© © John Mc Manus 2009 Disseminating IP Knowledge in Universities IP Teaching and Industry - illustration of IP problems that arise in business Dr John

©© John Mc Manus 2009

Disseminating IP Knowledge in Universities

IP Teaching and Industry - illustration of IP problems that arise in business

Dr John Mc Manus

EPA Roving Workshop Series

Prague, 2nd December 2009

Industrial Property Office of the Czech Republic


Key IP Issues in a Business Context

Integrity & Chain of Title

Skills & Opportunities

Scope & Strength of IP

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Identifying Your IPR


IP Audit

Technology

- patents/secret know-how for fundamental aspects of technology

Manufacturing

- patents/secret know-how for technologies, methods, processes used in manufacturing of products

Products

- patents (for function) and design rights (for appearance) of products

Sales & Marketing

- trade marks for the company name, its products and services

IT

- patents, copyright for key software, domain names for websites

Where does IP exist your Business?

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The Objectives

Catalogue existing IP - patents/applications, trademarks, know-how

Evaluate the status of IP in development

Uncover unknown IP assets

Determine the scope of ownership rights in IP

Identify strengths and weaknesses of new IP

Audit Report contains a comprehensive record of

- where IP exists in the organisation

- where it is likely to be generated shortly

- recommendations on how to manage the IP

Auditing Your IP

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Due Diligence Focus

A. Assess the level of protection for the IP – Scope & Strength validate the status of the IP rights protecting the invention assess scope of the monopoly provided by the IP rights

(i.e. how broad and strong is it?)

B. Examines the legal basis of the IP – Integrity & Validity review the documentation / process in creating the IP identify and assess any risks surrounding the IP


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Does the IP provide the protection you require?

For patents we need to look at:

- status of protection

- patentability

- scope of protection

- strength of protection

Scope & Strength of the IPScope & Strength of the IP

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Invention is only useful when it begins to make money

- i.e. it begins to erode someone else’s profits

- it provokes an adverse reaction in the market

What can competitors do about it?

- Ignore it – might be very costly for them in the long run!!

- Invent around it – costly investments required

- Challenge it – easy, let’s invalidate the patent

- How?

Case Studies


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Search databases to see if information relevant to the invention has been placed in the public domain – How?

Publications

Interviews and Articles in the News

Marketing Material

Samples, Prototypes, Products passed on non-confidentially

Why should this have a legal basis for Invalidation?

Novelty and Inventiveness is destroyed


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US District Court Patent Invalidity Judgement, October 5, 1994

Ciba-Geigy alleges Alza's NICODERM transdermal nicotine delivery patchinfringed claims 1, 2, 4, 5, and 7 of U.S. Patent No. 5,016,652

1. A patch adapted for application to the skin of a user for the transdermal administration of nicotine to the user, said patch comprising:…………..

Alza counterclaims that the patent claims were invalid an anticipated by Cecil H. Fox - Letter to Nature, 1984, Re: Nicotine delivery

“Alternative routes of drug administration more cosmetic than chewing tobacco or snuffs should be developed so that the nicotine addict has alternatives to cigarettes. Nicotine chewing gum has had limited success, but may soon become available worldwide. Another alternative might be transdermal application much in the manner of nitroglycerine (sic) and scopolomine (sic) patches. Nicotine “inhalers” might also be feasible if dosage could be adjusted.”


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Requirements for a Patent

Novelty - Inventive Step - Industrial Application

But, also requires “Enablement and Sufficiency of Disclosure”

20th. June 2001 - EPO revoked ICOS patent after opposition from

SmithKlineBeecham and Duphar International Research. The patent included

speculation as to the specific function of a protein encoded by a DNA

sequence, but lacked working examples of function and utility of that protein.

i.e. “accurate speculation is not enough”- sufficient information to show how the invention works is required

Many patents revoked on the basis of insufficiency of disclosure


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UK Life Sciences Patent Litigation - Summary for 2007

© Bird & Bird 2007

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Integrity of the IP (Validity)

Relates back to processes used to create, manage and protect the IP

i.e. need to check the following points:

Original Results/Data lab notebooks & invention disclosures

Disclosure Records publications & confidential information

Inventorship / Authorship correct designation

Ownership execute assignments

Third Party Rights clarify

Right to Practice verify(Freedom to Operate)

Integrity of IP

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Chain of Title

Inventor Owner Assignee

Collaborators!

(opps!!!)

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Consequences of Poor Management – Chain of Title

Ethicon Inc. v United States Surgical Corp.,

Safety Trocar developed & patented by Dr. In Bae Yoon- Yoon named as sole inventor

Ethicon is granted exclusive licence to patent by Yoon

US Surgical infringed claims 34 and 50 of patent

US Surgical discovered a non-joined inventor- Mr. Young Jae Choi, electronics technician- worked with Dr. Yoon on development of safety trocar- not paid for his work- not informed of patent

What could they do with this information?

Integrity of IP

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Ethicon v. United States Surgical Corp

US Federal Ruling 1998

Choi contributed to claims 33 and 47 – is an inventor therefore

Inventorship of patent corrected at USPTO

Choi named as inventor – i.e. Yoon and Choi are joint-inventors

Absence of exploitation agreement between Yoon and Choi !!

Choi licensed joint-patent to US Surgical

US Surgical has rights to use of whole patent

Infringement of claims 34 and 50 became invalid

Integrity of IP

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At best

- non-joined or misjoined inventors can form the basis for a new division

of ownership of the patent

At worst

- non-joined or misjoined inventors can form the basis for a an

invalidation of a patent

Integrity of IP

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Lessons Learnt

Infringers will attempt to Invalidate the patent

“Insufficiency of Disclosure” is a ground for revoking a patent

Confidentiality – Disclosure is also a target for invalidation

Correct designation of Inventorship and Ownership is critical

Exploitation Agreement is essential in Collaborations

Inventors contributing to one claim have rights to whole patent

Common Law will allow joint owners to exploit independently

Common Law rights vary from jurisdiction to jurisdiction

Scope, Strength &Integrity of IP

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Due Diligence Conclusion

Clarity on all points and status of supporting documents

Aware of risk level on potential legal issues

Confidence in accuracy of IP status

Conviction in the strength and value of the asset

Success means

- defending against all challenges

- avoiding legal faults and loopholes

Scope, Strength &Integrity of IP

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IP auditing

Understanding patent system

Analysis of patent claims

Analysis of competition’s patents

Proficiency in patent database searching

Understanding collaboration and consortium agreements

Understanding licensing agreements

Evaluating and valuing IP

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Skills Required


Employment Opportunities

Graduates with IP Knowledge

Technology Transfer Offices Research Centres and Consortium Projects – manage project IP Patent Agents Patent Examiners IP Lawyers – tech. understanding allows them to predict possible issues Start-up Companies

- technology, IP and business knowledge is valuable combination Large Companies – science graduates fit well into R&D and IP Depts.

- R&D, IP and Business Strategies are all interdependent

- IP Departments manage Patents, DR, ©, TM & K-H,

- Technology Licensing, Acquisition, Litigation,

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Thank You

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Documents

© © John Mc Manus 2009 Disseminating IP Knowledge in Universities IP Teaching and Industry - illustration of IP problems that arise in business Dr John