Intellectual property rights are at the heart of virtually every research collaboration between academia and industry, and the negotiation around IP is often contentious, frustrating – and too often a deal-breaker. Every negotiation is unique and loaded with complexity. By gaining practical knowledge of the various situations that arise in these negotiations – and the creative solutions used to resolve them — you can dramatically increase the chances of resolving IP issues and establishing long-term relationships that bring critical benefits to both partners. This practical session will focus on arriving at a win-win strategy for resolving IP-related issues and structuring a deal that benefits both parties. The session will draw from the direct experiences of the speakers in handling sensitive situations, including a role-playing exercise in a mock negotiation to illustrate specific sticking points and showcase proven strategies for resolving them. Here is a brief look at the areas covered: Who owns the foreground IP? Rights to background IP? Publication Patent prosecution Patent enforcement Research, Development & Commercialization Improvements Other issues in IP negotiations Mock negotiations to illustrate win-win resolutions We’ve teamed with a pair of experts with extensive experience on both sides of the table. Join Dr. DJ Nag, PhD, MBA, CLP, RTTP, President of Innovaito, LLC, and Tatiana Litvin-Vechnyak, PhD, Vice President of Technology Commercialization for Georgetown University, for this important program

1. § DR.TATIANA LITVIN-VECHNYAK
§ PROF. DJ NAG
Acknowledgment to Alan Naidoff, ex-Merck

2. KEY TOPICS FOR TODAY’S DISCUSSION
§ General Philosophy
§ Who Owns The Foreground IP*
§ Rights to Background IP*
§ Publication*
§ Patent Prosecution*
§ Patent Enforcement*
§ Research, Development & Commercialization*
§ Improvements*
§ Other Issues
§ Conclusions

3. GENERAL PHILOSOPHY: INDUSTRY
PERSPECTIVE
§ Looking to university/research institution for:
§ subject matter expertise;
§ special skills/equipment/research tools;
§ Increase resources
§ University provides Research, not Development (well, maybe not?)
§ IP among most strategic assets
§ Protect product development investment
§ Control competition, product differentiation
§ For many, without IP, you’re out of business
§ Proper Case Selection – Too proprietary, keep in-house.
§ Industry has competition

4. Pharma/Biotech
§ IP provides licensing
revenue and product
protection
§ If we pay for the research,
why don’t we own it
(results and/or IP)
§ Exclusivity maybe the key
§ Only 1 or a few patents
are possibly relevant
IT
§ IP provides defensive
protection
§ Due to cross-licenses,
may be little value in
owning patents even if we
pay for it.
§ Non-exclusive license is
all we need.
§ 500,000+ patents are
possibly relevant

5. GENERAL PHILOSOPHY:
UNIVERSITY/RESEARCH INSTITUTION
PERSPECTIVE
§ IP is important to a Research Institutional (Bayh-Dole) but is
not essential or top priority as compared to industry. We
protect it when commercially viable or requested by an
industry collaborator
§ More important to publish, obtain grants and educate
students.
§ Protection of intellectual property to encourage
commercialization is an obligation under Bayh-Dole for
federally funded research and is increasingly a goal outside
of federal funding
§ Difficult for institution to carry unreimbursed IP costs for
long; thus the goal is to patent when partnership w/ industry
is likely.

6. WHO OWNS THE FOREGROUND IP?
INDUSTRY PERSPECTIVE
§ IP among most strategic assets; goes to the core of industry
vitality and objectives
§ Possible licensing revenue; necessary for viable product
§ Pharma: If we pay for it, we need access?
§ IT: may provide more value to have school own it. Better able
to negotiate overhead fees (≈50-55% of funds).
§ Differentiate: new compound /
transferred material/research tool
§ Ownership vs. License Right (exclusive/non-exclusive)
vs. Option right

7. WHO OWNS THE FOREGROUND IP?
UNIVERSITY/RESEARCH INSTITUTION
PERSPECTIVE
§ ** Distinguish between Service Agreement, Sponsored Research
Agreement and Collaborative Research Agreement
§ Based on whose employees invented or created it
§ Rarely is IP developed by industry funds alone – Bayh Dole and
other implications
§ Research projects rarely reflect the entire cost, even when “full”
indirect costs are included
§ Government funds created the specialized research facility,
equipment and capabilities required for the project
§ Background IP
§ Government-owned inventions have additional considerations
§ Public domain is OK for some types of inventions

8. WHO OWNS THE IP?
UNIV./RES. INSTITUTION PERSPECTIVE (CONT’D)
§ Other arrangements could affect university tax-exempt bond
status
§ Revenue Procedure 97-14
§ “safe harbor” for certain types of activities
§ “The sponsor must pay a competitive price for use.”
§ License fee must be determined at the time the resulting technology is
available for use

9. BACKGROUND RIGHTS: INDUSTRY
PERSPECTIVE
§ If we’ve paid for the research and can’t benefit from the
discoveries because of your blocking technology, is that fair?
§ Professor in position to contaminate new research with
background IP.
§ When we license something we expect to be able to use it.

