Biotechnology and the Law

Name: Biotechnology and the Law
Brand: American Bar Association
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Hugh Wellons Robert F. Copple Bill Wofford(Autor*in)

American Bar Association (Verlag)

2. Auflage

Erschienen am 1. April 2020

1200 Seiten

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Inhalt

Intro
Title Page
Copyright Page
Contents
Preface
About the Editors
About the Authors
Chapter One: Introduction to Biotechnology and the Law
A. The Biotech Primer
B. Biotech Defined
1. Three-Branch Approach
C. The Biotech Company Life Cycle
1. Phase I: Startup
a. Intellectual Property
b. Company Formation
c. Investment Capital
2. Phase II: Early Development
a. Additional Investment
b. The Regulatory Track
c. Business Growth and Complexity
3. Phase III: Later Stage Development and Product Approval
4. Phase IV: Challenges Facing the Now Mature Company
a. Commercialization
b. Regulatory Oversight
c. Litigation
D. Conclusion
Chapter Two: Managing Innovation: Patent Basics for Biotechnology Counsel
A. Introduction to Patents
B. U.S. Patent Portfolios
1. Introduction
2. Changes to the U.S. Patent System
a. Patent Term
b. The America Invents Act
3. What Is-and Is Not-Patentable?
a. Laws of Nature
b. Abstract Ideas
4. Requirements for Patentability-New, Useful, and Nonobvious
a. Novel
b. Nonobvious
c. Utility
d. Other Requirements
5. Patent Application Process
a. Types of U.S. Patents
b. Provisional Applications
c. Utility and Patent Cooperation Treaty Patent Applications
d. Preparing the Patent Application
e. Filing the Patent Application
f. Publication of Patent Applications
g. Patent Prosecution
6. Post-Issue Patent Considerations
a. Maintenance Fees
b. PTAs and Extensions
c. Corrections to the Patent
d. Additional Patent Applications
e. Post-Issue Patent Challenges
C. Foreign Patent Portfolios
1. Protection Strategy
2. Patentability Differences
3. Other Considerations
4. Prerequisites to Filing
5. Options for Filing in Other Jurisdictions
6. Additional Considerations
D. Managing the Company's Patent Estate
1. A Family Portrait
2. Keeping It in the Family
3. Skeletons in the Closet
a. Rights of Ownership
b. Correspondence to Products or Business Strategies
c. Freedom to Operate
Chapter Three: Company Formation
A. Introduction
1."But Will It Help Us Get Money?"
2. The Importance of the Board of Directors
3. Speed
4. Simplicity
5. Founders
6. Financing and Product Development Plan
7. The Role of the Company's Attorneys
B. Biotechnology Company Models
1. Company Formed before In-Licensing While Research and Development Continues at University
2. Technology Flip
3. Revenue-Funded Company
4. Corporate Deal-Funded Company
5. Holding Company and Series LLC
6. Venture Fund-Launched Company
7. Angel Investor-Funded Company
8. Significant Self-Funded Company
9. Shoestring Self-Funded Company
10. Charitable Corporation or Foundation
11. Debt-Funded Company
C. Building a Strong Team
1. Founders
2. Board of Directors or Board of Managers
3. Scientific Advisory Board
4. Management
a. Chief Executive Officer
b. Chief Financial Officer
c. Chief Scientific Officer
d. Clinical/Regulatory
5. Employees
D. Entity Selection and Formation
1. No Perfect Choice
2. Sole Proprietorships and Partnerships
3. C-corporations
a. Limited Liability
b. Centralized Management
c. Owners
d. Transferability of Ownership
e. Classes of Ownership
f. Incentive Compensation
g. Taxation
4. S-corporations
a. Shareholder Type
b. Shareholder Number
c. Shareholder Residency
d. Class of Stock
e. Other Considerations
5. LLCs
a. LLC Organization
b. Advantages
c. Problems Using an LLC
6. Exotic Entity Types
7. State of Incorporation or Organization
8. Name Selection
a. Trademark Search
b. Unique Name
c. Trademark Registration
d. Foreign Registration
e. State Corporate Law
E. Capital Structure and Stock Grants
1. Introduction
2. Securities Law Compliance
3. Founders' Stock, Restricted Stock, and Stock Options
a. Grants or Sales of Stock
b. Restricted Stock
c. Warrants and Stock Options
4. Common and Preferred Stock
5. Convertible Debt
6. Simple Agreement for Future Equity
7. Series Seed Preferred Stock
F. Incubators
G. University Relationships
H. Early Stage Company Agreements
1. Brief Review of Intellectual Property for the Non-Intellectual Property Attorney
a. Patents
b. Trade Secrets
c. Trademarks
d. Copyrights
2. Confidentiality Agreements
3. Material Transfer Agreements
4. Research Collaboration Agreements
I. Positioning for an Exit
Chapter Four: Acquisition of Biotechnology-Technology Transfer
A. Technology Creation
1. Protecting Propriety of the Invention in the Early Stages
a. Confidentiality Agreements
b. Who Was First?
c. Company Records
2. Keeping Necessary Records
3. Who Owns What? (Employer versus Employee and Joint Venture Issues)
a. Work Made for Hire
b. Employee Rights
c. State Laws
d. Canadian and European Union Laws
e. Trade Secrets
f. Joint Venture Ownership
4. Patent Filing: Protecting an Invention and Limiting Others' Use
a. Why File a Patent?
