InstructorRoyed Training
TypeOnline Course
Student Enrolled2
Price$490 / 34300 INR.
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pharmaceutical ipr management

Introduction

Feature

Course objectives

Key Learning Areas

Who should enroll

About Pharma IPR Management

pharmaceutical IPR Management

Royed Training’s Pharmaceutical IPR Management course offers a comprehensive exploration of Intellectual Property Rights (IPR) specifically tailored to the pharmaceutical and biopharmaceutical sectors. This program equips professionals with practical skills and deep knowledge to navigate the complex IPR landscape, ensuring their products and innovations are well-protected in competitive markets. Emphasizing the essentials of patents, trademarks, and copyright in pharma, the course covers legal frameworks, application processes, protection strategies, and dispute resolutions.

The course provides training on patent, trademark, copyright, etc. with real life simulation and case studies. Moreover the course provide advanced training in licensing in pharmaceutical and biopharmaceutical industry.

The current pharmacy syllabus of most of the pharmacy courses do not provide adequate practical exposure on intellectual property right management, licensing business models of innovator and generic companies. This online course bridge this gaps. Hence, Pharmaceutical IPR Management course is ideal for pharmacy students. At the same time, this course equally benefits the strategic management professionals and scientists working in the pharma industry. This helps them to  learn the essentials of intellectual property right.

Course Snapshots

  • Title of the course: Advanced Certification in Pharmaceutical IPR Management (ACPIPR)
  • Course Code: RYD-042
  • Nature of the course: Online distance learning course. Therefore the course can be accessed online across anywhere 24×7.
  • Duration: 1 Month.
  • Eligibility: Graduation in any discipline. Even the final year student can join the course.
  • Course Certificate: Certificate will be provided at the end of the successful completion of the course.

Features of the Course:

  • The course provide practical training on IPR management practices. Therefore it helps the students to identify the IPR tools and techniques which commonly used in pharmaceutical industry.
  • Simulation to real life working in licensing, technology transfer and litigation management.
  • The course provides clear cut understanding how IPR management helps in Decision Making and Strategic Planning and new product innovation.
  • Above all, this course provide access to Online Data bank of pharma IPR case studies. Certainly, accessing these case studies can be helpful for students to understand various strategies used in industry.

Here we have listed key objectives of the courses –

  • Understand IP Fundamentals: Gain a foundational understanding of IPR, including patents, trademarks, and copyright, and their significance in pharmaceuticals.
  • Navigate Patent Law: Learn the essentials of patent applications, filing procedures, protection strategies, and infringement avoidance specific to pharmaceuticals.
  • Master Trademark Management: Explore trademark creation, registration, and enforcement for pharmaceuticals and biopharmaceuticals, ensuring brand recognition and protection.
  • Apply Copyright Knowledge: Understand copyright regulations and their application in protecting packaging, labeling, and documentation.
  • Manage International IPR: Understand the global landscape of pharmaceutical IPR with insights on managing IP across borders.
  • Pharmaceutical Licensing: Master the concept of inlicensing outlicensing and also various concepts with practical simulations.

Pharmaceutical and Biopharmaceutical Patent Laws

  • Basics of patents, including the criteria for patentability and types of pharmaceutical patents.
  • Patent application process, including drafting, filing, and managing patent applications.
  • Patent protection strategies and lifecycle management.
  • Patent litigation, disputes, and infringement cases.

Trademark Management for Pharmaceuticals

  • Basics of trademarks, including creation, distinctiveness, and international registration.
  • Trademark enforcement, infringement, and brand protection strategies.
  • Insights on maintaining brand reputation and consumer trust in the pharmaceutical industry.

Copyright in Pharmaceuticals

  • Overview of copyright law and its role in pharmaceuticals.
  • Copyright protection for branding elements, labeling, and promotional materials.
  • Compliance with copyright regulations and avoiding infringement.

