Source: http://thespcblog.blogspot.com/2015/
Timestamp: 2019-04-20 04:59:32+00:00

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Little did I realise, when we started The SPC Blog back in June 2008, that I would be saying goodbye to a thriving weblog with an email subscription list of nearly 2,100 – a blog that has also attracted well in excess of 800,000 pageviews and which has supported highly popular annual seminars in which people from all sectors of the pharma and agrochemical patent term extension world have gathered to share their thoughts, their experiences and, all too often, their frustration with the rulings of the Court of Justice of the European Union.
Anyway, it is with a feeling of great happiness that The SPC Blog has been so popular – and so useful – that I take my leave of it and step down as I take the retirement route.
Do please continue to give the blog your every support and help to keep it as the valuable resource which it has become!
Earlier this month The SPC Blog was delighted to host "Patent term extension in Japan: a guest post", here, by Dr Seigen Tsukuda (Ohno & Partners, Japan). Here's a sequel, bringing some fresh news.
In order to reject an application for a patent term extension (PTE) based on a prior authorization, in view of category and subject of patented invention(s) for which the application is submitted, a prior authorization and a new authorization shall be compared in terms of elements examined for authorization, such elements being relevant to substantial identity as a pharmaceutical product, and it must be established that the prior authorization encompasses the new authorization in terms of an authorization for production and sales of a pharmaceutical product.
"... intravenous drip infusion of 7.5mg/kg (body weight) per dose ... administration interval is 3-week or longer ...".
Further, production and sales of the subject pharmaceutical product for a combination therapy of XELOX therapy and bevacizumab therapy newly became available by such new authorization. Based on the facts described above, it is not established that the prior authorization encompasses the new authorization in terms of an authorization for production and sales of a pharmaceutical product. Therefore, the decision of appeal board of the JPO is not legitimate, and the IPHC Grand Panel decision is approved.
As can be seen from the above, it seems that the Supreme Court accepted almost the whole framework of the IPHC Grand Panel decision establishing that a PTE may be allowed based on any substantially new authorization, so long as the subject patent covers the newly authorized pharmaceutical product.
In this respect it should be noted that, when a patentee wishes to obtain a PTE, if an authorization is not delivered by 6 months and one day before the expiration date of a subject patent, a provisional application must be submitted by that day, i.e. 6 months and one day before the expiration date (Patent Act Article 67-2-2, paragraph 1), otherwise a non-provisional application must be submitted within three months from the delivery of an authorization (Patent Act Article 67-2, paragraph 2 and Implementing Regulation of Patent Act Article 3).
"If the patentee may wish to obtain a PTE corresponding to a dependent claim in the future, it is recommended to file a divisional application to establish a patent specifically directed to the invention of the dependent claim, describing the invention as an independent claim".
Under the new examination guidelines, PTE may become available without filing such divisional applications.
With apologies for the slight delay, The SPC Blog can now proudly give you the original (or ever so slightly tweaked) PowerPoint presentations attached to last week's seminar.
We're trying to sort out the videos and will get back to you soon. Hang on in there!
Here's a guest post from Dr Seigen Tsukuda (Ohno & Partners, Japan, right) on patent term extensions in that important jurisdiction. Our thanks go both to Dr Tsukuda and to Darren Smyth (EIP)) for procuring it on our behalf and giving it the benefit of his editorial scrutiny.
Patent systems differ from nation to nation, and the practice relating to patent term extension (PTE) shows an extreme example of such variation. The Japanese PTE system is quite distinct from those of Europe and United States. Significant features of the present Japanese PTE procedure are as follows.
(1) Although it is required that an authorized pharmaceutical product falls within the scope of a claim of the patent, it is NOT required that the claim recites (specifies) any active ingredient. Thus, patents relating to drug delivery systems (DDS), for example, can be extended in principle.
(2) Multiple extensions are available for a single patent (but the term of extension may not exceed 5 years).
(3) Multiple patents belonging to the same patentee can be extended based on a single authorization.
