IP, Licensing, & Open Source in Synthetic Biology: Perspectives …relais-audiovisuel.com/genopole/Gregory_Schreiber.pdf · • Prevent others from filing patents and blocking you

IP, Licensing, & Open Source in Synthetic Biology:Perspectives from Industry

About the Speaker

• Greg Schreiber , Manager of Corporate Development at Life Technologies Corporation

− Life Technologies (Invitrogen) – 4 years− The Johns Hopkins University TTO – 4 years− Washington University – PhD, Immunology− UC Berkeley – BA, Biochemistry

• Life Technologies In-licensing Team

2 | Life Technologies Proprietary & Confidential | 12/19/2010

2

• Life Technologies In-licensing Team− 8 Licensing Professionals (PhD/MBA/Patent Agents/CLPTM)− ~150 Licenses/year: Patent / know-how licenses, biological materials

agreements, sponsored research agreements (excluding CDAs, MTAs)− Based in Carlsbad, California USA

Who is Life Technologies?

We provide:

essential life science

Our Business

Communities where understanding biology

We serve


essential life science technologies through products, systems, services, and expertise

understanding biology and applying that knowledge can make a difference

Recognized Brands


Profile of Life Technologies

Products ~50,000

Customers ~75,000

Revenue ~$3.3B

Employees 9,000


R&D Expenditure ~$334M

Countries 160

Patents, licenses ~3,900

Note: LTC revenue as of December 31, 2009

Build and retain a competitive market position • Raise funding

• Prevent valuable products & services from being commoditized or misused (therapeutics, TOPO®)

• Generate revenue through out-licensing (Taq, qPCR, Quantum Dots)

• Provide leverage for deals

Property Rights Play Critical Roles in Industry:


• Provide leverage for deals

• Prevent others from filing patents and blocking you

Secure freedom-to-operate• Assure rights for you and your customers to practice the technology

without being sued

Roles of Property Rights in the Commercialization of a Research Tool – A Case Study

Product Concept : A kit to deliver genes of interest into target cells and to track the expressed proteins in the cells

� Optimized tet-inducible Lentiviral vector � Cell-specific promoter� GFP tag� Zeocin antibiotic resistance


� Zeocin antibiotic resistance marker

� Transfection Reagent� Viral packaging cell line� Protocol� A university investigator has

built a plasmid with the desirable properties and the university is willing to provide LIFE with the plasmid under a tangible property license.




Lentiviral Vector• Salk Institute Licensee (Pharma) – desired

vector format• Chemical Co – certain uses of lenti

Preliminary Patent Search Reveals…





• Chemical Co – certain uses of lenti• Dana Farber – vector design• Brigham & Women’s – tet-inducible expression• Salk Institute – WPRE Woodchuck expression

enhancer element• Pasteur Institute – cPPT DNA Flap vector

element




GFP Tag• Columbia U. – general IP on GFP• UC Regents – use of GFP as a tag






• UC Regents – use of GFP as a tag• U. Florida / MGH – humanized GFP• GE – uses of GFP for certain screening applications• Stanford U. – specific sequence mutations of GFP




Zeocin• Kaken Pharma – blasticidin antibiotic resistance marker

Transfection Reagent






Transfection Reagent• U. Pitts. – chemical structure of the reagent

Packaging Cell Line• U. Wisconsin – method of using a 293 cell line for

viral packaging

Vector• University X – biological materials (encumbrances?)


Product : A kit to deliver genes of interest into target cells and to track the expressed proteins in the cells

Licensing

LIFE negotiates and executes 15 licenses to

Commercialization

• Product is developed• IP team signs-off

LULLS

• Limited Use Label Licenses are used to


executes 15 licenses to secure the rights necessary to make & sell the kits to enable customers to utilize the product for the desired applications

• IP team signs-off• Manufacturing &

inventory• QA/QC• Technical support team

is trained• Product launch

Licenses are used to convey ‘use’ rights to the customer

• Limitations in LULLS mayexpressly prohibit certain unauthorized uses

• Field restrictions• Manufacturing• Services

• LIFE does not have grant-back requirements in its LULLs

• Foundational Patents – Technical standards, use of cellular machinery for logic/computing functions

