SPCs and the Unified Court Agreement

Given the length of time it has
taken to put together a unitary
patent scheme with a unified court,
this logo would seem most
appropriate for the venture

So much has happened in such a short time in terms of the rapid sprint towards a unitary patent system for the European Union and the Unified Court Agreement that even some of The SPC Blog's best-informed readers aren't sure what's happening.  One such reader has written to seek confirmation that what he believes to be the position is indeed so.  He writes:

"Do any readers of The SPC Blog have any comments or views on Article 3(b) of the Unified Court Agreement?

In Article 3(b) of the Unified Patent Court Agreement concerning the jurisdiction of the court over European patents, there is a reference to “supplementary protection certificate issued for a patent”. Article 2(7) of the Agreement indicates that “patent” means a European patent and a European patent with unitary effect.

My observation arises as follows:

An SPC is a national property right granted by a national patent office – unlike the Unified European patent or the regular European patent granted by the EPO. Often an SPC will be based on a European patent granted by the EPO -- or presumably a Unitary European patent in future – but not always, since national patents can be used also as the basis for an SPC.

Although the SPC is a creation of EU law and its inclusion in the Court Agreement has some logic, it still looks a bit strange to have a national property right bundled up in the supranational Unified Patent Court Agreement. On the other hand, maybe it does make sense since standard European patents (which are in effect national property rights too, after grant and validation) will fall under the Court’s jurisdiction.

I’m still left wondering though. Maybe I missed something in all the excitement recently (in particular the hoo-hah over Articles 6 to 8).

Does this mean that the Unified Patent Court will get jurisdiction over existing or future SPCs based on national patents? Or maybe the Agreement is meant to refer only to SPCs granted on European patents but not national patents?

Does this further mean that the Court could get to rule on the validity of such SPCs (based on national patents) but not where the validity of the national patent is reserved for the national court? (is there some additional unintended bifurcation here?)"

Can any reader advise?

Benoxacor and (S)-metolachlor: French ruling now available in English too

On Thursday 16 February The SPC Blog posted this item from France on the rejection by the Cour de Cassation -- the nation's highest court -- of an appeal against the refusal of an SPC for Benoxacor and (S)-metolachlor.  Edouard Kling and his colleague François Pochart (august & debouzy avocats) provided the original news and said they'd let us have an English translation. Well, here it is. It's five sides long which, though very short by the standards of many countries, actually seems quite lengthy for a Cour de Cassation ruling.

Thanks, Edouard and François, for your help and support.

SPCs and PTEs in East Asia

The SPC Blog has recently received an email from Michael Lin (Marks&Clerk, Hong Kong), who helpfully tells us:

"I’ve received quite a few questions recently about SPC/PTEs in East Asia, so I thought this may be useful for those subscribing to the SPC blog:

SPC/PTE available: Australia, Brunei, Japan, Macau, Singapore, S. Korea, & Taiwan.

SPC/PTE not available: China PRC, Hong Kong, India, Indonesia, Malaysia, New Zealand, Pakistan, Philippines, Thailand, Vietnam".

Readers of this weblog will already be familiar with the case of Macau (see earlier posts here and here). As for the rest, The SPC Blog will watch carefully for news and developments.

France: Cour de Cassation upholds rejection of SPC for Benoxacor and (S)-metolachlor.

From Edouard Kling and his colleague François Pochart (of the Paris-based international practice of august & debouzy avocats) comes this fascinating news of a recent decision of the French Cour de Cassation -- its Supreme Court. Edouard writes:

"Here is a link to a ruling of the French Supreme Court for your blog which may have remained unnoticed among the various Medeva and Queensland discussions. This ruling is concerned with SPC Regulation 1610/96.

