editorial: we are what we eat - ptmg · vicerex, which was registered for dietary supplements. in...
TRANSCRIPT
The US Trademark Trial and AppealBoard (TTAB) affirmed an Examiner’srefusal to register VICORYX forpharmaceutical preparations for thetreatment of cancer on the basis ofVICEREX, which was registered fordietary supplements. In so ruling, theTTAB found the goods involved wererelated, noting the Examiner’sevidence that dietary supplementswere used in conjunction with cancertreatment, that both pharmaceuticalpreparations and dietary supplementswere included together in numerousother registrations, and that cancerpatients would be customers of both
goods. In re Oryx VerwaltungsGmbH, TTAB, Ser. No. 85823101,9/2/2014 (non-precedential).
In a case of first impression, the TTABrecently ruled on the standard fordetermining abandonment for nonuseinvolving a Section 66(a) registration(under the Madrid Protocol). UnderUS trade mark law, non-use for threeconsecutive years constitutes primafacie evidence of abandonment. Withrespect to applications based on useor an intention to use, for which useis required prior to registration, thisnon-use period can be calculated atany time beginning with the applicant’s
declaration of use, including non-useoccurring prior to registration. In thecase of a Section 66(a) registration,however, no use is required beforeregistration. Therefore, the TTAB heldthat in a cancellation action based onnon-use involving a Section 66(a)registration, the non-use period couldnot begin until at least the registrationissues. Dragon Bleu (SARL) v VENM,LLC, TTAB, Opp. No. 91212231,12/1/2014.
As Christmas approches and thoughtsturn to menus, one wonders whetherthe media actually do bombard us withmore food related stories or whetherour senses are merely more tuned in tothis topic at this time of year. Theoutbreak of avian influenza on a duckfarm in Yorkshire, UK last month brought
bio security back on the radar whilst the Archbishop ofCanterbury's recent comments in a UK Sunday newspaper againraised the profile of the issue of food poverty.
You could be forgiven for thinking that living in France gives youa warped view of the importance of eating in the daily routine.After all, in this country you live to eat rather than the otherway round. A clear indication of this is the so-called"Commission Menu" which takes place twice a term in everysecondary school to determine what will be served at the schoolcanteen. Parents, students and school management staff as wellas the school chef and his purchasing team discuss, sharefeedback and plan upcoming menus. School dinners here are afour course affair with very stringent criteria to ensure abalanced, low salt and sugar diet is offered to teenagers. A farcry from the tuck shop ! However, the net result of theseregulations is massive waste since a lot of what is served doesn't
look like food from home.
There is definitely a revival in the developed world for locallygrown and sourced food supplies. Vegetables that had gone outof fashion are back with a vengeance and allotments havebecome a very trendy way to socialize. Major supermarketchains are having to re-think their global business models andpeople are voting with their shopping baskets.
What we eat, how we eat and where the food comes fromconcerns us all wherever we live. Government leaders met inNovember this year at the second International Conference onnutrition and the World Health Organisation will dedicate itsWorld Health Day on April 7, 2015 to food safety. WHO'sDirector-General, Margaret Chan's comments in the Lancet onthe topic underlined the intrinsic link between what we swallowand our on-going health. Hopefully the next generation will bemore attuned to sustainable food supplies and thus naturallyimprove their long term health prospects.
What we can be sure of is that the food served at the PTMGConference in Venice next March will be of the highest quality,as always. I look forward to seeing many of you there andmeanwhile wish you a very happy and healthy festive season.
Vanessa
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PharmaceuticalTrade Marks GroupPharmaceuticalTrade Marks Group Dec 2014
Editorial: We are what we eat....
US Law UpdateJames A. Thomas, Merck & Co., Inc., Whitehouse Station, USA
IntroductionIt is common practice to use trade marksfor pharmaceuticals which are capable ofproviding prescribing doctors, pharmacistsor other health professionals with certaininformation about the branded products.To give but two examples, Aspirin alludesto its active ingredients, i.e. A stands foracetyl and the syllable spir is derived fromspireic acid. Likewise, Botox refers to itsactive ingredient botulinum toxin. Suchsigns are often referred to as so-calledsuggestive, evocative or allusive signs. Inmany cases they refer to the internationalnonproprietary name (INN) of the activeingredient. However, they can also referto other characteristics of the drug, suchas its indication, target group or means ofadministration. It is beyond question thathealth professionals are familiar with theexistence of this naming practice in thepharmaceutical sector and that they caneasily decipher the information conveyedin suggestive signs. However, it is oftenoverlooked that when assessing thelikelihood of confusion between twopharmaceutical trade marks, theconsumer’s understanding of suchsuggestive marks can tip the scales. Thisarticle explains why and how theconsumer’s view impacts on the legalassessment.
Why is the consumer’sperception decisive?
Under Community trade mark law, it iscrucial to assess the likelihood ofconfusion from the consumer’sperspective. Initially, the General Court(GC) held that consumers may only betaken into account in the case of non-prescription drugs (GC, judgment of 13February 2007 in Case T-256/04[RESPICORT/RESPICUR], para. 45).Subsequently, the Court of Justice of theEuropean Union (CJEU) held that even ifthe drugs are available in pharmacies onlyand despite the fact that the choice ofthose products is influenced ordetermined by intermediaries, thelikelihood of confusion must also beassessed from the end consumer’sperspective (Judgment of 26 April 2007 inCase C-412/05 P[TRIVASTAN/TRAVATAN], para. 58).
Meanwhile, it is well-established case-lawthat in the case of pharmaceutical trademarks, the relevant public comprises bothend-consumers and health professionalseven if the preparations require a doctor’sprescription (GC, judgment of 9 February2011 in Case T-222/09 [ALPHAD3/ALPHAREN], para. 43 et seq.).
For the assessment of the likelihood ofconfusion, the fact that the relevant publiccomprises both health professionals andend consumers cannot be overestimated.Whilst it is always easy to argue that theprofessional public is able to understandthe precise meaning of conflicting signs andto grasp small differences which helpdifferentiate between the conflicting signs,these arguments do not apply to endconsumers. However, given that likelihoodof confusion on the part of the public issufficient, it is the end consumer’sperception which is decisive for theassessment of the likelihood of confusion.
In particular, the argument that the merecoincidence in a descriptive or at leastweak element does not suffice to cause alikelihood of confusion cannot be given anyweight if one cannot establish that therelevant public understands the allegeddescriptive meaning of an element. It isprecisely for that reason that the GCrecently annulled the Board of Appeal’sdecisions in the two parallelPENTASA/OCTASA cases, therebyhighlighting that the Board failed toestablish the descriptive character of thesuffix -ASA from the perspective of theend consumers when carrying out thecomparison of the conflicting signs.
Are consumers familiar withsuggestive marks?Having regard to the importance of theconsumer’s perception of suggestive signs,the question arises whether they arefamiliar with the common use of suchmarks in the pharmaceutical sector. If so,it is more likely that they will identifyallusive elements when being confrontedwith the marks. Remarkably, in onejudgment the General Court held that theapplicant’s submissions on the frequent useof allusive signs in the sector oftherapeutic preparations cannot beaccepted", because, inter alia,
A Community trade mark law’s perspective on suggestive signsDavid E.F. Slopek, Hogan Lovells, Germany
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Words from theChair
Once again, we are approachingthe end of the year and our finalissue of LL&P in 2014. In terms ofPTMG Conferences, I think it isfair to say that 2014 has been abrilliant year!
