IPO decision on Cetuximab and irinotecan

The UKIPO has released a decision on SPC applications SPC/GB/04/037 and SPC/GB/04/038 in the name of Imclone Systems, Inc. Ltd. and Aventis Holdings Inc.

SPC/GB/04/037 is for the combination of products cetuximab, a monoclonal antibody, and irinotecan, an anti-cancer agent, whereas SPC/GB/04/038 is for cetuximab alone. Both applications rely on the same basic patent EP0667165, which claims a therapeutic composition comprising a monoclonal antibody such as cetuximab, and an anti-neoplastic agent, such as irinotecan. The patent however does not disclose compositions or the use of monoclonal antibodies on their own. The same marketing authorisation (MA) EU/1/04/282/001 for the medicinal product "Erbitux" was cited in support of both SPC applications.

The hearing officer, Dr L. Cullen, held that the MA has to be considered in its entirety in deciding exactly what product can be protected by an SPC. It is not possible to just take account of the clinical particulars. The marketing authorisation was found to authorise "Erbitux", which comprises the product cetuximab, and not the product cetuximab and irinotecan, as claimed by the applicant. The MA was therefore found not to be a valid authorisation in support of SPC/GB/04/037 for the product "cetuximab in combination with irinotecan" according to Article 3(b) of the SPC regulation.

The basic patent was not considered to protect cetuximab which is the subject of SPC application SCP/GB/04/038 according to Article 3(a).

Both applications were rejected in accordance with Article 10(4) after the applicant was provided with an opportunity to correct the irregularities of each of the application.

You can read the decision in full on the IPO website here.

Advocate General's Opinion out for C-66/09

Last year, Lithuania referred some preliminary questions for a ruling by the Court of Justice of the European Communities in C-66/09 (Kirin Amgen, Inc. v Lietuvos Respublikos valstybinis patentų biuras). You can refresh your mind by reading the questions referred here.

The Advocate General has now presented his conclusions on C-66/09 to the Court of Justice and these can be summarized as follows:

- the SPC Regulation took effect in Lithuania on the accession date (1 May 04)
- the EMEA marketing authorization for Aranesp (granted in 2001) also took effect in Lithuania on the accession date [NB: Kirin did not seek a separate MA in Lithuania]
- the 'effective' MA date in Lithuania cannot be equated to the date on which the product was first placed on the market within the meaning of article 3(b) of the Regulation
- Kirin cannot therefore be granted a SPC because they had not obtained a Lithuanian MA for Aranesp before the accession date.

Unfortunately, the Opinion isn't available in English yet, but in French or in German, or if you're up for a challenge this weekend you can read it in Lithuanian here.

Thanks to Marc Nevant (Cabinet Beau de Loménie) for providing an English summary of the conclusions.

CJ Referral on Negative Term SPCs

The German Federal Patent Court has decided to refer a question for preliminary ruling on negative term SPCs to the Court of Justice of the European Union in the Sitagliptin case (Case 15 W (pat) 36/08):

"Can an SPC be granted for a medicament if the period between the filing of the application for the basic patent and the time point of first authorization for marketing in the Community is shorter than five years?"

A copy of the decision can be downloaded here (for the moment, in German only).

Thanks to Klemens Stratmann (Hoffmann Eitle, Munich) for providing a translation of the question.

Hatch-Waxman extensions: PowerPoint now available

The PowerPoint notes which supported the presentation by Jeffrey S. Boone (Covidien), "Patent Term Extensions under the US Hatch-Waxman Act", which was given at the seminar hosted by The SPC Blog on 13 January 2010, are now available online. You can access them here.

