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?"
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
Sunday, 28 October 2012
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.