b. Patent Requirements
c. Patent Claims and Rights
d. Types and Stages of Patents
e. Patent Prosecution
f. Post-Issue Considerations
g. Foreign Patent Filing
5. Possible Effects of Outside Funding
a. Ownership
b. Public Domain
c. Manufacturing or Sales Restrictions
B. Forms of Technology Transfer
1. Acquisition of Owner
a. Acquiring the Owner
b. Employing the Owner
2. Assignment
3. License and Sublicense
a. Common Form of Transfer
b. Alternative to Assignment
c. Sublicense
4. Fair Use Agreement
a. Fair Use and Experimental Use
b. Fair Use Agreements
c. Doctrine and Agreements' Effect on IP Ownership and Due Diligence
5. Public Domain
C. Typical Considerations of the Licensor
1. Having Incentives to Disclose Inventions
2. Considering First to Invent versus First to File
3. Deciding Whether to License to Startups versus Established Companies
4. Emerging and Early Stage of Technology
5. Reimbursing the Cost of IP Protection
6. Disconnect between Universities/Nonprofits and Industry with IP Rights Arising from Sponsored Research
7. Education of Faculty and Staff Regarding IP Issues
8. Free or One-Size-Fits-All Models for Technology Licensing
9. Additional Considerations
a. Assignment
b. Royalties
c. Confidence in Licensee
d. Reimbursement of Patent Costs
e. Consultation/Say-So in Approving Sublicensees
f. Statement Licensee Will Not Sue
g. Requirement That Sublicensees Are Subject to License Terms
h. Who Is on the Hook?
i. Indemnification
j. Minimal Representations and Warranties
k. Sufficiency of Insurance
l. Trademark Protection
m. Original Missions
n. Due Diligence Milestones and Fair Return Targets to Satisfy Bayh-Dole Act
o. Reporting
p. Sponsored Research Opportunities
D. Transfer from Academia
1. University Considerations
a. Considerations of Employee/Researcher
b. Considerations of Community and Society (and Also, Sometimes, the University)
2. Material Transfer Agreements
3. Principal Investigator Considerations
a. Conflict of Interest and Conflict of Commitment
b. Conflict of Interest
c. Conflict of Commitment
d. Special Knowledge
4. Licensee Considerations
a. Policies and Procedures
b. It Is a Long Way to Market, So Wrap Up the People You Need
c. Public Disclosure?
d. Stakeholders
5. Interests of Other Stakeholders
a. Other Underwriters
b. Government Agencies
c. Special Government Considerations
d. Nonprofits
6. Common Restrictions
a. License Only, Not an Assignment
b. Time Limitations
c. Restrictions on Participation by the Inventors
d. Audit
e. Scope of License
f. Indemnification
g. Sublicense Approval
h. Sublicensee Subject to License Terms
i. Original Licensee Always Liable
j. Cannot Use the Name of the University
k. Government Has a License
l. Other Restrictions
7. Common Guidelines for Price and Provisions of the License
a. Standstill Fee
b. Up-Front License Fee
c. Minimum Annual Payments
d. Periodic Licensing Fees (Such as Quarterly or Annual)
e. Participation in Third-Party Payments
f. Lump Sum Royalties
g. Milestone Payments
h. Sales-Based Royalties
i. Equity in the Licensee
j. Equity Protections
k. Put of Shares
l. A Time for Sale
8. When Equity Is the Primary Consideration for the License
a. Equity
b. Activity
9. Applicability of Bayh-Dole Act
a. Written Employee Agreements
b. Royalty Sharing
c. Reporting
d. U.S. Manufacturing
e. United States Retains License
f. License Only, No Assignment?
