A brief guide how you can manage your intellectual property

Albert Ferraloro (Wrays) published in Lexology an interesing and helpful brief guide what steps you can take to start managing your intellectual proerty.

The article covers some essential points in that regard such as:

– Who may create IP?

– When might IP be created?

– What steps can be taken to help identify and capture IP?

– Good business practices.

– Know the ‘IP Landscape’.

– Promoting an ‘IP culture’ in the workplace.

– What are the risks of poor IP management?

– Action items – Trade Marks Considerations.

The full article can be found here.

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Brief IP news

briefs_1131. CJEU in C-395/16, Doceram vs. CeramTec, interprets the concept of technically required features of appearance excluded from protection under Community designs Regulation. For more information here.

2. Colour it mine: protecting colour trademarks. For more information here.

3.  Euro-PCT Guide: PCT procedure at the EPO. For more information here.

Source: Intellectual Property Center at the UNWE. More information can be found here

A European Court’s decision regarding parallel import and trademark rights

flag-2608475_960_720The European Court issued a decision on Case  C‑642/16 Junek Europ-Vertrieb GmbH v Lohmann & Rauscher International GmbH & Co. KG. The case concerns the following:

Lohmann & Rauscher International is the proprietor of the EU trademark ‘Debrisoft’, No 8852279, registered on 22 June 2010 for ‘sanitary preparations for medical purposes’, ‘plasters, materials for dressings’ and ‘dressings, medical’. It manufactures and markets, inter alia, the product ‘Debrisoft for debridement, STERILE, 10 x 10 cm, 5 pieces’, which is a dressing used for the superficial treatment of wounds.

Junek Europ-Vertrieb is a company established in Austria and markets in Germany, by way of parallel importation, sanitary preparations for medical purposes and medical dressings manufactured and exported to Austria by the applicant.

On 25 May 2012, Lohmann & Rauscher International purchased in a pharmacy in Düsseldorf a pack of ‘Debrisoft for debridement, STERILE, 10 x 10 cm, 5 pieces’ which Junek Europ-Vertrieb had previously imported from Austria. Before the sale to the pharmacy, that company had affixed on that box a label (‘the contested label’) featuring the following information: the company responsible for the importation, its address and telephone number, a barcode and a central pharmaceutical number. The label was applied neatly to an unprinted part of the box and did not conceal the mark of Lohmann & Rauscher International.

The packaging of the product had been modified as illustrated below, with the contested label located on the bottom left.

The contested label, enlarged, presents as follows:

Junek Europ-Vertrieb had not given prior notice to Lohmann & Rauscher International of the reimportation of the product concerned and also had not supplied it with the modified packaging of the product with the contested label affixed. Lohmann & Rauscher International considered that the conduct of Junek Europ-Vertrieb was an infringement of the Debrisoft mark of which it was the proprietor.

It therefore lodged an action before the Landgericht Düsseldorf (Regional Court, Düsseldorf, Germany), seeking, in particular, to prohibit, under threat of a penalty, Junek Europ-Vertrieb from using in the course of trade, without its agreement, that mark for the purpose of designating dressings for debridement and to order that company to recall, withdraw from the market and destroy the products concerned.

The Landgericht Düsseldorf (Regional Court, Düsseldorf) upheld that claim.

The Oberlandesgericht Düsseldorf (Higher Regional Court, Düsseldorf, Germany), dismissed the appeal that Junek Europ-Vertrieb had lodged against the judgment given by the Landgericht Düsseldorf (Regional Court, Düsseldorf), with the reservation that the prohibition on use of the mark at issue related to Germany only. Junek Europ-Vertrieb then lodged an appeal on a point of law before the Bundesgerichtshof (Federal Court of Justice, Germany).

According to the referring court, the outcome of the dispute before it depends on whether the principles developed by the Court in respect of parallel imports of pharmaceutical products, according to which prior notice and the supply of a packaging specimen on demand by the trade mark proprietor are conditions for exhaustion of the rights conferred by its trade mark, also apply to the parallel importation of medical devices.

