©© 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
©© John Mc Manus 2009
Key IP Issues in a Business Context
Integrity & Chain of Title
Skills & Opportunities
Scope & Strength of IP
2
Identifying Your IPR
©© John Mc Manus 2009
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?
3
©© John Mc Manus 2009
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
4
©© John Mc Manus 2009
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
Scope & Strength of IP
5
©© John Mc Manus 2009
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
6
©© John Mc Manus 2009
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
Scope & Strength of IP
7
©© John Mc Manus 2009
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
Scope & Strength of IP
8
©© John Mc Manus 2009
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.”
Scope & Strength of IP
9
©© John Mc Manus 2009
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
Scope & Strength of IP
10
©© John Mc Manus 2009
Scope & Strength of IP
UK Life Sciences Patent Litigation - Summary for 2007
© Bird & Bird 2007
11
©© John Mc Manus 2009
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
12
©© John Mc Manus 2009
Chain of Title
Inventor Owner Assignee
Collaborators!
(opps!!!)
13
©© John Mc Manus 2009
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
14
©© John Mc Manus 2009
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
15
©© John Mc Manus 2009
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
16
©© John Mc Manus 2009
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
17
©© John Mc Manus 2009
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
18
©© John Mc Manus 2009
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
19
Skills Required
©© John Mc Manus 2009
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,
20
©© John Mc Manus 2009
Thank You
21