g. Termination of License If Commercialization Is Inadequate
h. Other Considerations
10. Application of "CREATE" Act of 2004
11. Conflict between Publication and Protection of IP
a. Academicians Want to Publish
b. Licensee Due Diligence
E. Transfer from Other Nonprofit Entities
1. Implications of Nonprofit Status
2. Unrelated Business Income Tax
3. Priorities of Nonprofit Technology Owner
4. Joint Venturing (Especially Qualification for STTR Grants)
a. SBIR Grants
b. STTR Grants
c. Problems with STTR and SBIR Grants
5. Common Misconceptions F.
1. Consideration of Terms
a. Parties
b. Recitals
c. Definitions
d. Property Licensed
e. Scope of the Assignment or License
f. Territory
g. Right to Sublicense
h. Follow-on and Later-Developed Technology
i. Term and Renewal of License
j. Termination
k. Deliveries
l. Retention of Rights
m. Payments
n. Audit Rights
o. Reporting and Marketing Responsibility
p. Representations and Warranties of the Inventor
q. Indemnification
r. IP Protection
s. Insurance
t. Assignability
u. Amendments
v. ADR
w. "Boilerplate" Language
2. Common Negotiation Points
a. Price Paid/Consideration
b. Fees and Royalties Are Both Negotiable Points
c. Records and Reporting
d. Warranty
e. Indemnification
f. IP Matters
g. Confirmation of Ownership
3. Patent Filing
G. Summary-What We Learned in Kindergarten
Chapter Five: Financing a Biotech Company
A. Overview
1. Drug Development Costs
2. Product Development Time Lines
B. Basic Securities Law Considerations
1. Registration or Exemption under the Securities Act
2. Section 4(2) Exempt Transaction
3. Regulation D Exempt Transaction
4. New Section 4(6) "Crowdfunding" Exempt Transaction
5. Rule 701-Compensation Plans
6. State "Blue Sky" Laws
C. Pre-Seed and Seed Capital
1. Founders' Stock
a. Restrictions on Transfer
b. Vesting
c. Lock Up
d. Drag Along
2. Employee Stock
a. Plan Basics
b. Securities
c. Tax
d. Corporate
e. Commercial
3. Stock to Service or Technology Providers
a. Securities
b. Tax
c. Conflicts of Interest
4. Friends and Family
a. Securities
b. Corporate
5. Crowdfunding
a. Securities
b. Corporate
c. Commercial
6. Angel Investors
a. Securities
7. Loans
8. Generating Revenues to Reduce or Defer Need for Investment
a. IP
b. Commercial
9. Government Funding
a. SBIR Grants
b. STTR Grants
c. Advantages to Receiving Federal Grant Funding
d. Disadvantages to Receiving Federal Grant Funding
e. Eligibility/More Than 50 Percent Rule
f. State Resources
D. Venture Capital
1. Financial Rights
a. Valuation
b. Liquidation Preference
c. Participating Preferred
d. Accruing Dividends
e. Protection of Ownership Percentage
2. Governance Rights
a. Board Representation
b. Protective Provisions/Class Voting
3. Exit Rights
a. Registration Rights
b. Redemption Rights
c. Co-Sale Rights
4. Pay-to-Play Provisions
5. Series B-Time to Start All Over
E. Corporate Investment
F. Philanthropic or Social Investing
G. IPO
H. Post-IPO Financing
1. Private Investments in Public Equity
2. Convertible Debt
3. Project Finance
I. Conclusion
Appendix A: Glossary of Frequently Used Basic Equity, Venture Capital, and Securities Law Terms
Basic Equity Terms
Venture Capital Terms
Securities Law Terms
Chapter Six: Employment Issues for Biotechnology Companies
A. Employment at Will
B. Employee or Independent Contractor
1. The Common Law Control Test
2. The IRS 20-Factor Test
3. New IRS Guidance
a. Behavioral Control
b. Financial Control
c. Relationship
4. The Economic Reality Test
5. Potential Liability
C. Employer Coverage under Federal Civil Rights Laws
1. Title VII of the Civil Rights Act of 1964 (42 U.S.C. § 2000e et seq.)
a. Basic Coverage
b. Sexual Harassment
2. ADEA (29 U.S.C. § 621 et seq.)
a. Basic Coverage
b. Older Workers Benefit Protection Act
3. ADA (42 U.S.C. § 12101 et seq.)
a. Basic Coverage
b. Reasonable Accommodation
4. Equal Pay Act (29 U.S.C. § 206(d))
5. Genetic Information Nondiscrimination Act of 2008 (Pub. L. No. 110-233, 122 Stat. 881)
D. Employer Coverage under State and Local Civil Rights Laws
1. State Civil Rights Law
2. Local Laws and Ordinances
E. Equal Opportunity and Affirmative Action Obligations of Government Contractors and Subcontractors
F. Other Federal Employment Laws
1. FLSA (29 U.S.C. § 201 et seq.)
a. Basic Coverage
b. Basic Requirements
c. Overtime Exemptions
d. Child Labor
e. Recordkeeping
2. FMLA (29 U.S.C. § 2601 et seq.)
3. NLRA (29 U.S.C. § 151 et seq.)
a. Coverage of the NLRA
b. Employee Rights under the NLRA
c. "Protected Concerted Activity"
