llp_sep18.pdf - Pharmaceutical Trade Marks Group

When a company seeks the review of anex parte decision issued by the TrademarkTrial and Appeal Board (TTAB), oneoption, other than an appeal to theFederal Circuit, is a direct appeal to aUnited States District Court. Pursuingthis option, however, may result in theunusual circumstance of the companypaying the USPTO's attorneys' fees even ifthe company prevails.

In Shammas v Focarino, 784 F.3d 219 (4thCir. 2015), the Fourth Circuit affirmed theaward of the USPTO's attorneys' fees in atrade mark case finding that such feesconstituted 'expenses' under the relevantstatute. This summer, by contrast, theFederal Circuit in the patent caseNantkwest, Inc. v Iancu, 898 F. 3d 1177(Fed. Cir. 2018)(en banc), held that suchexpenses did not include attorneys' fees.

These contradictory decisions create a'circuit split' even though Shammasinvolved trade mark and Nantkwestinvolved patent law, as the statutoryprovisions at issue are very similar. TheUSPTO may seek review of Nantkwest bythe Supreme Court. In the meantime, theFourth Circuit will have the chance torevisit this issue during the pending appealof the District Court trade mark caseBooking.com B.V. v Matal, 2017 WL4853755 (E.D. Va. October 26, 2017). Inthat case, the District Court orderedBooking.com to pay USD $51,472.53 inthe USPTO's 'personnel' expenses(covering the fees of attorneys and aparalegal). This case has attractedconsiderable attention as the courtordered Booking.com to pay the USPTO'sattorneys' fees even though Booking.comwas the prevailing party!

For Pharma companies considering thereview of an ex parte TTABdetermination, the decision to pursue adirect appeal to a District Court, where itmay involve the payment of a significantsum of money for the USPTO's attorneys'fees, may make the option of an appeal tothe Federal Circuit more desirable. Thereis no similar provision for paying theUSPTO's attorneys' fees in a FederalCircuit appeal. Nonetheless, a directappeal to a District Court may makemore strategic sense in certaincircumstances. The issue of whether acompany must pay the USPTO's attorneys'fees could be headed to the US SupremeCourt for ultimate resolution. For now,pursuing the appeal of a TTAB ex partedecision to a District Court clearlyimplicates potentially paying the USPTO'sattorneys' fees no matter who wins.

Here in mainland Europe, we areenjoying an ongoing hot summer, withtemperatures reaching 30°C still. This initself is glorious, an Indian summeralways being one of my favouritemoments of the year when the feeling ofpushing back winter is most agreeableand early al fresco dinners before the

light fades are still possible. However, coming on the back of twosolid months of wall to wall heat with almost no rainfall, this yearalso raises questions and concerns which inevitably lead back toglobal warming. The lawns look like straw, the shrubs are wiltingand farmers have long had to resort to feeding their animals withwinter feed, posing issues for the months to come.

Two years ago, the World Health Organisation had alreadywarned that 250000 supplementary deaths per annum were tobe expected between 2030 and 2050, given the projected impactof climate change on clean air, drinking water and sufficient foodsupplies. Even on a very local level, some of the insects flying

around this year in the gardens have rarely been seen in suchquantities – notably May beetles and Asian hornets. Due toincreased international travel, illnesses such as the dengue andmalaria crop up in conversations more regularly than in the past.

Whilst I am certainly not a Luddite, proning a return to theinfamous “good old days”, I am entitled to be concerned aboutmy ageing immune system and its ability to adapt to these newenvironmental conditions and our collective response to them.Ignoring the consequences of mankind's impact on the naturalworld would be yet another example of the folly of our species.In this connection, Cormak McCarthy's post-Apocalyptic novelThe Road should be made compulsory reading – but not just inschools.

I look forward to seeing many of you in Dubrovnik where thebalmy evenings (hopefully without mosquitos) will be the perfectoccasion to discuss this and pharmaceutical matters – of course!

Vanessa

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PharmaceuticalTrade Marks GroupPharmaceuticalTrade Marks Group Sept 2017

How hot can it get?

US Update Jonathan S. Jennings, Pattishall, McAuliffe, Newbury, Hilliard & Geraldson LLP

Sept 2018

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Words from the Chair

Preparing for my summer vacation(again in France, but this time in theProvence) I am still in shock aboutthe latest political developments:President Trump has made asensational trip to Europe leaving hisNATO allies (and especially theGermans) reeling. Afterwards heenjoyed dinner at Blenheim Palacewith Theresa May. At the same timethe press published an interviewwhere he basically said that May haswrecked Brexit (because she did notsue the EU as he had advised her todo) and that Boris Johnson wouldmake a perfect Prime Minister. Perfecttiming, indeed! Well, who needsenemies if you have friends like that?And finally Mr. Trump made anappearance in Helsinki at a summitwith Vladimir Putin. Wow, I am stillbaffled and look forward to myholidays in France where I hopefullywill not be exposed to any furtherworld news.

Here in the European IP worldAntonio Campinos meanwhile has leftAlicante and has taken over his newrole as President of the EPO inMunich. At the EUIPO Antonio hasdefinitely left an impressive footprint.We wish him all the best for this newjob and at the same time can't wait tosee his successor in Alicanteappointed.

In early October we will be reunitedin beautiful Dubrovnik for our nextconference under the title ‘Pearls oftrade mark wisdom from the Pearl ofthe Adriatic’. Something to lookforward to..... Until then enjoy afantastic summer (wherever youspend it) and take care!

Frank Meixner

New Members

We are delighted to welcome the following new members to the Group:

Evrard van Zuylen of Darts-IP, ClosLucien Outers 11-21, Brussels, 1160,Belgium [email protected]

Barbara Solomon of Fross ZelnickLehrman & Zissu, 4 Times Square, 4thFloor, New York, NY, 10036, [email protected]

Moves and Mergers

Marianne Hollands has left OrionCorporation to join Berggren Oy inHelsinki, Finland. Marianne can becontacted [email protected]

Sandrine Pernod Boulanger is nowwith Reflexlegal in Westmount, Quebec,Canada and can be contacted at [email protected]

Toni Polson Ashton has left Sim &McBurney to join Marks & Clerk Canadain Toronto, Canada. Toni can now be contacted at [email protected]

Agnieszka Sztoldman has leftDentons to join SMM Legal in Warsaw,Poland. Agnieszka can be contacted [email protected]

Maria Angeles Moreno and SergioGonzalez have both left Herrero &Asociados to join Arochi & Lindner inMadrid, Spain. Maria can be contacted [email protected] and Sergioat [email protected]

Tiffany Valeriano has leftTrademarkNow to join Corsearch inAschaffenburg, Germany. Tiffany can nowbe contacted [email protected]

Steve Anderson from Corsearch has anew email address;[email protected].

