Developing an IP Portfolio in an Emerging Biotechnology Company Silicon Forest Forum Hillsboro, Oreg

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Developing an IP Portfolio in an Emerging
Biotechnology Company Silicon Forest Forum
(Hillsboro, Oregon) Keith K. Daellenbach,
M.S.M.E., P.E.Director of Engineering
ResearchBioject, Inc. (Tualatin, Oregon)10
November 2006
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Outline of Presentation

• Company and Product Overview
• IP Terrain and IP Creation Timeframe
• Challenges in Early Patent Strategy
• Establishing Improved Patent Strategy
• Educating Workforce
• New Opportunities

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Company Overview

• Mission To be the development and innovation
  leader in the field of needle-free drug delivery
  and leading supplier of needle-free systems to
  the pharmaceutical and biotech industries
• Operations Commenced in 1985 to develop
  needle-free drug delivery systems that improve
  the way patients take medications and vaccines.
• Corporate Headquarters 20245 S.W. 95th Avenue,
  Tualatin, Oregon, www.bioject.com
• NASDAQ (SC) BJCT
• 14.3 MM shares outstanding
• Market Cap. 17.6 MM U.S.
• 54 share/10MM market(1)
• 80 employees

(1) Greystone Associates Needle-free Injection
Report, Amherst, New Hampshire, 2004.
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Marketed Bioject Products
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Basic Map of IP Terrain Bioject and
Competition
products not yet on market
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IP Creation Timeline
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IP Creation Timeline
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Challenges of Early Patent Strategy

• Organic and unfocused patent strategy which
  included five separate outside patent firms (some
  resulting from acquisitions)
• Cohesive approach to establish PCT applications
  and foreign national phase filings not
  established
• Disorganized patent docketing because no
  centralized management
• In spite of challenges, managed to establish many
  key early patents (e.g., pressure profile)
• Evolution of strategy started in 2001 and took
  about one year to establish improvements

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Consolidation of IP Docketing with Single Counsel

• Established working relationship with single
  local outside patent counsel and consolidated all
  IP
• Local availability to meet patent counsel for key
  meetings saves time and money
• Working with single patent counsel allows Bioject
  to seek new opportunities outside traditional IP
  landscape
• Created standard IP ownership language,
  especially ownership and assignee rights, for
  confidentiality/non disclosure agreements,
  research agreements, and contracts
• Established a standard national phase filing
  approach in major markets (Europe, Canada,
  Japan), manufacturing base of competition, and
  customer locations

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Established Patent Ranking System

• High, Medium, Low rank established by
  internal experts and outside patent counsel
• Identifies patents of strategic importance
  potential future economic value, platform
  technology, IP in new and developing areas,
  patent blocking ability
• Helps conserve expenditures by judiciously
  selecting promising IP for foreign filing

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Created comprehensive patent and trademark list

• Basic information on list
• Title
• Inventors
• Claims
• Country
• Filing/issue date
• Patent and Term
• Type (utility or design)
• Thumbnail drawing aids recognition
• Product platform
• Ranking High, Medium, Low
• Status OAs, date of expected examination
• Serves as basis for the reliable and timely
  filing of maintenance fees
• Useful to easily extract summary IP information
  for marketing and customer due diligence

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Educating Workforce

• IP Fundamentals
• Patent types utility, design, plant
• Independent/dependent claims
• Patent filing options provisional application,
  non provisional patent application, CIP,
  divisional, and PCT
• Patent term
• Patent marking requirements infringement
  damages not eligible for collection until after
  date of first marking
• Use bound laboratory notebooks to record new
  ideas with witness signature
• Involve patent counsel early to identify novelty
  and aggressively submit applications in a timely
  fashion

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Educating Workforce

• Useful, novel, non-obvious IP originate from
  product development, manufacturing, and clinical
  departments
• Damage possible with unprotected disclosure.
  Best to file provisional application before
  getting on the plane (to give presentation) to
  establish priority date and meet absolute
  novelty clause necessary for foreign filings.
• Duty of Disclosure must fully disclose
  background research used to prepare patent
  application
• Staff refrain from conducting patent searches and
  rely on outside patent counsel to prepare
  application and claim language from staff input
  and drawings

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New Opportunities

• Challenges exist to establish ownership/assignee
  rights if novelty is not clearly a drug or a
  device invention
• If Bioject pays for research, Bioject owns
  patent rights
• New patent terrain
• Beyond mechanisms cross-over patents combing
  device mechanism and injectables
• Non parenteral applications injections directly
  into soft tissue and organs (e.g., cardiac
  ablation)
• Applications with new classes of injectable drugs
  (e.g., DNA vaccines, cancer fighting agents)
• Enhanced efficacy of needle-free drug delivery
  (dose sparing)

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Thank You!

• Kolisch Hartwell, P.C., Biojects outside patent
  counsel
• SFF Organizers Intel Capital and White Lee LLP
• SFF Sponsors and Contributors
• Silicon Forest Forum attendees for your interest
  and attention