"1. Does Article 3(c) of the Regulation preclude, in a situation where there is a basic patent in force which protects several products, the holder of the basic patent from being granted a certificate for each of the protected products?If you would like to comment on this case and advise the UK government whether it should make any representations, please email firstname.lastname@example.org by the agreeably generous deadline of 10 January 2013 -- a welcome change from the three or four days within which one usually needs to respond.
2. If so, how should Article 3(C) be interpreted in the situation where there is one basic patent in force which protects several products, and where, at the date of the application for a certificate in respect of one of the products (A) protected by the basic patent, no certificates had in fact yet been granted in respect of other products (B, C) protected by the same basic patent, but where certificates were nevertheless granted in respect of those applications in respect of the products (B, C) before a decision was made with regard to the application for a certificate in respect of the first-mentioned product (A)?
3. Is it significant for the answer to the second question whether the application in respect of one of the products (A) protected by the basic patent was submitted on the same date as the applications in respect of other products (B, C) protected by the same basic patent?
4. If the answer to question one is in the affirmative, may a certificate be granted for a product protected by a basic patent which is in force if a certificate had already been granted earlier for another product protected by the same basic patent, but where the applicant surrenders the latter certificate with a view to obtaining a new certificate on the basis of the same basic patent?
5. If the issue of whether the surrender has retroactive effect is relevant for the purpose of answering question four, is the question of whether surrender has retroactive effect governed by Article 14(b) of the Regulation or by national law? If it is governed by Article 14(b), should that provision be interpreted to mean that surrender does have retroactive effect?".
A niche blog dedicated to the issues that arise when supplementary protection certificates (SPCs) extend patents beyond their normal life -- and to the respective positions of patent owners, investors, competitors and consumers. The blog also addresses wider issues that may be of interest or use to those involved in the extension of patent rights. You can email The SPC Blog here
Thursday, 20 December 2012
In brief, Pfizer applied for and was granted a paediatric extension for Atorvastatin (Lipitor). Dr Reddy's challenged the grant of the paediatric extension on three grounds:
(1) The European Medicines Agency (EMA) acted ultra vires it powers under the Paediatric Regulation by approving a paediatric investigation plan (PIP) that let Pfizer to defer completion of the third of its three required studies. The circumstances in which studies in a PIP may be started but not finished are expressly defined by the Regulation and must be covered by a deferral under Article 20. No such deferral was applied for by Pfizer or granted in this case. Accordingly, the PIP was not lawfully approved under the Paediatric Regulation and Pfizer was therefore not entitled to the extension.
(2) Under Article 45(3), a paediatric extension should be granted only when significant studies contained in the PIP have been completed. Here, none of the relevant bodies made an assessment as to whether either of the two studies which had been completed was significant; and, on the facts, they were clearly not significant.
(3) Even if, contrary to ground (1), it was legitimate for the EMA to approve a PIP that required the initiation but not the completion of the third study, under Article 36 Pfizer was not entitled to a paediatric extension unless it included, within its application for a marketing authorisation, the results of the completed third study.The learned judge dismissed all three challenges, describing the third as "misconceived", and declined to follow what seems almost standard practice these days when he decided that there was no need to make a reference to the Court of Justice of the European Union relating to the second ground.
The decision is quite long -- some 76 paragraphs -- and would have benefited from being just a little bit longer, if Roth J had added a short paragraph at the end which summarised what he actually decided.
Friday, 14 December 2012
Thursday, 13 December 2012
I am trying to track down the decision that leads to the reference C-493/12 [on which see The SPC Blog post here] but cannot find it on BAILII or Curia. I have emailed the UKIPO policy unit but have had no reply. Are you able to put out a request on the blog for the decision or order for reference?
I understand from another source that it is a Patents Court decision dated 24 October 2012. I would have thought that those involved in it are assiduous blog readers and might be happy to share the information (which should be in the public domain, surely).
One further thought. Why doesn’t the CJEU put the reference from the national court onto the relevant part of Curia? All it says in the relevant bit of C-493/12 is:
Source of the question referred for a preliminary ruling High Court of Justice (Chancery Division) - United Kingdom
The main focus of the appeal was not specifically related to the law or practice with regard to SPCs, but rather to whether the trial judge had taken the correct approach to the question of inventive step. An analysis of the Court of Appeal's reasoning on this point has been written for the IPKat weblog by David Brophy (FR Kelly), here.
Tuesday, 11 December 2012
The questions posed of the Luxembourg tribunal have at least some familiarity to them:
" (1) What are the criteria for deciding whether the product is protected by a basic patent in force in Article 3(a) of Regulation 469/2009/EC;If you would like to comment on this case, please email email@example.com by 17 December 2012. This may interfere with your end-of-year
(2) Are the criteria different where the product is not a combination product, and if so, what are the criteria?
(3) In the case of a claim to an antibody or a class of antibodies, is it sufficient that the antibody or antibodies are defined in terms of their binding characteristics to a target protein, or is it necessary to provide a structural definition for the antibody or antibodies, and if so, how much?".
Thursday, 6 December 2012
|AZ: probably feeling|
a bit blue today ...
The decision, in Case C-457/10 P AstraZeneca v Commission, is neatly summarised in the Curia press release here.
