The HFA pMDI Patent Landscape: Minefield or Goldmine


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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.

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The HFA pMDI Patent Landscape: Minefield or Goldmine

  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 © 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, 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. 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 • 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 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 – 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. 7
  8. 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. 8
  9. 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. 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. 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. 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) 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: Sheraton House 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. 12