Droit des Brevets et Marques

Patents and Trademarks LawsCRA-UD 2013-2014Slide #Intellectual property2

Slide #Framework3

Slide #Patents Monopoly granted to the inventor monopoly of working for 20 years, -in exchange for the disclosure of the inventionPatent = contract between the company and the inventorNot all creation can be patented

4

Slide #Le brevet est un monopole confr linventeur qui va tre dnomm le brevet, cest un monopole dexploitation de 20 ans en change de la divulgation de son invention, ce qui est un avantage pour la socit car linventeur pourrait garder le secret, inconvnient: pas de protection de la part de la socit et chercheurs ne connaitront pas larchitecture de linvention. Brevet est un systme juridique, cest une sorte de contrat entre la socit et linventeur: on livre le secret mais en change monopole dexploitation conomique pendant 20 ans, cest du donnant donnant. Cest un contrat.Toute cration ne pourra pas tre brevete, ou certaines crations ne seront pas brevetables pour des raisons diverses.

4Advantage / DisadvantageDisadvantage: no protection by society and researchers will not know the architecture of the invention.A patent: is an economic exploitation monopoly for 20 years, it's a giving giving contract.We can not make a patent of everything, some creations are not patentable for various reasons.

5Slide #Discoveries in: Pharmaceutical Industries6

Slide #Development of the chemical industry7

Slide #Development of biotechnology8

Slide #Example of HIV9

Slide #Dr. Robert Gallo caseHe is an ex-discoverer of the AIDS virus.As a lab chief at the NIH, in Bethesda, Gallo is probably the best-known AIDS researcher in the world. He is usually called, albeit erroneously, ''co-discoverer of the AIDS virus.The virus that Gallo put forth in 1984 as the cause of AIDS was not an independent discovery but merely a copy of a virus sample sent to him nine months earlier by cooperative French scientists at the Pasteur Institute in Paris.In the three-year battle for credit and patents that followed, the French were shown to be the rightful discoverers, despite the politically maneuvered "amicable" agreement to split the credit for the discovery between the two countries.

10Slide #Development of the computer industry11

Slide #The most important pointCommercial profitTaking benefices

12

Slide #Evolution of Industrial PropertyEvolution with the evolution of society and discoveriesStill lags behind the evolution of research and development13Slide #What is the economic logic?Secret V / S Patent-secret:advantage if:-Small group of researchers-Limited number of intervening-Possibility of secrecy-cheapdisadvantage if:-Several speakers to produce the finished product-Need a collaborative work example:-The chemical formula of Coca Cola-Steak sauce of Paris (transmitted from father to son)14Slide #What is the economic logic (2)?Secret V/S BrevetPatent (obstacle for free competition )advantage:-State and legal protection of inventions-Investment protection-Opportunity to share with others the invention (as validations of patents)disadvantage:-Implementation very complicated-There is no single international protection-Preparation of a file into several languages-High costexamples:Patent active drugsPatents filed by technology companies like Apple, Intel, Sharp, Sony, BMW ...15Slide #frein au libre jeu de la concurrence 15What is the economic logic (3)?Investment V / S Return on Investment (1/3):The discovery of a drug is expensive: European investments in R & D:1980: 2.3 billion1990: 7.7 billion1997: 12 billion2009: 26 billionInvestment in the U.S. in R & Din 2009: $ 34.8 billion

16Slide #Most important R&D investment is in USA

17Slide #Number of new molecules / Innovative drugs

18Slide #Cycle de financement dun mdicament

19Slide #Return on investment: between yesterday and today

Cost increase of R & D10 ans20 ansDevelopment is increasingly longFaster generic entryAcceleration of diffusionFlux financiers

Approximately 70% of drugs on the market do not provide companies that have marketed the return on investment, it is provided by a limited number of drugs.20Slide #- Les investissements des entreprises europennes en matire de R & D sont passs de 2.3 milliards d'euros en 1980 7.7 milliards d'euros en 1990 et 12 milliards d'euros en 1997.

- Les investissements ncessaires la mise sur le march d'un mdicament d'innovation sont estims, au minimum 500 millions d'euros.

- Le temps ncessaire au dveloppement de nouveaux mdicaments a substantiellement augment au cours des dernires annes et se situe aujourd'hui entre 8 et 12 ans.

- A partir de 5 10 000 nouvelles entits chimiques inventes et dveloppes par une entreprise, seule l'une d'entre elles sera mise sur le march.

- Environ 70 % des mdicaments mis sur le march n'assurent pas aux entreprises qui les ont commercialiss un retour sur investissements, celui-ci tant assur par un nombre limit de mdicaments.