First, the referring court states that, according to the case-law of the Court, it is the repackaging of the trade-marked pharmaceutical products in itself which is prejudicial to the specific subject matter of the mark, which is to guarantee the origin of the product that it identifies. It refers, in particular, to the judgments of 23 April 2002, Boehringer Ingelheim and Others (C‑143/00, EU:C:2002:246), and of 26 April 2007, Boehringer Ingelheim and Others (C‑348/04, EU:C:2007:249), according to which the Court held that the repackaging of a pharmaceutical product by a third party without the permission of the proprietor gives rise to real risks for the guarantee of origin and that affixing a new label to the packaging also constitutes repackaging.

Second, it is clear from the case-law of the Court that the trade mark proprietor’s opposition to commercialisation of repackaged pharmaceutical products under Article 13(2) of Regulation No 207/2009, which is a derogation from the free movement of goods, cannot, however, be accepted if the proprietor’s exercise of that right constitutes a disguised restriction on trade between Member States within the meaning of Article 36 TFEU (judgments of 11 July 1996, Bristol-Myers Squibb and Others, C‑427/93, C‑429/93 and C‑436/93, EU:C:1996:282, and of 26 April 2007, Boehringer Ingelheim and Others, C‑348/04, EU:C:2007:249). It follows that the proprietor of a mark may oppose a modification which involves any repackaging of a pharmaceutical product bearing its mark, which, by its very nature, creates real risks for the guarantee of origin of the pharmaceutical product, unless five conditions are met, namely:

–  it is established that the use of the trade mark rights by the proprietor thereof to oppose the marketing of the relabelled products under that trade mark would contribute to the artificial partitioning of the markets between Member States;

–  it is shown that the repackaging cannot affect the original condition of the product inside the packaging;

–  the new packaging states clearly who repackaged the product and the name of the manufacturer;

–   the presentation of the repackaged product is not such as to be liable to damage the reputation of the trade mark and of its owner; thus, the packaging must not be defective, of poor quality, or untidy; and

–   the importer gives notice to the trade mark proprietor before the repackaged product is put on sale, and, on demand, supplies him with a specimen of the repackaged product.

Secondly, the application of those principles is not restricted to cases of the parallel importation of pharmaceutical products. Thus, in its judgment of 11 November 1997, Loendersloot (C‑349/95, EU:C:1997:530), the Court held that the criteria relating to the repackaging of pharmaceutical products could also, in principle, apply to parallel trade of alcoholic beverages. In addition, it notes that the conditions for the exhaustion of the rights conferred by a mark that are applicable depends on the relevant legitimate interests of the proprietor of the mark in the given case, having regard to the particular nature of the product.

Thirdly, the referring court considers that there was relabelling in the present case. Agreeing with the appellate court, it considers that the contested label affixed by Junek Europ-Vertrieb includes important information in the language of the importing country and that that label could give rise to the suspicion on the part of the consumer that the product which is offered to them was the object, at an earlier stage of its marketing, to interference by a third party, without the authorisation of the proprietor of the mark, which affects the original condition of the product.

Fourthly, as regards the question of whether the principles developed by the Court in respect of the parallel importation of pharmaceutical products apply without restriction to the parallel importation of medical devices, the referring court notes that even though medicinal devices are not, as is the case for pharmaceutical products, subject to authorisation procedures, nevertheless, the conformity assessment procedure necessary for them to be allowed onto the market makes them, from the point of view of both manufacturers and consumers, particularly sensitive products for which the guarantee of origin provided by the mark covering the product, owing to the high degree of responsibility of the manufacturer, has particular importance.

It adds that medical devices, just like pharmaceutical products, are products that have a direct connection with health. Since customers particularly value and pay attention to their own health, it was not necessary, according to the referring court, to call in question the appellate court’s finding that medical devices, as well as pharmaceuticals, are particularly sensitive products for which the guarantee of origin provided by the mark affixed to the product is of particular importance because of the high degree of responsibility of the manufacturer.

