______________________________________________________
The Unitary Patent Plan Beta – Update
on National Case Law in Europe
Leythem Wall
28 November 2013
_______________________________________________________
Declarations of Non-Infringement
______________________________________________________
• Article 15 of the Unified Patent Court (UPC) Agreement sets out the areas
in which the UPC has "exclusive" competence
• These include actions for declarations of non-infringement (DNI)
• To be handled at the UPC Central Division (London, Munich or Paris)
• But… the UPC Agreement has not yet been fully ratified
(minimum 13 EU states including UK, Germany and France required)
_______________________________________________________
English Court is ‘Appropriate’
______________________________________________________
• Actavis Group hf v Eli Lilly and Company [2012] EWHC 3316 (Pat)
• 27 November 2012 Arnold J ruled that a declaration of non-infringement
in relation to both a UK and foreign designations of a European patent
can be requested before the English Court
• This decision related not only to the UK designation of Eli Lilly’s European
patent (EP 1313508), but also those of France, Germany, Italy and Spain
_______________________________________________________
England Not Brussels
______________________________________________________
• Eli Lilly own the compound patent for the active pharmaceutical ingredient
pemetrexed (under SPC, set to expire 2015), and another patent (“the ‘508 Patent”,
set to expire 2021) which protects the use of pemetrexed disodium in the
treatment of cancer
• Actavis wanted to resolve whether its proposed sale of pemetrexed dipotassium
relating to a cancer treatment would infringe Lilly’s rights, and wanted to enter the
major pharmaceutical markets in Europe on SPC expiry
• Actavis commenced proceedings in the English Patents Court seeking declarations
of non-infringement under section 71 of the UK Patents Act in relation to each of
the English, French, German, Italian and Spanish national designations
• Importantly, Actavis did not challenge the validity of the patent. It irrevocably
bound itself through undertakings to the Court not to challenge validity
• This meant that the exclusive jurisdiction given to countries in Europe under the
Brussels Convention for challenges to the validity of registered rights was not used
_______________________________________________________
Questions
______________________________________________________
• The main questions before the Court were:
(i) had Lilly consented to accept service in respect of the claim (including the
requests in respect of the non-UK patents)?
(ii) if not, had service been effected under Civil Procedure Rules (CPR) 6.9(2)? and
(iii) if service was effected only pursuant to (ii), should the proceedings be stayed
under the doctrine of forum non conveniens?
_______________________________________________________
Answers
______________________________________________________
(i) had Lilly consented to accept service in respect of the claim (including the
requests in respect of the non-UK patents)?
• A letter from Lilly’s English solicitors which stated that they “were
instructed to accept service on behalf of their client” was held to amount to
accepting service of the proceedings in respect of the non-UK designations
(ii) if not, had service been effected under CPR 6.9(2)? and
• Arnold J. held that even if there was no consent, service had been validly
effected under CPR 6.9(2) because Lilly’s European Patent Operations
Department constituted a place of business in the UK.
_______________________________________________________
Copyright is ‘no different’
______________________________________________________
(iii) should the proceedings be stayed under the doctrine of forum non conveniens (i.e.
in favour of a more appropriate forum)?
• Arnold J. considered the Supreme Court’s decision in a copyright case
Lucasfilm v Ainsworth [2012]
• If patents were no different to copyright for the purposes of justiciability ( Lilly did not argue otherwise), then no reason why different for purposes
of forum non conveniens when validity was not in issue.
• Arnold J preferred Actavis’ reasons why the claims should be determined in
one court (e.g. cost savings and reduced risk of inconsistent decisions)
• Lilly’s argument based on difficulties of a court applying foreign law were
not enough. Lilly had not shown that the courts of the other jurisdictions
were clearly more appropriate than the English court.
