The SPC blog

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

Tuesday, 25 August 2015

Another article, another case note: SPCs loom large in latest BioSLR

The just-published issue 5 of volume 14 of Lawtext Publishing's Bio-science Law Review has two items that should be interest to the SPC enthusiast. It opens with an article, "Supplementary Protection Certificates for biologicals -- some guidance from Pharmaq v Intervet" by the Potter Clarkson LLP pair of John Miles and Michael Pears. According the abstract:
The Pharmaq v Intervet case [the EFTA Court ruling, here, discussed on this weblog here] considers, in the context of a salmon virus vaccine, the important issues of what types of marketing authorisations count for the purposes of determining whether a supplementary protection certificate (SPC) is available and what its duration is, and whether an SPC based on a particular authorised biological product can validly extend protection to an authorised variant of that product. Possible implications with respect to SPCs for human biological medicines are also discussed.
This is followed by a case analysis by Katie Hutchinson and Laura Reynolds (Bristows), "CJEU rules again on combination SPCs - Actavis v Boehringer". Explains the journal:
This comment considers the latest judgment from the CJEU on combination SPCs. It summarises earlier cases from the court in order to build up a picture of the position the CJEU is now taking.
Further details of the journal can be accessed here.

Monday, 24 August 2015

SPC Blog Seminar 2015: mark your diaries, give us your suggestions

The SPC Blog is pleased to confirm that its next seminar takes place on the afternoon of Tuesday 10 November. Once again we'd like to thank the London office of Olswang LLP for letting us have the use of its lovely facilities on the top floor of 90 High Holborn,

We have already secured the participation of Examiners from the United Kingdom, Ireland and the Netherlands -- and we're hoping to add another couple of countries to that list.  The programme is however still flexible at this stage so, if there are any pressing topics that you'd like to see covered, whether formally as a programme topic or as part of a discussion session, do please email Rob Stephen at and let him know.

Friday, 21 August 2015

Queensland, SPCs based on process claims and third party observations: the UK Fabrazyme SPC application

The attention of The SPC Blog has been caught by a recent decision of the UK Intellectual Property Office (IPO) in Icahn School of Medicine at Mount Sinai's application (Case O/552/14), a decision of Hearing Officer L. Cullen which was given on 14 December last but which has hitherto escaped us. According to the IPO summary:
Application SPC/GB13/069 concerns the product Agalsidase-beta, a glycosylated human a-galactosidase A enzyme which is the active ingredient in the medicinal product Fabrazyme (RTM). This product is used to treat Fabry disease where a deficiency in this enzyme means that those with this disease cannot break down a specific glycolipid leading to renal, cardiovascular and cerebro-vascular problems.

The applicant considered that the application met the requirements of Article 3(a) of the SPC Regulation because the wording of the process claim of EP(UK) 2210947 B1 filed in support of the application identifies the product which is the subject of their SPC application. The applicant argues that this is sufficient to satisfy Article 3(a) in light of the decision of the Court of Justice of the European Union (CJEU) in C-630/10 (University of Queensland, CSL Ltd v Comptroller-General of Patents, Designs and Trade Marks).

After considering the relevant case law, including C-630/10, the hearing officer found that in order to satisfy Article 3(a), the product of the SPC application has to be identified in the wording of the claims of the basic patent as the product deriving from the process in question. The key step is to establish what is the product that is identified in the claim and decide if this is the product for which the SPC is being sought. A further consideration of whether the product for which the SPC is sought is (or could be) produced directly by the process claimed in the basic patent is not relevant to the basis for granting an SPC under Article 3(a).

The hearing officer examined what was the product that was identified in the process claim of the basic patent and was satisfied that this was the same product approved by the marketing authorisation and for which the SPC was sought. As the product of the SPC application was indeed identified in the wording of the claims of the basic patent as the product deriving from the process in question, the hearing officer thus concluded that the application met the requirements of Article 3(a) of the Regulation. The case was remitted back to the examiner.
This decision is also of note in that it considers third party observations made under Section 21 of the Patents Act 1977 -- which can be made in respect of the grant of an SPC. The Hearing Officer confirmed that the examiner correctly took such observations (made in this case by Genzyme Corporation) into account when reaching his decision and reiterated that a third party making such observations does not thereby become a party to the proceedings.

