Patents & health: focus on access World Health Organization 17 November 2017 Patents & health: focus on access – WHO TBS June 2017 Dr Peter Beyer, Senior Advisor 1

Patent Gives the right to the inventor to exclude others from commercially using the invention against disclosure Claims define the scope and can differ from one country to the other depending on examination Only what is claimed is protected: a patent on use of an antibiotic to treat ophthalmological infections does not prevent marketing a generic tablet; patent on polymorph B does not prevent a tablet using polymorph A

Patents There is nothing such as a worldwide patent! WIPO Patent Cooperation Treaty allows for worldwide filing, but applicant receives individual national/regional patents

One drug = one patent? "…a key element of life cycle management strategies is to extent patent protection for as long as possible by filing secondary patents to keep generics off the market" (Burdon and Sloper, The art of using secondary patents to improve protection, International Journal of Medical Marketing, Volume 3, Number 3, June 2003, pp. 226-238(13)

Typical patent flow for pharmaceuticals (chemicals) First patent: covers class of compounds (Markush claim) Second patent: individual compound Third patent: Crystalline form(s) Combination with other drugs Composition&dosage Life cycle patents Typical patent flow for pharmaceuticals (chemicals)

Sofosbuvir: Expiry without patent term extension(s) 2024 Broad compound patent (Markush) WO2005003147A2 2028 Compound patent on prodrug WO2008121634A2 2031 Crystalline forms WO2011123645A2 2032 Combination with ledipasvir WO2013040492A Composition & dosage WO2013082003A1 Market Authorization US: 2013/14 www.who.int/phi/implementation/ip_trade/ip_patent_landscapes/en/

Patentability criteria: incremental innovation vs. "evergreening" India: patent applications rejected as known substances are not considered novel under Section 3d Patent Act (e.g. paediatric formulations, combination patents, polymorphs) unless patent applicant can prove enhanced efficacy Examples: patents refused on: polymorph of imatinib mesylate; suspension of nevirapine hemihydrate; tenofovir disoproxil

What is a voluntary license? The owner of a patent can allow others to use the invention, in particular to manufacture, sell, export or import the patented product Such a mutual agreement is called voluntary license

What is a voluntary license? The owner of a patent can allow others to use the invention, in particular to manufacture, sell, export or import the patented product Such a mutual agreement is called voluntary license It lays down the conditions, namely the territory (list of countries in which the licensee may sell the invention) Royalties Exclusive or non-exclusive

Voluntary licenses HIV treatments (adults) June 2016 INN Licensor Year Scope No countries Licsees EFV MSD 2007 South Africa 1 (allows export to SSA) Several d4T BMS 2001 SSA, India. country list 50 DDL 2006 SSA; India; country list RAL 2011 LIC; SSA 56 2 SQV Roche LDC; SSA 65 DRV Tibotec (Janssen/J&J) 2012 Non-assert: LDC; SSA License: India   1+non-assert. ZDV; ZDV/3TC ViiV Healthcare 2010 LDC; LIC; SSA 69 TPV Boehringer-Ingelheim 2004/07 LIC; LDC; Africa, India 78 NVP LIC; LDC; Africa; India DTG; DTG/ABC MPP: ViiV Healthcare 2014 Country list 73 (+ no patent count.) MPP EVG; QUAD TDF+FTC+EVG MPP: Gilead Sciences 100 Gilead Sciences 100 + 9 semi-exclusive licenses for MICs 4 ATV MPP: BMS 2013 110 (+ 34 no patent count.) RPV/TDF/3TC or FTC; RPV 112 5 TDF 2006/11 TDF; TAF; FTC 2011/14

What is a compulsory license? National patent laws mandate national authorities to allow third parties to use a patented invention without the authorization of the patent owner under certain conditions to address certain unwanted consequences unfair competition, not working the invention, abusively high prices, health emergencies and others WTO TRIPS contains certain conditions, but does not limit the grounds

Recent compulsory licenses & government use Country Medicine Indication Measure Period Royalties Remarks Ecuador Abacavir+lamivudine HIV/AIDS Gov use 2012 5% of US price adjusted by diff. in GDP Local prod. Indonesia Seven products HIV/AIDS; hepatitis 0.5% India Sorafenib Cancer CL 6% Ritonavir 2010 0.42% of US price Import; local prod. Thailand erlotinib; letrozole; docetaxel; clopidogrel; lopinavir/ritonavir Cancer; heart disease; 2006-2008 3-5% Import Brazil Efavirenz 2007 1.5% Import & local prod. 2006

Patent protection vs Data Exclusivity Patent Issued FDA Approved Data Exclusivity, NCE (5 yrs) Data Exclusivity, Non-NCE (3 yrs) Orphan Drug Market Exclusivity (7 yrs) Patent Term Restoration Original Patent Term - 20 Years from filing Biologicals (12 yrs) Patent Application Filed

WHO Patent Landscapes sofosbuvir (updated) Harvoni Gilead Sciences ledipasvir (updated) Daclatasvir (updated) BMS dasabuvir Viekira Pak with ritonavir AbbVie ombitasvir paritaprevir simeprevir Janssen www.who.int/phi/implementation/ip_trade/ip_patent_landscapes/en/

The of intellectual property in local production in developing countries http://www.who.int/phi/publications/int_prop_local_prod_opportunities_chanllenge s/en/ www.who.int/phi/publications/category/en/

WHO Global Report on Access to Hepatitis C Treatment http://www.who.int/phi/publicat ions/category/en/

Promoting Access to Medical Technologies and Innovation www.who.int/phi/promoting_access_medical_innovation/en/ www.who.int/phi/publications/category/en/ Dr Peter Beyer Senior Advisor World Health Organization beyerp@who.int Tel. +41-22-791 25 07