the European Commission’s decision to the applicant.

This development follows similar arguments first proposed by Mike in his October 2011 article in SCRIP Regulatory Affairs (as reported here in this blog).

Longer SPC Term

As a result of the decision, longer term should now be available in the UK for those SPCs where:

(a)        the earliest marketing authorisation (MA) in the European Economic Area is a “centralised” MA issued by the European Commission (EC); and

(b)        less than 10 years have elapsed between the filing of the basic patent and the date of the EC’s decision to grant a MA.

The number of SPCs potentially affected is significant.  For example, longer exclusivity could now be available for over 140 human or veterinary medicinal products.  Further, the percentage of SPCs that could benefit from longer term appears to have significantly increased in recent years.  For example, for SPCs filed to date in the UK in 2013, over 40% could gain additional days of term.

For affected SPCs, the additional term that will now be obtainable in the UK is typically in the region of 2 to 4 days.  However, research conducted by Mike has identified numerous examples of SPCs in the UK for which the additional term would be longer than this, even in excess of 1 week (or, in one instance, in excess of 2 weeks).

At least for granted SPCs, positive action by proprietors will be necessary in order for them to benefit from the additional term now available.

Implications for filing deadline

Where the MA for the UK is a “centralised” MA, the deadline mentioned in Article 7(1) should now be interpreted as meaning 6 months from the date of notification of the “centralised” MA.  This (later) deadline ought not to be relied upon outside of the UK unless and until practice of the national patent offices becomes completely harmonised on this point.

Euratom

As an aside, Mike advises that he personally has not given up on trying to persuade patent offices such as the UK IPO to accept further arguments based upon provisions of the Euratom treaty - though such arguments were not accepted on this occasion.  If they had been, they could have provided an additional day of SPC term for almost all UK SPCs where (a) and (b) above are true.

Portugal: the mystery deepens

João Jorge, a patent and trade mark attorney with Raul César Ferreira (RCF), Lisbon, has emailed The SPC Blog in order to "add a little mystery" to the recent publication from Portugal's Patent and Trade Mark Office (PTMO) concerning corrected SPC terms referred to in yesterday's post from Baptista, Monteverde e Associados. This is what he writes:

"In reality, there is nothing "new" about the rules the PTMO have used to calculate the expiry dates of SPCs, and there should have been no surprises but only very few minorachanges.

However, this is not what really happened ...

It is interesting to note that, in that publication from the PTMO, the first two lines concern the "old starting date of the SPC " and the "new starting date of the SPC". It is quite intriguing and challenging to understand how a new formula to calculate an SPC's duration can have the result that all base patents that have SPC applications have reduced their duration by one day: the new starting date is (at least) one day before than the old starting date It is also interesting that this "rule" seems to apply only to patents which are extended by SPCs, while  the expiry date of the other patents remain unchanged. Needless to say, the note posted by the PTMO is silent about this change ...

Taking into account all the data published by the PTMO, we can try to understand the PTMO's arithmetic:

* the expiry date of the patent is taken as 20 years, including the application date, meaning that a patent filed, for example, on January 2, 2000 would expire at 23:59:59 on January 1, 2020;

* the corresponding SPC would be in force from 00:00:00 of January 2, 2020;

* the expiry date was calculated by adding the difference between the Marketing Authorisation date and the application date to the first day the SPC is in force (and not to the last day of the patent) and then deducting five years.

Thus the two mistakes cancel each other out and the new expiry dates are, in general, correct, since the PTMO has reduced the duration of the patents by one day but has extended the duration of the SPC by... one day! This would not have been noticed, had the PTMO published only a list of the old and new expiry dates.

Another quite interesting detail that has been revealed in this new publication is that corrections have been made previously (but not published) in the duration of some SPCs.

The affected SPCs (which in some cases have had their duration extended by years) relate to SPCs where the base patent was a national patent that was applied for before the entry into force of the IP Code of 1995 and granted after that IP Code came into force.

For these patents, the expiry date of the patent is calculated as the later date of (a) the date of application + 20 years (as stated for the first time in the 1995 IP Code) or (b) the date of grant + 15 years (the duration of patents according to the old IP Code of 1940).

This transitional provision of the 1995 IP Code resulted in patents that have more than 20 years of duration. For instance, a patent applied in 1990 and granted in 1999 will be valid until 2014, thus achieving 24 years from application date.

Now, the existence of these patents having a duration of more than 20 years from the application date has given rise to some problems regarding the calculation of the period covered by the base patent and the SPC.  Regulations 469/2009 and 1610/96 and also the old Regulation 1768/92 do not take into consideration for the calculation of the duration of the SPC that in some situations a patent can have a duration of more than 20 years.

In the grant procedure for some of these SPCs, the Portuguese PTMO took into consideration recital (9) of Regulations 469/2009, which states that the holder of both a patent and a certificate should be able to enjoy an overall maximum of 15 years of exclusivity from the time the medicinal product in question first obtains authorisation to be placed on the market in the Community.

