Telmisartan/HCTZ combination: a French appeal

Here, thanks to our good friend and European patent attorney Edouard Kling ("en collaboration avec august & debouzy avocats"), is an English translation of Boehringer Ingelheim v Actavis, a limitation decision (which you can read or download) issued a couple of months ago by the French Court of Appeal which, though French readers are already aware of it, is ripe for spreading to the rest of the SPC Blog community. Edouard explains:

The decision actually relates to some of the previous posts of the Blog:

* first, because it deals with the basic patent and SPC application for the Telmisartan/HCTZ combination product and 

* secondly because it further illustrates the trend among the French jurisdictions to focus on the technical content of the specification and examples when assessing the subject matter disclosed in pharmaceutical patents.

In line with the previous decision of the High Court of Paris which revoked, for insufficiency of disclosure, the basic claim directed to the Irbesartan/Diuretic combinations in the absence of any related example, the Court of Appeal ruled that Boehringer should not be entitled to limit the subject matter of claim 8 to a combination product comprising both Telmisartan and HCTZ. The underlying reason for this was that, even though the specification explicitly teaches that the benzimidazoles of the invention could be administered in combination with a list of additional active ingredients (among which was HCTZ), such combinations should not be part of invention as the patent fails to study and exemplify the effects of these combination therapies. The Court considered that the teaching of the patent was merely speculative.

The readers will probably remember that a different section of the Court of Appeal of Paris decided last year (on June 8, 2012) to confirm the rejection of the SPC application to the combination product regardless of the pending request for limitation of claim 8. Notably the Court had, at the time, already raised concerns about the “hypothetical” combinations envisaged in the specification. The case is currently pending before the Supreme Court, but will most certainly be impacted by this decision.

The original French version of the decision can be read or downloaded.

Curia Fairies busy last night, posting reasoned orders

Luxembourg night-workers ...

Yesterday the SPC Blog posted that it had been asked by a correspondent if we had a text for another reasoned order of the Court of Justice of the European Union of 14 November, Case C-617/12 AstraZeneca AB v Comptroller-General of Patents. This reasoned order was not accessible via the Curia website.

Good news!  The reasoned order must have been uploaded by the Curia Fairies overnight, since it's now available online here. For the record, the CJEU ruled in that order as follows:

"In the context of the European Economic Area (EEA), Article 13(1) of Regulation ... 469/2009 [on SPCs] must be interpreted as meaning that an administrative authorisation issued for a medicinal product by the Swiss Institute for Medicinal Products (SwissMedic), which is automatically recognised in Liechtenstein, must be regarded as the first authorisation to place that medicinal product on the market within the meaning of that provision in the European Economic Area where that authorisation predates marketing authorisations issued for the same medicinal product, either by the European Medicines Agency (EMA), or by the competent authorities of European Union Member States in accordance with the requirements laid down in Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, and with the requirements of the Republic of Iceland and the Kingdom of Norway. The fact that, on the basis of similar clinical data, the European Medicines Agency, unlike the Swiss authority, refused to grant a marketing authorisation for that medicinal product at the conclusion of its examination of those data, or the fact that the Swiss authorisation to place the product on the market was suspended by the Swiss Institute for Medicinal Products and subsequently reinstated by the latter only when the holder of the authorisation submitted additional data to it are irrelevant".

Further good news is that the reasoned order in Case C-210/13 Glaxosmithkline is now also miraculously available online. A big thank-you to the Curia Fairies for working their magic spells last night ...

The "Special Mechanism": some 'Merck-y' questions for the CJEU

In April The SPC Blog reported on Merck Canada Inc and another v Sigma Pharmaceuticals plc [2013] EWCA Civ 326, a Court of Appeal for England and Wales reference to the Court of Justice of the European Union (CJEU) for preliminary rulings on a number of questions -- not precisely articulated at that time -- on SPCs and the "special mechanism". Case C-539/13 Merck Canada and Merck Sharpe and Dohme.

The UK Intellectual Property Office (IPO) is now seeking your opinion as to how these questions should be answered. Writes the IPO:

"We have received notification of a new case referred to the Court of Justice: C-539/13. This is a request for a preliminary ruling in a case concerning the importation into the UK from Poland of a drug by the defendant. The claimant states that the importation of the drug in question was an infringement of the Claimant companies' rights covered by a Supplementary Protection Certificate.