Nicole Linker has left ActelionPharmaceuticals to join Abbott ProductsOperations AG in Allschwil, Switzerland.

Nicole can be contacted [email protected].

Jennifer Insley-Pruitt has left FrossZelnick Lehrman & Zissu to join DechertLLP in New York, USA. Jennifer can nowbe contacted at [email protected]

Coleen Morrison has left Marks &Clerk Canada to join Perry & CurrierInc. in Toronto, Canada. Coleen can becontacted at [email protected]

Philip Harris is now Managing Directorof Novagraaf UK in London, UK. Philipcan be contacted [email protected]

Wolfgang Danner is now withBilltrader PTY Ltd and can be contactedat [email protected]

Kana Enomoto has left MaucherJenkins to join Johnson & Johnson inAllschwil, Switzerland. Kana can be contacted at [email protected]

Heidi Gorenstein Nigri has left LuizLeonardos Intellectual Property to joinMcLaw – Müller, Cid, Noronha, Cruz &Gorenstein Attorneys at Law in Rio deJaneiro, Brazil. Heidi can be contacted [email protected]

Sonia Elkrief formerly with MerckSerono, is now in private practice basedin Geneva, Switzerland. Sonia can becontacted at [email protected].

Please remember to let us know of anychanges to your contact details. You cannotify me either via the PTMG websitewww.ptmg.org or directly [email protected] or by writing to me atTillingbourne House, 115 GregoriesRoad, Beaconsfield, Bucks, HP9 1HZ

Lesley EdwardsPTMG Secretary

Members News

On 19 June 2018, the EU General Courtannulled the Fourth Board of Appeal'sfinding that there was a likelihood ofconfusion between the marks XENASAand PENTASA. The decision raisesinteresting issues relating to the impact ofthe understanding of different types ofend-users on the assessment of similarityof signs, and of the likelihood of confusion.The outcome can be contrasted with theGeneral Court's June 2017 decision thatthere was a likelihood of confusionbetween OCTASA and PENTASA, in adispute involving the same parties (see theSeptember 2017 edition of LL&P).

This dispute dates back to 2013, whenTillotts Pharma AG applied to register anEU trade mark for the word signXENASA in relation to Class 5 goods(pharmaceutical preparations, namely forthe diagnosis, prevention and/or treatmentof gastrointestinal disorders andconditions; pharmaceutical preparationsfor the treatment of inflammation of thegastrointestinal tract; dietetic substancesadapted for medical use, namely for thediagnosis, prevention and/or treatment ofgastrointestinal orders and conditions).Ferring BV filed a notice of oppositionbased on its earlier EU word markPENTASA, covering 'pharmaceuticalproducts and substances', also in Class 5.The Board of Appeal annulled theOpposition Division's decision, holdingthat there was a likelihood of confusionbetween the marks (see the September2016 edition). The Board's decision wasseen as surprising at the time, given thehigh level of attention that both the publicand professionals display in relation topharmaceutical products.

In its decision, the General Court agreedthat the attention of the relevant public(both professionals and end-user patients)would be high, rejecting the EUIPO'sargument that, for dietetic preparationsfor diagnosing, preventing and treatinggastrointestinal disorders, the level ofconsumer attentiveness should be set at a

lower level, namely just above average. TheCourt also upheld the Board of Appeal'sdecision that the goods were identical orvery similar.

When comparing the signs, the Court paidparticular attention to the differentcategories of end-users. In particular, theCourt only partially upheld the Board ofAppeal's finding that the descriptivecharacter of the suffix ASA, as a referenceto the active ingredient mesalazine, alsoknown as 5-asa, would not be understoodby all end-users (the Board's finding hadbeen based on the General Court's firstOCTASA decision). Here, the GeneralCourt concluded that, given that someend-users may in fact regularly takemedications containing 5-asa ormesalazine for treatment of inflammationof the gastrointestinal tract, a significantpart of end-users would perceive ASA torefer to that ingredient.

Accordingly, when assessing the visual,phonetic and conceptual similaritiesbetween the signs and the likelihood ofconfusion, the General Court distinguishedbetween

(a) those end-users who would, and thosewho would not, understand ASA as a reference to the active ingredient 5-asaor mesalazine (which, for example, impacted on how XENASA would be pronounced); and also;

(b) between those end-users who would, and those who would not, perceive thebeginnings of the signs as references tothe Greek word xenos and the prefix of Greek origin penta respectively (which, in particular, impacted on the conceptual comparison).

For each category of end-user however,the Court concluded that there was nolikelihood of confusion.

In contrast, in its June 2017 OCTASA

decision, the General Court had decidedthere was a likelihood of confusionbetween OCTASA and PENTASA, eventhough there was only a low degree ofaural, visual and conceptual similarity, anddespite the higher level of attention thatwould be displayed by both professionalsand end-users. In that case, there was nochallenge to the Board's finding that asignificant number of end users (asopposed to medical professionals) wouldnot be able to identify the descriptivecharacter of ASA, which had a significantimpact on the assessment of similarity ofthe signs.

The Court's latest decision demonstratesthat the assessment of similarity of signs,and of the likelihood of confusion, can bea complex one in relation topharmaceutical products, particularlywhere a number of categories of end-users may have varying perceptions ofdifferent elements of a mark. In turn, thiswill impact on the relevant evidence thatmust be obtained in relation to differentcategories of user.

EU General Court annuls Board of Appeal decisionin XENASA v PENTASANina O'Sullivan and Humam Al-Jibouri, Mishcon de Reya LLP

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3

Interlocutory or interim injunctions areattractive to plaintiffs because the grant ofan injunction often ends the litigation, atmuch less cost than a full-blown trial.Pharma cases are no exception. That said,such injunctions are not easy to obtain,and when granted there is a risk ofdamages to the defendant should the caseproceed to trial and the defendant isfound not to have infringed.