To start with, we came back toLondon for the SpringConference, after a (too) longabsence from the British capital.This proved to be a great successand the quality of the presenta-tions as well as the venue werecommended. The level of serviceat the Savoy is definitely not amyth and it was a pleasure to beholding a Conference in such amagnificent hotel.
The continent on which theAutumn Conference would takeplace was the subject of many discussions within the PTMGCommittee. Some of you mightremember that the only time thePTMG organised a conference inthe United States was in 2006, inBoston. Going back to the US forthe second time was not an easydecision but the reality hasproven that the Committee’sdecision was the right one. Wehad a remarkable Conference,and the feedback received wasvery positive: “Magnificent Conference” –“Congratulations on a fantasticmeeting from beginning to end” –“the presentations were out-standing” – “Sessions were veryinformative and interesting” –“outstanding social events”.
One of our objectives was to gaina good attendance level from ourUS colleagues and it was so greatto see many delegates from theStates, including a significantnumber from the pharmaceuticalindustry. In particular, it waslovely to see some of our industrycolleagues joining a PTMGConference for the very first timeand I hope it will only be the firstof a very long series.
I wish all the PTMG community,your family and friends, a MerryChristmas and Happy New Year. Ihope you will get a very welldeserved end of year break.
Sophie Bodet
Internat ionalUpdateHungary
PETOSEVIC
The Budapest police authorities haverecently discovered and seized almost170,000 pieces of counterfeit medicines inthe basement of a building in Budapest. The police arrested a 45-year-old man on suspicion of counterfeiting pharmaceuticalproducts.
On 21 October, 2014, the Budapest policereceived a tip that a man will probably buynarcotics at a certain address in the 3rddistrict of Budapest. The police went tothe site where they checked the identity oftwo men found standing next to a car. Theowner of the car was the 45-year-old man.The police searched the car and discovered several hundred bottles labelledRivotril, filled with counterfeit pills, as wellas pills in unmarked bags, several hundred unmarked bottles, and a bag withwhite powder of unknown composition.
The police discovered that the suspectowns keys to certain premises in the 22nddistrict of Budapest. After searching thepremises, the police discovered large quantities of Rivotril 2mg labels, emptybottles, bottle caps, cotton balls, digitalscales, label applicators and other equipment used for making counterfeitdrugs.
The criminal procedure is underway.
Hungary
PETOSEVIC
The Hungarian National Board AgainstCounterfeiting announced on its websitethat in the next few years, European Unionmember states are expected to implementa stricter prescription drug monitoringsystem, aimed at preventing counterfeitmedicines from entering the supply chain,based on the Falsified Medicines Directive,which will enter into force in 2018 in theEU.
According to the Directive, each drugpackage will need to be tamper-resistantand coated with a unique two-dimensionalbarcode, containing manufacturer’s code,serial number, national healthcare reimbursement number, batch number andexpiration date. These measures will make
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accepted", because, inter alia, they havenot been developed (GC, judgment of 13February 2007 in Case T-256/04[RESPICORT/RESPICUR], para. 72).However, there are good reasons not togeneralize this passage from a singlejudgment. In fact, OHIM’s practice takesinto account that allusive signs are verycommon in the pharmaceutical sectorand, more importantly, that theconsumer is used to this practice (seee.g. Board of Appeal, decision of 18 July2013 in Case R 699/2012-1 [ANGIN-SAN/JUNIOR-ANGIN], para. 23).
What does the consumerunderstand?
In any case, the decisive question is notwhether the consumer is generally awareof the widespread existence of allusivesigns in the pharmaceutical sector, butrather if the consumer is able tounderstand the descriptive or allusivemeaning of a specific sign. The answer tothis question depends on thecircumstances of the specific case.Consequently, it does not come as asurprise that the relevant case-law doesnot rely on general guidelines, butappears rather casuistic. With that beingsaid, the following decisions aresupposed to give some hints as to theGC’s approach to assess the endconsumer’s understanding of suggestivesigns.
The GC has taken the view that the endconsumer is capable of understandingRESPI as a reference to respiratory (GC,judgment of 13 February 2007 in Case T-256/04 [RESPIRORT/RESPICUR], para.71 et seq.); VISC as a reference toviscosity (GC, judgment of 10 September2008 in Case T-106/07 [PROVISC,DUOVISC/BIOVISC], para. 40]); NICOas a reference to nicotine (GC, judgmentof 6 June 2013 in Case T580/11[NICORETTE/NICORONO], para. 30);CHOL as a reference to cholesterine(GC, judgment of 12 July 2012 in Case T-517/10 [HITRECHOL/HYPOCHOL],para. 27) and ECHIN(A) as a referenceto the Latin name of the plant Echinacea(Court of First Instance, judgment of 5April 2006 in Case T-202/04[ECHINACIN/ECHINAID], para. 44).
Whilst the above-mentioned examplescould indicate that the consumer has a(partly surprisingly) good understandingof suggestive terms, there is also case-law pointing in the opposite
direction. By way of example, the GCheld that the consumer will notunderstand CORT as a reference tocorticoids (GC, judgment of 13 February2007 in Case T-256/04[RESPIRORT/RESPICUR], para. 71); VIRas a reference to antiviral (GC, judgmentof 13 September 2010 in Case T-149/08[NORVIR/SORVIR], para. 39) or Latin orGreek terms such as MENO or CHRON(GC, judgment of 28 April 2014 in CaseT-473/11[MENODORON/MENOCHRON], para.39).
In some cases, the GC also put emphasison the rule that the consumer generallyperceives the mark as a whole, so that itis harder for the end-user to grasp anydescriptive meaning of an element, if it ispart of a single word (see to this effectGC, judgment of 9 April 2014 in Case T-501/12 [PENTASA/OCTASA], para. 50;the GC adopted a similar reasoning in itsjudgment of 13 September 2010 in CaseT-149/08 [NORVIR/SORVIR], para. 39).
Summary
Case-law establishes that the likelihoodof confusion between two conflictingtrade marks has to be assessed from theperspective of the relevant public. In thecase of pharmaceutical trade marks, therelevant public comprises both healthprofessionals and end consumers. Withrespect to end consumers, the decisivequestion is if they understand thedescriptive meaning of certain elementswithin suggestive marks. If so, there isroom to argue that the element is weakand that the mere coincidence in suchelements is not sufficient to cause alikelihood of confusion. There isextensive case-law on the whether and,as the case may be, to what extentconsumers understand the descriptive orallusive meaning of suggestive marks.
Whilst it can be difficult to predictwhether the GC will regard an elementas descriptive or not, precise knowledgeof the relevant case-law and OHIM’spractice is not only very helpful, but canactually make the difference betweenwinning or losing a case.
unauthorized access to the protectedpackage easily detected and allow genuinepacks of drugs to be traced back tomanufacturers and distributors.
Every prescription drug package will haveto be registered in the common EU database from which it can only beremoved if purchased by pharmacies orused in hospitals. To comply with the newsystem, the EU member states will need tointroduce major IT-related changes, someof which may be complicated or time-consuming to implement. Some estimates say that this will affect 17 billionboxes of prescribed medicines per year,which come from 4,600 manufacturers andreach 177,000 distribution places.