The Cour de Cassation confirmed the decision of the Cour d'Appel to reject SPC application No 02C0020 directed to a mixture of Benoxacor and (S)-metolachlor. It came to the conclusion that the product was already the subject matter of a previous SPC (No 97C0048 based on a different basic patent), though the former SPC did not specify the stereochemistry of the metolachlor component. Said the Cour de Cassation

“Whereas, first, the Cour d'Appel decision found that SPC no. 02C0020 was requested for a plant protection product whose active substance is the combination of benoxacor and S-Metolachlor and that SPC no. 97C0048 granted previously on the basis of patent no. 84810599 covers the combination of benoxacor and metolachlor without reference to one or more specific spatial forms of metolachlor; it further pointed out, on specific and adopted grounds, that the metolachlor molecule has two R and S enantiomers and four possible spatial forms, and that S-Metolachlor is only one enantiomer of the metolachlor substance; finally, it pointed out, on valid grounds, that it is not demonstrated that the transition of the active substance in question, from a racemic form to an enantiomer form, implies that the product has a different activity profile; from these findings and assessments, the Court of Appeal, which carried out the study referred to in the second part of the argument, was able to infer that the combination of benoxacor and S-Metolachlor constituted the same active substance as the combination of benoxacor and metolachlor since it was composed of the same sequence of atoms and, thus, one and the same product within the meaning of Articles 1. 3, 1. 8 and 3 of EC Regulation 1610/96”

This ruling may be related to the different European Escitalopram decisions dealing with the definition of a product under the scope of medicament SPCs, i.e. the Austrian and German decisions you have posted earlier. It however remains unclear about the burden, requirements and means left to the patentee to demonstrate an improved profile".

Edouard and François look forward to providing readers of this weblog with a complete translation as soon as possible.

The last word on Queensland? Two SPCs for one patent OK in the UK

The ruling of Mr Justice Arnold in University of Queensland CSL Ltd and another v Comptroller-General of Patents, Designs and Trade Marks [2012] EWHC 223 (Pat), discussed in last Friday's hot-off-the-press post here, has now been posted on BAILII so you can read the decision in full here.

Mark your diaries for next SPC Blog seminar

There are hardly any details yet, other than the date itself -- but you can mark your diary now! The SPC Blog's 2012 seminar will take place in the afternoon of Tuesday 22 May, in the congenial surroundings of the London office of Olswang LLP.  Further details will be published as soon as possible, so watch this space.

22 May: its place in history here

"One SPC per patent"? Not in Sweden!

Regular readers of The SPC Blog will recall how much interest has been generated by the question whether, following the recent round of Court of Justice rulings, there is a rule of "one SPC per patent" (see for example earlier posts here and here).

Now we have a fresh contribution on this topic from Camilla Lidén (Valea AB, Stockholm), who has written in to tell us how the Swedish Patent and Registration Office (PRV) is dealing with the situation:

"With reference to your earlier posting regarding MedImmune and Queensland and the issue with the “one SPC per patent” I just wanted to add that the PRV has actually published a notice on its homepage regarding this issue last week, after receiving several questions from the public.

PRV announced that at this stage it sees no reason for changing its practice regarding the number of supplementary protection certificates (SPCs) that can be obtained from one basic patent. One of the reasons is that this issue does not form part of the Medeva referral and, further, as far as it can tell, neither Biogen nor Medeva contain any judgment providing the basis for the conclusion that the Court should consider that the patent term for a basic patent only can be extended by one single SPC no matter how many products that are protected by the basic patent and that several of these products have been authorized for marketing as a pharmaceutical. Accordingly we conclude that, for now in Sweden, there should be no direct obstacle to obtaining several SPCs from one basic patent.

More information can be found here (currently only in Swedish)".

Many thanks, Camilla. It will be good to hear from correspondents in other countries as to whether their authorities issue similar or contradictory statements.

MedImmune and Queensland: UK court wrestles with the meaning of Medeva and related referrals

The SPC Blog is delighted to have received this morning a three-headed note from Hugh Goodfellow, Daniel Wise and Edward Oates (Carpmaels & Ransford), who thought we might be interested in the local events which transpired in the Patents Court for England and Wales this morning, when that court had to grapple with some recent rulings from the Court of Justice of the European Union (CJEU). They write:

"The Patents Court had a busy morning applying the CJEU’s recent decisions in Medeva (C‑322/10) and the related Georgetown (C-422/10), Queensland (C-630/10), Yeda (C‑518/10) and Daiichi (C-6/11) referrals to real world SPC cases.  We now therefore have the UK judiciary’s first guidance as to how the CJEU’s rulings should be interpreted.

