PATENTS, TRIPS, FLEXIBILITIES & ACCESS TO MEDICINES – LEGAL PERSPECTIVE by Chikosa Banda [email protected].

PATENTS, TRIPS, FLEXIBILITIES & ACCESS TO MEDICINES – LEGAL PERSPECTIVE

byChikosa Banda

[email protected]

WHAT IS TRIPS? WHY DOES IT MATTER?

• The Agreement on Trade Related Aspects of Intellectual Property Rights

• The TRIPS Agreement came into force in 1995 • Minimum standards agreement• introduced minimum standards for protecting and enforcing IPRs-

one size fits all system• Members might introduce higher standards if they wish to• LDC members obliged to comply with the general provisions of the

TRIPS by 1 July 2021 (original expiry dates 2005/2013)• With respect to medicines LDC members have flexibility to defer

compliance with TRIPS until 2016• The extensions do not obviate the need to reform existing Patent

legislation to take advantage of TRIPS flexibilities to achieve developmental objectives

• Especially in the areas of Public Health and Agriculture.

STATE OBLIGATIONS UNDER THE TRIPS AGREEMENT/RIGHTS OF PATENTEES

TRIPS obliges members to provide patent protection for inventions (products/processes)

in all fields of technologySo long as they are new, inventive and capable of

industrial application (useful)For a minimum term of 20 yearsA patent gives the patent holder the right to

exclude others from:• making, • importing• using, • selling patented products

TRIPS WAIVER EXTENSION FOR LDCS

• Recently (June 11, 2013) LDCs were granted an 8 year extension to implement international IP protection rules• The June 2013 extension will end on 1 July 2021.• However, confusion abounds over a parallel WTO

waiver for pharmaceuticals conferred upon LDCs until 2016• Some contend that since the extension is for the

full TRIPS Agreement it applies to all products including pharmaceuticals

WTO OFFICIAL VIEW ON THE EXTENSION

“The decision does not affect the separate transition period for least developed countries to protect patents on pharmaceuticals, which was agreed in 2002 as a result of the Doha Ministerial Declaration on TRIPS and public health; under that earlier decision, least developed countries are not required to protect these patents until 2016. The least developed countries did not refer to this in their proposal (document IP/C/W/583) for the general transition period.”

It is therefore important that LDCs should actively use the policy space that has been given to them to design their IP laws in line with their needs and priorities.

Motivate for an extension to the pharmaceutical exemption

ARIPO ARV PATENTS- 2011A SNAPSHOT

• Abacavir Sulphate (ABC) – Wellcome (GSK) –• Expired -2010• hemisulfate salt, AP2009 (expiry 2018)• composition for ped.use, AP 1212, (expiry 2019), • Comb with 3TC or FTC (and AZT), AP 652 (expiry 2016)• Didasone (enteric coated), BMS, AP1206, (expiry 2018)• Efavirenz (EFV), Merck (MSD), No ARIPO patent (Expiry August 2013)• Comb with FTC/TDF, Gilead/MSD, No Aripo Patent, (Exp2026)• Lamivudine (3TC), IAF Biochem/GSK, AP 136, (Expired: Feb 2010),• Liquid composition, AP 1141, (Expiry 2018)• Lopinavir (LPV), Abbot, No ARIPO Patent• Nevirapine (NVP), Boerlinger, Extended Release Formulation, ARIPO Patent

status unknown, (Expiry2028)• Ritonavir – No ARIPO patent• Tenofovir Disoproxil Phosphate Fumerate (TDF) , (Expiry 2018)

• (Source Medicines Patent Pool)

PATENTED ARVS

• Emtricitabine (FTC)-original patent (AP136) expired in 2011In combination with Tonofovir Disoproxil Fumarate, patent holder Gilead, Expiry 2024, AP2089.

• New arrival• The FDA recently (13/08/2013) approved dolutegravir

[Tivicay] ( a protease inhibitor- and a promising drug) – effective at reducing viral load and fewer side effects

• GSK/Shionogi• Patents for synthesis process• intermediates• ARIPO designated in international application

CANCER

• Trastuzumub (Herceptin)• In India – a Swiss pharmaceutical giant recently

announced that it is relinquishing the patent for its anticancer drug Herceptin/tactical move to avoid compulsory licensing and bad publicity• 27 July 2013- Indian Federal Board of Patent

revoked a patent on a slightly modified form of a breast cancer drug Lapatinib ( sold by GSK as Tykerb) • But allowed other patents that will protect the

drug from generic competition until 2019.

FLEXIBILITIES

• The TRIPS agreement obliges members to abide by minimum standards of IP protection• However, member states retain important policy options, flexibilities and safeguards to facilitate access to medicines:

TRIPS FLEXIBILITIES INCLUDE

• Preventative - • exclusions from patentability- exclude new uses, minor modifications,

methods of treatment

• Setting and applying strict patentability criteria– ensuring that only deserving inventions are protected• India- no patent on mere discoveries of new forms of a known

substance unless there is enhancement of the known efficacy- Gleevec Case

• No patents on mere discoveries of new properties or new uses-----

• S18 of Zambian Act –mere admixtures.• Allowing pre-grant and post-grant opposition• Waivers and transition periods- including LDC waivers

FLEXIBILITIES

• Remedial flexibilities• Parallel importation• Use of an innovation without authorization of patent holder

• States retain the freedom to determine the grounds upon which such CLs are granted