The idiosyncrasy of the Japanese system has increased even further recently. In order to elucidate the current situation, let us look briefly into the Patent Act provisions and the history of Japanese PTE practice.
Article 67 paragraph 2 provides conditions for PTE, mentioning "Where there is a period during which the patented invention is unable to be worked because ... disposition [authorization] ... is necessary to obtain for the working of the patented invention, the duration of the patent right may be extended ..., by a period not exceeding 5 years."
Conventionally, the JPO assumed that "product" and "usage" recited in Article 68-2 should be interpreted as "active ingredient(s)" and "effect and efficacy" respectively. Based on this assumption, the JPO further interpreted Article 67 paragraph 2 as meaning that a PTE can only be based on an authorization that is "new" in terms of a combination of "active ingredient(s)" and "effect and efficacy". For example, let us assume a case where an authorization is obtained for a pharmaceutical product using a new DDS technology, and the DDS technology is protected by a patent. In this case, according to the JPO practice, the patent could NOT be extended so long as there is a previous authorization corresponding to a pharmaceutical product whose active ingredient, effect and efficacy are the same for those of the newly authorized pharmaceutical product. It is not relevant whether the previously authorized pharmaceutical product falls within or outside the claims of the subject patent (situation was similar to MIT case [C-431/04]).
According to Article 67 paragraph 2, a PTE may be allowed "when there is a period during which the patented invention is unable to be worked". Under the Japanese Pharmaceutical Affairs Act, it is not permitted to market a pharmaceutical product of new formulation or new dosage until a new corresponding authorization is obtained, even if a previously authorized pharmaceutical product contained the same active ingredient and was authorized for the same effect and efficacy. It could thus be argued that there is "a period during which the patented invention is unable to be worked". Accordingly, since late 1990s, new-drug developers have been struggling in courts arguing that the above JPO's practice is not legitimate.
Forced by the Supreme Court decision, the JPO revised its examination guidelines for PTE in December 2011. The revised guidelines are fairly complicated, but could be summarized as follows. An application for a PTE based on a new authorization for a new pharmaceutical product cannot be rejected if an old pharmaceutical product authorized by a previous authorization falls outside the scope of all of the claims of the subject patent. On the other hand, if the old pharmaceutical product falls within the scope of a broadest claim of the subject patent, the application for PTE must be rejected so long as the old and new pharmaceutical products do not differ in term of the elements described in the broadest claim of the subject patent.
For example, assume a case in which a new pharmaceutical product is a new formulation including active ingredient A and excipient polymers B and C2, where the old pharmaceutical product was a formulation including active ingredient A and excipient polymers B and C1. In this case, a PTE will not be allowed if an independent claim of the subject patent simply recites active ingredient A, or a combination of active ingredient A and excipient polymer B. On the other hand, a PTE may be allowed if the independent claim of the subject patent recites a combination of active ingredient A and excipient C (C1 and C2 are examples of C).
On 30 May 2014, the Grand Panel of IPHC rendered a decision determining that the revised examination guidelines are not legitimate [2013(Gyo-Ke)10195: Genentech v Commissioner of Patents]. According to the decision, if an authorization is new in terms of a combination of components (not only active ingredients), quantity, administration, dosage amount, effect and efficacy, the application for a PTE shall not be refused based on a prior authorization. This means that a PTE may be allowed based on any substantially new authorization, so long as the subject patent covers the newly authorized pharmaceutical product.
As mentioned above, under the current examination guidelines, a PTE is allowed on a patent-by-patent basis, and examination will be performed based on the broadest claim of a patent. In a case where a prior authorized pharmaceutical product falls within the broadest claim and there is a reason for rejection with respect to the broadest claim, a PTE is not allowed even if the old pharmaceutical product falls outside a narrower dependent claim (and the new pharmaceutical product falls within the dependent claim). However, if a divisional application including the dependent claim is filed to separate the claim from the independent broadest claim of the parent, and a secondary patent is obtained, a PTE may be allowed for such secondary patent under the current examination guidelines, based on the authorization for the new pharmaceutical product. If the patentee may wish to obtain a PTE corresponding to a dependent claim in the future, it is recommended to file a divisional application to establish a patent specifically directed to the invention of the dependent claim, describing the invention as an independent claim.
