The Medicines Patent Cliff

Ian AllenLead Category Manager

Commercial Medicines Unit

BASICS

• 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.html?hp=stages

• Companies own publications, e.g. Annual Reports, Investor Relations materials etc. (esp. useful for complex/combination products):

ProductsU.S. Patent Expiration

European Patent

ExpirationVistide 2010 2012Hepsera 2014    2011(1)

Letairis 2015 2015AmBisome

2016 2008Tamiflu 2016 2016Macugen 2017 2017Viread 2017 2018Ranexa 2019    2019(2)

Lexiscan   2019(3)    2020(4)

Emtriva 2021 2016Truvada 2021    2018(5)

Atripla 2021    2018(6)

Cayston 2021    2021(7)

Notes

-1Supplementary Protection Certificate (SPC) protection has been obtained in certain European countries that confers an auxiliary form of patent exclusivity until 2016.

-2SPC protection has been obtained in certain European countries that confers an auxiliary form of patent exclusivity until 2023.

-3Patent term extension applied for.

-4An SPC can be applied for upon marketing approval in the European Union.

-5Based on the European patent expiration date of Viread, one of the components of Truvada

-6Based on the European patent expiration date of Viread, one of the components of Atripla.

-7Application pending.

N.B. LITIGATION

US SEC Form 10-K 2011 Gilead Sciences, Inc.

PMSG TRANSITION PRODUCT SUB-GROUP PATENT EXPIRY REVIEW

http://nww.cmu.nhs.uk/Medicines/Documents/patent%20review%20May%202012.pdf

Date Pre 2010INN AcitretinTender 2011_2Awarded? YesPatentee ActavisExpiry Date  SPC Expiry Date 28/03/1999

Paediatric Extension  

EU mutual recognition procedure search Genus, ActavisPxMolecule AcitretinBaseline £ 2011 £1,459,914Baseline £ 2012 £1,462,062

Patent reviewto 2020 and >£20millions

INN Patentee Expiry DateSPC Expiry

DateBaseline £ 2012

EnoxaparinRhone Poulenc   07/05/2001 £26,906,257

rituximabBiogen Idec 21/11/2013 21/11/2013

£107,051,017

infliximab

Centocor Inc.;/ New York Univ. 17/03/2012 12/08/2014 £96,846,135

Moroctocog alfa

Kabi Pharmacia AB 05/12/2010 12/04/2014 £23,464,364

trastuzumab

Protein Design Labs 27/12/2009 28/12/2014 £95,084,761

abacavir + lamivudine

The Wellcome Foundation 27/03/2016 16/12/2019 £22,329,647

adalimumabYeda Research 12/12/2005 12/12/2010

£125,374,433

atazanavir sulphate

Novartis AG 13/04/2017 01/03/2019 £20,882,878

INN Patentee Expiry DateSPC Expiry

DateBaseline £ 2012

bevicazumabProtein Design Labs. 27/12/2009 15/12/2019 £22,284,196

bortezomibMillennium Pharm. Inc 26/10/2015 25/04/2019 £27,138,417

darunavir G.D. Searle 23/08/2013 23/08/2018 £24,551,229

eculizumab

Alexion Pharmaceuticals Inc 30/04/2015 30/04/2020 £23,638,860

etanercept

BASF Aktiengese llschaft 03/05/2010 31/10/2015 £101,899,052

imatinib mesylate Novartis 24/03/2013 20/06/2016 £52,431,868

Natalizumab

Fred Hutchinson Cancer Research Centre 30/08/2010 24/01/2020 £26,222,707

pemetrexed disodium

Princeton University 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