"An uncertain equation"

Howrey's IP Intelligence Newsletter Europe, Summer 2009, carries an article, "Calculating an SPC Term: An Uncertain Equation", by Marjan Noor and Claudia Zeri. It sets out the relevant recent case law and its context in a most effective fashion.

Right: when calculating the term of an SPC, be prepared for the occasional surprising result.

Some of the cases discussed can be found in the earlier postings of on the SPC Blog here and here

A Recent Review of the Scene

Alice de Pastors of Cabinet Alice de Pastors has kindly provided a shortened version of her firm's SPC News, which we're posting below:

What is the situation in July 2009?
Supplementary Protection Certificates in Europe are governed
– in the 27 EU countries, Norway and Iceland by recently codified Regulation EC Regulation No. 469/2009, replacing Regulation 1768/92, amended by Regulation (EC) No 1901/2006 of 12 December 2006 relating to medicinal products for paediatric use
– in Switzerland by National law of 3 February 1995.

Paediatric SPC extensions in Europe
- EC Regulation No. 1901/2006 on medicinal products for paediatric use entered into force, with direct effect in member states, on 26 January 2007.
As far as intellectual property is concerned, the main paediatric reward is a six-month extension of the SPC.

- Situation on 31 July 2009
We noticed applications for paediatric extension for 2 active substances.
§ Caspofungin
The corresponding applications were filed in August 2008.
For the time being the status of these applications is as follows
- Paediatric extension granted in Denmark and The Netherlands
- Paediatric extension application published in Belgium, Finland, France, The United Kingdom, Ireland, and Sweden. It is important to note that the UK Patent Office refused the paediatric extension because the application does not include an authorisation containing a statement of compliance with an agreed completed paediatric investigation plan as referred to in Article 36(1) of EC Regulation 1901/2006.
§ Losartan
The corresponding applications were filed in February 2009.
For the time being the status of these applications is as follows
- Paediatric extension granted in Denmark, Finland, France, The Netherlands and Sweden
- Paediatric extension application published in Austria, Belgium, Germany, The United Kingdom and Ireland. It is important to note that the UK Patent Office refused the paediatric extension because a statement on compliance with agreed PIP was not included in the marketing authorisation and authorisation in all the EU member states must be confirmed before the six-month extension to the SPC can be granted.

- Potential paediatric extensions for the next years
We reviewed EMEA decisions agreeing on PIP or granting waivers and noted data for medicinal active substances that are protected by a supplementary protection certificate due to expire in the next three years.
In addition to losartan (see above), we identified 10 products which could benefit from paediatric SPC extensions:
- anastrozole, docetaxel and pramipexole, protected by SPCs expiring in 2010,
- atorvastatin, latanoprost and valsartan, protected by SPCs expiring in 2011,
- zoledronic acid, rabeprazole, montelukast and candesartan, protected by SPCs expiring in 2012.

Medicinal Product SPCs in Europe from 1991 to 2008

About 11900 SPC applications for medicinal products regulated by EEC Regulation 1768/92 or National laws have been filed in European countries from January 1991 to December 2008, and published until the end of June 2009.
In the graph below, is shown, for each country the number of SPCs filed from 1991 to 2008, dispatched according to their status.

1991-2008 SPCs

The situation differs from one country to another due to the importance of the markets and/or to the applicable laws and/or to the date of entry in force of the EU Regulation.
So for SPCs in force in June 2009 we noted:
- in the twelve new EU countries (SPC EU Regulation since 2004 or later) there are few SPCs in force : 0 to 14 SPCs per country
- in Spain, Greece, Portugal and Iceland (SPC EU Regulation since 1998) there are 67, 53, 44, 3 SPCs in force, respectively
- in Denmark, Finland, Ireland and Norway (SPC EU Regulation since 1993 or 1994) there are 83, 67, 75, 52 SPCs in force, respectively
- in Austria, Belgium, Switzerland, Germany, France, United-Kingdom, Italy Luxembourg, The Netherlands, Sweden (SPC EU Regulation since 1993 or 1994 or Swiss Law) there are 108 to 134 EU or CH SPCs in force.
There are no more national SPCs in force in France and Sweden and only 19 in Italy.