It should also be kept in mind that the current examination guidelines have been disapproved by the Grand Panel decision and the situation is quite unstable. The JPO appealed against the Grand Panel decision, and the case is still pending at the Supreme Court. It is expected that a decision will be given within a few years. The JPO's practice has not substantially been changed since December 2011, but it is quite possible the guidelines will be revised again after a new Supreme Court decision. If the Supreme Court affirms the Grand Panel decision, then a PTE will become more easily allowed, but the scope of protection provided by an extended patent will become more restricted. In 2011, the Supreme Court decision stopped all PTE examination at the JPO until the examination guidelines were revised and fixed. It is therefore recommended that, whenever a new pharmaceutical product is authorized in Japan, an application for a PTE shall be considered for any patent covering the new pharmaceutical product, even if the PTE might appear unallowable based on the present guidelines.
I have a particular reason to welcome the judgement in Seattle Genetics. This is because it validates an argument that I first proposed in an article published in Scrip Regulatory Affairs in October 2011 (discussed on the SPC Blog here), namely that the duration of SPC protection should (where relevant) be calculated upon the basis of the notification date of a "centralised" Marketing Authorisation -- and not the (earlier) date of the European Commission's decision to issue the MA.
It is gratifying that the CJEU has validated another novel concept that I devised (the first being zero / negative term SPCs -– see this RAJ Pharma article from July 2007 and this SPC Blog post from 2011). However, it is disappointing to note that the CJEU's judgement in Seattle Genetics solely addresses the issue of SPC duration but does not comment upon the interpretation of other provisions of the SPC legislation that also rely upon the precise date ascribed to a MA.
With this in mind, I have published an article that, while noting the additional duration that should be awarded to certain SPCs (perhaps up to about 40% of all SPC applications for medicinal products), also discusses some potentially broader implications with respect to:- the deadline for filing some SPCs;- determining the date of certain national MAs; and- determining the MA date for the purposes of Articles 3(b) and 3(d) (which are two of the four key provisions that determine entitlement to SPC protection). Finally, the article mentions the battles that companies may face when trying to persuade certain national patent offices and courts to correct (by lengthening) the duration of SPCs already granted -- and points to a recent decision (discussed on the SPC Blog here) that may help to win those battles. My latest article may be viewed by clicking here. With two validated concepts under my belt, I am now keen to complete my hat-trick. Indeed, there may already be an opportunity for this. This is because another concept that I proposed (again relating to SPC duration, but this time based upon the Euratom treaty), although rejected by the UK IPO in the Genzyme case, would appear to be eminently arguable in the light of the CJEU’s decision in Merck Canada (C-555/13, see this Scrip Regulatory Affairs article from June 2014, as discussed on the SPC Blog here). However, with only one additional day at stake for less than half of all SPCs in a handful of countries, I doubt that there will be sufficient commercial incentive for any applicant to vigorously pursue the relevant arguments. Having said that, this is one occasion on which I would be delighted to be proved wrong!
Our attention has been drawn to a very recent decision of the UK Intellectual Property Office (IPO) on 6 October: it's BL O/466/15 Angiotech & UBC, a decision of Hearing Officer Dr L. Cullen.
EC Design Examination Certificate no. ID 60004045 0001, dated 21 January 2003, was filed in support of SPC applications, SPC/GB/14/030 for the product “Taxol®” and SPC/GB/14/031 for the product “Taxol®-eluding stent”. These SPC applications concern the use of paclitaxel (referred to by its trade mark, Taxol®) for preventing restenosis. The stent prevents restenosis by physically keeping the blood vessel open while a paclitaxel coating on the stent hinders cell division so preventing the formation of new blood tissue that would block the open blood vessel. The applicant argued that the procedure for obtaining an EC Design Examination Certificate under Directive 93/42/EEC for this device is sufficiently identical to the procedure under Directive 2001/83/EC for the approval of a medicinal product for human use and, as such, it can be used in support of an SPC application under article 3(b) of the SPC Regulation.