Hungarian experts are somewhat concerned about these big changes, especially since in Hungary counterfeit pillshave never got into the legal medicine chain, i.e. manufacturer – retailer– pharmacy/hospital/doctor.
“The best practice would be to graduallydevelop the IT system, starting with themost narrow medicine circle first, whichmeans fewer packages with safety featuresand more drugs on the exception list”,stated Dr. Livia Ilku, head of the HungarianPharmaceutical Manufacturers Association.
India
Sharabh Shrivastava, CHADHA &CHADHA
In a recent decision dated 12 September,2014 involving pharmaceutical products inthe matter of Sun PharmaceuticalIndustries Limited v Anglo French Drugsand Industries Limited, the Division Benchof the Delhi High Court while holdingOXETOL to be dissimilar to EXITOLopined that slight semblance of phoneticsimilarity between two marks would notautomatically satisfy the test of confusionto a man of average intelligence havingimperfect recollection and it is necessarythat the marks are compared as a whole.
The quintessence of the decision of theAppellate Court lies in the fact that thecourt, while determining the question ofsimilarity between two marks, relied moreon the entire visual representation of thetwo pharmaceutical products rather thanconsidering the marks to be words per se.Further, what seems to have guided thecourt to hold OXETOL to be dissimilar toEXITOL is that EXITOL was sold in syrupand granule form whereas OXETOL wassold in the form of tablets or capsules.
Moreover, OXETOL was being sold in blister packs whereas EXITOL was beingsold in bottles or sachets. The graphics onthe OXETOL pack displayed a man and hisbrain, clearly representing that this was adrug for treating a brain disorder whereason the EXITOL pack, the graphics showedan intestine, which again showed that thedrug was directed to treat an intestinaldisorder (constipation). Further, thegraphics on the OXETOL product was inorange script on a white background andthe use of the color brown whereas onthe EXITOL pack there was a yellow andwhite color scheme and EXITOL waswritten in a distinctive blue script. Bothdrugs were available on prescription basisonly. In the case of OXETOL, theprescribing doctor would be a neurologist,whereas in the case of EXITOL it wouldbe a physician at a hospital, EXITOL beinga hospital administered laxative.
The Court further observed that theconsuming patients would also be different, neuro patients in one case and inthe other case patients suffering fromintestinal disorders who were admitted toa hospital.
The decision interestingly lays emphasis onan important factor of visual representation while determining the question of deceptive similarity in the The decision interestingly lays emphasis onan important factor of visual representation while determining the question of deceptive similarity in the context of pharmaceutical products aspatients in India may differentiate betweenthe products based on the visual representation of packaging or colourscheme of the drug rather than discerningor comprehending the word element mentioned on the packaging.
In view of the varying infrastructure forsupervision of physicians and pharmacistsof the medical profession in our countrydue to linguistic, urban, semi-urban andrural divide across the country and with ahigh degree of possibility of even accidental negligence, this decision certainly comes at an opportune time. Itdirects to take into account significantconsequential factors namely active ingredient, product form, packaging, artwork/ graphics, visual impression, disease condition, prescribing doctor, purchasing public, consuming public andprice in addition to merely comparing theword element while determining the question of deceptive similarity of marks inthe context of pharmaceutical products inIndia.
Members News New Members
We are delighted to welcome thefollowing new members to the Group:
Merel Kamp of Signify B.V.,Amsterdam, The [email protected]
Keith Weltsch of Scully, Scott, Murphy& Presser, PC, Garden City, New York,USA [email protected]
Sheldon Pontaoe of AlconLaboratories, Inc., Fort Worth, Texas,USA [email protected]
Peter Spies of Dineff Trademark LawLimited, Chicago, Illinois, [email protected]
James Saul of Faegre Baker DanielsLLP, Chicago, Illinois, [email protected]
Priyanka Sukhija of S.S. Rana & Co,New Delhi, India [email protected]
Timothy Lyden of Hogan Lovells,McLean, Virginia, [email protected]
John Ward of Novartis Vaccines,Cambridge, Massachusetts, [email protected]
Ricardo Enrique Antequera [email protected] andRicardo Alberto Antequera [email protected] of Estudio Antequera Parilli &Rodriguez, Caracas, Venezuela
Leticia Provedel da Cunha ofProvedel Advogados, Sao Paulo, [email protected]
Chris Tangang of Thomson Reuters,Washington, DC, [email protected]
Amber Koslucher of ComputerPackages Inc., Rockville, Maryland, [email protected]
Dmitri Anohin of Agency Tria Robit,Riga, Latvia [email protected]
Neha Ramani of Krishna & SaurastriAssociates, Mumbai, India [email protected]
Patrick Hayford of ThomsonReuters, La Grange, Illinois, [email protected]
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Frode Moen of Zacco Norway AS,Oslo, Norway [email protected]
Rudy Gaines of Marksmen,Carrboro, North Carolina, [email protected]
Reyes Campello of CEALAW,Alicante, Spain [email protected]
Nina Osseiran of Cedar White &Bradley Consulting LLC, Washington,DC, [email protected]
Jeremiah Thompson of ThomsonReuters, Philadelphia, PA, USA [email protected]
Melinda Achermann of AbbottProducts Operations AG, Allschwil,[email protected]
Joshua Green [email protected] James [email protected] both ofDarts-ip, Brussels, Belgium
Alex Ferdinand Fider of AngaraAbello Concepcion Regala & CruzLaw Offices of Metro Manila,Philippines [email protected]
Gilles Rubens of SMD International,Amersfoort, The [email protected]
Anne Jacobsen of H. Lundbeck A/S,Valby, Denmark [email protected]
Maria del Pilar Lopez of ZurcherLawyers, San José, Costa [email protected]
Michelle Martone of Dennemeyer &Co. LLC, Chicago, Illinois, [email protected]
A Suryanarayanan of D. P. Ahuja &Co., Calcutta, [email protected]
Maria Nebreda of Hoet PelaezCastillo & Duque, Caracas, [email protected]
Jeremy [email protected] andJessica [email protected] bothof Brand Institute Inc., Miami, Florida,USA
Toe Su Aung of Elipe Limited,London, UK [email protected]
Erildema Pascual of Astellas USLLC, Farmingdale, NY, [email protected]
Prudence [email protected] and AndrewDiamond [email protected] bothof Januar Jahja & Partners, Jakarta,Indonesia
Ayroinde Odunayo of Jackson, Etti& Edu, Lagos, [email protected]
Gail Karet of USAN Program /American Medical Association,Chicago, Illinois, USA [email protected]
Michiel Haegens of V.O. Patents &Trademarks, The Hague, TheNetherlands [email protected]
Mariano Municoy of Moeller IPAdvisors, Buenos Aires, Argentina [email protected]
Jonas Kölle of Merck KGaA,Darmstadt, [email protected]
Jeffrey Gitchel of BayerCorporation, Pittsburgh, PA, [email protected]
Marina Karaldina of Patentica LLP,St. Petersburg, Russia [email protected]
Laural Boone of AlexionPharmaceuticals Inc., Cheshire, CT,USA [email protected]
Stephen Anderson of Corsearch,New York, NY, USA [email protected]
Tiffany Monchen-Valeriano ofBrandstock Services AG, Munich,Germany [email protected]
Ese Akpogheneta of Pitmans LLP,London, [email protected]
Peter Hochberg of D. PeterHochberg Co., L.P.A., Cleveland, Ohio,[email protected]
Tim Whitfield of Powell Gilbert LLP,London, [email protected]
Viviana Rolon of BerkemeyerAttorneys and Counselors, Asuncion,Paraguay [email protected]
Juli Gutierrez-Zanelli of Muniz,Ramirez, Perez-Taiman & OlayaAbogados, Lima, Peru [email protected]
Michael Ullman [email protected] Joe [email protected] of WebTMS, Reading, Berkshire,UK
Mahya [email protected] and GiselleReyes [email protected] bothof Jorge Mera & Villegas, SantoDomingo, Dominican Republic
Marsha Hoover of Marshall,Gerstein & Borun LLP, Chicago, Illinois,USA [email protected]
Joseph Patterson of TrademarkNow,Elmwood Park, NJ, USA [email protected]
Noëlle Wolfs of V.O. Patents &Trademarks, The Hague, TheNetherlands [email protected]
Scott Kammer of TakedaPharmaceuticals USA Inc., Deerfield,Illinois, [email protected]
Moves and Mergers
Isabelle Dini has left Norgine to joinL’Oreal in London, UK. Isabelle cannow be contacted [email protected]
Erratum
Patrick Van de Vorst is now withCorseach who are based in Mechelen,Belgium, not Edegem as reported inthe previous edition of LL&P.