Medicinal Product SPCs in Europe in 2008
How many SPCs?
868 SPCs filed in 2008 were published at the end of June 2009.
In the graph below, is shown the number of SPCs for each country.
Medicinal Product SPCs filed in 2008

Which medicinal products?
The 868 SPCs filed in 2008 and published at the end of June 2009 cover about 100 different products (active ingredients, combinations of active ingredients, or formulations).
- Among these 868 SPCs, about 18,3% relate to antineoplastic agents, 15,7% to influenza or papillomavirus vaccines, 14,6% to antiviral agents, and 10% to glucose lowering agents.
- We noted products, for which were lodged at least 20 SPCs. These products can be roughly sorted according to their therapeutic category:
· Glucose lowering agents: metformin and vildagliptin combination (30), metformin and sitagliptin combination (27)
· Direct thrombin inhibitors: dabigatran etexilate (26)
· Antivirals: efavirenz+emtricitabine+tenofovir disoproxil fumarate combination (45; 23 referring to Merck, 16 to Gilead Sciences, 3 to Emory University and 3 to Shire patents), raltegravir (25), fosamprenavir (20), maraviroc (23)
· Vaccines: H5N1 influenza vaccine (96; 29 referring to GlaxoSmithkline Biologicals, 21 to Medimmune Vaccines, 18 to Mount Sinai School of Medicine and 28 to Wisconsin Alumni Research Foundation patents), Papillomavirus vaccine (27; Cervarix® 17, Gardasil® 10)
· Antineoplastic agents: panitumumab (62; 20 referring to Amgen Fremont, 42 to Aventis Holdings and Yeda Research and Development patents), lapatinib (25), sunitinib (22), temsirolimus (21), trabectedin (20)
· Drugs used in nicotine dependence: varenicline (20).

French decisions affecting SPCs
As usual, there are very few French decisions relating to patents. We mention however a few decisions relating to SPCs.

- Decisions affecting Zinnat® drugs
Two decisions of TGI Paris relate to French SPC 92C0212 referring to French patent FR2531087:
TGI Paris (20/02/2009) Glaxo Group Ltd and Laboratoire GlaxoSmithKline / Qualimed and Merck Génériques,
TGI Paris (20/02/2009) Glaxo Group Ltd and Laboratoire GlaxoSmithKline / Sandoz
French SPC 92C0212 expired on 8 August 2008. This SPC was referring to FR2531087 patent relating to amorphous cefuroxime axetil.
According to these decisions the Court revoked French SPC 92C0212, for lack of novelty of claims 1 2 and 3 and for lack of inventive step of claims 4, 5, 7, 8, 11 and 13 of French patent FR2531087 over GB1571683 patent relating to cefuroxime axetil.

- Other decisions
We noted 3 decisions relating to French SPCs
- Cour d'appel de Paris rejected on 14/01/2009 Medimmune Vaccines appeal against the decision of the French Patent Office granting a SPC for A/Vietnam/1194/2004 (H5N1) whole virus inactivated antigen and not for Daronrix® drug: new plea in law, no substantive decision.
- The French Patent Office rejected on 26/09/2008 a SPC application for lipid complex of amphotericin B, a phosphatidyl choline and a phosphatidyl glycerol on the grounds that the 2 phospholipids were mere excipients and the SPC application did not refer to the first marketing authorisation for amphotericin B.
- Cour d'appel de Paris rejected on 11/04/2008 Novo Nordisk appeal against the refusal by French Patent Office of a SPC application for somatropin because the MA referred to was not the first MA for somatropin.

BIA Forum 2009 to tackle SPCs again

Celebrating its 20th anniversary, the BioIndustry Association has designed an attractive and colourful logo for its 2009 Forum. This event takes place on Thursday 1 October, which sadly clashes with the first full day of the CIPA Congress (both events are being held in Central London).

