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U.S. IP licensing - Bio Korea 2016
- 2. KOREA U.S. 라이센싱 = Licensing (?) Licensing in U.S. 2 1. Language 2. Culture 3. Law
- 3. • Illustration source: BrandMagazine.com Leading Brands have the Most Valuable IP 3
- 5. 5 Success Story – PDL BioPharma • Source: http://pdl.com
- 6. 6 • PDL BioPharma: Pioneer of humanized monoclonal antibodies Humanized Antibody • Source: http://pdl.com
- 7. 7 Success Story – PDL BioPharma • PDL Queen Patent License – Licensees: Genentech, Roche, Novartis, Biogen, etc. – Sales of licensed products: >$20 billions – Paying royalty v. patent invalidation • PDL Success Formula – Strong patent portfolio – Successful patent litigation defense
- 8. Enablement Demonstration Development Probability of Success Effort/Time Idea Invention Patent License Invention Disclosure Commercialization Stage Commercialization Steps Source: Michigan Technological University (http://www.mtu.edu/research/references/training/docs-new/Intellectual%20Issues%20in%20Research%20Presentation.ppt.) Technology Commercialization Process 8
- 9. • Internal review process • Review by in‐house counsels • Making a patent filing decision based on prior art, scientific maturity, commercial value, market conditions, etc. • Patent v. Trade Secret Invention Evaluation 9
- 10. Three Stages of Patent Acquisition: A. Invention and Prior Art Search B. Patent Preparation C. Patent Prosecution Acquisition of Strong Patent 10 • Two possible approaches: vs.
- 11. Source: MIDAS©, 2005–2012, IMS Health Incorporated or its affiliates. Where to File & License? 11 • Drug Sales
- 12. 12 Licensing Timeline • Typical licensing procedure Non‐ Confidential Presentation Confidential Disclosure Agreement (CDA) Due Diligence Term Sheets Final Agreement • Assessment of intellectual property assets owned by (or licensed to) a company • Critical part of licensing • Complex legal review process
- 14. • Due Diligence = checking various (critical) points • No high price for a product having defects Licensing = Used Car ? 14
- 15. 1. Freedom To Operate (FTO) – Any potential infringement? – Any risks to be sued? 2. Ownership & Transferability – Owner of your IP? 3. Validity & Enforceability – Protect target product? – Strong patents? IP Due Diligence – Main Points 15
- 16. • Investigation to determine if you infringe patents of others • Expensive process but necessary for commercialization 1. Freedom To Operate (FTO) 16
- 17. • Patent procurement v. Patent infringement • Samsung: Top 2 patent filer in U.S. 1. Freedom To Operate (FTO) 17 vs.
- 18. • Source: Lex Machina ‐ Patent Litigation Year in Review (2013). 1. FTO - Patent Damages in U.S. 18
- 19. Source: http://ptopatenttrials.com/2012/05/20/uspto‐post‐grant‐opposition‐costs‐a‐forum‐conveniens‐for‐ invalidity‐disputes/ 1. FTO - U.S. Litigation Costs 19 • Assess potential litigation risks in U.S.
- 20. • Conduct FTO Search – Conduct patent searches regularly – Search competitors’ patents • Monitor screened patents/applications • Keep search/review record – Patent search/review assessment • Consult patent counsel 1. FTO - ID Infringement Risks 20
- 21. • Wrong Inventorship Unenforceable patent. See Stark v. Advanced Magnetics, 119 F.3d 1551 (Fed. Cir. 1997) • Wrong inventorship a) Nonjoinder: Non‐inclusion of a true inventor b) Misjoinder: Inclusion of a non‐inventor • Record keeping – Invention disclosure 2. Inventorship 21
- 22. Invention Disclosure • Develop invention disclosure form • Information to be included: – Title of invention – Identification of prior art (patents and publications) – Detailed description of invention: • Differences, improvements, and advantages of the invention • Specific experimental examples – Date of invention, inventor names 2. Inventorship 22 Source: http://www.uclb.com, Invention Disclosure Form
- 23. • Common Ownership Issues 1. The target does not hold the IP rights 2. Prior agreements limiting the target’s IP rights 3. IP rights encumbered by liens 2. Ownership 23
- 24. • Ownership Transfer ‐ Assignment – Check chain of title – Review assignment recordation – Tip: Obtain signatures as quickly as possible • Potential ownership leaks – Collaboration, Government support, etc. • Review agreements with third parties 2. Ownership 24
- 25. 1. Patent Exploitation in U.S. a) Each joint owner can exploit without permission of others b) No duty to share royalties 2. Patent Enforcement in U.S. a) All joint owners must join suit b) Other owners can grant license (circumvention) 2. Avoid Joint Ownership! 25
- 26. • Anticipation and Obviousness – Collect prior art info – Cross‐check references – Competitor’s patents and publications • Section 101 Patent Eligibility – Mayo & Myriad cases • Inequitable Conduct (Duty of Candor) – Cross‐check related applications – Review inventor publication files • Enablement and Written Description 3. Patent Validity 26
- 27. • Obtain description of target product – Specifications/product literature – Manufacturing documents – Product inserts • Identify critical terms in claims – Specification, file history, normal usage – Review file histories • Categorize claims – Covers target product? How? – Covers competitor’s products? 3. Claim Scope 27
- 28. • Expiration date: Determine the expiration of patents • Patent Term Adjustment/Extension: PTA v. PTE 4. Other Issues - Patent Term 28 Patent Term Adjustment (PTA) under 35 USC §154 Patent Term Extension (PTE) under 35 USC §156 Eligibility Any Issued Patents Drug & Device Patents Delay Patent Office Examination FDA Regulatory Review Calculation 14 + 4 + 4 + 4 Rule ½ Clinical Trial + FDA Review Terminal Disclaimer Reduces PTA No Reduction Maximum Term PTO Delay (A+B+C periods) Five Years
- 29. • Provide NCE/NBE info and related documents • IND and NDA filing dates and estimated NDA approval date 4. Other Issues – FDA Exclusivity 29 NBE Reference Product Approval Biosimilar Application Biosimilar Approval 0 12 Years4 Years NCE Expiration 5 Years 30‐month stay NCE 0
- 30. • Possible Targets: – New use/indication, new target patient strata, new administration route, new formulation • Adjunct Benefit for Existing Drug: – Reduced side‐effect, improved therapeutic index, diagnostic application • New “Article‐type” invention: – Racemate‐to‐chiral switch – New salt, ester, amide, hydrolysate – New crystal form or polymorph, Metabolite or pro‐drug – Combination therapy – Formulation with improved bioavailability 4. Other issues - Life Cycle Management 30
- 31. Prepare IP status reports Check assignments/invention disclosures Perform prior art/patent searching Review file histories Prepare strategy for patents having potential issues Preparation of IP Diligence 31
- 32. IP Diligence Checklist 32 Source: http://media.lockelord.com/files/uploads/Documents/Folios/US‐IP‐DueDiligenceChecklist.pdf • Due diligence check list
- 33. Virtual Data Room 33 • Virtual data room: for exchanging secret information • Transparency is the key to success. • Be prepared for data/document disclosure! Source: http://www.ethosdata.com/advanced_functionality/
- 34. Set up good IP policy Build strong IP portfolio Evaluate IP portfolio regularly Look for licensing opportunities Prepare for due diligence Take Home Message 34