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Inter Partes Review and the Life Sciences

October 9, 2013

In Part IX of our series, we explored the use of inter partes review in the context of life sciences patents, including pharmaceuticals and diagnostics. We examined selected petitions filed to date involving life sciences patents. We also discussed strategic considerations and practice tips for both patent owners and challengers in this growing area.

Speakers:
Dorothy Whelan, Principal and Post-Grant Practice Co-Chair, Twin Cities
Gwilym Attwell, Principal, Delaware
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Webinar Summary

  • General benefits (to patent challenger) of IPR over district court litigation
    • Lower burden of proof to invalidate patent
    • Faster & less expensive (but constrained scope)
    • All testimony by declaration / no live testimony (cuts both ways)
    • Petitioner gets to tell its story first
    • Board more receptive to obviousness challenges than district court judge/jury
  • Pharma Specific Scenarios
    • Subsequent generic ANDA filers (i.e., party seeking FDA approval to market a generic drug)
      • 1st generic filer to successfully invalidate (in district court) patent on corresponding innovator drug gains 180 days of market exclusivity
        • 2nd generic filer can realize no such benefit, but…
          • if 2nd generic filer prevails in IPR it can prevent 1st filer from “parking” its exclusivity
          • Leverage provided by IPR may cause patent owner to settle with 2nd generic filer on favorable terms
    • IPR useful in both Hatch Waxman and non-Hatch Waxman scenarios
    • Prodrugs
      • Ranbaxy Labs v. Vertex – PTAB adopted “lead compound” analysis
        • Suggests that IPR route is more conducive to technically complicated arguments
    • Platform technologies
      • Quick resolution of IPR might have changed result in litigation of Genetech’s Cabilly patents, which languished unresolved for years
    • Freedom-to-Operate (FTO)
      • Relatively quick & inexpensive method to remove potential threat uncovered during FTO investigation
    • Patents directed to new drugs
      • Arguably, IPR likely not to be useful since only patents and printed publications may be used to establish invalidity
        • Typically, such challenges are based on lack of enablement / written description, which cannot be asserted in IPR
  • Other Life Sciences Scenarios
    • Biotech
      • Lots of IPRs being filed in various big patent wars
        • Sequenom / Ariosa / ISIS / Verinata Health / Gene Security / Artemis Health / Stanford / Illumina / etc.
    • Medical Devices
      • Atrium Medical v. Davol – stay denied because IPRs filed on 5 of 6 patents in suit would not resolve all issues in dispute
        • Even though stay denied, IPR provides advantages to Petitioner
          • IPR is faster than most district courts
          • Technically complex challenges are better accepted by PTAB
          • Claim constructions obtained in IPR may prove useful in litigation
  • Patent Owner’s perspective – what can patent owner do to strengthen its patents to better withstand IPR challenges?
    • Include narrow “picture” claims directed to commercially useful embodiments
    • Include a large quantity & variety of claims including lots of meaningful dependent claims
      • Difficult / expensive for petitioner to challenge large number of claims due to IPR constraints
    • Maintain pending continuation applications
  • Update on Post Grant Statistics
    • Continued acceleration in quantity of IPR and CBM filings
      • No PGR petitions filed yet
    • IPR / CBM instituted in almost all cases but almost always with (significantly) pared down grounds and/or claims
    • Subject matter of patents is about 70% electrical / computer ; only 8% Bio / Pharma
    • Stays in related district court proceedings
      • Granted ~73% ; Denied ~27%
      • Primary factor in favor of stay: IPR is fast
      • Factors against stay:
        • advanced stage of litigation
        • premature (i.e., wait until IPR institution decision is made)
        • prejudice to patent owner
        • desire to resolve all litigation issues, including those not eligible in IPR
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