Lawyers for Bristows LLP, who have been keeping a watchful eye on this case on behalf of their clients, have been quick to comment. Said Marie Manley, head of Bristows’ Pharmaceutical Regulatory team:
“The Commission will be delighted with the endorsement to its approach; innovative pharma less so. The pharmaceutical industry is now subject to a set of onerous but not fully clear obligations. Ensuring compliance will require pharmaceutical companies to build in more checks and balances to their internal procedures. Strategic corporate decisions when a product is close to patent expiry should be particularly carefully scrutinised”Pat Treacy, head of Bristows’ competition team, added:
"The effects of this judgment resonate beyond the pharmaceutical sector. Companies which may be dominant now have an obligation to conduct themselves transparently when dealing with the public authorities. AstraZeneca has been penalised for making arguments that favoured its position when the issue was legally unclear. The Commission, in a position which has been endorsed by the courts, believes that AstraZeneca should have made the uncertainty about the legal position clear to the patent authority. This has wide implications for the way dominant companies conduct themselves".
Friday, 30 November 2012
|Luxembourg: home to the Court of Justice|
and place where AGs sometimes get it right ...
"Verica is is the AG who caused all the confusion over “one SPC per patent” and “subject matter of the invention” in Medeva. If she is off the scene, then perhaps these ideas will have fewer supporters in the referrals on these points in Actavis v Sanofi, Lilly v HGS etc. Credit where credit is due, though - she got Neurim absolutely right!"
The SPC Blog has been closely watching developments in Australia, where a serious no-holds-barred review of pharmaceutical patent protection, taking in patent term extension is in full swing.
This blogger received this email this morning:
Recently, the Pharmaceutical Patents Review Panel released a Background and Suggested Issues Paper in regard to patent extension of term provisions. We are aware that your blog has contained posts relating to pharmaceutical patents in the past and thought you may be interested in the issues under review and the views posted on the Pharmaceutical Patents Review blog.At present the Pharmaceutical Patents Review blog has just two items posted on it, but it may be a good idea to watch it closely and see what sort of responses are posted -- and from whom.
The Pharmaceutical Patents Review blog can be accessed at the below link:
Pharmaceutical Patents Review Secretariat IP Australia
Thursday, 22 November 2012
The Background and Special Issues paper is 72 pages long; patent term extension is dealt with on pages 4 to 14.Pharmaceutical Patents Review Panel releases Issues Paper
The Pharmaceutical Patents Review Panel has released an Issues Paper, inviting the public to make submissions by 21 January 2013. The Panel conducting the review will submit a final report to Government in April 2013.
The review will evaluate whether the system for pharmaceutical patents is effectively balancing the objectives of securing timely access to competitively priced pharmaceuticals, while fostering innovation and supporting research. In particular, the extension of term provisions will be reviewed.
The public are also invited to contribute to the review by commenting on the review's blog. The Review Panel will be posting topics and papers on the blog for further discussion during the review.
See the Background and Suggested Issues paper.
This blogger is not certain how inclusively the word "public" is understood within the context of the review, but suspects that its intention is to encourage a wide range of responses rather than merely those from the various sectors of the pharma industry.
The SPC Blog thanks Anna Feros (Shepherd and Wedderburn LLP) for the link.
Monday, 12 November 2012
The reference is now Case C-443/12 and the two questions posed are confirmed as being as follows:
"1. What are the criteria for deciding whether "the product is protected by a basic patent in force" in Article 3(a) of Regulation 469/2009/EC ("the Regulation")?If you would like to send a comment to the UK Intellectual Property Office on this case, which might result in the UK making representations to the court, please email firstname.lastname@example.org by 16 November 2012.
2. In a situation in which multiple products are protected by a basic patent in force, does the Regulation, and in particular Article 3(c), preclude the proprietor of the patent being issued a certificate for each of the products protected?"
Sunday, 11 November 2012
"Only very recently, the Italian Parliament had abolished a provision contained in the Italian IP Code and corresponding to a form of patent linkage. This provision indicated that an application for a generic marketing authorization could be filed only within the last year of life of the patent or SPC protecting the originator product, also taking into account any paediatric extension filed with respect to the SPC. The abolition of this provision followed from an infringement procedure started by the EU Commission against Italy.
Now, on 8 November 2012, the Italian Parliament has passed a law entitled "Urgent measures for promoting the development of the [Italian] State by way of a higher level of health protection". Among other things, this law provides that the Italian Regulatory Authority (Agenzia Italiana del Farmaco, AIFA) shall carry out an extraordinary review of the national list of authorized pharmaceutical products, so as to more clearly identify any therapeutically obsolete medicinal products.
When carrying out such extraordinary revision, and on the occasion of any subsequent revision of the national list of authorized pharmaceutical products, Art. 11(1) of the new law provides that [per Micaela's English translation]:
"the medicinal products which are equivalent, according to the law, to medicinal products whose patent or SPCs is yet to expire/about to expire [translator's note: the Italian terms of the law are not clear on this point!] cannot be classified as reimbursed by the Italian national health service prior to the patent or SPC expiry date published by the Ministry of Economic Development [translator's note: this is the Ministry encompassing the Italian PTO] according to the provisions of law."
The new law therefore does not appear to introduce a patent linkage regarding when a generic marketing authorization should be filed or when it should be granted; nevertheless, the language of Art. 11(1) appears to introduce a patent linkage regarding when a generic product can be reimbursed by the national health service.
While the law was under discussion at the Italian Parliament, the Italian Antitrust Authority had sent a formal communication to the Parliament proposing that the provision of Art. 11(1) be abolished given that, in the Authority's own words, such provision "introduces ... a clear form of 'patent linkage'". Despite this comment by the Authority, the provision was maintained and is still part of the new law.
The full text of the new law as published in the Italian OJ of November 8, 2012 can be found here.
Art. 11(1) of the new law should be read and assessed also in the context of Art. 14 of the current version of the Proposal for a Directive of the European Parliament and of the Council relating to the transparency of measures regulating the prices of medicinal products for human use and their inclusion in the scope of public health insurance systems, which can be found here.
