EPLAW Patent Blog

HU - Refusal to withdraw PI after revocation of patent

The Metropolitan Tribunal in Budapest refuses to withdraw preliminary injunctions in the VIAGRA case after the first instance revocation of the patent

Not long after the Metropolitan Tribunal had granted six  preliminary injunctions against distributors of generic versions of VIAGRA (see post of October 2012) the Hungarian Intellectual Property Office (HIPO) revoked the underlying national patent.

Each defendant of the six parallel cases requested the withdrawal of the respective preliminary injunction immediately but the Metropolitan Tribunal Court rejected each request and maintained the injunctions (in one case an out-of-court agreement was reached). The importance of the decision lies in the fact that this is the first time that the first instance revocation of the patent did not prevent the patentee from keeping a preliminary injunction against presumably infringing products. The present report is based on one of the remaining five cases, as the questions dealt with by the court were similar in each proceeding.

HU - Parallel preliminary injunctions

Metropolitan Court, Boedapest, Hungary, 2012, Case no's 3.Pk.22.015/2012; 3.Pk.22.013/2012; date June 12, 2012, 3.Pk.22.014/2012, date June 19, 2012, 3.Pk.22.006/2012; 3.Pk.22.007/2012; 3.Pk.22.024/2012, reported by Eszter Szakacs

"Hungary – Six parallel preliminary injunctions in a pharmaceutical patent infringement proceeding

"With the heaviest wave of interim measures ever seen in the history of pharmaceutical patent litigation in Hungary, the Metropolitan Court of Budapest granted six preliminary injunctions in June 2012 at the same time against pharmaceutical companies and wholesalers due to the likely infringement of the patentee’s medical use patent related to a blockbuster product.

"The patentee’ first generation product patent covering the subject compound expired in June 2011, after which several generic competitors launched their own products in Hungary, even though the patentee still had a further pending patent application for a second medical use. Their hopes for the refusal of this application must have been turned down by the grant of this use patent in April 2012, after an extremely long examination period of 18 years, leaving barely two years of market exclusivity for the patentee."

Read the entire summary (in English) here.

NL - Lundbeck v. Sandoz / escitalopram

H. Lundbeck S/A v. Sandoz B.V., District Court The Hague, The Netherlands, 14 August 2012, Case No. 424154 / KG ZA 12-787, with thanks to Willem Hoyng, Jeroen den Hartog and Geert Theuws, Hoyng Monegier, for sending in the judgment and a translation in English

*** Now with translation in English ***

The Judge in Interlocutory Proceedings of the District Court in The Hague ordered a preliminary injunction against Sandoz based on Lundbeck’s  escitalopram patent.

The Judge followed Lundbeck’s reasoning that an earlier decision of the Dutch Court of Appeal (which may be read here), stating (in brief) that a substance may only be patented if the substance itself is inventive, is likely to be erroneous. The Judge awarded the injunction based on a process claim in the patent. Sandoz, according to the Judge, did not successfully argue that it did not implement the patented process.

Interestingly, the Judge awarded a provisional injunction already at the oral hearing, for the duration of the preliminary injunction proceedings.

Read the decision (in Dutch) here.
Read the decision (in English) here.

NL - Boehringer v. Teva

Boehringer Ingelheim Pharma GmbH & Co.KG v. Teva Pharma B.V., Teva Pharmaceuticals Europe B.V., Pharmachemie B.V., District Court Utrecht/The Hague, Preliminary Injunction proceedings, 15 August 2012, Case No. KG ZA 12-319 KG ZA 12-559

A Dutch Teva company (“Teva NL”) holds a European MA for drugs with nevaripin as active substance. On the basis of this MA, the drugs are marketed by a Portuguese affiliate of Teva NL in Portgual. Boehringer Ingelheim holds a Portuguese SPC that covers the Teva product and started preliminary injunction proceedings against Teva NL in The Netherlands, claiming an injunction against alleged unlawful acts, consisting in short of involvement by Teva NL in the infringement on the Portuguese SPC by its Portuguese affiliate.

Teva NL inter alia raised invalidity of the Portuguese SPC as a defense. The President of the Court of The Hague questions in the context of Article 22(4) of the EEX Regulation whether GAT/LuK is applicable in the case at hand, as the claim for an injunction was  not based on patent infringement but on unlawful act. He, however, leaves this point undecided as jurisdiction could be based on Article 31 of the EEX Regulation.

IT - HL Display AB vs. Synco spa

Milan court 20 July 2010 - 20 July 2010 and Milan court 23 September 2010 - 24 November 2010, HL Display AB vs. Synco spa
 
Both decisions related to a request for preliminary injunction based on two European patents, relating to mounting systems for label holders and to a profile moulding for shop shelves. One of defendant's arguments was that the sales of the products in dispute had been known to plaintiff for several years, so that there was really no urgency justifying a preliminary injunction. Plaintiff had replied that an opposition was previously pending against one of the patents, so that caution had suggested to await the end of the opposition procedure. Defendant counterreplied that the Italian law admits precautionary proceedings even when a patent application is still pending, so that nothing would have barred plaintiff from taking action long before. If plaintiff had decided to wait due to the uncertainty of the opposition procedure, that evidently meant that the problem was not sufficiently serious or urgent.
 

HU - Court maintained preliminary injunction after limitation of Patent

Budapest Metropolitan Court, date of the decision: January 3, 2011, delivery date of the decision: January 21, 2011.

