1. The 2015 IGBA Report Key Recommendations · 1. The 2015 IGBA Report –Key Recommendations a) ... Intellectual Property Rights d) Competition e) ... of the KORUS FTA;

1

12th EGA Legal Affairs ConferenceBrussels, 9 March 2016

Summary

1. The 2015 IGBA Report – Key Recommendationsa) General Recommendations

b) Regulatory Convergence

c) Intellectual Property Rights

d) Competition

e) Incentives to Generic and Biosimilar Medicines

2. The Impact of PTAs on Domestic Legislationa) Patent Linkage

b) Data Exclusivity

c) Extension of Duration of the Rights conferred by Patents

d) Appropriate Frameworks on Incentives to Generic and BiosimilarMedicines

3. Conclusions2

2

Part 1

The 2015 IGBA Report – Key Recommendations

3


The 2015 IGBA Report - Fostering International Trade in Generic and Biosimilar Medicines

Preferential Trade Agreements (PTAs) play an increasingly important role vis-à-vis the generics and biosimilars sectors and must be shaped, negotiated and implemented with the industry taking a proactive stand;

Proactive and systematic engagement would bring substantial improvements to the regulatory environments affecting generic and biosimilar medicines, stimulating trade, competition and increasing patent access to develop high quality generic and biosimilar medicines.

4

3


General Recommendations

PTAs must:

Contain a dedicated Pharmaceutical-specific Chapter or Annex and provisions enhancing the development of, and access to, high-quality generic medicines;

Contain transparency requirements enabling stakeholders to be promptly informed about new regulations, and to present their views to the regulators/legislators;

Refer to a system of international standardisation and contain an obligation for parties to conform to such standards;

Contain provisions establishing the basic framework of regulatory cooperation and regulatory exchange among authorities; and

Provide for an institutional framework through dedicated working groups or committees.

5


Regulatory Convergence

PTAs must:

Establish appropriate frameworks to promote regulatory cooperation and the mutual recognition of compliance inspections;

Achieve convergence of requirements with respect to the authorisations;

Establish mechanisms that institutionalise regulatory exchanges;

Provide mechanisms to avoid unnecessary and duplicative inspections.

6

4


Intellectual Property Rights

PTAs generally cover the following key issues on IPRs:

Patents;

‘Best mode’ requirement;

Patent linkage;

Regulatory review (“Bolar”) clause;

Data exclusivity;

Extension of the duration of the rights conferred to patents;

Enforcement of IPRs.

7


Intellectual Property Rights

PTAs must provide a balanced approach with respect to the regulation of IPRs, based on the standards established by the TRIPs Agreement;

When the level of IP protection is already high, negotiations must not seek to harmonise IPR frameworks, but recognise the different domestic approaches.

8

5


Competition

PTAs must establish:

Binding provisions to prevent misuse and abuse of IPRs and anti-competitive practices;

Binding provisions on competitive safeguards to protect against IPR misuse and abuse;

Provisions calling for considering a determination of anti-competitive behaviour issued by relevant judicial and administrative authorities as grounds for patent revocability.

9


Incentives to Generic and Biosimilar Medicines

PTAs must establish a legal framework to incentivise access of generic and biosimilar medicines in the domestic markets;

Such incentives may be granted to encourage challenges of weak or invalid patents, stimulating competition and innovation, as well as to increase savings for national health care systems and facilitate access to affordable medicines.

10

6

11

Part 2

The Impact of Preferential Trade Agreements on Domestic Legislation

The Impact of PTAs on Domestic Legislation

The Impact of Preferential Trade Agreements on Domestic Legislation

Preferential Trade Agreements can have an important impact on domestic legislation, this is evidenced in previous negotiations;

The EU reiterated this fact in the Annual Report on the Implementation of the EU-Korea Free Trade Agreement, stressing ‘the need for aligning Korean legislation with the FTA’;

New domestic provisions will not only apply to the PTA Parties, but also to all WTO Members, pursuant to the non-discrimination principles of the TRIPs Agreement.

12

7


Patent Linkage

Examples:

South Korea introduced patent linkage in order to comply with the requirements contained in Article 18.9(5) of the KORUS FTA;

Singapore had to change its domestic legislation and amended the ‘Medicines Act’ Section 12A in 2004 to comply with Article 16.8.4 (b) and (c) of the US-Singapore Free Trade Agreement;

The EU-Canada Free Trade Agreement (CETA) looks poised to compel Canada to implement a new right of appeal under the patent linkage system that will likely lead to further delays for the entry of generics. At the same time, however, this will allow Canada to end the practice of dual litigation.

13


Data Exclusivity

Examples:

In July 2004, Singapore introduced Section 19D into its ‘Medicines Act’ in order to fulfil its obligations under Article 16.8.1 of the US-Singapore FTA;

The Trans-Pacific Partnership Agreement (TPPA) provides for a range of 5-8 years of data exclusivity that Parties to the agreement need to implement following the ratification of the agreement.

14

8


Data Exclusivity

Examples:

Due to the EU-Korea FTA, Korea had to amend its domestic legislation regarding the time limits of data exclusivity;

The EU-Canada Free Trade Agreement (CETA) will lock-in Canada’s current term of data protection and create barriers for future Governments wanting to reverse it.

15


Extension of Duration of the Rights conferred by Patents

Examples:

Due to the EU-Korea FTA, Korea had to amend its domestic legislation (the ‘Patent Act’) regarding the time limits of the extension of duration of the rights conferred by patents.

As a consequence of the EU-Viet Nam FTA, Viet Nam will have to amend its domestic legislation to allow for a patent extension of up to 2 years if delays in marketing authorization occur.

The CETA provides that Canada must implement a new system of patent term extension that will, in practice, delay the entry of generics. At the same time, however, the CETA allows Parties to grant an export exception during this period of patent protection.

16

9


Appropriate Frameworks on Incentives to Generic and Biosimilar Medicines

Examples:

Korea amended its patent laws in order to implement the requirements of the KORUS FTA. The new system contemplates that there may be a period of generic exclusivity;

The EU-Korea FTA and the KORUS FTA provide for a framework of incentives that may also be used by generic and biosimilarmanufacturers;

The US-Colombia FTA, US-Panama FTA and US-Peru FTA introduce the possibility of providing for rewards, or incentives, to those that successfully challenge patents. However, incentives are linked to patent linkage.

17

18

Part 3

Conclusions

10

Monitor – Analyse – Engage – Shape!

Be proactive and systematically involved!

Use templates, non-papers, negotiating techniques!

‘Educate’ and assist the negotiators!

Act on multiple levels and fora!

If you do not engage in the negotiations, your competitors will and you will not be able to shape the

negotiations and the agreements as well as the subsequent changes in domestic legislation!

Conclusions

19

Documents

1. The 2015 IGBA Report Key Recommendations · 1. The 2015 IGBA Report –Key Recommendations a) ... Intellectual Property Rights d) Competition e) ... of the KORUS FTA;