Its Not Just Boilerplate! Best practices for drafting collaboration - - PowerPoint PPT Presentation

MARCH 13, 2013

By Elizabeth A. Howard, Ph.D. & Michael C. Spillner

It’s Not Just Boilerplate!

Best practices for drafting collaboration agreements to protect your IP

Elizabeth A. Howard, Ph.D.

Presenters

Michael C. Spillner

• Orrick IP partner
• J.D., Hastings College of the Law
• Ph.D., U.C. Berkeley, Molecular Biology
• Orrick IP partner
• J.D., Stanford Law School
• B.A., UCLA

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• 1. The collaboration conundrum
• 2. The Tekmira case: a cautionary tale

Outline

• 3. Best practices for drafting specific provisions

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• 1. The collaboration conundrum
• 2. The Tekmira case: a cautionary tale

Outline

• 3. Best practices for drafting specific provisions

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• Collaborations are for the parties’ mutual benefit,

The collaboration conundrum

Collaborations are for the parties’ mutual benefit,

• but their interests are never fully aligned.

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• A collaborator today can be a competitor tomorrow.

The collaboration conundrum

• A collaborator today can be a competitor tomorrow.

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The risk

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The risk

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• rock the boat
• achieve clarity

Strategies to deal with the conundrum

• limit access
• don’t share what you can’t afford to lose

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• 1. The collaboration conundrum
• 2. The Tekmira case: a cautionary tale

Outline

• 3. Best practices for drafting specific provisions

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The Tekmira case: a cautionary tale

• drug development collaboration
• collaborators became competitors
• lawsuit over IP ownership

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• 1. The collaboration conundrum
• 2. The Tekmira case: a cautionary tale

Outline

• 3. Best practices for drafting specific provisions

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• confidentiality clauses
• IP clauses

Best practices for specific provisions

• license and sublicense rights
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• confidentiality clauses
• IP clauses

Best practices for specific provisions

• license and sublicense rights
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Confidentiality clauses

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Confidentiality clauses: non-use

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Confidentiality clauses: non-disclosure

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• Exceptions – they can swallow the rule.
• Confidentiality clauses: exceptions

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• known by receiving party prior to effective date
• lawfully disclosed to receiving party by another
• the information becomes published through no fault of

Standard exceptions

• the information becomes published through no fault of

the receiving party

• independently developed by receiving party without

reference to the confidential information

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information can be disclosed if “reasonably necessary” to

Non-standard exceptions

information can be disclosed if “reasonably necessary” to conduct clinical trials or obtain regulatory approval

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information can be disclosed if “reasonably necessary” for

Non-standard exceptions

information can be disclosed if “reasonably necessary” for the prosecution or maintenance of patent rights

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information can be disclosed if “reasonably required” for a party to obtain financing or conduct discussions with development or commercialization partners, so long as

Non-standard exceptions

development or commercialization partners, so long as such third party recipients are bound by an obligation of confidentiality

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information can be disclosed if “reasonably required” for a party to obtain financing or conduct discussions with development or commercialization partners, so long as

Non-standard exceptions

development or commercialization partners, so long as such third party recipients are bound by an obligation of confidentiality

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information can be disclosed if “reasonably required” for a party to obtain financing or conduct discussions with development or commercialization partners, so long as

Non-standard exceptions

development or commercialization partners, so long as such third party recipients are bound by an obligation of confidentiality

• or: “You must keep my information confidential

. . . . unless you can sell it.”

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information can be disclosed if “reasonably required” for a party to obtain financing or conduct discussions with development or commercialization partners, so long as

Non-standard exceptions

development or commercialization partners, so long as such third party recipients are bound by an obligation of confidentiality

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information can be disclosed if “reasonably required” to

Non-standard exceptions

information can be disclosed if “reasonably required” to comply with applicable laws or regulations or legal process

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Notice and consent

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Limitations on disclosures

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• limit disclosure to specific persons named in advance in writing
• limit disclosure to specific purpose
• require employees to personally execute NDA

Advanced confidentiality protection

• require employees to personally execute NDA
• require encryption and passwords for electronic files
• require maintenance of access log and audit rights
• prohibit any disclosure to third parties
• always require advance notice & written consent

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• confidentiality clauses
• IP clauses

Best practices for specific provisions

• license and sublicense rights
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• example provision

IP Clauses

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• ownership – keep with original owner
• how to define

Preexisting IP

• right to use / license / sublicense

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when one party uses the information it learns from the collaboration as a starting point for new inventions

Improvements / derivatives

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Patent thicket

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Your Your IP IP Your Your IP IP

Patent thicket

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Your Your IP IP Your Your IP IP

• threshold issue of whether to allow improvements
• if you decide to allow improvements
• specify purposes for which improvements can be made

Improvements / derivatives

• specify purposes for which improvements can be made
• address ownership
• address ability to use, license, sublicense improvements

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• defining collaboration IP
• consider periodic updates to ensure parties are on same page
• consider streamlined arbitration process to resolve disputes

Collaboration IP

• consider streamlined arbitration process to resolve disputes
• ownership of collaboration IP
• rights to use, license, sublicense collaboration IP

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Right to patent

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• preexisting IP
• improvements

Right to patent

• collaboration IP
• notice & consent

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• confidentiality clauses
• IP clauses

Best practices for specific provisions

• license and sublicense rights
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Ownership Ownership

Ownership vs. licensing

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License License

clarify what is being licensed

• patents
• know-how

License grant

• know-how
• other rights
• other information

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clarify scope of license

• right to use, commercialize, manufacture, etc.
• for any purpose, or only purpose of collaboration?

License grant

• for any purpose, or only purpose of collaboration?
• for any use?
• for whose benefit?

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decide whether to allow sublicense rights or not

• you may lose control over your IP

Sublicense rights

• you may not be getting an appropriate benefit
• you may lose business opportunities

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if you decide to grant sublicense rights

• get the appropriate benefit of any sublicense

Sublicense rights

• get the appropriate benefit of any sublicense
• protect your information

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• rock the boat
• clarity and transparency

Best practices

• limit access of what is shared
• don’t share what you can’t afford to lose

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• For copies of this presentation
• and MCLE forms, please visit:

Thank you

• http://www.orrick.com/Events-and-

Publications/Pages/It-Is-Not-Just-Boilerplate.aspx

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Elizabeth A. Howard, Ph.D.

Thank you

Michael C. Spillner

ehoward@orrick.com (650) 614-7316 mspillner@orrick.com (650) 614-7395

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