That interpretation is exactly what has been corrected prior to the recalculation now published and had resulted in an extension on the duration of the SPCs.

The PTMO seems no longer to take this recital into account and we have now cases where the overall maximum of 15 years of exclusivity is largely exceeded, as is also the total 25 years of protection.

Thanks so much, João, for this explanation -- which is sure to leave many readers even more puzzled than ever before!

Every day counts -- and this is how Portugal counts them

The SPC Blog has just received the following news-flash from Baptista, Monteverde & Associados (BMA) of Lisbon, Portugal:

July 15, 2013 

Correction of the formula to calculate the duration of Supplementary Protection Certificates (SPCs) 

Due to some inaccuracies detected in the formula to calculate the duration of Supplementary Protection Certificates (SPCs), the Portuguese Patent and Trademark Office (INPI) has decided to reevaluate and change the calculation formula. 

Further to an ex officio correction of the formula for calculating the SPC duration made by the INPI, the correction of SPC duration dates was published in the Industrial Property Bulletin on July 8, 2013. 

Pursuant to the provisions of article 13(1) of the Regulation (EC) No. 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the SPC and also the Regulation (EC) No. 1610/96 of the European Parliament and of the Council of 23 July 1996, the INPI established that the formula to calculate the duration of SPC(s) shall obey the following rules:

1 – The period of time between the Marketing Authorization (MA) date and the application date of the basic patent must be calculated in days; 

2 – The period of time between the MA date and the basic patent application date shall take into account leap years, i.e., the actual days of each year;

3 – The duration (in days) obtained in the period of time between the MA date and the basic patent application date shall be added to the expiry date of the basic patent; 

4 – The five-year period to be deducted from the expiry date shall not be deducted from the number of days initially obtained from the difference between the MA and the basic patent application, but from the date resulting from the sum of the duration in days with the expiry date of the patent; 

5 – Once the five-year period is deducted, if the result corresponds to non-existent days, then the effective date is the last day of that month.

These changes shall be applied ex officio by the INPI to new SPC applications, to pending SPC applications and to SPC(s) that have already been granted.

The SPC Blog thanks Baptista, Monteverde & Associados for this information and wonders whether the mode of calculation here corresponds to that employed by other EU Member States. Can readers advise?

Every day counts -- but how do we count them?

“Every day counts: why pharmaceutical companies in the EU need to make sure they get the right SPC term” is the title of an article by Mike Snodin (Potter Clarkson) which has just been published in the October 2011 edition of Scrip Regulatory Affairs. Mike's article addresses the calculation of SPC term (and the deadline for applying for an SPC) in circumstances where the relevant marketing authorisation has been issued by the European Commission (under the centralised procedure).

Mike notes that, when the first marketing authorisation in the EEA for a medicinal product is obtained via the centralised procedure, the standard practice of many patent offices in Europe (including the offices of Germany, France, the UK, Italy, Ireland, Sweden, the Czech Republic and the Netherlands) has been to set the SPC term based on the date that the European Commission decided to issue the centralised authorisation.

In his new article, Mike argues that the standard practice of many patent offices is incorrect, and that the term of SPCs should (where relevant) instead be calculated using the date of notification to the applicant of the European Commission decision to authorise the medicinal product.

The date of notification is typically two to four days later than the date of the Commission's decision. For this reason, Mike argues that a correspondingly longer SPC term should be available where:

(i) a medicinal product is first authorised in the EEA by way of the centralised procedure;(ii) that authorisation represents the first authorisation in the EEA for a "product" that represents the (combination of) active ingredient(s) present in the medicinal product; and(iii) less than 10 years has elapsed between the date of filing of a patent that protects the "product" and the date that the European Commission decided to issue the centralised authorisation.

If Mike's theory is correct, then in these circumstances the duration of the SPC may be a few days (e.g. 2 to 4 days) longer than has previously been thought to be the case. Of course, for successful medicines, even a few extra days' protection will be valuable.

Moreover, Mike points out that Article 17(2) and Recital 17 of Regulation 1610/96 together make it possible for an SPC holder to file an appeal aimed at correcting the term of a granted SPC.  This means that, provided the SPC in question has not expired, it may not be too late for a proprietor to take action to correct the official registers of those patent offices that have incorrectly calculated the term of the SPC.

You can read Mike's article in full here.

"An uncertain equation"

Howrey's IP Intelligence Newsletter Europe, Summer 2009, carries an article, "Calculating an SPC Term: An Uncertain Equation", by Marjan Noor and Claudia Zeri. It sets out the relevant recent case law and its context in a most effective fashion.

Right: when calculating the term of an SPC, be prepared for the occasional surprising result.

Some of the cases discussed can be found in the earlier postings of on the SPC Blog here and here