Titel

LIFE SCIENCE
Injunction granted in a case between Novartis and Teva
By Attorney-at-Law Peter-Ulrik Plesner and Attorney-at-Law Mikkel Vittrup
On 18 November 2008 the Eastern Division of the Danish High Court ruled in a case between Novartis and Teva to grant an injunction against Teva's marketing of a generic pharmaceutical product, which contained Valsartan as an active substance. Teva had already ob- tained marketing authorisation concerning the pharmaceutical product in question. In its ruling the High Court held that the conditions for grant- ing an injunction had been fulfilled despite Teva having stated that it had no current plans to market the pharmaceutical product in Den- mark. Novartis was represented by Attorney-at-Law and Attorney-at-Law . The main issue of the case was the actuality requirement in relation to the granting of an interlocutory injunction, cf. section 642(i ) of the Danish Admini- stration of Justice Act, i.e. under which circumstances there is an actual, and not only a hypothetical, threat of infringement. In the spring of 2007 it came to Novartis' attention that Teva had submitted an application for marketing authorisation concerning a pharmaceutical product, which contained Valsartan as an active substance. Novartis, who owns patent rights to Valsartan, wanted Teva to state that Teva would not start marketing the pharmaceutical product before the expiry of Novartis' patent rights. Alter- natively, Novartis requested that Teva should ensure that the legality of Teva's marketing of the pharmaceutical product could be tried by the enforcement court before such marketing would start. Teva refused to make such statements. Instead, Teva stated that it had no cur- With 195 lawyers, and a total staff of 345, Plesner is one of Denmark's leading international law firms with expertise in all areas of commercial and public law. Plesner's vision is to be the best law firm in Denmark - the natural choice for any Danish or for- eign business needing legal advice on commercial matters. 1 rent plans and had not made any specific arrangements to start marketing the pharmaceutical product in question in Denmark. Teva also stated that the pri- mary purpose of the submitted marketing authorisation application was to use Denmark as a Reference Member State in accordance with the decentralised On that basis Novartis submitted an application to the Enforcement Court in Lyngby for an interlocutory injunction against Teva. By its ruling of 11 March 2008 the Enforcement Court refused to grant the requested injunction. At that point in time Teva had only applied for marketing authorisation. Novartis subsequently appealed the Enforcement Court's ruling to the Eastern Division of the Danish High Court. The High Court granted an injunction against Teva by its ruling of 18 November 2008. At the time of the oral hearing before the High Court Teva had obtained marketing authorisation for its pharmaceuti- cal product containing Valsartan as an active substance. In its reasoning the High Court noted that even if an application for marketing authorisation does not in itself involve any patent infringement, such marketing authorisation - combined with other circumstances - can render it probable that the party in question wil take actions that infringe the patent, thus fulfil ing the conditions for granting an injunction. The High Court found that the circumstances of the case rendered it probable that Teva would take actions infringing Novartis' patent rights. Consequently, the requirement for actuality in section 642(i ) of the Danish Administration of Justice Act was fulfil ed. The High Court emphasized the fact that Teva had submitted the application for marketing authorisation at a very early stage be- fore the expiry of Novartis' patent rights and that Teva refused to state that it would respect Novartis' patent rights under Danish patents law. The High Court found that Teva's statement, which indicated that the primary purpose of the submitted marketing application was to use Denmark as a Ref- erence Member State in accordance with the decentralised application pro- cedure, did not make any difference to the result. In that connection the High Court referred to the fact that Teva had also obtained a marketing authorisa- tion in Ireland where the patent in suit was registered with product claims as The High Court subsequently granted an injunction against Teva restraining Teva from the marketing etc of the approved pharmaceutical, which con- tained Valsartan as an active substance. Any questions to the ruling can be directed to Attorney-at-Law
Plesner's Life Science group
Plesner's Life Science group deals with all aspects of life science, including regulatory issues, IP, competition law and marketing as well as corporate issues Attorneys specialising in regulatory issues and/or IP and/or specialised life sci- Karen Dyekjær (Reg/Comp/IP), Peter Ulrik Plesner (IP), Per Håkon Schmidt
(IP/Reg), Søren Stenderup Jensen (Reg), Christian Karhula Lauridsen (Comp),
Sture Rygaard (IP), Gitte Holtsø (Comp), Mikkel Vittrup (IP/Reg), Signe Toft
(Reg), Jacob Borum (Comp) and Jakob Krag Nielsen (IP)
Plesner's Corporate group counts several partners with experience in life sci-ence-related transactions.
The former president of the Court of First Instance Bo Vesterdorf is senior con-
sultant to Plesner and assists the Life Science team in regulatory and competi- Contact our attorneys by phone +45 33 12 11 33, or at the following email addresses: Attorney-at-Law, partner Christian Karhula Attorney-at-Law, partner Søren Stenderup Jen- Attorney-at-Law, partner Peter-Ulrik Plesner Attorney-at-Law, partner Per Håkon Schmidt Attorney-at-Law, juniorpartner Gitte Holtsø The contents of this newsletter serve as general information and cannot replace legal advice. Plesner will not be liable for incorrect infor-mation or errors or omissions in the newsletter.

Source: http://www.plesner.com/plesner_publikationer/Files/Pdf/557.pdf