One important requirement for obtainingsuch relief is proof of irreparable harm.The issue to which this note is addressedis whether irreparable harm should bepresumed if the Court is of the view thatthe plaintiff is likely to succeed at trial. Inthe author’s view, such a presumptiongenerally is not in the public interest.Instead, Courts should require evidence oflikely irreparable harm unless there areexceptional circumstances to the contrary.

For the UK and other commonwealthcountries including Canada, the usualstarting point is the 1975 judgment ofLord Diplock in American Cyanamid vEthicon. That case involved absorbablesynthetic sutures that were covered by apatent owned by American Cyanamid.Ethicon introduced into the UK market,synthetic sutures intended to competedirectly with those of American Cyanamid.Graham, J. granted an interlocutoryinjunction, which was vacated by theCourt of Appeal. On appeal to the Houseof Lords, the decision of Graham J. wasrestored.

The reasons given by Lord Diplock wereintended to serve as guidelines for thefuture grant of interlocutory injunctions.They are summarized as follows: (1) thereis a serious question to be tried, (2) theplaintiff will suffer irreparable harm if theinterlocutory injunction is denied, and (3)the balance of convenience favours theplaintiff. These guidelines in general applyto both trade marks and patents, butthere are differences, as indicated below.

The requirement of a 'serious question tobe tried' is a low threshold. It is generallyconsidered sufficient if the plaintiff has apossibility of success at trial, rather than aprobability of success. It appears thatLord Diplock’s guidelines were intendedfor those cases where it is neitherpossible nor practical for the Court at aninterlocutory stage of the action to make

a proper assessment of the plaintiff ’schances of success at trial, which is whyproof of liability was set low, and proof ofirreparable harm and balance of conven-ience were set high.

In the UK, the relative strength of therespective parties’ positions has become afactor, notwithstanding the low thresholdtest envisaged by Lord Diplock. In Series5 Software Ltd. v Clarke, Justice Laddiestated that 'Lord Diplock did not intend ...to exclude consideration of the strengthof the cases in most applications forinterlocutory relief.' This implies a 'slidingscale' approach, i.e. the level of requiredproof of irreparable harm is an inversefunction of the perceived strength of theplaintiff ’s case. Even so, interim injunctionsin trade mark cases remain difficult toobtain in the UK, Canada and othercommonwealth countries.

Interestingly, interim injunctions in the UKmay more readily be obtained in pharmapatent cases than trade mark cases unlessthe defendant has taken steps to 'clear theway' of any blocking patents prior toentering the market: seeSmithKlineBeecham v Apotex and casesthat follow. That said, much depends onthe relevant facts. In Cephalon v Orchid,an interim injunction was refusedessentially based on Cephalon’s failure toprove irreparable harm. In Canada,interlocutory injunctive relief in patentcases remains problematic, see TearlabCorporation v I-Med Pharma Inc., wherethe Canadian Federal Court of Appealaffirmed a trial judgment refusing aninterlocutory injunction in a pharmapatent case.

US case law has developed along differentlines. Historically, irreparable harm hasbeen presumed once the Court is satisfiedthe plaintiff is likely to succeed. This haschanged as a result of two United StatesSupreme Court cases: eBay Inc. vMercExchange and Winter v NaturalResources Defense Council, Inc. Accordingto the Winter case, in order to obtain apreliminary injunction, a plaintiff 'mustestablish that he is likely to succeed onthe merits, that he is likely to sufferirreparable harm in the absence ofpreliminary relief, that the balance ofequities tips in his favor, and that aninjunction is in the public interest.'

Although eBay and Winter are importantcases that indicate the present state of USlaw, it remains unclear whether it isappropriate for US Courts to apply a'sliding scale' approach as mentionedabove. In the author’s view, the fact thatan interlocutory injunction is anextraordinary remedy that can affect thepublic interest as well as the interests ofrival traders, means that irreparable harmgenerally should not be presumed.

There appears to be divergent viewsamong the Federal circuits in the US as tothe applicability of a sliding scale test. As aresult, in 2017 the Board of Directors ofthe INTA passed a resolution proposingthat the Lanham Act should be amendedto provide that 'when a claimant seeksinjunctive relief under Section 34 of theAct, a rebuttable presumption ofirreparable harm shall apply where therehas been a finding of liability, or in the caseof a motion for a preliminary injunction, afinding of probable success on the meritsof the claim'. This means that the burdenof proof then shifts to the defendant todisprove irreparable harm.

In the author’s view, this approach mayencourage trade mark bullying, and may beinconsistent with the public interest infreedom of competition and freedom ofexpression. Proving 'probable success' isnot the same thing as proving liability forinfringement or unfair competition, andcould lead to cases where injunctions areissued without proof of any likely harm tothe trade mark owner.

All that said, we do live in the real world,and in cases where the defendant’sconduct is considered to be clearly wrong,perhaps even borderline outrageous, theCourt may well decide that to apply toostrict an approach to irreparable harmcould put the Court in the position ofsiding with a wrongdoer. This was wellexpressed in Ludlow Music Inc. v CanintMusic Corp. 1967 CarswellNat 19, acopyright decision of Jackett, P. of the thenExchequer Court of Canada, now theFederal Court of Canada. 'In effect, as itseems to me, it is a proper exercise ofjudicial discretion to protect propertyrights against encroachment that has noapparent justification, and, in particular, toprotect copyright against what appears tobe piracy.'

4

Interlocutory Injunctions and Irreparable HarmDaniel R. Bereskin, Q.C., Bereskin & Parr LLP

A new trade mark regulation entered intoforce in Albania on 7 June 2018, clarifying arange of issues raised by the changes tothe Albanian Industrial Property Law inforce as of 24 March 2017. Some of themost significant changes and clarificationsconcern the following:

Clear Definitions and RepresentationRequirements

While the Albanian IP law defines a trademark in general terms, the new regulationmore clearly defines different types oftrade marks as well as representationrequirements for the most commontraditional and non-traditional trademarks. It provides definitions for word,figurative, position, pattern, color andshape marks that are in line with theImplementing Regulation (EU) 2018/626 of5 March 2018.

