Pharmaceutical;Trademark;Patents;News

Granrut Avocats is a French law firm involved in intellectual property law, pharmaceutical law and European Union law that provides services to healthcare, biotech and pharmaceutical companies

This section is intended to be a synopsis of recent developments and is not intended to be exhaustive. If any (issue) information referred to in this section is to be relied upon, specific advice should be sought. Please contact the Editor:

Richard Milchior and Séverine Charbonnel

SCP Granrut Avocats

91 rue du Faubourg Saint Honore

75008 Paris

France

Tel: +33 (0)1 53 43 15 15

Fax: +33 (0) 1 53 43 15 00

Email: r.milchior@granrut.com

German decision XZR 120/11 of October 23, 2012, “Gelomyrtol”

The Xth senate of the Bundesgerichtshof had to judge a request of nullity concerning a patent for a cough syrup that smells like eucalyptus and citrus fruits.

Usually, it can be noticed that cough syrup smells like eucalyptus and citrus fruits.

EPO granted a patent in 2004 with the following claim: “A pharmaceutical composition for administration in the form of hard or soft gelatine capsule comprising eucalyptus oil and orange oil.”

Gelomyrtol, a product that smells like eucalyptus and orange oil, was available in the form of capsules long before the filing date of the application.

The official German pharmaceutical description (“Rote Liste”) mentions that Gelomyrtol is a plant extract containing inter alia substances called d-Limonen (made up of 90% of orange oil), a-Pinen and 1,8-Cineol (the main ingredients of eucalyptus oil).

In the nullity proceedings, the patentee argued that despite the suspicious scent and the revealing chemically pure ingredients, the mix of essential oils could have been synthesized otherwise than by mixing eucalyptus oil and orange oil such that the composition was not directly and unambiguously derivable for the skilled person.

The senate did not follow this argument. Actually the judges did not even mention the fragrance but found that the indications in the pharmaceutical description were sufficient for the skilled person to establish a manageable number of hypothesis on the potential composition, one of which could then be confirmed with the available analysis tools.

These tools did not include the nose but rather gas chromatography and mass spectroscopy.

For those reasons, the Senate judged that the patent has not to be cancelled.

Actavis Group HF v. Eli Lilly and Company

English Patents Court Decision of 27 November 2012, 2012 EWHC 3316 (Pat)

On 27 November, the Patents Court handed down a ruling which is that a declaration of non-infringement in relation to the UK, French, German, Italian and Spanish designations of a European patent could be brought before the English Court.

The case opposed two companies: Eli Lilly, which marketed Permetrexed, a cancer treatment, and Actavis, a multinational supplier of generic pharmaceuticals.

Actavis did not challenge the validity of the European patent but sought declarations of non-infringement for each of the UK, French, German, Italian and Spanish designations.

Eli Lilly did not contest the English Court's jurisdiction with regard to the UK designation but sought a declaration that the Court does not have, or should not exercise, jurisdiction in respect of the foreign designations.

Eli Lilly argued that only the courts of the state in which the patent was registered can have jurisdiction to determine whether there is or not an infringement to this patent.

However, the Patent Court considered that although there are different national approaches, these differences “are rather less now than they have been in the past. Certainly in recent years the European patent judiciary have been striving for consistency. […] Certainly I do not consider that […] that those courts are clearly or distinctly more appropriate than this Court.”

The Court, noting that invalidity was not an issue, referred to last year's English Supreme Court case Lucasfilm v Ainsworth, establishing that the English courts would accept jurisdiction to deal with infringements of foreign copyrights and suggesting that this would apply equally to other foreign IP rights.

The fact is the decision would have certainly been different if the validity of the patent had been contested.

In any case, it seems that such decision is really important and can make at least possible to obtain pan-Europeans declarations of non-infringement.

Primus v. Roche, Court of Appeal The Hague (Gerechtshof Den Haag), 21 August 2012

This decision is a new episode in the Roche v. Primus saga.

The case first went up to the Supreme Court, who referred a preliminary ruling regarding the jurisdiction to the ECJ (C-539/03).

The Supreme Court ruled that the Dutch courts do not have jurisdiction to hear the claims against the other European entities, but only with regard to the Dutch and US entity.

The case was referred back to the Court of Appeal to rule again on a part of the infringement question, which was not adequately motivated in the earlier judgment of the Court of Appeal.

This judgment therefore largely concerns the experiments submitted by Primus in order to establish whether the antibody of Roche meets one of the elements of the claims.

The Court of Appeal held that Roche infringed the patent.

Test results regarding the allegedly infringing product were admitted as evidence because Roche's arguments were held insufficient to render these tests results unreliable.

Furthermore, the court ruled that it had jurisdiction to decide on the infringement in Germany based on Article 24 of EC Regulation 44/2001, because the amended German part of the patent was held valid by final judgment between the same parties in Germany.

The Court ruled that it has been insufficiently established if the US entity sold or delivered infringing products in the Netherlands and/or Germany.