Interestingly enough, Art. 14 is entitled "Non interference of intellectual property rights...". It will be watching carefully to see how Art. 11(1) of the new Italian law will be reconciled with the text of Art. 14 of this draft directive.
Surely this will not be the last we hear regarding Italy and patent linkage!"
Sunday, 28 October 2012
On 12 October 2012 the District court of The Hague referred questions relating to Article 3(c) of the SPC Regulation to the CJEU in proceedings between the Dutch patent office and Georgetown University.
Georgetown was the proprietor of a basic patent which protected four active substances, which are indicated as HPV6, HPV11, HPV16 and HPV18 and had been granted a marketing authorisation for the combination of these substances. Based on the above mentioned marketing authorisation and patent, Georgetown had applied -in 2007- for an SPC for each of HPV6, HPV11, HPV16 and HPV18 individually. The application for HPV 16 had been refused by the Dutch Patent Office; the other applications were still pending. Georgetown subsequently appealed to the District Court.
The Patent Office stated that the application (for a certificate for HPV16) should be refused based on article 3 under c, because two certificates had already been granted based on the same basic patent, namely one for the combination of HPV16 and 18, and one for the combination of HPV6, 11, 16 and 18.
One certificate per patent?
The court considered that in paragraphs 40 and 41 of the Medeva case (C-322/10), the Court of Justice, of its own accord, had explicitly stated in the context of article 3 under c:
"in a situation such as in the main proceedings (…) where the patent protects a product, in accordance with article 3(c) of Regulation No 469/2009, only one certificate may be granted for that basic patent (see Biogen, paragraph 28)."Strictly speaking, this could be read as a "one certificate per patent" rule. However, the court does not consider this an 'acte clair'. It remarks that, if the rule should be interpreted as prescribing only one certificate per basic patent, a patentee could simply circumvent this by applying simultaneously for several patents each protecting one single product, instead of protecting several products in one patent. The patent holder would thus still be able to receive SPCs for each product.
In addition, the Court wonders, if only one SPC per patent could be granted, how to deal with the situation that several applications are pending simultaneously, and one application is decided on before the other applications.
Surrender of the earlier certificate
Another issue in this case related to the surrender of SPCs. Georgetown stated that it was willing to surrender its SPCs for the combination of HPV16 and 18, and for the combination of HPV6, 11, 16 and 18, if that would mean that it would be able to obtain an SPC for HPV 16. Georgetown argued that surrendering a certificate has retrospective effect and that, therefore, after the surrender, the SPCs should be deemed to never have been granted, and the SPC for HPV 16 applied for would be the first certificate for the product.
The Court considers that article 14 of the Regulation provides the right to surrender but does not mention retrospective effect. In addition, the Court states that it appears that the definition of the term 'surrenders' must be considered to be a matter of Community law.
Furthermore, the text of article 3 (c) of the Regulation does not clearly imply that a surrendered certificate would or would preclude a new certificate for the product being granted.
The court then refers five questions to the Court of Justice, the informal translation of which is as follows:
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?
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? (emphasis added)
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?
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?
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?"
Wednesday, 24 October 2012
Of particular note in the Court of Appeal's judgment, which makes substantial reference to European Patent Law (EPO) case law and Guidelines, are the following:
• As to the novelty of the product claims, in the light of the EPO decisions in T297/87 (Hoechst) and T1048/92 (Pfizer), the generic manufacturers had failed to show that the prior art (including the earlier patent on the racemate) unambiguously disclosed the specific configuration of the claimed S-enantiomer in the form of a technical teaching. Since no document cited would let the skilled person obtain the enantiomers of citalopram in an individualised form, the product claims on the S-enantiomer (i.e. the product escitalopram) were novel.The full text of the judgment, all 128 pages of it, has now been rendered into English and can be read here.
• As for inventive step, after restating the general principles of the EPO's problem-solution approach, the Court referred, inter alia, to the teaching in T595/90 (Kawasaki Steel) that an otherwise obvious entity may become non-obvious (and thus claimable as such) if there is no known way in the art to make this entity and the patent is the first to achieve this in an inventive manner. The Court then examined whether the process set out in the patent was indeed the first and an inventive method to prepare escitalopram.
This blogpost is based on a note by Steven Cattoor that was first posted on the EPLAW Patent Blog here.
Tuesday, 23 October 2012
AstraZeneca: SPCs, marketing authorisations and Directive 2001/83 -- what's the safest bet?
The latest decision of the Patents Court for England and Wales refers another series of questions (three in total) on SPCs to the CJEU: AstraZeneca AB v Comptroller-General. This time the Court is revisiting the position where a "first authorisation" may be deemed to be a Swiss MA by virtue of its automatic recognition in Liechtenstein, following the CJEU's decision in Novartis (Cases C-207/03 and C-252/03).
It is important to note that the facts occurred before the introduction of the negative-list in Liechtenstein in 2006, which sought to prevent the automatic recognition of Swiss authorisations in Lichtenstein, but that is not to say the case is not relevant to products with SPCs where the first authorisation was in Switzerland and the negative-list was used.
In this case, AZ obtained a Swiss MA for gefitinib in March 2004 (when every Swiss MA was automatically recognised in Liechtenstein), which was suspended in October 2005 and not reinstated until December 2010. By December 2010, AZ had (in June 2009) obtained an MA via the centralised procedure and claimed that this should be the "first authorisation" from which to calculate its SPC term. To achieve this outcome, AZ argued that Novartis should be overturned or confined to its own facts.