At 10 am, Mr Justice Arnold handed down a decision in the second leg of the MedImmune v Novartis Lucentis litigation [the ruling, in [2012] EWHC 181 (Pat), can be read in full here].  A key issue was whether MedImmune’s patent to a method for producing “a molecule with binding specificity for a particular target” included within its claims adequate “specification” of the active ingredient in Lucentis (the ranibizumab monoclonal antibody) to obtain an SPC for this product.  MedImmune had argued that the CJEU’s requirement, set out in the Medeva judgment, for the active ingredient to be “specified in the wording of the claims” was unclear and required a further reference to the CJEU to determine how much “specification” was required.  The Court had some sympathy for this argument:

53. In my view, counsel for MedImmune is also correct to say that the test laid down by the Court of Justice in Medeva and its progeny is unclear save in its rejection of the infringement test in combination cases. In particular, it is unclear precisely what is meant by “specified (or identified) in the wording of the claims”. Does this mean that it is sufficient for the product to fall within the scope of the claim on its true construction, or is something more required and if so what? For example, is it sufficient, say, for the claim to incorporate a Markush formula which covers a large number of compounds one of which is the product in respect of which an SPC is sought? Is it sufficient for the product to be defined in functional terms? Even in combination cases, it is not clear to me how the test enunciated by the Court should be applied in a case like Gilead. Regrettably, therefore, it is inevitable that there will have to be further references to the CJEU to obtain clarification of the test.

Despite this sympathy, the Court found that the patent did not contain an adequate level of “specification”.  Among other reasons, the Court said:

57. […] In the present case, claim 1 merely identifies the product of the method as “a molecule with binding specificity for a particular target”. This covers millions of different molecules of various kinds. It is not even limited to antibodies. Although ranibizumab falls within this extremely broad class of products, there is nothing at all in the wording of the claim, or even the lengthy specification of the Patent, to identify ranibizumab as the product of the process in question.

MedImmune had argued that Arnold J should refer the matter in suit to the CJEU for further consideration but he declined to do so.  The first leg of the litigation, in which MedImmune’s patent was found to be invalid and not infringed, is already due to be heard by the Court of Appeal for England and Wales later this year, so the High Court felt that the higher court was better placed to order a reference should that become necessary to settle the dispute.

Although no referral was ordered in this case, many commentators have questioned the meaning of “specified in the wording of the claims” and time will tell whether the Court of Appeal -- or indeed another EU national court (e.g. the German court which will be considering the same facts soon) -- decides that the CJEU needs to explain what it meant by its test.  The Court of Appeal in the Hague has already opined on the point in Lundbeck v Tiefenbacher (escitalopram), holding that although escitalopram oxalate was not explicitly recited in the claims, the reference in the claims to non-toxic acid addition salts was adequate “specification” of escitalopram oxalate to support an SPC for this product.

Of further concern to some will be the Court’s questioning of the practice of applying for SPCs based on unlicensed third party products.  Although this point was not taken up by the parties, it seems that SPCs based on third party marketing authorisations might now, in certain cases, be challenged by alleged infringers:

61.          As noted above, in the present case the SPC is based upon a product obtained by means of an allegedly infringing process and upon a marketing authorisation obtained by an alleged infringer of the Patent. It might be thought that it was not the purpose of the Regulation to enable a patent owner to obtain an SPC in such circumstances, since the owner has not been delayed in getting the product to market by the need to get a marketing authorisation, and therefore no extension to the term of the patent is needed to compensate him for that delay.