Tuesday, 11 August 2015

Seattle Genetics: CJEU calls for an AG's Opinion

Our good friend Mike Snodin (Park Grove IP) has spotted that the Court of Justice of the European Union (CJEU) has indicated that the Advocate-General’s opinion in Case C-471/14 Seattle Genetics will be issued on 10 September 2015.  To remind readers, this is a reference for a preliminary ruling from the Oberlandesgericht Wien (Austria) which was made in October of last year, so it's proceeding fairly swiftly through the CJEU. The questions referred are:
Is the date of the first authorisation to place the product on the market in the Community pursuant to Article 13(1) of Regulation 469/2009 concerning the supplementary protection certificate for medicinal products determined according to Community law or does that provision refer to the date on which the authorisation takes effect under the law of the Member State in question?

If the Court’s answer is that the date referred to in Question 1 is determined by Community law, which date must be taken into account — the date of authorisation or the date of notification?
Mike hypothesises that the call for an Advocate General's opinion must mean that the CJEU does not believe that the answers to the questions posed are either obvious or clearly deducible from existing case-law.

For further information see The SPC Blog's posts here (announcing the reference) and here (flagging an article by Mike Snodin).

Monday, 3 August 2015

Rosuvastatin: is it a “pharmaceutically acceptable salt”?

On 15 July 2015 the District Court for The Hague handed down its decision in Resolution Chemicals v Shionogi and AstraZeneca. This case turned on the validity and scope of protection of Shionogi’s SPC -- in particular, was Resolution Chemicals’ proposed zinc salt of rosuvastatin a “pharmaceutically acceptable salt” as claimed in the basic patent and which would infringe the SPC? The District Court granted a declaration of non-infringement. 

Jan Pot and Mark van Gardingen (both of Brinkhof, which acted for Resolution Chemicals) know how interesting this decision is for our readers and therefore have kindly let us have both the authentic Dutch text of the judgment and an English translation. Their summary of the decision -- without any commentary -- appears below.

Thanks so much, Jan and Mark, for your efforts, which are much appreciated!
Shionogi holds supplementary protection certificate (SPC) 300125 for ‘Rosuvastatinum, if desired in the form of a non-toxic pharmaceutically acceptable salt, in particular the calcium salt’. AstraZeneca is the exclusive licensee for this SPC. The basic patent for the SPC was EP 0 521 471 (“EP 471”), which had expired in 2012. Claim 1 of EP 471 was for “the compound [rosuvastatin, described using its molecular formula] acid or a non-toxic pharmaceutically acceptable salt thereof.” Resolution Chemicals requested the Court to partly nullify the SPC, namely insofar as it extended to more than the calcium and sodium salt of rosuvastatin, and to grant a declaration of non-infringement in relation to its rosuvastatin zinc salt. The case is somewhat unusual in that Resolution Chemicals attacked the validity and scope of protection of the basic patent after its expiration in order to limit (the scope of protection of) the SPC.

The first issue before the court was construction of the term “non-toxic pharmaceutically acceptable salt” as used in claim 1 of EP 471. Resolution Chemicals argued that this term was limited to salts with an alkali metal ion, an alkaline earth metal ion or an ammonium ion by virtue of a definition in paragraph [0007] of the patent, which stated that “the term "a non-toxic pharmaceutically acceptable salt" refers to a salt in which the cation is an alkali metal ion, an alkaline earth metal ion, or an ammonium ion”. As a consequence, rosuvastatin zinc was not within the scope of claim 1. Shionogi and AstraZeneca however contended that para. [0007] should not be considered limiting and that “a non-toxic pharmaceutically acceptable salt” should be understood to include the zinc salt. The Court concluded that the skilled person would read the claim term “non-toxic pharmaceutically acceptable salt” in claim 1 in conjunction with para. [0007], and that the skilled person would construe this paragraph as a limiting definition. The court observed that at other points the specification used non-limiting terms such as “and the like”, whereas para. [0007] used the more restrictive “refers to”. The Court also noted that it was common general knowledge at the priority date that the choice for a particular salt form for a medicinal product matters in terms of therapeutic availability, and that performing a salt screen was for that reason routinely applied. Consequently, the skilled person may presume that the choice for the salts disclosed in paragraph [0007] was a conscious choice by the patentee. The Court therefore ruled that the zinc salt was not within the scope of EP 471.

