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Securing and SharingUniversity Data

Presented to Oregon Health & Science Universityat

Doernbecher Children’s Hospital / Vey AuditoriumPortland, OR

November 4, 2016

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Speakers

• Tammy BuistVice President and Chief Business Development Officer, Cancer Research And Biostatistics (CRAB), Seattle, WA

• Frank X. CurciPartner, Ater Wynne LLP, Portland, OR; Director, Cancer Research And Biostatistics (CRAB), Seattle, WA

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Tammy BuistVice President & Chief Business Development Officer,

Cancer Research And Biostatistics (CRAB)

Tammy is a Vice President and the Chief Business Development Officer of Cancer Research And Biostatistics (CRAB), a Seattle-based bioscience research institution. At CRAB, Tammy is responsible for all Grants & Contracts, and contributes pharmaceutical, biotechnology, venture capital and consulting experience in the cancer field including cancer therapeutics and cancer diagnostics.

Before joining CRAB, Tammy specialized in biotechnology as CEO of Phoenix, Inc., and has been on the leadership team of Tekmira Pharmaceuticals, Epigenomics, Targeted Growth and AnorMED.

Tammy is a member of the Licensing Executive Society, and has an M.B.A. from the Massachusetts Institute of Technology. She holds a B.A. in Chemistry from Whitman College.

Contact Information:[email protected]

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Frank X. Curci, JDPartner, Ater Wynne LLP

Director, Cancer Research And Biostatistics (CRAB)

Frank is a Partner in Ater Wynne LLP, a Pacific Northwest law firm. He is a bioscience, intellectual property, technology, and business attorney and advisor.

Frank works with bioscience companies, bioscience research universities/research institutions, high tech industry companies (ranging from emerging growth companies to global companies), technology accelerators, and other technology-based entities. He advises these entities concerning a broad range of scientific and medical research, technology, intellectual property, policy, governance, corporate, and business matters.

He counsels clients in the bioscience sector regarding collaborations, bioscience alliances, research matters, IP Strategies related to the development or pubic use of the entity’s research/discoveries, IP licensing, additional technology commercialization matters, clinical trial matters, grants, spinout/startups, and internal governance/policies.

Frank is active with various bioscience and high tech organizations. He is an elected Director on the Board of Directors of Cancer Research And Biostatistics (a Seattle bioscience research institution) and the Board of Directors of the Oregon Translational Research & Development Institute/OTRADI (an Oregon nonprofit bioscience entity). He is also a co-founder of the Seattle-based Pacific Northwest Life Sciences Executive Forum, a roundtable for executives from bioscience institutions in the region.

Contact Information: Ater Wynne [email protected] www.aterwynne.com

http://www.aterwynne.com/

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Overview

The Critical Role of Big Data in Research

and Developing Smart IP Strategies for

Data Sharing

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Yesterday and Tomorrow

At this moment less than 0.5% of all data is ever analyzed or used

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What is happening?

•Volume•Variety•Velocity

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Volume

More data has been created in the past two years than in the entire previous history of the human race.

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Variety

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Velocity

Volume per minute

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The Critical Role of Big Data In Research

Apple’s Open Source Research Kit Platform

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Importance for Healthcare

• Estimates suggest that by better integrating big data, healthcare could save as much as $300 billion per year that’s equal to reducing costs by $1000 a year for every man, woman, and child

• The White House has already invested more than $200 million in big data projects

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IP STRATEGIES FOR SHARING DATA

Someone once said to me:“Data is not intellectual property. So, our research institution (or bioscience company) does not need to spend any time negotiating the ownership of the data in this research collaboration because everyone can freely use and share the Data anyway.”

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• While many understand that Data in life sciences research is critical to their R&D . . .

• All parties may not fully appreciate the nuances of: • Whether and to what degree is Data protectable as an “intellectual

property” (IP) right?• If so--what type of IP rights are involved?

• Who owns the IP rights in that Data?• If another party owns the IP rights in that Data

• Can that party try to control your access to & use of that Data?

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• Data arising out of life sciences research is an increasingly valuable asset for both non-profit research institutions and for-profit companies they collaborate with:

• Data is often the “secret ingredient” that’s critical to fully understand and implement the larger discovery

• Analytics-derived data can be particularly important

• Core-underlying data could have more value in its aggregated form depending on its selection criteria and organization

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• Even if your institution wants to promote “open and free” access to Data:• you still need to be concerned about the underlying IP rights in

the Data.

• Why?• You may be asking---why do you need to care about IP if all you

want to do is allow “open and free” access of your Data to others in the scientific community?

• Answer: • You normally cannot give away (ie: openly share) something that

you don’t first own.

