Introduction
Who should attend
Related Courses
Course Features
The 3-Day Online Microlearning Course on Biosimilar Patent Dance is designed to provide participants with an in-depth understanding of the intricate patent litigation and regulatory pathways in the biosimilar industry. This course unravels the complexities of the “patent dance,” a critical process in biosimilar development under the Biologics Price Competition and Innovation Act (BPCIA).
Through concise, engaging modules, participants will learn how to navigate the patent exchange process, strategize for legal challenges, and leverage insights to expedite market access for biosimilars.
Snapshot of Microlearning Course on Biosimilar Patent Dance
- Course Code: RYD-127
- Title of the course: Microlearning Training in Biosimilar Patent Dance (MTBPD)
- Types of the course: Online self pace learning course. User can conveniently access the course at own convenient timing.
- Duration: 3 Days
- Course Certification: It will be provided on completion of the course.
- Eligibility: Graduation / 3rd or final year graduation in any discipline. Even the final year student can join the course.
Objective of the Biosimilar Patent Dance Training
This course equips participants with the tools to navigate the legal complexities of biosimilar development confidently, helping them streamline market access while minimizing litigation risks.
Who should attend this course?
- Biopharma Professionals: Regulatory affairs specialists, legal teams, R&D professionals, and business development executives in the biopharma industry.
- Legal Experts: Patent attorneys, IP consultants, and legal advisors involved in biosimilar patent strategies.
- Academia and Researchers: Scholars specializing in biosimilar development, pharmaceutical IP, and related fields.
- Aspiring Professionals: Individuals looking to build expertise in biosimilar regulation, development, and patent management.
Few of the other popular Biologic Training Courses
- Biopharmaceutical Regulatory Affairs
- Biopharma Global Business
- Biopharmaceutical Project Management
- Biopharmaceutical Business Development
- Biopharmaceutical Medical Representative Selling Skill Training
- Basics of Biopharma
- Biopharmaceutical Business and Brand Valuation
- Biopharma Market Access & Pricing
Course Code |
Course |
Duration |
RYD-093 |
Biopharma Global Management |
1 Year |
RYD-110 |
Biologic Regulatory Affairs (PGBRA) |
1 Year |
RYD-078 |
Biopharma Project Management |
1 Month |
RYD-021 |
Basics of Biopharma |
1 Week |
RYD-037 |
Biopharma Valuation |
1 Month |
RYD-059 |
Biopharma Business Development |
1 Month |
RYD-127 |
Biosimilar Patent Dance |
1 Week |
RYD-079 |
Biopharma Medical Representative Training |
1 Week |
Biosimilar Patent Dance Course Features – Uniqueness of the Course
- Focused Microlearning: The short, intensive format ensures targeted knowledge acquisition without overwhelming participants.
- Industry-Driven Content: Content tailored to the unique challenges faced by biosimilar professionals, with actionable takeaways.
- Real-World Scenarios: Leveraging landmark cases and interactive simulations to bridge theory and practice.
- Flexibility: Online delivery allows participants to learn at their own pace while engaging with experts in live sessions.
- Comprehensive Coverage: Merges legal, regulatory, and strategic perspectives for a holistic understanding of the biosimilar patent dance.
Section 1Biologics - Regulatory Affairs
Lecture 1R&D Process & Introduction to drug discovery
Lecture 2Investigational New Drug Application (INDA)
Lecture 3New Drug Application (NDA)
Lecture 4Biological Licensing Application (BLA) | 351(a) application | Form 356h | Differentiation with NDA | Timeline | Handling FDA queries
Lecture 5Abbreviated Biosimilar Application - 351(k): Advance Strategic Planning Process : Originator Vs. Biosimilar Development and Regulatory Approval Process | Reference Biologic | Purple Book | Data Requirements
Lecture 6351(a) Vs. 351(k)
Lecture 7Purple Book: Significance | Searching | Assignments
Lecture 8Patent & Exclusivity - Strategic Understanding
Lecture 9Biosimilar Approval and Patent Management | Strategic Pathway of Patent Negotiation and Litigation in Biosimilar Approval | Patent Dance | FAQs on Biologic Patent Management
Lecture 10Biosimilar launch case study | Patent Dance Framework
Lecture 11Biosimilar Launch Framework
Lecture 12Biosimilar 180 Day Notice
Lecture 133(A) List | Significance | Importance | How to interpret
Lecture 14Steps to win over innovator patents | Step wise planning
Lecture 15Biosimilar Launch Project Roadmap with defined stages of project
Lecture 16Timing of Biosimilar Submission and Approvals | Two Scenario based timeline assessments
Lecture 17Hands on Training on Reference Biologic Patent | Classify RPS Biologic Patents | Case Simulation
Lecture 18How to work on RPS’s Patent | Walkthrough | Case Study
Lecture 19Biosimilar Launch Project With Milestones
Lecture 20Analysis of Biologic Patents | Work Assignments
Lecture 21Biologic Patent Insight Worksheet
Lecture 22Patent Thickets | Concept | Implication | Case Based Learning
Section 2Add on Sessions on Biosimilar Development
Lecture 23Biosimilar Development Process
Lecture 24Strategic Consideration for Biosimilar Development
Lecture 25Bio-Manufacturing Process Information
Section 3Request for Course Certificate
biosimilar commercialization, biosimilar launch, biosimilar patent, biosimilar patent dance, biosimilar patent dance process, biosimilar training, How to launch biosimilar
