The Medicines Patent Cliff
Ian Allen
Lead Category Manager
Commercial Medicines Unit
BASICS
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Invention – inventive step
20 Year Period
Obviousness
Prior Art
Publication:
– Protection allows others to learn from the
invention
Pharmaceuticals – a
strategy problem
• Patent period can be eaten up by R&D, trials
etc.
• Others may patent in the same area
• The wait may reveal more data, e.g. activity or
acceptability to better define the patent
• Secondary patents may arise, e.g. further
indications or for manufacturing processes
• Thickets* or clusters of patents
*See: Intellectual Property Office “Patent Thickets – An Overview” November 2011
Pharma strategy – some
regulatory help
• Patent period can be eaten up by R&D, trials
etc.: Supplementary Protection Certificates
– 5 years
• Paediatric Investigation Plans
– 6 months
Expiring patents
• PMSG Transition sub-group
– Assessment of optimum time to tender
• Patent loss dates as a driver
– Remember: Secondary patents (or other IP
protection!) may arise, e.g. further indications or for
manufacturing processes
– Biological, complex and/or nano-size
molecules(liposomal, pegylated etc.) require further
investigation
– Typically involving clinical trials – area of evolving
regulation
Sources
• Commercial sources of patent analysis
• Product licensing is public domain information
• Only suppliers really know when they will bring
a product to market
• http://nww.cmu.nhs.uk/Medicines/Documents
/patent%20review%20May%202012.pdf
Research resources
• Commercial research agents
• UK: http://www.ipo.gov.uk/
• European:
http://www.epo.org/searching/free/register.ht
ml?hp=stages
• Companies own publications, e.g. Annual
Reports, Investor Relations materials etc. (esp.
useful for complex/combination products):
Products
Vistide
Hepsera
Letairis
AmBisome
Tamiflu
Macugen
Viread
Ranexa
U.S. Patent
Expiration
European
Patent
Expiration
2010
2012
2014
2011(1)
2015
2015
2016
2008
2016
2017
2016
2017
2017
2018
2019
2019(2)
2019(3)
2020(4)
2021
2016
2021
2018(5)
2021
2018(6)
2021
2021(7)
Lexiscan
Emtriva
Truvada
Atripla
Cayston
N.B. LITIGATION
Notes
-1
Supplementary Protection Certificate
(SPC) protection has been obtained in
certain European countries that confers
an auxiliary form of patent exclusivity
until 2016.
-2
SPC protection has been obtained in
certain European countries that confers
an auxiliary form of patent exclusivity
until 2023.
-3
Patent term extension applied for.
-4
An SPC can be applied for upon
marketing approval in the European
Union.
-5
Based on the European patent expiration
date of Viread, one of the components of
Truvada
-6
Based on the European patent expiration
date of Viread, one of the components of
Atripla.
-7
Application pending.
US SEC Form 10-K 2011 Gilead
Sciences, Inc.
http://nww.cmu.nhs.uk/Medicines/Documents/patent%20review%20May
%202012.pdf
PMSG TRANSITION PRODUCT
SUB-GROUP PATENT EXPIRY
REVIEW
Date
INN
Tender
Awarded?
Patentee
Expiry Date
SPC Expiry Date
Pre 2010
Acitretin
2011_2
Yes
Actavis
28/03/1999
Paediatric
Extension
EU mutual
recognition
procedure
search
Genus, Actavis
PxMolecule
Acitretin
Baseline £ 2011
£1,459,914
Baseline £ 2012
£1,462,062
Patent review
to 2020 and >£20millions
INN
Patentee
Rhone
Poulenc
SPC Expiry Baseline £
Expiry Date
Date 2012
INN
Patentee
Protein
Enoxaparin
07/05/2001 £26,906,257 bevicazumab Design Labs.
£107,051,01
Millennium
rituximab
Biogen Idec 21/11/2013 21/11/2013
7 bortezomib Pharm. Inc
Centocor
darunavir
G.D. Searle
Inc.;/ New
infliximab
York Univ.
17/03/2012 12/08/2014 £96,846,135
Alexion
Pharmaceuti
Kabi
eculizumab cals Inc
Moroctocog Pharmacia
alfa
AB
05/12/2010 12/04/2014 £23,464,364
BASF
Aktiengese
Protein
etanercept llschaft
Design
trastuzumab Labs
27/12/2009 28/12/2014 £95,084,761 imatinib
mesylate
Novartis
The
abacavir +
Wellcome
Fred
lamivudine
Foundation 27/03/2016 16/12/2019 £22,329,647
Hutchinson
Cancer
Yeda
£125,374,43
Research
adalimumab Research
12/12/2005 12/12/2010
3
Natalizumab
Centre
atazanavir
Novartis
sulphate
AG
13/04/2017 01/03/2019 £20,882,878 pemetrexed Princeton
disodium
University
SPC Expiry Baseline £
Expiry Date
Date 2012
27/12/2009 15/12/2019 £22,284,196
26/10/2015 25/04/2019 £27,138,417
23/08/2013 23/08/2018 £24,551,229
30/04/2015 30/04/2020 £23,638,860
03/05/2010 31/10/2015 £101,899,052
24/03/2013 20/06/2016 £52,431,868
30/08/2010 24/01/2020 £26,222,707
09/12/2010 09/12/2015 £22,642,236
£818,748,057
A Changing paradigm?
• Chemical entities – patent expiry date = key
milestone in terms of competition
• Biological, complex and nanopharmaceuticals –
patent expiry date = not the critical RLS
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Ian Allen