Princeton, New Jersey

Department Page

Intellectual Property

Patents - Exclusivity - Trademarks

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Advisors

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Introduction to the Department

Free Basic Course

1.  Term of Patents 

  • Base Term
  • Patent Term Adjustment
  • Patent Term Extension 
  • Pediatric Extension
  • Provisional Patents

Learn how long patents last and understand how they can be extended.  Visualize a timeline for patents as part of the development and life cycle management of a drug franchise.

Instructor:
Matthew Holley
Pharmaceutical Officers Academy

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Core Courses

2.  Prosecution process

  • The steps to getting a patent
  • Rejection - good and bad
  • Continuations / Divisionals
  • "Priority filings" and patent families
  • PCT phase (12 months to 30/31)
  • Maintenance Fees
  • Duty to Disclose, Inequitable Conduct, and Best Practices

Knowing the basic process is critical to understanding what is going on in the protection of your products.  

Instructor:  
Matthew Holley
Pharmaceutical Officer Academy

3.  Patent Types

  • Know the primary types
  • Practical and technical categories
  • International categories 
  • Parts of a patent filing
  • Claims structure
  • Nature of Patent Law

Get oriented as to what types of patents there are, and which are relevant to biotech.  This is to "know what you are looking at" course for patents.

Instructor:  
Matthew Holley
Pharmaceutical Officers Academy


4.  Exclusivities

  • Market vs. Data
  • New Chemical Entity
  • Orphan
  • Biologics
  • International variations

Patents are half the picture.  To understand the market protection for products you are developing we teach the types of data exclusivities as well.

Instructor:  
Matthew Holley
Pharmaceutical Officers Academy

5.  Generic Entry

  • Baseline process without patent challene
  • Timelines
  • Expectations usual outcomes
  • Cost of cases
  • Joint and distributed infringement

Welcome to the dance!  Know what you would know if you had been through several such cases.

Instructor:
Matthew Holley
Pharmaceutical Officers Academy

6.  Primary Issues - 101, 102, 103, and 112

Course in development

  • Structure of patent law.
  • 101 - Patentability of the idea / invention.
  • 102 - Novelty 
  • 103 - Obviousness
  • 112 - Enablement and Written Description

These issues are each introduced as concepts and tied to pharmaceutical patents, and then each is fully addressed in the specialty courses on various types of patents.

Instructor:  
Matthew Holley
Pharmaceutical Officers Academy

7.  Claims 

Course in development

  • Claim format
  • Structuring a set of claims
  • Independent and dependent
  • Customary phrasing

Knowing a bit about how patent claims are structured and worded can really help when asking someone to explain the scope and strength of patents.  This course gives you the basics.

Instructor:
Matthew Holley
Pharmaceutical Officers Academy


8.  Life Cycle Extension

Course in development

  • Skinny label possibilities and limitations
  • Innovation success examples
  • Timing of investment

Instructor:
[Title and Employer]

9.  Program Management

Course in development

  • Capture and cull.
  • Players, roles and best practices
  • Research Publication
  • Disclosure in securities filings 
  • SWOT your portfolio
  • Visualize and articulate
  • Law Firm Relationships

Instructor:  
[Title and Employer]

Expert Courses

Small Molecule Patents

Course in development

  • Understanding scope of exclusions 
  • Variations in salts, phosphates etc.
  • Successes and failures

Instructor:
[Title and Employer]

Nucleic Acid Patents

Course in development

  • Evolution and Status of Patentability
  • Claim writing for RNA, DNA and antisense
  • Prior Art issues.

Instructor:
[Title and Employer]

Protein and Antibody Patents

Course in development

  • Evolution and Status of Patentability
  • Protein scopes of exclusion.
  • Team roles for prosecution.

Instructor:
[Title and Employer]

Digital Health Patents

Course in development

  • Business process patentability.
  • Software patentability.
  • Successes and Failures.

Instructor:  
[Title and Employer]

Artificial Intelligence in Patents

Course in development

Instructor:
[Title and Employer]

Trade Secrets

Course in development

  • Defining trade secrets
  • Selecting best protection route
  • Optimizing controls

Trademarks and Copyrights

Course in development

  • Types of marks
  • Scope and limitations

Instructor:
[Title and Employer]

Patent Searching and Due Diligence

Course in development

  • Types of searches by purpose
  • The licensing dance

Instructor:
[Title and Employer]

Generic Challenges - Generic View

  • Commercial considerations
  • Anti-trust restrictions
  • Exclusivities and pricing 

Instructor:
[Title and Employer]


Patent Strategies for Generic Medicines and Generic Medicine Companies Training Course

Prosecution Complications

  • Patent Tree diagrams
  • PCT - European - National and other examples
    (see Coursera course Module II, Making Patent Timelines)
  • USPTO Central Reexamination Unit
  • U.S. Patent Trial and Appeal Board "PTAB"
  • International Trade Commission
  • Requests for Continued Examination
  • Inter parties review

Instructor:
[Title and Employer]

When your learning fades, refresh it by reviewing a course.
Access is forever on Academy courses you take.

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 References and Resources

Use this site as your resource.   In particular, for patent matters, use it to augment your memory and refresh you on topics that arise in your work.  From here you can access whatever level of detail you may need.  

Evaluation Foci

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. 
 

Country specific resources

China

European Union

India
Mexico
Canada

Podcasts

Blogs

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

Internal POA Notes for this page

Potential Contributors List - IP
https://www.dropbox.com/scl/fi/7ha4g4r9znzdusmbga6ie/Potential-Contributor-List-IP-Department.docx?rlkey=5hi6ipjeuepwhntadt8gdcpzl&st=j2uyyhys&dl=0

Things to include in courses

Rankings of Law Firms that do Patents

https://www.lmglifesciences.com/

https://www.iam-media.com/rankings/patent-1000

https://chambers.com/

https://harrityllp.com/services/patent-analytics/top-patent-firms/ 

2https://blog.patentbots.com/2024/04/2024-patent-quality-rankings-top-50.html

Leads for other countries

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