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CRA-UD 2013-2014 Slide 1 Intellectual property Slide 2 2 Framework Slide 3 3 Patents Monopoly granted to the inventor monopoly of working for 20 years, -in exchange for the disclosure of the invention Patent = contract between the company and the inventor Not all creation can be patented Slide 4 4 Advantage / Disadvantage Disadvantage: 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. Slide 5 5 Discoveries in: Pharmaceutical Industries Slide 6 6 Development of the chemical industry Slide 7 7 Development of biotechnology Slide 8 8 Example of HIV Slide 9 9 Dr. Robert Gallo case He is an ex-discoverer of the AIDS virus. As a lab chief at the NIH, in Bethesda, Gallo is probably the bestknown 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. Slide 10 10 Development of the computer industry Slide 11 11 The most important point Commercial profit Taking benefices Slide 12 12 Evolution of Industrial Property Evolution with the evolution of society and discoveries Still lags behind the evolution of research and development Slide 13 13 What is the economic logic? Secret V / S Patent -secret: advantage if: -Small group of researchers -Limited number of intervening -Possibility of secrecy -cheap disadvantage 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) Slide 14 14 What is the economic logic (2)? Secret V/S Brevet Patent (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 cost examples: Patent active drugs Patents filed by technology companies like Apple, Intel, Sharp, Sony, BMW ... Slide 15 15 What 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 billion 1990: € 7.7 billion 1997: € 12 billion 2009: € 26 billion Investment in the U.S. in R & Din 2009: $ 34.8 billion Slide 16 16 Most important R&D investment is in USA Slide 17 17 Number of new molecules / Innovative drugs Slide 18 18 Cycle de financement d’un médicament Slide 19 19 Return on investment: between yesterday and today Acceleration of diffusion Faster generic entry Flux financiers 10 ans 20 ans Cost increase of R & D Development is increasingly long Approximately 70% of drugs on the market do not provide companies that have marketed the return on investment, it is provided by Slide a limited number of drugs. 20 20 What 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 drug 20-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 Japan Slide 21 21 Slide 22 22 Slide 23 23 Slide 24 24 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 countries The patent reinforces the imbalance between the north and south Importance of the Doha Declaration = easy access to essential drugs in poor countries An 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 therapeuticSlide needs 25 of the population. 25 Lebanon- patent law OJ 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 LL • Annual cost = cost year (n-1) + 50 000 LL -Compulsory license held under certain conditions: • Public health purposes • Reasons vital to the economy Slide 26 26 Conditions of patency – Liban Article 2 de la loi n°240 novelty -It is an invention that has not been previously described -Any oral disclosure (communication at a conference) or written (poster, abstract, article ...) destroys the novelty innovation -A skilled artisan can ( not) achieve in the current knowledge of the state of the art industrial application -Invention can be manufactured by any type of industry Slide 27 27 Are not patentable - Lebanon? Articles 3 and 4 of Act No. 240 Any scientific discovery, theory or mathematical program without industrial application Any 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 Slide 28 28 Slide 29 29 Category Regulatory Data Protection Length • 5 years • 7 yrs for orphan drugs Legal Hatch -Waxman When it’s granted 1. 2. 3. NDA Approval for NME sNDA Pediatric exclusivity Patent Protection • 8 years (+ 2 + 1) NME •10 years (orphan) •12 years (orphanPUMA) •1 year (new indication for well-established) 1. Directive 2001/83 amended by 2004/27 1. 2. MAA approval Significant medical advancement 20 years from filing (Orange Book) Patent and Trademark Office 1. 2. After review by Patent and Trademark Office Pediatric exclusivity 20 years from filing (country specific and not posted) + 5y SPC Country specific SPC: Regulation No 1798/92/EC Pediatric reward: (+ 6 months) NDA – New Drug Application; NME - New Molecular Entity; sNDA – supplemental New Drug Application; SPC – Supplementary protection Slide 30 certificate Autres différences en E-U et Europe United 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 valid Slide 31 31 RDP (years) Paediatric data US 7 + 6 months EU 10 + 2 years Australia 5 Similar to other drugs Japan 10 + 4 years (max 10 years) Canada No Orphan drug status Russia No Orphan drug status Turkey Israel No Orphan drug status Let’s see if I can find more countries… Slide 32 1. NEW molecular entity: “old” product introduced in United States 2. 