_______________________________________________________
The Appeal
______________________________________________________
• Actavis Group hf v Eli Lilly and Company [2013] EWCA Civ 517
• 21 May 2013 Court of Appeal upheld Arnold J's first instance decision
• the willingness of the English court to entertain applications for crossborder declarations is limited to the following circumstances:
- the patentee must be either domiciled in the UK, or outside the EU
- the claim must be validly served; and
- validity will not be challenged in the proceedings
_______________________________________________________
Race to The Courts and German Proceedings
______________________________________________________
• 12 July 2012 Bird & Bird LLP representing Activis sent a letter to Lilly’s
registered address for the EP patent indicating intention to seek DNI
• 27 July 2012 Bird & Bird LLP filed a request for the DNI at the UK Court
• 30 July 2012 Lilly issued proceedings against Actavis PTC and Actavis
Deutschland in the Düsseldorf Landgericht (Düsseldorf Regional Court) for
threatened infringement of the German designation of the Patent
• Since the UK court also held it had jurisdiction regarding the German noninfringement claim, under Article 27 of the Brussels Regulation the
Düsseldorf court has had to suspend its proceedings
_______________________________________________________
The Opposition
______________________________________________________
• Lilly’s patent was in fact opposed by Teva in January 2008
• The opposition was rejected on 18 November 2010
• Teva appealed the decision on 3 March 2011 (T0542/11)
• Despite Actavis not contesting validity before the UK Court, on 30 October
2012 Actavis Deutschland filed a notice of intervention in the appeal
relying upon the German proceedings as basis for Rule 89 (1) EPC
• In effect, therefore, the Actavis group has voluntarily bifurcated the
infringement and validity aspects of its case with respect to the Patent
_______________________________________________________
DNI and Opposition – Best of Both Worlds
______________________________________________________
• Possible strategy is to file for a pan-European declaration of noninfringement at the UK Court (not contesting validity) and separately
file/intervene in an opposition (handled by the EPO, not the UK Court)
for pan-European revocation
_______________________________________________________
Italy and Declarations of Non-Infringement
______________________________________________________
• Italian torpedo was a popular defence in European patent litigation
• A company, under threat of infringement proceedings, applied in Italy for a
DNI in respect of Italian and foreign parts of competitor’s European patent
• Italian court jurisidiction by virtue of Article 5.3 Brussels Convention “a
person domiciled in a Contracting State may, in another Contracting State,
be sued … in matters relating to tort, delict or quasi-delict, in the courts for
the place where the harmful event occurred”
• In line with Article 21 of the Brussels Convention, foreign courts (e.g.
German courts) stayed infringement proceedings if the alleged infringer
had already launched a cross-border DNI action in Italy
• As a result, once the alleged infringer had filed a torpedo suit in Italy, the
patentee was prevented from enforcing its patent in other jurisdictions
_______________________________________________________
End of the Torpedo?
______________________________________________________
• In 2003, the Italian Supreme Court ruled that Italian courts did not have
jurisdiction (BL Macchine Automatiche v Windmoeller)
• The plaintiff in a DNI action could not rely upon Article 5.3 Brussels
Convention because – by bringing a DNI action – the plaintiff had already
denied that a harmful event had occurred
• Considered big step forward for effective protection of patents in Europe
• September 2010, German company (Asclepion) filed a torpedo DNI claim
before the Court of Rome relating to Italian and German parts of EP 0 806
913 and EP 1 230 900 (owned by Massachusetts General Hospital) (MGH)
_______________________________________________________
The Torpedo is back
______________________________________________________
• May 2011, MGH and exclusive licensee filed an application with the Italian
Supreme Court challenging the international jurisdiction of the Italian
Courts for deciding infringement of the non-Italian parts of the EP’s
• 10 June 2013, the Supreme Court handed down its judgment that Court of
Rome has jurisdiction for being the judge of the place where the harmful
event may occur, in respect of both German and Italian parts
• Since wording of Article 5.3 of Council Regulation (EC) No 44/2001 now
also refers to where harm may occur, IT courts have jurisidiction
• Based on this ruling it appears Italian courts will have to accept DNI
claims also in respect of non-Italy EP designations
_______________________________________________________
Bolar Exemptions
______________________________________________________
• Producers of generic medicines can use original manufacturer's approval if
can demonstrate that generic is bioequivalent to the approved medicine
• The 'Bolar’ exemption is an attempt to ensure that these necessary
studies, tests and trials will not amount to patent infringement
• This exemption does not replace the experimental use defence, rather it
supplements it
• Experiments designed to elicit new knowledge – that is, which can be
considered to advance scientific knowledge – will generally be exempted
under the ‘experimental use’ exemption
• Experiments and clinical trials using the patented drug and which are
designed to obtain regulatory approval will generally be considered for
exemption under the ‘Bolar’ provisions
_______________________________________________________
Bolar Exemptions – The First Final Decision
______________________________________________________
• A Polish manufacturer advertised and sold active pharmaceutical
ingredients (API) to generics in Germany and Poland to carry out trials
• Patentee subsequently sues Polish manufacturer
• The Regional Court in Dusseldorf (O 282/10) and the Higher Regional Court
in Gdansk (GC 76/11) ruled in June and July 2012 that the Bolar exemption
only applies to the testing entity and that a third party’s manufacturing
and selling to the testing entity is not exempted
• October 23, 2013, the Polish Supreme Court (CSK 92/13) upholds decision.
Parallel proceedings are pending in Germany
_______________________________________________________
______________________________________________________
THANK YOU
_______________________________________________________