Paediatric extensions: is there an official county-by-country list?

One of our readers has asked if there exists a reliable and authentic source that lists all of the countries which support paediatric patent extensions. This blogger clicked around the World Intellectual Property Organization and World Health Organization websites a bit, but couldn't find such a list in either of them -- and he's not sure who else might compile one. Does anyone know?

What has the CJEU said this time? A review of the latest SPC musings from Luxembourg

Following the Actavis v Boehringer (C-577/13) judgment from earlier this month (on which see the SPC Blog post here), AIPPI is putting on another Rapid Response event to discuss the implications of this decision for existing and future SPCs.  The event will also look at January’s Forsgren (C-631/13) judgment (discussed here), which has profound things to say on the way active ingredients can be protected by SPCs, particularly for complex biologic products.  

Michael Lubienski (UCB), who was closely involved in the Forsgren referral, will be joined by Edward Oates and Daniel Wise from the SPC group at Carpmaels & Ransford LLP to discuss these decisions.  

The event takes place this Monday, 30 March 2015 (5.30 pm for 6 pm start) at Carpmaels & Ransford (1 Southampton Row, London, WC1B 5HA), with drinks afterwards.  

Attendance is free for UK AIPPI members and new applicants for membership, and a mere £25 for non-members.  If you would like to attend the event, please register at https://aippiuk-cjeu-spcs-again.eventbrite.co.uk/

SPCs for beginners

Recently The SPC Blog posted this item on the forthcoming SPC for Beginners, run by FORUM-Institut on 6 May in Frankfurt, offering a 10% registration fee reduction to readers of this weblog. It's not the only course of its kind, though. One of our readers has drawn our attention to the fact that there's another one coming up a few weeks later in London. There's no special rate for SPC Blog readers, but there is a 15% early bird reduction if you register before 1 May. Its details are as follows:

"SPCs for beginners", Tuesday 16 June 2015. Venue: The Rembrandt Hotel, London. In the chair is Paul Inman (Wragge Lawrence Graham LLP). Speakers are four Drs: Paul Brady (Abel & Imray), Oliver Kingsbury (Elkington & Fife LLP), Andrew Rudge (Pfizer Ltd) and Mike Snodin (Park Grove IP). For further details and registration, just click here.

This blogger believes that FORUM Institut and Management Forum were once related, but wonders whether it is time for their branding to diverge a little ...

Notification dates, (co)exclusivity, similar drugs, orphans and the FDA: a comment

Further to Marc Nevant's observations, posted on The SPC Blog yesterday (here), Mike Snodin -- whose article Marc cited -- has added some further comments of his own. Says Mike:

The EMA’s reliance upon the Notification Date for calculating periods (data exclusivity and orphan market exclusivity) running from the date of a MA is confirmed in the answer to question 12 in “EMA Procedural advice for users of the centralised procedure for generic/hybrid applications” (see this link).

The EMA’s practice on this point was the basis of one of the arguments in my article from October 2011. The legal basis for that practice is Article 297(2) of the Treaty on the Functioning of the EU, which is a point noted in my article from October 2014.

The decision in T-140/12 is fascinating, as it appears to mean that the (co-)exclusivity awarded to one product can effectively extend the period of (co-)exclusivity on the market for another, “similar” product. In this respect, that decision is similar to that in Depomed Inc. v U.S. Department of Health and Human Services et al., Case No. 1:12-cv-01592, where orphan exclusivity was awarded to a non-identical drug in circumstances where “clinical superiority” of that drug had not been demonstrated over an already approved, “similar” drug.

The FDA does not appear to be inclined to follow the ruling in Depomed (see this link), and so it will be very interesting to see what Teva does in respect of the ruling in T140/12 – and whether the CJEU will eventually get to rule on this aspect of orphan marketing exclusivities.

Thanks, Mike!

Determination of periods of regulatory exclusivity: grant date v notification again!

From our friend and reader Marc Nevant (French and European Patent Attorney, Cabinet Beau de Loménie, Paris) comes the following note, for which The SPC Blog offers its sincere thanks. Writes Marc:

I have recently come across Case T-140/12, a General Court of the European Union ruling in Teva v European Medicines Agency (EMA). In short, Teva sought an order to annul the EMA’s refusal to grant its application for marketing authorisation (MA) for imatinib Ratiopharm, a generic version of (Novartis's) orphan drug product imatinib (trade name Glivec), in so far as it concerned therapeutic indications for the treatment of chronic myeloid leukaemia (CML).

