overig

LS&R 1074

De Syngenta-ABC-uitspraak landmark-case in Life Sciences

Bijdrage ingezonden door Rogier de Vrey, CMS. In de zaak Syngenta/Octrooicentrum NL [IEF 14669] speelden aspecten van octrooirecht / aanvullend beschermingscertificaat, bestuursrecht en Europees recht. Deze zaak is behandeld door mij, tezamen met mijn Nederlandse kantoorgenoten Conny Delissen (bestuursrecht), Willem Hoorneman (net als ik octrooirecht) en mijn kantoorgenoot uit Brussel, Edmon Oude Elferink (Europees recht).

Octrooicentrum Nederland (=OCNL) heeft Syngenta op 9 december 2005 een aanvullend beschermingscertificaat verleend. Inmiddels is duidelijk, na de University of Queensland uitspraak van het HvJEU (C-630/10), dat bij het verlenen van het ABC ten onrechte niet is uitgegaan van de primair door Syngenta aangedragen Finse "combi-vergunning". Als gevolg daarvan is de duur van het certificaat een stuk korter dan deze zou zijn geweest indien de juiste vergunning zou zijn gebruikt voor de berekening van de duur. Syngenta heeft ongeveer acht jaar na de verlening van het certificaat verzocht tot correctie van de duur van het certificaat. Op het moment van dit verzoek was het certificaat nog van kracht. Dit verzoek is geweigerd door het OCNL. Het OCNL heeft tevens het door Syngenta daartegen gemaakte bezwaar ongegrond verklaard. De rechtbank Den Haag heeft vervolgens het daartegen ingestelde beroep ongegrond verklaard. Tegen deze uitspraak heeft Syngenta hoger beroep ingesteld bij de Raad van State en daarbij de voorzitter verzocht een voorlopige voorziening te treffen. Ook dit verzoek om een voorlopige voorziening is afgewezen [IEF 14023].

In de bodemprocedure in hoger beroep heeft OCNL zich op het standpunt gesteld dat er geen verplichting is om terug te komen op haar besluit tot verlening van het certificaat in 2005. Syngenta had binnen de wettelijke termijn van 6 weken (na 9 december 2005) bezwaar dienen in te stellen, wat zij niet heeft gedaan. Artikel 17 lid 2 van de Verordening 1610/96 (de Verordening) maakt dit niet anders en zou enkel verwijzen naar de mogelijkheid van bezwaar volgens de nationale procedureregels (6 weken termijn). Tevens zouden er geen nieuw gebleken feiten of veranderde omstandigheden zijn die tot heroverweging ex art. 4:6 AWB nopen. Tenslotte was OCNL van mening dat correctie van de duur derden in hun belang zou kunnen treffen.

Syngenta heeft – zeer kort gezegd – betoogd dat de interpretatie van OCNL van art. 17 lid 2 van de Verordening zich niet verhoudt met het dwingende en supranationale karakter van Verordening 1610/96, de algemene opzet en doelstelling van deze verordening en het principe van Unietrouw. Tevens zou de in art. 17 lid 2 beoogde correctiemogelijkheid zinledig worden indien een beroep hierop aan een nationale beroepstermijn van 6 weken zou worden gebonden. Het feit dat in dit geval de foutieve berekening van de geldigheidsduur van het certificaat niet het gevolg is van een fout bij de vermelding in de aanvraag van de datum van de eerste handelsvergunning, maar het gevolg van een verkeerde vergunning als uitgangspunt, kan geen beletsel zijn voor toepassing van art. 17 lid 2.

De Raad van State heeft (in de bodemprocedure) Syngenta in het gelijk gesteld en bepaald dat de geldigheidsduur van het inmiddels vervallen certificaat dient te worden verlengd tot 18 december 2015.

Met name deze ruime uitleg van artikel 17(2) en de mogelijkheid om op in principe elk moment op deze correctiemogelijkheid een beroep te doen, is interessant voor certificaathouders.

Rogier de Vrey

LS&R 647

Correction of the formula to calculate the duration of Supplementary Protection Certificates (SPCs)

Due to some inaccuracies detected in the formula to calculate the duration of Supplementary Protection Certificates (SPCs), the Portuguese Patent and Trademark Office (INPI) has decided to reevaluate and change the calculation formula.

Further to an ex officio correction of the formula for calculating the SPC duration made by the INPI, the correction of SPC duration dates was published in the Industrial Property Bulletin on July 8, 2013.