Having clear rules on trade markrepresentation enables applicants toclearly demonstrate the nature and fea-tures of their marks, which allows forproper examination and, at a later stage,adequate determination of the nature andscope of protection, especially inenforcement proceedings.

Literal Interpretation of ClassHeadings

The regulation adopts the literal approachwhen interpreting the scope of protectionwhen class headings are used in lists ofgoods and services in trade markapplications and registrations. Namely,Article 13(2) of the regulation states thatgeneral terms, including class headings ofthe Nice Classification, are to beinterpreted as including only the goodsand services covered by the literalmeaning of these terms.

This provision aligns Albanian legislationwith that of the EU. Following theEuropean Court of Justice 19 June 2012decision in the IP Translator case, nationalIPOs in the EU moved away from the'class heading covers all' to the 'meanswhat it says' approach.

In the absence of a previous provision thatprovided otherwise, it is likely the Albanianauthorities will apply this provision to

both new and existing registrations.However, holders of existing registrationshave so far been allowed to specify the listof goods and services intended to becovered when filing a renewal application,if they have not done so in their trademark application. Therefore, applicants andholders of existing registrations areadvised to clearly indicate whether theyare seeking protection for all goods orservices that fall within a particular classor only for the specific goods or servicesmentioned in the class heading, at the timeof registration or renewal.

The regulation also introduces aninteresting provision regarding thecomparison of goods, namely Article 13(6)specifies that, when comparing goods orservices, those covered by the same classshould not necessarily be deemed similar,and those belonging to different classesshould not necessarily be considereddissimilar. This is an improvement and adeparture from previous practice, whenthe Albanian IPO often deemed goods orservices similar or dissimilar solely basedon their class.

Identical Marks

Article 22(8) of the regulation provides adefinition of identical signs which does notlimit the term to its literal meaning: 'signsshould be considered identical where,when viewed as a whole, they are notdifferentiated, or contain insignificantdifferences.' It seems that, when drafting this provision,the IPO took into account the definitionfrom the decision in the Arthur et Féliciecase.http://curia.europa.eu/juris/liste.jsf?num=C-291/00.

Further, according to the regulation, theIPO can refuse a trade mark ex-officio ifthere is an earlier identical registeredtrade mark. This is in line with existingpractice of the IPO. However, Article143(2)(a) of the Albanian IP law providesfor oppositions based on identity, ratherthan leaving the issue to the discretionarypower of the IPO.

Unlike the law, the regulation also providesthat the IPO can intervene ex-officio evenwhen the goods designated by the

identical marks are similar or related toeach other. The regulation thereforesignificantly expands the definition of theidentical mark, broadening the category oftrade marks the IPO will be able tointervene in ex-officio. This may make theIPO decisions vulnerable to cancellationand create unsteady practice.

'Restitutio in Integrum' Procedure

The regulation clarifies the 'restitutio inintegrum' procedure, which wasintroduced for trade marks, industrialdesigns and geographical indicationsfollowing the IP law amendments in Marchof last year, while it has existed for patentssince 2014.

Namely, an applicant who, for justifiedreasons and despite due diligence, failed toperform a certain action by a certaindeadline, may request 'restitutio inintegrum' if this failure resulted in loss ofrights. This request must be filed within 60days from the removal of the cause fornon-compliance and no later than oneyear after the expiration of the misseddeadline and is subject to the payment ofa fee.

The IPO then examines the request withina month, and if the request is accepted,the IPO informs the applicant about thetime period within which they shouldremedy the situation. If the request isrefused, the applicant may oppose thedecision before the IPO’s Appeal Boardwithin a month after receiving the writtennotification.

'Restitutio in integrum' does not apply toopposition and cancellation proceedingsor to appeals against decisions in theseproceedings.

Criteria for Determining Well-Known Marks

Article 58(1) of the regulation specifiesthat, when determining whether a mark iswell-known, the Albanian authoritiesshould take into account the JointRecommendation Concerning Provisionson the Protection of Well-Known Marksadopted by WIPO in September 1999.

Albania Introduces New Trademark RegulationIrma Cami, PETOŠEVIC Albania

continued on next page

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The Falsified Medicines Directive:the next 6 monthsRachel Havard and Julie Barrett-Major, A.A.Thornton & Co.

Although Albanian authorities havealready followed the JointRecommendation in practice, having itspecified as binding by the regulation willcontribute to establishing steadypractice.

However, the regulation failed todetermine the procedure for establishingwell-known status. It remains unclearwhether it should be established in aseparate procedure, or along with otherclaims, in court, or before the IPO.

Enforcement Procedures Held Before the IPO

Further to the March 2017 IP lawamendments, the regulation establishesprocedural rules for oppositions andcancellation actions held before the IPO.Under the amended IP law, the IPO willnot only examine oppositions andappeals against refusals on absolutegrounds, but will also handle otheractions, including cancellation, invalidationand non-use actions and claims based onwell-known status. The amended law alsoestablished two instances in the IPO, thefirst being the Examination Division andthe second being the Appeal Board.

The regulation provides more time forthe opponent and the applicant torespectively complete the file andrespond to an opposition. It is now twomonths following the IPO’s notification,whereas the previous regulationprovided a shorter, one-month deadline.

While deadlines for enforcement casescannot be extended or reinstated, theregulation enables claimants to actquickly. Namely, claimants can file aformal action by completing the standardform and paying the fee within thestipulated deadline, while they can filesupporting documents and argumentswithin two months after receiving aninvitation from the IPO to complete thefile.

AlbanianTrademarkIntroductioncontinued

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Directive 2011/62/EU, better known asThe Falsified Medicines Directive or FMD,came into force on 2 January 2013, withthe aim of preventing falsified medicinesfrom entering the legitimate supply chainin the European Union.

Delegated Regulation (EU) 2016/161 hassince supplemented FMD, setting outdetailed rules for new safety features toappear on the packaging ofprescription-only and some non-prescription medicines to enable them tobe verified and authenticated:

• a unique identifier (a 2D data matrix code or barcode) is to be placed on product packaging, to be scanned at fixed points along the supply chain; and

• anti-tamper devices (ATDs) are to be applied to product packaging.