Solvay v. Honeywell, Court of Justice of the European Union, 12 July 2012, Case No C-616/10

The Court of Justice ruled that claims against different companies located in different Member States marketing the same product regarding infringement of a European patent in one jurisdiction were so closely connected that they may be decided jointly to prevent “irreconcilable judgments” in the sense of Article 6(1) EC 44/2001 of 22 December 2000 on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters.

In the present circumstances, a provisional judgment regarding the validity of a patent on the basis of Article 31 of Regulation EC 44/2001 of 22 December 2000 on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters is not prohibited by Article 22(4) of the same Regulation 44/2001 of 22 December 2000 on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters, because it regards only a provisional finding.

The Court of Justice clarified in that decision some aspects of the cross-border enforcement.

Boehringer Ingelheim v. Teva c.s., District Court Utrecht (Rechtbank Utrecht), 15 August 2012

The Dutch preliminary relief judge has ordered a Dutch defendant to stop the promotion and/or facilitation of patent infringement in Portugal.

A Dutch Teva company (“Teva NL”) holds a European market authorization for drugs with nevaripin as active substance.

On the basis of this market authorization, the drugs are marketed by a Portuguese affiliate of Teva NL in Portugal.

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 raised invalidity of the Portuguese SPC as a defense.

The Dutch preliminary relief judge rules that it is competent to hear the claims of Boehringer Ingelheim.

Although the case concerns unlawful acts in the Netherlands, the validity questions are nevertheless relevant because of the defenses of Teva.

According to the judge, in case Article 22(4) of the Brussels Regulation (EC 44/2001) would apply in this situation, the court is nevertheless competent on the basis of Article 31 of the Brussels Regulation because, since the defendant is based in the Netherlands, there is a sufficiently real connection with the Dutch territory (see European Court of Justice 17 November 1998, C-391/95, Van Uden/Deco-Line).

The judge further rules that it is not relevant that an assessment of foreign law is necessary in order to decide the case.

Next to that there is no chance of conflicting decisions as this case would not in any way conflict with the decision on the merits of the Portuguese judge, since the Dutch judge does not give a final ruling on the validity of the Portuguese national patent (see the previous decision commented: European Court of Justice 12 July 2012, C-616/10, Solvay/Honeywell).

After having established that it had jurisdiction to hear the case, the judge also considered the validity of the patent (under Portuguese law) and provisionally ruled the patent to be valid.

On inventive step, an earlier Boehringer patent was chosen as closest prior art.

This earlier patent disclosed a molecule similar to nevaripin but with a different chemical structure.

According to the Dutch judge, small differences in chemical structure can amount to great differences in reactivity, and Teva NL did not submit additional prior art from which it would follow that the man skilled in the art would have an incentive to amend the chemical structure to that of nevaripin with a reasonable expectation of success to obtain a substance with a higher efficacy.

Furthermore, according to this judge, Teva NL could be deemed to be aware of the Portuguese SPC.

Provoking or facilitating infringement by a Portuguese affiliate, that necessarily needed Teva NL's permission to market the infringing product in Portugal, was held to constitute an unlawful act against Boehringer, and an injunction was awarded.

The case is a first in its kind and a special example of how the Dutch Courts are willing to assist in pan European patent infringement.

This judgment follows shortly after the decision of the European Court of Justice in the Solvay Honeywell case, in which the Court of Justice had clarified some aspects of the cross-border practice. It has now been confirmed that it is still possible to obtain injunctions with cross-border effect from the Dutch courts.

Judgment of the European Court of Justice (Fifth Chamber) 6 September 2012 Case C-308/11

Reference for a preliminary ruling under Article 267 TFEU from the Oberlandesgericht Frankfurt a Main (Germany).

The Court has been questioned about the interpretation of the “pharmacological action” which has to be taken into consideration for the determination of the legal nature of the product.

Chemische Fabrik Kreussler and John O. Butler are competitors on the German market for the marketing of mouthwash solutions containing chlorhexidine.

On that market, John O. Butler markets as a cosmetic product a mouthwash solution called “PAROEX 0,12%” in which chlorhexidine, an antiseptic, accounts for 0.12% of the product contents.

The following is stated on the packaging, namely ‘Mouthrinse for oral care – Helps reduce dental plaque accumulation – Protects gums and maintains oral health’.

The information leaflet provided with the product states that users should rinse their mouth with 10 ml of undiluted solution for 30 seconds twice daily.

In the main proceedings, Chemische Fabrik Kreussler is of the view that the mouthwash marketed by John O. Butler is a medicinal product within the meaning of Paragraph 2 of the Law on the marketing of medicinal products inasmuch as it has a pharmacological action.

Consequently, Chemische Fabrik Kreussler brought an action before the Landgericht Frankfurt am Main (Regional Court, Frankfurt am Main) on 14 September 2006 seeking an injunction requiring John O. Butler to desist from advertising the product PAROEX 0,12% on bottles and/or folding boxes and/or instructions for use and/or from marketing that product for as long as it had not been authorised as a medicinal product.

The Landgericht Frankfurt am Main dismissed the action on the ground that PAROEX 0,12% does not exert a pharmacological action because the interaction between the molecules of chlorhexidine and a cellular constituent of the user required for such an action had not been established.