The second issue was that of added matter. While the patent as granted was limited to rosuvastatin, the original application disclosed and claimed a broad class of compounds using a Markush formula. Resolution contended that the application as filed only offered support for rosuvastatin calcium and rosuvastatin sodium: these were the only salt forms of rosuvastatin disclosed by the examples and it was not permissible to extend this disclosure to other salt forms or to the acid. AstraZeneca and Shionogi claimed that rosuvastatin was the essence of the invention and that it was permissible to claim other salts as well as the acid. After examining the application as filed, the Court came to the conclusion that there was support in the original application not only for sodium and calcium but also for the other salts mentioned in para. [0007]. However, the Court found that there was no direct and unambiguous disclosure in the application for rosuvastatin acid. The Court therefore concluded that the SPC would have to be limited to the salt forms of rosuvastatin in which the cation was an alkali metal ion, an alkaline earth metal ion or an ammonium ion, as there would have been grounds to nullify the basic patent insofar as it had a broader scope.

Having dealt with validity and scope of protection of the basic patent and the SPC, the Court swiftly dealt with infringement. As zinc is neither an alkali metal ion, nor an alkaline earth metal ion, nor an ammonium ion, there was no direct infringement. The Court rejected infringement through equivalence, as zinc would have been a foreseeable alternative at the priority date which are taken into account when construing the claims according to Article 69 EPC. Accordingly, there was no need to discuss whether the zinc salt is “technically” equivalent to the calcium or sodium salt of rosuvastatin (or any of the other salts defined in para. [0007]). Finally, the Court also rejected indirect infringement. Shionogi and AstraZeneca’s indirect infringement argument was based on the premise that the scope of protection extended to rosuvastatin acid, which had already been rejected by the Court on the basis of added matter. The Court did not deal with AstraZeneca’s further argument that the rosuvastatin anions in solution associate with sodium cations present in the gastric fluid, since this argument was raised too late.

Tuesday, 7 July 2015

SPCs on the agenda, and a chance to save some money

If you are attending this year's C5 Life Sciences IP Summit (programme here) in Berlin on 22 to 23 October 2015, it has a session on SPCs that looks like this:
4:15 to 5:30 A Case-Law Review of the Jurisprudence on Supplementary Protection Certificates in Europe
  • Matthew Royle
    Taylor Wessing (United Kingdom)
  • Lessons learnt from C-493/12 (Lilly-HGS), C-631/13 (Forsgren), E-16/14 (Pharmaq-Intervet)
  • An overview of the pending referrals concerning SPCs before the CJEU
  • Understanding under which circumstances you can obtain an SPC in the context of antibody claims
  • Obtaining an SPC on combinations of active ingredients for new uses
  • Neurim’s, Medeva’s, Georgetown’s, AstraZeneca’s, Merck’s aftermath: an overview of the CJEU’s interpretation on development of a new indication from an old substance
IPKat blog readers can get a 15% reduction on the registration fee: details can be found here.

Thursday, 25 June 2015

Quetiapine in Turin: court-appointed expert's analysis rejected

In an IPKat post back in March 2012 Darren Smyth wrote about what he called the “tigers v lions” quetiapine case; patents for this substance have been litigated in various locations [including Bulgaria, where some vigorous litigation over the SPC was noted by this weblog here back in 2011], and most recently in Italy before the Turin Court. The guest post below comes from Gian Paolo di Santo (Pavia e Ansaldo), who writes as follows:
With its decision n. 4000/15 issued on 1 June in Case 628/2013 [in the original Italian here and in English translation here] between Sandoz and AstraZeneca a Panel of three specialized Judges of the Turin Court has declared the Italian portion of European Patent No. EP 0 907 364, which had as object an extended-release formulation containing a gelling agent and quetiapine as an active principle having an antipsychotic function, to be null and void for lack of inventive step.