• the right to determine what constitutes a national emergency or other circumstances of extreme urgency- (Zambia declared 5 yr HIV emergency in 2004)• Compulsory Licenses- s38 of Zambian Act• Compulsory Licenses Solely or Largely for export (30th August decision)• Public non-commercial use

• Exceptions – early working (Bolar), research experimental use exception

• Competition laws

• Enforcement related • decriminalization of infringement

DECLARATION ON TRIPS AND PUBLIC HEALTH (DOHA, SEPT.2001)

• Reaffirms the rights of member states to use to the full the flexibilities provided for under the TRIPS

• Paragraph 6 of the declaration:• Recognised that members with insufficient or no

manufacturing capacities in the pharmaceutical sector could face difficulties in making effective use of compulsory licensing under the TRIPS agreement

• Reason – compulsory licence is subject to strict conditions- including that CL shall be authorized predominantly be for the supply of the local market [Art. 31(f)]

• Urged the TRIPS Council to find an expeditious solution to this problem.

PARAGRAPH 6 SOLUTION

• The decision of the General Council of the WTO of 30th August 2003 – on the implementation of Paragraph 6 of the Doha Declaration

• Waives the requirement that CL should be predominantly for domestic use- where it is necessary to export to a country with limited capacity

• Allows CL for exports to countries with little or insufficient manufacturing capacity (incl. LDCs)

• Intending to import generic medicines to address public health problems

• Subject to strict conditions

PARAGRAPH 6 CONDITIONS

• The TRIPS Council must be notified by importing member• Contents of notification• Names and expected quantities of products• Confirmation of eligibility• Where a product is patented by importer-

confirmation that a CL has been granted or will be granted• Alternatively an LDC must state that it is availing

itself of the additional transitional period

PARAGRAPH 6 SOLUTION

• Exporting member must issue a CL permitting production for exportation-

• Conditions of CL-• only amounts necessary to meet needs of the importing

member to be manufactured• Entire production to be exported• Product must be clearly identified as having been produced

under this system – through labelling/marking/colouring/packaging/shaping

• Details of shipment must be placed on website by the licensee- distinguishing features

• Exporting member to notify TRIPS council about CL conditions- very detailed information- names of licensee, products and quantities, destination, duration of licence,

CONDITIONS OF A LICENCE

• Exporting members obliged to attach conditions to licence• Only the amount necessary to meet the needs of the

importer can be manufactured• Entire production should be exported to the importing

member• Clear identification requirements- specific labelling,

marking, special packaging, and/or special colouring, shaping of products-

• Provided that these are feasible and do not impact on price

• Importing member must-• Put in place measures to prevent re-exportation

SYSTEM TOO COMPLEX

• System too complex. bureaucratic• Not an effective / expeditious solution to

LDC problems• Rwanda used it in 2006 to import generic:

FDC- Zidovudine/Lamivudine/Nevirapine• Need to lobby for a simpler system

COMFORT LETTERS

• A number of LDCs have introduced the practice of “comfort letters”- to procurement authorities and generic suppliers indicating they were taking advantage of paragraph 7 flexibility not to enforce patents.

• The letters simply state that “the government approves procurement of a generic medicine irrespective of its IP status.”

• This appears to be a result of misreading World Bank Procurement Guidelines

• However, it is not adequate merely to say that LDCs were exempted from implementing TRIPS

COMFORT LETTERS

• The fact that LDCs do not have to enforce pharmaceutical patents is not self-executing

• Countries must find a way of addressing patent rights that were granted under national law

• The transition period gives LDCs freedom to choose whether or not to protect trademarks, patents, geographical indications etc

• If they choose to protect patents then they cannot simply ignore them

• There is need for explicit national legal authorization allowing procurement letters, informal compulsory licences, non-enforcement of existing patents on medicines etc.

COMFORT LETTERS

• This lax procedure is being questioned by Republicans in the US Congress• Pressure is being exerted on the Global Fund to

tighten up its due diligence standards ( the ones that require compliance with international and national law).

The best approach would be to repeal patent protection for any pharmaceutical products – hoping that the waiver will be extended beyond 2016.

HARNESSING ECONOMIES OF SCALE AND FACILITATING REGIONAL PRODUCTION

• The paragraph 6 solution also endeavours to solve the problem of “insufficient manufacturing capacity”

• by attempting to harness economies of scale using regional trade blocs.

• Waives certain TRIPS obligations in favour of developing countries or LDCs that are members of regional trade agreements

• At least 50% of whose membership comprises LDCS

• To the extent necessary to enable a pharmaceutical product produced or imported under a compulsory licence in that member

• To be exported to markets of other developing or LDC members within the trade bloc

• That share the health problem in question

• Parag 6 : Recognizes the need to promote the development of systems providing for the grant of regional patents to support initiatives under this paragraph

ACTION POINTS

• Consider advocating for the speedy enactment of the Patents Bill in order to ensure that TRIPS flexibilities are fully domesticated and utilized.

• The new law should put more emphasis on preventative flexibilities than remedial flexibilities

• Consider taking the necessary measures to use the transitional period not to grant pharma patents until the expiry of the transition

• Avoid TRIPS+ agreements and anti-counterfeiting measures that equate generics to counterfeits

• Collaborate with other SADC and COMESA countries to lobby for a simpler procedure for importing generics under the paragraph 6 system

• Explore the option of local production using the paragraph 6 system

THANK YOU

• Name: Chikosa BandaE-mail: [email protected]: Mobile: +265991380580Skype: chikosa.bandawebsite: http://www.cc.ac.mw