Official UK patent law reports focus on SPCs

Issue 2 (February 2010) of volume 127 of the Reports of Patent, Design and Trade Mark Cases (RPC), published for the Intellectual Property Office of the UK by Oxford University Press, contains official reports of four British decisions concerning SPCs. They are

* Merck & Co.'s SPC Extension Application (IPO, 6 February 2009, noted on The SPC Blog here);
* E. I. du Pont de Nemours & Co.'s SPC Extension Application (IPO, 9
April 2009, noted by The SPC Blog here);
* E. I. du Pont de Nemours & Co. v Intellectual Property Office
(Patents Court, 22 May 2009, noted by The SPC Blog here);
* E. I. du Pont de Nemours & Co. v Intellectual Property Office (Court of Appeal, 17 September 2009, noted on The SPC Blog here) .

More on Gardasil and Silgard from Portugal

A few weeks ago, we posted a piece on Gardasil in Portugal. João Jorge (Raul César Ferreira, Portugal) has kindly indicated that the Court decision on Gardasil stems from the Court of Appeal (Tribunal da Relação de Lisboa) and not from the 1st Instance Court (Tribunal do Comércio de Lisboa), as reported in our earlier posting. The decision maintained the 1st Instance Court decision (confirming the PTMO refusal decision).

Joao writes: "in Portugal several SPCs were applied for based on MAs for Gardasil/Silgard for several base patent, and that up to now and to my knowledge, one SPC has been granted." He has also provided the table below containing information on SPC applications regarding Gardasil/Silgard in Portugal:

Base Patent/(owner)	SPC number	Product / Medicament	Status
EP 647140 / (GEORGETOWNUNIVERSITY)	SPC 297	HUMAN PAPILLOMAVIRUS VACCINE [TYPES 6, 11, 16, 18] (RECOMBINANT, ADSORVED) /GARDASIL	Pending
	SPC 298	HUMAN PAPILLOMAVIRUS VACCINE [TYPES 6, 11, 16, 18] (RECOMBINANT, ADSORVED) /GARDASIL	Pending
	SPC 299	HUMAN PAPILLOMAVIRUS VACCINE [TYPES 6, 11, 16, 18] (RECOMBINANT, ADSORVED) /GARDASIL	Pending
	SPC 300	HUMAN PAPILLOMAVIRUS VACCINE [TYPES 6, 11, 16, 18] (RECOMBINANT, ADSORVED) /GARDASIL	Pending
	SPC 301	HUMAN PAPILLOMAVIRUS VACCINE [TYPES 6, 11, 16, 18] (RECOMBINANT, ADSORVED) /GARDASIL	Pending
EP 662132 / (U.S. GOV. BY THE SEC. DEP. HEALTH AND HUMAN SERV.)	SPC 257	PAPILLOMAVIRUS-LIKE PARTICLES /GARDASIL	REFUSED
	SPC 259	PAPILLOMAVIRUS-LIKE PARTICLES /GARDASIL	REFUSED
	SPC 261	PAPILLOMAVIRUS-LIKE PARTICLES /GARDASIL, SILGARD	REFUSED (awaits Court decision)
EP 688227 / (UNIV. OFROCHESTER)	SPC 255	- / SILGARD	REFUSED (awaits Court decision)
EP 817851 / (MERCK & CO., INC.)	SPC 258	PAPILLOMAVIRUS-LIKE PARTICLES /GARDASIL	REFUSED
	SPC 260	PAPILLOMAVIRUS-LIKE PARTICLES /GARDASIL, SILGARD	REFUSED (Courts maintained the decision)
	SPC 262	PAPILLOMAVIRUS-LIKE PARTICLES / SILGARD	REFUSED
EP 1015561 / (MEDIMMUNE, INC.)	SPC 256	PAPILLOMAVIRUS-LIKE PARTICLES /GARDASIL	Granted
EP 1165126 / (MERCK & CO. INC.)	SPC 266	PAPILLOMAVIRUS-LIKE PARTICLES /GARDASIL	REFUSED (awaits Court decision)
	SPC 267	PAPILLOMAVIRUS-LIKE PARTICLES /GARDASIL	REFUSED
	SPC 268	PAPILLOMAVIRUS-LIKE PARTICLES /GARDASIL, SILGARD	Granted

Correction - there are two SPCs granted so far:

SPC 256 to Medimmune based on EP1015561
SPC268 to Merck & Co. based on EP1165126 (here for the register extract)

Thanks to Andreas Schmidtt for letting us know.

