Advanced Patent Law and Strategy in Biotechnology training course

Advanced Patent Law and Strategy in Biotechnology training course

Introduction

Advanced Patent Law and Strategy in Biotechnology training course provides a comprehensive and practical deep dive into the complex world of intellectual property (IP) law as it applies to the biotechnology industry. We'll explore the critical intersection of cutting-edge scientific innovation and legal strategy, focusing on how to protect and monetize groundbreaking biotech inventions. This training is designed for professionals who need to navigate the unique challenges of biopharma patenting, including issues related to gene patents, CRISPR technology, personalized medicine, and regulatory exclusivities. You'll gain a strategic toolkit for patent portfolio management, freedom-to-operate analysis, and biotech litigation, empowering you to build a robust and defensible IP position for your organization.

The biotech landscape is rapidly evolving, making a sophisticated understanding of patent law essential for success. This course will go beyond the basics of patent prosecution to cover advanced patent strategy, technology transfer, and licensing agreements. Through a series of real-world case studies and practical exercises, you will learn how to identify patentable subject matter, draft strong claims, and anticipate legal challenges. We'll also examine the global dimension of biotech IP, including international patent treaties and the nuances of obtaining protection in key jurisdictions. By the end of this program, you will be equipped to make informed, strategic decisions that drive innovation, secure competitive advantage, and maximize the value of your company's intellectual assets.

Course Duration

10 days

Course Objectives

Upon completion of this course, participants will be able to:

• Master the patentability requirements for biotechnological inventions.
• Develop advanced patent search strategies for prior art analysis.
• Draft robust and defensible claims for biopharma assets.
• Perform comprehensive freedom-to-operate (FTO) analysis and risk assessment.
• Formulate a strategic patent portfolio management plan.
• Understand the interplay between regulatory exclusivity and patent term extension.
• Navigate the complexities of gene patents and CRISPR IP.
• Conduct due diligence for biotech mergers & acquisitions (M&A) and licensing.
• Evaluate and value patent portfolios for monetization and investment.
• Manage international patent prosecution in major jurisdictions.
• Anticipate and prepare for biotech patent litigation and dispute resolution.
• Leverage intellectual property to secure venture capital (VC) funding.
• Implement best practices for trade secret protection and know-how management.

Organizational Benefits

• Reducing the risk of costly patent infringement lawsuits and invalidation challenges.
• Increasing the value of the company's intellectual property portfolio for future licensing, M&A, or public offerings.
• Fostering an internal culture that recognizes and protects novel inventions, leading to more strategic and valuable research and development efforts.
• Establishing a strong, defensible position in the market by creating barriers to entry for competitors.
• Improving efficiency in patent application, prosecution, and due diligence processes.
• Providing valuable, specialized training that makes the organization more appealing to top scientific and legal professionals.

Target Audience

• Patent Agents & Attorneys specializing in biotechnology.
• In-house Counsel at biotech and pharmaceutical companies.
• R&D Scientists & Researchers who need to understand IP implications.
• Technology Transfer Officers at universities and research institutions.
• Biotech Executives & Entrepreneurs leading startups.
• Venture Capital Investors focused on the life sciences.
• Business Development Professionals involved in partnerships and licensing.
• IP Paralegals & Managers seeking advanced, strategic knowledge.

Course Modules

Module 1: Foundational Principles of Biotech Patentability

• The legal framework for patenting life sciences inventions.
• Patentable subject matter: what's in and what's out?
• The standards of novelty and non-obviousness.
• Written description and enablement requirements.
• Case Study: The landmark Diamond v. Chakrabarty case and its impact on patenting living organisms.

Module 2: Advanced Claim Drafting for Biologics and Small Molecules

• Drafting strategies for composition of matter and method of use claims.
• The art of drafting dependent claims to build a robust claim tree.
• Using functional and structural language effectively.
• Claiming new formulations and drug delivery systems.
• Case Study: Analyzing claims from a blockbuster biologic patent to understand claim scope and defensibility.

Module 3: Gene, Diagnostic, and Personalized Medicine Patents

• The evolving legal landscape for gene patents and diagnostic methods.
• The impact of the Myriad Genetics and Mayo Collaborative Services decisions.
• CRISPR IP disputes and the concept of inventive step in gene editing.
• Patenting biomarkers and personalized treatment protocols.
• Case Study: The ongoing legal battle over CRISPR patent rights between UC Berkeley and the Broad Institute.

Module 4: Freedom-to-Operate (FTO) and Risk Management

• The essential steps of a comprehensive FTO analysis.
• Identifying and evaluating patent infringement risks.
• Strategies for designing around competitor patents.
• Navigating the patent thicket in crowded technology spaces.
• Case Study: Conducting a mock FTO analysis for a new antibody therapeutic and presenting risk mitigation strategies.

Module 5: Strategic Patent Portfolio Management

• Developing a global patent strategy aligned with business goals.
• Building a defensible patent portfolio for key products.
• Deciding when to file, abandon, or license patents.
• The role of utility patents, design patents, and trade secrets.
• Case Study: A company's evolution from a single patent to a diversified portfolio as it expands into new markets.

