3D Bioprinting and

Intellectual Property Considerations

Cyfuse Biomedical K.K. Jiro (Joe) Ono

jiro.ono@cyfusebm.com

LifeNet Health Jingsong Chen, M.D.

jingsong_chen@lifenethealth.org

Crowell & Moring LLP Lisa A. Adelson ladelson@crowell.com

Michael H. Jacobs mjacobs@crowell.com

mailto:jiro.ono@cyfusebm.commailto:jingsong_chen@lifenethealth.orgmailto:mjacobs@crowell.commailto:mjacobs@crowell.com

3D Printing Market Overview

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Traditional sectors in the 3D printing market: • Automotive • Aerospace • Industrial (e.g., power generation equipment, such

as turbines) • Consumer (e.g., appliances, razors, toothbrush

heads) • Medical (e.g., insulin pen injectors)

What Is Traditional 3D Printing?

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• Process for making a physical object from a three-dimensional digital model, typically by placing numerous successive layers of material.

• Referred to as “additive” manufacturing.

Jiro (Joe) Ono

• Mr. Ono has experience as an international business development manager in the life sciences field.

• Mr. Ono manages Sales & Marketing for

Cyfuse, which has installed four bioprinters in North America.

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What Is 3D Bioprinting?

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Scaffold Free 3D Tissue Fabrication

No Gel. No Scaffold. Only Cells.

Cyfuse Biomedical K.K.

Regenova

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4㎜ 4㎜

10mm

Kenzan 9ｘ9 Standard Type

26 x 26 Standard Type

Regenova Process Flow

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Step 2: Printing Step 1:

Spheroid Prep

500um Approx. 20,000 cells

Cells

Most of constructive cells are usable.

Form spheroid in 96-well plate for 24 hr.

Print on needle array; takes a few hours.

Mature in bioreactor for 2 to 7 days.

Step 3: Maturation

Step 1: Spheroid (Cell Aggregate) Preparation

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500um

Approx. 20,000 cells

Cell

Spheroid

Low Attach Plate

• Nothing is added. • Cells aggregate

by themselves. • Cells are alive inside.

Step 2: 3D Printing into the Kenzan

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Spheroid

• Nozzle picks up spheroid by vacuum and places as 3D designed.

• Spheroid is spatially held by needle.

Pick & Place

Printed

Step 3: Maturation

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• Medium flow between spheroids improves oxygen and nutrient supply.

• Lift up plate for removal.

2~7 Days

Matures in Perfusion Chamber

• Cells fuse together and generate ECM.

Becomes a solid structure

Scaffold-Free Tissue Fabrication

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In Vivo Transplantation

In Vitro Research Model

Nerve Graft Cancer Model Blood Vessel Hepatocyte Toxicity Test

• No foreign materials • Less proving • Reproducible

• In vivo-like environment • Visually observable • Reproducible

Self Organization

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Inside spheroid Hepatocyte (Black): Outside Endothelial cells (Green): inside

4 days after printing

Print 3D structure

Hepatocyte Endothelial cells

Endothelial cells relocate to surfaces in 3D printed tissue

Hybrid Type

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Regenova/Kenzan Method: A World of Possibilities

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Examples • Blood vessel • Liver • Nerve • Heart • Cartilage

A BLOOD VESSEL!

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Jingsong Chen, M.D.

• Dr. Chen is a physician/scientist with experience in translational research, new technology innovation, and business management.

• Dr. Chen is Vice President of Intellectual Property,

General Manager for the Life Sciences Division of LifeNet Health, the world’s largest provider of bio-implants and organs.

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Institute of Regenerative Medicine

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LifeNet’s 3D Bioprinter

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3D Bioprinting Is Applicable to Implants

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Real World Applications for Bioprinting

• What is LifeNet doing with bioprinting? • Results with LifeNet’s bioprinter

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Lisa A. Adelson • Ms. Adelson is a Counsel at Crowell & Moring. She is

a patent attorney with extensive experience in patent prosecution and counseling, including managing patent portfolios and conducting analyses related to major due diligence and patent litigation matters.

• Ms. Adelson is a chemist by training and has broad-

ranging technical experience, including representing clients in the fields of biotechnology, pharmaceuticals, and industrial design.

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Michael H. Jacobs • Mr. Jacobs is a partner in the Intellectual

Property Group at Crowell & Moring and currently serves as the Group's vice-chair.

• Mr. Jacobs focuses on patent, trademark,

trade secret, and copyright infringement litigation, post-grant patent proceedings, intellectual property portfolio management, patent procurement, counseling, and licensing.