At 1030 am, the same judge heard Queensland v CSL and UK Intellectual Property Office, which he had himself referred to the CJEU in late 2010.  The CJEU issued its decision in this referral shortly after Medeva, and today marked the first time that any of the referred cases had been back before a British judge to apply the CJEU’s logic.  The parties agreed that the effect of the CJEU’s decisions was that Queensland/CSL’s four SPC applications for the individual active ingredients in the Gardasil combination vaccine were allowable based on Queensland/CSL’s three basic patents.  Granting an order for these applications to proceed to allowance, neither the Court nor the IPO raised the controversial “one SPC per patent” objection that some commentators have derived from the CJEU’s judgments.  It seems that in the UK, at least, the established practice that more than one SPC is allowable per patent provided that each SPC is directed towards a different active ingredient remains alive and well.  It will be interesting to see whether other countries take the same approach: initial comments from the Dutch Patent Office suggest that things may be seen differently elsewhere.  Moreover, counsel for the IPO suggested that this point will be raised by Medeva when its own referral gets back to the UK Court of Appeal later this year".

Disclosure of interest: Carpmaels & Ransford acts for Queensland/CSL in their SPC applications across the EU and is also leading the Neurim SPC referral at the CJEU, which raises further fundamental questions of SPC law.

SPCs in Guernsey and Jersey -- an answer too good to miss!

Following this morning's post on the position of SPCs in Guernsey and Jersey, The SPC Blog has received this terrific response from Louise Audhlam-Gardiner (Lysaght & Co, right):

"I can answer the question about the registrability of SPCs in Jersey and Guernsey…………to say that unfortunately there is no definite answer! 

In Jersey, we have certainly recorded the existence of a UK SPC at the Judicial Greffe before. However, the Greffe indicated in those cases that it could give no undertaking as to the efficacy of the certificate. As you may be aware, there are certain deficiencies in the Patents (Jersey) Law, 1957. One such deficiency is that, arguably, the 1958 Law does not provide for supplementary protection, nor does it recognise the procedure adopted by the Greffe in issuing an SPC certificate. 

We expect that the same situation applies in Guernsey - it is likely that the Court would agree to record the presence of a UK SPC and even issue a certificate of some sort, but the enforcement of any rights afforded by such a certificate would not be clear. 

The question of the registrability of SPCs in the reregistration jurisdictions has come up previously, and indeed we have specifically written to the Registries in all such jurisdictions when the SPC Regulations were first introduced in the UK pursuant to European Council Regulation No. 1768/92 in 1993. As expected, we did not receive many responses, and we do not expect that they understand the issues involved.We have also written more recently to the legislators in certain jurisdictions, e.g. Guernsey (a new  Patent Law is currently being drafted there) to raise similar issues again, but to date we have not received satisfactory answers.

However, the Patent Laws of most of these jurisdictions do provide that the privileges, rights and conditions conferred to and imposed by a Certificate of Registration are, mutatis mutandis, those conferred or imposed by the base patent and such privileges, etc., date from the date of Fthe base patent, and remain in force during the period of subsistence thereof. Therefore, whilst we do not believe that the separate right of an SPC is explicitly covered by such provisions, and presumably the local laws were enacted without any consideration towards or knowledge of such SPC rights in these jurisdictions, the extension of term of a UK patent by virtue of the grant of an SPC may well, by implication, automatically apply to reregistration patents based on that UK patent in at least some of these jurisdictions. 

Notwithstanding the above, and in view of the lack of understanding of SPCs in these jurisdictions, an SPC may also be specifically recognized by the Registries in certain of these jurisdictions if it has firstly been recorded at the UK IPO, and indeed, we have done so with success on previous occasions in several such jurisdictions (e.g. Gibraltar, Fiji, Montserrat). 

However, again, we are not certain that the registration of such SPCs would be enforceable if ever challenged by a third party. 

I apologize for the uncertainty of my comments, but as you will appreciate, this subject is somewhat obscure and unclear in view of the lack of understanding of the Registries in these jurisdictions regarding SPCs".

.Thanks so much, Louise, this is really helpful.

Offshore SPCs: what's the position of Guernsey and Jersey?