d. Union Organizing
e. NLRA Applicability to Nonunion Employers
4. ERISA (29 U.S.C. § 1001 et seq.)
5. Occupational Safety and Health Act (29 U.S.C. § 651 et seq.)
6. Immigration Reform and Control Act of 1986 (18 U.S.C. §§ 274A-274C)
7. Uniformed Services Employment and Reemployment Rights Act of 1994 (38 U.S.C. § 4301 et seq.)
8. Fair Credit Reporting Act (15 U.S.C. § 1681 et seq.)
a. Written Notice and Authorization
b. Adverse Actions Procedures
9. Employee Polygraph Protection Act (29 U.S.C. § 2001 et seq.)
10. The Affordable Care Act-Nursing Mothers (29 U.S.C. § 207(r))
G. Use of Employment Contracts
1. When Is an Employment Agreement Useful?
a. Security
b. Recruitment Incentive
c. Defined Performance Expectations
d. Defined Compensation Expectations
e. Confidentiality and Intellectual Property Ownership
2. Items to Be Covered
a. Duration
b. Position and Title
c. Compensation
H. Employee Handbooks
1. Pros and Cons of Using
a. Reasons for Using
b. Reasons for Not Using
2. Items to Be Covered
a. Disclaimers and At-Will Statements
b. EEO Policies
c. Harassment Policy
d. Family and Medical Leave Policy
e. E-mail, Computer Usage, and Social Media Policies
f. Description of Benefits
g. Discipline Policy
I. Immigration Options for Biotech Employees
1. Obtaining a Visa and U.S. Entry
2. Nonimmigrant Visas
a. H-1B "Specialty Worker" Visa
b. TN "NAFTA Professional" Visa
c. L-1 "Intracompany Transfer" Visa
d. E-1 "Treaty Trader" and E-2 "Treaty Investor" Visas
e. E-3 Visa for Australian Professionals
f. O-1 "Extraordinary Ability Alien" Visa
g. F-1 Student Visa and Practical Training
3. Immigrant Visas and Permanent Residence Status
a. EB Preferences
b. Visa Backlogs and Priority Dates
c. Labor Certification
d. Immigrant Visa and Adjustment of Status
Chapter Seven: Regulation of Preclinical Research
A. Introduction
B. Animal Use in Biomedical Research and Testing
1. The Basic Regulatory Scheme-The Animal Welfare Act and Regulations
a. Overview of the AWA
b. Overview of the AWA Regulations
c. Implementation and Enforcement of the AWA and the AWA Regulations by APHIS
2. U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training
3. Memorandum of Understanding among APHIS, the Food and Drug Administration, and the NIH
4. NIH Considerations
a. Health Research Extension Act
b. NIH Extramural Research
c. Guide for the Care and Use of Laboratory Animals and Institutional Animal Care and Use Committee Guidebook
d. NIH Policies Regarding the Use of Chimpanzees in Research
5. FDA Considerations and Good Laboratory Practices
6. CDC Considerations
7. State Law
8. Conclusion
C. Other Regulatory Schemes Applicable to Preclinical Research- Protection of the Environment and Public Health
1. Introduction
2. EPA Jurisdiction and the Resource Conservation and Recovery Act
3. Applying Environmental Law to Academic Research Facilities
4. IACUC Responsibility
5. The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and Select Agents and Toxins
D. Other Regulatory Schemes Applicable to Preclinical Research-Occupational Safety and Health Considerations and the Protection of Individuals Conducting Preclinical Research
1. Introduction
2. OSHA Regulation, Standards, and Resources
3. Selected Resource Tools-Chemicals and Biohazards
4. Radioactive Materials in the Research Setting
E. Conclusion
Key Acronyms Used
Chapter Eight: Research and Development Collaborations
A. Introduction: The Collaborator as Biotechnology's White Knight
B. Finding a Strategic Partner: Beating the Mathematical Odds
1. Don't Expect Big Pharma to Find You
2. It's About the Science
3. Approaching Big Pharma with an Opportunity to Collaborate
4. Use of Third Parties as Valuable Contacts
C. Negotiating a Term Sheet
1. The Importance of the Term Sheet to the Transaction
2. Issues Crucial to Address at the Term Sheet Stage
3. Issues to Avoid Negotiating at the Term Sheet Stage
D. Key Issues in a Research Collaboration Agreement
1. Governance of the Research Collaboration
a. Composition of the Joint Steering Committee
b. Duties of the Joint Steering Committee
c. Meetings of the Joint Steering Committee
d. Decision Making by the Joint Steering Committee
2. The Scope of the Collaboration
a. Field
b. Scope Limitations Based on Patent Family
c. Scope Limitations Based on Timing
d. Scope Limitations Based on Project Funding
3. IP
a. Core IP of the Target, Developed Prior, but Highly Relevant, to the Collaboration
b. Core IP of the Larger Funding Partner, Developed Prior, but Highly Relevant, to the Collaboration
c. Background IP of the Target, Developed Prior to the Collaboration but of Possible Utility
d. Background IP of the Larger Funding Partner, Developed Prior to the Collaboration but of Possible Utility
e. IP Developed by One or Both Parties Arising out of the Collaboration
f. IP Developed by the Target during, but outside of, the Collaboration
g. Novel IP Developed by One or Both Parties during the Collaboration That Does Not Arise out of the Existing IP of Either Party
4. License Grants
a. Research Licenses
b. Development and Commercialization Licenses
c. Cross-Licenses
Freedom to Operate
d. Enabling Licenses
e. License as Protection against Infringement Claims
f. Protect the IP against a Later Attack on the Patents
5. Financial Terms
a. Signature Payments
b. Research Funding
c. Equity Investments
d. Milestone Payments
6. Option to Develop and Commercialize
a. Notice of Exercise
b. Right of First Refusal
c. Right of First Negotiation
d. Rights in Unoptioned IP
7. Term and Termination
a. Term
b. Early Termination
E. Post-Closing Pitfalls That Can Derail an R&D Collaboration
1. Change in Strategic Fit or Commitment to the Project
2. Communication and Control Issues
3. Unrealistic Expectations
F. Alliances with Third Parties-Keeping Other Options Open
1. Right of First Refusal May Preclude Other Transactions
2. Right of First Negotiation May Also Have a Chilling Effect
3. The Deal May Be Worth It
Rely on Contractual Protections
G. Conclusion: Where Do the Parties Go from Here?
Chapter Nine: Federal Regulation of Clinical Research
A. Background
1. The Role of Clinical Research
2. Government Entities That Regulate Clinical Research
a. HHS: FDA
b. HHS: Office for Human Research Protections
c. HHS: NIH
d. HHS: Office of Civil Rights
e. HHS: CMS
f. HHS: Office of Inspector General
g. DOJ
h. The States
B. The Roles and Responsibilities of the Parties
1. Subject
2. Sponsor
3. PI
4. CRO
5. Monitor
6. IRB
7. Data Monitoring Committee
8. Institutional Biosafety Committee
C. Premarket Clinical Trial Process
1. Drug Trials
a. Exploratory INDs (Phase 0 Trials)
b. Phases I-III
2. Device Trials
3. Prior to Start of Clinical Trial
a. Designing the Clinical Trial
b. Selecting Qualified Investigators
c. Obtaining IRB Review and Approval
d. Obtaining Informed Consent from Subjects
e. Submitting an IND or IDE
f. Registering the Trial
4. Conducting the Trial
a. Reporting, Auditing, and Recordkeeping
b. Terminating an IND or IDE
5. After the Trial
a. Study Close Out
b. Clinical Trial Results Posting
c. Other Dissemination of Clinical Trial Results
D. Enforcement
1. FDA Inspections
2. Form 483 Observations
3. Warning and Untitled Letters
4. Administrative Consequences
5. Civil and Criminal Liability
E. Other Issues
1. Postmarket Trials
a. Phase IV Commitments
b. Trials Required Pursuant to Section 505(o)