Arnold J agreed that the law was not acte clair and referred two questions to the CJEU (which both AZ and the UK's Intellectual Property Office agreed were necessary):
1. Is a Swiss marketing authorisation not granted pursuant to the administrative authorisation procedure laid down in Directive 2001/83, but automatically recognised by Liechtenstein, capable of constituting the ‘first authorisation to place the product on the market’ for the purposes of Article 13(1) of Regulation 469/2009?Arnold J's third question deals with the consequences of the Swiss authorisation not counting as the "first authorisation" for the purposes of calculating duration (i.e. a 'no' to the first question) because it is deemed not to be compliant with Directive 2001/83:
2. Does it make a difference to the answer to the first question if:
(a) the set of clinical data upon which the Swiss authority granted the marketing authorisation was considered by the European Medicines Agency as not satisfying the conditions for the grant of a marketing authorisation pursuant to Regulation 726/2004 and/or
(b) the Swiss marketing authorisation was suspended after grant and was only reinstated following the submission of additional data?
The Court also addressed the more fundamental issue raised by the CJEU in Merz v Synthon and Generics v Synaptech (Joined Cases C-195/09 and C-427/09), whereby products authorised not in accordance with Directive 2001/83 were deemed outside the scope of the SPC regime altogether under Article 2.
3. If Article 13(1) of Regulation 469/2009 refers solely to marketing authorisations granted pursuant to the administrative authorisation procedure laid down in Directive 2001/83, does the fact that a medicinal product was first placed on the market within the EEA pursuant to a Swiss marketing authorisation automatically recognised in Liechtenstein which was not granted pursuant to Directive 2001/83 render that product ineligible for the grant of a supplementary protection certificate pursuant to Article 2 of Regulation 469/2009?Arnold J offers his thoughts on the answers to both issues. He considers that the earlier Swiss/Liechtenstein MA should be the "first authorisation" for the purposes of Article 13 because the factual scenarios set out in question 2 do not provide a cogent basis for distinguishing Novartis. However, Arnold J considers that, if the Liechtenstein MA does not count as the first authorisation because it is not Directive 2001/83-compliant, for the same reasons the product should fall outside the scope of the SPC regime and not be entitled to an SPC at all as it would have been placed on the market in Europe before the grant of a Directive 2001/83 complaint MA (i.e. following Merz and Generics).
If the CJEU's answer does not maintain the Novartis position as proposed by Arnold J, then the impact of a knock on affirmative answer to Q3 (following Merz) would be significant. SPCs granted before the negative-list would be vulnerable to revocation. Since 2006, although the negative-list procedure in Liechtenstein has provided a mechanism for companies to delay the automatic recognition of MAs between Switzerland and Liechtenstein, this procedure will need to be carefully assessed and managed pending CJEU clarification on this issue. At the very least companies will need to ensure their products remain on the negative-list pending a Directive 2001/83-compliant authorisation. The safest bet would be to ensure that the Swiss MA is delayed until after a Directive 2001/83-compliant European authorisation but this may not be commercially desirable or practical.
Monday, 22 October 2012
Apologies to everyone who has been inconvenienced. My only excuse is that I was not sufficiently awake to the perils of late-night blogging!
Sunday, 21 October 2012
Friday, 19 October 2012
|Small country with a|
long name -- and not
significance for SPCs
The first and second questions (at ) are:
""1. Is a Swiss marketing authorisation, not granted pursuant to the administrative authorisation procedure laid down in Directive 2001/83/EC, but automatically recognised by Liechtenstein, capable of constituting the 'first authorisation to place the product on the market' for the purposes of Article 13(1) of Regulation 469/2009/EC?
2. Does it make a difference to the answer to the first question if:
(a) the set of clinical data upon which the Swiss authority granted the marketing authorisation was considered by the European Medicines Agency as not satisfying the conditions for the grant of a marketing authorisation pursuant to Regulation 726/2004/EC; and/or
(b) the Swiss marketing authorisation was suspended after grant and was only reinstated following the submission of additional data?".The third question (at ) is:
"If Article 13(1) of Regulation 469/2009 refers solely to marketing authorisations granted pursuant to the administrative authorisation procedure laid down in Directive 2001/83/EC, does the fact that a medicinal product was first placed on the market within the EEA pursuant to a Swiss marketing authorisation automatically recognised in Liechtenstein which was not granted pursuant to Directive 2001/83/EC render that product ineligible for the grant of a supplementary protection certificate pursuant to Article 2 of Regulation 469/2009?"In his judgment, Arnold J explains both the context within which these questions are being asked and the reasoning behind them.
Wednesday, 17 October 2012
"GOVERNMENT LAUNCHES REVIEW OF PHARMACEUTICAL PATENTS
The Australian Government is taking practical steps to ensure that the patent system is delivering effective outcomes for consumers and industry with the appointment of an expert panel to review pharmaceutical patents. The Panel will seek public comment before submitting a final report to Government in April 2013.
The Australian Government is taking practical steps to ensure access to affordable medicines, while fostering innovation and research, with the appointment of an expert panel to review the appropriateness of the extension of term arrangements for pharmaceutical patents.
