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

2. 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

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

4. 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 (13)

5. 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)

6. Sofosbuvir: Expiry without patent term extension(s)
2024
Broad compound patent (Markush)
WO A2
2028
Compound patent on prodrug
WO A2
2031
Crystalline forms
WO A2
2032
Combination with ledipasvir
WO A
Composition & dosage
WO A1
Market Authorization
US: 2013/14

7. 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

8. 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

9. 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

10. 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
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

11. 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

12. 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;
3-5%
Import
Brazil
Efavirenz
2007
1.5%
Import & local prod.
2006

13. 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

14. WHO Patent Landscapes sofosbuvir (updated) Harvoni Gilead Sciences
ledipasvir (updated)
Daclatasvir (updated)
BMS
dasabuvir
Viekira Pak with ritonavir
AbbVie
ombitasvir
paritaprevir
simeprevir
Janssen

15. The of intellectual property in local production in developing countries
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16. WHO Global Report on Access to Hepatitis C Treatment
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17. Promoting Access to Medical Technologies and Innovation
Dr Peter Beyer Senior Advisor World Health Organization Tel