c. Deferred Pediatric Studies
d. Studies to Support Pediatric Exclusivity
e. Voluntary Research to Support New Conditions of Use
f. Investigator-Initiated Trials
2. Sites and Trials in Foreign Countries
3. Expanded Access
a. Drugs and Biologics
b. Devices
Key Acronyms Used
Chapter Ten: Privacy Issues for Biotechnology Companies
A. Introduction
1. Overview of Relevant Privacy Laws
2. How Do HIPAA and the Privacy Laws Apply to Biotechnology Companies?
B. HIPAA, the Privacy Rule, the Security Rule, the Breach Notification Rule, and the Health Information Technology for Economic and Clinical Health Act
1. Basic Overview and Important Definitions
a. Statutory and Regulatory Background
b. Important Definitions
2. Individual Rights
a. Notice of Privacy Practices (45 C.F.R. § 164.520)
b. Restriction of PHI by Individuals (45 C.F.R. § 164.522(a))
c. Access to PHI by Individuals (45 C.F.R. § 164.524)
d. Amendment or Change of PHI (45 C.F.R. § 164.526)
e. Accounting of Disclosures (45 C.F.R. § 164.528)
f. Complaints (45 C.F.R. § 160.306)
3. Permissible Uses and Disclosures of PHI That Do Not Require Authorization
a. Uses and Disclosures for Treatment, Payment, and Health Care Operations (45 C.F.R. § 164.506(c))
b. Uses and Disclosures for Fund-Raising Activities (45 C.F.R. § 164.514(f))
c. Disclosures Required by Law (45 C.F.R. § 164.512(a))
d. Disclosures for Public Health Activities (Including Child Abuse Reporting) (45 C.F.R. § 164.512(b))
e. Disclosures for Victims of Abuse, Neglect, or Domestic Violence (45 C.F.R. § 164.512(c))
f. Disclosures for Health Oversight Activities (45 C.F.R. § 164.512(d))
g. Disclosures for Judicial and Administrative Proceedings (45 C.F.R. § 164.512(e))
h. Disclosures for Law Enforcement Purposes (45 C.F.R. § 164.512(f))
i. Disclosures about Decedents to Coroners, Medical Examiners, and Funeral Directors (45 C.F.R. § 164.512(g))
j. Uses and Disclosures for Cadaveric Organ, Eye, or Tissue Donation Purposes (45 C.F.R. § 164.512(h))
k. Uses and Disclosures for Research Purposes (45 C.F.R. § 164.512(i))
l. Disclosures to Avert a Serious Threat to Health or Safety (45 C.F.R. § 164.512(j))
m. Disclosures for Specialized Government Functions (45 C.F.R. § 164.512(k))
n. Disclosures for Workers' Compensation (45 C.F.R. § 164.512(l))
4. Business Associates
a. Disclosures to Business Associates (45 C.F.R. § 164.502(e)(1)(i))
b. BAAs (45 C.F.R. § 164.504(e))
c. Direct Liability of Business Associates
5. Uses or Disclosures That Require Authorization
a. Uses and Disclosures for Marketing (45 C.F.R. § 164.508(a)(3))
b. Sale of PHI (45 C.F.R. § 164.502(a)(5)(ii))
6. Uses and Disclosures Requiring an Opportunity to Agree or Object (45 C.F.R. § 164.510)
7. HIPAA-Compliant Authorizations (45 C.F.R. § 164.508)
a. General Content
b. Defective Authorizations
c. Compound Authorizations
d. Conditioning Authorizations
e. Authorizations for Marketing and the Sale of PHI
8. More about Research
a. When Is an Authorization Required?
b. Research Authorization Requirements
c. Using a Limited Data Set for Research Purposes
9. Data Use Agreements
10. Notification of Breach Requirements
a. Obligations of a Covered Entity (45 C.F.R. § 164.404 et seq.)
b. Obligations of a Business Associate (45 C.F.R. § 164.410)
c. State Law Considerations
11. The Security Rule
a. Required Compliance by Business Associates
b. Safeguards (45 C.F.R. § 164.306)