At each stage of the supply chain,products will be inspected to ensure theyhave not been tampered with, have notpreviously been dispensed and that thepackaging is intact.

The Regulation will apply from 9 February2019, and Marketing AuthorizationHolders will by then have to place theabove safety features on the packaging ofmedicines regulated. These obligations areputting additional pressure on all in thepharmaceutical supply chain in the EU, notleast parallel traders.

Parallel traders, who import medicinesfrom lower-price into higher pricemarkets, are considered ‘manufacturers’under FMD, and will have to bolster theirpackaging and IT infrastructures.

To comply, when a parallel distributorreceives packs of medicine from anotherEU country, they must first remove theunique identifiers and ‘decommission’these packs from the country of origin’sdatabase. They must then re-package thosemedicines with new unique identifiers andATDs, and re-commission them.

Although certain repackaging will notamount to registered trade markinfringement as established under EU caselaw, increased obligations upon paralleltraders as a result of FMD could be apositive outcome for trade marks ownersand their licensees. That said, packagingdesigns will need careful managing byparallel traders and originators alike, withadditional features taking up spacepreviously available for logos or distinctiveget-up. This could reduce the opportunityfor trade mark protection.

Brexit, set for 29 March 2019, addsuncertainty to the law and practicearound parallel importing. The current UKTrade Marks Act (1994) effectivelymaintains a form of regional exhaustionapplicable to the EEA. Unless or until adeal is reached with the EU, it is unclearwhether the UK will remain in the EEA orin a relevant customs union with the EU.The UK Government suggests - in its 23August 2018 guidance ‘How medicines,medical devices and clinical trials would beregulated if there’s no Brexit deal’ - that'the UK will unilaterally align to theEU/EEA exhaustion regime from Exit dayto provide continuity in the immediateterm ..' but as a 'temporary fix’. In thelonger term, without amendment of the1994 Act, the UK would revert to itspre-1973 position of internationalexhaustion, something that thosesupporting strong trade marks rights wishto avoid. Watch this space!

India

Samta Mehra, Remfry & Sagar

Glenmark sells an anti-fungal creamCANDID-B and filed a trade markinfringement suit against GalphaLaboratories on account of the latter’s useof the mark CLODID-B, also foranti-fungal cream. The similarity was notjust in the marks; Glenmark alleged theentire trade dress was near identical to itsown product. Further, the currentproceedings revealed that Galpha was a'habitual offender' – previous instanceswere cited of its violation of Glenmark’strade mark rights as well as those ofvarious other pharmaceutical companies.

Galpha did not contest the instant suit – itsaid its adoption of CLODID was amistake and that it was willing to submitto a decree. 'Drugs are not sweets', thecourt said – pharma companies mustexercise a high degree of care. Galpha wasan 'audacious' repeat offender. Issuing it a'final warning', the court imposed recordcosts of INR 15 million (USD $ 200,000approximately).

Kosovo

Djurdja Krivokapic, PETOŠEVICSerbia

The new Law on Customs Measures forProtection of Intellectual Property Rightsenters into force in Kosovo on 23 May2018 introducing important changesintended to align local customs procedureswith Regulation (EU) No. 608/2013concerning customs enforcement of IPrights.

Besides abolishing the annual EUR €100(USD $118) customs watch applicationfee, the new law further streamlines thesimplified procedure for the destruction ofcounterfeit goods and introduces the smallconsignments procedure.

According to the amended simplifiedprocedure, rights holders are no longerrequired to send a cease and desist letterto notify the owner of the goods aboutthe seizure and to seek consent fordestruction. Instead, Kosovo Customs willnotify both the rights holder and the

owner about the detention within oneworking day. The rights holder will thenhave 10 working days to confirm whetherthe goods are infringing and consent tothe destruction of the goods by sending awritten notification to the Customs. In themeantime, the owner will also have 10working days to agree or object to thedestruction of goods. As under theprevious law, if the owner does notexplicitly object to the destruction, theCustoms will destroy the goods (tacitconsent). The goods will be released if therights holder does not confirm that thegoods are infringing or does not consentto the destruction, or if the owner of thegoods has opposed the destruction andthe rights holder has not filed a lawsuitwithin a maximum of 20 working daysafter the detention of the goods.

The new law introduces a new procedureunder which small consignments (up tothree units or weighing less than 2kg) canbe destroyed without the explicit rightsholder’s consent. When filing a customswatch application, rights holders may optin for this procedure, according to which,after seizing a small consignment, theCustoms will inform the owner of thegoods within one working day that itintends to destroy the goods. The ownerthen has 10 working days to either opposethe destruction or consent to it. If theowner agrees or fails to respond, thegoods will be destroyed. If the owneropposes the destruction, the process isthe same as in the simplified procedure.

The new law also clarifies that rightsholders are:

• Required to inform the Customs that an IP right has ceased to have effect within one working day.

• Required to act according to the provisions of the simplified procedure. If they fail to do so, they must be able to provide a reason deemed appropriate by the Customs.

• Only allowed to use information provided to them by the Customs, such as information on the quantity and nature of the detained goods and contact details of the owner of the goods, for the following purposes:

(1) to contact the importer to get consent for the destruction;

(2) to initiate trade mark infringement or damage compensation proceedings; and

(3) to initiate a criminal procedure. Theuse of such information in other ways could be considered misuse.

If rights holders fail to act as specified bythe new law, they could face sanctionsvarying from monetary fines andrevocations of customs watch applicationsto not being allowed to re-apply forcustoms watch for the IP right in questionfor a period of one year.

Laos

Denise Mirandah, mirandah asia

Laos’s new Law on Intellectual PropertyNo.38/NA of 15 November 2017 waspublished electronically in the Laos officialgazette on 25 May 2018, and becameeffective 15 days subsequent to itspublication. This supersedes the previousLaw on Intellectual Property No. 01/NAdated 20 December 2011.

The new legislation brings reform to avariety of areas of intellectual property lawin the country, but it is with respect totrade marks where the greatest number ofamendments have been made.

A new digital platform is to be createdwhich will publish submissions of newtrade mark applications. Within 60 days ofthe publication of a new application, thirdparties can now oppose the registration ofthe mark concerned.