The Intellectual Property Hot Tops once again include SPCs, the full list being:

* Innovative Medicines Initiative (IMI) Policy and Guidance
* European Patent Office (EPO) procedural changes
* Patent litigation update
* EPO referral on dosage regimes
* US legislation – an update following the introduction of the Obama administration
Court costs updates
* Supplementary Protection Certificates (SPCs)
* European Litigation and Legislation updates)

The Hot Topics speakers and panelists are

* Michael Burdon, Partner, Olswang
* Kristina Cornish, Partner, Kilburn & Strode
* Fiona Crawley, Counsel, Bryan Cave
* Sue Foster, Attorney, Mintz, Levin, Cohn, Ferris, Glovsky & Popeo
* Tim Powell, Partner, Powell Gilbert
* Sarah Roques, Partner, JA Kemp & Co
* Olivér Várhelyi, Head of Unit Industrial Property, DG Internal Market & Services, European Commission

The 2009 Forum web page, with lots 0f details and registration form, can be accessed here. The SPC Blog recalls that last year's BIA Forum was greatly appreciated by those who attended, and is sure that the special attention again devoted to SPCs will help keep this topic high on the agenda of priority issues in the bio-sector.

SPCS: good for Europe, bad for India?

From the Institute of International Trade (the Centre for WTO Studies affiliated to the West Bengal University of Technology) comes a report that India is currently engaged in bilateral negotiations with the European Union over a Free Trade Agreement which contains a chapter on the Intellectual Property. The article quotes IP commentator and author Carlos M. Correa as warning that higher IP standards sought by the EU can create disaster for the supply the FTA resulting in the future extension of patents as well as the possibility of preventing generic competition.

Left: The Taj Mahal: steps were famously taken here to prevent the manufacture of copies ...

The article continues:

"Not only ‘data exclusivity’ provision, FTA also contains the idea of ‘supplementary protection certificate’ that requires for the extension of patent term for an additional 5 years so that it can compensate the minimum time required for the marketing approval of a medicinal product".

The article concludes that the FTA would be bad news for India -- a conclusion that is presumably coloured by the assumption that the only sector of the Indian pharma industry that needs the protection of law is the generic sector, and this will remain the case.

A brisk search of the usual European news sources has not thrown any light on these negotiations. Can any reader of this weblog enlighten us?

IPI initiative on paediatric inconsistencies links patent offices

For what may well be the first time in its history, the lead article in the August Newsletter of the Intellectual Property Institute (IPI), London is about SPCs -- and indeed about the particularly live issue of paediatric extensions. The text runs as follows:

"Paediatric Extensions to Supplementary Protection Certificates

The Institute has been in discussion with a number of stakeholders about present legal uncertainties surrounding applications for the 6-month paediatric extension to a supplementary protection certificate. In order to express concerns that have been expressed about the implementation of the scheme for the examination of applications for paediatric extensions, the Institute convened a meeting at the European Patent Office in The Hague. Delegates included representatives from patent offices all over Europe, officials from the regulatory agencies, and industry (the users).

Genevieve Michaux, a regulatory expert from Covington and Burling LLP, set the scene by outlining the current, rather complex provisions, and there followed an extensive round table discussion among the delegates under the Chatham House rule.

A full report of the meeting will be issued at a later date, but one key issue arising from the meeting was the fact that there were differing views among the national patent offices concerning the documents to be submitted upon filing an application for an extension. It was argued that the end of procedure notification should sufficiently demonstrate the approval of a paediatric product in all Member States. However, the notification is not currently set out in a standard form and it may not include some of the information needed by the national patent offices: it was clear that it would be very useful to develop a common format for this document. This was just one of a number of issues discussed at the meeting which we will be following up in due course".

The IPI should be commended for taking this initiative. It is a small organisation with few resources, yet it selflessly takes on tasks for the benefit of the wider community. Readers whose companies would like to participate in or otherwise support the work of the IPI, which has charitable status, should email its Director, Dr Paul Leonard, here or telephone him on +44 20 7436 3040.