12. State Law and Preemption Issues
13. Penalties for Violations of the Privacy Rule and the Security Rule
C. The Federal Common Rule and Federal Certificates of Confidentiality
1. The Common Rule and HIPAA
2. Federal Certificates of Confidentiality (42 C.F.R. Part 2a)
D. Canadian Privacy Legislation
E. General Data Protection Regulation
1. Consent
2. Security
3. Breach Notification
4. Data Protection Officers
5. Cross-Border Data Transfers
6. Other Requirements
7. Penalties
F. California Consumer Privacy Act of 2018
G. Privacy Shield Framework
Key Acronyms Used
Chapter Eleven: Medical Reimbursement
A. Introduction
B. Reimbursement Basics
1. Key Terms and Concepts
2. Coverage
a. Determining the Scope of Benefits
b. Checking for Specific Exclusions from Coverage
c. The Reasonable and Necessary Test
d. Medical Necessity for the Particular Patient
e. Implications of Coverage/Non-coverage
f. Coverage Process
3. Payment Law and Policy
4. Coding
5. Appeals
6. Who Are the Payers?
C. Applying the Basics
1. Coverage, Payment, and Coding for Drugs and Biologicals
2. Coverage, Payment, and Coding for Procedures Involving the Use of Medical Devices
3. Coverage Payment and Coding for DME, Prosthetics, Orthotics, and Supplies
4. Coverage, Payment, and Coding for In Vitro Diagnostics
D. Special Payment Rules for New Technologies
1. IPPS
2. OPPS
3. Ambulatory Surgical Centers-Payment for New Technology Intraocular Lenses
4. Private Payer Carve-Outs
E. Reimbursement for Investigational Products
1. NCD on Routine Costs of Qualifying Clinical Trials
2. Investigational Device Exemptions
F. Compliance Considerations
1. Requirements for Proper Billing
2. Reimbursement Support Services
3. Discounts and Related Fraud and Abuse Considerations
G. Conclusion
Key Acronyms Used
Chapter Twelve: Environmental Regulation of Biotechnology
A. Introduction
B. Regulation of Biotechnology under TSCA
1. Summary of TSCA
2. EPA's TSCA Biotechnology Regulations
a. MCAN
b. Notice of Commencement of Manufacture or Import
c. Exemptions from the MCAN Requirement
3. TSCA Experimental Release Application
4. Test Marketing Exemption
5. General Exemptions from the MCAN Requirement
a. Tier I Exemption
b. Tier II Exemption
C. Biotechnology Regulation under FIFRA
1. Review of Pesticide Registration Applications
2. Data Requirements for Pesticide Registration Applications
3. Field Tests of Genetically Engineered Pesticides
a. Experimental Use Permits
b. Information Required for EUP Applications
4. Special Requirements for Biotechnology Pesticide Products
a. Biochemical Pesticides
b. Microbial Pesticides
c. Small-Scale Field Tests of Certain Genetically Modified Microbial Pesticides
d. PIPs
e. EUPs for PIPs
f. Gene Flow Assessment for PIPs
g. IRM
Chapter Thirteen: Approval of Biotechnology Products for Human Use
A. Introduction
1. Overview of the FDA Approval Process
a. Relevant Laws
b. Definitions
B. Standard Pathways to Market
1. Drugs: The Traditional New Drug Application
a. Standard for Approval
b. NDA Content and Format Requirements
c. NDA Classification Codes
d. Filing the NDA or BLA
e. Review of the NDA
f. Facility Inspection
g. Labeling Review
h. Advisory Committees
i. Completion of Review and Decision
j. Risk Evaluation and Mitigation Strategies
2. Drugs: The Faster 505(b)(2) Application
3. Biological Products
a. The BLA
b. Biosimilars
c. HCT/Ps
4. Medical Devices
a. Device Classifications
b. The 510(k) Notification Process
c. The PMA Process
d. Investigational Device Exemption
5. Combination Products
a. The Pathway
b. Primary Mode of Action
c. Center with Primary Jurisdiction
d. Single or Multiple Marketing Applications
e. Request for Designation
C. Expedited Pathways to Market
1. Fast Track
2. Breakthrough Therapies
3. Accelerated Approval
4. Priority Review
5. Rare Pediatric Disease Priority Review
6. Orphan Drug Designation
7. HUD
D. Future Pathways to Market
Key Acronyms Used
Chapter Fourteen: Agricultural Biotechnology Approval Processes
A. Introduction
B. U.S. Coordinated Framework
C. Role of USDA
1. Notification of Deregulation
2. Permits for PMPs and Industrial Crops
D. Role of EPA
1. EPA Regulation of PIPs
2. EPA Regulation of Agricultural Chemical Residues
E. Role of FDA
F. Regulation of Genetic Editing in Agriculture
1. U.S. Regulatory Policy Evolving
2. International Regulation of Genetic Editing in Agriculture
G. Role of the States in Regulation of Biotech Crops
1. State-Based Agricultural Management
a. Seed Purity Laws
b. GMO Labeling Movement and Federal Preemption
c. "Noxious" Weed Management
d. Managing the Economic Impact of Agricultural Biotechnology
e. EPA and the States
f. USDA and the States
g. FDA and the States
H. Biotech Crop Regulation in Other Countries
1. Argentina
2. Brazil
3. Canada
4. China
5. The EU
Chapter Fifteen: Federal and State Regulation after Approval
A. Regulatory Authorities
1. Food and Drug Administration
2. Office of Inspector General, Department of Health and Human Services
3. DOJ Civil Division
4. Federal Trade Commission
5. Securities and Exchange Commission
B. Postapproval Responsibilities
1. CGMP
a. Drug and Biological Products
b. Medical Devices
c. FDA Inspections
d. Mitigating Cybersecurity Risks Related to Networked Medical Devices
2. Postapproval Reporting
a. Product Problem Reports
b. Adverse Experience Reports
c. Annual and Periodic Reports
d. Early Notification of Possible Drug Shortages
e. Labeling Changes
3. Import and Export Requirements
a. Import
b. Import for Export
c. Export
4. Regulation of Advertising and Labeling
a. Key Terms
b. Basic Principles
c. Types of Advertisements
d. Limitations on FDA Regulation of Advertising
e. Off-Label Use and the Exchange of Scientific Information
f. The Good Reprint Practice Guidance
g. Proposed Guidance for Responding to Unsolicited Requests for Off-Label Information