This is a fairly substantial innovation whencompared to what means have beenpreviously at the disposal of the third-party mark holder – solely cancellation. Toachieve this, a cancellation request neededto be filed with the Department ofIntellectual Property (DIP), which couldonly be done after the mark had beenissued its trade mark certificate andregistered – and within five years of thepublication of said registration in theofficial gazette. Factoring in delays in thepublication of registrations in the officialgazette, this often meant that successfulcancellation actions could only prevailafter the mark had been put to use inLaos for a somewhat significant amount oftime.

A further important amendment that thenew law introduces relates to the term ofprotection of registered Laos trade marks.Trade mark registrations will now be validfor a period of 10 years following the filingdate. Previously, marks had been valid for10 years from the date of registration.

International Update

7continued on next page

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Lastly, the updated legislation also expandsthe range of matters which may beregistered as trade marks in Laos. Withthe new law coming into effect, 3D imagesand animated images are now registrable.

It is anticipated that regulations will beissued in due course to supply furtherguidance to mark-holders on the scopeand application of the new law. Given theextent of the changes introduced, time willneed to be taken to develop infrastructureand train local officers in order tostreamline registration and oppositionprocedures. Nevertheless, the introductionof the new legislation signifies a majorstep forward for Laos’s trade markregime.

Ukraine

Marina Maltykh, PETOŠEVIC

The IP-related provisions of the EU-Ukraine Association Agreement, signedand ratified by Ukraine in 2014, came intoforce on 1 September 2017, introducingnew rules regulating the non-use graceperiod for trade marks. Namely, theexisting trade mark law provides for athree-year non-use grace period, whileArticle 198 of the Agreement sets forth afive-year non-use grace period. However,Ukraine has not adopted any laws thatimplement such provisions in the nationallegislation and consequently, Ukrainiancourts have faced a dilemma in non-usecancellation actions as to what theapplicable grace period really is. This raisedthe question of direct applicability of theEU-Ukraine Association Agreementprovisions, widely contested amongUkrainian IP professionals.

In a court ruling dated 12 February 2018by the Commercial Court of Kyiv in thecase no. 910/14972/17, the judge applied afive-year non-use grace period, asprovided for under the AssociationAgreement (Art. 198), and rejected thenon-use cancellation action, which wasbased on the three-year grace period, asper Ukrainian Trade Mark Law. The courtheld that the EU-Ukraine AssociationAgreement is a binding internationalagreement, thus its provisions shouldprevail and be directly applicable if theydiffer from the rules provided by theUkrainian law. The ruling also emphasizesthat the Association Agreement does not

foresee any particular means ofimplementation of these provisions in theUkrainian national law. This ruling wasappealed before the Kyiv City CommercialCourt of Appeal, which affirmed thejudgement of the Commercial Court ofKyiv on 23 April 2018. The case ended upreaching the Ukrainian Supreme Court,which upheld the decisions of the lowercourts on 17 July 2018. While theSupreme Court’s arguments were similarto those of the Commercial Court ofKyiv, it did not explicitly address the issueof direct applicability of the AssociationAgreement.

In the debate surrounding this issue, oneof the arguments against the Agreement’sdirect applicability considers the subjectsto whom it is addressed. Namely, Art. 198of the Association Agreement states that'the Parties shall provide that a trade markshall be liable to revocation if, within acontinuous period of five years, it has notbeen put to genuine use...' The majority ofthe Agreement’s other provisions are alsoaddressed to the parties of theAgreement, not legal entities andindividuals, which leads to the conclusionthat these provisions are not self-executing and require furtherimplementation into national legislation. Infact, the Cabinet of Ministers submitted toParliament a draft law implementing theprovisions of Art. 198 into the UkrainianTrade Mark Law on 23 January 2017,proving the Government’s intentions totake additional steps to implement theAgreement’s provisions into the local law.However, this law has not yet beenadopted.

While the cassation appeal brought beforethe Supreme Court in case no.910/14972/17 mentioned the AssociationAgreement implementing measurescontained in the Resolution of the Cabinetof Ministers No. 847 of 17 September2014 'On the Implementation of theAgreement' and in the explanatory noteto the draft law 'On Ratification ofthe EU-Ukraine Association Agreement',the Supreme Court ruled that these werenot regulatory legal acts, and that suchmeasures did not prevent commercialcourts from applying the AssociationAgreement’s provisions when consideringthis dispute. Therefore, the Supreme

Court de facto ruled on the directapplicability of the EU-Ukraine AssociationAgreement.

Art. 198 of the Association Agreementseems to be the only provision of theAgreement which has been so far directlyapplied by courts. For instance, courts,including the Supreme Court, have beenapplying provisions of Art. 52 of theUkrainian Law 'On Copyright and RelatedRights' when regulating the compensationamount for the infringement of copyrightand related rights, in spite of Art. 240 ofthe Association Agreement foreseeing adifferent mechanism of compensation. Infact, a law implementing the modifiedprovisions of Art. 240 of the Agreementcame into force on 22 July 2018.

The cassation appeal referenced theprovisions of the Decree of the Cabinet ofMinisters No. 15-93 of 19 February 1993,which require obtaining licenses for someoperations with currency and which areactually applied in practice, as opposed toArt. 145 of the Association Agreement,which provides for the free movement ofcapital. The Supreme Court however ruledthat this reference was inappropriatebecause the mentioned provisions do notregulate the dispute in question.

The appellant also claimed that applyingprovisions of Art. 198 in this case wouldset a precedent with negativeconsequences, but the Supreme Courtruled that the Ukrainian legal system doesnot recognize judicial practice as a sourceof law. However, in accordance with Art.13 of the Ukrainian Law 'On the JudicialSystem and the Status of Judges', theSupreme Court’s conclusions regardingthe application of the rules of law are tobe taken into account by other courtswhen applying such rules of law.

In conclusion, while on the one hand theSupreme Court’s ruling ends the long-term debate on what the non-use graceperiod in Ukraine actually is, on the otherhand it still raises a number of issues thatremain vague. It appears that only furthercase law may clarify the issue of the EU-Ukraine Association Agreement’s directapplicability. However, this case should betaken into account when filing a non-usecancellation action in Ukraine.