Pursuant to the provisions of article 13(1) of the Regulation (EC) No. 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the SPC and also the Regulation (EC) No. 1610/96 of the European Parliament and of the Council of 23 July 1996, the INPI established that the formula to calculate the duration of SPC(s) shall obey the following rules:

1 – The period of time between the Marketing Authorization (MA) date and the application date of the basic patent must be calculated in days;
2 – The period of time between the MA date and the basic patent application date shall take into account leap years, i.e., the actual days of each year;
3 – The duration (in days) obtained in the period of time between the MA date and the basic patent application date shall be added to the expiry date of the basic patent;
4 – The five-year period to be deducted from the expiry date shall not be deducted from the number of days initially obtained from the difference between the MA and the basic patent application, but from the date resulting from the sum of the duration in days with the expiry date of the patent;
5 – Once the five-year period is deducted, if the result corresponds to non-existent days, then the effective date is the last day of that month.

These changes shall be applied ex officio by the INPI to new SPC applications, to pending SPC applications and to SPC(s) that have already been granted.

LS&R 285

Healthcare policy meets patent law: preferential treatment of generics while the originator has patent protection

Een bijdrage van John Allen, uit de nieuwsbrief Nauta Dutilh N.V..

The Court of Appeals of The Hague has recently ruled that healthcare insurance companies, by inviting parties to bid in a tender to become the preferred supplier of a medicinal product which is still under patent (SPC) protection, do not infringe the originator's patent and do not commit an "unlawful act" (i.e. a tort). That is, provided certain strict conditions are observed [red. LSenR 253].

Facts of the case
Pfizer was the holder of a now expired SPC for the compound latanoprost, sold under the name Xalatan. At the time, Xalatan was sold by Pfizer as well as by six parallel importers. In addition, several generic competitors held marketing authorisations for latanoprost.

Within the framework of their "preference policy", healthcare insurers UVIT and VGZ organised a sealed-bid tender to appoint the preferred supplier of latanoprost. This means that clients of the insurers only receive reimbursement if they obtain the product of the preferred supplier.

In mid 2011, UVIT and VGZ invited Pfizer, the parallel importers and the generic competitors to bid in the tender. Pfizer's SPC was in force until 17 January 2012, and the suppliers were asked to submit their offer before September 2011. After Pfizer objected, the insurers moved the deadline for submissions in the tender to 25 January 2012.

Pfizer's arguments
Pfizer argued that the tender would lead to an agreement between the insurers and the generic manufacturers which would result in a commitment to supply latanoprost to pharmacies and that by doing so before the SPC expired, they would necessarily infringe Pfizer's rights. According to Pfizer, by organising the tender the insurers were "otherwise trading in" the substance protected by the SPC, within the meaning of article 53 of the Dutch Patents Act 1995 ("DPA").
In the alternative, Pfizer alleged that the tender procedure amounted to an unlawful aiding or facilitating of patent infringement. The parties agreed, in line with current case law, that there would be an infringement by a generic competitor (as opposed to the insurer) if the former made an offer during the period in which the SPC was still in force, even where the offer specified that the protected substance would only be delivered after the SPC expired.

Decision
The Court considered the legislative history of article 53, and acknowledged that "otherwise trading in" should be interpreted broadly. However, it found that this concept in any event required that the product actually be made available to a third party. Since the insurers did not make the product available to a third party, they did not "otherwise trade in" the patented products and therefore did not infringe the SPC.

The Court held that the insurers would only have committed an act of tort if they had provoked or incited the generic competitors to commit an infringement. That was not the case here as it concerned a general invitation, addressed to all known suppliers, including the patent owner as well as the parallel importers of the medicine. This means that several of the parties invited to participate in the tender could supply the product without committing patent infringement. The court furthermore attached importance to the fact that in the invitation, the insurers indicated that they would respect third parties' patent rights and that the tendering parties would be obliged to do the same. Under such circumstances, the invitation did not provoke or incite generic manufacturers to commit a patent infringement. This was especially true because the parties could place their bid after the SPC had expired.

Conclusion
The Court of Appeal's decision attached considerable weight to the fact that the tender was open to multiple 'non-infringing' parties and that the deadline was extended until after SPC expiry.

It can be inferred from the decision that the Court of Appeal is prepared to intervene in tender procedures conducted by insurance companies where generic competitors are invited to compete whilst there is still a valid patent or SPC.
This decision is in line with the recent Supreme Court decision in Pharmachemie/Glaxo (2012), in which it was held that entering a generic pharmaceutical in the national pharmacy database, even with the explicit proviso that products will not be delivered until after patent expiry, constitutes an infringing offer under the DPA.

Also notable in this series of decisions exploring the boundaries of what conduct constitutes an infringement or tort is the preliminary finding that tacitly approving and/or facilitating a foreign patent infringement may constitute a tort under Dutch law (see our recent newsletter on the Boehringer Ingelheim/Teva case).

LS&R 151

Further SPC Granting Guidelines

J.P. Hustinx, G. Kuipers en T. Douma, Further SPC Granting Guidelines, DeBrauw Legal Alert december 2011.