20What is the economic logic?Investment V / S Return on Investment (2/3)-The discovery of a drug is expensive-Laboratories to make an investment must earn sufficient income from the marketing of a drug20-year monopoly-No copy of the same drug can reach the market during this period of protection-However possibility of arriving competitors on the market (different molecule with identical efficiency)Exclusivity for orphan drugs-7-year monopoly over the U.S.-10 years in Europe and Japan21Slide #

22Slide #

23Slide #

24Slide #What is the economic logic?Investment V / S Return on Investment (3/3)injustice:Rich countries can invest, but this is not the case in poor countriesThe patent reinforces the imbalance between the north and southImportance of the Doha Declaration = easy access to essential drugs in poor countriesAn obstacle to free competition

As a result of patents, pharmaceutical companies are investing heavily in research and development and take financial risks in order to respond to the growing therapeutic needs of the population.25Slide #Grce aux brevets, les entreprises pharmaceutiques investissent des sommes considrables dans la recherche et le dveloppement et prennent des risques financiers importants afin d'apporter des rponses aux besoins thrapeutiques croissants de la population. 25Lebanon- patent lawOJ 14 August 2000: Act No. 240

-Protection of Pharmaceutical Products-Protection of 20 years from the filing date-Filing language: Arabic-Description and claims in Arabic, French or English-cost:The first year: 50,000 LL fee + 100 000 LLAnnual cost = cost year (n-1) + 50 000 LL-Compulsory license held under certain conditions:

Public health purposesReasons vital to the economy26Slide #Conditions of patency LibanArticle 2 de la loi n240novelty-It is an invention that has not been previously described-Any oral disclosure (communication at a conference) or written (poster, abstract, article ...) destroys the noveltyinnovation-A skilled artisan can ( not) achieve in the current knowledge of the state of the artindustrial application-Invention can be manufactured by any type of industry

27Slide #Are not patentable - Lebanon? Articles 3 and 4 of Act No. 240Any scientific discovery, theory or mathematical program without industrial applicationAny concept or method in connection with intellectual, economic, financial or in connection with the field of toy.Any diagnostic or therapeutic method for the treatment of humans or animals with the exception of products or equipment used to carry out these methods.Any invention against public order or moral

28Slide #Protection des donnes29Slide #RDP is NOT the same as patent protectionCategoryRegulatory Data ProtectionPatent ProtectionLength 5 years 7 yrs for orphan drugs 8 years (+ 2 + 1) NME10 years (orphan)12 years (orphanPUMA)1 year (new indication for well-established)20 years from filing (Orange Book)20 years from filing (country specific and not posted) + 5y SPCLegal Hatch -WaxmanDirective 2001/83 amended by 2004/27Patent and Trademark Office

Country specificSPC: Regulation No 1798/92/ECWhen its grantedNDA Approval for NMEsNDAPediatric exclusivityMAA approvalSignificant medical advancement

After review by Patent and Trademark OfficePediatric exclusivity

Pediatric reward: (+ 6 months)

NDA New Drug Application; NME - New Molecular Entity; sNDA supplemental New Drug Application; SPC Supplementary protection certificate

Slide #Autres diffrences en E-U et EuropeUnited States:No possibility to register generic prior to the expiration of all patents of the reference molecule

Europe:-Ability to register a molecule generic if the registration data of the reference molecule are no longer protected (expires 10 years of protection)-No opportunity to market a generic (even if an authorization for placing on the market) if there is a patent valid31Slide #International RDP Period for Orphan DrugsRDP (years)Paediatric dataUS7+ 6 monthsEU10+ 2 yearsAustralia5Similar to other drugsJapan10+ 4 years (max 10 years)CanadaNo Orphan drug statusRussiaNo Orphan drug statusTurkeyIsraelNo Orphan drug statusLets see if I can find more countriesSlide #Case StudiesNEW molecular entity: old product introduced in United States

NEW product: combination products

NEW formulation: extended release

Slide #Start of RDP period for products first authorised in the countries before their entry to the EU. Galantamin case (C-527/07)(Namenda is another example. Need to confirm when Patent expires).

Nivalin 1st MA in AustriaTreatment of polio1963200020012010MA for Alzheimer via MRP to Cilag Janssen(full application)RDP ExpiryRDP 10 yearsNivalinwithdrawalGeneric galantamin MAA submitted to MHRABE vs. Remnyl20052009ECJ:Nivalin cant be used a Referenc Medicinal Product1995Alzheimer indication approvedFile never updated to EU standardsMHRA rejected the application (RDP not expired)Slide #Namenda is another example. Need to confirm when Patent expires.Using RDP for a NEW ProductSource: Electronic Orange Book: http://www.accessdata.fda.gov/scripts/cder/ob/docs/tempai.cfm (June 9, 2009)Source: Drugs@FDA: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Search_Drug_Name (June 9, 2009)Foreign Approvals1990-1999200020052007Jan 14, 2000Approved in USJan 14, 2005RDP ExpiredOctober 9, 2007First Generic ApprovedSlide #Namenda is another example. Need to confirm when Patent expires.Case Studies will evaluate topic questionNEW molecular entity: old product introduced in United States