Please remember to let us know ofany changes to your contact details.You can notify me either via thePTMG website www.ptmg.org ordirectly to [email protected] or bywriting to me at Tillingbourne House,115 Gregories Road, Beaconsfield,Bucks, HP9 1HZ
Lesley EdwardsPTMG Secretary
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On 24 November 2014, the Office forHarmonisation in the Internal Market, theEuropean Union’s trade mark office,(OHIM) introduced a new fast track trademark application procedure forCommunity Trade Marks (CTMs). Thisoptional new route is generally expectedto considerably shorten the time fromfiling to registration and thereby increasethe attractiveness of the CTM route. Sohow does it work, what conditions willhave to be met to qualify for the fast trackand what are the expected practicalconsequences?
The Community trade marksystem: a brief overview
By way of reminder and background, aquick overview of the CTM system. In anutshell, a CTM offers its owner trademark protection throughout the whole ofthe European Union. CTMs are registeredat OHIM and give their owners protectionin all 28 EU member states in one singletrade mark and thus a single, unitaryregistration, enforceable throughout theEU. As OHIM states on its website, aCTM is an “all or nothing deal”: either youget it for all member states or you do notget a CTM at all. CTMs are usuallyconsidered a very cost effective route forapplicants that seek pan-European trademark protection but may not always bethe right choice for an applicant. Nationaltrade mark systems in the EU memberstates operate alongside the CTM systemand OHIM joined the Madrid Protocol on1 October 2004, meaning that a CTM canalso be designated in an InternationalRegistration. The registration process atOHIM has traditionally been rather fastwith OHIM most notably not citing earliermarks as obstacles to registration: onaverage the examination period for a CTMis about 8-11 weeks. Once theexamination procedure has beensuccessfully concluded, the mark movesforward to publication giving third partiesan opportunity to oppose registrationwithin three months from the date ofpublication.
OHIM’s new Fast Track System
As of 24 November 2014 OHIM has nowintroduced an optional fast trackapplication procedure, which is intended
to further accelerate its already quitespeedy examination process. While thenew fast track procedure will not shortenthe three months opposition period forCTM applications, the new procedure ismeant to be “faster” as well as “safer”:faster since only applications that complywith certain conditions are eligible for thefast track (more on this below). If they docomply, applications can be published inhalf of the time or less compared withregular applications. Safer, since applicantsmay only select pre-translated and pre-validated terms of goods and servicesfrom OHIM’s harmonised database. Theterms in this database have been approvedby OHIM as well as virtually all the international property offices in the EU.Using terms from this database, - evenoutside the fast track system - thereforereduces the likelihood of deficiencies andallows a smooth processing of theapplication. OHIM has also developed adedicated 5-step online application form,which includes mandatory options that aremeant to ensure that the application isprocessed on the fast track. Helpfully, theapplication form flags whether or not anapplication complies with the fast trackconditions and also proposes correctionswhich render an application suitable forthe fast track. It should be noted howeverthat CTM applications may fall outside thefast track system after filing, e.g. if themark falls foul of any of the absolutegrounds of refusal, such as lacking inherentdistinctiveness.
How to qualify for the fasttrack?
To qualify for the fast track, a CTM has to,inter alia, meet the following (additional)cumulative conditions. Notably, the filingfees will not increase for a fast trackapplication.
• The applicant has to be domiciled in the EU or appoint an EU representative;
• The application has to be for a word, figurative 3D or sound trade mark (i.e. not a collective mark);
• Goods/services have to be selected from OHIM’s harmonised database of pre-validated and pre-translated terms;
• No request for national searches can be included;
• If priority is claimed, the priority certificate(s) must be included uponfiling;
• Filing fees have to be paid upon filing the application.
Concurrently with the introduction of thefast track system, OHIM has alsoannounced that CTM applications will nowonly enter the examination process oncethe official filing fee has been received atthe Office. Whilst it is still possible todelay payment for one month followingfiling, OHIM decided to introduce thischange to prevent speculative applicationsfor borderline non-distinctive/descriptivesigns, which in the past may have beenexamined and potentially refused beforethe official filing fee had been paid.According to OHIM, in 4% of all cases,applicants had used this convenient optionand received an examination reportwithout having paid the official fees. Forfast track applications, users thereforehave to select the “debit now” button onOHIM’s 5 step application form.
Practical significance
OHIM’s new fast track process is designedto make the CTM route even moreattractive, especially for those applicantsthat are happy to draft their specificationso that it only includes the pre-approvedterms from OHIM’s database. For someapplicants this may lead to the drafting ofstandard specifications consisting entirelyof pre-approved terms. However, this maynot always be suitable, especially in thepharmaceutical industry, wherespecifications often are “bespoke” and/orclaim priority from other jurisdictions,where the priority mark may not includepre-approved terms under OHIM’spractice. OHIM’s fast track system should,nonetheless, allow for an increasednumber of CTMs achieving registrationwithin the six months priority periodunder the Paris Convention, which couldin turn make CTMs more attractive as abasis for International trade marks.
Faster, safer and more attractive? OHIM introduces “Fast Track” Application System Dr Birgit Clark, Trade Mark Attorney, London
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Chicago has been described as "perhapsthe most typically American place inAmerica" and so what an inspired choiceby the PTMG Committee to host the 89thPTMG conference, visiting the USA foronly the second time in its history. If anyof the attendees were feeling the effectsof a longer journey than usual, there wereno signs of it as we gathered in the ball-room of The Drake Hotel to greet oldfriends and make new ones at theWelcome Reception on Wednesdayevening.
On Thursday morning our ChairmanSophie Bodet introduced and thanked theCommittee members and welcomed theattendees, including more than 100 'firsttimers', many from the pharma industry.The conference had been fully booked atan early stage but Sophie assuaged anyconcerns that the Committee had plans tomake the conferences 'bigger'. So manymembers appreciate the very 'manageable'size of the event and this reassurance waswelcomed.