International Update continued

8

´

Although there is plenty of case law fromboth the European Court of Justice (ECJ)and the EU national Courts on the parallelimport of drugs, very few decisions existregarding the parallel import of medicaldevices. The Court of Milan recentlyissued a landmark ruling in a case relatingto the parallel import of home-selfmonitoring medical devices whoserepackaging was challenged by the trademark holder.

Facts

The multinational Johnson & Johnson (J&J)has been marketing in Italy a glucosehome-control device in packagescontaining either 25 or 100 strips underthe registered EU trade markONE TOUCH ULTRA.

The product was also commercialized byJ&J in other EU countries in packets of 25,50 or 100-strips.

In 2013, the parallel importing company,Medifarm Srl (Medifarm) operating in Italyand abroad, purchased J&J's ONE TOUCHULTRA devices in 50-strip packages inanother EU country and started to marketthem in Italy, after repackaging in packs of25 or 100-strips.

In 2014, J&J promptly started preliminaryinjunction proceedings before the Courtof Milan claiming, inter alia, trade markinfringement, alleging (i) the lack of anyactual need to repackage the device and(ii) that the repackaging was justified onlyby Medifarm's attempt to secure acommercial advantage.

Medifarm, for its part, contended that therepackaging was necessary (i) to gainaccess to the Italian market and (ii) tobenefit from the reimbursement providedby the National Health System for thepurchase of 25 or 100-strip packets only.

In 2014, the Court of Milan, referring toEU case law (in particular, C-379/97-Upjohn, and C-348/04 BoehringerIngelheim and Others), decided toprovisionally seize the contested devices

deeming that Medifarm had notdemonstrated that the repackaging wasstrictly necessary. In fact, the Courtobserved that the Defendant could havepurchased and imported, without any needto repackage, the 25 or 100-strip packetsavailable in many other EU markets.

Following the above interim reliefdecision, J&J commenced the law suitagainst Medifarm, where the parties'arguments were substantially the same.In addition, the Defendant asked theCourt of Milan to refer to the ECJ theissues whether (i) the principles as in ECJcase law (the so called 'BMS/Boehringer'conditions) could apply to this medicaldevice repackaging case, (ii) and, if so, howit would be applicable to the subject issue.

Decision

In a decision dated 13 December 2017,the court of Milan upheld all J&J's claims,deeming Medifarm's repackaging illicitpursuant to Art. 15 of the EC DirectiveNo. 2015/2436 (former Art. 7 of ECDirective No. 2008/95), for the followingreasons:

(1) The criteria stated by the ECJ can apply to this medical device repackaging case: there is no need to refer the issue to the Court considering its solid case law on the principles concerning the justified repackaging of drugs;

(2) In particular, the ECJ stated that the repackaging is necessary when the sizeof the packets used by the trade mark owner in the exporting Member State could not be marketed in the importing Member State because of, in particular, national rules permitting packaging of a certain size only, a national practice to the same effect, orwell-established medical prescription practices based on, inter alia, standard sizes recommended by medical professional and medical insurance institutions (ECJ decisions in joined cases Bristol-Myers Squibb and Othersv Paranova);

(3) This was not the case, considering thatthere was no entry barrier to market the 50-strip packs. In fact, it was proved that Medifarm had also successfully marketed in Italy the 50-strip packs and not only the 25 or 100-strip packets and, in any case, the latter packets were available in other EEA countries. The Court of Milan cited, in particular, the recent ECJ decision C-297/15 - Ferring Lægemidler v Orifarm

http://curia.europa.eu/juris/liste.jsf?num=C-297/15

Comments

This decision is relevant for the followingaspects.

(1) Firstly, because it confirms the trend ofour Court’s, basically restrictive interpretation of justified repackaging. The reason for our Courts’ position can be found in the particular caution given to the protection of both manufacturers and consumers regarding tampering of products with adirect link to health. For such sensitive goods, guarantee of origin, sterility and reliability are of great importance because of the high degree of responsibility of the producers and theparticular attention customers pay towards their own health.

(2) Secondly, because it is one of the few decisions of the EU Courts on the topic of parallel imports of medical devices and necessary repackaging and the first ruling in Italy on this subject issued in ordinary proceedings. This decision was anticipated by two ordersof 21 September and 20 October 2009(Roche Diagnostic v BB Farma Srl) issued by the Court of Milan in the framework of preliminary proceedings and again in favour of the trade mark owner.

Italy – Parallel imports of medical devices: alandmark decision, a manufacturers’ win. Laura Pedemonte, Barzanò & Zanardo

9

continued on next page

The United Kingdom Intellectual PropertyOffice (UK IPO) has dismissed anopposition by GlaxoSmithKline ConsumerHealthcare (UK) IP Limited (GSK) to anapplication for ZANAMOL in class 5.

Background

In October 2016, Apollo Generic Limited(Apollo), a pharmaceutical companyspecialising in prescription pharmaceuticalsand over-the-counter medicines, filed a UKapplication for a series of two marks,ZANAMOL and Zanamol. When pub-lished, GSK opposed the application onthe basis of its earlier European UnionTrade Mark (EUTM) registration ofPANADOL in class 5. GSK argued thatthere was a likelihood of confusionbetween the marks.

The decision

To assess the likelihood of confusion, theIPO’s Hearing Officer (HO) firstcompared the respective goods. In itscounterstatement, Apollo had admittedthat some of the class 5 goods covered byits application were identical and/or similarto the goods in the specification of GSK’searlier registration. Having compared theremaining goods and considering the rel-evant factors, including method of use,users of the goods, physical nature of thegoods and trade channels, the HO foundthat the respective goods were similar. The HO then considered the averageconsumers for the goods. As the goodswere pharmaceuticals and medicalpreparations, the HO found that theaverage consumers were pharmaceutical /healthcare professionals, in addition tomembers of the general public, all ofwhom pay a reasonable to high degree ofattention when purchasing the goods.

Comparison of the marks

Although the ZANAMOL and PANADOLmarks consist of seven letters and

coincide in the letters A-N-A-O-L in thesame order, the HO found that the markswere visually and aurally similar only to alow degree. The HO emphasised that thestriking difference at the beginning of themarks and the attention that consumerspay to the beginning of a mark were keyfactors when conducting the comparisonof the marks. The HO found theconceptual comparison of the marks to beneutral.