Ruling on the appeal, the Oberlandesgericht Frankfurt am Main (Higher Regional Court, Frankfurt am Main) also held that the product at issue did not exert a pharmacological action.

According to that court, it is apparent that for a substance to be recognized as exerting a pharmacological action within the meaning of Article 1(2)(b) of Directive 2001/83, there must be an interaction between the molecules of the substance in question and a cellular constituent of the user's body, which there is not as regards the product at issue.

Taking the view that the outcome of the proceedings before it is dependent upon the interpretation of Article 1(2)(b) of Directive 2001/83, the Oberlandesgericht Frankfurt am Main decided to stay the proceedings and to refer the following questions to the Court of Justice for a preliminary ruling:

For the purpose of defining the term “pharmacological action” in Article 1(2)(b) of Directive 2001/83 … , can recourse be had to [the guidance document on medical devices], which states that there must be an interaction between the molecules of the substance in question and a cellular constituent, usually referred to as a receptor, which either results in a direct response or blocks the response of another agent?

On those grounds, the Court (Fifth Chamber) hereby rules:

Article 1(2)(b) of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, as amended by Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004, must be interpreted as meaning that, for the purpose of defining the term ‘pharmacological action’ within the meaning of that provision, account may be taken of the definition of that term in the Guidance Document on the demarcation between the Cosmetic Products Directive 76/768 and the Medicinal Products Directive 2001/83 as agreed between the Commission services and the competent authorities of the Member States.

Article 1er paragraph 2, (a), third point of Directive 93/42/EEC of Council regarding medical device

ECJ, November 22, 2011 C-219/11

The Court of Justice of the European Union had to answer to the following question: can be qualified as medical device a product, for which the non-medical use has been defined by its manufacturer, which is intended for investigation of a physiological process?

In the case, the product involved was an electronic system and equipment which allows recording the human brain activity.

ECJ answered to the question by the negative. Actually according to the Court “the concept of “medical device” covers an object conceived by its manufacturer to be used for human beings for the purpose of investigation of a physiological process only if it is intended for a medical purpose”.

Case of Hristozov and Others v. Bulgaria (n°47039/11 and 358/12), 13 November 2012

Bulgaria's refusal to allow terminally-ill cancer patients to use experimental medicine did not violate their rights.

The applicants are ten Bulgarian nationals, nine of whom are or were terminally-ill cancer patients.

Four of them have died since lodging their case and the proceedings have been pursued by their relatives in their stead.

Having either unsuccessfully tried a number of conventional treatments or obtained a medical opinion that such forms of treatment would not work in their respective cases or were not available in Bulgaria, all applicants approached a private clinic in Sofia.

There they were told about an experimental anti-cancer product developed by a Canadian company which, according to that company's information, had not been authorized in any country, but had been allowed for “compassionate use” in a number of countries, which meant that those countries could make the product available to patients with a life-threatening disease which could not be treated satisfactorily by an authorized medicine.

The company informed the Bulgarian Ministry of Health in January 2011 that during its pre-clinical development phase it would be willing to provide the product free of charge to the clinic, for use on cancer patients who could no longer benefit from conventional therapies, in return for data on the effects of the treatment. The applicants applied to the authorities for permission to use the product, but were each informed by the Executive Medicines Agency, between June and August 2011, that since the experimental product was not yet authorized or undergoing clinical trials in any country it could not be authorized for use in Bulgaria under the applicable provisions. The Bulgarian Ministry of Health, on appeal by some of the applicants, confirmed the agency's position. The Bulgarian Ombudsman, to whom three applicants applied, also essentially confirmed that position.

The applicants complained that the Bulgarian authority's refusal to allow them the use of the experimental anticancer drug breached their rights under Article 2, Article 3 and Article 8.

The Court dismissed the Bulgarian Government's request to have the application struck out of the list of cases as regards those applicants who had died in the course of the proceedings. It held in particular that the case also had a moral dimension and that therefore the applicants' relatives had a legitimate interest in obtaining a ruling even after the applicants' death. Moreover, the subject matter of the case was closely connected with the applicants' death. The Court also dismissed the Government's objection that the applicants had not sought judicial review of the authorities' decision.

As regards the applicants' argument that Bulgarian law should be framed in a way as to entitle them to exceptionally have access to an experimental and yet untested product, the Court noted that a State's obligation under Article 2 might include the duty to put in place an appropriate legal framework in order to protect people's lives. For instance, a State might be obliged to put in place regulations compelling hospitals to adopt appropriate measures for the protection of their patients' lives.

However, Bulgaria did have in place regulations governing access to unauthorized medicine in cases where conventional forms of medical treatment appeared insufficient. In the Court's view, Article 2 could not be interpreted as requiring that access to unauthorized medicine for the terminally ill be regulated in a particular way. It also noted that under European Union law this matter remained within the competence of the member States and that European States dealt differently with the conditions and manner of providing access to unauthorized medicinal products. There had therefore been no violation of Article 2.

There had accordingly been no violation of Article 3 and of Article 8.