Protecting Your Intellectual Property

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1 Protecting Your Intellectual Property presented by Angus Livingstone UBC University-Industry Liaison Office March 26, 2003

2 Protecting Your Intellectual Property Outline! Good IP Management Starts at Home! IP Assessment Process! IP Protection Strategy

3 Good IP Management Starts at Home " Record Keeping Policy " Security Policy! Physical! Systems " Consulting Agreements " 3 rd Party Agreements! Non-Disclosure! Secrecy! Confidentiality " Employee Agreements! Prior Employment! Confidentiality! IP Assignment! Waiver of moral rights! Non-compete provisions " Exit Interviews Basis of Venture Capital Due Diligence Review Start your DD-Binder NOW!

4 Northwest Mettech vs Metcon Services " UBC files U.S. Patent filed June 26, issued April 16, 1991 " UBC licenced NW Mettech - August 1, 1991 " Delcia starts work with Mettech - fall 1991 " Delcea quits Northwest Mettech and joins Metcon Services on June 8, 1994 " Delcea files a US patent application on June 20, 1994 " September 8, 1995 Northwest Mettech files suit against Metcon Services for allegedly misappropiating intellectual property

5 Inadvertent Public Disclosure " Patenting Requirements! Novelty! Usefulness! Non-obviousness " If enabling, then public disclosure can bar patent filing including:! Public talks! Formal printed publications! Internet publication " Can be protected through confidentiality agreement

6 Northwest Mettech vs Metcon Services " September 1995 Northwest Mettech files suit against Metcon Services for allegedly misappropiating intellectual property " Next 28 months spent in and out of court " Dalcea chooses to defend himself and becomes profecient at filing motions in court " January 1999, out of court settlement reached

7 Patent Interference UBC, Interomex BioPharmaceuticals, Nycomed Amersham UBC Patent U.S. Patent 5,885,779 Filing Date: September 9, 1997 Priority Date: September 9, 1997 Issue Date: March 23, 1999 Nycomed Amersham Patent U.S. Patent application 08/905,375 Filing Date: August 4, 1997 Priority Date: August 5, 1996 Issues Date: pending " September US PTO invokes interference between UBC and Nycomed Amersham patents " UBC needed to demonstrate 1st to invent! Lab notebooks (unsigned)! Depositions from department head and collaborators! Thesis filed in January

8 Patent Interference " Under a settlement agreement, UBC agreed to provide Nycomed Amersham with copies of relevant documents " Amersham used the unsigned notebooks and seemingly long delay from the date of invention to patent filing to challenge UBC s position " Interomex BioPharmaceuticals, the UBC licensee, was as start-up with only seed level financing Final Settlement " Interomex purchased Nycomed s patent in UBC s name for $50,000 " UBC included Nycomed s patent licence to Interomex " Interomex covered legal fees (exceeded $75,000)

9 UILO Technology Assessment Overview Invention Disclosure Preliminary Assessment UBC rights? 3 rd party rights? Protectable IP? Commercial viability? Detailed Assessment IP issues assessed? Inventor role defined? Market confirmed? Technical status assessed? Action Planning Technology assessment report

10 Invention Disclosure " Detailed description of invention " Background science behind the technology " Funding that supported the research " Related papers, public disclosures " Reference to other (competing) work in the same area " Researchers assessment of the commercial potential " Contacts that might be interested " Contributors assign IP to UBC

11 Preliminary Screen UBC rights? 3 rd party rights? Protectable IP? Commercial viability? Is invention a result of research at UBC? Industry-sponsored or inter-institutional research Share ownership / revenue Obvious technical or patent literature Software excepted Better mousetrap? Option to exclusive license

12 Keepers " Revolutionary / platform technologies " Very large blue sky potential " Inventor track record " Enabling technology " Freedom to practise " Fits with portfolio

13 Losers " Incremental improvement " Easily engineered around " Highly fragmented market " Entrenched competitor controlling distribution channels " Commodity item " Low volume / low cost " Market dissonance / non-standard " Inventor unwilling to give up control

14 Other considerations " Know-how, show-how & trade secrets! how long will information remain confidential? " Software! time to market often critical " Business methods on the Internet " Engineering / physical sciences! time to market 3-5 years " Biotechnology / pharmaceutical compounds! time to market 7-12 years

15 Detailed Assessment IP issues? Inventor role? Market confirmed? Technical status assessed?

16 Assessment Process " Background Information " Technology " Market " Competition " Revenue model " Commercialization plan

17 Background issues " Clear ownership of technology " Commitment of inventors " Patent and literature search! presence of dominating patents! scope of patent protection! ease of reverse engineering or duplicating! ease of monitoring infringement " Timing of public disclosures

18 Patentability " Patent and literature searches Literature databases (CAS, PubMed, etc) Patent databases (Delphion, Patscan (Koerner Library) Nerac (paid subscription) " Require utility, novelty, non-obviousness " Want broad scope, freedom to operate " Nature of patent claims composition of matter, method of production, use

19 The Market " Web-based market research Market reports Financial filings Patent databases (classifications) "Research existing products, processes, systems Deficiencies vs advantages of IP Does IP address a need, fill a hole Barriers to market entry (regulatory hurdles, etc)

