Preventative TRIPS Flexibilities and Good Practices for Public Health

Tahir AminInitiative for Medicines, Access, & Knowledge

1 June 2015

Outline

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Setting up a legal framework with preventative flexibilities

Setting up administrative systems in patent offices to implement preventative flexibilities in practice

Test data protection

Preventative Flexibilities

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Exclusion from patentability and applying strict patentability criteria

Pre-grant patent oppositions

Test data protection

Exclusion of subject matter as inventions e.g. diagnostic, therapeutic and surgical methods, see TRIPS Art 27.2 and 3).

Strict patentablity criteria – countries can define what subject matter is novel, inventive (non-obvious) and has industrial application (useful), see TRIPS Articles 1 and 27.1).

Exclusion of certain subject matter as inventions and applying strict patentability criteria

New forms and uses of known substances;

Broad markush claims;

Commonly repeated pharmaceutical industry techniques to obtain new patents e.g. salt selection, prodrugs, enantiomers, polymorphs, formulations and combinations

Applying strict patentability criteria

Why exclude certain subject matter as inventions and apply strict patentability

criteria?

Why exclude certain subject matter as inventions and apply strict patentability

criteria?

Observations and Re-examinations (ex parte)

Pre-grant patent oppositions (inter partes)

Pre-Grant Patent Opposition Mechanisms

InterventionAt the European Patent Office level:

• 60% of drug patents studied that were subject to post-grant oppositions were revoked.

• In another 15%, post-grant oppositions led to reductions in the scope of patent claims.

• Of the drug patents studied and which were litigated in court, 55% were annulled.

European Commission Competition DG, Pharmaceutical Sector Inquiry, Final Report, 8 July 2009, page 249-250.

Why have a Pre-Grant Patent Opposition Mechanism?

Administrative systems to help implement strict patentability standards and pre-grant

oppositions in practice

Transparent and easy access to patent information, patent documents (including claim amendments) and examination reports.

Countries should develop their own patent examination guidelines and practices rather than rely on the standards of the USPTO, EPO and WIPO.

Implement practice guidelines to curb the abuse of divisional patenting practices by pharmaceutical companies.

Test Data Protection

TRIPS Article 39.3 only requires protection for clinical trial data but not exclusivity.

Implementing a data exclusivity system undermines other preventative flexibilities to make medicines unaffordable and delays competition.

Why Use Preventative Flexibilities?

They are legal rights permitted under TRIPS;

Helps to weed out bad patenting practices/strategies by pharmaceutical companies;

Keeps the market open for competition and can provide the freedom to help grow local industry capability;

Removes illegitimate barriers that cause the prices of medicines to be unaffordable and impact health budgets.