The Hearing Officer (HO) reviewed the SPC regulation, the relevant parts of the Medical Devices Directive (Directive 93/42/EEC) and of the Medicinal Products Directive (Directive 2001/83/EC). He took account of the purpose and the actual procedure that is being assessed under both Directives, as well as relevant guidance on both Directives. He reviewed relevant CJEU case law including the recent decision in Laboratoires Lyocentre, C-109/12 and also considered the relevance of previous IPO decisions concerning medical devices Cerus (BL O/141/14) and Leibniz (BL O/328/14). The HO concluded that the SPC Regulation does not provide for all products which have to have some form of authorisation before being placed on the market as being worthy of an SPC but only those authorised under the directives referred to in Article 2 of this Regulation, including Directive 2001/83/EC. He did not consider that the assessment criteria used to obtain an EC Design Examination Certificate under Directive 93/42/EEC is the same as that to obtain a marketing authorisation under Directive 2001/83/EC. The objectives of both of these systems are different given the differing uses of medicinal products and medical devices and the different means used to approve their use in humans. As a consequence, the SPC applications were found not to meet the requirements of the SPC Regulation and were rejected under Article 10(2) of this Regulation.
This is the third decision of the IPO since March 2014 on whether an SPC can be obtained based on the approval for a class III medical device. Of interest here is that fact that there was a significant difference between the date when the device was approved and the date when the patent was granted. This made it necessary to consider which was the relevant version of the legislation with regard to approval of medical device or approval of medicinal products: was it the version in force when the device approval was granted or the version in force when the patent was granted for a medical device?
The decision also considered the relevance of CJEU Case C-109/12 Laboratoires Lyocentre where the CJEU was asked whether the classification of a capsule as a medical device under Directive 93/42 in some Members States prevented it being classified as a medical product under Directive 2001/83 in others.
Article 13(1) of Regulation (EC) No 469/2009 concerning the SPC for medicinal products must be interpreted as meaning that the ‘date of the first authorisation to place the product on the market in the [European Union]’ is determined by EU law.
And that is to the provision is to be interpreted as meaning the ‘date of the first authorisation to place the product on the market in the [European Union]’ within the meaning of that provision is the date on which notification of the decision granting marketing authorisation was given to the addressee of the decision.
Many thanks go to Axel Paul Ringelhann for being the first of our readers to spot the ruling.
The issue concerned the duration of supplementary patent protection afforded to the innovative pharmaceutical industry. EU legislation provides the possibility of a supplementary protection certificate (“SPC”) to compensate a patent holder for the erosion of patent protection suffered due to the lengthy regulatory process leading to the grant of marketing authorisation (“MA”). In the EU, no medicinal product may be commercially exploited before the relevant authority has issued an MA.
However, there was confusion as to how the duration of an SPC should be calculated. EU legislation provides that the SPC is to be calculated on the basis of “the date of first authorisation to place the product on the market in the Community”. But what constitutes the date of the first MA? Is it the date when the decision granting the MA is adopted by the relevant authority? Or, is it the date on which the applicant is notified of the decision?
Following a preliminary reference from Austria, the CJEU has cleared all confusion: the relevant date is the date on which the decision is notified to the applicant.
Why will the decision benefit the pharmaceutical industry?
Not only has the CJEU’s ruling put an end to the uncertainty faced by both the innovative and generic pharmaceutical industries regarding the duration of effective patent protection afforded to medicinal products, the additional two to five days typically seen between grant of an MA and notification to the applicant can be of significant commercial value. This is particularly so as the market for a medicinal product will often reach its peak towards the end of the patent term. Taking this into consideration, the additional days per product, in every member state in which the product is marketed, potentially multiplied by several products is not insignificant!
Furthermore, although the SPC regime is harmonised throughout the EU, patents remain a national right and SPCs are granted by national patent offices. Following the CJEU’s ruling, divergence should no longer exist between member states regarding the relevant date for calculation of the SPC term allowing patent holders to be certain of a uniform SPC duration throughout the EU and, similarly, allowing competing generic companies certainty as to when patent protection will expire.