The filing date of the application for the Patent was prior to the date when Poland introduced patent protection for pharmaceutical products under its laws, and the application date for the SPC was before the date when SPCs could be applied for under the laws of Poland.

The questions referred relate to the Specific Mechanism in Chapter 2 of Annex IV to the Act concerning the conditions of accession of (inter alia) the Republic of Poland".

The questions are somewhat cumbersome on account of their interrelationship:

Conditions for reliance upon the Specific Mechanism

1. May the holder, or his beneficiary, of a patent or supplementary protection certificate rely upon his rights under the first paragraph of the Specific Mechanism only if he has first demonstrated his intention to do so?

2. If the answer to Question 1 is yes:

(a) How must that intention be demonstrated?

(b) Is the holder, or his beneficiary, precluded from relying upon his rights with respect to any import or marketing of the pharmaceutical product in a Member State that occurred prior to the demonstration of his intention to rely upon those rights?

The notifier

3. Who must give the prior notification to the holder or beneficiary of a patent or supplementary protection certificate under the second paragraph of the Specific Mechanism? In particular:

(a) Must the prior notification be given by the person intending to import or market the pharmaceutical product?

or

(b) Where, as permitted by the national regulatory system, an application for regulatory approval is made by someone other than the intended importer, can prior notification given by the applicant for regulatory approval be effective if that person does not itself intend to import or market the pharmaceutical product but where the intended importation and marketing will be carried out under the applicant's regulatory approval?; and

(i) Does it make any difference if the prior notification identifies the person that will import or market the pharmaceutical product?

(ii) Does it make any difference if the prior notification is given and the application for regulatory approval is made by one legal person within a group of companies which form a single economic unit, and the acts of importation and marketing are to be carried out by another legal person within that group under licence from the first legal person, but where the prior notification does not identify the legal person that will import or market the pharmaceutical product?

Who should be notified? 

4. To whom must prior notification be given under the second paragraph of the Specific Mechanism? In particular:

(a) Is the beneficiary of a patent or supplementary protection certificate limited to persons who have a legal right under national law to bring proceedings to enforce that patent or supplementary protection certification?

or

(b) In a case where a group of companies forms a single economic unit comprising a number of legal entities, is it sufficient if the notification is addressed to a legal entity which is the operating subsidiary and marketing authorisation holder in the Member State of importation rather than the entity within the group that has a legal right under national law to bring proceedings to enforce that patent or supplementary protection certificate, on the basis either that such legal entity may be characterised as a beneficiary of the patent or SPC. or that it is to be expected that such notification in the ordinary course of events will to come to the attention of the persons who make decisions on behalf of the patent or SPC holder?

(c) If the answer to Question 4(b) is yes, is a notification which is otherwise compliant rendered non-compliant if it is addressed to the "the Manager, Regulatory Affairs" of a company when that company is not the entity within the group that has a legal right under national law to bring proceedings to enforce that patent or supplementary protection certificate but is the operating subsidiary or marketing authorisation holder in the Member State of importation and when that Regulatory Affairs department in practice regularly receives notifications from parallel importers regarding the Specific Mechanism and other matters?

Adds the IPO (if you're still reading after all this!):

"If you would like to comment on this case please email policy@ipo.gov.uk by 27 November 2013. 

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 ECJ 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".

AstraZeneca: another reasoned order. Can you help?

Following today's earlier post with news of Case C-210/13 Glaxosmithline Biologicals SA, Glaxosmithkline Biologicals, Niederlassung der Smithkline Beecham Pharma GmbH & Co. KG v Comptroller-General of Patents, Designs and Trade Marks, The SPC Blog has been asked by a correspondent if we have a text for what appears to be another reasoned order of the Court of Justice of the European Union that was delivered on the same date in Case C-617/12 AstraZeneca AB v Comptroller-General of Patents. Again, the reasoned order does not appear to be accessible via the Curia website.

If any kind reader has a copy of this reasoned order which he or she is willing to share, do please get in touch!