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• Securing your IP rights in your Data gives you the “power” to do what you want with your Data:• including any goal or mission you may have to allow open and

free access to your Data by others in the scientific community

• Think of IP rights as your “tool”:• This “tool” gives you the ability to control the “destiny” of your

Data• Including any mission/goal you may have to make sure your Data

is openly and freely accessible by others in the scientific community

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• Before “sharing” any Data, bioscience research institutions should first:• identify all proprietary Data:

• used in their research • otherwise involved in any collaboration with another entity• otherwise under their control

• determine if the Data is protectable IP

• Address who owns/controls the Data and each party’s right to access & use the Data

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• Thus, research Institutions should redouble their efforts to identify all potentially-protectable Data:

• Clinical trial data• Any other data derived or gathered as part of any other

bioscience/medical research • Research lab notes • Data & reports from a confidential pilot project

• Analytics-derived data can be particularly important • Data from beta tests for software applications

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• How Data is Protected by IP:

• Trade Secret protection in USA:• “Trade secret” is confidential / proprietary information of an owner:

• Has commercial value to the owner• Because that information is not generally available to the public• Owner takes reasonable measures to keep information secret

• Examples of Data which may be protectable trade secrets:• Clinical trial data you organize in a special database• Research derived knowledge/data---think about your laboratory notes• Analytics-derived data from a research project or clinical trial

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IP STRATEGIES FOR SHARING DATA• How Data is Protected by IP:

• Copyright protection in USA: • A “work” is protectable under US copyright law if it’s:

• An original “work of authorship” • ie: original to that creator/author

• Fixed in a tangible medium of expression• Not an intangible “idea”

• In other words----original expressions of author are protected

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• How Data is Protected by IP:• Copyright protection (continue):

• Example of Data which may be copyright-protectable:• Lab notes

• Analytics-derived data may have certain copyright protection due to “creativity” in the analytical components

• Databases may have certain copyright protection due to “creativity” in selection criteria & organization of the Data.

• Selection criteria & organization of aggregated core-underlying Data could give rise to certain copyright protection

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• IP Ownership & Controlling Access to Data:• Some people may not fully appreciate the nuances of:

• Who owns the Data• Who may control the Data• Who has a right to use the Data (under what rules)

• Yet, for-profit companies ---including those collaborating with non-profit Research Institutions--- increasingly see tremendous value in Data.

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• IP Ownership & Controlling Access to Data:

• That’s why these for-profit companies are focusing more on ownership of Data and controlling access to Data!

• For-profit companies taking these positions regarding Data:• Increasingly claim they own all IP Rights in the Data

• then try to limit your researcher’s ability to use that Data • by inserting “rules” about that use

• If Research Institution owns the IP Rights in the Data• For-profits try to obtain broad access rights to use that Data

• With limited intervention by the research institution about their use of that Data

• Still try to impose restrictions on Research Institution’s use of its own Data

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• Recommendations about sharing your Research Institution’s Data with other parties:

• Prudent to have a written agreement addressing :• Ownership of Data • Rights to access and use the Data

• Clearly identify and define:• Data that your Research Institution will share with the other party

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• Recommendations about sharing Research Institution’s Data with other parties (continued):• Try to preserve Research Institution’s ownership of IP Rights in the Data

• Clearly define other party’s right to access and use the Research Institution’s Data:

• Will the other party get access to all--or just part--of the Data?• What can the other party do with the Data?• For how long?• Does the other party have to return the Data?

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• Again, you may be asking?• Why worry about these IP issues when sharing my Research

Institution’s Data with others?• What’s wrong if the other party suggests “informality” about how we

share your Research Institution’s Data with the other party?

• Think about this: Could lack of parameters about giving access to your Data evolve into an open “pipeline” of Data from your Research Institution?

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• Recommendations about Research Institution gaining access to Data from other parties you collaborate with:• Better identify new Data that other party may develop during the collaboration

with your research institution:• Including analytics-derived data developed by the other party

• If Data solely created by the other party:• probably have to concede that the other party owns the IP Rights in that new

Data

• But your Research Institution may want/need access to this new Data:• At least to continue your internal research• Thus, you should negotiate contractual provisions:

• Giving your Research Institution access rights to use this “new” Data• Try to minimize any restrictions on your use of this Data.

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• Why you should care about these IP issues when sharing Data?• Your collaboration partners see Data as an extremely valuable

asset which they would like to own and control

• Thus, you should not under-estimate the IP value of Data

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“While patents are king, other IP rights (including Data) are royalty too”

securing and sharing university software and data · securing and sharing university data ... he is...

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