Global IPR Strategy

  • Managing intellectual property internationally with a focus on regulatory compliance.
  • Harmonization of IP laws across countries and handling international IP disputes.
  • Navigating patent, trademark, and copyright protections in key global markets.

This course is designed for professionals in the pharmaceutical and biopharmaceutical industries, including IP managers, regulatory affairs professionals, legal advisors, product managers, R&D managers, and anyone involved in the protection and commercialization of pharmaceutical products.

Career in IPR Management in Pharmaceutical, Biopharmaceutical Industry 

A career in IPR management is both a challenging and highly rewarding career. Therefore, it opens up lot of opportunities as it covers a variety of disciplines. Individuals who are directly involved in patent, trademark, copyright and licensing right management in pharmaceutical company. In all established pharmaceutical company there are dedicated IPR department  and they take care of filing of the patent, trademark, issuing and management of the licensing etc. Hence, they work in close proximity with strategic management, regulatory team in company.

How IPR plays a role in pharmaceutical industry?

IPR is a prerequisite for pharma companies for identification, planning, commercialization, and protection of invention. It is also an important tool to protect investment, time, and effort and encourages healthy competition—thus promoting industrial development and economic growth. IPRs also provide incentives to pharma companies to invest in research and development.

It is important to have well defined practice of IPR management skill for pharmaceutical companies. In turn, it helps organization to be robust and strong in innovation management.

In fact, the IPR management directly link with product development. Hence, by focusing on IP strategy, companies can avoid litigation that might lead to financial loss to the company. Moreover, they can exploit IP-related products through commercialization and licensing. Above all, this increases the demand of low-value drugs and rapid growth of pharma companies.