This decision is perfectly in line with a long and rather straightforward sequence of European decisions that held this same patent EP 364 to be invalid (similar decisions have indeed been issued in UK, Germany and The Netherlands (with final decisions) as well as in Spain and Belgium (with decisions that are currently under appeal by AstraZeneca).

The patent at stake is a formulation patent applied for in 1997 that was meant to protect the sustained release version of quetiapine, now a blockbuster drug in the antipsychotic field, already patented as such in 1987 and for which AstraZeneca enjoyed exclusivity until 2012 by virtue of an SPC. In a nutshell the patent holder claimed that at the priority date of EP 364 there was not enough information on quetiapine as such in order for an expert in the field to embark him/herself in the realization of a new formulation for such a compound, given also a series of possible downside of sustained release formulation in antipsychotic field and in particular with respect to the quetiapine molecule. The position of Sandoz was that, since the expert was aware of the need for a reduced posology of medicines in general and especially of antipsychotics (in Italy in particular it was proven that at least three other antipsychotics drugs had been formulated in sustained release before the priority date), it would have been obvious to go for a sustained release formulation of quetiapine, which was the perfect candidate both under a commercial point of view and from a pharmacology point of view.

What I consider interesting in the Italian extension of the case is that, when assessing the invalidity the Turin Court has -- rather unusually -- rejected the opinion of the Expert that had been appointed by the same Court to provide technical guidance (the appointment by courts of a technical Expert in patent proceedings is common practice).

The Expert appointed by the Court had analyzed all the alleged problems put forward by AstraZeneca (to name a few among a very very long list: occupancy of D2 receptors; PH-dependent solubility; clinical prejudice against once-a-day formulations) and found them not to be actual “prejudices” but simple “obstacles” that an expert in the field could overcome by means of simple routine activities. Still, however, the Expert suggested in his report to the Court that, given that no medicine based on quetiapine had yet been put into the market at the priority date of EP 364 (the studies on quetiapine were in advanced phase III), an expert in the field would not have had sufficient reasons to try and test a sustained release formulation in order to overcome the problem of reducing the number of daily doses. This, in fact, would have implied the necessity to start lengthy and expensive research. The Expert consideretherefore the patent to be valid since the expert in the field did not have sufficient motivation nor pointers towards the then patented solution.

The Italian Court completely rejected this point by affirming the following: 
the overcoming of those obstacles and the identification of the pharmacokinetics data concerning quetiapine – the latter was not yet marketed at the priority date of the patent –  implied an activity, which can be qualified as a mere routine activity for the expert of the field, consisting of clinical trials. The statement of  the Court Technical Expert who affirmed that those barriers would have discouraged the expert of the field, who could have reached the invention but would have not found a stimulus to do that, is not shareable. After all, the same Court Technical Expert affirmed that the expert of the field could have identified such elements through clinic research and that the long analysis which were necessary may also be qualified as routine ones in the pharmaceutical field, in the sense that they have in any case to be carried out but require the use of a great number of employees and resources as well as a substantial economic disbursement. Moreover, the necessity to make use of employees and resources and the costs of the analysis is an element which is not enough to state the inventive step of the patented technical solution because the expert of the field was not required to carry out any inventive activity but instead merely usual clinic research and tests” (see lines 276, ff. of the English translation).
In the context of such a long and high-value proceeding the aspects scrutinized were many more and a full reading of the decision may provide further valuable insights (almost every aspect such as definition of the technical problem, identification of the expert in the field and so on were discussed). Still, I think this particular aspect is an interesting interpretation of the inventive step requirement in Italy that may come into question in other cases where the patent holder tries to sustain the validity of the patent on the basis of an “economic analysis” of the situation in the prior art, instead than demonstrating the true technical advancement brought by the patented solution (which in this case was held to be minimum or even absent).

To what I said above I should add a couple more pieces of information. On the one side two parallel cases on the merits (involving Accord and TEVA v AstraZeneca) have not been decided yet on this same patent, although preliminary injunctions requests have been submitted by AstraZeneca and refused by the same Court on the basis of the same arguments on which the decision at stake is based. I should also add that AstraZeneca can still appeal this decision in favour of Sandoz before the Court of Appeal.

