Presentation for Korea Research Institute of Bioscience … · Presentation for Korea Research...
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Presentation for Korea Research Institute of Bioscience and Biotechnology (KRIBB) Roger Chulhong Hahn Daejon, S. Korea April 27, 2012 Strategies for Commercializing University Innovation in the US: A Corporate Perspective
Transcript of Presentation for Korea Research Institute of Bioscience … · Presentation for Korea Research...
Presentation for Korea Research Institute of
Bioscience and Biotechnology (KRIBB)
Roger Chulhong Hahn Daejon, S. Korea April 27, 2012
Strategies for Commercializing University Innovation in the US:
A Corporate Perspective
Corporate & University/RO Experience
Global Fortune 500s Mid-Size Biotechs University/Research Organizations
© Hahn & Voight 2012 2
Questions Presented to AIPLA Committee
Q1. How do research organizations and universities in the US make a profit from IP?
1. Finding a Partner 2. Mechanics of the Deal 3. Negotiating the License 4. Takeaways for Korean Organizations
Q2. Where do they place the focus? 1. State of Deal-Making Today (Pharma/Drug-Device Combos) 2. Review of High Tech and Healthcare: University and Industry
© Hahn & Voight 2012 3
Finding a Partner: Preliminary Considerations
1. Is the Invention Commercially Ready? a) Basic Science (need) b) 7% ready c) Less likely to succeed
2. Valley of Death a) Industry Partnerships b) Proof of Concept Center
1. Deshpande Center at the MIT 2. von Liebig Center UCSD
c) Engineering Centers d) Initiatives
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Discovery/Fundamental Research Proof of concept/Test Beds Prototypes Development Scale-UP Commercialization
Be Creative!
Finding a Partner: What are Companies Looking For?
1. Scientific Fit 2. Unmet Commercial Need 3. IP Adds Value 4. Feasible and Realistic 5. Reasonable Deal Terms 6. Aligned Expectations
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Mechanics of the Deal: Big Company’s Assessment Process
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Scientific Fit Unmet need Feasibility Commercial Value
Technology Awareness Publication, Databases
Assess Non- Confidential Information
Meet with University/ Company Non-Confidential
Program Team Team Leader - VP Scientists Project champion Strategic Alliances Patents and Legal
More
Information Needed?
Risk to Internal
Programs?
Decline
Execute CDA
Review Confidential Information
Enter Negotiation
Milestones
Reevaluate
De-Risk
Multiple Non-
exclusive
The Paths to Commercialization
University Track Industry Track
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Business strategy and risk
Market and competitor analysis
Management Shifts
Candidate Attrition
File applications
Find Potential Partners
Negotiate Deal Terms
Manage License/IP
Collect Royalties
Obtain IP
Candidate Attrition: The Realities of Drug/Combo Development
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12
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8
6
4
2
0 0 1 2 3 4 5 6 7 8 9 10
On Average, it takes 12 drug candidates to yield one marketed product
Pre-Clin Phase I Phase II Phase III Registration Market
Animal Toxicity, Chemical Stability, Superior Compound
Human PK, Toleration, Formulation
Efficacy, Safety Differentiation, Dose
Long-term Safety Non-approval
Negotiating the License: Royalty Clauses
1. Percent Licensing Revenue: Net sales v. Gross? 2. Improvements – Who owns it? What do you own? “University Improvements” shall mean Intellectual Property pertaining to University Materials or the use or manufacture (in whole or part) of University Materials conceived in or otherwise resulting from the performance of the Clinical Study, regardless of inventorship. “University Improvements” shall mean Intellectual Property pertaining to University Materials or the use conceived in or otherwise resulting from the performance of the Clinical Study, regardless of inventorship or manufacture (in whole or part) of University Materials conceived in or otherwise resulting from the performance of the Clinical Study, regardless of inventorship.
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Negotiating the License: Control and Downstream Events
35 U.S.C. § 103(c) (CREATE Act) provides two avenues to remove the citability of a 35 U.S.C. § 102(e) reference: 1. Under an obligation of assignment to the same person (entity or joint entity) at the “time of
invention,” and 2. Work done pursuant to a written joint research agreement.
