IP RIGHTS MANAGEMENT AND LICENSING: THE EXPERIENCE OF A SWISS GROUP. Lugano, 13 th June 2013 Matteo Missaglia, Lidia Lanza -Helsinn Healthcare SA

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1 IP RIGHTS MANAGEMENT AND LICENSING: THE EXPERIENCE OF A SWISS GROUP Lugano, 13 th June 2013 Matteo Missaglia, Lidia Lanza -Helsinn Healthcare SA

2 TOPICS: IP Rights Definition and Categories Licensing of IP Rights The License Agreement IP Rights and Competition Rules The Helsinn Experience and Business Model Managing a Trademarks Portfolio 2

3 Intellectual Property Creations of the mind which are used in commerce (inventions, designs, names, artistic work, etc.) Intellectual Property Rights Rights of exclusivity / prohibition Intangible by nature 3

4 Intellectual Property Rights Legal Classification (main) Patents Trade secrets (know-how) Trademarks Industrial Design Copyrights Tax/Accounting Intangible Assets / Property (acquired or internally generated) 4

5 Technology Acquired/created through experience / R&D Not available to the public Transferable Reproducible (industrial/commercial exploitation) PATENT (Legal Protection) KNOW-HOW (de facto protection) 5

6 Patent The right to exploit on exclusivebasis an invention in a certain territory for a defined period of time Right to inventorship (personal) Exclusive commercial exploitation through legal protection (generally enforceable against third parties) Novelty Originality Industrial application Product Process Use/Application Formulation 6

7 Know-How Non legal term Knowledge-technology Independent or relevant to patented technology De facto protection / legal protection Monopoly through secrecy (not generally enforceable against third parties) 7

8 PATENT Absolute Right (enforceability) Territorial extension (international treaties) Certain duration (subject to invalidation) KNOW-HOW No information to competitors/third parties No time limit Less expensive than patent protection Promotion of product No concerns on disclosure 8

9 Licensing of IP Rights Concept of Licence Permission Removal of a prohibition Right to the licensee to do what is prohibited (by law or de facto) to any other party Limited right (time, territory, field) Alternative to direct exploitation, transfer and sale etc. (business/legal decision) 9

10 Licensing of IP Rights PROS Flexibility International expansion (SME) Quicker penetration of markets Lower investments needed Knowledge of markets / cultures CONS Lower revenues Share of knowledge with competitors Less control of product / market 10

11 Licensing Agreement The owner of an IP Right (licensor) grants to the licensee the right to use the IP Right and to use and sell the product/service incorporating said IP Right. -Mixed / pure license - Sui generis contract -International contract 11

12 Licensing Agreement Sui generis contract, International contract Rules applicable to sui generis contracts and to international contracts Interpretation Mandatory terms (IP statutes, competition law, national and international regulations on specific matters) Often lengthy, complex negotiation Business purpose / legal purpose Clear, complete, fair 12

13 IP Rights, Licensing and Competition Rules Restraint of Trade Monopoly Price Control Free Competition Public Interest ( Exhaustion of IP Rights Parallel Import 13

14 IP Rights, Licensing and Competition Rules Swiss law LCart 6/10/1995 EU Treaty and BERs Artt (anticompeting undertaking, abuse of dominant position) BER on Technology Transfer Agreements (772/2004) BER on Vertical Agreements and Concerted Practices (330/2010) US Title 15 USC Sherman Act Illegality per se Rule of reason DOJ Antistrust Guidelines on IP Licensing 14

15 Helsinn Experience / Business Model Mixed Licenses Technology Know-how patents Trademarks Integrated Licensing IP Rights Supply Services to partners (regulatory, drug-safety, postmarketing development, marketing support, enforcement of IPR, etc.) IN Licensing OUT Licensing (not for trademarks) 15

16 Helsinn s Business Approach Commercial Licensing out a ready-to-sell product Financial and development risk bearing pre/post launch support Post-marketing surveillance Global branding & marketing strategy Post approval studies regulatory affairs FDA and Centralized EMA Registrations directly managed In House Chemical and Drug Product Development, Manufacturing, logistic and supply product development & CMC pre & clinical development Worldwide Development directly managed Acquiring product rights for development Licensing in Compound originator

17 Helsinn s Main Partners Worldwide & Market Presence Selected partners

18 MANAGING OF TRADEMARKS PORTFOLIO 18

19 MAIN ACTIVITIES Creation of the marks Creation of trademark rights International extension of trademark rights Broadening the protection: domain names Licensing out Monitoring: survey services 19

20 Creation of the marks /I Peculiarity of pharmaceutical trademarks: approval by Health Authorities (usually FDA and EMA at a first stage) is compulsory Timelines provided by Health Authorities Preferred option: global trademark Double set of criteria to assess likelihood of confusion with earlier marks Time constraints necessity to have several options available at the same time 20

21 Creation of the marks /II Best option: hiring a to: brand naming agency - develop a naming strategy - make the necessary trademark screenings - make a linguistic screening - carry out the regulatory evaluation and prepare the dossiers for the Health Authorities - create the brand image 21

22 Creation of trademark rights /I filing of the first trademark application selecting Countries of commercial and strategic value 6-month period to file a subsequent application in another country for the same trademark effective as of the date of filing the first application (right of priority - Art. 4 Paris Convention As of 2013, 174 contracting member countries) A good network of trusted trademark agents in foreign Countries is of paramount importance 22

23 Creation of trademark rights /II One Trademark, Many Possibilities 23

24 International extension of trademark rights Pros and cons of Swiss location Access to International Registration (Swiss is party to Madrid Agreement and Protocol): possibility to designate up to 90 Countries Access to CTM: possibility to cover 27 Countries with one registration The Swiss Trademark Office is notoriously very persnickety in examining absolute grounds of refusal (lack of distinctive character, geographical origin, inclusion of badges, emblems or escutcheons of particular public interest) 5-year dependance between the IR and the Basic Mark from the date of the IR Swiss Trademark Office extremely fast in granting the registration and expedite procedure available (4 to 6 months) 24

25 Broadening the protection: domain names /I roughly 20 gtlds now (.com,.org,.net,.asia, etc.) around 250 national TLDs (.ch,.it,.eu, etc.) new gtlds program sponsored by ICANN applications received: 1930 passing applications as of May 31, 2013: 514 (.fiat,.hermes,.swiss,.pizza,.lawyer,.vodka) 25

26 Broadening the protection: domain names /II Basic principle for domain names registration: first come first served register domain names as soon as mark is identified necessary to involve legal and marketing for : - identifying names to be protected - defining extent of protection (top / country level, etc.) - proactive activities: cover dangerous areas, register common mispellings 26

27 Licensing out /I Helsinn s approach to protect its trademarks when licensing out is to include a standard full set of provisions in the Distributionand Licence Agreements withpartners. Theseclauses rule: -the choice of the product trademark -the authoriseduses of said mark -the use of Helsinn s corporate marks -the licensee s extent of cooperation in case of infringement or unfair competition acts alwaysinrespect ofanti-trustand competitionlaws. 27

28 Licensing out /II Helsinn also licenses and protects its domain names by means of: a set of provisions in the same agreements to rule authorisedregistration of domain names corresponding to the licensed product(s), compound(s) and trademark(s) by partners separate Domain Name License Agreements to partners where country level domains must be registered by a local entity 28

29 Monitoring: survey services A wide variety of services offered by dedicated companies to patrol: -applications for similar trademarks -registration of similar domain names -use of the trademarks on the web 29

30 Thank you 30

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