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3D BIOPRINTING IS NEW AND IT IS HERE!

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As lawyers, how do we adapt to protect the results of 3D

bioprinting?

The Same 5 Arrows…

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• Utility Patents • Design Patents • Trademarks and Trade Dress • Copyrights • Trade Secrets

Utility Patents

• 35 U.S.C. § 101, Utility (statutory subject matter) • 35 U.S.C. § 112

– Written description – Enablement – Best mode

• 35 U.S.C. § 102, Novelty • 35 U.S.C. § 103, Non-obviousness

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Possible Utility Patent Protection

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• Utility Patents – Obtain patents related to bioprinted tissues

• How does bioprinted tissue differ from native tissue?

• Section 101 issues

– Obtain patents to new, improved printing machines or components of those machines

– Obtain patents related to methods of printing – Obtain patents related to new cell culture media,

new techniques, etc., used in printing.

Design Patents

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35 U.S.C. § 171

“Whoever invents any new, original and ornamental design for an article of manufacture may obtain a patent therefor, subject to the conditions and requirements of this title.”

+

35 U.S.C. § 112 35 U.S.C. § 102 35 U.S.C. § 103

Possible Design Patent Protection

• New machines

• New features of machines

• New instruments (e.g., Kenzan apparatus itself, tools for transferring cell aggregates, etc.)

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Trademark and Trade Dress Protection

A trademark is “any word, name, symbol or device (or any combination thereof) that identifies and distinguishes the source of the goods of one party from those of others.”

A trade dress is the overall commercial image (look and feel) of a product or service that indicates or identifies the source of the product or service and distinguishes it from those of others.

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Protectable under the Lanham Act

• Section 1 (for registered marks), codified at

15 U.S.C. § 1051 • Section 43(a) (for unregistered marks),

codified at 15 U.S.C. § 1125

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DISTINCTIVE

AND

NON-FUNCTIONAL

Requirements for Trade Dress Protection

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PRODUCT PACKAGING

(may be inherently distinctive)

VS.

PRODUCT DESIGN (requires secondary meaning)

TREATMENT OF DISTINCTIVENESS IS DISTINCT

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Trade Dress May Not Be Purely Functional Feature is functional if:

• Essential to use or purpose • Exclusive use puts competitors at non-

reputational disadvantage

Underlying policy rationale: a useful or necessary feature should not be monopolized for unlimited term by trademark laws.

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Enhancing Trademark Protection • Apply mark (e.g., logo) to, or better

yet, into bioprinted materials

• Develop additional commercially identifiable features (e.g., shape, color)

• Ensure that these features *** IDENTIFY and DISTINGUISH ***

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Possible Trademark/Trade Dress Protection

• Color bioprinted products with FDA-approved

coloring agent • Utilize identifiable, non-functional shape • Etch trademark on products • Apply trademark to product packaging

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Copyright Protection

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“Copyright protection subsists, in accordance with this title, in original works of authorship fixed in any tangible medium of expression….”

17 U.S.C. § 102

Possible Copyright Protection

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Copyrights © • CAD files containing digital blueprints for 3D printed

biological tissue may be copyrighted • Control software for machinery

No copyright protection for tissues themselves!

Copyright Term

For works created on or after January 1, 1978,

• For solo creator, author’s life plus 70 years • For a joint work, 70 years after the last surviving

author’s death

• For works for hire, 95 years from first publication, or 120 years from creation, whichever is shorter

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Increased Appeal of Trade Secret

• Some products/processes may be less

amenable to patent protection. • Traditionally protected under state law;

federal protection now available.

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Defend Trade Secrets Act 2016 (DTSA)

“An owner of a trade secret that is misappropriated may bring a civil action under this subsection if the trade secret is related to a product or service used in, or intended for use

in, interstate or foreign commerce.” 18 U.S.C. § 1836(b)(1).

• Effective May 11, 2016

• Three year statute of limitations 40

Benefits of DTSA

• Uniform definition of trade secrets • Uniform standard for misappropriation • Nationwide service of process • Nationwide execution of judgments

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What Is A Trade Secret? “[T]he term ‘trade secret’ means all forms and

types of financial, business, scientific, technical, economic, or engineering information, including patterns, plans, compilations, program devices,

formulas, designs, prototypes, methods, techniques, processes, procedures, programs, or

codes, whether tangible or intangible, and whether or how stored, compiled, or memorialized

physically, electronically, graphically, photographically, or in writing.”