3. NEW product: combination products NEW formulation: extended release Slide 33 RDP 10 years File never updated to EU standards 1963 Nivalin 1st MA in Austria Treatment of polio 2000 1995 Alzheimer indication approved 2001 Nivalin withdrawal 2005 Generic galantamin MAA submitted to MHRA BE vs. Remnyl MA for Alzheimer via MRP to Cilag Janssen (full application) MHRA rejected the application (RDP not expired) Slide 34 2009 2010 RDP Expiry ECJ: Nivalin can’t be used a Referenc Medicinal Product 1990-1999 2000 2005 2007 Jan 14, 2005 RDP Expired Foreign Approvals Jan 14, 2000 Approved in US October 9, 2007 First Generic Approved Source: 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) Slide 35 1. NEW molecular entity: “old” product introduced in United States 2. NEW product: combination products 3. NEW formulation: extended release Slide 36 December Diovan (valsartan) Approved 1992 July Norvasc (amlodipine) Approved 1996 June Exforge (valsartan/amlodipine) Approved 2003 September Amlodipine generic Approved 2007 October Tentative Approved valsartan generic March Diovan patent Expires 2011-12 June RDP Expires for Exforge Source: 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) Slide 37 Products Exforge® 160/5 Diovan® 160 mg Amlodipine 5 mg Exforge® 320/10 Diovan® 320 mg Amlodipine 10 mg 90 day supply $246.61 Total $246.61 $220.28 $22.99 $338.28 $243.27 $338.28 $311.72 $23.99 $335.71 Source: http://www.drugstore.com/pharmacy/prices/drugprice.asp?ndc=00078049115&trx=1Z5006; accessed June 2, 2009 Slide 38 1. NEW molecular entity: “old” product introduced in United States 2. NEW product: combination products 3. NEW formulation: extended release Slide 39 September IR Approved (low doses) 1997 May XR Approved 2002 September Data Exclusivity Ends (IR) 2007 April Data Exclusivity Ends (XR) December Generic Tentative Approval (IR) Rejected 2008 April FDA Advisory Committee Meeting for MDD and GAD for XR formulation 2009 2012 2017 March Patent Expires (IR) November Patent Expires (XR) IR – Immediate Release, XR – Extended Release, MDD- Major Depressive Disorder; GAD-General Anxiety Disorder Source: 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) Slide 40 A new formulation RDP 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 authorisation All 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 41 Slide 42 42 The brand "The brand is ... a non-negligible value of business assets" Brand = Quality Assurance Brand = Fight against generic Brand = Fight against counterfeiting Brand = Fight against parallel trade Slide 43 43 Anti-brand health authorities Right of substitution by the pharmacist DCI prescription Framework agreements with prescribers Limiting medical prescribers in the TFR Slide 44 44 Criteria for the validity of a trade mark - Absolute Criteria A brand must not contain any prohibited sign and it must be distinctive. Article L711-3 of the ICC forbidden 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) Slide 45 45 Criteria for the validity of a trade mark - Absolute Criteria A brand must not contain any prohibited sign and it must be distinctive. article L711-3 du CPI Distinctive signs A generic term (by ex.une DCI) is not a valid trademark Ordinary terms or necessary in the current language or professional for identity of the product are not valid trademarks mark consists of a name or a sign which may serve to designate a characteristic of the product is not valid signs which consist exclusively of the shape imposed by the nature or function of the product are not considered valid it is possible to make a shape as a trade mark, provided that it does not present a functional and technical character. Slide 46 46 Criteria of validity of a mark – Relative criteria mark 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 deposition Research is conducted at least in principle in Class 5 of the Nice International Classification Right to object to the use by third Slide 47 47 Brand Control In France: Double control INPI: verifies the absolute criteria for the validity of a trademark In 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 Authorization Brand Refusal = Refusal of the Marketing Authorization Slide 48 48 Contrôle de la Marque par l’AFSSAPS Article 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 specialty“ Link between brand control and protection of public health Slide 49 49 Contrôle de la Marque par l’AFSSAPS Recommendation for the choice of a drug name: Preferably one word No hyphen No diminutive or superlative (HIGH, LOW, RETARD, PLUS, MINUS ...) No syllable that resembles a diminutive or superlative Attention to the likelihood of confusion: With another drug With a cosmetic product or foodstuff No trivialization of drug Major points of comparison with another name The position of letters The first letters of distinct preference The confusion associated with handwriting The number of letter in common with respect to all of the letters of the name Slide 50 50 En résumé – Quel type de protection? Slide 51 51