CambridgeIP’s Arthur Lallement presented at the Drug Delivery for Lungs conference at Edinburgh on December 9, 2009. Over four hundred senior scientists from the inhaler and respiratory disease industry attended the conference and shared some of the latest research in the inhaler space.

1. The HFA pMDI Patent Landscape:
Minefield or Goldmine
Drug Delivery to the Lungs – DDL20
Edinburgh, 09/12/2009
Arthur Lallement
Senior Associate, CambridgeIP
Ilian Iliev
CEO and co-founder, CambridgeIP
© 2009 CambridgeIP Ltd. All rights reserved.

2. Contents
• About CambridgeIP
• Patent Study Methodology
• Non-CFC pMDIs
• DPIs
• Patent Applications by year for pMDIs and DPIs
• Development perspectives
• CambridgeIP Contacts
© 2009 CambridgeIP Ltd. All rights reserved.
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3. About CambridgeIP
CambridgeIP uses patent-based business intelligence to meet IP
strategy, technology mapping and business development
information requirements
• Helping formulate IP and R&D Strategy
• Assist with licensing-in and licensing-out business development
• Assist R&D Managers/CTO in technology mapping and identifying white
spaces
• Assist Freedom to Operate and Patentability Analysis
• Competitor patent portfolio analysis
• Independent analysis for investment due diligence
Accurate patent datasets: Inventor Network Analysis Technology
Top Patenting Companies
matched to your strategic Applications
concerns
Patent Distribution: Top 5 IPCs
H01R 12/00, 5.8%
H01R 13/22, 5.4%
70
65 Top 10 Assignees and Number of Patents
H01R 13/24, 5.3%
60
55
H01R 11/11, 5.1%
50
45
40 H01R 11/28, 4.5%
40
30
3
30 26
20 19
20 18
16
`
10 Other: 74%
© 2007
© 2009 CambridgeIP. All rights reserved..
0
Assignee 1 Assignee 2 Assignee 3 Assignee 4 Assignee 5 Assignee 6 Assignee 7 Assignee 8 Assignee 9 Assignee
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4. The Montreal Protocol
• Production of CFCs banned by the
developed nations in 1996, in
accordance with the 1987 Montreal
Protocol.
• CFCs “Essential use” exemption was
granted to the pharmaceutical industry,
notably for pMDI manufacture, to allow
replacement products using HFA to be
brought to market.
• On December 31, 2008 the US banned
the production and sale of CFC
(chlorofluorocarbon) inhalers that
contain Albuterol Ozone-depleting gas trends
Source: U.S. National Oceanic and
• Today, there are very few CFC-pMDIs Atmospheric Administration (2005)
left on the market © 2009 CambridgeIP Ltd. All rights reserved.
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5. Patent Study Methodology
In order to evaluate the impact of the Montreal Protocol on
innovation in the inhaler space we conducted a detailed patent
landscaping exercise
• We used our patent analysis platform to:
– Build a 900+ patent dataset covering non-CFC pMDIs
– Build a 2000+ dataset of patents related to DPIs
• We conducted a semi-automated and expert-validated
analysis of the history of the space and identifying
foundational patents
• In the next slides we show some of the history
5 © 2009 CambridgeIP Ltd. All rights reserved.

6. What are the non-CFC propellants used in pMDIs?
We developed a typology of non-CFC
propellants to drive our patent
searches
Most of the pMDIs use HFA 227 and HFA 134
6 © 2009 CambridgeIP Ltd. All rights reserved.

7. Non-CFC pMDIs: Original Patent Holders –
Citations and Oppositions
• There was an initial flurry of patenting activity around non-CFC propellants
• It was notable that there was also a high degree of opposition by other players to
these original patents
• A number of patent families have emerged from these ‘grandfather’ patents –
which have dominated the propellants space until now
We used citation
analysis to identify the
GB9002351 US5182097 ‘grandfather’ patents of
non-CFC pMDIs
Riker filed the first HFA134a
patent (EP372777
opposed in 1995, 1996
obtained in 1999)
DE4003272A1
The first patents filled in the HFA
Hoescht filed the first HFA227 patent
pMDI space began to expire
(DE3905726A1 acquired by Solvay Fluor) DE3905726A1 © 2009 CambridgeIP Ltd. All rights reserved.
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8. Impact on Industry Patenting Strategies: 2 trends
• The CFC ban impacted many of the inhaler industry’s key
players
• We identified two broad strategies for industry adaptation
to the Montreal Protocol
– pMDI space innovations: innovation in propellant
formulations based on the 2 HFAs that were allowed to be used
(HFA 134a and HFA 227), which led to propellants-focused
patents in the pMDI space
– Moving out of pMDIs: A number of companies moved out of
pMDIs and into Dry Powder Inhalers, essentially ‘substituting’ the
need for a propellant with the patient’s breath. As a result we have
seen accelerated innovation in the DPI space
• See the next slides for patent trends in these 2 areas
© 2009 CambridgeIP Ltd. All rights reserved.
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9. Non-CFC pMDIs: Patent applications by Year
Percentage of non-CFC pMDI Patent Applications:
Annual and Cumulative
Number of New Applications Cumulative
12% 100%
90%
Montreal Protocol
10%
80%
Patents - Cumulative
Patents - Yearly
70%
signature
8%
60%
6% 50%
40%
4%
30%
20%
2%
10%
0% 0%
The patenting trends suggest that the Montreal protocol had a strong impact on
innovation in the non-CFC propellant devices space: as evidenced by
increasing patenting rates of non-CFC pMDIs lasting through to the mid-2000s
9 © 2009 CambridgeIP Ltd. All rights reserved.

10. DPI patents increase in the aftermath of the Montreal
Protocol
• Overall innovation in the DPI space increased rapidly in the aftermath of
the Montreal protocol: possibly indicating a ‘switching’ strategy by some
inhaler manufacturers moving away from CFCs
Percentage of DPI Patent Applications by year:
Annual and Cumulative DPIs
‘Rush’
Number of New Applications Cumulative
10% 100%
Montreal Protocol
8% 80%
Patents - Cumulative
Patents - Yearly
6% signature 60%
4% 40%
2% 20%
0% 0%
10 © 2009 CambridgeIP Ltd. All rights reserved.

11. DPIs + non-CFC pMDI
Development perspectives
• In conclusion: what developments can we expect in
the DPI and pMDI space over the next decade?
• As a number of the original patents on HFC propellants
expire there may be increased opportunities for all inhaler
industry players
• There is a correlation between the number of application
in the HFA pMDI space and in the DPI space, suggesting a
strategy switch for some companies
– Could the popularity of pMDIs grow again as HFC propellant
patents expire?
• But there is still a need to create better HFA pMDI
formulations: the field of other propellants like CO2 and
NO2 is still open
11 © 2009 CambridgeIP Ltd. All rights reserved.

12. …and finally…
CambridgeIP can provide you with a cost-effective solution:
whether for a once-off project or repeat needs
Feel free to discuss your specific IP Intelligence requirements
with Arthur or Ilian
Sign up to our Newsletter and visit our blog
to get regular IP Intelligence insights
Thank You !
Arthur Lallement Ilian Iliev
(Senior Associate) (CEO and Founder)
Arthur.Lallement@cambridgeip.com ilian.iliev@cambridgeip.com
GSM +44-772-357-4708 GSM: +44-077-863-73965
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