Manager – API IPR Management
Location: India
Company: Biocon Limited
Department: Intellectual Property Rights (IPR)
Role Summary:
Biocon is hiring a Manager to lead API IPR management initiatives. This strategic role ensures that all products from selection through to launch comply with intellectual property standards, with risks proactively identified and managed. The candidate will also play a vital role in patent drafting, prosecution, and supporting both licensing and litigation strategies.
Key Responsibilities:
General IPR Management:
Ensure IP compliance across product lifecycle: from selection and development to launch.
Identify IP risks and create mitigation plans.
Evaluate new developments for patentability; file and prosecute patents when required.
Manage priorities and knowledge enhancement for self and team.
Ensure adherence to Biocon’s policies.
Product Selection:
Analyze patents related to polymorphs, routes of synthesis (ROS), MoUs, and compositions.
Evaluate approval status, clinical data, PILs, and define labeling strategies.
Conduct competitive intelligence reviews on litigations and oppositions.
Devise strategic recommendations including polymorph targets and MFDs.
Freedom to Operate (FTO) Analysis:
Conduct full IP landscape reviews.
Analyze compositions against existing patents and identify additional concerns.
Create and fine-tune mitigation strategies based on supplementary data.
Coordinate with development teams to create design-around proposals.
Track competitive market intelligence regularly.
Patent Drafting & Prosecution:
Review patentability analysis and collaborate with R&D to define invention scope.
Supervise drafting of provisional and complete patent applications.
Guide data generation for PCT filings; review and coordinate with external law firms.
Ensure timely filing and prosecution of national phase applications.
Filing & Launch Activities:
Oversee PILs and exclusivity statements.
Manage Law firm interactions for opinions, notices, oppositions, and litigation.
Analyze legal matters to recommend settlements or launch strategies.
Out-Licensing Support:
Evaluate and refine agreements (CDA, license, supply) with legal teams.
Review patent scenarios in target markets and prepare responses to customer queries.
Support marketing teams in customer interactions via emails and calls.
In-Licensing Evaluation:
Analyze MFDs and relevant patents for target countries.
Conduct due diligence on dossiers/DMFs.
Identify risks, data gaps, and propose mitigation strategies.
People Management:
Mentor and guide team members to meet their professional development and performance goals.
Educational Qualifications:
Required Qualification: M.Sc in a relevant field
Experience Required: 11 – 18 years in IPR management within the pharmaceutical industry
Estimated Salary: ₹28–36 LPA (depending on experience and specialization)
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