In those circumstances the Bundesgerichtshof (Federal Court of Justice) decided to stay the proceedings before it and to refer the following question to the Court for a preliminary ruling:

‘Must Article 13(2) of Regulation […] No 207/2009 be interpreted as meaning that the proprietor of the mark can oppose further commercialisation of a medical device imported from another Member State in its original internal and external packaging, to which the importer has affixed an additional external label, unless

–  it is established that reliance on trade-mark rights by the proprietor in order to oppose the marketing of the overstickered product under that trade mark would contribute to an artificial partitioning of the markets between Member States;

–  it is shown that the new labelling cannot adversely affect the original condition of the product inside the packaging;

–  the packaging states clearly who overstickered the product and the name of the manufacturer;

–  the presentation of the overstickered product is not such as to be liable to damage the reputation of the trade mark and of its proprietor; thus, the label must not be defective, of poor quality, or untidy; and

–  the importer gives notice to the trade mark proprietor before the overstickered product is placed on the market, and, on demand, provides him with a specimen of that product?’

The Court decision:

Article 13(2) of Council Regulation (EC) No 207/2009 of 26 February 2009 on the European Union trade mark must be interpreted as meaning that the proprietor of a mark cannot oppose the further commercialisation, by a parallel importer, of a medical device in its original internal and external packaging where an additional label, such as that at issue in the case in the main proceedings, has been added by the importer, which, by its content, function, size, presentation and placement, does not give rise to a risk to the guarantee of origin of the medical device bearing the mark.

Advocate General’s opinion on Article 3(a) of SPC Regulation

pexels-photo-613508Advocate General of the European Court M. WATHELET issued an opinion on case C-121/17 Teva UK Ltd, Accord Healthcare Ltd, Lupin Ltd, Lupin (Europe) Ltd, Generics (UK), v Gilead Sciences Inc. The case concerns the following:

Gilead is a pharmaceutical company which markets an antiretroviral medicinal product indicated for the treatment of persons infected with HIV, under the name Truvada. That medicinal product contains two active ingredients, tenofovir disoproxil (‘TD’) and emtricitabine. (5) It was granted marketing authorisation (‘MA’) in 2005 by the European Medicines Agency (EMA).

Gilead holds European patent No EP 0 915 894 (‘the basic patent’). That patent, which was applied for on 25 July 1997 with a claimed priority date of 26 July 1996, was granted on 14 May 2003 and expired on 24 July 2017. It covers, in general terms, a series of molecules which are helpful in the therapeutic treatment of a number of viral infections in humans and animals, in particular HIV.

The ‘Summary of the Invention’ states that the invention provides compounds in accordance with two Markush formulae, formula (1a) and formula (1), and methods for preparing such compounds.

laim 1 is a claim to compounds of formula (1a) and claim 2 is a claim to compounds of formula (1). Claims 3 to 24 are dependent compound claims which get progressively narrower in scope.

Claim 25 is an independent compound claim to TD.

Claim 27 is in the following terms:

‘A pharmaceutical composition comprising a compound according to any one of claims 1 to 25 together with a pharmaceutically acceptable carrier and optionally other therapeutic ingredients’. (6)

Claims 28 to 33 are method claims.

In 2008, Gilead was granted SPC SPC/GB05/041 on the basis of claim 27 of the basic patent and the MA obtained for Truvada. The SPC relates to a ‘composition containing [TD], optionally in the form of a pharmaceutically acceptable salt, hydrate, tautomer or solvate, together with Emtricitabine’. (7)

The applicants in the main proceedings, who intended to market generic versions of Truvada on the UK market once the basic patent had expired, brought proceedings before the referring court disputing the validity of that SPC.

In support of their action, the applicants in the main proceedings argue essentially that, in order for Article 3(a) of Regulation No 469/2009 to be satisfied, the product in question must be ‘specified in the wording of the claims’ (8) and, where the claim contains a functional definition, it must ‘relate, implicitly but necessarily and specifically’ to that product. (9) They observe that emtricitabine is not specified anywhere in the wording of claim 27 and that the words ‘other therapeutic ingredients’ do not specify any active ingredient, whether structurally, functionally or otherwise. ‘On the contrary, they cover a virtually unlimited range of active ingredients for the treatment of many diseases. Indeed, emtricitabine was not approved for clinical use until seven years after the priority date of the Patent and there is no evidence that it was known to be efficacious at that date.’