Terminal Disclaimers Under Provision 1, a terminal disclaimer requires that an “application or any patent . . . shall be
enforceable only for and during such period that said patent is commonly owned with the application or patent which formed the basis for the judicially created double patenting.”
Under Provision 2, parties to a joint research agreement are treated as the same person for
purposes of terminal disclaimers regardless of actual differences in legal ownership. Waive right to separately enforce Require Cooperation
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Establish an obligation to assign to a joint entity under Provision 1 is by employee employment agreements
University Filed Application(s)
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Ownership University
+ Corp. X
Corp. X Owns 100% Interest
University Owns 100%
Interest
Ownership University
+ Corp. X
University Inventors(s) Legal Interest
Corporation X Filed Application(s)
Corp. X Inventors(s) Legal Interest
Corp. X Inventors(s) Legal Interest
University Inventors(s) Legal Interest
Assign to
University
Assign to
Corp. X
Assign to
Corp. X
Assign to
University
Corp. X Assign to
University
University Assign to
Corp. X
Observations for ROK Universities and Organizations
1. ROK Universities Can Replicate US Model a) Foster Entrepreneurial Spirit
Bigger Stake to Inventors (40% UNC)+ b) “Technology transfer will not make your university rich” - Lita Nelsen,
Director, M.I.T. Technology Licensing Office, c) Time Frame is in Years, But Long Tail
2. ROK Companies Can Penetrate US
a) Entirely Market-driven v. Network b) Strong IP
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State of Deal-Making Today?
1. GlaxoSmithKline and Targacept 2. Shire and Renovo 3. Merck and Addex Pharmaceuticals 4. J&J's Janssen Pharmaceutical and Diamyd Medical 5. Cephalon and ImmuPharma 6. Novartis and Peptimmune 7. Novartis/Paratek Pharmaceuticals 8. Merck and Portola Pharmaceuticals 9. Eli Lilly and Amylin 10. Solvay and Depomed
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2011Terminations
Lilly - antipsychotic Zyprexa went off patent and Cymbalta fall off in 2013 Report on Alzheimer's’ trial this Fall
Review of BioPharma in 2009 Survey Report Number of Deals
NCE/Product Deals represented 62% of submissions, platforms (e.g. new excipients) represented 12%
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Other is specified as reagent, antibodies, software license, acquisition of portfolio, avoidance of litigation, method of natural extract
359 total responses 18% Not-for-profit 57% Academic 36% Other (Res. inst., CRO) 9% Government 64% Operating Co. 59% Pharma (diagnostics) 28% Biotech (device) 9% Other (law firm, consultant)
Review of BioPharma in 2009: Deal Reason within Drug Delivery
Primary Reason for a drug delivery deal: a product with novel labeling
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Review of BioPharma in 2009: Expected Route of Administration
Almost 80% of deals involved injectable or oral administration, large molecules predominated in injectable and small molecules predominated in oral.
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Review of BioPharma in 2009: Stage of Development
The largest category of deals were in discovery phase (36%). Registered /Approved product represented ~15% of deals. (n=165)
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Review of BioPharma in 2009: Type of Product
Small molecules represented 38% of the deals (n=184) For small molecules, oncology represented 25% of deals For monoclonal antibodies, oncology products accounted for ~50% of deals
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Review of BioPharma in 2009: Royalty Rate Structure
Majority of deals had royalty rates with flat (or fixed) royalty rates (n=184)
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Review of BioPharma in 2009: Royalty Paid On
Vast majority of royalty rates are paid on net sale (n=151)
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Review of BioPharma in 2009: Royalty Paid On
87% of deals without royalties did not
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Review of BioPharma in 2009: Distribution of Flat Royalty Rates (Preclinical)
~80% of preclinical deals had a royalty rate <6% (n=27) Location of deal did not dramatically impact the royalty on preclinical deals.
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Review of High Tech Survey Report 2011: Respondents
Respondents Primarily from Academia (n=54) & Aerospace/Transportation (n=26)
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Review of High Tech Survey Report 2011: Breakdown of Technology Space
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Review of High Tech Survey Report 2011: Average Royalty Rate by Technology
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