Pradaxa in Portugal: IP court trumps Patent Office refusal

A note on Boehringer Ingelheim Pharma GmbH & Co. KG v Instituto Nacional da Propriedade Industrial (Case File No. 300/13.0HYLSB) appears in the most recent BMA Newsflash from the Lisbon, Portugal firm of Baptista, Monteverde & Asociados.  It reads like this:

A decision of the Intellectual Property Court (IP Court) granting a Supplementary Protection Certificate (SPC) on a second medical use, despite the existence of a previous SPC for the same product and the same basic patent, contradicting the practice of the Portuguese Patent Office (PTO), was published in the IP Bulletin.

Boehringer applied for the SPC No. 511 referring to the medicine Pradaxa (dabigatran etexilate in the form of a mesylate) and respecting the basic patent EP1485094, to protect the medical use of dabigatran etexilate for the prevention of cerebrovascular accident (CVA) and systemic embolism in adult patients with non-valvular atrial fibrillation.

The PTO refused SPC 511 by sustaining that it does not comply with the requirements of Article 3(d) of Regulation 469/2009 (SPC Regulation), alleging that this SPC is not associated with the first marketing authorization (MA) for the same product, since a SPC based on the same patent and on the same active ingredient had already been applied for (SPC 490).

Boehringer filed a judicial appeal against the decision of refusal of the PTO claiming that SPC 490 was applied for the use of the active ingredient dabigatran etexilate (as mesylate) for primary prevention of venous thromboembolic events in adults who have undergone an operation to replace the hip or knee, while SPC 511 is intended to protect the use of the same active ingredient for the prevention of cerebrovascular accident (CVA) and systemic embolism in adult patients with non-valvular atrial fibrillation. Consequently, Boehringer concluded that since the therapeutic use is different, it cannot be said that there is more than one SPC for the same basic patent.

The IP Court allowed Boehringer’s appeal and revoked the decision of refusal of the PTO.

In the aforementioned decision, the IP Court quoted the jurisprudence of CJEU, namely Case 130/2011 Neurim [on which see earlier SPC Blog posts here]), according to which "like a patent protecting a ‘product’ or a patent protecting a process by which a ‘product’ is obtained, a patent protecting a new application of a new or known product, such as that at issue in the main proceedings, may, in accordance with Article 2 of the SPC Regulation, enable an SPC to be granted and, in that case, in accordance with Article 5 of the regulation, the SPC confers the same rights as conferred by the basic patent as regards the new use of that product".

Considering the teachings of the CJEU, the IP Court held that since the new therapeutic use of the drug Pradaxa -- prevention of cerebrovascular accident (CVA) and systemic embolism in adult patients with non-valvular atrial fibrillation -- comprises the active ingredient protected by the basic patent of the SPC 511, it should be understood that this therapeutic use is not covered by any previous MA and therefore SPC 511 must be granted.

This decision shows the harmonization of Portuguese jurisprudence with the jurisprudence of the CJEU regarding SPC and shall serve as an important precedent for the PTO to change its practice relating to SPC on second medical uses".

Calculation of dates in Portugal: notification of MA

João Jorge (Raul-Cesar Ferreira) has kindly sent us some hot news from the Portuguese Intellectual Property Court in Case 457/12.7YHLSB, which is being published today although it was reflected even yesterday on the court's online database. This decision concerns the date used to calculate the term of SPC 474.

Takeda Pharmaceutical Company Ltd. filed the application for the SPC on 26/03/2012, having EP 1718641 as the base patent and based on the MA for azilsartan medoxomil -- Edarbi.  The marketing authorization (MA) for Edarbi was granted by Decision C(2011)9280 of 07/12/2011, with publication in the Official Journal of European Union dated 24/02/2012, where the date of notification to the owner is identified has being 09/12/2011, two days after the date of the Decision.

During prosecution, Takeda filed a note with the PTMO with their arguments in favour of using the Notification date (09/12/2011) instead of the Decision date (07/12/2011) for the calculation of the SPC expiry dates. This SPC was granted on 25/09/2012 with the duration being calculated using the Decision date. The Patent Office argument was the following: 

“The purpose of the present Official Communication is to inform that after analyzing the arguments filed on 06/06/2012 related to Supplementary Protection Certificate (SPC) 474, the date of the Marketing Authorization (MA) that is used to calculate the expiry date is, according to Article 13(1) of Regulation 469/2009 of the European Parliament and of the Council of 6 May 2009, the date written in the MA, in this particular case 07/12/2011.”

With this, the expected validity end was 07/12/2026 instead of 09/12/2026.

After publication of the Decision from the PTMO, Takeda appealed from said Decision to the Portuguese Intellectual Property Court requiring that the date to be used in the calculation should be the date of the Notification.

