1. bangkok | hanoi | ho chi minh city | jakarta | vientiane | yangon ASEAN Economic Community (AEC) A New Market for IP Monetization Alan Adcock October 14, 2014 Regulatory Impingement of IP Rights

2. Regulatory impingement of IP rights Acts by non-IP regulatory agencies which limit or preclude full exploitation or enjoyment of legitimately granted IP rights

3. 3 Cosmetics There are a number of examples of trademarks, words or slogans which the Thai Food and Drug Administration (FDA) will not allow to be used in connection with cosmetic products unless prior approval is obtained. For example, words such as BIO, NANO or 24K GOLD, would not be permitted, even if these are registered trademarks, unless it can be proven that there are such acceptable ingredients in the cosmetic product’s formula. Industry Example of Regulatory impingement

4. 4 Food products Health claims such as words or slogans relating to benefits, efficacies or functions of a food product are forbidden in Thailand. Product names which include the words “slim,” “lean,” “white,” and “boost,” among others, are not acceptable, even if these are the business’ registered trademarks. Industry Example of Regulatory impingement

5. 5 Medical Devices There are many trademarks, words and slogans which are specifically prohibited from being used on medical devices in Thailand. These include words such as “excellent,” “special,” “the best,” “completely cured,” “holy,” “marvelous,” “safe,” “number one,” “no adverse effects,” “superior,” “most appropriate,” and many others. Condoms, for example, cannot use terms like “super,” “wonderful,” “quality,” etc. Such terms might be acceptable as part of their registered trademarks, but they will not be allowed to be used on packaging or marketing materials. Industry Example of Regulatory impingement

6. 6 Pediatric Nutrition The FDA holds meetings to approve any product names. Here again, a business’ registered trademark, granted by the DIP and likely used in many countries, would not assist in overcoming a rejection from the FDA. Industry Example of Regulatory impingement

7. Tobacco Products Tobacco products are not allowed to be advertised or marketed in Thailand MOPH’s current draft Tobacco Consumption Control Act may further prevent tobacco companies, retailers, distributors and others from additional activities essential to any business such as: (i) providing price discounts as a part of advertising and promotion, (ii) displaying prices for products, (iii) extending their trademarks on to other goods and services, and (iv) deciding themselves on how to design their product packaging - a Committee which may not include tobacco representatives will decide on packaging – “Plain Packaging” Industry Example of Regulatory impingement 7

8. Plain Packaging An introduction 1990s “a reasonable step in the overall strategy to reduce tobacco consumption” Plain packaging vs Standardized packaging 8

9. 9 Plain Packaging Australia  The Australian story  Impact of standardized packaging in the tobacco industry  The international reaction to Australia  Where the future might lead

10.  Tobacco Plain Packaging Act 2011 gains Royal Assent  Claims filed in High Court of Australia Draft legislation for consultation released Intention to bring standardize d packaging legislation announced Senator Fielding’s Plain Tobacco Packaging Bill Australia The legislation and how it came to pass 2009 April 2010 April 2011 Dec 2011 10

11. Anti- competitive (ossify the market) Depress PricesIncrease in youth smoking Lead to a significant increase in counterfeits Impact of legislation How Standardized Packaging will affect trade 11

12. Claims  Ukraine  Honduras  Dominican Republic  Cuba  Indonesia Commenced claim under the Australia / Hong Kong Bilateral Investment Treaty International reaction Ongoing legal challenges to Australia 12

13. In favour of PP Countries’ Positions Discussions in WTO Committees Neutral Position Chile Columbia Cuba Dominican Republic El Salvador Honduras Indonesia Jordan Mexico Nicaragua Nigeria Philippines Ukraine Zambia Zimbabwe Russia China EU Hong Kong Japan Switzerland Turkey Australia Brazil Canada New Zealand Norway Uruguay + WHO Plain Packaging In favor of Plain Packaging 13

14. International reaction The TRIPS arguments Article 20 imposes an obligation to refrain from imposing special requirements which: (i) encumber the use of trademarks in the course of trade; and (ii) do so unjustifiably 14

15.  Relevance of the WTO  Different legal barriers in different countries  Broad base of opposition The future “Domino” Effect? 15

16. The future “Domino” Effect?  Broad base of opposition 16

17. The future 17

18. The future 18

19. The future 19

20. Plain Packaging Update 2014  Ireland has become the first in EU to introduce plain packaging regulations for cigarettes by approving its Public Health (Standardized Packaging of Tobacco) Bill 2014  Following the UK, the French Health Minister announced last month that a draft bill will be introduced in six months  South Africa set to introduce plain packaging by 2015 20

21. Fast Food  Consumers International and the World Obesity Federation call for the adoption of more stringent rules  Recommendations for a Global Convention to protect and promote healthy diets includes increased taxation, advertising controls, labeling/packaging, health warnings/graphical warnings etc 21

22. Infant Nutritional Supplements  In South Africa, 2-6 of Regulations R991 will come into effect from 6 December 2014 which will prohibit displaying pictures of infants, distribution of educational material and marketing material  Intent is to prevent aggressive advertising and reliance on infant milk supplements 22

23. Sugary drinks  UK to consider special tax on sugary drinks due to adverse effects on health  California legislature rejects Bill to have health warning labels on sugary drinks 23 Sugary drinks to be treated as unhealthy Debate ongoing for plain packaging

24. Disclosure of drug trial data  European Medicines Agency (EMA) has adopted a new policy on disclosing clinical trial data and is set to go into effect on 1 st Jan 2015  Ambiguity in the terms of the policy has led to an ongoing debate that the policy will impinge on commercially valuable trade secrets  AbbVie last year went to court to block the EMA from releasing data for specific drugs but reached a compromise to consider part of the disclosure material viable for public access 24