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Reverse Payment Agreement for the United Kingdom

Reverse Payment Agreement Template for England and Wales

A Reverse Payment Agreement is a legal arrangement under English and Welsh law where a patent holder pays a potential competitor to delay entry into the market with a competing product. These agreements are common in pharmaceutical sectors and are subject to intense scrutiny under competition law. They must comply with both UK and retained EU competition regulations, particularly regarding anti-competitive practices. The agreement typically includes settlement terms, payment structures, and market entry dates, while ensuring compliance with competition law requirements.

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Reverse Payment Agreement

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What is a Reverse Payment Agreement?

Reverse Payment Agreements arise when patent holders seek to resolve patent disputes with potential market entrants, typically in pharmaceutical markets. These agreements, governed by English and Welsh law, involve the patent holder making payments to delay generic competition. They must be carefully structured to comply with competition law while protecting legitimate intellectual property rights. The document includes essential provisions covering settlement terms, payment arrangements, market entry dates, and competition law compliance measures. Such agreements are particularly relevant when resolving pharmaceutical patent litigation and managing market entry timing for generic drugs.

What sections should be included in a Reverse Payment Agreement?

1. Parties: Identification and details of the contracting parties, typically the patent holder (originator) and the generic manufacturer

2. Background: Context of the agreement, including details of the patent dispute, relevant market context, and existing litigation status

3. Definitions: Key terms used throughout the agreement, including product definitions, patent rights, and territory definitions

4. Settlement Terms: Core terms of the patent dispute settlement, including acknowledgments and undertakings regarding patent validity

5. Payment Provisions: Details of reverse payments, including amount, timing, and any conditions precedent

6. Entry Date: Specific provisions regarding the agreed date for generic entry into the market and any associated conditions

7. Competition Compliance: Provisions ensuring compliance with competition law and antitrust regulations

8. Term and Termination: Duration of the agreement and circumstances under which it may be terminated

9. Confidentiality: Provisions regarding the confidentiality of the agreement terms and any shared information

10. Governing Law and Jurisdiction: Specification of English and Welsh law as governing law and jurisdiction for disputes

What sections are optional to include in a Reverse Payment Agreement?

1. Supply Arrangements: Terms for any product supply between parties, including pricing, volumes, and quality standards

2. Marketing Rights: Terms for marketing and distribution rights, including territory restrictions and branding requirements

3. Research Collaboration: Terms for joint research activities or technology transfer arrangements

4. Regulatory Compliance: Additional provisions regarding compliance with pharmaceutical regulations and reporting requirements

5. License Provisions: Terms of any patent license granted as part of the settlement

What schedules should be included in a Reverse Payment Agreement?

1. Patent Schedule: Comprehensive list of relevant patents and patent applications covered by the agreement

2. Payment Schedule: Detailed payment terms, calculations, and mechanisms for payment adjustments

3. Competition Law Compliance Protocol: Detailed procedures and guidelines for ensuring ongoing competition law compliance

4. Product Specifications: Technical specifications of pharmaceutical products covered by the agreement

5. Form of Public Announcement: Template for any required public announcements regarding the settlement

Authors

Alex Denne

Head of Growth (Open Source Law) @ tiktok成人版 | 3 x UCL-Certified in Contract Law & Drafting | 4+ Years Managing 1M+ Legal Documents | Serial Founder & Legal AI Author

Jurisdiction

England and Wales

Cost

Free to use
Relevant legal definitions






























Clauses



























Industries

Competition Act 1998: Primary UK competition legislation, particularly Chapter I prohibitions on anti-competitive agreements. Critical for reverse payment agreements as they may be scrutinized for potential anti-competitive effects.

Article 101 TFEU: Treaty on the Functioning of the European Union article governing anti-competitive agreements. Remains relevant as persuasive authority post-Brexit.

Enterprise Act 2002: UK legislation providing framework for competition law enforcement and market investigations.

Patents Act 1977: Primary UK patent legislation governing intellectual property rights, essential for understanding the underlying patent disputes in reverse payment agreements.

Trade Marks Act 1994: Legislation governing trademark rights which may be relevant if branded pharmaceuticals are involved in the agreement.

Medicines Act 1968: Fundamental legislation governing the control of medicines in the UK, including licensing and marketing authorization.

Human Medicines Regulations 2012: Current regulatory framework for medicines, including requirements for marketing authorization and distribution.

Patents Regulations 2007: Regulations governing compulsory licensing and supplementary protection certificates, relevant for pharmaceutical patent term extensions.

CMA Guidelines: Competition and Markets Authority guidance on competition law compliance and enforcement, particularly relevant for assessment of reverse payment agreements.

Consumer Rights Act 2015: Legislation protecting consumer interests, relevant for considering public impact of reverse payment agreements.

Unfair Contract Terms Act 1977: Legislation controlling unfair terms in contracts, ensuring balance and fairness in agreement provisions.

Teams

Employer, Employee, Start Date, Job Title, Department, Location, Probationary Period, Notice Period, Salary, Overtime, Vacation Pay, Statutory Holidays, Benefits, Bonus, Expenses, Working Hours, Rest Breaks, 聽Leaves of Absence, Confidentiality, Intellectual Property, Non-Solicitation, Non-Competition, Code of Conduct, Termination, 聽Severance Pay, Governing Law, Entire Agreemen

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