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Intellectual Property

Patents, Exclusivity, Trade Secrets, Trademarks.
Understand the market protection of your current and future products.
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Core Curriculum

Executives who know the Core Curriculum will be able to participate capably in discussions about pharmaceutical and biotech patents, regulatory exclusivities, trade secrets and trademarks.  

1. Term of Patents

Visualize a timeline for patents as part of the development and life cycle management of a drug franchise.
  • Base Term
  • Patent Term Adjustment
  • Patent Term Extension
  • Pediatric Exclusivity

Instructor: 
Matthew Holley, JD, MEd


2. Regulatory Exclusivities

Patents are half the picture.  Know each exclusivity and what it takes to qualify.
  • New Chemical Entity
  • New Clinical Investigation
  • Orphan
  • New Antibiotic

Instructor:  Matthew Holley. JD, MEd


3. Non-Patent IP

Maintaining confidentiality is critical, Learn the pitfalls of trade secret protection.
  • Trademarks
  • Trade Secrets
  • Copyrights 

Instructor: 
Matthew Holley, JD, MEd


4. Patent Basics

These issues are each introduced as concepts and tied to pharmaceutical patents.
  • 101-What can be patented
  • 102 Novelity
  • 103-Obviousness
  • 112-Enablement and Written Description

Instructor:  Matthew Holley, JD, MEd


5. Patent Prosecution

Knowing the basic process is critical to useful participation.  

  • Process of getting a patent
  • Divisionals 
  • Continuations
  • Examiner relations

Instructor: 
Matthew Holley, JD, MEd


6. Generic Entry

Welcome to the dance!  Know what you would know if you had been through several such cases.
  • Baseline process
  • Timelines
  • Setting expectations
  • Cost of cases
  • Joint defenses

Instructors: 
 Rami Bardenstein, JD
                       Matthew Holley, JD, MEd


$125 per course, or all six courses of the Core Curriculum for $500

Get Immediate Access To

our Introductory Course - Completely Free.

Learn the base term of patents and how they can be extended—essential knowledge for making informed decisions.

When your learning fades, refresh it by reviewing a course.

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Complementary Resources

PowerPoint for Patent Terms Course


Download the deck and modify it as you see fit to teach people in your organization, or your clients. 

Review the deck with a patent attorney before finalizing and teaching it, and if you come up with any improvements to it, submit them back to us so that we can continue to improve the course. 

Live Avatar Development Guide



Using live avatars can really help your students to learn, and can also faciltate having people throughout your organization think of you as someone who is really on top of the AI trends.  



WIPO Invention Disclosure Form



Use this guide in your company to document new discoveries that may be patent eligible

  

Expert Courses

7.  Small Molecule Patents

Course in development

  • Landscape of chemical synthesis
  • .Variations on salts, phosphares etc.
  • Suyccesses and failures

Instructor:
[Title and Employer]

8.  Biologic Patents

Course in development

  • Evolution and Status of Patentability
  • Protein scopes of exclusion.
  • Claim writing for RNA, DNA and antisense

Instructor:
[Title and Employer]

9.  Digital Health IP
Strategies

Course in development

  • Sytem entirety protection
  • Software patents and copyrights
  • Data capture and leverage

Instructor:
[Title and Employer]

10.  AI
in patents

Course in development

  •     Inventorship by AI
  • Current strategies of development
  • Information control - Not feeding the beast 

Instructor:
[Title and Employer]

11.  Licensing &
 Transactions

Course in development

  •    Effective Due diligence
  • Matching terms to strategy
  • Team dynamics and expectations


Instructor:
[Title and Employer]

12.  Life Cycle Extension

Course in development

  • Innovation examples and vectors
  • Visualize and Time investment
  •    Rx to OTC

Instructor:
[Title and Employer]

In the U.S. about 200,000 patents are issued each year.

In the U.S. about 350,000 patent applications are filed each year.

There are about 8,000 patent examiners in the USPTO

USPTO Technology Center 1600 handles drug and biologic therapies and diagnostics Most patent examiners are attorneys

Patent examiners are divided among nine centers, each with a different technology focus.

The average amount of time a USPTO examiner spends with a patent is 19 hours.

Most patents have no, or very limited, commercial value.

About 3% of patents have a Patent Trials and Appeals Board hearing or litigation

Article 1, Clause 8 of the U.S. Constitution provides for a patent and trademark system

Length of time a patent lasts is 20 years plus extensions

Things to include in courses

Patent Timeline and Presentation

Having a clear understanding of the life cycle of your company's current products, those in development, and those being looked at by Business Development is critical.  Use the template not only for your understanding, but also to communicate about the products.

Use this template if you would like to teach all or part of the Patent Term course in your own organization. 

Invention Disclosure
Form & Questionnaire

Your company or institution should have an established process for capturing ideas that may be patentable.  Here are some template forms you may want to compare to your company's version, or (if your company does not have such things), use as a starting point for working with your patent attorneys to develop your company's version.   

IP Due Diligence Checklist

Your company or institution should have an established process for making certain that you have done your due diligence and have covered all the bases. use this as a starting point for working with your patent attorneys to develop your company's version.   

Company Program Evaluation

It can be helpful to have a mental checklist of things you are looking for in a good corporate intellectual property program.  Our courses teach the concepts, and this list will help you recall and apply them. 

The primary purpose is for you to have this as an thought structure when you are functioning in a company as a director, executive or manager, or are picking a company to join.