The Court decision was based on the following most relevant reasons: 

“…the relevant date to determine the validity period of the certificate consists of the starting date of the marketing authorisation associated therewith. It is from that date that the medicament can start to be commercialized. This does not occur with the pronunciation of the marketing authorisation decision but with the effective validity of that authorisation”.

It further clarifies:

“It is provided in Article 297 of the Treaty on the Functioning of the European Union, which replaces the Treaty Establishing the European Community, that decisions that are not a legislative act and mentioning a addressee are notified to him/her and producing effects upon that notification.

From this it results that the decision to grant a marketing authorisation only has effect from the notification date, for which reason the common practice is to make reference to it by publication in the Official Journal of the mention of the date of the decision and of the date of notification to its addressee.

It would not be understandable how an administrative act granting the authorisation for the practice of a fact could produce effects before its notification to the addressee and how the addressee could know that he/she may legitimately practise that fact without being aware of that decision”

Thus, this decision confirmed that the date to be considered in the calculation of the duration of a SPC is the date of notification of the decision. Briefly, the Court decided that:

* the decision of grant of a Marketing Authorisation has effect as from its date of Notification, not from the Decision date;

* the administrative act which grants an authorisation could not have effect before its applicant had been notified.

This decision is in agreement with the previous decision BL O/418/13 of the UKIPO [on which see Mike Snodin's earlier contribution on this blog here].

It is still to be seen what will be the understanding of the PTMO of this decision and if it will apply it (to future cases or, even, to previous cases) or if the PTMO will maintain its practice waiting for a referral to the CJEU on this matter.

Earlier news from was posted by João on The SPC Blog here this April.

Portugal adjusts term to match CJEU order

From our friend João Jorge (RCF - Intellectual Property, Lisbon) comes the following information for which we gratefully thank him:

As a consequence of CJEU Decision C-555/13 (that's Merck Canada, noted on The SPC Blog here), the Portuguese PTMO has released on 17 April a Directive from the Board (2/2014), dated 10 April, informing that a verification is to be conducted to ensure that the term for all SPCs complies with the referred decision ensuring that "the 15 years exclusivity defined in that CJEU decision is not exceeded".

In practice this decision will affect about 30 SPCs currently in force, all corresponding to products in the market as SPCs normally do.

This Directive was not unexpected.

However, as PT patent attorneys we are used to seeing in this type of change, the PTMO has already corrected the term in the online database and has sent notifications informing the respective patent attorneys. The effect of the recalculation is that some of the SPCs will have a sudden death, some of them with a new end of validity date that is before the date of entry into force. The others will see a reduction in the duration but still remaining in force.

The Directive has a final note stating that a one month term shall be given to the owners of these affected SPCs that wish to file paediatric extensions but that, due to this recalculation, they would no longer be able to do it. We have to bear in mind that the duration of some of these SPCs was cut by more than two years.

Finally, publication in the Official Journal will be carried out for those SPCs that, with these changes, have already reached the end of their validity. For all the other affected SPCs, no publication is expected to occur.

Just a final note: this publication of end of validity will only happen in 21 April. So, until then what a wonderful grey area for lawyers!"

The SPC Blog also thanks its friends at the Lisbon practice of Baptista, Monteverde & Associados for sending us the link to the same information on the BMA Newsflash, here.

With all this news coming from Portugal, it almost feels as though that lovely country lies right at the heart of Europe and not at its distant Atlantic edge.

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?

Portuguese tribunal rules on Gardasil SPC

Thank you, Alice de Pastors, for letting us know some news from the Far West of the European Union. Today, 21 January, the Portuguese Patent Gazette (at pages 7-17) published the decision of the Tribunal do Commercio de Lisboa relating to the cancellation of Portuguese SPC 260 for Gardasil and Silgard, referring to Merck & Co's patent EP0817851.

Alice has also kindly provided us with this link to the issue of the Patent Gazette in which the decision appears.

Tour of Patent Offices: Portugal

This week the SPC Blog is takes a look at the Portuguese Patent Office.

Similarly to its Spanish counterpart, the Portuguese Patent Office's website is a colourful site. Information is available to the user both in Portuguese as well as in English.

Under the section devoted to patents, there is a subsection on SPCs containing the usual information. The legal basis for SPCs is found in another section. However, the legal basis for plant protection products (EC Regulation 1610/96) is missing from the list...

And last but not least, and in no way related to SPCs but nevertheless interesting, the INPI has made an effort to reach out to young people on IP issues by using comics. Click here for some Portuguese IP-related comics (but then again, how many kids out there still read comics instead of being glued to a virtual entertainment device?)