Remedial TRIPS Flexibilities and Good Practices for Public Health

Tahir Amin Initiative for Medicines, Access, & Knowledge

1 June 2015

Remedial TRIP Flexibilities

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Post-grant opposition/revocation/invalidation

Compulsory licensing

Government use authorisation

Exceptions to patent rights

Post-grant opposition/revocation/invalidation

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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

Post-Grant Opposition/Revocation/Invalidation

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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.

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.

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).

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

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

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

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 RightsEarly Working (Bolar) Provision

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

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