Friday, 5 June 2015

Forsgren: a new case note

The Bio-Science Law Review (Bio-SLR), published by Lawtext Publishing, carries a note on SPCs on vol.14 issue 4: it's "CJEU rules on the requirements for protecting carrier proteins using Supplementary Protection Certificates (SPCs)" and the author is Jennifer O'Farrell (Boult Wade Tennant, London). According to the abstract:
"Supplementary Protection Certificates (SPCs) extend the duration of protection conferred by a European patent for a medicinal product requiring marketing authorisation. The Court of Justice of the European Union (CJEU) has recently handed down the latest in a series of judgments (C-631/13 [a.k.a. Forsgren, noted briefly on The SPC Blog here]) which seeks to clarify what can, and cannot, be protected under EC Regulation No 469/2009 (the SPC Regulation). Here the CJEU has decided that an SPC may be granted for an active ingredient covalently bound to another substance only if the active ingredient for which supplementary protection is sought has a therapeutic effect covered by the wording of the marketing authorisation".

Friday, 29 May 2015

Reliable information on non-EU and non-US patent term extension: can you help?

I have been approached by a correspondent who has posed the following question:
Can you recommend a reference work or website that can provide reliable information as to the availability and rules surrounding Patent Term Extensions or Supplementary Patent Protection in countries other than the US or Europe?
Offhand, I couldn't think of one, though I'm sure that one must exist somewhere -- and one certainly should if none has yet been compiled.

Can readers of this weblog make any recommendations or point our correspondent to an appropriate source -- in English or in any other language?

Monday, 25 May 2015

MAs and APIs: the Austrian Supreme Court applies Forsgren ruling

Last week our friend Rainer Schultes (Geistwert) posted on his blog this note, which we are happy to reproduce below with his permission, on the Austrian Supreme Court's application of the provisions of the SPC Regulation in the light of a recent ruling of the Court of Justice of the European Union (CJEU) in response to the Austrian court's reference in the Synflorix case.  For the benefit of any first-time readers, API stands for "active pharmaceutical ingredient" and an MA is not a higher degree but a marketing authorisation:
The API of an SPC need not be mentioned in the MA

In Case C-631/13 Forsgren [noted briefly here on The SPC Blog], the CJEU already ruled: Article 3(b) of Regulation 469/2009 must be interpreted as precluding the grant of a supplementary protection certificate for an active ingredient whose effect does not fall within the therapeutic indications covered by the wording of the marketing authorisation.

Article 1(b) of Regulation 469/2009 must be interpreted as meaning that a carrier protein conjugated with a polysaccharide antigen by means of a covalent binding may be categorised as an ‘active ingredient’ within the meaning of that provision only if it is established that it produces a pharmacological, immunological or metabolic action of its own which is covered by the therapeutic indications of the marketing authorisation.

GEISTWERT has blogged already (link).

Now, the Austrian Supreme Court shed further light on the SPC Regulation when applying the CJEU's judgment (Austrian Supreme Court, 4Ob20/15t).

In the matter at stake an SPC was requested for a protein D, which is a carrier protein covalently bonded to other active ingredients. Covalent binding does not exclude an SPC.

The Supreme Court analysed the context between the order for reference, the statement of the European Commission and the CJEU’s judgment: The Supreme Patent- and Trademark Senate, which referred the question to the CJEU had individualized the protein D as a carrier for which no pharmaceutical effect was mentioned in the Marketing Authorisation (MA). With regard to that, the Commission meant that the protein’s activity had to be mentioned in the MA, otherwise the request for SPC was not justified. The CJEU did not follow that but referred to the facts, thus to the effectiveness of the protein within Synflorix.

Upon this analysis, the Supreme Court now held that an own pharmacological, immunological or metabolic action of the protein D within the indications covered by the MA has to be established but it is not necessary that the protein D is explicitly mentioned in the Marketing Authorisation.

To verify that, the matter was referred back to the first instance.
Thanks so much, Rainer, for keeping us informed!