PTMG conference presentations arerenowned for their quality and relevanceand this year did not disappoint at all,beginning with the Founder's Lecture.Created to honour and celebrate thefounding of the organisation by DerekRossitter, who unfortunately was unableto attend this conference, each year ayoung and rising lawyer is selected topresent the Founder's Lecture. This yearthat honour fell to Christopher Hanes,Senior Counsel for GSK, who provided acomprehensive overview of the historicaland current challenges specific to therequirement for 'use' of pharmaceuticaltrade marks in the USA. The registrationof these marks can be difficult in anyterritory (with very lengthy lead times and
the need to balance the requirements oftrade mark applications and regulatoryapproval) but where registration is treatedsimply as the recognition of rightsacquired by common law , as in the USA,obtaining registration becomes morechallenging. There is a clear advantage tobe exploited by the brand owner that canbase their application on an earlier regis-
tration elsewhere, rather than use in theUSA; but of course under US law therequirement for 'use' affects all stages ofthe life cycle of a trade mark registration -at some point the owner will have toprovide specimens of use and Christopherprovided helpful examples of what is likelyto satisfy. Finally Christopher introduceda theme that was picked up throughoutthe conference, namely the conflictbetween national trade mark offices andregulatory bodies, which apply differenttests to assess the availability and approvalof trade marks. A clear (and robust)strategy is required to navigatecorresponding applications to a successfuloutcome for the client.
Kellie Taylor's review of recentdevelopments in the Food and DrugAuthority (FDA) approval of proprietarynames provided an excellent insight into asystem that was surely unfamiliar to manyin the audience - and yet it became quiteclear that it is important for attorneys tounderstand its workings if we are toprovide truly comprehensive advice onthe registrability of pharma trade marks.One would expect the examinationprocess to be stringent, but it was stillfascinating to be led through the complexlayers of analysis applied to each proposedname, including of course searches of drugnames used outside the US. Whilst thereis some international cooperation
between regulatory authorities, each hasits own considerations. Interesting toowas the contrast between the trade markapplication and FDA name approvalsystems, the first being a 'first to use'whilst the second is a first to registersystem.
Gail Karet, Rafaella Balocco Matavelli andAntoinette Lachat made up the panel ofexperts that provided a set of lively,informative and entertaining presentationsand discussions. Rafaella really broughtthe subject of non-proprietary names tolife in her presentation on the WHO INNProgramme. We were an unusualaudience to consider the selection processfor non-proprietary names - names thatbelong to everyone and through whichthey cannot make money! However theINN programme does not work within avacuum and pharma companies necessarilyneed to work with it from a marketingperspective in respect of which thereappears to be a settled approach of "theydo their business and we do ours." Gailprovided a very practical overview of the
PTMG 89th Conference, Chicago October 8th - 11thThe Multi-Faceted Personality of a PharmaceuticalTrade MarkRigel Moss McGrath, W.P.Thompson & Co.
7
Sophie Bodet
Christopher Hanes
Kellie Taylor
Gail Karet
activities of the USAN program, withwhich relatively few in the audience willhave had direct engagement and yet theconsiderations are very familiar; from amarketing perspective each pharmacompany wants to establish a new non-proprietary name to indicate a new and
revolutionary drug, but of course theseare more meaningful if there are fewer ofthem.
The panellists acknowledged that thereare serious limitations to theeffectiveness of the programs that hadbeen discussed and it was hard not to bestruck that this seemed at such odds tothe importance of the work they weredoing. There seems to be a dangerouslack of cooperation between trade markoffices and regulatory bodies and yet, forexample, INN is dependent upon nationalauthorities implementing what are ineffect only recommendations. India wascited as a country that posed particularproblems as it appears to be reluctant tounderstand the INN programme andwhat it seeks to achieve and yet this issuch a crucial territory to thepharmaceutical industry as a whole. Therisks were clearly highlighted by sometruly frightening examples of trade marksso similar to non-proprietary names as tocreate a genuine risk of confusion,
provided during Antoinette's presentationon the importance of non-proprietarynames to industry. Antoinette alsooutlined future challenges from theindustry perspective and one could butagree that the world is going to becomeincreasingly complicated for those thatwant to bring their drugs to the market.
The focus shifted slightly as CarmenCatizone presented details of thebackground and purpose of the.pharmacy gTLD. A frighteningproportion of pharmaceuticals are solddirect to the consumer via the internet,creating complex problems for theregulatory authorities. Despite clear andserious risks, increasing numbers ofconsumers place both their health andfinancial information on the internet, butit seems that the .pharmacy gTLD hasthe potential to provide some genuineprotection by creating a safe andlegitimate marketplace. There is globalsupport for .pharmacy, but it will onlysucceed if the authorities can maintaincontinuous compliance monitoring,pharma companies invest in the domainand, crucially, there is significant jointinvestment in consumer education.
Jonathan Jennings' presentationcomprehensively covered the interplay
between trade marks and identity rightsin the USA, where identity rights aregranted strong protection understatutory provisions. By way of contrastthe UK is still fumbling with theprotection of identity rights by way of'false endorsement', a form of 'passingoff'. In a world that seems to beincreasingly subject to the power ofsocial media, which acknowledges few ifany borders, the conflict between legalsystems is a source of increasing concern.
To a visitor from Europe (or as I was tolearn from anywhere other than NewZealand) the prevalence of direct toconsumer advertising of pharmaceutical
products in the USA is astonishing andThursday's final presentation, made byAnthony Genovese, provided anentertaining and informative overview ofthe subject. There appears to be areassuring system of validating claimswithin adverts and there is no doubt thatthe pros and cons of DTC advertising arewell balanced. Whilst I remainbewildered by the idea that a lack of'eyelash fullness' could be considered a'medical' condition, by the end ofAnthony's presentation my understandingand indeed appreciation of DTC hadincreased considerably.
On Thursday evening delegatesheaded to Lake Michigan for anevening cruise. It was a wonderfullyrelaxed environment and we wereaccompanied by an excellent Chicagoblues band as we travelled along theshoreline. It is a universal fact that nomatter how old one gets, fireworks stillhave an almost magical effect andalthough the air was crisp mostdelegates enjoyed a glorious displayfrom the deck.
8
Rafaella Balocco Matavelli
Antoinette Lachat
Carmen Catizone
Jonathan Jennings
Anthony Genovese
On Friday morning Jacques Labruniedrew our attention away from the USAtemporarily, to Brazil, the focus ofconsiderable international attention withthe world cup a recent memory, aforthcoming general election and thebuild up to the Olympics, in less than 2years, underway. The supply ofpharmaceutical products in Brazil is animportant issue; it is a large and growingmarket with over half of the populationregularly taking medications, which areexpensive to the extent that price isinhibiting use. In common with the USA(and many other territories) there isconflict between the trade mark andregulatory authorities. Trade markregistration is only the first step in theregulatory process, taking 2-3 yearsbefore the trade mark is placed beforethe regulatory authority, ANVISA, wherethe proposed mark is examined ondifferent grounds. A lack ofharmonisation between the systems is soextreme that, for example, thecancellation of a trade mark registrationmay not be recognised by ANVISA.Again, it is difficult to make sense of suchconflict in these circumstances.