The matter is essentially about orphan drug exclusivity and the interpretation of Regulation 141/2000 on orphan medicinal products. There is, however, a parapraph in the decision that should be of interest for the readers of this blog. Paragraph 12 mentions that 

“Pursuant to Article 8 of Regulation No 141/2000, the period of market exclusivity enjoyed by the medicinal product imatinib, marketed under the commercial name Glivec, in so far as concerns the CML therapeutic indications — the original marketing authorisation for which took effect on 12 November 2001 — expired on 12 November 2011”.

It turns out that 12 November 2001 is the date of notification of the MA (the grant date being 7 November 2001). This suggests that the determination of periods of Regulatory Exclusivity for centrally approved products could be affected by the “grant date v notification date” debate, and further suggests (if the decision is transposed to SPC cases) that, for centrally approved products, the date of notification of the MA is de facto the date referred to in §1 of Article 13 of SPC Regulation 469/2009, as already argued at length by Mike Snodin (see e.g. the post on this blog of 30 October 2014).

Let’s hope that the judges in Seattle Genetics (on which see earlier posts here and here) will share this view!

SPCs for first-timers and old hands: a couple of forthcoming events

From Rechtsassessor Jean-Claude Alexandre Ho (Conference Manager Intellectual Property, FORUM Institut für Management GmbH) comes news of two more SPC seminars. They are:

The Frankfurt coat of arms

1. 'Supplementary Protection Certificates', the sixth edition of FORUM's English SPC seminar with Dr Christopher Brückner, the author of the SPC commentary (participants will receive the latest edition on top of course documentation). Date: 7 and 8 May 2015; venue: Frankfurt. More information is available here. SPC Blog readers are entitled to a 10% discount against the registration fee (€ 1,200 instead of € 1,340).

2. 'SPC for Beginners', the fourth edition of FORUM'S basic SPC seminar in English, once again with Dr Christopher Brückner. Date: 6 May 2015; Venue: Frankfurt. More information is available here. SPC Blog readers are entitled to a 10% discount against the registration fee (€ 880 down from € 980). 

To register and gain the benefit of your reduced fee (valid only for registrations until 8 April 2015), just forward this blogpost to Jean-Claude himself at jc.alexandreho@forum-institut.de, or call him, quoting "The SPC Blog" (+49 6211 500-675) and specifying which event(s) you would like to attend.

This blog is always pleased to learn of events for which discounts are available for its readers.

No paediatric extension when conditions are not met before SPC expires

In BL O/098/15 Otsuka Pharmaceuticals Company Limited's application, 4 March 2015, Dr Lawrence Cullen, for the United Kingdom's Intellectual Property Office (UKIPO), held that it was not possible to grant an application for a paediatric extension for patent protection when the conditions for establishing one's entitlement to a paediatric extension -- the completion of investigations relating to paediatric indications and the issue of an updated marketing authorisation  -- had not been fulfilled before the expiry of the SPC.

Otsuka, who had an SPC for ‘aripiprazole or a salt thereof’, used in the treatment of schziphrenia and bipolar affective disorder, was unsuccessful in securing a paediatric extension. In reaching his decision, Dr Cullen distinguished the earlier and authoritative decision of the Court of Appeal for England and Wales in EI du Pont de Nemours & Co v UKIPO [2009] EWCA Civ 966 [on which see The SPC Blog post here and note by Sebastian Moore and Jonathan Turnbull here], on the basis that, in that case, while the requirements for an extension had not been met at the date of application, they had still been met before the date of expiry of the related SPC and it was the case that matters in relation to the extension of an SPC had to be decided before that SPC expired. This was so even if the decision was taken on the last day of the SPC's existence because, once the SPC expired, others were entitled to enter the market and the interest of third parties (i.e. generic pharmaceutical companies) had to be taken into account.

In Dr Cullen's own words:

"55 I accept that the applicant has to carry out the studies in the paediatric population first and get approval from the EMEA. This involves a commitment of time and resources up front. I accept that if the applicant carries out the necessary steps, then they should be entitled to the reward without taking too restrictive a view of how and when the applicant meets the requirements to qualify for an extension to the SPC.