The Channel Island States of Guernsey have been in the IP news headlines recently. Yesterday Guernsey announced publication of its draft proposals for a registrable Image Right.  Today, The SPC Blog has received a reader's question specifically relating to that charming holiday isle with a lightly-taxed population of just some 65,000 souls:

"Does a United Kingdom SPC automatically extend to a registration of the corresponding basic patent in Guernsey and/or Jersey?"

Any thoughts would be much appreciated, particularly if they can point or link to any explicit legislation -- and don't write in to say that, given the location of Guernsey and Jersey, it would be easier to extend a neighbourly French SPC than a more distant UK one ...

Case comment now available online

Last Thursday The SPC Blog posted a notice concerning a case comment by Mike Snodin, John Miles and Michael Pears (all of Potter Clarkson’s SPC & Regulatory Group), published in Lawtext's Bio-Science Law Review (BSLR).  This case comment discusses the Medeva (C-322/10) and Georgetown et al. (C-422/10) decisions of the Court of Justice of the European Union, as well as three further cases which were decided by reasoned order (Yeda, Daiichi and Queensland).

This blogger has since contacted the proprietor of Lawtext Publishing, who has kindly agreed to make the case comment freely available to readers of this weblog, even if they are not subscribers to the BSLR. You can now read it in full here.

Thanks, BSLR, for this very kind gesture.

patent term extension in Macau: even more information

If anyone ever doubted that The SPC Blog was a useful tool for finding out about jurisdictions in which a person has little or no personal involvement or experience, the answers received in response to a reader's question concerning Macau must surely go some way towards dispelling those doubts.  First we received this response; now we have been sent even more information by our ever-helpful friend Alice de Pastors, which we are delighted to reproduce here:

A few SPC data are available on the website of Macau Patent Office.For instance
- SPC 5 for linezolid has an expiry date 18/08/2021 (7 years from the patent term)- SPC 8 for atorvastatin has an expiry date 05/10/2017 (10 years from the first MA date).Below please find an extract from the Macau Patent Office database.


SPC data from Macau Patent Office No. of Complementary Certificate for the Protection of Medicines and Phyto-pharmaceutical Products F/5Applicant / Holder 法瑪西雅厄普約翰美國公司 PHARMACIA & UPJOHN COMPANY LLC
Address
Address 美國密執安 7000 Portage Road, Kalamazoo, MI 49001, USA
Invention Patent No. / Extension Invention Patent No. J/65 - 16/08/1994 Invention Patent No. / Extension Invention Patent No. J/65 - 16/08/1994Title of Patent (Chinese / Portuguese Version Only) 取代的噁嗪和噻嗪噁唑烷酮抗微生物劑。 Date of Application 23/06/2008
Date of Ruling 05/02/2009
Protecção de certificado complementar de protecção para medicamentos e produtos fito-farmacêuticos  05/02/2009                         9/2009              II  04/03/2009 
Product Identification Zyvox (Linezolid)
No. of the First Authorization to Place the Product on the Local Market 600459
Date of the First Authorization to Place the Product on the Local Market 25/01/2002Valid Until 16/08/2021 7 years from the patent termStatus Foi emitido

No. of Complementary Certificate for the Protection of Medicines and Phyto-pharmaceutical Products     F/8Applicant / Holder WARNER-LAMBERT COMPANY LLC Address 235 East 42nd Street, New York, NY 10017, United States of America Invention Patent No. / Extension Invention Patent No.     J/64 - 08/07/1996Title of Patent (Chinese / Portuguese Version Only) 結晶〔R－（R*，R*）〕－2－（4－氟苯基）－β，δ－二羥基－5－（1－甲基乙基）－3－苯基－4－〔（苯氨基）羰基〕－1H－吡咯－1－庚酸半鈣鹽。Date of Application 13/11/2008
Date of Ruling 05/02/2009
Protecção de certificado complementar de protecção para medicamentos e produtos fito-farmacêuticos 05/02/2009        9/2009                         II                       04/03/2009
Product Identification Lipitor (Atorvastatin)
No. of the First Authorization to Place the Product on the Local Market    605193
Date of the First Authorization to Place the Product on the Local Market 05/10/1997Valid Until 05/10/2017 10 years from the first MAStatus Foi emitido 