History of the case is that in November 2009 the Metropolitan Court banned the Respondent by means of preliminary injunction from distributing its pharmaceutical product upon the request of the Patentee. The patent in suit covers a pharmaceutical composition consisting of a given active ingredient and certain additives defined in the claim. The product of the defendant contains the said active ingredient and among its additives ethanol, which in the Metropolitan Court’s assessment fulfilled the requirements concerning the additives described in the patent. The Metropolitan Court placed the preliminary injunction even though there were pending nullity requests against the patent, with respect to the specialty of the Hungarian patent litigation system, namely the strict separation of infringement and validity questions (bifurcation). The Patentee was obliged to HUF 150 000 000 as security.

DE - Mannheim Regional Court decision I

Mannheim Regional Court, decision of 29/10/2010, docket no.: 7 O 214/10

- An interim injunction can only be granted in patent disputes if the question of infringement can be readily judged without doubt and if there are no serious doubts as to the patentability of the patent in suit. Even if these requirements are satisfied the respective interests of the parties must be appraised and weighed up against each other.

- The fact that a product which makes use of all features of at least one claim of the patent in suit is exhibited at a trade fair and that product catalogues containing order numbers for such product are also on display at the trade fair stand does not per se constitutes an offer pursuant to § 9 no. 1 Patent Act.

Read the decision (in German) here.

Headnote: Jan Dombrowski

BE - Novartis v. Mylan / Fluvastatin

Novartis v. Mylan, Brussels court of appeal, Belgium, 26 October 2010, Docket number A.R. 2010/KR/175, with thanks to Philippe de Jong, Altius, for sending in the case and translation

The Brussels court of appeal has reversed a decision from the Brussels commercial court which had rejected Novartis’ claim for a preliminary injunction against Mylan’s intended commercialisation of a generic sustained release formulation of fluvastatin. In doing so, the Brussels court of appeal upheld the established approach applied by the Belgian courts that a granted (European) patent is presumed to be valid for the purpose of obtaining an interim injunction. According to the court, upon a proprer application of Article 106(1) EPC, it is irrelevant that the EPO Opposition Division revoked the patent, even in its entirety, since the appeal against that decision before the EPO Technical Board of Appeal has suspensive effect.

Read the decision (in Dutch) here.

Read the decision (in English) here.

Head note: Philippe de Jong


HU - Preliminary injunction is not available if the scope of protection defined in the main claim is different from the one that can be derived based on the description

Hungary, Mertropolitan Court (first instance decision), 29 October 2010

The Metropolitan Court ruled in a first instance decision that a preliminary injunction is not available if the scope of protection defined in the main claim is different from the one that can be derived based on the description.

The patentee is the owner of a pharmaceutical patent which extends to an injectable pharmaceutical product having a taxane derivative as ingredient, a certain surfactant defined by its quality and an additive defined by its molecular weight, the latter serving the prevention of gelling or breaking the gelled phase when the patented solution is injected into perfusion.

In order to assess the probability of infringement in a preliminary injunction proceeding the court examined the scope of the protection defined by the main claim and established that in the product of the defendant, all components listed in the main claim – a taxane derivative as active ingredient, a surfactant and an additive with limited molecular weight – are present. Therefore, the court concluded that the product of the defendant falls into the scope of the patent.

NL - Merck Sharp & Dohme v. Sandoz

Merck Sharp & Dohme Corp. v. Sandoz B.V., the preliminary injunction judge of the District Court of The Hague, The Netherlands, 4 June 2010, Case No. 363158 / KG ZA 10-427

Merck claimed that Sandoz infringes its EP 752 and SPC 990041 for ‘ophthalmic compositions comprising combinations of a carbonic anhydrase inhibitor and a beta-adrenergic antagonist’ by marketing a dorzolamide/timolol-product (anti-glaucoma eye drops). The preliminary injunction judge rules that the fact that EP 752 (in amended form) was invalidated in parallel UK proceedings is in and of itself not sufficient for the judge in preliminary injunction proceedings to rule that there is a non-negligible chance that the (Dutch part of) the patent will be invalidated in proceedings on the merits. The Dutch judge must make up its own mind. However, the view of a respected fellow patent-judge in parallel proceedings on the merits will be given considerable weight. Merck also failed to explain or criticize the English verdict in any meaningful way, according to the preliminary injunction judge.

A point of interest was the discussion on whether or not the so-called Nardin-abstract was indeed to be considered prior art. Merck initially argued that the abstract was from a later date than the priority date (17 April 1991), but Sandoz obtained inter alia a statement from the British Library to the effect that the abstract had been received by the Library on April 11, 1991 and had been cataloged on April 16, 1991 ‘and would have been available for public use from that date’. The preliminary injunction judge refers to the Enlarged Board of Appeal T314/99 decision, in which it was held that a document “by its mere arrival in the archive [of a library; ed.] publicly available, since that did not mean it was as of that point in time cataloged or otherwise prepared for the public to acquire knowledge of it’. Since the Nardin-abstract had been cataloged the day before the priority date, the preliminary injunction judge therefore judged it to be prior art.

After reviewing the prior art (and especially the Nardin-abstract) the preliminary injunction judge came to the conclusion that there is a non-negligible chance that the Dutch part of the patent will be invalidated in proceedings on the merits. Therefore, the requested injunction was denied.

Read the judgment (in Dutch) here.

Head note: Maurits Westerik