20 Competitor Analysis: Patent Databases " Searched chemokine in abstract for US patents " Returned >500 hits " Top 8 companies: SmithKline Beecham (GSK) Human Genome Sciences Schering, Merck, Incyte Leukosite, Icos, Zymogenetics " Sorted by patent classification and company

21 Competitive Analysis: Chemokine patent literature # Patents A61K-031/17 0 A61K-031/40 A61K-031/42 A61K-031/445 A61K-031/ 495 A61K-031/55 A61K-039/395 Heterocyclic antagonists C07C-273/ 18 C07D-211/ 56 C07D-213/ 86 Classifications C07D-217/ 02 C07D-261/ 20 C07D-333/ 50 C07D-401/ 14 C07D-471/ 04 C07H-021/ 04 C07K-014/ 715 Cell lines C12N-001/ 19 C12N-005/ 18 C12N-015/ 12 C12N-015/ 64 G01N-033/ 566 Transfection agents ZYM OGENETICS ICOS CORPORATION LEUKOSITE INCYTE PHARM ACEUTICALS MERCK SCHERING CORPORATION HUMAN GENOME SCIENCES Companies SM ITHKLINE BEECHAM

22 Valuation Methodologies " Direct development costs " Replacement cost " Discounted cash flow (NPV)! difficult to determine production costs for early stage technologies! how to estimate appropriate discount rates! does not value future developments " Option theory (Black-Scholes) " Market Comparators

23 " Software Industry practices! often looking for early assignment! copyright vs software patent " Resource industries - ie mining! IP treated like trading cards " Semiconductor / electronics industry! freedom to practise! one-time fee " Biotechnology / pharmaceutical! royalty stacking provisions

24 Technology Assessment Report " Technology Status " Intellectual Property Issues " Market Information " Competitor Intelligence " Financial Model " Summary: SWOT Analysis " Recommendations

25 Action Planning Recommendations UILO Commercialization NewCo Existing Co Broker Further Development Alternatives to licensing Government Programs UILO PDP Further R&D Close file Reassign to inventors

26 UBC Assessment Statistics FY 2001 Technology Status FY 2002 Technology Status Optioned 10% Assigned 5% Closed 31% Optioned 19% Assigned 2% Closed 29% Licensed 29% Available 25% Licensed 13% Available 37% FY 2003 To Date Active Technology Status Licensed 7% Optioned 11% Assigned 1% Closed 7% Available or Under Assessme nt 74%

27 Alternate methodologies " Evaluation software! Progrid customized methodology to measure intangibles! Innovalue set of 55 questions with predefined answers multiple independent respondents weighting functions to compute scores! Crystal Ball Excel Spreadsheet Monte Carlo simulation! Analytica DCF Modelling & Risk Analysis

28 IP Protection Strategy " Create and IP Protection Umbrella " Stage Gate Approach to IP Protection! Initial Assessment! Detailed Assessment Provisional Patent Filing - $1,500 (start the clock)! Business & Technical Assessment PCT Patent Filing - $10,000 (at 12 month mark)! Business, Market, IP & Technical Assessment National Filings - $10,000 per country (at 30 month mark)

29 CBD - The Technology Cellulose binding domains (CBD s) are regions of enzymes that bind to cellulose but which do not have catalytic activity. Applications Protein purification Industrial Enzymes Diagnostics Biomedical Plant growth modulation Protein immobilization on a cellulose matrix

30 CELLULOSE BINDING DOMAIN # 1- Patenting a Platform Technology

31 1988 Field of Use Methods for Modifying Fibers Field of Use 2 CBD - Growth Factor Fusion Proteins Patent Status (2000) U.S. patents issued: 7 U.S. patents pending: 5 U.S. patents abandoned: 1 International patents issued: 3 International patents pending: 16 International patents abandoned: 3

32 Patent Cost Summary 300, , , , ,000 50, University Annual Company Annual 1988 to 1998: Over $400,000 for patent costs. 1996: Approximately $100,000 recovered in licensing fees 1997: UBC pays $165,000 for patent fees - Company re-finances 1998: Company reimburses $165,000 and resumes paying patent fees 1999: All past patent costs recovered through milestone payments

33 Bizarre Patent of the Month US 5,966,743 - Substance dispensing headgear A headgear for dispensing a substance has a container to carry the substance. A spigot is secured to the container. The spigot can be opened to dispense the substance by gravity, suction, pressure or levity flow. A hat-like recess is formed within the bottom wall of the container sized for wearing on an individual's head, and for maintaining the container in a freestanding condition during handsfree ambulation of the individual.

34 Creating an IP Umbrella Forms of IP Protection! Patents! Copyright! Trademarks! Trade Secrets! Integrated Circuit Topography! Industrial Designs! Plant Breeders Rights Protect Software through a combination of:! Patents! Copyright! Trade Secret! Trademark Pop Quiz: How many types of intellectual property in a bottle of coke?

35 For More Information Angus Livingstone, Managing Director University-Industry Liaison Office Phone: (604) Web:

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