Court of Justice rulings and combination products: an article

Volume 12, Issue 2 of Lawtext Publishing's Bio-Science Law Review contains an article from Mike Snodin, John Miles and Michael Pears (all of Potter Clarkson’s SPC & Regulatory Group) entitled “Supplementary protection certificates: The CJEU issues its decision in two seminal cases”. This article discusses the Medeva (C-322/10) and Georgetown et al. (C-422/10) decisions, as well as the three further cases decided by reasoned order (Yeda, Daiichi and Queensland). In the article, Mike, John and Michael conclude that likely consequences of the Medeva and Georgetown et al. decisions in the short to medium term will include:

“• National courts will invalidate SPCs to combination products that have been granted on the basis of the ‘infringement test’ but where the active ingredient(s) are not specified in the wording of the claims of the basic patent. 

• More SPC applications will be filed in which the product is defined as one or more (but not all) of the active ingredients present in the authorised medicinal product. 

• Subject to confirmation in Case C-442/11 of the Court of Justice’s comments on point (C) above, national courts will enforce SPCs to single active ingredients against the manufacturers of generic versions of combination products containing a protected active. 

• Generic manufacturers will delay launch of combination products until SPCs to the individual actives have expired (or have been invalidated). 

Further, although it is a point of view that may not be shared by all practitioners, the authors believe that the decisions may not lead to any changes in established practices with regard to the numbers of SPCs granted for basic patents that protect more than one product.”

In relation to the latter issue, the article points to the similarity in wording between the Biogen decision and the Medeva and Georgetown et al. decisions in respect of comments on the number of SPCs that may be granted for each basic patent, and questions whether any change to the status quo was really intended by the Court of Justice on this issue.

The article also discusses possible longer term implications of the decisions, and suggests that further judicial interpretation will be required in order to clarify what is meant by “specified (or identified) in the wording of the claims” - particularly in connection with patent applications that can be argued to “specify” both a novel active ingredient (A) and the combination of that active with another, specific active ingredient (i.e. A+B).

Mike, John and Michael conclude the article by saying:

“Putting aside the issues where there is a need for further clarification, the Medeva and Georgetown et al. decisions should be welcomed by the pharmaceutical and agrochemical industries as representing a carefully balanced approach that rewards genuine innovation with an appropriate degree of protection.”

The points mentioned above are all explained in more detail in the article.

Patent term extension in Macau: an answer

In swift response to today's earlier post seeking information on patent term extension in Macau, a kind reader has submitted the following information which this weblog gratefully posts:

"Section III, Articles 125 to 128 of Decree-Law Nº 97/99/M of 13 December 1999 provides for Complementary Protection Certificates (CPCs) in Macao. The Macao CPC law is a vestige of Macao having been a Portuguese colony, since Portugal had provided for CPCs even before other European countries enacted their Supplementary Protection Certificate (SPC) laws.

Patents pertaining to medicines and “phyto-pharmaceutical products” (i.e., plant extracts) are eligible for a CPC. Veterinary drugs may be included within the scope of “medicines” -- but the statute does not expressly mention them.

The CPC application cannot be filed until six months from the original (unextended) expiration date. It is recommended that the application be filed on the first possible day, since the legal effect of a patent’s expiration during the pendency of a CPC application is not known. There is no specific provision in the law for interim extensions comparable to that under the U.S. law.

The statute does not describe any limitation on the scope of the CPC.

The maximum duration of a CPC is 7 years. However, the statute does not provide any formula for calculating the duration in individual cases".

Patent term extension in Macau: a question

A reader has emailed The SPC Blog to ask a question to which this blogger has no immediate answer:

"Do you know anything about Supplementary Protection Certificate legislation in Macau?"

If anyone can provide information or guidance concerning any formal or informal means of extending patent term in Macau, can he or she please let us know?