The presentation is prepared by Tahir Amin of Initiative for Medicines, Access, & Knowledge. It is about preventative TRIPS flexibilities and good practices for public health relating to access to affordable HIV drugs. The content includes: - Setting up a legal framework with preventative flexibilities; - Setting up administrative systems in patent offices to implement preventative flexibilities in practice; - Test data protection. Tahir Amin

1. Preventative TRIPS Flexibilities and Good Practices for
Public Health
Tahir Amin
Initiative for Medicines, Access, & Knowledge
1 June 2015

2. Outline
2
Setting up a legal framework with
preventative flexibilities
Setting up administrative systems in patent
offices to implement preventative flexibilities
in practice
Test data protection

3. Preventative Flexibilities
3
Exclusion from patentability and applying
strict patentability criteria
Pre-grant patent oppositions
Test data protection

4.  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

5. 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

6. Why exclude certain subject matter as
inventions and apply strict patentability criteria?
How can Salt and Polymorph Patents Provide Additional
Patent Protection?
Compound Claimed
1990
Original API
Product Lunch
2001
Polymorphs/Salts
Claimed
1998
Patent expired
2010
Extension
2015
Generic Entry
Generic Entry
for All Other
Forms not
Covered
Salts and Polymorphs
PTR
PTR: Patent Term Restoration = half of the investigational period + all of the FDA review period
Ref: Lucas J and Burgess P., PharmVOICE, Feb., 2004

7. Why exclude certain subject matter as
inventions and apply strict patentability criteria?

8. Observations and Re-examinations (ex
parte)
Pre-grant patent oppositions (inter
partes)
Pre-Grant Patent Opposition Mechanisms

9. Intervention
At 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?

10. 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.

11. 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.

12. 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.