NEW product: combination products

NEW formulation: extended release

Slide #Symbax and Caduet are other examplesUtilizing RDP through combination productsSource: Electronic Orange Book: http://www.accessdata.fda.gov/scripts/cder/ob/docs/tempai.cfm (June 9, 2009)Source: Drugs@FDA: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Search_Drug_Name (June 9, 2009)20071996199220032011-12MarchDiovan patentExpiresOctoberTentativeApprovedvalsartangenericSeptemberAmlodipine genericApprovedDecemberDiovan (valsartan)ApprovedJulyNorvasc (amlodipine)Approved JuneExforge(valsartan/amlodipine)ApprovedJuneRDP Expires forExforgeSlide #Sum is greater than the individual parts (2 + 2 = 5)Products90 day supplyTotalExforge 160/5$246.61$246.61 Diovan 160 mg$220.28$243.27 Amlodipine 5 mg$22.99Exforge 320/10$338.28$338.28 Diovan 320 mg$311.72$335.71 Amlodipine 10 mg$23.99Source: http://www.drugstore.com/pharmacy/prices/drugprice.asp?ndc=00078049115&trx=1Z5006; accessed June 2, 2009Slide #Case Studies will evaluate topic questionNEW molecular entity: old product introduced in United States

NEW product: combination products

NEW formulation: extended release

Slide #A new formulation RDPIR Immediate Release, XR Extended Release, MDD- Major Depressive Disorder; GAD-General Anxiety DisorderSource: Electronic Orange Book: http://www.accessdata.fda.gov/scripts/cder/ob/docs/tempai.cfm (June 9, 2009)Source: Drugs@FDA: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Search_Drug_Name (June 9, 2009)SeptemberIR Approved(low doses)SeptemberDataExclusivity Ends (IR)MayXR ApprovedMarchPatent Expires (IR)2012200219972007200820092017DecemberGenericTentative Approval (IR)RejectedApril DataExclusivity Ends (XR)AprilFDA AdvisoryCommittee Meetingfor MDD and GAD forXR formulationNovember Patent Expires (XR)Slide #Global Marketing Authorisation contains the initial authorisation and all variations and extensions thereof, as well as any additional strengths, pharmaceutical forms, administration route or presentations authorized through separate procedures and under a different name, granted to a MA holder of the initial authorisationA new formulation RDPAll presentations of a given product are considered as part of the same MA.

The start of the data exclusivity period is the date when the first MA was granted in the EU Community.Slide #Trademark law42Slide #The brand"The brand is ... a non-negligible value of business assets"

Brand = Quality AssuranceBrand = Fight against genericBrand = Fight against counterfeitingBrand = Fight against parallel trade

43Slide #Anti-brand health authoritiesRight of substitution by the pharmacistDCI prescriptionFramework agreements with prescribersLimiting medical prescribers in theTFR44Slide #Criteria for the validity of a trade mark - Absolute CriteriaA brand must not contain any prohibited sign and it must be distinctive. Article L711-3 of the ICCforbidden signs-Signs reserved for official or semi-official (Red Cross, pharmaceutical caduceus, caduceus medical ...)-Misleading signs on the nature, quality or geographical origin of a product ("pharm" and "pharma" are reserved for pharmaceutical product)45Slide #Criteria for the validity of a trade mark - Absolute CriteriaA brand must not contain any prohibited sign and it must be distinctive.article L711-3 du CPIDistinctive signsA generic term (by ex.une DCI) is not a valid trademarkOrdinary terms or necessary in the current language or professional for identity of the product are not valid trademarksmark consists of a name or a sign which may serve to designate a characteristic of the product is not validsigns which consist exclusively of the shape imposed by the nature or function of the product are not considered validit is possible to make a shape as a trade mark, provided that it does not present a functional and technical character.

46Slide #Criteria of validity of a mark Relative criteriamark must not infringe (harm) prior rights held by third parties (brand name, trade name, brand, domain names ...), that is to say they should not be identical or similar.

Assessing the availability of a mark before depositionResearch is conducted at least in principle in Class 5 of the Nice International ClassificationRight to object to the use by third47Slide #Brand ControlIn France: Double controlINPI:verifies the absolute criteria for the validity of a trademarkIn France, the criteria must be supervised by trademark owners => right to object => increases the risk of conflict

AFSSAPS:the brand is part of the Marketing AuthorizationBrand Refusal = Refusal of the Marketing Authorization

48Slide #Contrle de la Marque par lAFSSAPSArticle L 5111-2 of the CSP:"Any medicinal product prepared in advance in a special pack and characterized by a special name

Article R. 5121-2 of the CSP:"The name of a drug can be either an invented name or a common or scientific name accompanied by a trade mark or name of the manufacturer. The fancy name can not be confused with the common name

Article R. 5121-21 of the CSP:"... The fancy name must be chosen to avoid confusion with other medicinal products and not misleading as to the quality or properties of the specialtyLink between brand control and protection of public health49Slide #Contrle de la Marque par lAFSSAPSRecommendation for the choice of a drug name:Preferably one wordNo hyphenNo diminutive or superlative (HIGH, LOW, RETARD, PLUS, MINUS ...)No syllable that resembles a diminutive or superlative

Attention to the likelihood of confusion:With another drugWith a cosmetic product or foodstuffNo trivialization of drug

Major points of comparison with another nameThe position of lettersThe first letters of distinct preferenceThe confusion associated with handwritingThe number of letter in common with respect to all of the letters of the name50Slide #En rsum Quel type de protection?

51Slide #