The end of a dream: reasoned order puts paid to SPC hopes for adjuvants

Back in March, Mr Justice Arnold referred two short, succinct questions to the Court of Justice of the European Union for a preliminary ruling. Just eight months later we now have, in place of the Advocate General's Opinion and CJEU ruling, what the CJEU calls a "reasoned order". The case in question is Case C-210/13 Glaxosmithline Biologicals SA, Glaxosmithkline Biologicals, Niederlassung der Smithkline Beecham Pharma GmbH & Co. KG v Comptroller-General of Patents, Designs and Trade Marks and the questions referred were these:

Is an adjuvant which has no therapeutic effect on its own, but which enhances the therapeutic effect of an antigen when combined with that antigen in a vaccine, an 'active ingredient' within the meaning of Article 1(b) of Regulation 469/2009/EC ?

2. If the answer to question 1 is no, can the combination of such an adjuvant with an antigen nevertheless be regarded as a 'combination of active ingredients' within the meaning of Article 1(b) of Regulation 469/2009/EC?

The answer given in the reasoned order is as follows:

"Article 1(b) ... must be interpreted as meaning that, just as an adjuvant does not fall within the definition of 'active ingredient' within the meaning of that provision, so a combination of two substances, namely an active ingredient having therapeutic effects on its own, and an adjuvant which, while enhancing those therapeutic effects, has no therapeutic effect on its own, does not fall within the definition of 'combination of active ingredients' within the meaning of that provision".

You can read the reasoned order (which is not currently on the Curia website) here or download it here.

Re-revision of patent term extension in Israel

"Revision to the Israel Patent Law Revision Regarding Patent Term Extensions Revised Again" is a short blogpost by Michael Factor (the IP Factor) which you can read here. The blogpost is in English but the proposed amendment to the Israel Patent Law is in Hebrew only, here.

Calculating duration: new UKIPO practice

Further to this weblog's post on some happy news from Mike Snodin (here), the UK Intellectual Property Office has now issued this notice on calculation of the duration of SPCs. The trigger for this is the IPO's recent decision in Genzyme BL O418/13, which you can read in full here.

"Calculation of the duration of a Supplementary Protection Certificate

Issue

1. This Practice Notice outlines a change in practice of the Intellectual Property Office (IPO) as regards the calculation of the duration of a Supplementary Protection Certificate (SPC) where the first authorisation in the Community is one granted by a decision of the European Commission.

Introduction

2. Article 13 of Council Regulation (EC) 469/2009 concerning the creation of a supplementary protection certificate for medicinal products ("the SPC Regulation") sets out how the duration of an SPC may be calculated. Article 13(1) provides that the duration is calculated having regard to the "date of the first authorisation to place the product on the market in the Community", and Article 13(2) provides that the duration of an SPC may not exceed 5 years.

3. In the situation where the earliest authorisation is one granted by a decision of the European Commission following a favourable opinion from the European Medicines Authority, it has been the IPO's practice that the date of the first authorisation in the Community, for the purposes of Article 13(1) of the SPC Regulation, is the date of grant by the European Commission of this European authorisation.

The Practice Change

4. In decision BL O/418/13 (Genzyme Corporation) the hearing officer determined that the duration of the SPC should be rectified (Under Article 17(2) of Regulation (EC) No 1610/96 of the European Parliament and of the Council of 23 July 1996 concerning the creation of a supplementary protection certificate for plant protection products (which recital 17 applies to the SPC regulation) because the date of the first authorisation in the Community, for the purposes of Article 13(1) of the SPC Regulation, should be the date of notification.

5. The date of notification is the date that the applicant for the marketing authorisation is notified of the decision by the European Commission to grant the marketing authorisation and this is the date from which the granted authorisation takes effect. This date is recorded in the Official Journal of the European Union (OJEU). The date of notification is often a few days later than the date of grant of the marketing authorisation. As a consequence, when Article 13(1) is applied the duration of the SPC based on the authorisation date may be correspondingly longer (unless it exceeds the limit of 5 years provided for in Article 13(2)).

6. We will now calculate SPC duration in accordance with this decision. This may also affect the dates, but not the duration, of related paediatric extensions (Under Article 13(3) of the SPC Regulation and Article 36 of Regulation (EC) No 1901/2006).

The Procedure

7. This change will affect applications for SPCs, granted SPCs and paediatric extensions to SPCs.

SPC Applications

8. To amend a SPC application you should:

a. write to the comptroller, for the attention of the examiner, either when a response to an official action comes due, or in a separate letter; and

b. provide the number of the SPC and a copy of the relevant entry in the OJEU which shows the date of notification of the European marketing authorisation entered at item 8 of Form SP1.

