Resolution not barred from challenge to escitalopram SPC by earlier Arrow action

Resolution Chemicals Ltd v H. Lundbeck A/S [2013] EWCA Civ 924 is not so much about SPCs themselves as about who may challenge their validity. In this Court of Appeal decision, the ruling of the Patents Court, England and Wales, was upheld. That was a decision by Mr Justice Arnold that Resolution was entitled to attack the validity of the patent upon which Lundbeck's escitalopram SPC was based -- even though Resolution was part of the same group of companies as Arrow Generics Ltd, which unsuccessfully challenged the same patent back in 2005. Resolution had not taken an active part in the 2005 litigation and, at that time, had given up its attempts to develop its own generic version of the drug at the time those proceedings took place. Accordingly, Resolution was not estopped by the doctrine of privity of interest from bringing a challenge to the same patent several years later.

Our 2013 Seminar: at last, the PowerPoints!

At last, The SPC Blog is delighted to announce that the PowerPoints from this month's seminar are now available for all to enjoy. They may be accessed as a PDF document here or in PowerPoint format here. We hope that you will find them useful and instructive and take this opportunity to thank all of the seminar participants once again for their time and effort.

Several people who attended the seminar have emailed to ask about CPD points. The seminar accrues 2 CPD hours and its SRA Reference is 096/SOLS.

Too late, Tulane: appeal dismissed

Tulane Education Fund v Comptroller General of Patents [2013] EWCA Civ 890 is a ruling delivered yesterday by the Court of Appeal for England and Wales. The court had a somewhat unfamiliar line-up, featuring one specialist IP judge in Lord Justice Kitchin, plus Sir Terence Etherton -- Chancellor of the High Court -- and Lord Justice Underhill. The name Underhill is better associated with hobbits and with a football stadium with a notoriously sloping pitch from which North London team Barnet FC was ignominiously driven, than with anything to do with patent-related appeals.

This was an appeal against the decision of Roger Wyand QC (sitting as a Deputy High Court judge) in July 2011 (noted on The SPC Blog here) to uphold the rejection by the Intellectual Property Office (IPO) hearing officer of Tulane's application to reinstate its supplementary protection certificate (SPC), following its failure to pay the prescribed fees in time.

In short, the basic patent upon which the SPC application relied expired on 10 July 2008, the SPC being due to come into effect the next day. Tulane instructed Dennemeyer & Co to pay the SPC fees within the period for making payment which was prescribed under the Patents Act 1977, but this did not happen. Dennemeyer did try to pay the fee immediately following the prescribed period, using the electronic renewal system for patents, at the same time as it made payments for over 3,000 other patent renewals. Unfortunately, the system attempted to read the SPC number as if it was a patent number; since the number was not recognised as a valid patent number, the payment was rejected. Dennemeyer was confused by the reference in the rejection report to a patent number which it did not recognise, and took no further action. The error was only realised after the period for late payment of the prescribed fee had expired, which meant that the SPC lapsed on the date of expiry of the basic patent.

At this point, Tulane then applied to the IPO for (i) a correction of an irregularity under the Patents Rules 2007 r.107 or (ii) reinstatement of the SPC under s.20A of the Patents Act or (iii) restoration of the SPC under s.28 of the same Act. However, both the hearing officer and Roger Wyand QC concluded that Tulane had failed to pay the prescribed fee in due time and that accordingly the SPC, although properly applied for and granted, never came into effect.

On appeal, Tulane submitted that the judge fell into error in failing to find that the fee regime in sch.4A para.5 of the Patents (Compulsory Licensing and Supplementary Protection Certificates) Regulations 2007 (SI 2007 No 3293) was ultra vires, since Regulation 1768/92 art.13 contained a mandatory requirement that the SPC would take effect at the end of the lawful term of the basic patent, which was not contingent on any fee being paid. Tulane further argued that the judge should not have found that the reference to the 1992 Regulation in s.128B could be construed as a reference to Regulation 469/2009.

The Court of Appeal dismissed Tulane's appeal.  According to the Court:

• An SPC could be granted quite some time before it was due to take effect and the maximum term of each SPC would vary, subject to the requirement that the duration of the certificate could not exceed five years from the date on which it took effect. The Patents (Fees) Rules 2007 r.6 provided that the fee increased as the number of years for which the SPC was to have effect increased, and that an applicant was not required to take an SPC for the whole permitted period, but could do so for a shorter time and then only pay a fee in respect of those years for which he had elected.
• The requirement imposed by r.116 of the 2007 Rules, that the fee had to be paid before the SPC could take effect, did not mean that the fee ceased to be an annual fee. Nor did the fee cease to be an annual fee because the Rules imposed an obligation to pay it all at once. The Rules were not in conflict with art.13. So long as the fee was paid within the prescribed period, the SPC would automatically take effect on the day after the expiry of the basic patent.
• Section 128B explicitly defined the SPCs to which it applied as including certificates issued under the 1992 Regulation. It was thus beyond doubt that Tulane's SPC was granted under the 1992 Regulation and was therefore an SPC to which s.128B applied. Section 128B had not been repealed or amended.
• Tulane's SPC remained an SPC granted under the 1992 Regulation; the mere fact that the 1992 Regulation had been repealed could not change its status as an SPC granted under the 1992 Regulation. For that reason, the only provisions of the 1977 Act which applied to it were those set out in sch.4A (para.61).

EU trumps Member States over TRIPS

Case C‑414/11, Daiichi Sankyo Co. Ltd, Sanofi-Aventis Deutschland GmbH v DEMO Anonimos Viomikhaniki kai Emporiki Etairia Farmakon, a reference to the Court of Justice of the European Union from the Greek Polimeles Protodikio Athinon, resulted in a ruling last week.

While this case does involve an SPC (for levofloxacin hemihydrate, marketed as Tavanic), the reference was not so much about SPCs as about the relationship of EU law and the law of EU Member States to the Agreement on Trade-Related Intellectual Property Rights (TRIPS). The CJEU concluded that TRIPS does not have retrospective effect in EU Member States and that it falls within the exclusive competence of the EU and not the Member States.

To get a swift summary of the decision, you can speed-read through the Curia press release here.

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?

Transcripts of SPC decisions: can you help?

We hope that this will not be the case
for those documents we can no longer access!

Over the past few years, this weblog has hosted, and the SPC Blog: Resources weblog has stored, a fair number of SPC decisions under national law. Some of these are texts in the original language of the judgment; others are English translations.

These cases were uploaded on to the hosting facility of Google Groups.  Unfortunately, a couple of years ago Google announced that the document hosting facility of Google Groups would be withdrawn.  When it was withdrawn, the stored SPC cases were lost and the links to them from The SPC Blog and the Resources blog no longer worked.

We now have the resources to work all the way through both blogs so that we can identify every broken link and the case or translation to which that link should lead.  We shall be hosting the documents afresh -- but we need those documents before we can do this.

Can you please help us? If you still have the original PDF of any case or translation that you sent us, can you please re-send it so that we can carry our the restoration work more speedily?  Just send them to me at jjip@btinternet.com with the subject line 'SPC Cases' and I'll get back to you as soon as I can.

Thank you in anticipation!