Negotiations are underway to change theregulatory landscape in Brazil, but there isperceptible frustration caused by theslow pace of change and genuineconcerns that ANVISA has stepped backfrom a protection role, leaving the BPOto fill the void in protection, which iscontrary to the position in almost allother territories. (see article on page 11).
Steven Garland brought us back toNorth America, with another highlytopical matter, the long awaited changesto Canadian trade mark law, whichshould come into force at the end of2015/2016. The proposed changes areintended to make it easier, faster andcheaper to obtain trade mark registrationand to make the system more similar to
that of other territories. The proposedchanges are fundamental in nature; thevery definition of a trademark is to beamended to incorporate a broad range ofnon-traditional marks, the requirementfor use before registration is granted isto be removed and a classification system
will be introduced, which will also enableparticipation in the WIPO system. Whilstthis is all positive the removal of the userequirements will create an environmentwelcoming to trade mark squatters andthose trade mark owners who haverelied upon unregistered rights are urgedto formalise those rights before theintroduction of the new provisions.Steven provided some practical guidanceas to the kind of cases that may be moreeffectively prosecuted before the newlaws are enacted, such as the formalprotection of unregistered rights andapplications claiming multiple classspecifications. I am sure that many of uswill look forward to updates at futurePTMG meetings.
We moved very firmly back to the USAfor the next presentation, an examinationof US trade mark law and the FirstAmendment, focusing upon the right to
use trade marks as a form of free speech.It often feels as if the USA is in almostconstant state of pre-election fever, and Ibecame familiar with a number ofcampaign adverts during the conferencewhich provided a very relevant backdropto James Thomas' presentation, whichbegan with an examination of politicalspeech and artistic expression protectedby the First Amendment. James thenturned to the use of pharmaceuticaltrade marks as a form of 'commercialspeech'. Currently trade markapplications are not subject to FirstAmendment analysis, primarily becausethe application process does not concernuse of the mark. However the samecannot be said for cancellation caseswhich can raise constitutional issues. It
was a fascinating insight intoconsiderations of which I had notpreviously been aware.
In contrast Tom Farrand's presentationon brand valuation concerns a matter atthe very core of our professionthroughout the world. Whilst formalbrand valuation is undertaken byaccountants and analysts wieldingcomplicated formulas, the notion of abrand as a 'valuable' asset is one that wework hard every day to reinforce -"What gets measured gets managed"indeed! Tom's comparison ofintangible/tangible assets of pharmacompanies was striking, but perhapsmore so was the comparison of the valueof pharma brands to technology brands.Could there be any better cue to set outvery practical advice concerning portfoliomanagement and its direct impact uponbrand value?
Jacques Labrunie
Steven Garland
James Thomas
Tom Farrand
9
I must confess that prior to RobLitowitz's highly engaging presentation Ihad given (at best) limited considerationto the concept of 'floating brands', but Ihave now been duly educated and I findmyself far more sensitive to their use byinnovative brand owners! A 'fluid brand'goes beyond the normal evolution of abrand and is best exemplified by the'Google Doodles'. Fluid brands are usedto good effect in vastly different areas ofcommerce including technology, drinksmanufacturers and retailers. Clearlybrand owners must be mindful to avoidabandonment, but the examples provideddemonstrated how effective use of fluidbrands can be. Their popularity withbrand managers is unlikely to wane andthis is an area of brand protection thatwe as attorneys need to embrace.
At the beginning of her presentation,having polled the delegates, Toe Su Aungexpressed surprise at our lack ofawareness of The Medicrime Conventionand proceeded, very successfully, torectify the situation. The Conventionseeks to provide a legal framework tomake the counterfeiting of medicines(whether protected by IPRs or not) a
criminal offence in as many countries aspossible. Perhaps our lack of awarenessstems from the fact that the conventionis not based upon existing IP laws (to theextent that the definition of 'counterfeit'is subtly different) and shifts the basis foraction away from IPRs to product safety.It is not yet in force and there seems afrustratingly long way to go before all 28Member States of the EU ratify theConvention; but we were urged toencourage our Governments to makeprogress and in this respect the Pharmaindustry will play a key role! Thepresentation created considerablediscussion, particularly by way ofcomparison with and the lessons to belearned from ACTA.
Fittingly the final presentation of theconference focused on the USA and thecontinuing fight against counterfeits.During his presentation BruceLongbottom introduced the DQSA,ASOP and CSIP to the audience, in theprocess neatly echoing some of theissues that had been identified in earlierpresentations. Statistics concerning theonline market for counterfeit goodscontinue to stagger me, as do theexamples of sophisticated onlinemarketing of counterfeit products, whichdemonstrate how easy it must be for theconsumer to feel confident that they arepurchasing goods from a reputableregulated vendor. Whilst Governmentenforcement agencies have imposed hugefines upon third parties such as Googleand UPS, given the value of the businessgenerated by illicit online pharmacies, it isclear that those fines will need to beeven greater in size if they are to have ameaningful effect on the counterfeitdrugs market. This is another topic onwhich I look forward to receivingupdates at future conferences.
To conclude, the presentations wereexcellent, without exception, tacklingvaried and often complex subject mattersand making them understandable andrelevant. I recommend accessing thepresentation slides whilst they remainavailable and, as always, look forward tothe next conference to be held in Venicein March 2015.
The Gala dinner, held at the Museumof Science and Industry, was a greatvenue to end the conference in style.Many delegates took the opportunityto visit the exhibitions which wereopen for our visit, the mostspectacular of which was a U-505submarine.
Rob Litowitz
Bruce Longbottom
Toe Su Aung
PTMG 90thConference
Venice
23rd-24th March 2015
Registration will open on PTMG website in mid
January 2015
10
Sophie Bodet presents TheFounder’s Lecture Award toChristopher Hanes on the morningof Day 1
In October 2014, the Brazilian HealthSurveillance Agency (ANVISA) enactedResolution RDC nº 59/2014 settingseveral criteria for the formation ofnames for pharmaceutical products.
The new rules are likely to cause a significant impact to the practice ofthe pharmaceutical industry. As aresult, it is imperative that regulatoryand IP professionals are aware of thenew regulations enacted by theBrazilian health surveillance authorities.
The purpose of this article is to provide an overview about ResolutionRDC n° 59/2014 and comment aboutthe aspects which should be considered in the selection and adoption of drug names by a pharmaceutical company.
It also examines the Resolution from apractical perspective, shedding light onthe interface between the new rulesand some fundamental tenets of trademark law.
Reach of the new Resolution
Firstly, an important disclaimer:Resolution RDC nº 59/2014 makesclear, in its article 20, that product registrations granted under the priorrules will not be reviewed by ANVISA.
This means that the new regulationdoes not affect already granted registrations and will be limited tofuture registrations or to productapplications that have not yet beenapproved by the agency.
Pharmaceutical companies thereforedo not need to bring into line existingproduct registrations to the new rules,which denotes ANVISA’s praiseworthyconcern to protect vested rights.
Criteria for names of pharmaceutical products
Resolution RDC nº 59/2014 bringsforth two positive aspects in respectof the names of pharmaceutical products.
The first refers to terminology.ANVISA has finally abandoned theterm “trade name” to refer to thetrade mark of a pharmaceutical product. From now on, ANVISA willuse the term “drug name”, which ismore appropriate than its predecessor,since the term “trade name” is commonly used as a synonym of “corporate name” in Brazil.
