ROW IP Litigator and Regulatory Exclusivity Expert - Berne, Schweiz - CSL Behring

The position is for an IP and Regulatory exclusivity (Pharmaceutical Incentives) senior lawyer. The role involves providing advice, assistance, and leadership on regulatory issues which are an integral part of the exclusivity of a product, especially regarding regulatory exclusivities, developing strategies to create synergies with IP exclusivities for optimized life cycle management (LCM), enhancing the creation of exclusivities for development/pipeline products, and managing the loss of exclusivity (LoE) position of CSL's products.

This IP lawyer will oversee complex regulatory exclusivity and related activities, such as LoE strategies, by considering the IP landscape and broader political and commercial environment.

This role reports to the head of IP and is part of the global IP leadership team.

The Role

• Stay informed about Regulatory and Pharmaceutical Incentives legislation in the EU and new regulatory developments worldwide to ensure proper implementation throughout the global IP organization

• Assist the global IP organization in implementing the new EU Pharma legislation package and EU transparency rules

• Create and support the implementation of life cycle management (LCM) strategies and loss of exclusivity (LoE) strategies focusing on the regulatory exclusivity aspects in collaboration with IP team member(s) and business partners

• Develop and support periodic exclusivity reviews for pipeline/development products to maximize the duration and strength of regulatory and IP exclusivities

• Provide advice on patent litigation strategies emphasizing regulatory exclusivity linkage

• Ensure consistency in approaches towards life cycle management (LCM) strategies and loss of exclusivity (LoE) strategies throughout the global IP organization

• Create and coordinate collaboration streams with Global Regulatory and R&D to enhance value creation through Patent Term Extensions, Patent Linkage, Paediatric Extension, and review of critical registration dossier sections

• Guide patent drafting and prosecution based on regulatory and pharmacovigilance innovation like risk management plans, side effects, and precautions

• Establish an LCM/LoE functional team that collaborates on challenging issues and offers mutual support

• Devise and execute RoW IP litigation strategies in collaboration with team members

• Directly handle specific RoW IP or Pharmaceutical Incentives disputes

• Negotiate agreements and license settlements

• Advise RoW business partners on IP strategy and litigation risks

• Establish a functional RoW IP litigation team to address complex issues and provide mutual support

• Support the professional growth of functional RoW IP litigation team members through mentoring, coaching, legal education, and sharing best practices

• Ensure consistency in approaches for handling RoW IP litigation cases

• Oversee governance and reporting for RoW IP litigation

• Manage the budget for RoW IP litigation

• Leverage IP assets through licensing and, if needed, patent enforcement

• Efficiently collaborate with multiple stakeholders across functions

Skills and Experience

Experience/Education

• Minimum of 15+ years of international IP litigation experience focusing on biologics IP litigation (brand on brand or biosimilar)

• At least 10+ years of experience in life cycle management and loss of exclusivity strategizing

• At least 10+ years of experience in dealing with complex IP incentives and regulatory strategies or disputes

• At least 10+ years of experience in litigating and resolving IP and regulatory exclusivity-related contract disputes

• At least 10+ years of experience in monetizing IP assets

• Experience in leading teams of in-house IP lawyers

Critical Competencies

• Thorough understanding of IP, Pharmaceutical Incentives, and associated regulatory legislations

• Extensive experience in developing and executing life cycle management and loss of exclusivity strategies

• Proven ability to deliver optimal results in IP litigation cases; advantage in Pharmaceutical Incentives/Regulatory exclusivity disputes

• Strong negotiation skills

• Ability to solve intricate and demanding problems

• Practical and innovative mindset

• Demonstrated business insight and capacity to provide valuable advice

• Outstanding verbal and written communication skills to convey complex concepts to business partners effectively

• Sound judgment

• Effective interpersonal skills and ability to collaborate with individuals from various backgrounds

• Capability to prioritize and manage multiple projects simultaneously

• Comfortable working both independently and in teams

• Quick learner able to adapt to new situations promptlyLeadership skills such as strategic thinking, team building, and development, mentoring, and coaching of team members

Our Benefits

CSL employees working a minimum of 30 hours per week qualify for benefits from day 1. We prioritize the well-being of our employees and their families, offering resources and benefits—from healthcare to financial security—so you can concentrate on meaningful work. Our benefits are tailored to support our employees at every stage of life, whether planning for the future, needing assistance with childcare or looking for mental health resources. With benefits like these, CSL aims to help you achieve success in your personal and professional life.

Take a moment to explore the benefits available to CSL employees on our website.

About CSL Behring

CSL Behring stands at the forefront of developing and providing top-quality medications for individuals battling rare and severe diseases across more than 100 countries. Our treatments offer hope for those with conditions in areas such as immunology, hematology, cardiovascular and metabolic health, respiratory issues, and transplant medicine. Discover more about CSL Behring on our website.

Inclusivity at CSL Behring

With a global presence spanning over 35 countries, CSL values diversity and inclusivity in the workplace. Learn further about Diversity & Inclusion initiatives at CSL on our website.

Create Impact at CSL Behring!