h. Guidance on Industry-Supported Scientific and Education Activities
i. Guidance on Communication of Health Care Economic Information
C. Withdrawal of FDA Approval
D. False Claims Act
1. The Neurontin Case (2004)
2. The Serono Laboratories Serostim Settlement (2005)
3. The Bristol-Myers Squibb Abilify Settlement (2007)
4. The Cephalon Actiq, Gabitril, and Provigil Settlement (2008)
a. Actiq
b. Gabitril
c. Provigil
5. The AstraZeneca Seroquel Settlement (2010)
6. The Allergan Botox Settlement (2010)
7. The Abbott Laboratories Depakote Plea Agreement (2012)
8. The Amgen Aranesp Settlement (2012)
9. The Par Pharmaceuticals Megace ES Settlement (2013)
10. The J&J Risperdal Settlement (2013)
11. The Genzyme Seprafilm Settlement (2013)
12. Endo Pharmaceuticals (2014)
13. Astellas Pharma US Inc. (2014)
14. Shire Pharmaceuticals (2014)
15. NuVasive Inc. Settlement (2015)
16. Medtronic, Inc. Settlement (2015)
17. Warner Chilcott Plea Agreement (2015)
18. OtisMed (2015)
19. Acclarent Inc. Settlement (2016)
20. Aegerion Pharmaceuticals Inc. (2017)
21. Shire Pharmaceuticals LLC Settlement (2017)
22. Baxter Healthcare Corp. Settlement (2017)
23. Novo Nordisk Settlement (2017)
E. Anti-Kickback Statute and Other Illegal Remuneration
F. The Physician Payments Sunshine Act
Key Acronyms Used
Chapter Sixteen: Development and Commercialization Alliances
A. Introduction: Why Choose to Partner?
B. Considerations in Choosing a Partner
C. The Stage of the Drug Candidate Will Define the Alliance
1. Early Stage Deals
a. Target Identification and Validation
b. Hits
c. Leads
d. Optimized Leads
2. Preclinical Stage Licensing
a. ADME/Tox Studies
b. Human Trials in Australia/China
c. Investigational New Drug Application
3. Clinical Stage Licensing
a. Phase I
b. Phase II
c. Clinical Trials (Phase III)
4. Prelaunch Licensing
D. The Development and Commercialization License Agreement
1. Nature and Scope of License Grant
a. Identifying the Subject Technology
b. The Rights Granted
c. Scope of Rights
d. Retained Rights of the Licensor
2. Consideration for the License Grant
a. Milestone Payments
b. Royalty Payments, Generally
c. Term of Royalty Payments
d. Punitive Reduction in Royalty Rates
e. Reduction in Royalty Rates for Third-Party Licenses
3. Other IP Issues
a. Responsibility for Patent Prosecution and Maintenance
b. Abandoned Jurisdictions
c. Ongoing Cooperation
d. Trademarks and the Like
e. Prosecution of Infringers
4. Cooperation of the Parties during the Regulatory Approval Process
5. Participation in the Upside
a. "Co-Rights"
b. Bulk Supply Rights
E. Anticipating Changes of Control of Either Party
1. Licensor Issues
2. Licensee Issues
3. Tailoring a Solution
F. Terminating the Agreement If the Alliance Fails
1. Material Breach by the Licensee
a. The Licensor's Perspective
b. The Licensee's Perspective
2. Material Breach by the Licensor
a. The Licensor's Perspective
b. The Licensee's Perspective
3. Termination without Cause
G. Conclusion: The Importance of Getting It Right
Chapter Seventeen: Patent Litigation and Dispute Proceedings Overview for the Non-Patent Attorney
A. Introduction
B. General Overview of Patent Litigation in Federal Court
1. Patent Infringement Defined
a. Direct Infringement (35 U.S.C. § 271(a))
b. Indirect Infringement (35 U.S.C. § 271(b), (c))
c. Literal Infringement and Doctrine of Equivalents
2. Proving Infringement
a. Claim Construction
b. Applying the Construed Claims to the Accused Product
C. Pre-Litigation Considerations
1. Prefiling Investigation
2. Whether to Send a Cease and Desist Letter
D. Litigation Procedure Overview
1. Choosing an Appropriate Forum
2. Choosing Appropriate Parties
3. Pleadings
a. Complaints
b. Defenses and Counterclaims
4. Remedies
a. Damages
b. Equitable Relief
c. Attorneys' Fees
E. General Overview of Post-Grant Proceedings before the USPTO
1. PGR
2. IPR
3. CBM Review
4. Ex Parte Reexamination
5. Derivation Proceedings
6. Director-Initiated Reexamination
7. Reissue
F. ADR
1. General ADR Considerations
2. Participation by Senior Management
3. Advantages of ADR Confidentiality
4. ADR as an Alternative to Foreign Litigation
Chapter Eighteen: The Impact of Bankruptcy
A. Introduction-Bankruptcy Basics
1. The Origin of Modern Bankruptcy Law
2. Bankruptcy Protection for Individuals
3. Bankruptcy Protection for Entities
4. Bankruptcy in Biotech Entities
B. A Primer on Creditors' Rights
1. Introduction
2."Creditors' Rights"?