The applicants in the main proceedings also contend that claim 27 does not require the presence of any ‘other therapeutic ingredients’ since such ingredients are only ‘optionally’ present. According to the applicants, ‘it is clear from the case-law of the Court that it is not enough that a claim to “A composition comprising compound A” would be infringed due to the presence of A in a combination product consisting of A and B. There is no distinction between such a claim and a claim to “A composition consisting of compound A and optionally other active ingredients”’.

Gilead asserts that in order for Article 3(a) of Regulation No 469/2009 to be satisfied, it is necessary and sufficient that the product in question falls within the scope of protection of at least one claim of the basic patent applying the Extent of Protection Rules. (10) It takes the view that the combination of TD and emtricitabine does fall within the scope of protection of claim 27 of the patent under Article 69 of the EPC and under the Protocol on interpretation.

The referring court considers that, notwithstanding the many judgments delivered by the Court of Justice on interpretation of Article 3(a) of Regulation No 469/2009, (11) the meaning to be given to that article ‘remains unclear’. The referring court asserts that the need to make a reference to the Court of Justice is confirmed by the divergent decisions that have been reached around Europe as to the availability of an SPC on the facts of the present case and by the differing interpretations of Article 3(a) of Regulation No 469/2009 that have been adopted in the case-law of the national courts. (12)

The referring court states that it is not sufficient that the product falls within at least one claim of the basic patent and that ‘more is required’. The judgments of 12 December 2013, Actavis Group PTC and Actavis UK (C‑443/12, EU:C:2013:833); of 12 December 2013, Eli Lilly and Company (C‑493/12, EU:C:2013:835) and of 12 March 2015, Actavis Group PTC and Actavis UK (C‑577/13, EU:C:2015:165) suggest that, in order to determine whether a ‘product is protected by a basic patent’, ‘the subject matter of the invention covered by the basic patent’ or the ‘core inventive advance’ must also be taken into consideration. However, the referring court submits, those judgments do not make clear the meaning and scope of those new tests, or even whether they apply to interpretation of Article 3(a) of Regulation No 469/2009. (13)

According to the referring court, the product must contain an active ingredient, or a combination of active ingredients, which embodies the inventive advance (or technical contribution) of the basic patent. (14)

In the present case, the referring court notes that emtricitabine is not mentioned in the basic patent at issue. Nor is there any evidence that emtricitabine was known to be efficacious for the treatment of HIV on the priority date claimed by that patent. In view of those considerations, the referring court hesitates to find that the TD/emtricitabine combination is protected by the basic patent within the meaning of Article 3(a) of Regulation No 469/2009, especially as the criteria laid down in the case-law provide but little clarification for the purpose of resolving that question.

In those circumstances, the High Court of Justice (England and Wales), Chancery Division (Patents Court) decided to stay the proceedings and to refer the following question to the Court of Justice for a preliminary ruling:

‘What are the criteria for deciding whether “the product is protected by a basic patent in force” in Article 3(a) of Regulation No 469/2009’.

The Advocate’s opinion:

Article 3(a) of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products precludes the grant of a supplementary protection certificate relating to active ingredients which are not specified in the wording of the claims of the basic patent. The fact that a substance or combination of substances falls within the scope of protection of the basic patent is a necessary, but not sufficient, requirement for it to constitute a product protected by a patent within the meaning of Article 3(a) of Regulation No 469/2009. A product is protected by a patent within the meaning of Article 3(a) of that regulation if, on the priority date of the patent, it would have been obvious to a person skilled in the art that the active ingredient in question was specifically and precisely identifiable in the wording of the claims of the basic patent. In the case of a combination of active ingredients, each active ingredient in that combination must be specifically, precisely and individually identifiable in the wording of the claims of the basic patent.

 

 

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