The slideshow is about remedial TRIPS flexibilities and good practices for public health relating to access to and price of HIV drugs. It is prepared by Tahir Amin who works for the Initiative for Medicine Access and Knowledge. It includes: - Post-grant opposition, revocation, invalidation - Compulsory licensing - Government use authorisation - Exceptions to patent rights

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

2. Remedial TRIP Flexibilities
2
Post-grant opposition/revocation/invalidation
Compulsory licensing
Government use authorisation
Exceptions to patent rights

3. Post-grant opposition/revocation/invalidation
3
Administrative
 Post-grant opposition:
- Time period within which to oppose (E.g. EPO - 9 months from
date of publication of grant)
- Legal standing (E.g. EPO - any person)
- Costs should not be prohibitive
Judicial
 Revocation/invalidation
- Legal standing
- Costs of litigation are too prohibitive

4. Post-Grant Opposition/Revocation/Invalidation
4
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.

5. Compulsory Licensing
Designed to prevent dominant position/anti-
competitive behaviour by allowing one or more
parties to use a patented invention without the
authorisation of the patent holder
 Compulsory licences (CL) are subject to the
refusal by patent holder to issue authorisation
on reasonable commercial terms within a
reasonable time and the payment of
remuneration.

6. Compulsory Licensing
TRIPS, Article 31 allows the the requirement for
obtaining authorisation from the patent holder
before issuing a CL to be waived in case of an
emergency.
Countries have the right to determine their own
grounds for the use of a CL - whether in an
emergency or not, and what constitutes a national
emergency (Doha Declaration).

7.  Allowing for a CL where the patented invention is not available at a
reasonably affordable price or reasonable requirement of the public
are not being met;
 Develop guidelines as to what constitutes reasonable terms and
remuneration for a CL;
 Strict timelines within which the patent holder must respond to a
request to issue authorisation to use the patented invention on
reasonable commercial terms within a reasonable time;
 Any challenge to delay the issuing of a CL should not affect the
operation of the license during the course of such proceedings
Creating a Legal Framework that Reduces the
Barriers for Compulsory Licensing

8.  TRIPS permits the use of patented inventions for
government non-commercial use without the
authorisation of the patent holder, but subject to
payment of remuneration.
 A much speedier way to authorise the issuing of a license
compared to CL discussed above as it waives the need for
the reasonable and prior negotiation with the patent
owner.
Government Use

9.  Italy, 2005 – CL for the antibiotic imipenem cilastatina,
allowing manufacture and export to countries where Merck
had lost its patent rights.
 Italy 2006 – CL granted to local company to manufatcure the
migrane medicine sumatriptan succinate after Glaxo’s refusal
to grant a license.
 Other countries: Brazil, Ecuador, India, Indonesia, Malaysia
and Thailand. Even the U.S threatened to use a CL for
ciprofloxacin in 2001 .
Examples of Compulsory Licenses/Government
Use

10. Intervention
 Permits a generic manufacturer to work the patented
invention prior to the expiry of the patent for the
purpose of regulatory approval.
 Helps speed up the time the generic product will come to
market.
 Without such a provision, generic products entering the
market after patent expiry could be delayed by at least 6
months to a year, essentially extending the patent life.
Exceptions to Patent Rights
Early Working (Bolar) Provision

11.  Allows for the importation of a medicine from a
country where it is being sold at a lesser price.
Only possible where countries recognise the
‘international exhaustion’ doctrine i.e. the rights
of the patent holder over the product (not the
patent itself) are exhausted once the product is
released into the market anywhere in the world.
Parallel Importation

12. Why Use Remedial Flexibilities?
 They are legal rights permitted under TRIPS;
Helps to overcome anti-competitive behaviour,
especially where patents cannot be challenged on legal
grounds;
Patents are government given rights and so can be taken
away where the patent holder is abusing its dominant
position;
Can help speed up generic medicines coming to the
market