56 However, I do not take this to mean that this should extend beyond the expiry date of the SPC. I think that it is reasonable to expect that matters in relation to an extension to an SPC are decided before the SPC expires, even if this decision is taken on the last day of the SPCs existence! Once the SPC expires, others are entitled to enter the market. Because of this, I think that, after the expiry date of the SPC, one must take account of the interest of third parties. Knowing when the SPC will expire is important for the entry of third parties, such as generic medicine companies, into the market because once the SPC expires; they are free to bring their own versions of the medicines comprising this active ingredient to market. If an application for an extension to a granted SPC was still considered to be capable of rectification after the expiry date of the SPC and the grant of an extension could be back-dated, this would, in my view, introduce uncertainty and, even, the potential for abuse. It would not be clear in such a situation when the paediatric studies would have to be completed by and when the updated MA would be available. There needs to be some clarity as to when matters are complete and others can enter the market. This seems to me to represent an appropriate balance, as referred to in recital 10 of the SPC regulation, to take account of all the interests at stake “in a sector as sensitive and complex as pharmaceuticals” while also making sure that research into paediatric uses of medicines is given the necessary incentive".

An applicant for a paediatric extension has 28 days in which to appeal.

Telmisartan: no double-dipping says CJEU, as it avoids answering all the questions

This morning the Court of Justice of the European Union (CJEU) delivered its ruling in Case C‑577/13, Actavis Group PTC EHF, Actavis UK Ltd v Boehringer Ingelheim Pharma GmbH & Co. KG, this being a request for a preliminary ruling from the Patents Court, England and Wales.

In short, this is a tale of a European patent application for ‘Benzimidazol derivatives, medicaments containing them and process for their preparation’ which Boehringer filed 23 years ago, in 31 January 1992 and which was granted in May 1998 (the ‘basic patent’). This patent disclosed and claimed numerous molecules, one of which is telmisartan -- an active ingredient for treating high blood pressure and to reduce cardiovascular morbidity (a fancy term for 'heart disease') in adults.  Claims 5 and 8 of the basic patent were for telmisartan alone and for one of its salts.

On the basis of that patent and a marketing authorisation granted on in December 1998 for the medicinal product Micardis, which contained telmisartan as the sole active ingredient, Boehringer obtained in August 1990 a supplementary protection certificate (SPC -- a patent term extention) for it. The product description for this SPC was ‘[t]elmisartan, optionally in the form of a pharmaceutically acceptable salt’. This SPC expired in December 2013.

Meanwhile, in April 2002 a company in the Boehringer group secured a marketing authorisation for a combination of telmisartan and hydrochlorothiazide (a diuretic that acts by inhibiting the kidney’s ability to retain water). The hydrochlorothiazide molecule has been known since 1958 and is in the public domain. Telmisartan and hydrochlorothiazide are the sole active ingredients of the medicinal product sold by Boehringer as MicardisPlus. In September 2002 Boehringer applied to the UK  Intellectual Property Office (UKIPO) for an SPC for the combination of the active ingredients telmisartan and hydrochlorothiazide. Hold on, said the UKIPO, the combination must be clearly claimed in the patent if it is to be regarded as requiring protection as such -- but the basic patent contained only claims which related to telmisartan by itself. So why not apply to amend the basic patent by inserting a claim to the combination of telmisartan and hydrochlorothiazide?

Boehringer, taking the UKIPO up on this suggestion, asked for the application for the combination SPC to be suspended and, in November 2003, applied to the UKIPO to amend the basic patent by inserting a new claim 12, relating to a pharmaceutical combination of telmisartan and hydrochlorothiazide. The UKIPO agreed to all of this, granting the application to amend in November 2004: the patent as amended expired on 30 January 2012.

As soon as the amendment was allowed, Boehringer asked the UK IPO to revive its suspended application for the combination SPC application. Fine, said the UKIPO, and the combination SPC was granted in January 2005. It is due to expire on 30 January 2017.

This all looks so straightforward that it is hard to imagine that anything might go wrong.  But we have not yet reached the end of the story.

Actavis, a generic medicinal products manufacturer, claimed that the combination SPC was invalid since, at the date on which the application was originally made for it back in September 2002, claim 12 did not yet exist and the product in question was not therefore specified anywhere in the claims of Boehringer’s basic patent. But this is no problem, responded Boehringer. After all, is it not allowed under both EU and national legislation to amend patents after they have been granted?  Since the result of an amendment has retrospective effect, the basic patent retrospectively protected the product for which the combination SPC application was originally made before the amendment.

