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Mr. Son DoanIP Expert

IP Protection Strategies for EU SMEs

from the Pharmaceutics Sector in

Vietnam

South-East Asia IPR SME Helpdesk

17 June 2016

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Marianne KaruProject Executive


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Speaker’s bio

Name: Mr. Son DoanFirm: IPMAX Law FirmLocation: Hanoi, VietnamEmail: [email protected]

Son Doan is the managing partner of IPMAX Law Firm with more than 20 years ofexperience practising Intellectual Property Law in Vietnam. Son has extensiveexperience from securing protection to enforcement of intellectual property rights inVietnam including patents, trade marks, industrial designs and copyrights. He has alsoassisted multinational corporations in devising enforcement strategies and organizingnationwide enforcement programs. He has been ranked as one of the leadingindividuals in WTR 1000 (2016), Chambers Asia Pacific (2016) and Legal 500 (2016).

Son has provided comments to various draft laws including the Intellectual PropertyLaw, the Law on Competition and subsequent guiding regulations.


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mailto:[email protected]

Content Overview

717 June 2016

Copyright © 2016 South-East Asia IPR SME Helpdesk. All rights reserved.

• Introduction

• Current landscape of IP in Vietnam

• IPR challenges for SMEs from the Pharma sector

• Watch Outs and Tips

• Conclusion

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Current landscape of intellectual property in Vietnam

• Paris Convention 1883 for the Protection of Industrial Property;

• Berne Convention for the Protection of Literary and Artistic Works;

• Madrid Agreement 1981 and Madrid Agreement 1989 Concerning the International Registration of Marks;

• Patent Cooperation Treaty 1970;

• Agreement on Trade - related aspects of IPR – TRIPS;

• Vietnam signed Trans-Pacific Partnership Agreement on 04 February 2016 and will be effective in 2018.

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International Treaties

National legislations

• Civil Code, last amended in 2015, containing general and basic provisions on intellectual property.

• IP Law - effective since July 2006 (amended in June 2009)

- cover all subject-matters of IP protection required by TRIPS

- consolidate all existing IP laws (in the past, IP was governed by various legal documents, i.e. Decrees, Circulars, Regulations)

• New Penal Code, amended in 2015, shall become effective on 1 July 2016

- Criminal liability to legal entities;

- More specific guidance for determination of the crime of infringing IP rights

• Pharmacy Law: effective since 01 October 2005: Governs the management of drugs and biological in Vietnam including guidelines on manufacture, registration, circulation and use, clinical trials, promotion, advertising and authorisation.

New Law on Pharmacy will be effective on 01 January 2017

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Practical enforcement

• Administrative procedure is the common route

Competent authorities: Police, Market Surveillance Agency, Inspectorate from National to provincial levels

• Criminal procedure:

By Police, or passed on by other authorities to Police for investigation. Independent process

Manufacture or traders of counterfeit drugs are usually handled criminally

• Civil Procedure: Time consuming and uncertain outcome

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Visible signs: Words, letters, logos, including 3D, in one or more colours

Serves to differentiate the goods or services of an enterprise from those of others

Trademark protection begins when the trademark is registered and lasts for ten years from the date of filing the application.

Can be renewed indefinitely for consecutive terms of ten years each.

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Trademarks

A medicinal brand can be registered as a trademark.

The Ministry of Health encourages a drug registration applicant to register IPRs.

The Ministry of Health can refuse to grant a drug registration if there are sufficient grounds that the drug may infringe another party’s protected IPRs.

Article 13.4 Circular No. 44/2014/TT-BYT issued by the Ministry of Health on 25 November 2014 on registration of drug.

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Pharmaceutical Trademarks

Difficult to act against ‘bad faith’ applications

File as soon as possible

Registration can be made through Madrid Protocol (members of Madrid Protocol include Vietnam, China, Japan, Korea, India, Philippines, Singapore etc.)

Parallel import is not illegal

Territorial limitation must be specified in distribution/ license agreement

Registration in a neighboring countries may be helpful

Customs recordal for monitoring of export/import goods

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Trademarks

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Trade name is a name under which an organisation or individual carries on business. IP rights in trade name are established through “lawful use of the name”.