The review panel announced today by the Parliamentary Secretary for Industry and Innovation, Mark Dreyfus, comprises:
Mr Tony Harris, former NSW Auditor-General and Parliamentary Budget Officer, as Chair;
Professor Dianne Nicol, Associate Dean, Research, of the University of Tasmania; and
Readers' comments are welcome, as usual. A cynic might suggest that, in global terms, Australia can easily scrap SPCs without fear that "fostering innovation and supporting research" will be harmed since the Australian market is a relatively small one and no serious pharma company is going to shut up shop just because it stops giving SPCs, for at least as long as plenty of other countries with lucrative domestic markets continue to offer patent term extension. Come to think of it, Australia might want to contemplate abolishing its patent system in its entirety for much the same reason ...Dr Nicholas Gruen, CEO of Lateral Economics.The review will evaluate whether the system for pharmaceutical patents is effectively balancing the objectives of securing timely access to competitively priced pharmaceuticals, while fostering innovation and supporting research. In particular, the extension of term provisions will be reviewed.
Currently under the Patents Act 1990, patents for pharmaceuticals may be extended by up to five years beyond the standard 20 year term. The extension of term provision was introduced in 1998 and is due for review.
The Panel's final report is due to be provided to the Government in early 2013. A public consultation process will form part of the review.
We will provide secretariat and research support to the review.
For more information, contact Sean Applegate on (02) 6283 2207".
Here's some data concerning the Australian pharmaceutical sector.
Monday, 15 October 2012
|Arc de Triomphe: who|
will eventually triumph in
the Combination SPC War?
"On 3 October 2012 the presiding judge of the tribunal de grande instance de Paris issued a preliminary injunction against Teva Santé. This is a French development of the European litigation concerning Sanofi’s combination SPC irbesartan/HCTZ covering its flagship drug for the treatment of hypertension marketed under the brand CoAprovel which gave rise, inter alia, to the following decisions:
The order handed down on 3 October 2012 by the presiding judge of the tribunal de grande instance de Paris enjoins Teva Santé from marketing in France a generic irbesartan/ hydrochlorothiazide (HCTZ).
- UK - Actavis v Sanofi (ECJ referral)
- NL - Sanofi / Pharmachemie & Teva – Irbetasan & HCTZ (preliminary injunction against Pharmachemie and Teva)
- DE – Sanofi / Actavis Landgericht Düsseldorf 15 August 2012 (preliminary injunction against Actavis)
Sanofi’s French SPC No. 99 C0001 on the combination of the two active ingredients irbesartan, an angiotensin II receptor antagonist, and hydrochlorothiazide, a diuretic, is based on claim 20 of European patent No. 0 454 511 protecting the combination of irbesartan and “a diuretic”. Teva challenged the standing to sue of the plaintiffs (Sanofi itself, but also Sanofi Pharma Bristol Myers Squibb and Sanofi Aventis France which market in France CoAprovel): the judge dismissed this challenge. Teva also disputed the validity of the basic patent, European patent No. 0 454 511, for insufficiency and obviousness: having noted that it was somewhat surprising that such a challenge occurs only after the expiration of a successful patent, the judge examined these criticisms in greater details but held that she did not see any serious attack on this ground.
The main attack was based on article 3(a) of Regulation 469/2009 and the Medeva holding that an SPC can only be granted for active ingredients which are “specified in the wording of the claims of the basic patent”. Teva argued that Medeva required that “hydrochlorothiazide” be mentioned in the claim as such, the mere mention of a “diuretic” being insufficient. Teva further argued that Sanofi’s SPC was invalid on the basis of articles 3(c) and 3(d) of Regulation 469/2009.
The judge considered that none of the arguments put forward by Teva cast a serious doubt on its validity.
About article (a) she considered that Medeva was not applicable because HCTZ was sufficiently identified in the wording of claim 20 by the word “diuretic”:
“HCTZ, which indisputably belongs to a therapeutic class of active ingredients, namely the diuretics family, could easily be identified at the time of the priority date of the patent, as was seen concerning the dispute relating to insufficiency; it is not obvious that the SPC is not valid.
It cannot be inferred from Medeva, as the defendant does, that for a combination of active ingredients to be protected by an SPC, the basic claim must refer to all the active ingredients of the product.”
The judge further considered that the referral to the ECJ in parallel UK proceedings, concerning Actavis’ invalidity action of the UK corresponding SPC, by Arnold J on 20 September 2012, about articles 3(a) and 3(c) of Regulation 469/2009 did not preclude the grant of the requested preliminary injunction in France.
She adopted a different view from that of earlier French decisions of 10 August 2012 which dismissed Sanofi’s request for a preliminary injunction against Mylan, Sandoz and Arrow Génériques because the validity of the SPC was “questionable”; in those previous cases, another French judge had considered that, with regard to article 3(a) and Medeva, the word “diuretic” in claim 20 of Sanofi’s patent No. 0 454 511 on the combination of irbesartan and a diuretic was not precise enough to cover HCTZ; appeals against these decisions are pending.
The French decision of 3 October 2012 is in line with the decisions of the Landgericht Düsseldorf of 15 and 17 August 2012 which granted Sanofi preliminary injunction respectively against Actavis and Hexal, and the decision of the district court of The Hague of 14 September 2012 which granted similar relief against Teva.
Thanks, Pierre and Isabelle, both for providing all of the above and for letting us have the original German and English translation of the judgment handed down on 15 August 2012 by the Landgericht Düsseldorf which are referred to above.
