MSF Access to Essential Medicines Campaign Universal Access What to do about patent barriers to access and innovation? Ellen ‘t Hoen MSF Access to Essential Medicines Campaign IAS, Mexico 3-8 August 2008

In MSF we are treating more than 140,000 patients in xx projects in 27 countries ….and approximately 10,000 of these are children

Effect of Generic Competition Until 2005 India ’s excluded pharmaceutical products from patenting (1970 Patents Act) 80% of ARVs MSF uses are purchased in India 70% of the treatment purchased by UNICEF, IDA, the Global Fund and the Clinton Foundation comes from Indian suppliers. PEPFAR, the US President’s AIDS initiative purchase of Indian ARVs resulted in cost-savings up to 90%. 91% of the generic ARVs approved by the US Food and Drug Administration for PEPFAR are from India.

Fixed Dose Combinations

Access to Generics Until 2005 India ’s excluded pharmaceutical products from patenting (1970 Patents Act) 80% of ARVs MSF uses are purchased in India “Generics fuel Aids Programme”: Generics accounted for 57% of $131 million U.S. PEPFAR spending in 2007 (WSJ, 31 July 08)

But …Times Are Changing 2005 WTO TRIPS Agreement fully implemented Medicines become patentable everywhere India started granting product patents following amendment of the Patents Act in 2005 Affect on the price of new ARVs are becoming apparent

Universal Access to What?

The replacement of stavudine/lamivudine/nevirapine (d4T/3TC/NVP) with tenofovir/lamivudine/efavirenz (TDF/3TC/EFV) would increase ART costs from €64 to €248 PPY (February 2008 prices). The most expensive option is to switch all patients to TDF immediately: first-line ART costs would increase from €1.3M to €5.4M (late breaker session on Thursday 14.30 session room 4)

Responses 1 Differential pricing ‘Voluntary’ licenses Discounts not steep enough and not as effective as generic competition No solution to patent barriers to the development of FDCs and new formulations e.g. for children ‘Voluntary’ licenses Restrictions that hamper full effect of generic competitions e.g on trade in API, export markets Rare and response to threats e.g CL or legal action, e.g. TAC’s complaint at the South African Competition Commission and pre grant oppositions

Responses 2 Compulsory licensing Thailand => EFV price 1400 Baht (45$) to 615 Baht (19$) a bottle. Brazil ==> EFV 77% price drop ==> increase of patients from 23.300 to 75.000 DC’s use “government use” powers to procure generics regardless of patent status LDC’s exclude product patents when patented India – strict patentability criteria 15 Patent-grant oppositions related to AIDS medicines by Indian civil society : Implementation of the 2001 Doha Declaration on TRIPS and Public Health and TRIPS CL predominantly for the domestic market These measures largely lean on the ability of India to produce generics

Prioritising Health over Patent Protection Harsh criticism on countries with AIDS programmes aiming at universal access that use CL to increase access Retaliation e.g. Abbott refusal to make new drugs avaiable in Thailand (withdrawal of new drug applications at the NDRA incl heatstable lopi/r) Legal action Novartis against section 3d of the Indian Patents Act Limiting the scope and effectiveness of TRIPS flexibilities through TRIPS+ measures in bilateral trade agreements

Need for a more systematic approach Hand to Hand Combat Price increase of newer ARVs and 2nd line ARVs lead to rapid increase in cost of treatment We can no longer count on automatic generic competition to bring prices down Threat to scale up, improve care and universal access (to what?) Patent disputes break out  Need for a more systematic approach

Times are changing again? UNITAID Board decided in principle to establish a patent pool and set in motion a process to do so. (EB8 2 -3 July 08) “Patent pools of upstream technologies may be useful in some circumstances to promote innovation relevant to developing countries. WHO and WIPO should consider playing a bigger role in promoting such arrangements, particularly to address diseases that disproportionately affect developing countries. (WHO Commission on Intellectual Property, Innovation and Public Health, April 2006) “Examine the feasibility of voluntary patent pools of upstream and downstream technologies to promote innovation of and access to health products and medical devices” (WHO Global Strategy and Plan of Action on public health, innovation and intellectual property. May 08) “The use of patent pools in the biotechnology field could serve the interests of both the public and private industry, a win–win situation” (USPTO 2000) Initial responses from patent holdling companies has been very encouraging

What is a patent pool? A number of patent rights held by different owners are brought together (pooled) and collectively managed Third parties e.g. generic manufactures of AIDS drugs can make use of the patents against the payment of a royalty “One stop shop” - no need for case by case negotiations

Patent Pool and WHO recommended improved 1st line ARV New WHO recommended 1st line regimen: TDF/ 3TC or FTC/ EFV or NVP 4 to 11 fold increase in price compared to d4t containing regimen TDF and FTC– Gilead 3TC – GSK EFV – Merck NVP – BI TDF/FTC/EFV – Gilead/BMS joint patent application PI - tipranavir (TPV) just approved only in liquid form (BI), duranavir, atazanavir/r (for children once a day not approved for peds yet)

Patent Pool and 2nd line and paediatric ARVs Patent pool would enable the development of FDC for both adult and paediatric use ATV/r/TDF/3TC once a day second line Paediatric new formulations: PI adaptable for small children e.g. ATV/r - once a day!

Is the Patent Pool Feasible? Political momentum - WHO GSPA paved the way UNITAID commitment NGO commitment Companies’ initial responses positive: IFPMA “very interesting” GSK willing to put licensed patents in the pool European generics “interesting” Individual companies response at this meeting positive e.g. Gilead Hard work ahead to succeed Devil will be in the details of the licenses, remuneration

Conclusion Changed environment post TRIPS era Newer products patented in developing countries Prices will not come down automatically IP barriers to FDC development Deliberate action needed to counter the consequences of global pharmaceutical patenting Momentum to do so