Patent term extension in Japan: a guest post

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. 

  Introduction            

  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] 

  Practical suggestions            

  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. 

Repercussions of Seattle additional duration: an article

It is no secret that our good friend Mike Snodin (Park Grove IP) has taken a keen interest in the Seattle Genetics reference to the Court of Justice of the European Union (Case C-471/14), so no readers of this weblog will be surprised that he has some further thoughts about this ruling which he is happy to share with us.  As Mike explains: 

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!

Paclitaxel: when Design Examination Certificates are not enough

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.

According to the IPO's summary (to which we have added some handy links and emboldened text):

Paclitaxel

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.

More pay-days for pharma patents, thanks to Seattle Genetics ruling

Today, in a very short judgment of just 41 paragraphs, the Court of Justice of the European Union (CJEU) confirmed the Advocate General’s Opinion in Case C-471/14 Seattle Genetics Inc, by holding that:

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.

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:

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.

There follows a quick word from Mark Sandbaken, VP, Intellectual Property for Seattle Genetics, who was clearly quite chuffed by the decision:

“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”.

Date fixed for Seattle ruling

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.

"SPC Law and Practice 2015: All you need to know": now open for registration

Anyone working with SPCs must have
a very special sort of understanding ...

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.

Details of the programme can be accessed by clicking here. To register, please email Natalie Whiteford at natalie.whiteford@olswang.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.

SPCs and polymorphs

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.

Seattle Genetics and the question of dates: the Advocate General opines

Congratulations to JA Kemp for so speedily posting this news item on yesterday's Advocate General's Opinion in the Court of Justice of the European Union (CJEU) SPC reference in Case C-471/14 Seattle Genetics. This was a request for a preliminary ruling from the Oberlandesgericht Wien. According to this note:

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.

This issue came before the Oberlandesgericht Wien after Seattle Genetics appealed a decision of the Austrian Patent Office to use the date of Marketing Authorisation to calculate the term of an SPC. Given the divergent practice across the EU territories, and the fact that it was not clear whether Community law or local law should apply, the Oberlandesgericht Wien referred two questions to the CJEU. The questions referred were:

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.

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.

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 Robert.Stephen@olswang.com and let him know.