9. The IPO will acknowledge receipt and notify you of the amended maximum expiry accordingly.

Granted SPCs

10. To rectify the term of a granted SPC you should:

a. write to the comptroller, for the attention of the examiner; and

b. provide the number of the SPC and a copy of the relevant entry in the OJEU which shows the date of notification of the European marketing authorisation entered at item 8 of Form SP1.

11. The IPO will issue a corrected version of the SPC certificate and extension certificate as necessary; publish the correction in the Patents Journal; and amend the Register entry for the basic patent to reflect the change.

Paediatric Extensions 

12. To amend the dates of an extension you should mention the extension when you write to the IPO about the granted SPC or application.  

13. The IPO will then ensure the necessary steps are taken to amend the dates in line with our practice set out above".

Genzyme translation: problem solved!

Within a very short time of posting this plea for a copy of the English-language version of the Dutch Genzyme decision, a copy miraculously found its way to The SPC Blog, from Kathryn Nicholls (Mewburn & Ellis)) via Edward Oates (Carpmaels & Ransford LLP). Thanks, Kathryn and Ed!

Readers can access the translated judgment here or download it here.

Genzyme: lost (in) translation: can you help?

One of our readers is looking for an “old” decision on SPC/medical devices -- Genzyme Biosurgery Corp v Industrial Property Office, BIE 70 (2002) 360-362 (Netherlands) DC (the Hague); Rechtsbank 's-Gravenhage, AWB 02/1729 OCT.

This decision was originally available on this weblog but the link to a now defunct storage site doesn't work and we've lost the English translation. If any reader by any chance has a copy of that translation, can he or she please let us have sight of it so that we can make it available again.  Thanks in anticipation!

SPC Regulations and transitional regime: a new article

From our friend and reader Dimitar Batalkiev comes the following message. Writes Dimitar:

"I would like to share with the readers of The SPC Blog information of a recently published article on the transitional regime of the SPC regulations in the IIC journal [a learned and respected title published by the Max-Planck-Institute]. It discusses the rationale and structure of the provisions concerning the initial entry into force of Council Regulation 1768/92, the subsequent enlargement of the EU and the conflict with existing national regimes for extended patent protection. The analysis of the Community legislation is carried out in the light of the national law of the Member States and the case-law of the Court of Justice of the European Union.

The article is also available online through this link".

Thanks, Dimitar, for letting us know.  If you are not an IIC subscriber and pursue the link, you can purchase access to this article via Springer.com for $39.95 / €34.95 / £29.95 (though the final gross prices may vary according to local VAT).

SPCs, drug costs, evidence and proof: can you help?

The SPC Blog has received a request for information from David Verbeeten, PhD (Cantab). David, a Research Associate, Health Innovation, Policy and Evaluation, The Conference Board of Canada, Ottawa, wonders whether any of those kind souls who contribute to this weblog are aware of evidence as to the effects of SPCs effects on European drug prices since their implementation in the early 1990s. He also asks:

"Have drug costs gone up as a result of this mechanism? Is there any definitive proof? Are there studies that have looked into this question?"

This blogger isn't immediately aware of such statistics, but he finds it difficult to imagine that an industry sector as closely monitored and regulated as the pharmaceutical sector, and as closely scrutinised by the competition authorities, could have gone from the early 1990s until now without there being quantities of evidence, both from the two sides of industry and from third parties, to which David might profitably be pointed. If you have a handy reference or weblink to any helpful data, please post it as a comment beneath this blog post -- together with any pertinent comments you may have as to their currency, veracity or objectivity.

Georgetown Opinion: now in English too

Yesterday The SPC Blog posted this item on the Opinion of the Advocate General in Case C-484/12 Georgetown University v Octrooicentrum Nederland, acting under the name NL Octrooicentrum.

Unfortunately the Opinion was available on the Curia in a wonderful selection of languages -- but not English.  Now, thanks to Mary Smillie (Rouse), we have an unofficial English translation prepared by her colleagues. You can read it here.