Questions about the codified Regulation No. 469/2009

The SPC Blog has received a few interesting questions about the new codified Medicinal Product Regulation (EC Regulation No. 469/2009) from John Miles of Potter Clarkson:

"The codified Medicinal Products SPC Regulation (Regulation No 469/2009) does not include within its text any of the apparent amendments made to its predecessor (Regulation No 1768/92) by virtue of Recital 17 of the Plant Protection Products Regulation (Regulation No 1610/96). In particular, Article 3(2) of the Plant Protection Products Regulation is not included in the codified Medicinal Products Regulation.

Article 3(2) of Reg. 1610/96 states:

"The holder of more than one patent for the same product shall not be granted more than one certificate for that product. However, where two or more applications concerning the same product and emanating from two or more holders of different patents are pending, one certificate for this product may be issued to each of these holders. "

This point was addressed to an extent in the following extract from the Record of the third meeting of national SPC experts held at the EMEA on 26 September 2008 (the bit in bold is the question, and the bit in plain text thereafter is the answer recorded).

The Commission has reccently proposed a codified version of Regulation1768/92 including the amendments introducted by Regulation (EC) No 1901/2006, see http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:52008PC0369:EN:HTMLWhy does this version not include amendments that were introduced by Regulation 1610/96 (see in particular recital 17)?

Some enquiries have been received in this regard and transmitted to the Commission services competent on the codification legislation. They considered that Regulation 1610/96 did not introduce any amendment into Regulation 1768/92. Therefore, no provision originating from Regulation 1610/96 is present in the consolidated version of Regulation 1768/92.

Recital 17 of Regulation 1610/96 does no more than state that certain provisions of Regulation 1768/92 must be interpreted in accordance with certain "detailed rules" contained in Regulation 1610/96.

Regulation No 1768/92 was repealed by Regulation No 469/2009 (see Article 22). The second paragraph of Article 22 states that

References to the repealed Regulation shall be construed as references to this Regulation and shall be read in accordance with the correlation table in Annex II.

Does this mean that Recital 17 of the Plant Protection Products Regulation applies to the codified Regulation No 469/2009 in the same way it applied to Regulation No 1768/92 (now repealed)?

If so, is it certain the codified Medicinal Products Regulation has to be interpreted to include Article 3(2) of the Plant Protection Products Regulation?

If Article 3(2) does not apply to the codified Medicinal Products Regulation, is there anything in that Regulation to prevent the holder of more than one patent for the same product obtaining more than one certificate for that product?

Below is an extract from the Record of the first meeting of national SPC experts held on 3 February 1995 (ie before the 1610/96 Regulation came into force) which seems to indicate that the original 1768/92 Regulation should be interpreted to allow for more than one certificate in that circumstance.

First Question
After an application for an SPC has been lodged for a particular product but before the certificate is granted, may a second party lodge a separate application for an SPC in respect of the same product and obtain a certificate like the first applicant?

Answer:
The Commission representative indicated that severall applications could be lodged for a particular product, either by the same company or different companies. With regard to the admissibility of these application, the only condition to be met was that, at the date of the application, the product had not already been the subject of a certificate (Article 3(c)). Accordingly, if on the date of lodging the application a certificate had already been granted for the product on the basis of the Regulation, the new application was inadmissible under Article 3(c). On teh other hand, if no certificate had been granted, the second application was admissible.

No delegation expressed a dissenting view. "

If someone can clarify some of these points, please do so in the Comments section below.

Losartan paediatric extension: news from France

The SPC Blog is pleased to have heard from Michèle Lavé (Cabinet Alice de Pastors, Le Chesnay, France) that on Friday the French Patent Office published in the BOPI the grant of the paediatric extension of French SPC for Losartan (95C0018). The extension was granted on 6 July 2009, giving a new expiry date of 2 March 2010.

Losartan extension: not granted in the United Kingdom, but granted in The Netherlands