The second good news is even moreimportant: the new Resolution revokesthe “3-letter rule”, according to which“the name of a medication could besimilar to an already registered nameas long as they differ in at least 3 different letters”.
That rule was in blatant disagreementwith traditional principles of trademark law. After all, there might existconfusingly similar trade marks thatdiffer in three or more letters and sufficiently distinct marks that differ injust two.
Thus, ANVISA acted correctly inrevoking the 3-letters rule and replacing it by section 7, sole paragraph, of the current Resolution.This section provides that “the intended drug name must have sufficient graphic and phonetic distinction in relation to the names ofother registered drug products”.
As seen above, the current rule mandates that the name to be registered before the agency must begraphically and phonetically different asopposed to prior registered names.
Although other criteria could havebeen added, this is unquestionably animprovement in respect of the priorrule, since the conflict assessmentbetween two names should be doneon a case-by-case basis and should notbe governed by mathematical standards.
The new Resolution also provides thatthe trade mark of a pharmaceuticalproduct should preferably compriseonly one word and its intended pronunciation in Portuguese must havedirect relation to its spelling.
The existence of the term “preferably”indicates that the one-word structureis not mandatory.
The spelling rule, in its turn, indicatesthat ANVISA can reject names thatcan cause certain inconsistencies as tothe way they are spoken or written.
For example, when seeing the markTHERAHAIR identifying a medicationused to stimulate hair growth, aBrazilian consumer familiarized withthe English language would probablyface no difficulty in pronouncing theterm correctly.
The same, however, would probablynot occur with a consumer who is notacquainted with the English language,since when positioned in the middle ofthe word, letter h produces no soundin Portuguese.
It is precisely this kind of inconsistencythat ANVISA seeks to avoid. As aresult, it is imperative that pharmaceutical companies take thisrule into consideration while selectinga new mark to be used in the Brazilianmarket.
Prohibitions set forth by the newResolution
Resolution RDC n° 59/2014 provides,in its article 15, that trade marks ofdrug products and their complementscannot use:
• The suffixes of nonproprietary names recommended for each therapeutic class of pharmaceutical substances, even if in a position different to that usually recommended – this rule prohibits the use of suffixes recommended for each therapeutic class of the pharmacology, such as - ADOL for analgesics and CICLOVIR for antiviral compounds (according to the Manual of the Brazilian Nonproprietary Names);
• The parcel of the nonproprietary name of the drug substance, usuallyassociated with a particular active
11
New rules about names of pharmaceutical productsenacted in Brazil Gustavo Piva de Andrade, Dannemann Siemsen
12
ingredient, when it is not part of the drug product composition – the aim of this rule is to guarantee that the parcel of the non-proprietary name associated with aparticular active ingredient is only used when the active ingredient is present in the medication. The termTAMOL therefore, can only be used in connection with medications which have paracetamol as an active ingredient;
• Abbreviations, isolated letters, random sequence of letters, Arabic or Roman numbers, without clear meaning to the consumer or that do not have any relation to the features of the product – this rule is self-explanatory and can be used to prevent the use of terms and abbreviations that do not have a clear meaning to the Brazilian consumer; and can be used to prevent the use of terms and abbreviations that do not have a clear meaning to the Brazilian consumer;
• Names that do not correspond to the way the drug product is given –the goal of this rule is to prevent confusion as to the pharmaceutical form of the drug or as to how the medication is administered. Thus, for instance, the terms spray or lotion cannot be used in connection with a liquid preparation administered orally;
• Words or expressions that may lead to the understanding that the drug product is innocuous, natural, exempt from or with reduced side effects, or that the drug product has superior potency and quality orunproven special properties – this rule prohibits the use of expressions such as NATURAL, SOFT and LIGHT or any other term that may lead the consumer
into doubt or error as to thefeatures of the medication;
• Words or expressions that emphasize a therapeutic action, without evidence from clinical studies, and that may lead the consumer to believe that such drugproduct has superior therapeutic effect as opposed to another drug product of equal composition – thisrule forbids the use of terms such as MAX, PLUS, SUPER in
connection to variations of an existing medication, unless the manufacturer is able to prove that the variation is indeed superior to the prior one;
• Name of drug product that has been rejected due to efficacy or safety reasons.
Finally, the Resolution provides that,when evaluating other cases notincluded in the prohibitions, ANVISAmay still reject the proposed namewhen it detects any sanitary risk tothe consumer.
Families of drug products
Resolution RDC nº 59/2014fortunately embraces the concept offamilies of drug products. It providesthat drug products of the same company, whose formulation containsthe same active ingredient, may begrouped in families sharing the samemark and adopting complements thatdistinguish the drug products.
The Resolution also mandates that theexclusion or replacement of the activeingredient demands the adoption ofanother mark for the medication. Thus,consider a family of analgesics whoseactive ingredient is ibuprofen. If themanufacturer replaces the ibuprofenby dipyrone in one of the products,the mark of that product would haveto be changed, in a manner to adopt adifferent mark as opposed to the family.
The exceptions are the multivitamin,multimineral and multi amino acidproducts. In these cases, the mark ofthe family can be maintained, but themanufacturer should use complementsindicating the target public of theproduct.
Criteria for complements ofnames of drug products
Finally, Resolution RDC nº 59/2014regulates the use of complements inpharmaceutical trade marks, pointingout that the complements must beused to distinguish certain medicationfrom other medication registered bythe same company, within the samefamily of products.
In respect to these complements, theResolution provides that:
• ANVISA will not consider, for purposes of registration, the existence of exclusive rights over the name complement – this meansthat, in principle, the agency will presume that the name complement cannot be appropriated. Thus, if the company believes that the complement is distinctive and able to function as amark, it should take judicial measures to avoid the inclusion of the complement in subsequent third party registrations;
• Using the same name complement with different meanings is prohibited;
• Pharmaceutical companies can, upon substantiated justification, usename complements to distinguish routes of administration, pharmaceutical forms, target groupsand absorption details of the drug products;
• Drug products presenting kinetics of different release, different pharmaceutical forms or different routes of administration within the same family must adopt name complements.
Conclusion
ANVISA’s new Resolution regulatesseveral aspects relating to the namesof pharmaceutical products. Somechanges are quite positive, such as theabolition of the 3-letters rule, a testwhich was severely criticized by thepharmaceutical industry and the entiretrade mark community.
On the other hand, the Resolutionbrings some specific provisions to thecurrent regulatory scenario. This isextremely relevant because the rejection of the application canobstruct the launching and sale of thedrug product in the market.
Pharmaceutical companies operating inBrazil therefore, should be attentive tothese rules and create an efficientinteraction between their regulatoryand intellectual property departments.
The regulatory framework in Sloveniaallows prescribing of medicines by theirinternational non-proprietary name (INN).However, as INN prescribing is not compulsory, physicians mostly prescribemedicines by their invented names.Pharmaceutical branding thus plays animportant role in marketing of pharmaceuticals in Slovenia.
The competent authority in Sloveniaresponsible for granting marketing authorisations through the national, decentralised or mutual recognition procedure is the Agency for MedicinalProducts and Medical Devices of theRepublic of Slovenia (hereafter referred toas the JAZMP). Part of its role in evaluating the safety of medicinal productsis to approve their proposed (invented)names. In that regard the JAZMP issuedthe Guideline governing the acceptabilityof names for human medicinal products(hereafter referred to as the JAZMPGuideline).