Historical Examples:- Wright Brothers: Flying Machine (with controlled flight; pitch, roll & yaw), 5/22/1906- Cohen-Boyer : recombinant DNA technology, 12/2/1980. - James Thomson: WARF stem cell patentsStrategies pursued to license each example had significant impacts on the respective field

New Technology Fields Often Bring New IP & Licensing Challenges – Synthetic Biology


• “Overly” broad patents - patentable subject matter and standards for obviousness/inventive step have some synthetic biologists concerned

• Patent Thicket / “Anticommons” – a large number of patents with different owners may become fragmented such that it’s difficult for a single entity to access all the necessary rights

Patent pooling, as done in the IT industry, could help to facilitate transactions in a crowded IP landscape

• Laws in the US do not support a broad research use exemption- Madey v. Duke University (2002): Scope of the research exemption limited to for

“amusement, to satisfy idle curiosity, or for strictly philosophical inquiry”- Merck KGaA v. Integra Lifesciences (2005): Patented compounds can be used in

pre-clinical studies and clinical trials if the intent is FDA submission.

However,

• Academics generally don’t assert their IP aggressively to block

The Research Use Exemption?


• Academics generally don’t assert their IP aggressively to block other academic’s non-commercial basic research

• Small sampling of US TTOs report a rational forbearance by industry to not assert patents against academics (Nat Biotechnol. 2006 24(1):31)

- Maintain goodwill- The academic may improve the invention and license the improvement back- There is an awareness that these policies may change

Without property rights

• Public domain- No control over who or how technology is used- Limits patentability by others

With property rights : patents, tangible materials, (confidential know-how?), (copyrights?)

Open Source-Type Models for Synthetic Biology


know-how?), (copyrights?)

• Commons- Can control who and how technology is used through Licenses/MTAs - Limits patentability by others

• Expanding Commons- Users of these commons must also contribute their work products back into

the commons

Exactly how a work product is defined and what is included will have a large impact on both academic and industry participation.

Potential Benefits of Open Source to Industry

• Motivate the development of common standards

• Accelerate the field by promoting the sharing and distribution of parts

• Reduce costs of development

• More scientists working on more complex products may drive demand for tools & reagents


• Gene synthesis providers will benefit by synthesizing the parts, devices, and systems customers obtain using open source information

• While FTO analysis would still need to be performed, fewer licenses would likely be needed

• Commercialize open source wares by bundling with other products, services, support, and/or FTO.

Questions & Concerns about Open Source 1• For what uses would open source be open for industry?

− Research, sell as is (quick, reliable, QA/QC, supported, FTO), systems development, sale of the systems and their expressed products?

• Expanding commons are ≈ grant back provisions. − Unless the product line is to be a commodity, indus try must

be able to mix open source with proprietary technol ogies and


be able to mix open source with proprietary technol ogies and retain appropriate rights to stay competitive

− University TTOs currently reject grant-back provisions when receiving materials from industry under MTA. Similarly, the UBMTA provides for the recipient to retain rights to modifications and other substances created by recipient using the materials. Therefore, even university TTOs would likely have issue with the terms of an expanding commons.

Questions & Concerns about Open Source 2• BioBricks-type non-assert ≠ FTO. Industry will perform its own FTO

and could benefit from purchasing from a company that has already assembled some or all of the desired use rights.

• Course of action and accountability if the commons is polluted with proprietary property from a 3rd party? An expanding commons would increase the likelihood of this issue.

• As synthesis costs continue to drop, will parts still be inventoried? If


• As synthesis costs continue to drop, will parts still be inventoried? If not, what property rights will these organizations rely on to remain a commons?

THANK YOU!


Documents

IP, Licensing, & Open Source in Synthetic Biology: Perspectives …relais-audiovisuel.com/genopole/Gregory_Schreiber.pdf · • Prevent others from filing patents and blocking you