Module 6: Patent Licensing and Technology Transfer

• Structuring in-licensing and out-licensing agreements.
• Negotiating key terms: royalties, milestones, and exclusivity.
• Valuation of biotech IP for licensing and M&A.
• Managing cross-licensing and strategic collaborations.
• Case Study: A real-world example of a university-to-startup technology transfer agreement, highlighting key negotiation points.

Module 7: Regulatory Exclusivity vs. Patent Term Extension

• Understanding Data Exclusivity (e.g., Hatch-Waxman Act in the US).
• The interaction between regulatory exclusivity and patent term extension (PTE).
• Strategies for maximizing exclusivity periods for a drug.
• Global differences in regulatory and patent-based protection.
• Case Study: Analyzing the regulatory and patent timelines for a successful drug launch to understand the combined protection period.

Module 8: Biotech Patent Litigation and Dispute Resolution

• The basics of patent infringement litigation.
• Strategies for enforcing patents and defending against claims.
• Inter Partes Review (IPR) and other post-grant proceedings.
• Alternative dispute resolution (ADR) in IP matters.
• Case Study: A recent biotech litigation case, examining the arguments for infringement and invalidity.

Module 9: IP Due Diligence for Mergers, Acquisitions, and Investments

• The role of IP in biotech M&A.
• Conducting a thorough IP due diligence audit.
• Identifying hidden risks and opportunities in a target company's portfolio.
• Assessing the strength and scope of patents.
• Case Study: A company's acquisition of a promising startup, highlighting the crucial role of IP due diligence in the final deal.

Module 10: International Patent Strategy and Harmonization

• Navigating the Patent Cooperation Treaty (PCT).
• Filing strategies in key jurisdictions (US, EU, China, Japan).
• Understanding the differences in patent law and practice across countries.
• Managing a global patent portfolio.
• Case Study: A company's strategy for simultaneous filing and prosecution of a new medical device in multiple global markets.

Module 11: Trade Secrets and Confidential Information

• Protecting confidential information and know-how.
• The advantages and disadvantages of trade secret protection over patents.
• Best practices for creating a robust trade secret program.
• IP agreements for employees, contractors, and partners.
• Case Study: A company's decision to protect a proprietary cell line as a trade secret instead of pursuing a patent.

Module 12: IP Valuation and Monetization

• Methods for valuing intellectual property assets.
• Using patents to attract and secure venture capital funding.
• The role of IP in creating corporate value.
• Developing a monetization strategy through licensing, sales, or litigation.
• Case Study: A biotech startup's journey from early-stage funding to a successful IPO, demonstrating the role of IP in each stage.

Module 13: Emerging Topics in Biotech IP

• The intersection of AI and biotechnology and its IP implications.
• IP issues related to biomimetics and synthetic biology.
• Ethical and legal challenges of patenting life.
• The future of biotech patent law.
• Case Study: The challenges of patenting a new AI-driven drug discovery platform.

Module 14: Practical Skills for the Patent Professional

• Using patent databases for competitive intelligence.
• Drafting inventor disclosure forms and conducting interviews.
• Responding to Office Actions from patent examiners.
• Effective communication between scientists, lawyers, and business teams.
• Case Study: A hands-on exercise in drafting a response to a rejection based on prior art.

Module 15: Capstone Project and Mock Scenarios

• Participants will work in teams on a comprehensive case study.
• Developing an end-to-end IP strategy for a new biotech startup.
• Drafting claims, conducting an FTO analysis, and outlining a licensing strategy.
• Presenting the strategic plan to a panel of "investors" and "IP experts."
• Case Study: A simulated scenario where a team must protect a new gene therapy from a competing company's patent and secure funding.

Training Methodology

This course employs a blended learning approach that combines theory with practical application. The methodology includes:

• Interactive Lectures: Led by experienced patent attorneys and industry experts.
• Case Studies: In-depth analysis of real-world scenarios and landmark legal decisions.
• Workshops & Exercises.
• Group Discussions.
• Mock Scenarios & Role-Playing
• Mentorship & Feedback.

Register as a group from 3 participants for a Discount

Send us an email: [email protected] or call +254724527104 

Certification

Upon successful completion of this training, participants will be issued with a globally- recognized certificate.

Tailor-Made Course

 We also offer tailor-made courses based on your needs.

Key Notes

a. The participant must be conversant with English.

b. Upon completion of training the participant will be issued with an Authorized Training Certificate

c. Course duration is flexible and the contents can be modified to fit any number of days.

d. The course fee includes facilitation training materials, 2 coffee breaks, buffet lunch and A Certificate upon successful completion of Training.

e. One-year post-training support Consultation and Coaching provided after the course.

f. Payment should be done at least a week before commence of the training, to DATASTAT CONSULTANCY LTD account, as indicated in the invoice so as to enable us prepare better for you.