Georgetown: Advocate General Jääskinen advises the CJEU

The Opinion of Advocate General Niilo Jääskinen (right) in the Dutch reference for a preliminary ruling from the Court of Justice of the European Union in Case C-484/12 Georgetown University v Octrooicentrum Nederland, acting under the name NL Octrooicentrum  was posted on the Curia website this morning, but at the time of this blogpost was not yet available in English.

The referring court asked the following five questions:

"Question 1

In the situation that a basic patent in force protects several products, does regulation 469/2009 […], more specifically article 3, preamble and under c thereof, preclude the grant of a certificate for each of the protected products to the holder of the basic patent?

Question 2

If the first question is to be answered in the affirmative, how should article 3, preamble and under c of the Regulation be interpreted in the situation wherein a basic patent in force protects several products and on the date of the application for a certificate for one of the products protected by the basic patent (A), other products protected by the basic patent (B,C) have not already been the subject of a certificate, however, certificates on the applications for those products (B,C) have been granted before the application for a certificate for the first product (A) has been decided on?

Question 3

Is it important, when answering the previous question, whether the application for one of the products protected by the basic patent (A) has been submitted on the same date as the applications for other products (B,C) protected by the same basic patent?

Question 4

If the first question is to be answered in the affirmative, can a certificate be granted for a product protected by the basic patent in force, if another product protected by the basic patent has already been the subject of a certificate, but the holder of the certificate surrenders this last-named certificate with the intention to be granted a new certificate based on the same basic patent?

Question 5

Is it important, when answering the previous question, whether the surrender has retrospective effect, and is the question whether the surrender has retrospective effect determined by article 14, preamble and under b of the Regulation, or is it determined by national law? In the event that the question whether surrender has retrospective effect is determined by article 14, preamble and under b of the Regulation, should that provision be taken to mean that surrender has retrospective effect?""

As for the first question

"7. Given the jurisprudence of the Court and the Advocate General Trstenjak in the cases which gave rise to the judgments in Medeva and Georgetown University and Others, the Court is already sufficient information to respond to said first question. Thus, in this case, it is appropriate to conclude only the second to fifth questions, which are unpublished. In addition, it should be noted that these four questions were asked by the court only if the answer to the first question is yes, which is the premise presented in 1 of these conclusions".

The Advocate General has advised the Court to rule as follows (thanks to Google Translate):

"I propose that the Court reply as follows to the second to fifth questions referred by the Court in 's-Gravenhage (Netherlands)

(1) A waiver of the supplementary protection certificate is governed by Article 14 b) of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for drugs, not by national law. In addition, when such waiver is effective only for the future, it may not subsequently be admitted that, as a result of such waiver, the product in question had never been to a certificate within the meaning of Article 3 c) of that Regulation.

(2) In the event that an applicant has filed several supplementary protection certificate for separate products but covered by the same patent, it is up to him to decide which of these applications is a priority. In the absence of choice, it is up to national authorities to draw the consequences under national law".

Watch this space for comment and analysis, which is bound to be forthcoming.

Canada opts for "SPC-type" protection under CTEU

From our good friend Martijn de Lange at the Netherlands Patent Office comes news from afar. He tells us that there has been an interesting development in Canada, where "SPC-type" protection will be introduced there as a consequence of the CTEU, the recently-concluded free trade agreement between Canada and the European Union. See here for some further information.

The full text of the CTEU does not yet seem to be available, but a bit more information on this pact can be found here.

More on SPCs in Cyprus

On 28 October this blog asked for information concerning the theory and practice of SPC filing in Cyprus. A comment outlining practice was posted beneath this piece by Eleni Chrysostomides and Alexandros Georgiades (Dr. K. Chrysostomides & Co LLC).  The following information, from Despina Morgianni (Assistant Examiner) has now been forwarded to us by martin Paltnoi (MPA Business Services Ltd) 

"When an SPC application is filed at our Office based on a patent which is valid in Cyprus (European or national), a notification of the application is published in Cyprus Official Gazette. The same applies when a certificate is granted.
 Unfortunately, there is not an online searching system for public inspection on patents registries in Cyprus. However, a search can be made locally at our office premises, either by you or by an authorized third person, but the information received will be in Greek language. Please note that inspection is only allowed for Granted patents and SPCs and not for those which are still pending applications".

 Thanks for your responses!

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.