10. BACKGROUND RIGHTS:
UNIVERSITY/RESEARCH INSTITUTION
PERSPECTIVE
§ Granting a sponsor an unfettered right to any and all
background technology
§ Ties up the technology
§ If free, gives sponsor un paid-for benefits
§ Can impact researchers who aren’t benefiting from the
sponsored research
§ Government-owned technology licensed separate from the
research agreement
§ Look to provide research-only licenses to others, as needed

11. PUBLICATION: INDUSTRY PERSPECTIVE
§ Industry understands university/research institution’s need to
publish
§ Industry may seek “reasonable” limitations on publication
right
§ Exclusion of confidential information
§ Exclusion of information that adversely affects patent rights
§ Post-AIA Changes

12. PUBLICATION: UNIVERSITY/RESEARCH
INSTITUTION PERSPECTIVE
§ University/research institution must publish but can:
§ Agree to delay for a short period of time to allow for patent
protection
§ Agree not to publish someone else’s (identifiable) confidential
information

13. PATENT PROSECUTION: INDUSTRY
PERSPECTIVE
§ Industry usually more aware of competitive environment and
can direct prosecution accordingly; timing of filings,
countries, claim structures
§ Depending on exclusivity, industry usually pays for some or
all of patent prosecution.
§ Whoever owns or has exclusive license should control and
pay for prosecution.

14. PATENT PROSECUTION:
UNIVERSITY/RESEARCH INSTITUTION
PERSPECTIVE
§ We must control prosecution and counsel for our inventions
§ It’s our asset!
§ However, copies and allows (and encourages) comments from
industry partner (Licensee)
§ May also allow industry to choose patent counsel provided
counsel is acceptable and will recognize research institution as
client
§ Costs generally to be paid by exclusive licensee for any
commercialization agreements other than reagents

15. PATENT ENFORCEMENT: INDUSTRY
PERSPECTIVE
§ Industry in the business of protecting technology and using patent
litigation to protect competitive position
§ Industry pays for its own participation; damages may be split with
university/research institution depending on exclusivity, royalties and
university/research institution involvement
§ Standing to sue likely to require “substantially all rights” under the
patent.
§ Orange Book listing requires exclusive rights

16. PATENT ENFORCEMENT:
UNIVERSITY/RESEARCH INSTITUTION
PERSPECTIVE
§ Cautious approach to risk
§ Balance with exclusive Licensee partner
§ Funding of activity
§ Resource management
§ Non-exclusively licensed technology – litigation is a rarity
§ Not generally worried about being co-plaintiff, so long as
licensee pays but reputation is important
§ Wants a path to make life-saving drugs available in
developing countries

17. RESEARCH, DEVELOPMENT &
COMMERCIALIZATION:
INDUSTRY PERSPECTIVE
§ Industry will develop and commercialize if economically
favorable to do so; specific diligence obligations are
disfavored, unpredictable and often inconsistent with other
products
§ Funded product development program in lieu of milestones
§ Unrestricted territory and field of use

18. RESEARCH, DEVELOPMENT &
COMMERCIALIZATION: UNIVERSITY/RESEARCH
INSTITUTION PERSPECTIVE
§ University/research institution has affirmative obligation to
bring technologies forward so that the public can benefit
§ “Putting it on the shelf” breaches this obligation
§ Must have due diligence obligations that allow them to find
another way if technology is not being moved forward by
company
§ Lab must be free to continue research & develop new or even
competing technology
§ Need to protect future careers of inventors from infringement
blockade

19. IMPROVEMENTS:
INDUSTRY PERSPECTIVE
§ Industry would like to have all future improvements made to a
sponsored research invention be made available
§ The improvement that is made by university should be
licensed under the same terms as the original invention
§ University should not “double dip” for the same kind of
invention
§ University should not work with competitors with the original
invention to create an improvement that may be competitive
to the sponsor

20. IMPROVEMENTS:
UNIVERSITY/RESEARCH INSTITUTION
PERSPECTIVE
§ Improvements covered by existing patents and/or funded by
Industry Partner vs.
§ Improvements NOT covered by existing patents (but closely
related) or NOT funded by Industry Partner
§ Research institution position is that improvements covered by
existing patents AND funded by industry partners follow
terms of contract. Everything else is a separate negotiation.

21. § Collaborative research provides universities and industry
(and society) with substantial benefits
§ The parties must be willing to strike a balance between
their often conflicting interests, especially regarding:
§ IP ownership and rights retained by the university or
granted to the research sponsor or collaboration
§ Handling (& licensing) co-owned inventions arising
from joint research projects
§ Right to the free publication of results
§ Making inventions available under conditions that
promote their effective development and utilization
§ Few issues cannot be resolved if the parties are motivated
to obtain the many benefits of sponsored or collaborative
research