3. Secured Creditors
4. Unsecured Creditors
5. Creditors' Right to Representation
6. Debtor's Duty to Creditors
7. Credit versus Equity
C. Liquidation versus Reorganization
D. The Debtor's Bankruptcy Estate
E. The Automatic Stay
F. Contracts and Leases in Bankruptcy
1. Assumption of Executory Contracts
2. Rejection of Executory Contracts
3. Assignment of Executory Contracts
G. Sale of Property in Bankruptcy
H. Equity Holders in Bankruptcy
I. Conclusion
Chapter Nineteen: Risky Business: Litigation, Risk Management, and Dispute Control
A. Introduction
B. The Biotech Lawyer as Dispute Manager
1. Dispute Management Provisions in Commercial Agreements and Documents
a. Indemnification Provisions and Limitations on Liability
b. Acquisition Hold Back Provisions
c. Record Retention and Control within the Deal
d. Alternative Dispute Provisions
2. Compliance Counseling
3. Early Claim Review and Response
4. Litigation
a. Choosing the Right Litigator and Firm
b. Litigation and Cost Control
c. Dual Track Strategies
C. Intellectual Property and Confidential Business Information
1. Trademark Issues
a. Registration and Protection
b. Litigation Claims-Infringement and Dilution
2. Trade Secrets
a. Trade Secrets Defined
b. Establishing the Foundation for Trade Secret Protection
c. Misappropriation
d. Inevitable Disclosure Doctrine
D. Products Liability
1. Defects and Causation
2. Establish a Record of Compliance and Responsibility
E. Business Liability
1. Corporate Disclosures and Insider Trading
a. Misstatements and Omissions
b. Insider Trading
2. Corporate Governance
3. False Claims and Whistleblowers
F. Document and Information Retention
1. Regulatory Recordkeeping Requirements
2. Litigation Discovery Issues
3. Data Management Policy
a. Identify the Objectives of the Enterprise
b. Minimalism and Control
c. Training and Simplicity of Procedures
d. Adequacy of Infrastructure
e. Information Security
f. Record Authenticity
g. Retrievability
h. Distribution Controls
i. Auditability
j. Consistency
k. Enforcement
G. ADR
1. ADR Defined
a. Arbitration
b. Mediation
2. ADR Myths and Misconceptions
a. A Sign of Weakness
b. Free Discovery
3. An Integrated Strategy for ADR
a. Before the Dispute Arises
b. In the Early Stages of the Dispute
c. Parallel Strategies
d. Private Forums and Confidentiality
Chapter Twenty: Bioethics
A. What Is Bioethics?
1. How Is Bioethics Different from Other Forms of Ethics?
2. Approaches to Bioethics
a. Deontological
b. Utilitarianism
c. Virtue Ethics
d. Four Principle Approach
e. Casuistry
3. Core Principles of Bioethics
a. Personal Autonomy
b. Beneficence/Nonmaleficence
c. Justice
d. Confidentiality
4. History and Foundational Sources of Bioethics
a. Hippocratic Oath
b. Percival's Medical Ethics
c. Nuremberg Code
d. Belmont Report
e. Helsinki Declaration
5. Relationship of Law and Bioethics
B. Legal Contexts for Bioethics
1. Constitutional Issues
a. Reproduction
b. Right to Die
2. Special Focus on Research
a. Historical Context
b. U.S. Federal Regulations
C. Case Studies
1. Product Safety
2. COIs
3. Research Risks
4. Informed Consent
5. Disclosure versus Privacy: A Physician's Duty to Disclose Patient Risks to a Third Party
6. Autonomy
7. Property Rights/Control of Your Body
8. Conflicting Rights
9. End-of-Life Issues
10. Personhood/Respect
11. Justice
D. Conclusion
Appendix A: Goat-Tech BioScience: A Legal/Biotech Case Study
Appendix B: Biotechnology Resources
Appendix C: Patent & Technology License Agreement
Background
1. Definitions
2. License Grant and Commercialization
2.1 Grant
2.2 Affiliates
2.3 Sublicensing
2.4 Diligent Commercialization
3. Compensation
3.1 Non-Royalty Payments Due from Licensee
3.2 Royalties
3.3 Minimum Royalties
3.4 Non-cash Consideration
3.5 Equity Consideration for License Grant
4. Reports and Plans
4.1 Quarterly Payment and Milestone Reports
4.2 Annual Written Progress Report and Commercialization Plan
4.3 Government and Economic Development Reporting
5. Payment, Records, and Audits
5.1 Payments
5.2 Sales outside the U.S.
5.3 Late Payments
5.4 Records
5.5 Auditing
6. Patent Expenses and Prosecution
6.1 Patent Expenses
6.2 Direction of Prosecution
6.3 Ownership
6.4 Foreign Filings
6.5 Withdrawal from Paying Patent Costs
6.6 U.S. Patent and Trademark Office Entity Size Status
7. Term and Termination
7.1 Term
7.2 Termination by Licensee
7.3 Termination by Licensor
7.4 Other Conditions of Termination
7.5 Effect of Termination
8. Confidentiality
8.1 Definition
8.2 Protection and Marking
8.3 Confidentiality of Terms of Agreement
8.4 Disclosure Required by Court Order or Law
8.5 Copies
8.6 Continuing Obligations
8.7 Exclusions
8.8 Copyright Notice
9. Infringement and Litigation
9.1 Notification
9.2 Licensee's Enforcement Rights
9.3 Licensor's Enforcement Rights
9.4 Cooperation between Licensor and Licensee
10. Export Compliance
11. Representations and Disclaimers
11.1 Licensor Representations
11.2 Government Rights
11.3 Licensor Disclaimers
11.4 Licensee Representations
12. Limit of Liability
13. Indemnification
13.1 Indemnification Obligation
13.2 Conditions of Indemnification
14. Insurance
14.1 Insurance Requirements
14.2 Evidence of Insurance and Notice of Changes
15. Assignment
16. Governmental Markings
16.1 Patent Markings
16.2 Governmental Approvals and Marketing of Licensed Products and/or Licensed Services
16.3 Foreign Registration and Laws
17. Use of Name
18. Notices
19. General Provisions
19.1 Binding Effect
19.2 Construction of Agreement
19.3 Counterparts and Signatures
19.4 Compliance with Laws
19.5 Governing Law
19.6 Modification
19.7 Severability
19.8 Third Party Beneficiaries
19.9 Waiver
19.10 Sovereign Immunity
19.11 Entire Agreement
19.12 Claims against Licensor for Breach of Agreement
19.13 Grant of Security Interest
20. No Other Promises and Agreements
Representation by Counsel
21. Deadline for Execution by Licensee
Index

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