Bijdrage ingezonden door Jan Pieter Hustinx, Gertjan Kuipers en Tjibbe Douma, De Brauw Blackstone Westbroek. Zie onderaan voor een interessante tabel.

In addition to its recent judgments in the Medeva and Georgetown cases (24 November, click here for the legal alert) and the Merck case (8 December, click here for the legal alert), the Court of Justice ("CJ")  of the European Union handed down three orders in Supplementary Protection Certificate ("SPC") cases which did not receive much attention.  Nevertheless, the Yeda (C-518/10), Queensland (C-630/10) and Daiichi Sankyo (C-6/11) orders of  25 November 2011 provide some interesting clarification on the granting of SPCs by national Industrial Property Offices ("IPOs"), especially as regards product-by-process claims and combination products.

Yeda (C-518/10): if the patent claims only a combination, can an SPC be granted for an individual active ingredient?

Yeda owns a European patent that discloses a therapeutic composition A+B. The patent also claims the administration of both components separately, provided they are part of the same composition. Yeda applied for two SPCs, one for the composition A+B and one for active ingredient A only. The supporting Marketing Authorisation ("MA") only covered product A, but indicated that it should be administered together with B. Both SPCs were refused by the British IPO. Yeda appealed and, following a referral by the Court of Appeal, the CJ clarified that an SPC cannot be granted:

"(…) where the active ingredient specified in the application, even though identified in the wording of the claims of the basic patent as an active ingredient forming part of a combination in conjunction with another active ingredient, is not the subject of any claim relating to that active ingredient alone."

Hence, no SPC for Yeda. This further narrows the "disclosure test" for Article 3(a): if the patent claims A + B in combination, an SPC cannot be granted for just A.

Queensland (C-630/10): One patent = one SPC? One MA = several SPCs?
Queensland is the owner of a parent patent and two divisional patents. The parent patent claims two active ingredients (by product-through-process claims), and the divisional patents claim additional active ingredients. The MA relied on for the SPC applications, contains a combination of active ingredients both from the divisional patents and from the parent patent. The actual CJ ruling regarding most questions referred is no surprise and a literal copy of the rulings in the Medeva case. However, an interesting paragraph in Yeda is:

"Moreover, where a product is protected by a number of basic patents in force, each of those patents may be designated for the purpose of the procedure for the grant of a certificate, but only one certificate may be granted for a basic patent (…)."  (paragraph 35)

Although that case concerned a patent family, this consideration is worded in broader form. It implies that one MA concerning a combination of active ingredients can be relied on for several SPC applications, provided the constituting active ingredients are specified in the wordings of the claims of different basic patents (and provided the other requirements of Article 3 are also met). We are of the view that, contrary to the wording of the CJ, it should also be possible to obtain more than one SPC relying on the same basic patent in case the patent claims several active ingredients independently (i.e. not as part of a combination).

Queensland (C-630-1-): product-by-process claims and SPCs

A new question at issue in Queensland was whether in a case involving a basic patent relating to a product-by-process claim, it is necessary for the ‘product’ to be obtained directly by means of that process.  The CJ clarified that it is irrelevant whether the product is derived directly from the process, but that an SPC can only be granted for a product identified in the wording of the claims of the patent. In other words, if the product is not specified, no SPC is possible for that active ingredient.

Daiichi: combination products

Daiichi owns a patent regarding an active ingredient A. It obtained an SPC for this product based on an MA containing A as sole active ingredient. Daiichi invested considerable time and resources in undertaking clinical trials and studies in order to secure an MA for a combination therapy of A+B. This was successful and Daiichi then sought an SPC relying on the MA for the combination product and on the same basic patent. The British IPO refused this second SPC for the combination therapy on the grounds that the active ingredients of the MA are not covered by the basic patent. In confirming the IPO's decision the CJ uses the exact wording of the Medeva case, clearing all doubts that Medeva is not limited to multi-disease vaccines but applies to all combination products.

Summary of the present situation for easy reference: what do the decisions mean in practice

CASE

Basic Patent Claims:

MA in place for:

SPC

Medeva

Combination A+B

A +B +C+D

multi-disease vaccine

A+B

Yeda

Combination A+B

A (+C)

No SPC possible

Queensland

Several basic patents

1. A+B

2. C

3. D

A+B+C+D

1. A+B (based on patent 1)

2. C (based on patent 2)

3. D (based on patent 3)

Queensland

Product through process

A

claimed in the wording as (in)direct product of the process claim

A (+B + C)

A

Queensland a contrario

Product through process

A

product of process but A not specified in the wording of the claim

A (+B + C)

No SPC possible

Daiichi

A

A+B combination therapy

A