Section 1Pharma and Biopahrma R&D Fundamental : Discovery to Development Stages
Lecture 1R&D Process & Introduction to drug discovery
Lecture 2Investigational New Drug Application (INDA)
Lecture 3New Drug Application (NDA) 
Lecture 4Basic concept and understanding of the Generic Drug
Lecture 5Abbreviated New Drug Application (ANDA) 
Lecture 6Handling of orange book
Lecture 7Clinical Research
Lecture 8Clinical Trial Protocol Writing
Lecture 9Ethics in Clinical Research
Lecture 10Informed Consent 
Lecture 11Patent & Exclusivity - Strategic Understanding | Patent Restoration| Orphan Drug Exclusivity (ODE) | NCE & NCI Exclusivity | GAIN Exclusivity | Pediatric Exclusivity | 180 days exclusivity
Lecture 12Orphan Drug Designation 
Lecture 13USFDA expedited programs
Lecture 14Biological Licensing Application (BLA) 
Lecture 15Abbreviated Biosimilar Application - 351(k): Advance Strategic Planning Process : Originator Vs. Biosimilar Development and Regulatory Approval Process | Reference Biologic | Purple Book | Data Requirements
Lecture 16Purple Book: Significance | Searching | Assignments
Lecture 17Data Exclusivity and Market Protection - Supplementary Patent Protection, Exclusivity, 6/10 Rule, 8+2+1 Formulae
Section 2Fundamental of IPR Management
Lecture 18General Introduction to intellectual Property Management
Lecture 19Introduction to Intellectual Property in Life Sciences | Types of IP | Introduction to Patent Portfolio Strategy
Lecture 20Introduction to Patent 
Lecture 21Global Pharmaceutical Patent Landscape | Strategic Overview of Global Patent Filing and Protection
Lecture 22Understanding on Patent System
Lecture 23Patent Grant and Managing Patent Filing Procedure
Lecture 24Scope of Patentability 
Lecture 25Stages of Patent Grant Procedure
Lecture 26Patent search in Indian Patent Office
Lecture 27Global Pharmaceutical Patent Filing Strategy
Lecture 28PCT Patent Filing
Lecture 29Patentability Criteria in Pharmaceuticals | Practical Case Study 
Lecture 30Patent Law Framework for Pharmaceuticals 
Lecture 31Understanding and Decoding Section 3(d) of the Indian Patent Act | Case Based Analysis
Lecture 32Evergreening vs Genuine Innovation in Pharmaceutical Patents | Evergreening and Genuine Innovation Evaluation
Lecture 33Pharmaceutical Patent Lifecycle - Integrated Layer Strategy
Lecture 34Blockbuster Drug Patent Thicket Strategy
Lecture 35Types of Pharmaceutical Patents | Patent Layering StrategiesTypes of Pharmaceutical Patents 
Lecture 36Understanding Patent Searching Process
Lecture 37IPC and CPC - Importance and Significance in Patent Search | Practical Hands on
Lecture 38IPC Structures for Pharmaceutical Patents
Lecture 39Freedom-to-Operate (FTO) | FTO Risk Assessment | Strategic Management
Lecture 40FTO Decision Tree – Generic Drug Launch Strategy
Lecture 41Fundamental of Pharmaceutical Patent Drafting | Structure | Component | Claim Anatomy | Effective Claim Writing
Lecture 42Pharmaceutical Patent Risk Management Framework
Lecture 43Patent Claim Coverage - Practical Example
Lecture 44Pharmaceutical Patent Filing Procedure and Global Filing Strategy | PCT Filing | Timeline
Lecture 45Advanced Understanding on Patent Opposition and Patent Litigation in Pharmaceutical Domain
Lecture 46Patent Prosecution and Handling Examiner Objections
Lecture 47Pharmaceutical Patent Portfolio Management | How to build and manage pharma patent portfolio
Lecture 48Pharmaceutical Patent Valuation and Licensing
Lecture 49Patent Landscape & Freedom to Operate (FTO) – EU Perspective - Strategic Regulatory + IP Integration Module (Drugs & Biologics)
Lecture 50EU Data Exclusivity, Market Protection & Orphan Exclusivity
Lecture 51Data Exclusivity and Market Protection - Supplementary Patent Protection, Exclusivity, 6/10 Rule, 8+2+1 Formulae
Lecture 52EU Orphan Medicinal Products Regulation
Lecture 53Paediatric use marketing authorisation (PUMA) & Paediatric Investigation Plan (PIP)
Lecture 54EU Supplementary Protection Certificates (SPC) & Paediatric Rewards
Lecture 55Patent vs Regulatory Exclusivity vs Trademark vs Launch Sequencing (EU Perspective)
Lecture 56“No EU-Style Patent Linkage” – What It Really Means (EU vs US)
Lecture 57EU vs US Regulatory–IP Framework
Lecture 58Global Patent + Exclusivity Timeline Dashboard - Executive-Level Strategic Tool (EU + US + Global Integration)
Lecture 59Full EU Submission Strategy Planner
Section 3Innovation and IPR Management in Pharma and Biopahrma Industry
Lecture 60Differences in US and European Patent
