(Project Title: Challenging Intellectual Property Barriers That Prevent Access To Priority Health Products)

INTRODUCTION

Our Client is a human rights NGO working to protect and promote health-related human rights in Kenya. They do this by providing legal services and support, training professionals on human rights, engaging in advocacy campaigns that promote awareness of human rights issues, conducting research and influencing policy that promotes evidence-based change. Our Client advocates for a holistic and rights-based system of service delivery in health and for the full enjoyment of the right to health by all, including the vulnerable, marginalized and excluded populations in four thematic areas.

BACKGROUND

Recently, Our Client has been developing strategies to challenge legal and Intellectual Property barriers to access to medicines. This includes conducting Market and Patent Intelligence Studies on Priority health products for HIV, TB, cancer, and HCV, raising awareness on the use of TRIPS Flexibilities on the one hand; and a campaign for the use of existing flexibilities in the National laws, including the issuance of compulsory licenses with discussions with pharmaceutical laboratories and intergovernmental organizations on the other hand.

These strategies are being implemented against the backdrop that while patents and other intellectual property (IP) rights can incentivize innovation, they can also contribute to global health inequity, especially in low- and middle-income countries (LMICs), which often lack access to affordable health products, including for global health emergencies and path-breaking new health products (such as long-acting [LA] technologies) for HIV and TB, as well as non-communicable diseases (NCDs) and numerous other conditions.

To this end, Our Client wishes to engage a consultant to file patent oppositions on identified drugs and other health technologies at the level of the Africa Regional Intellectual Property Organization (ARIPO).

The aim of the opposition is to advocate for:

1. A legal environment characterized by an Intellectual Property law that prevents abuse of the patent system by pharmaceuticals.
2. An environment where bilateral agreements do not introduce TRIPs-plus provisions.
3. The prohibition of patent ever greening/misuse of the patent system through patent oppositions.
4. The existing flexibilities in national laws are used.
5.  Increased access to medicines through promotion of local production in Africa.
6. Increased access to novel HIV, TB, HCV, HPV/cervical cancer, and MPOX prevention and treatment tools, including injectable long-acting antiretrovirals/therapeutics.

OBJECTIVE OF THE CONSULTANCY

Our client is looking for a regional or national legal consultant or a law firm to file a patent opposition application before the corresponding offices in ARIPO. The specific objective of this consultancy is to;

1. File a patent opposition (or third-party observation, or invalidation lawsuit) and/or
2. Represent Our Client during the entire litigation or opposition process (relating to an HIV, TB, HCV, MPOX, or HPV/cervical cancer drug or vaccine to be identified by Our Client).

The opposition or third-party observation will be filed at the regional level (ARIPO).

EXPECTED DELIVERABLES

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The key deliverables from this consultancy will include;

• Patent search report and opinion/analysis
• Draft pleadings of the patent opposition documents to be filed
• File the patent opposition or Third-Party Observation (PTO) with the patent office on behalf of Our Client
• Represent Our Client before the patent office at filed patent opposition hearings, if provided for by law, including the preparation of additional responses/comments to the patent applicants’ responses
• Represent Our Client before the Board of Appeal, if there is a possibility of appeal in opposition proceedings before the patent office (assuming a hearing)
• Prepare and gather all necessary documents with legal and scientific arguments to bring an invalidation action against the blocking patent (e.g., draft declaration, expert-chemist’s conclusion, other evidence and supporting documents)

DESIRED COMPETENCIES EXPERIENCE REQUIRED

• Advanced Bachelor’s Degree in Law, Chemistry, or Related Fields.
• Minimum 7 years’ relevant experience in IP law practice or IP chemistry practice
• Experience working in or for the nonprofit, philanthropic sector or related field is a plus
• Experience in patent litigation or patent oppositions or patent prosecution (CV and/or description of the nature of the cases, including examples of litigious cases handled
• Significant experience in opposition/invalidation of pharmaceutical or chemical patents is an advantage
• Litigation experience representing the defendant in patent infringement cases (description of examples of litigation, if applicable) is an advantage
• High level of experience and expertise in intellectual property law of the team submitted by the bidder for the implementation of the work of this mandate
• High level of experience and chemical expertise of the team submitted by the bidder for the implementation of the work of this TOR.
• Have a multidisciplinary team composed of legal and pharmaceutical chemistry professionals who could be involved by the bidder in the preparation of the scientific arguments (provide a brief CV or biography)
• No conflict of interest with targeted pharmaceutical companies (Gilead, Johnson & Johnson, Janssen, ViiV Healthcare, GlaxoSmithKline, Otsuka, Merck Sharp and Dohme, Bavarian Nordic, and Atea Pharmaceuticals). If your company has one or more of the pharmaceutical companies listed above as its current clients, please indicate this in the proposal.
• Right to carry out a business activity (certificate of incorporation, etc.)
• Excellent analytical, writing, and communication skills
• Ability to work independently to produce high-quality outputs in a timely manner while understanding and anticipating the evolving client needs
• Familiar with participatory approaches in data collection.

REPORTING AND SUPERVISION

The consultant will report to the Programme Manager and Programme Officer, HIV/TB and KAPs. Our Client shall provide overall supervisory support for the assignment and administrative/logistical support. The roles will be further defined at the inception meeting.

NOTE: Our Client understands that litigation may take longer than expected and involve more hearings than originally anticipated. However, and for the purposes of this consultancy, Our Client has adopted an optimistic approach. If, as a result of complications in the litigation/opposition process, the consultancy team requires more time and/or requires budgetary adjustments, this could be negotiated separately at a later stage of the litigation/opposition process between Our Client and the consultants.

DURATION OF THE CONSULTANCY ASSIGNMENT

The consultancy will run from 1st July 2025 to 31st December 2025.