The HO also held that the PANADOLmark enjoyed a level of enhanceddistinctiveness because of evidence of useof the mark in the UK since the 1950s andbecause of such evidence PANADOL wasone of the biggest selling brands ofparacetamol-based pain relief. This is animportant factor in the global appreciationof the likelihood of confusion because themore distinctive the earlier mark, thegreater the likelihood of confusion withthe mark applied for.

Having considered all of the relevantfactors, the HO concluded that there wasno likelihood of confusion between themarks because the differences far out-weighed the similarities. Accordingly, theHO found in favour of Apollo and orderedGSK to pay costs.

Comment

This decision highlights the emphasisplaced on the differences at the beginningof marks being compared, particularly incircumstances where the marks are usedon goods or services to which the averageconsumer pays a high degree of attentionwhen making purchasing decisions.Perhaps if GSK had also based theopposition on damage to reputation, theoutcome may have been different.

10

PANADOL v ZANAMOLChris McLeod & Luke Ingleton, Elkington + Fife

continued from previous page

(3) Last but not least, the subject decisionis also important because the Court of Milan applied ECJ case law and principles in connection with parallel import of pharmaceutical products to medical devices. The Court did not provide specific reasons for this extension other than referring to the solid case law on repackaging of drugs.

Actually, the fact that the application ofthose principles is not restricted to casesof parallel importation of pharmaceuticalproducts was affirmed by the ECJ in its11 November 1997 Loendersloot judg-ment. In said case, the Court held thatthe criteria relating to the repackaging ofpharmaceutical products could also, inprinciple, apply to parallel trade ofalcoholic beverages.

We may assume that, all the more so, theabove criteria have been deemedapplicable in the case of medical devicesconsidering their clear analogy withpharmaceutical products.

The issue of the extension of the ECJBMS/Boehringer conditions to medicaldevices has been very recently raised inJunek Europ-Vertrieb case. The Court ofJustice, in its decision of 17 May 2018, didnot take position on this specific matterbut made reference to said principles inconnection with a case of relabelling ofmedical devices. By excluding theapplicability of the BMS/Boehringerconditions provided for cases ofrepackaging to the specific case ofaddition of a small label on medicaldevice packs, the extension of saidprinciples to cases of repackaging ofmedical devices could be indirectlyinferred.

The topic of parallel imports of medicaldevices appears to be in the spotlight,most likely due to the increasingimportance of this market. It will beinteresting to see whether other EUnational Courts' decisions on the matterwill follow and whether the Court ofJustice will be called to take position oncases of justified repackaging of medicaldevices. Meanwhile, this case is animportant win in favour of themanufacturers in the never-ending battleagainst importers.

Chris McLeod is a Chartered Trade Mark Attorney and aFellow of CITMA, the Chartered Institute of Trade MarkAttorneys, of which he was President from 2014 to 2016 and inwhich he is still active. Chris has practised in trade marks,designs and related IP issues for over 30 years. He has been anactive member of PTMG since around 2000, his first PTMGconference being in Marrakesh, and has attended many ofPTMG’s conference since then. He is also a member of INTAand a regular speaker and commentator on trade mark issues.

Where were you brought up andeducated?

I was born in Hampshire, but soon movedto Cyprus, then to Derbyshire, Wiltshireand South Wales, all by the age of 10. Atthat point, I went to boarding school atChrist’s Hospital in West Sussex (Googleit to see the uniform), followed by the latelamented Bedford College which was partof the University of London.

How did you become involved intrade marks?

Through foreign languages. I studiedFrench and German at university, failed tobecome an interpreter, then found a job atthe Job Centre on High Holborn inLondon, working for Trade MarksDirectory Service (TMDS, now part ofCPA Global), conducting manual trademark watching and translatingspecifications of goods and services.

What would you have done if youhadn’t become involved inintellectual property?

I have always loved music and comedy, soperhaps a singing comedian, although mywife claims I cannot sing in tune and iseven less complimentary about my jokes.

Which three words would you use todescribe yourself?

Reliable, pedantic, optimistic.

Complete the following sentence. “Iwish ….”

….that Brexit was not happening.

What was (were) your best subject(s)at school?

French and German.

Complete the sentence: I’m no goodat …

…wrapping presents.

What do you wish more peoplewould take notice of?

Climate change / global warming.

What’s the best thing about yourjob?

Every day brings different challenges.Meeting those challenges and giving clientsa prompt commercial response brings asense of achievement.

If you weren’t completing thisinterview, what would you be doingright now?

Threatening to oppose a trade markapplication.

What is a common misperception ofyou?

That I tell bad jokes.

What is your philosophy in anutshell?

Life should be fun, so only take thingsseriously when necessary.

Which book or books are youcurrently reading?

‘Sticky Fingers: The Life and Times of JannWenner and Rolling Stone Magazine’ byJoe Hagan and ‘Dead Man’s Footsteps’ byPeter James.

Which music recording would youtake with you to a desert island?

It would have to be Arkology by Lee Perry.More versions of Police and Thieves thanyou could shake a stick at.

Which sport do you play and/orenjoy?

Football/Soccer. I still play twice a week,although I understand that I should havetaken up golf by now. I am also a lifelongfan of Derby County and am convincedthat they will rise into the English PremierLeague again soon.

Which is your favourite restaurant?

At the moment, it’s a tie between Anglo inFarringdon and Canaletes on WillesdenLane (north west London).

What is your favourite drink?

Wine – white: Picpoul de Pinet (French),red: Gift Horse (South African).

What is your favourite holidaydestination?

New York City.

If you could enact one law, whatwould it be?

Spot fines for people playing Candy Crushwith the sound on whilst on publictransport.

What is your favourite building /piece of architecture and why?

The High Line in Manhattan. The way ithas turned a disused elevated rail line intoa destination with amazing views,architecture and planting is just stunning.It is always on my list of places to revisit.

© 2018 The Pharmaceutical Trade Marks G roupC irculated fo r information only to PTMG Members. The G roup takes no responsibility fo r the contents

Edito r : Vanessa Parker

Tel.: +33 679 316 860 email: vparkercordier@wanadoo .fr

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PROFILE: Chris McLeod

llp_sep18.pdf - Pharmaceutical Trade Marks Group

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