Ddl20 Cambridge Ip Hfa 09 Dec09 V3al


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Ddl20 Cambridge Ip Hfa 09 Dec09 V3al

  1. 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. 2. Contents • About CambridgeIP • Patent Study Methodology • Non-CFC pMDIs • DPIs • Patent Applications by year for pMDIs and DPIs • Development perspectives • CambridgeIP Contacts g © 2009 CambridgeIP Ltd. All rights reserved. 2
  3. 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 10
  4. 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 industry, notably for pMDI manufacture, to allow replacement products using HFA to be brought to market. b h k • 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. 4
  5. 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 ou dat o a pate ts • In the next slides we show some of the history 5 © 2009 CambridgeIP Ltd. All rights reserved.
  6. 6. What are the non-CFC propellants used in pMDIs? We developed a typology of non-CFC 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. 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 – grandfather 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 1995 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. 7
  8. 8. 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% rotocol 10% 80% ulative arly 70% ure 8% Patents - Yea tents - Cumu Montreal Pr signatu 60% 6% 50% 40% 4% 30% P M 20% Pat 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 8 © 2009 CambridgeIP Ltd. All rights reserved.
  9. 9. A switching strategy? DPI patents also increased in the aftermath of the Montreal Protocol • Similarly overall innovation in the DPI space increased rapidly in the Similarly, 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% mulative early 6% ture 60% P Patents - Ye atents - Cum signat 4% 40% M 2% 20% Pa 0% 0% 9 © 2009 CambridgeIP Ltd. All rights reserved.
  10. 10. 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 development for all pharmaceutical companies • 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 i hf i – That might be reversed as HFA IP right is becoming less restrictive • But there is still a need to create better HFA pMDI formulations • The field of other propellants like CO2 and NO2 is still open 10 © 2009 CambridgeIP Ltd. All rights reserved.
  11. 11. …and finally… CambridgeIP C b id IP can provide you with a cost-effective solution: id ith t ff ti l ti 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 Tel: +44-1223-370-098 Tel: +44-1223-370-098 Corporate Office Internet Resources Cambridge Intellectual Property Ltd Website: www.cambridgeip.com Sheraton House Blog: www.cambridgeip.com/blog Castle Park, Cambridge CB3 OAX United Kingdom Sign-up for our Free Newsletter UK: +44 (0) 1223 370 098 on our Home Page Fax: +44 (0) 1223 370 040 © 2009 Cambridge Intellectual Property Ltd. All rights reserved. 11