Company name in a business registration may be more problematic. Company names can be searched at: http://hieudinh.dangkykinhdoanh.gov.vn/CheckExistName/tabid/63/scope/FL/language/en-US/Default.aspx (may not be properly updated).

Domain names – used to identify an internet address.

Even if you already have a .com registration, it is important to register .vn domain names to avoid cyber-squatting. “First come, first served” rule

.vn domain names can be searched at http://www.vnnic.vn/en/domain?lang=en


Trademarks - Vietnam

http://hieudinh.dangkykinhdoanh.gov.vn/CheckExistName/tabid/63/scope/FL/language/en-US/Default.aspx

http://www.vnnic.vn/en/domain?lang=en

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Appearance of a product expressed in dimensional configurations, lines, colours or a combination of them.

- Absolutely new- Creative- Mass production

Drawings and Photos are not enough. What you claim for protection must be specified in the description

Some designs may also be also registered as copyright

Term of protection: 5 years, renewable twice

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Industrial design - Vietnam

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Original works of authorship fixed in any tangible medium of expression, including: Literary works (books, journal articles,) computer programs, songs, cinematographic works, photos, paintings, drawings, sculptures, works of applied arts, architecture, maps, technical drawings….

Term of protection: Life of author plus 50 years.

Moral rights are protected for an indefinite term

Established upon the creation of the work. Registration can be made with the CopyrightOffice. It is not required but will be helpful in enforcement/ litigation.

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Copyright - Vietnam

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• SUNGAZ was applied in Nov 2000, granted design patent in Oct 2003;

• MISA BEAR obtained copyright registration in July 2002;

In this particular case, Design Patent should prevail copyright registration

However, BENGAY of Pfizer was granted design patent in 1994 (renewed in 1999)

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Copyright vs Industrial design

A solution to a specific problem

(may be a product or a process) that is:

(i) novel (worldwide)(ii) involve an “inventive step” (non-obvious) (not for utility model)

(iii) is industrially applicable

Disease prevention, diagnostic and treatment methods for human or animals shall not be protected as inventions in Vietnam.

• Term of protection:

- For invention patent: Protection begins from the issue of the patent and continues for 20 years from the date of filing.

- For utility solution patent: Protection begins from the issue of the patent and continues for ten years from the date of filing.

• Annual patent maintenance fee

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Patents

• For a drug containing active ingredients which are within the term of IP protection, the applicant may submit documents of protection to support the drug registration dossier.

• 2 years before expiry date of the patent for a drug, a third party may apply for registration for the generic drug with document proving that the patent for the drug is going to expire soon (within 2 years).

Article 14 Circular No. 44/2014/TT-BYT issued by the Ministry of Health on 25 November 2014 on registration of drug.

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Pharmaceutical patents

• Being trade secret obtained by investment of considerable effort, where the applicant expressly request such data to be kept secret.

• DAV’s obligation to keep secret the data until expiration of the drug registration (5 years)

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Protection of undisclosed test data

Poll I

What IPR have you registered for your pharmaceutical product?

a) Patent

b) Industrial design

c) Trademark

d) Others

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Challenges for SMEs from the Pharma sector

1) Counterfeit products - from China and made locally, in many ways Police took strong criminal actions. Trace to source is not always possible because the traders/manufacturers are extremely cautious

2) Imitations/unfair-competition: Imitating the packaging of a widely used drug for the purpose of trading on the goodwill of the product Difficult to handle

3) Patent infringement is too complicated for authority (even court) to handle


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4) Trademark piracy: Registration of trademark and then take enforcement action against legitimate products

5) DAV not active in IP protection

6) Unauthorised registration for circulation (marketing approval) - Fake documents

7) Leakage of data/registration information

8) Similar marks may pass through to registration (same suffix or prefix)

9) Delay of examination at NOIP for patent and trademark applications


Challenges for SMEs from the Pharma sector

Authentic product Infringing product

N.V.ORGANON (FR) TW25 Pharmaceutical Enterprise (VN)

Conclusion of competent authority: Infringement

TW25 is a state owned enterprise. “UPHA – BIO” label being used for the same products is confusingly similar to ANTIBIO label which has been protected as a trademark under Reg. 21670 dated 25 Oct 1995. Therefore, it constituted an act of infringement of trademark.