Saturday, 6 October 2012
Further to the recent posts (here and here) regarding the decision of the Patents Court for England and Wales in Actavis v Sanofi  EWHC 2545 , the Dutch decision in the somewhat similar Sanofi v Teva case rendered on 14 September 2012 (cited by the Patents Court in its own decision) gives a rather different perspective on the interpretation of the SPC Regulation post-Medeva.Where the Patents Court for England and Wales felt (again) that questions should be referred to the Court of Justice before establishing the validity of the SPC, the Dutch Court considered that it was in a position to decide (provisionally) on this issue and actually prohibited Teva from launching a generic version of Sanofi's product. To this end the interim relief judge held in the Dutch case that:(i) The one-SPC-per-patent rule should be interpreted to read "one-SPC-per-product-per-patent"; and(ii) The Medeva test "specified in the wording of the claims of the basic patent relied on" should in practice boil down to determining whether the combination product is part of the subject matter of the patent.This different approach (and outcome) can in some respects be explained by the difference of the facts and nature of these cases.Sanofi's patent, SPCs and MAs
Sanofi has two SPCs, one for irbesartan (the mono SPC) and another for irbesartan in combination with HCTZ (the combination SPC). The SPCs were based on separate Marketing Authorisations (MA) for the mono product and the combination product respectively. Both SPCs were based on (different claims of) the same patent. The mono SPC expired in August 2012, but the combination SPC is valid until October 2012. The combination SPC is based on claim 7 of the patent which claims irbesartan in combination with a diureticum. HCTZ is not mentioned explicitly as an example of a diureticum, neither in the claim nor in the description.Differences Dutch case and the England and Wales case
The case in England and Wales was brought forward by Actavis on 26 June 2012. Actavis apparently wanted to clear to road before entering the market and Patents Court to declare the SPC invalid; Sanofi was the defendant in that case. The Patents Court felt that there were reasons to refer questions to the Court of Justice --- and that the nature of the case allowed for that.In the Dutch case, however, there was no time for referrals. This case was a response by Sanofi to Teva's actions. Teva was preparing a launch at risk on 1 September 2012 (i.e. before the expiry of the SPC for the combination product). To this end, Teva's combination product was listed in the Dutch "G-standard" on 21 August 2012. In the Netherlands, a product needs to be announced on this list about two weeks before it can be marketed.Sanofi - as could be assumed - did not appreciate this move (enlisting on the G-standard is considered 'offering' and thus an infringing action in the Netherlands) and filed an action with the District Court of The Hague requesting preliminary relief with a writ of summons dated 23 August 2012. On 3 September 2012 the Court already granted Sanofi's initial preliminary relief claim: Teva was ordered to refrain from offering the generic version for the duration of the actual preliminary relief proceedings.Subsequently, the case was continued and resulted in the decision dated 14 September 2012. Teva argued as a defence that the SPC should be held invalid. Besides incompliance with Article 3(c), Teva also argued that Sanofi's combination SPC was invalid because of incompliance with Article 3(a) SPC Regulation because the product is not protected by the basic patent.One SPC per patent?
In the Dutch decision the interim relief judge provisionally ruled that the one-SPC-per-patent rule should be interpreted to read "one-SPC-per-product-per-patent" Teva's reference to a consideration in the Medeva ruling that "only one certificate may be granted for that basic patent" should not be read as meaning that only one SPC per patent could be granted. If the Court of Justice had meant to deviate from its earlier case-law which was widely interpreted to mean one-SPC-per-product-per patent, it would have done so explicitly, according to the judge. The preliminary relief judge also stated that, given Teva's announced launch at risk, there was no time for a referral and that the administrative court of the Hague had proposed to refer questions regarding thereto to the Court of Justice, so this question will already be dealt with by that court.Specified in the wording of the claims?
In the same judgment, the judge applied Medeva and Georgetown, interpreting "specified in the wording of the claims of the basic patent relied on" in a broader way than was done before.
The interim Judge considered that, on the basis of the Dutch Court of Appeal's decision in Lundbeck/generieken, it should be determined whether the combination product was part of the subject matter of the patent. To determine what the subject matter was, she interpreted the claims taking into account not only the description and the drawings, but the general knowledge of the man skilled in the art at the priority date. Sanofi submitted several publications proving that, at the time of the priority, the man skilled in the art would immediately think of HCTZ when reading "a diureticum". This reading was not contested by Teva. . The judge therefore provisionally considered the product specified/identified sufficiently in the wording of the claims of the patent, the requirement of 3(a) met and the SPC validThus, even though one of the active ingredients of the combination product for which an MA was obtained was not mentioned in the patent at all, the preliminary relief judge held that the SPC for the combination product was valid. This is different from the Lundbeck case where the active ingredient of the combination product was in fact mentioned in the (description of the) patent.Where the Patents Court referred to the Dutch Court of Appeal decision in Lundbeck/ generieken to point out the difference with Sanofi , the Dutch preliminary relief judge actually used Lundbeck/ Generieken to support her interpretation of the Medeva test,In Lundbeck/generieken (The Hague Court of Appeal 24 January 2012) the product of the MA was not mentioned literally in the wording of the claim. Claimed were escitalopram and certain salts thereof. The specific salt covered by the MA, escitalopramoxalaat, was mentioned in the description only. The Court of Appeal considered that escitalopramoxalaat "was obviously part of the subject matter of the patent" and was sufficiently 'specified or identified in the wording of the claims" for the SPC to be valid.The judge's 'new' interpretation of the Medeva test in Sanofi v Teva is interesting and it remains to be seen how this will proceed.
Saturday, 29 September 2012
I believe a distinction must be made between the treatment of novel and inventive products (for example two distinct antibodies or active ingredients) and a combination product where the invention solely resides in one active ingredient, e.g., irbesartan, which is combined with HCT or a diuretic in general. In the first case. In the first case it should be possible to secure SPCs for each active ingredient. It is a pity that the question before the CJEU lumps the two types of "products" together. In case of a non-inventive combination, it could be said that you are only dealing with one product (for example, irbesartan), whether it is irbesartan alone or in combination with a diuretic.Do readers agree with this sentiment? It presumably isn't too late to amend the questions which are being referred to the Court of Justice for a preliminary ruling but which, so far as one can tell from the Curia website, have not yet been received by the Court.
