Patents and Trademarks Laws

1. Patents and Trademarks Laws CRA-UD 2013-2014

2. Intellectual property

3. Framework

4. Patents • Monopoly granted to the inventormonopoly 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

5. 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.

6. Discoveries in: Pharmaceutical Industries

7. Development of the chemical industry

8. Development of biotechnology

9. Example of HIV

10. 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 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.

11. Development of the computer industry

12. The most important point • Commercial profit • Taking benefices

13. Evolution of Industrial Property • Evolution with the evolution of society and discoveries • Still lags behind the evolution of research and development

14. 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)

15. 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 drugsPatents filed by technology companies like Apple, Intel, Sharp, Sony, BMW ...

16. Whatis the economiclogic (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

17. Most important R&D investment is in USA

18. Number of new molecules / Innovative drugs

19. Cycle de financement d’un médicament

20. Return on investment: between yesterday and today Acceleration of diffusion Fastergeneric entry 10 ans 20 ans Flux financiers 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 a limited number of drugs.

21. Whatis the economiclogic? 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

25. Whatis the economiclogic? 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. • 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

26. 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

27. Conditions of patency – LibanArticle 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

28. 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

29. Protection des données

30. RDP is NOT the same as patent protection NDA – New Drug Application; NME - New Molecular Entity; sNDA – supplemental New Drug Application; SPC – Supplementary protection certificate

31. 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

32. International RDP Period for Orphan Drugs

33. Case Studies NEW molecular entity: “old” product introduced in United States NEW product: combination products NEW formulation: extended release

34. 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). RDP 10 years File never updated to EU standards 1963 2000 2001 2010 1995 2005 2009 Nivalin withdrawal Generic galantamin MAA submitted to MHRA BE vs. Remnyl Nivalin 1st MA in Austria Treatment of polio RDP Expiry Alzheimer indication approved ECJ: Nivalin can’t be used a Referenc Medicinal Product MA for Alzheimer via MRP to Cilag Janssen (full application) MHRA rejected the application (RDP not expired)

35. Using RDP for a “NEW” 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)

36. Case Studies will evaluate topic question NEW molecular entity: “old” product introduced in United States NEW product: combination products NEW formulation: extended release

37. June Exforge (valsartan/amlodipine) Approved June RDP Expires for Exforge Utilizing RDP through combination products December Diovan (valsartan) Approved March Diovan patent Expires 1992 1996 2003 2007 2011-12 October Tentative Approved valsartan generic July Norvasc (amlodipine) Approved September Amlodipine 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)

38. Sum is greater than the individual parts (2 + 2 = 5) Source: http://www.drugstore.com/pharmacy/prices/drugprice.asp?ndc=00078049115&trx=1Z5006; accessed June 2, 2009

39. Case Studies will evaluate topic question NEW molecular entity: “old” product introduced in United States NEW product: combination products NEW formulation: extended release

40. A new formulation RDP April Data Exclusivity Ends (XR) December Generic Tentative Approval (IR) Rejected September IR Approved (low doses) May XR Approved 1997 2002 2007 2008 2009 2012 2017 March Patent Expires (IR) April FDA Advisory Committee Meeting for MDD and GAD for XR formulation September Data Exclusivity Ends (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)

41. 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.

42. Trademarklaw

43. 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

44. Anti-brand health authorities Right of substitution by the pharmacist DCI prescription Framework agreements with prescribers Limiting medical prescribers in theTFR

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 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)

46. 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.

47. 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

48. Brand Control In France: Double controlINPI: • 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

49. 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

50. 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