Negative term SPC duration: a business intelligence consultant's perspective

Martin Paltnoi (Principal Consultant, Martin Paltnoi Associates) has written to The SPC Blog with the following observations:

"As a business intelligence consultant covering pharmaceuticals in general and patents in particular I have been following the SPC situation since its inception in 1993. Also in my capacity as joint editor of Pharma Patent Bulletin,  reporting in that journal on SPCs on a regular basis, I have obviously noticed the existence of negative SPC duration.

This phenomenon has been incurred through the existence of the paediatric investigation plans (PIP) through the Paediatric Use Marketing Authorisation (PUMA). This has evoked raised eyebrows and objections, the latest coming from Greg Perry, the EGA's Director General,  who is quite naturally concerned about giving more exclusivity to originators and thereby holding up access to generic activity. In the EGA's press release "Better Patents Make Better Medicines..." it was stated that "zero or negative term SPCs should not be extended".

This prompted me to look a little closer into the whole matter. It must be understood that the extra exclusivity time allowed was as an incentive and/or reward to conduct more work on paediatric medicines. This reward was to be by adding extra time (six months) to the SPC, but is this the right way? We have seen that there have been those originators whose patents give more than the minimum fifteen years exclusivity and thereby do not qualify for an SPC. But should they be excluded from qualifying for the extra six months for extra paediatric work? I suggest not. The way this has been dealt with is to allow negative duration SPCs.

Should the argument against negative SPCs be successful, this could have a negative effect. If there is no reward there will be no activity, which would be contrary to the objectives of PUMA. On the other hand, should these objections be noted by the European Commission's pharmaceutical sector enquiry, one possible outcome is that the extra six months be allowed either on the SPC or patent, whichever has the later expiry. This would definitely be against the intentions of the EGA, but would be more realistic as a means of rewarding paediatric product development".

The SPC Blog invites readers' comments, which may be posted below.

Harmonisation in Denmark: Patents covering pharmaceutical compositions may now be designated as basic patents

Casper Struve (Zacco Denmark A/S) has provided information on how the Danish Patent and Trademark Office deals with SPC applications where the basic patent is a pharmaceutical composition patent:

"The current Danish guidelines for SPC examination (as valid from 19 October 2005) explicitly states that patents on pharmaceutical compositions cannot be designated as a basic patent. This has long been the position of the Danish Patent and Trademark Office.

This position of the Danish Patent and Trademark Office have changed as explained in the following.

A hearing at the Danish Board of Appeal was scheduled for 25 March 2009 regarding the above issue of whether or not SPC applicants may validly designate pharmaceutical composition patents as basic patents. The hearing was cancelled, as the Danish Patent and Trademark Office in letters to the appellants dated 20 March 2009 acknowledges that neither the SPC regulation nor the preparatory work speaks against that a patent protecting a pharmaceutical composition containing the product concerned in the SPC application can be used as a basic patent for a supplementary protection certificate.

In letters relating to Case No CA 2007 00042 and Case No CA 2000 00008 dated 20 March 2009 the Danish Patent and Trademark Office states the following:

"In relation to the present case the Danish Patent and Trademark Office have
considered that a patent that solely protects a pharmaceutical composition containing the product cannot be used as a basic patent, cf. the definition of basic patent in Regulation (EEC) No 1768/92, Article 1(c).
[...]
The Danish Patent and Trademark Office acknowledges that neither Regulation EEC No 1768/92 concerning the creation of a supplementary protection certificate for medicinal products, nor the preparatory work (KOM(90) 101 final edition), speaks against that a patent protecting a pharmaceutical composition containing the product concerned in the SPC application, can be used as a basic patent for a supplementary protection certificate."

This new position adopted by the Danish Patent and Trademark Office is welcomed and seen as a positive step in harmonising the SPC regulation on community level. It should be incorporated into the new guidelines for examination of SPC's, which will issue together with the long awaited guidelines on Paediatric SPC extensions. Rumour has it that these guidelines are very close to being finalised."

Profender SPC (UK)

Astellas Pharma Inc's application, another decision on an SPC application on a combination product was handed down by the UK's IPO recently, where the Takeda decision was followed.

In the case in question, a combination of active ingredients emodepside and praziquantel, marketed under the trade mark Profender, was the subject of supplementary protection certificate (SPC) application number SPC/GB/06/002. The marketing authorisation on which this application was based was for the combination product emodepside and praziquantel. However, the patent on which the application was based clearly disclosed the active ingredient emodepside but provided no indication, specific or generic, of the other active ingredient praziquantel.

The Examiner refused the application on the grounds that the product, Profender, was not covered by the basic patent. Moreover, the Examiner had issues with the applicant's request to change the product definition to read "a product comprising Emodepside." Particularly, a product defined with reference to Emodepside alone would require a corresponding authorisation for Emodepside alone to satisfy Article 3(b).

In his decision, Lawrence Cullen, acting for the Comptroller, considered the case law on the interpretation of Art. 3(a) to determine what is "protected" and felt obliged to follow the decision in Takeda Chemical Industries Ltd's SPC Applications (No 3) [2004] RPC 3, and distinguished Gilead's SPC application [2008] EWHC 1902 (Pat) because in that case the patent included a claim for the patented compound in a carrier and "optionally other therapeutic ingredients". In this case there was no equivalent broad composition claim. The product, Profender was not protected by the designated basic patent for the purposes of satisfying Art. 3(a) of EC Regulation 1768/92.

In addition, the request by the applicant to change the product definition to read “A product comprising Emodepside” was found to be contrary to Article 3(b) of the Regulation. Article 1(b) of the Regulation dictates that the authorised combination of emodepside and praziquantel is a different product from emodepside alone. Therefore, the proposed product was not authorised and Article 3(b) was not complied with.