Sunday, 23 September 2012
The first question for reference relates to Article 3(a) of the SPC Regulation, which states that an SPC shall be granted in respect of a patent when, on the date of the application for it, "the product is protected by a basic patent in force". Arnold J's first question to the CJEU, at , is this:
"What are the criteria for deciding whether 'the product is protected by a basic patent in force' in Article 3(a) of the Regulation?"The second question is found at , where Arnold J states:
"It appears ... that the Dutch Patent Office has adopted the opposite interpretation of [the CJEU's ruling in Case C-322] Medeva to that adopted by the UK Intellectual Property Office, namely that it prohibits the grant of more than one SPC per patent regardless of the number of products claimed in the basic patent. In Case AWB 10/4769 Georgetown University v Octrooicentrum Nederland (11 July 2012), which is a parallel case to the Georgetown case in this country, the Rechtbank 'S-Gravenhage (Judge van Walderveen) held that the correct interpretation of Article 3(c) was unclear and decided to refer a question to the CJEU provisionally worded as follows:
"Does [the Regulation], more specifically Article 3(c), in the situation in which multiple products are protected by (the claims) of a basic patent, preclude the proprietor of the basic patent being issued a certificate for each of the products protected?" ...
Friday, 7 September 2012
reported he decision of the Italian Antitrust Authority in the latanoprost case. In that decision, the Authority found that Pfizer abused its dominant position as a result of a combination of activities including filing a divisional, validating it only in a part of the designated states, filing an SPC and a paediatric extension based on it and Pfizer's involvement in related litigation in Italy.
Pfizer filed an appeal against this decision. On 3 September 2012 the Italian administrative court competent for this appeal issued its decision on Pfizer's appeal. The appeal decision is very interesting because, while the Italian Antitrust Authority had held that Pfizer's behaviour represented an abuse of dominant position, the Italian administrative court has now decided that this finding is entirely incorrect. In particular, the most noteworthy points of the administrative court decision are -- as regards the issue of abuse of dominant position -- that:
* Pfizer's divisional does not amount to an abusively excluding activity, since it was filed several years before the anticipated market entry of generic companies (i.e. not simultaneously with it),
* the filing of Pfizer's divisional does not amount to an abusively excluding activity just because it took place when Pfizer realized the more limited protection conferred by the parent patent,
* contrary to what happened in the AstraZeneca case, Pfizer did not provide the EPO with elusive information when pursuing its divisional,
* Pfizer's litigation activity was not an abusively excluding activity, given that in most of the relevant litigation Pfizer was actually the defendant rather than the plaintiff,
* Pfizer's warning letters sent prior to the litigation were not an abusively excluding activity, given that they were sent on the basis of Pfizer objectively having obtained an SPC for Italy;
For those readers who are actually Italian or read Italian, the original decision is here. Micaela and Anna Maria are seeing what they can do to get us all an English translation. Thanks!* the Antitrust Authority finding is altogether flawed as it appears to be based on the fact that, at the time of the Authority's decision, the divisional patent had been revoked by the EPO Opposition Division, while ignoring that the revocation could be (and was indeed) appealed. That is to say, it was not final at the time, and was indeed overturned by the EPO Board of Appeal.Thus, while the Italian Antitrust Authority had held that a number of activities which are based on the provisions of the EPC and of the EC SPC and paediatric extension regulations allegedly represented, taken together and in the way in which Pfizer had carried them out, constituted an abuse of Pfizer's dominant position, the Italian administrative court has now held that Pfizer legitimately and non-abusively relied on such provisions simply to obtain the IP rights to which it was entitled.
The new Italian administrative court decision is therefore important as it appears to take away some of the very negative light shed in a blanket-like manner by the Italian Antitrust Authority on divisionals, SPCs and paediatric extensions. The new decision does not necessarily say that one can always and under any circumstance file a divisional, SPC or paediatric extension or sending warning letters or be involved in litigation without ever incurring in anticompetitive behaviour, but it surely says that in this particular case Pfizer merely relied on the available legal provisions to obtain certain rights it was entitled to.
We now wait to discover whether the administrative court decision will now be appealed by the Antitrust Authority"..
Thursday, 6 September 2012
Earlier today this weblog published a paediatric poser concerning plans for paediatric extensions in Switzerland and asked if any reader could assist. Kilian Schärli, (a Rechtsanwalt with meyerlustenberger lachenal) has kindly obliged with the following information:
"Switzerland is indeed planning to introduce paediatric extensions to its SPC (new Art. 140n PatG) along the same lines as the EU’s legislation with the Ordinary Revision of the Therapeutic Products Act (stage 2).
Here's the Explanatory Report (p. 98 f.) and the Results of the Consultation concerning the Ordinary Revision of the Therapeutic Products Act (p. 72 ff.). Unfortunately, both documents are not yet available in English.
The Federal Office of Public Health (FOPH) is in charge for the Ordinary Revision of the Therapeutic Products Act. According to FOPH’s webpage the following persons should be able to provide up-to-date information regarding the expected date for its entry into force: Matthias Enderle / Amedeo Cianci Tel: +41 31 324 50 41 / +41 31 322 63 19; email email@example.com; website www.bag.admin.ch
In this regard, it is worth to mention that the Swiss Federal Institute of Intellectual Property has changed its practice (sic! 6/2012, p. 419 f.) regarding the grant of SPC with a negative term of protection – effective as of now – based on the decision in Case C-125/10 Merck in June 2012".The SPC Blog has tried, so far without success, to email its personal gratitude to Kilian, so for the time being all we can say is a very public "thank-you!"
|One of these is a device for|
achieving Swiss paediatric
extensions -- but which is it?