“The CJEU’s ruling will benefit all those at Seattle Genetics, its partner Takeda, and other companies who have invested significant time and efforts in the development of many innovative products that benefit patients. Seattle Genetics is grateful to the Commission and those member states that submitted written observations in support of Seattle Genetics’ position and for the timely response from both the Advocate General and CJEU on this matter”.
“This is a decision of significant importance for the innovative pharmaceutical industry which invests millions in developing a medicinal product. As such, the duration of SPC protection is essential for their medicinal products. Importantly the decision provides certainty to both innovative and generic pharmaceutical companies by clarifying when SPCs expire”.
The ruling of the Court of Justice of the European Union in Case C-471/14 Seattle Genetics (on which see earlier SPC Blog post here and JA Kemp post here) is now expected on Tuesday 6 October.
Seattle is a city that is famous for its coffee, always a good way to help wake you up -- but on 6 October the SPC community will need no wake-up call. We'll all be waiting expectantly for the CJEU to make its pronouncement.
This year's seminar run by The SPC Blog, "SPC Law and Practice 2015: All you need to know", is now open for registration. To remind you, the date of the seminar is Tuesday 10 November 2015 and the venue has again been kindly provided by Olswang LLP in its London office, in the historical Holborn area.
We offer our apologies for the fact that we have not been able to reply to all emails already sent to us regarding the seminar -– we have had a large number requesting a place before this formal invitation. We promise to reply as soon as possible confirming places.
We will try to accommodate all comers, but if demand for places outstrips the supply it may be necessary to limit the number of people attending per law firm in order to give as many firms as possible a chance of attending. Preference will be given to anyone from industry, since they are kind enough to provide the patents, the SPCs, the litigation and the competitive edge that makes the whole seminar possible.
One of our readers, a European patent attorney, has emailed to ask if we are aware of any case law involving SPC polymorphs. Here's a chance for readers to help us compile a list -- particularly readers from countries whose case law rarely gets a mention.
Both the term of an SPC and the deadline for applying for an SPC may be set by the date of the first Marketing Authorisation for a product. An issue has arisen since many Marketing Authorisations have two dates associated with them: the date of the Marketing Authorisation itself and the (later) date on which the Marketing Authorisation is notified in the EU’s Official Journal. Practice across Europe has begun to diverge as to which of these dates should be used. The UK Intellectual Property Office, for instance, uses the date of notification, as do the Belgian, Slovenian and Portuguese Patent Offices. In many other EU territories, however, the earlier date of the Marketing Authorisation is used. In practical terms this has resulted in SPCs being granted in EU territories with different terms, albeit only differing by a few days in length.
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? The Advocate General (AG) has now issued his preliminary Opinion, answering the first question by confirming that it is Community law which applies. The AG has answered the second question by confirming it is the date of notification which should be used. The AG’s Opinion is therefore in conformity with the approach currently adopted by the UK Intellectual Property Office, and Belgian, Slovenian and Portuguese Patent Offices.
The questions referred by the Oberlandesgericht Wien and the AG’s Opinion deal only with Article 13 of the SPC Regulation, which sets the term of an SPC. It is nonetheless slightly disappointing that the AG did not see fit also to comment upon other Articles in the SPC Regulation which are affected by the date of the first Marketing Authorisation. In particular, Articles 3(d) and 7, which concern the requirement for an SPC to be based on the earliest Marketing Authorisation in an EU member state, and the deadline for applying for an SPC, respectively. However, it seems likely that the same reasoning would apply to those Articles.
The AG’s opinion is not binding on the CJEU, but does set out the key points which will be taken into account by the CJEU when coming to their decision. The CJEU’s final decision is not expected for another 12 months or so.
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 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.
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 Robert.Stephen@olswang.com and let him know.
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.
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).
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  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.  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. , 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.  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  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. . 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. ). 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.
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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 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.

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