The JAZMP Guideline mostly follows therequirements for approval of proposed(invented) names in the process of granting Community marketing authorisation for human medicinal productthrough the centralised procedure that isin the competence of the EuropeanMedicines Agency (hereafter referred to asthe EMA). A Community marketing authorisation for human medicinal productis valid throughout the European Unionand the invented name of the medicinalproduct is an integral part of the authorisation. According to Article 1(20)of Directive 2001/83/EC, as amended, thename of the medicinal product “may beeither an invented name not liable to confusion with the common name, or acommon name or scientific name accompanied by a trade mark or the nameof the marketing authorisation holder”.Article 6(1) of Regulation (EC) No726/2004 stipulates that a single name isused to identify a medicinal productauthorised under the centralised proce-dure.
For the purpose of reviewing proposed(invented) names of medicinal products,
the EMA established the (Invented) NameReview Group (NRG) composed of representatives from the EU MemberStates. The group's main role is to consider whether the invented name proposed by the applicant(s) or marketingauthorisation holder(s) could create apublic-health concern or potential safetyrisk. When assessing the acceptability ofthe proposed (invented) names, the NRGapplies criteria based on public health concerns and, in particular, safety.Specifically, the invented name should not:
• convey misleading therapeutic or pharmaceutical connotations;
• be misleading with respect to the composition of the product;
• be liable to cause confusion with the invented name of an existing medicinal product in print, handwriting or speech.
The criteria applied by the NRG whenreviewing the acceptability of proposed(invented) names are detailed in theGuideline on the acceptability of namesfor human medicinal products processedthrough the centralised procedure(EMA/CHMP/287710/2014 – Rev. 6), hereafter referred to as the EMAGuideline.
In reviewing the proposed (invented)names of medicinal products authorisedthrough the national, decentralised ormutual recognition procedure, the JAZMPtakes into consideration safety issues andpossible confusion with existing medicinalproduct names or names pendingapproval. As of late 2011 an increase in therejection rate with respect to the namesproposed to the JAZMP is noticeable. TheJAZMP decisions on the proposed (invented) names often seem arbitrary,which is evident from the situation on themarket.
The JAZMP Guideline introduced arequirement not comprised in the EMAGuideline prescribing that the names ofmedicinal products should differ in at leastthree characters. This criterion is vague
and may be interpreted in different ways.According to one possible interpretation,the names of two medicinal products mustdiffer in more than three letters, whereasthe letters are compared in the sequenceas they appear. The same requirement mayalso be interpreted in a way that thenames of two medicinal products must differ in three or more letters, whereasthe positioning of the individual letters isnot taken into account. The JAZMP hasnot made publicly available its officialstandpoint on this issue. There are examples of name pairs that have beenapproved by the JAZMP that do not fulfilthe aforesaid requirement, regardless ofthe interpretation applied, e.g. TOBREXand TOBRADEX, ZALDIAR and SELDIAR.The applicants for marketing authorisations often face rejections of theproposed invented names of medicinalproducts due to the alleged similarity tothe applied/registered invented name, eventhough the conflicting names are moredistant visually and phonetically than theaforesaid name pairs.
Furthermore, trade mark registration priority is not a determining factor in theJAZMP assessment of the acceptability ofthe proposed name for a human medicinalproduct. Since the first-come, first-servedrule is applied, the proposed name enjoining the trade mark registration priority can be rejected during the marketing authorisation granting procedure on the basis of a name thatobtained trade mark protection later, butfor which marketing authorisation wasrequested earlier.
The applicants have the possibility to consult with the JAZMP as regards theacceptability of the proposed (invented)name prior to filing an application for marketing authorisation. However, theopinion given beforehand is not binding inthe granting of marketing authorisation,and it neither helps in anticipating the outcome of the assessment of each proposed name nor does it remedy theJAZMP’s strict and inconsistent practice.
Approval of proposed invented names for medicinalproducts in Slovenia Ms. Tatjana Simovic, PETOSEVIC
13
© 2014 The Pharmaceutical Trade Marks GroupCirculated for information only to PTMG Members. PTMG does not accept any liability or responsibility for any inaccuracies contained within this edition of LL&P.
The views expressed by the authors do not necessarily respresent the views of PTMGEditor: Vanessa Parker
Tel.: +33 679 316 860 email: [email protected]
14
Where were you brought up andeducated ?
In Paris - France.
How did you become involved intrade marks ?
While studying law at University Iattended an IP Class. I wasparticularly interested in trade marksand decided to select IP as myspecialization for my Law Degree.
I was already working at RousselUclaf during this time and, when aposition for a trade mark lawyerbecame vacant there, I applied andwas hired to join the trade markdepartment.
What would you have done if youhadn’t become involved inintellectual property ?
A journalist.
Which three words would you useto describe yourself ?
Dedicated, sociable, dynamic.
What was (were) your bestsubject(s) at school ?
Economics, Languages.
Complete the sentence : If I havetime to myself
I would read more books and alsotravel more.
What is the best thing about yourjob ?
Apart from managing a team,practising in trade marks for a globalportfolio gives me the opportunityto work in many diverse areas withinmy field of practice, and also to facemany interesting challenges.
I also appreciate the opportunity tomeet and work with different peoplefrom all over the world.
What did you want to be as achild ?
A veterinarian to take care of pets (Ihad a cat at that time).
What is your biggest regret ?
Not to have time enough to spendwith my family and my friends.
What is your favourite work of art ?
Monet – Impression Sunrise.
What is the best age to be ?
I think there is no best age. Itdepends on how you feel.
What is your weakness ?
Chocolate and cakes.
Which book or books are youcurrently reading ?
Chess Story by Stefan Zweig.
What is your favourite children’sbook ?
The Little Prince by Antoine de SaintExupéry.
How do you relax ?
Walking, listening to music, readingand when possible gardening.
What is your favourite drink ?
A glass of good red wine.
Do you have any unfulfilledambitions ?
I would like to travel to Vietnam andSouth Africa.
What is your favourite building /piece of architecture and why ?
The Eiffel Tower - of course - I amFrench. Its structure is so amazingand original. At night when it is lit, itis magical.
What’s the best invention ever ?
Aviation in general – it is incrediblehow you can fly from one place toanother so quickly.
Which modern convenience couldyou not live without ?
A mobile phone.
PROFILE: Joëlle Sanit-HugotJoëlle Sanit-Hugot has been working in the pharmaceutical sector for morethan 25 years and exclusively in the area of Intellectual Property law for over20 years.
From the start of her career, she has worked continuously in variouspredecessor companies to SANOFI, and spent two years as the Head of theCompany’s Trade Mark Department in Germany. She now holds the position ofDeputy Director of the Trade Mark Legal Department, based in France,
Joëlle is on the PTMG’s Management Committee. She is also a member ofAPRAM (Association des Praticiens du Droit des Marques et des Modèles), andof several pharmaceutical related associations, such as EFPIA (EuropeanFederation of Pharmaceutical Industries and Associations), and Leem (LesEntreprises du Médicament) – for which she is the Chair of the Trademark AdHoc Group.
She has spoken at national and international conferences such as APRAM,PTMG, INTA, ASIPI.