18 U.S.C. § 1839(3).

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What Is Misappropriation? (A) acquisition of a trade secret of another by a person who knows or has reason to know that the trade secret was acquired by improper means; or (B) disclosure or use of a trade secret of another without express or implied consent by a person who—

(i) used improper means to acquire knowledge of the trade secret; (ii) …knew or had reason to know that the knowledge of the trade secret

was— (I) derived from or through a person who had used improper means … (II) acquired under circumstances giving rise to a duty to maintain the secrecy of the trade secret or limit the use of the trade secret; or (III) derived from or through a person who owed a duty to the person seeking relief to maintain the secrecy … or limit the use of the trade secret; or (iii) …knew or had reason to know that—

(I) the trade secret was a trade secret; and (II) knowledge of the trade secret had been acquired by accident or mistake . . . .

18 U.S.C. § 1839(5).

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Possible Trade Secret Protection

• Favored configuration of spheroids • Favored cell types • Preferred settings for equipment • Specialized new media for maturation • Timing of steps

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Trade Secret Applicability

• Reverse engineering is not possible • Restriction of access while still utilizing secret

information • Protection is desired for longer than patent term • Infringement difficult to detect or hard to enforce • Customers receive benefits without knowing

secret information

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Steps To Protect Trade Secrets • Need-to-know access to a limited number of people • Employees sign confidentiality agreements and are

drilled in protection of proprietary information • Non-disclosure agreements for outsiders • Visitors escorted and forbidden from taking photos • Contractors vetted before receiving information • Labs/files/formulae locked or guarded • Mark documents • Documents/files containing secret information signed

out

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LAST,

BUT REALLY FIRST,

Identify trade secret information!

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Back to Reality…

• What has LifeNet found useful in seeking

Intellectual Property rights related to bioprinting?

• What has LifeNet found to be challenging?

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Other Areas of Law Likely To Be Impacted by Bioprinting

• Product liability

– Safety of bioprinted materials • Regulatory issues

– FDA approval of bioprinted materials – Advertising of bioprinted materials

• Corporate issues – Technology transfer – Common interest and joint research agreements

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Questions?

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3D Bioprinting and

Intellectual Property Considerations

Cyfuse Biomedical K.K. Jiro (Joe) Ono

jiro.ono@cyfusebm.com

LifeNet Health Jingsong Chen, M.D.

jingsong_chen@lifenethealth.org

Crowell & Moring LLP Lisa A. Adelson ladelson@crowell.com

Michael H. Jacobs mjacobs@crowell.com

mailto:jiro.ono@cyfusebm.commailto:jingsong_chen@lifenethealth.orgmailto:mjacobs@crowell.commailto:mjacobs@crowell.com

3D Bioprinting �and �Intellectual Property Considerations3D Printing Market OverviewWhat Is Traditional 3D Printing?Jiro (Joe) OnoWhat Is 3D Bioprinting?RegenovaRegenova Process FlowStep 1: Spheroid (Cell Aggregate) PreparationStep 2: 3D Printing into the Kenzan Step 3: Maturation�Scaffold-Free Tissue FabricationSelf Organization�Hybrid Type�Regenova/Kenzan Method:�A World of Possibilities�A BLOOD VESSEL!Jingsong Chen, M.D.Institute of Regenerative MedicineLifeNet’s 3D Bioprinter3D Bioprinting Is Applicable to ImplantsReal World Applications for BioprintingLisa A. AdelsonMichael H. Jacobs3D BIOPRINTING IS NEW�AND IT IS HERE!The Same 5 Arrows…Utility PatentsPossible Utility Patent ProtectionDesign PatentsPossible Design Patent ProtectionTrademark and Trade Dress ProtectionProtectable under the Lanham ActRequirements for Trade Dress ProtectionTREATMENT OF DISTINCTIVENESS �IS DISTINCT�Trade Dress May Not Be Purely Functional�Enhancing Trademark ProtectionPossible Trademark/Trade Dress ProtectionCopyright ProtectionPossible Copyright ProtectionCopyright TermIncreased Appeal of Trade SecretDefend Trade Secrets Act 2016 (DTSA)Benefits of DTSA What Is A Trade Secret?What Is Misappropriation?Possible Trade Secret ProtectionTrade Secret ApplicabilitySteps To Protect Trade SecretsLAST,Back to Reality…Other Areas of Law Likely To Be Impacted by BioprintingSlide Number 503D Bioprinting �and �Intellectual Property Considerations