Actavis's action, lodged with the Patents Court, England and Wales, come before Mr Justice Birss who decided to pose the following questions for a preliminary ruling:

‘(1) (a) If a patent does not, upon grant, contain a claim that explicitly identifies two active ingredients in combination, but the patent could be amended so as to include such a claim, could this patent, whether or not such an amendment is made, be relied upon as a “a basic patent in force” for a product comprising those ingredients in combination pursuant to Article 3(a) of Regulation No 469/2009/EC?

(b) Can a patent that has been amended after the grant of the patent and either (i) before and/or (ii) after the grant of the SPC be relied upon as the “basic patent in force” for the purposes of fulfilling the conditions set out in Article 3(a) of Regulation No 469/2009?

(c) Where an applicant applies for an SPC for a product comprised of active ingredients A and B in circumstances where:

(i) after the date of application for the SPC but before the grant of the SPC, the basic patent in force, being a European Patent (UK) is amended so as to include a claim which explicitly identifies A and B;

and

(ii) the amendment is deemed, as a matter of national law, always to have had effect from the grant of the patent;

is the applicant for the SPC entitled to rely upon the patent in its amended form for the purposes of fulfilling the [Regulation No 469/2009] Article 3(a) condition?

(2) For the purposes of determining whether the conditions in Article 3 [of Regulation No 469/2009] are made out at the date of the application for an SPC for a product comprised of the combination of active ingredients A and B, where:

(a) the basic patent in force includes a claim to a product comprising active ingredient A and a further claim to a product comprising the combination of active ingredients A and B, and

(b) there is already an SPC for a product comprising active ingredient A (“Product X”), is it necessary to consider whether the combination of active ingredients A and B is a distinct and separate invention from that of A alone?

(3) Where the basic patent in force “protects” pursuant to Article 3(a) [of Regulation No 469/2009]:

(a) a product comprising active ingredient A (Product X); and

(b) a product comprising a combination of active ingredient A and active ingredient B (“Product Y”);

and where:

(c) an authorisation to place Product X on the market as a medicinal product has been granted;

(d) an SPC has been granted in respect of Product X; and

(e) a separate authorisation to place Product Y on the market as a medicinal product has subsequently been granted,

does … Regulation [No 469/2009], in particular Articles 3(c) and (d) and/or 13(1), preclude the proprietor of the patent being issued with an SPC in respect of Product Y? Alternatively, if an SPC can be granted in respect of Product Y, should its duration be assessed by reference to the grant of the authorisation for Product X or the authorisation for Product Y?

(4) If the answer to Question 1(a) is in the negative and the answer to Question 1(b)(i) is positive and the answer to Question 1(b)(ii) is negative, then in circumstances where:

(a) in accordance with Article 7(1) of … Regulation [No 469/2009], an application for an SPC for a product is lodged within six months of the date on which a valid authorisation to place that product on the market as a medicinal product has been granted in accordance with Directive 2001/83/EC or Directive 2001/82/EC [of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (OJ 2001 L 311, p. 1)];

(b) following the lodging of the application for the SPC, the competent industrial property office raises a potential objection to the grant of the SPC under Article 3(a) of … Regulation [No 469/2009];

(c) following and in order to meet the aforesaid potential objection by the competent industrial property office, an application to amend the basic patent in force relied upon by the SPC applicant is made and granted;

(d) upon amendment of the basic patent in force, the said amended patent complies with Article 3(a) [of Regulation No 469/2009];

does Regulation [No 469/2009] prevent the competent industrial property office from applying national procedural provisions to enable (a) suspension of the application for the SPC in order to allow the SPC applicant to apply to amend the basic patent, and (b) recommencement of the said application at a later date once the amendment has been granted, the said date of recommencement being

– after six months from the date on which a valid authorisation to place that product on the market as a medicinal product was granted, but

– within six months of the date on which the application to amend the basic patent in force was granted?’

This morning the CJEU cut to the chase and answered all these questions with a brevity which will be commendable if it provides the information that the trial judge actually needs in order to make his decision:

Article 3(a) and (c) of Regulation ... 469/2009 ... must be interpreted as meaning that, where a basic patent includes a claim to a product comprising an active ingredient which constitutes the sole subject-matter of the invention, for which the holder of that patent has already obtained a supplementary protection certificate, as well as a subsequent claim to a product comprising a combination of that active ingredient and another substance, that provision precludes the holder from obtaining a second supplementary protection certificate for that combination.

Comments on this decision are, as usual, welcomed.