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Infringing packaging

Authentic product Infringing product

IPSEN (FR) Ha Tay Pharmaceutical JSC (VN)

Conclusion of competent authority: Unfair competition

-The product “gastrodic” bears numbers of commercial indications which are identical and similar to those of “gastropulgite” product and confuse the consumers of the origin, quality and characteristic of the products when identifying and choosing products.

-Particularly, the consumers will well think that the “gastrodic” product is manufactured or licensed by the manufacturer of “gastropulgite” product and their quality and characteristics are the same.

Administrative sanctions were applied and infringing packaging were destroyed

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Infringing packaging

Which issue are you most worried/ concerned about in protecting your IPR?

a) Inadequate laws

b) Legal cost

c) Enforcement by the authority

d) Other

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Poll II

The trademark owner of VASTAREL - BIOFARMA - opposed the application forVOSFAREL of DOMESCO Medical Import Export JSC (VN). The Trademark Office foundthe marks are similar.

The Applicant changed the opposed trademark VOSRAREL to VOSRAREL–DOMESCOwhich was accepted by the NOIP. The Oppose, however, did not accept this change.After many long-time discussions, the NOIP issued the decision to reject theopposition. The Opponent appealed against the NOIP’s decision to the MOST.

The MOST upheld the appeal of the Opponent, finding that the changed trademarkVOSRAREL–DOMESCO was confusingly similar to VASTAREL . Addition of another wordinto a similar mark does not make it different to the opposing mark.

VOSFAREL, VOSFAREL–DOMESCO

VSVASTAREL

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Patent infringements

• The unauthorised use of a patent during its term of validity will constitute infringement of the patent.

• Infringement occurs when product or part (component) of a product that is identical or similar to a product or part (component) of a product being protected as an invention.

Article 8 Decree 105/2006/ND-CP dated 22 September 2006 on implementing and guiding a number of articles of IP Law.

• The handling of patent infringement is much more difficult than trademark infringement.

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Watch outs and tips

• Registering your trademarks and IPRs asap

• Registration of the packaging as industrial design or trademark, if possible

• Monitor gazettes and market

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Watch outs and Tips

• Due Diligence should be done

• Review and control carefully the information and documents to be provided to distributors as they may use them for drug registration. These can be used to apply for drug registration/marketing approval without your authorisation;

• IP terms should be set out clearly in contract as there are many issues unclear or not addressed in the laws.

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Conclusions


• Be cautious/ know well before you go;

• Due Diligence;

• Be extremely careful in disclosing information. Keep important information as strictly confidential as possible;

• Contract terms

CONCLUSIONS

Name: Mr. Son Doan

Firm: IPMAX Law Firm

Location: Hanoi, Vietnam

Email: [email protected]

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WHERE Hanoi & Ho Chi Minh City

WHAT Connects EU companies in healthcare, medical devices & pharmaceutical withpotential Vietnamese partners

HOW Tailored B2B meetings with potential partners Visit to Pharmedi 2016 hosted by the Ministry of HealthAccommodation, domestic flight and local transportationsInformation sessions with local experts Interpreters for B2B & visitsNetworking events

WHY Roughly half of EU pharmaceuticals exports will be duty free at entry intoforce of the EV FTA and the rest after seven years. Vietnam will allow foreignpharmaceutical companies to establish foreign-invested enterprises.

WEBSITE

www.evbn.org

“KNOW BEFORE YOU GO.

WE ARE HERE TO HELP YOU GROW...”

The South-East Asia IPR SME Helpdesk provides free, confidential, business-focused advice to European Small and Medium Enterprises (SMEs) relating to IPR in South-East-Asia.

To learn about any aspect of intellectual property rights in Vietnam or elsewhere in South East Asia, including Local partners Due diligence IP audits Or to simply learn about the local landscape and adapt your IP plan accordingly –

something which can save you EUR in the long term

Contact us on [email protected]

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