An appeal may be lodged by the applicant within 28 days of the decision, and we understand that it is likely that this will happen.

EGA opposes zero- and negative-term SPCs

The European Generic Medicines Association (EGA) issued a press release late last week under the heading "Better Patents Make Better MedicInes/ Improved Efficiency of the European Patent System Would Stimulate Innovation and Competition in the Pharmaceutical Sector". This press release reported on the opening speech of EGA's DG Greg Perry, at the 5th EGA Legal Affairs Forum, highlighting the generic medicines industry’s role in European healthcare and warning of increasing hurdles to competition and real innovation if the European patent system is not reformed. Perry welcomed welcoming the European Commission's pharmaceutical sector inquiry, supported initiatives to improve patent quality and urged the tightening of rules for filing divisional applications.

On SPCs the press release had this to say:

"A lengthy discussion on Supplementary Protection Certificates also took place during the day’s proceedings. The possibility of modifying the Regulation on Paediatric Medicines was raised in order to clarify that a paediatric extension should not be granted when there is no SPC granted with a positive term. Mr Perry stated “that zero or negative term SPCs should not be extended”".

SPC Wapedia entry

I discovered this entry for SPCs on Wapedia the other day. Wapedia, for the uninitiated, is a means of delivery of Wikipedia to users of mobile phones. Presumably anyone who would like to amend any of the information available through Wapedia must do so via Wikipedia.

Abelcet - a recent French SPC decision

Michèle Lavé of Cabinet Alice de Pastors in Paris has informed us of the following recently published decision by the French Patent Office:

"On 27 February 2009, the French Patent Office published the refusal of French SPC application FR97C0131.

SPC application FR97C0131, was lodged by The Liposome Company, Inc. on 8 December 1997 for a product comprising of a lipid complex of amphotericin B, a phosphatidyl choline and a phosphatidyl glycerol. The application is based on European patent EP0282405, on the British marketing authorisation 14188/0001 of 9 February 1995 and on the French marketing authorisation NL 21338 of 10 June 1997 for Abelcet®. The SPC application was transferred to Cephalon Limited.

On 26 September 2008, the French Patent Office rejected this SPC application on the following grounds:

• the French marketing authorisation NL 21338 relates to a drug containing amphotericin B as the sole active ingredient
• The 2 phospholipids which complex amphotericin B are mere excipients, which enable the reduction of the toxicity of amphotericin, but do not modify amphotericin therapeutic properties
• The therapeutic activity of Abelcet® is determined by amphotericin B
• The product subject of the SPC application can only be amphotericin B
• Amphotericin B was already covered by a previous French marketing authorisation, NL 5653 of 26 November 1973
• Therefore, as this SPC application does not refer to the first marketing authorisation for amphotericin B, it does not comply with conditions for obtaining an SPC set out in Regulation No. 1768/92.

This decision seems to be in line with the ECJ decision C-431/04 relating to carmustine/polifeprosan.

It is interesting to note that 12 SPC applications were filed in Europe by The Liposome Company, Inc. based on either EP0282405 or national corresponding patents. Ten applications were granted (AT, CH, DK, GB, IE, IT, LU, NO (2 SPCs), SE) and two were rejected (FR, NL). There is no published German SPC application referring to EP0282405 patent."

Article on ECJ case law

The SPC Blog has received an article which has been kindly sent in by Erik Vollebregt (of counsel, Greenberg Traurig, Amsterdam). It's "Aanvullende beschermingscertificaten voor geneesmiddelen", published in Jurisprudentie Geneesmiddelenrecht plus, 2007, pages 21-34. This article, says Erik, describes all available ECJ case law on SPCs up and including MIT and the SPC system for medicinal products.

If you can read Dutch, you can read the article in full here. If there's enough interest, Erik may be persuaded to have it rendered into English.  You can indicate your wish by clicking the e-Poll in the right hand side bar of The SPC Blog's home page.

Tour of European Patent Offices - Greece

The SPC Blog continues its tour of European patent office websites and this time, it's Greece.

The colourful Greek Patent Office website is accessible here for the original site and here for the English language site- and you may have time to grab a cup of coffee before it finally comes onto your screen.

You can search the patent register here for patents and SPCs active substances. If the patent you're looking at has a corresponding SPC application or granted SPC, you should be able to click your way to the corresponding SPC site.

Paedriatric extensions article now available

The SPC Blog thanks Leighton Howard (right) for making this PDF version of his article "Practicalities of paediatric extensions to the Supplementary Protection Certificate" (see earlier post here) to the blog's readers. Leighton adds:

"Please bear in mind that this was written about 4-5 months ago, but only recently published. I had another read through it and most of it seems relevant, although maybe a little dated but I’ll let others make that decision".

Leighton is currently writing an article on multiple SPCs applied for/granted per INN –- he promises to let us know as soon as he is allowed to publish it. He also welcomes comments which readers may have. You can post them below or send them directly to Leighton here.

Practicalities of paediatric extensions -- a recent article

I've just spotted details of a recent article, "Practicalities of paediatric extensions to the Supplementary Protection Certificate", by Leighton Howard (Genericsweb Pty Ltd), which was published in the Journal of Generic Medicines, Volume 6, Number 1, November 2008 , pp. 93-96(4).  I've not seen the article, but the author is described as "a patent information expert with extensive generics experience. He has worked within the professional patent information industry and major generic pharmaceutical firms and now provides consultancy services to the generics industry and government organisations via his company XIP Pty Ltd. He is also the founder of Genericsweb and remains instrumental in maintaining the high quality and accuracy of data contained in Pipeline Patent Intelligence".

The full electronic text is available here at the price of $40 plus tax.