1. © © 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, 2 nd December 2009 Industrial Property Office of the Czech Republic

2. © © 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

3. © © 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

4. © © 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

5. © © 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

6. © © 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 IP 6

7. © © 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

8. © © 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

9. © © John Mc Manus 2009 US District Court Patent Invalidity Judgement, October 5, 1994 Ciba-Geigy alleges Alza's NICODERM transdermal nicotine delivery patch infringed 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

10. © © John Mc Manus 2009 Requirements for a Patent Novelty - Inventive Step - Industrial Application But, also requires “Enablement and Sufficiency of Disclosure” 20 th. 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

11. © © John Mc Manus 2009 Scope & Strength of IP UK Life Sciences Patent Litigation - Summary for 2007 © Bird & Bird 2007 11

12. © © 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/Datalab notebooks & invention disclosures Disclosure Recordspublications & confidential information Inventorship / Authorshipcorrect designation Ownershipexecute assignments Third Party Rightsclarify Right to Practiceverify (Freedom to Operate) Integrity of IP 12

13. © © John Mc Manus 2009 Chain of Title Inventor OwnerAssignee Collaborators! (opps!!!) 13

14. © © 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

15. © © 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

16. © © 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

17. © © 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

18. © © 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

19. © © 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

20. © © 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

21. © © John Mc Manus 2009 Thank You 21