"Does anyone have any up-to-date information on the possibility of Switzerland introducing paediatric extensions to its SPC system? The last I heard was there was draft legislation along the same lines as the EU’s legislation -- but is there an expected date for its entry into force yet? And do we know what transitional provisions there will be for obtaining extensions of SPCs that are close to expiry (e.g. the extension request must be filed at least 6 months before expiry, as was originally the case in the EU)?"It would be much appreciated if one of our better-informed readers (of which we have many) could set our reader right.
Monday, 3 September 2012
|After Neurim many|
people view sheep
in a completely
different light ...
"significantly diverges from the opinion of the Advocate-General in a way that, through (arguably) focusing upon the need for a new therapeutic application / indication of an active substance, may just avoid some of the undesirable side-effects that could have arisen from strict adherence to the proposals in that opinion".
"Various further questions from national courts are now almost certain to be referred to the CJEU, if only to obtain clarification as to what the decision in Neurim actually means. In this respect, although the Neurim decision has improved the situation for the innovative pharmaceutical industry, the war is still far from won. The hardest battle yet to be faced relates to how to the CJEU can reach a clear and consistent interpretation of the SPC legislation that provides an appropriate reward for innovators. Although the current SPC legislation has survived the battle in Neurim, it is still perfectly possible that the legislation itself may become a casualty of future battles, especially if the CJEU fails to square the circle between Neurim and earlier case law such as Yissum".
Thursday, 30 August 2012
1. 'Supplementary Protection Certificates', the second edition of FORUM's English SPC seminar with Dr Christopher Brückner, the author of the SPC commentary (which participants will receive on top of course documentation). Date: 4 and 5 October 2012; venue: Amsterdam. More information is available here. SPC Blog readers are entitled to a 10% discount against the registration fee (€ 1,160 instead of € 1,290).In order to register for the reduced fee, SPC Blog readers need only to forward this blog to Jean-Claude at firstname.lastname@example.org, or call him, quoting The SPC Blog (+49 6211 500-675) and specifying which event(s) they would like to attend.
2. 'Ergänzende Schutzzertifikate', the second edition of FORUM'S SPC seminar in German, also with Dr Christopher Brückner and his SPC commentary as an add-on. Date: 23 and 24 October 2012; Venue: Frankfurt. More information is available here. SPC Blog readers are entitled to a 10% discount against the registration fee (€ 1,160, down from € 1,290).
3. 'SPC FORUM' - the first German round-table where German speaking SPC experts from both pharmaceutical and crop science can discuss new cases from Iodosulfuron to Neurim with industry speakers, Merck KGaA's Dr Arno Hartmann and Bayer's Dr Bettina Wanner. Date: 11 October 2012; venue Cologne. More information is available here. SPC Blog readers are entitled to a 10% discount for this event (€ 880 instead of € 980).
Sunday, 12 August 2012
Warren J ruled that Eli Lilly's application for declaratory relief should not to be struck out but should be allowed to proceed. However, the application would be stayed, pending the decision of the Court of Appeal. As to the application for an immediate reference to the Court of Justice for a preliminary ruling, his response was along the lines of "not yet, but maybe later". In the judge's view:
* The holder of a basic patent could apply for an SPC in reliance on an MA granted to a third party which had no connection of any sort with that holder; this issue was sufficiently devoid of doubt that there was no point in referring it for a preliminary reference;
* The 'specification issue' concerned the express words that a patent must contain in order to enable the grant of an SPC which related to an active ingredient within the scope of the patent. On this, the judge said at para.64:
" ... the law remains unclear in many aspects. Whilst sharing Arnold J's puzzlement with the reasoning in Case C-322/10 Medeva BV v Comptroller General of Patents, Designs and Trade Marks 24 November 2011,  ECR I-0000 ("Medeva") and Case C-630/10 University of Queensland v Comptroller General of Patents, Designs and Trade Marks  ECR I-0000 ("Queensland") (see at  and  of his judgment), it is not possible to disagree with what he says at  to the effect that the test laid down in Medeva and its progeny is unclear save in its rejection of the infringement test in combination cases or with his statement in  that it is inevitable that there will have to be further references to the ECJ.Since this was a matter of European law to which the answer was unclear in the light of the guidance so far given by the Court of Justice, a further reference would be needed before the Patents Court was able to give an answer to the specification issue;
* The Patents Court had the power under the Civil Procedure Rules, CPR r.40.20, to make binding declarations regardless of whether any other remedy was claimed -- and where there was a commercial imperative that a clearly defined dispute should be adjudicated on, there was no reason why the Patents Court should not have jurisdiction to resolve that dispute by granting declaratory relief;
* The action for a declaration should not be struck out since there were powerful commercial reasons why Eli Lilly should be allowed to proceed, not least because the company was unable to invoke the procedures for challenging the grant of an SPC because no MA had yet been obtained and no application for an SPC could yet be made.
* While it was right for the court to assist in providing the certainty which Eli Lilly reasonably required, the action should not be allowed to proceed until the Court of Appeal had given its decision on the validity issue and any subsequent application for permission to appeal had finally been dealt with. If it turned out that the patent was invalid and no appeal to the Supreme Court was made, that would be an end of the matter and there would be no need for the declaration. If however the patent was held valid, the claim for a declaration should be allowed to proceed.
* There was no point in making any reference to the Court of Justice for a preliminary ruling for as long as the stay was in place. In this instance, no reference should be made unless the facts relevant to each of the third party SPC issue and the specification issue were established.