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
Thursday, 26 November 2015
Friday, 20 November 2015
This is a quick notice that, on 17 November 2015, the Supreme Court rendered a decision rejecting the JPO's appeal against Intellectual Property High Court (IPHC) Grand Panel decision issued in May 2014. As a general principle, the Supreme Court decision can be outlined thuss:
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.The decision applied the above principle to the present facts as follows:
In the context of product patents directed to ingredients of pharmaceutical products, "elements examined for authorization relevant to substantial identicalness as a pharmaceutical product" are components, quantity, administration, dosage amount, effect and efficacy. Administration and dosage amount of the previously authorized pharmaceutical product are
"... intravenous drip infusion of 5mg/kg (body weight) per dose or 10mg/kg (body weight) per dose ... administration interval is 2-week or longer ...",
while those of the newly authorized pharmaceutical product are
"... 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.
Upon the Supreme Court decision, the JPO announced on 18 November 2015 that the JPO starts revising its PTE examination guidelines and stops examinations for PTEs until a publication of the revised guidelines. It is expected that under the revised guidelines, applications for PTE shall be more easily allowed. Further, while the Supreme Court decision is silent, as IPHC Grand Panel decision mentioned in obiter dictum, scope of an extended patent may become narrower than previously expected. 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
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).
Further, in our previous post, it was mentioned that
"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.
Wednesday, 18 November 2015
- Case Law Update - Hugh Goodfellow
- Pharmaq v Intervet International – 9 April 15 EFTA Court judgment re scope of protection of SPC for biologics - Patricia Cappuyns
- Concept of unitary SPCs - Bettina Wanner & Steven Ward
- Practice and Practically: Assessments from the national offices - Céline Magou-Santiano, Dolores Cassidy, Dr Oliver Werner, Martijn de Lange & Patrick Purcell
- SPCs - Advanced manufacturing waiver – Dr Gareth Morgan
We're trying to sort out the videos and will get back to you soon. Hang on in there!
Monday, 9 November 2015
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.
Relevant provisions of Japanese Patent Act
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."
Art 68-2 provides effects of PTE, i.e. "Where the duration of a patent right is extended ..., such patent right shall not be effective against any act other than the working of the patented invention for the product which was the subject of the disposition [authorization] ... which constituted the reason for the registration of extension (where the specific usage of the product is prescribed by the disposition [authorization], the product used for that usage)." [Japanese Patent Act]
PTE examination practice at JPO until 2011
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.
Supreme Court decision in April 2011
Finally, on 28 April 2011, the Supreme Court gave a decision determining that the above JPO practice is not legitimate [H21(Gyo-hi)326: Takeda v Commissioner of Patents]. According to the decision, an application for a PTE cannot be rejected based on a previous authorization if a pharmaceutical product authorized by the previous authorization does not fall within the scope of any of the claims of the subject patent for which PTE is applied. The decision opened a door for PTE of a patent protecting a new formulation, such as DDS drugs. [H21(Gyo-hi)326]
Revised examination guidelines in December 2011
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).
There remained a question of whether such revised guidelines (to refuse a PTE if the independent claim only recites active ingredient A, or a combination of active ingredient A and excipient polymer B) are in accordance with Article 67 paragraph 2, because marketing of the new pharmaceutical product (A+B+C2) is not allowed under authorization for the old pharmaceutical product (A+B+C1). It may be possible to argue that "there is a period during which the patented invention is unable to be worked" in respect of the pharmaceutical product (A+B+C2) until a new authorization is obtained for the new pharmaceutical product (A+B+C2), even though the patented invention was able to be worked in respect of the old pharmaceutical product (A+B+C1). New-drug developers again fought in courts questioning whether JPO's revised practice is legitimate or not. [Revised Guidelines]
Intellectual Property High Court (IPHC) Grand Panel decision in May 2014
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.
The decision also mentioned in obiter dictum that, during the extended period, the patent will cover only a drug within both the scope of claim of the patent and the scope of the authorized pharmaceutical product in respect of “components (not only active ingredients), administration, dosage amount, effect and efficacy”, and equivalents or substantially identical products thereof. Since the PTE system was established in 1988 in Japan, there has been no legal precedent determined in ratio decidendi what is the claim scope of an extended patent. [2013(Gyo-Ke)10195]
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.
Friday, 6 November 2015
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!
Sunday, 25 October 2015
According to the IPO's summary (to which we have added some handy links and emboldened text):
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?
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.
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.
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.
Tuesday, 6 October 2015
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.Many thanks go to Axel Paul Ringelhann for being the first of our readers to spot the ruling.
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.
An early press release from London-based law firm Bristows observes that the ruling will be welcomed by innovative (= patent-owning) pharmaceutical companies, explaining the decision like this:
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!There follows a quick word from Mark Sandbaken, VP, Intellectual Property for Seattle Genetics, who was clearly quite chuffed by the decision:
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”.Representing Seattle Genetics, Marie Manley (Partner and Head of Bristows' Regulatory Practice added:
“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”.
Tuesday, 22 September 2015
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.
Sunday, 20 September 2015
|Anyone working with SPCs must have|
a very special sort of understanding ...
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.
Details of the programme can be accessed by clicking here. To register, please email Natalie Whiteford at email@example.com
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.