Lecture 61Patent Claim | Types of Patent Claims 
Lecture 62Patent Cliff | How to calculate the patent cliff
Lecture 63Terminologies related to patent, trademark, copyright and licensing 
Lecture 64Patent Infringement
Lecture 65Introduction to Trademark | Trademark filing procedure
Lecture 66Trademark Searching Process | EUIPO Searching | USPTO Searching | IPINDIA Searching 
Lecture 67Trademark Infringement | Passing off | Practical Cases
Lecture 68Trademark Classes | How to search the right trademark class for for filing trademark application
Section 4IPR Strategic Management
Lecture 69Strategies in different phases of Clinical Trial
Lecture 70Authorized Generics: Key Understanding
Lecture 71Advance study on Para IV Filing
Lecture 72Para IV Notices
Lecture 73Evergreening - Patent Life Extension Strategies
Lecture 74Pay For Delay Strategy
Lecture 75Compulsory Licensing
Lecture 76Licensing & Technology Transfer
Lecture 77In-Licensing Vs. Outlicensing
Lecture 78LOE Strategies for Innovator Brands with case study
Lecture 79Advance Learning on 505B2 Pathway
Lecture 80Detailed Understanding on 505(b)(2) VS. Suitability Petition : Case Based Learning
Lecture 81NCE Vs. 505b2 application - Case Based Learning 
Lecture 82FTF - 180 Days Exclusivity - Case Based Learning
Lecture 83Classic case study of the 505b2 filing : Case Based Learning
Lecture 84Strategic Planning in Combating 30 months stay strategies of innovator company- Case Based Learning
Lecture 85Licensing and Technology Transfer
Lecture 86Licensing - Advance Learning 
Lecture 87Due Diligence Activities in Pharmaceutical Licensing
Section 5Advanced Licensing Training | Asset Management | Deal Structuring
Lecture 88Training on Basic Finance  |  Understanding Financial Statment | Income Statement | Balance Sheet | Cash Flow Statement
Lecture 89Portfolio Management Process | Portfolio Characteristics | Portfolio Analysis | Balancing the Portfolio | BD and Strategic Planning Department 
Lecture 90Modelling and Deal Valuation - Top Down Model | Epidemiology data method | Complex Model | Forecasting | Heuristic or ‘prophesy’ method | Different value perspectives | Deal Structuring Structuring the deal
Lecture 91Royalty Management - Royalty structuring | Royalty Calculation Method| Tiered Royalties | Terms | Royalty Reductions | Royalty Stacking - Concept and Calculation | Minimum Annual Royalties | Reach through royalties
Lecture 92Average Royalty Rate
Lecture 93Factor affecting the Royalty Rate in Pharmaceutical and Biopharmaceutical Deal
Lecture 94Distribution Licensing | Geography | Indication Splitting | Exclusive and Non-Exclusive Licensing | Sub Licenses
Lecture 95Acquisition in Pharma  | Product Acquisition| Company Acquisitions| Steps in acquisition | Financing acquisition deals | Trademark Assignment Process
Lecture 96Indication Splitting | Concept | Implementation feasibility analysis 
Lecture 97Valuation Methods: DCF | rNPV | Sunk Cost Method | Comparables | Sum of Parts | Deterministic Vs. Probabilistic rNPV |  Peak Sales - Max-Min Approach
Lecture 98Valuation Methods: EBITDA method of valuation | Enterprise Value and Enterprise Multiple Calculation
Lecture 99Valuation Methods: DCF | rNPV | Sunk Cost Method | Comparables | Sum of Parts | Deterministic Vs. Probabilistic rNPV |  Peak Sales - Max-Min Approach
Lecture 100Early Stage VS. Late Stage Valuation Methodology | Stair Step Model
Section 6IPR Management of Biologics and Biosimilar
Lecture 101Biosimilar Approval and Patent Management | Strategic Pathway of Patent Negotiation and Litigation in Biosimilar Approval | Patent Dance | FAQs on Biologic Patent Management 
Lecture 102Biosimilar launch case study | Patent Dance Framework
Lecture 103Biosimilar Launch Framework 
Lecture 104Biosimilar 180 Day Notice 
Lecture 1053(A) List | Significance | Importance | How to interpret
Lecture 106Steps to win over innovator patents | Step wise planning 
Lecture 107Biosimilar Launch Project Roadmap with defined stages of project
Lecture 108Timing of Biosimilar Submission and Approvals | Two Scenario based timeline assessments 
Lecture 109Hands on Training on Reference Biologic Patent | Classify RPS Biologic Patents | Case Simulation  
Lecture 110How to work on RPS’s Patent | Walkthrough | Case Study
Lecture 111Biosimilar Launch Project With Milestones
Lecture 112Analysis of Biologic Patents | Work Assignments
Lecture 113Biologic Patent Insight Worksheet
Lecture 114Patent Thickets | Concept | Implication | Case Based Learning 
Section 7Request for Course Certification