Agrochemicals, generics and competition

Writing for Farmers' Weekly Interactive ("Do generic pesticides deliver the same control as big brand products?"), Philip Case discusses the strategies employed by major agrochemical companies in seeking to extend the protection rights of their products, as well as the fact that absence of patent protection does not automatically lead to competition in the marketplace. Citing Nigel Uttley (Enigma Marketing Research) he writes:

"... One popular way is mixing the active ingredient with other active ingredients to make new mixtures or formulations, which they then protect under new patents.

Therefore, although the active ingredient may no longer be protected against generic competition, it may still be protected under different patents.

For example, the active ingredient patent for cyprodinil expired in 2008 but a UK Supplementary Protection Certificate (SPC) for a mixture product with picoxystrobin extended patent protection until 2013.

The potential benefit of that practice is that it drives the R&D firm's innovation, whether the original active comes off-patent or not.

For example, BASF has produced two new fungicides based on epoxiconazole, Ennobe (epoxiconazole + prochloraz) and Brutus (epoxiconazole + metconazole) that HGCA trials suggest perform better than Opus alone.

... About 35 active ingredients are due to come off patent in the next five years that are used in the UK or EU, Dr Uttley says.

The list includes major crop protection products popular with UK growers, such as azoxystrobin, flufenacet, clothianidin, cyprodinil and spiroxamine.

"But it's not an easy task for a generic manufacturer to get a product to the market," he stresses.

"You have still got mixtures, formulation and process patents to consider before a 'freedom to operate' scenario can be achieved and in addition registration issues can create a barrier to generics entering the market."

He has identified about 120 active ingredients that have lost patent protection over the past 10 years but some, as a result of these barriers, still have no generic competition".

Repurposing, repatenting ... and SPCs

The current issue (vol.10, no.4) of Lawtext Publishing's bimonthly Bio-Science Law Review contains one feature which may be of specific interest to readers of this weblog. It's an article entitled "Drug Repurposing and Repatenting" by Duncan Curley and Amanda Easey (Innovate Legal). According to the abstract,

"Sometimes, an ‘old’ pharmaceutical compound may be discovered to have new medical uses. The patent claims to the chemical structure of the compound per se may already have expired by the time that such ‘drug repurposing’ is explored. Patent protection for the new invention must therefore involve a claim to second or further medical indications (‘Swiss form’ patent claims). This article discusses the legal protection options for repurposed drugs in Europe, including a review of the current status of second and further medical use claims and the availability of supplementary protection".

French say "non" to olmesartan medoxomil and hydrochlorothiazide combination

Thank you, Alice de Pastors, for supplying The SPC Blog with a copy of the decision of the Cour d’appel de Paris, pôle 5, 2e ch., 6 novembre 2009 (here) in which that court dismissed the appeal of Daiichi Sankyo against the decision of the Director-General of the French Patent Office (INPI) on 13 February 2009 to reject French SPC 06C0019.

Daiichi Sankyo's 06C0019 SPC application was for an olmesartan medoxomil and hydrochlorothiazide combination, referring to EP0503785 patent and to the MA CIS 66838901 of 6 February 2006 relating to this combination and marketed as Colmetec®.
The Cour d'appel de Paris dismissed Daiichi Sankyo's appeal because it was not possible to get an SPC for the Olmesartan Medoxomil and Hydrochlorothiazide combination, as this combination was not protected by the patent.

The Cour d’appel de Paris added that the EP0503785 patent covered only Olmesartan Medoxomil and not the combination; SPC 03C0037 for Olmesartan Medoxomil was granted on 11 February 2005, referring to this patent and to MA NL No. 28,292, issued on 6 August 2003.