Preventative TRIPS Flexibilities and Good Practices for
Public Health
Tahir Amin
Initiative for Medicines, Access, & Knowl...
Outline
2
Setting up a legal framework with
preventative flexibilities
Setting up administrative systems in patent
offic...
Preventative Flexibilities
3
Exclusion from patentability and applying
strict patentability criteria
Pre-grant patent op...
 Exclusion of subject matter as inventions e.g.
diagnostic, therapeutic and surgical methods, see
TRIPS Art 27.2 and 3).
...
New forms and uses of known substances;
Broad markush claims;
Commonly repeated pharmaceutical industry
techniques to o...
Why exclude certain subject matter as
inventions and apply strict patentability criteria?
How can Salt and Polymorph Paten...
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 Mech...
Intervention
At the European Patent Office level:
• 60% of drug patents studied that were subject to post-grant
opposition...
Administrative systems to help implement strict
patentability standards and pre-grant
oppositions in practice
Transparent...
Test Data Protection
TRIPS Article 39.3 only requires protection
for clinical trial data but not exclusivity.
Implementi...
Why Use Preventative Flexibilities?
 They are legal rights permitted under TRIPS;
Helps to weed out bad patenting practi...
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Preventative TRIPS Flexibilities and Good Practices for Public Health

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
Published on: Mar 4, 2016
Published in: Education      
Source: www.slideshare.net


Transcripts - Preventative TRIPS Flexibilities and Good Practices for Public Health

  • 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.