The Role of Patents in Healthcare & Biomedical Research

Slides from a talk given to the National Healthcare Group in October 2013.

Copyright 2008-2013 Chong-Yee Khoo. All rights reserved.

Transcript

1. The Role of Patents in Healthcare & Biomedical Research Khoo Chong Yee, PhD Cantab LLP (@CantabIP) Chartered and European Patent Attorney Registered Singapore Patent Agent European Trade Mark and Design Attorney National Healthcare Group 24 October 2013 1
2. Contents • Introduction to IP • Patents in Biomed • Patentability • Novelty • Inventive Step • Priority 2
3. Introduction to Intellectual Property 3
4. What is Intellectual Property? • Scope of IP rights • Ownership • Exclusive use 4
5. Intellectual Property • Prevents • copying • working • using a confusing sign • Transactions in rights • Automatic subsistence vs registration 5
6. Patents • Protect inventions • Property right • Scope of rights • Registered vs unregistered rights • Enforcement 6
7. Patents in a Biomed Business 7
8. Knowledge Economy Industrial Labour Economy 8
9. 17% 32% 68% 80% 80% 83% 68% 32% 20% 20% 1975 1985 1995 2005 2010 S&P 500 Market Value Source: Brookings Institute, Ocean Tomo Intangible Assets Tangible Assets 9
10. Biomed IP = Patents 10
11. C B D A Yes, it’ll look good on my CV Should I patent my biomedical invention? 1 Yes, but only if it makes money I can do it myself! No, it’s too expensive 11
12. Patentability 12
13. Patent Process File Patent Application Search and Examination Application published Patent Granted Patentable invention? 13
14. Patentability - Singapore • Section 13 Singapore Patents Act • “...a patentable invention is one that satisfies the following conditions: • (a) the invention is new; • (b) it involves an inventive step; and • (c) it is capable of industrial application” 14
15. Novelty 15
16. Novelty • New vs novel vs known • Disclosure • Types of novelty destroying disclosure 16
17. Confidentiality and Disclosures • Non-confidential disclosures • Disclosures under confidence • Tests for confidentiality 17
18. • “Enabling character” • Ability of skilled person • Example: sale of chemical Enablement and Disclosures 18
19. Novelty Jargon Buster* * ™ © and everything else Cantab 19
20. known public domain prior art citation sufficiency priority date disclosure enablement secret confidential NDA available to the public sale demonstration abstract novel non-enabling disclosure disclosed new published not novel invention 20
21. Inventive Step 21
22. Inventive Step • “patentable invention...involves an inventive step” • No definition of “inventive step” in Act and Rules • Are differences between invention and prior art obvious? • No definition of “obvious”! 22
23. Windsurfer • United Kingdom • identify the inventive concept • identify what differences exist between the relevant prior art and the invention • decide, without knowledge of the invention, whether the differences constitute steps which would have been obvious to the skilled person 23
24. Problem and Solution • European Patent Office • identify the closest piece of prior art • identify the differences between this and the invention • ascertain the problem to be solved • ask if the solution to that problem is obvious 24
25. Inventive Step? • “mere collocation of integers”? • Logical step • Motivation in the art • Obvious to try vs reasonable expectation of success • Expectation of success 25
26. Inventive Step? • Technical prejudice • Long felt need • Combination • Obvious solution 26
27. Other Issues 27
28. Excluded Subject Matter • Certain categories of subject matter are not protectable by patent because • they are not “inventions” • they overlap with or are covered by other rights • Not in the public interest 28
29. Medical Methods • Methods of medical treatment • Methods of diagnosis • Methods of surgery • “Use” claims • Humans and animals • 1st medical use claims • 2nd medical use claims 29
30. Other Issues • Excluded subject matter • Industrial applicability / utility • Written description • Sufficiency and enablement • Best mode • Added subject matter 30
31. C B D A Surgical device What sorts of biomedical inventions are protectable by patent? 2 Diagnostic method Therapeutic method Combination of known drugs Dosage Sub-population 31
32. Strategies for Obtaining Broad and Strong Patents 32
33. Patenting Timeline Patent legally effective: can sue infringers Provisional protection: damages claimable to here Legal Effects Priority date established 0M Actions 18M Application filed Application published Exam reports Responses Am endm ents Patent granted Published 3-5 years? Search report? 33
34. Typical Patent Specification • Field of the Invention • Technical Background (Problem) • Summary of the Invention • Brief Description of the Drawings • Detailed Description • Examples • Claims • Drawings 34
35. Patent Attorneys • Scientists and engineers who have specialised in IP law • Qualified by rigourous examination • Not lawyers! • Both scientifically and legally trained • Able to understand the invention, how it works and what distinguishes it from the prior art 35
36. Choosing a Patent Attorney • Choose your patent attorney carefully • Questions to ask: • Are they technically and scientifically qualified? Have they done scientific research? • Are they legally qualified in a relevant jurisdiction? Are they qualified by examination? • Have they drafted or prosecuted patents in the technology? How many? • Find out who is actually drafting the patent specification and meet them! 36
37. C B D A A patent attorney Who should I get to draft my patent specification? 3 Someone on the Internet I can do it myself! A lawyer 37
38. Priority Strategies 38
39. 24 Oct 2013 24 Oct 2012 Disclosure Not novel P1 P1 P2 Priority in Practice Priority 39
40. Priority in Practice • First filing • Disclosure of application • “Cover page provisionals” • Identity of invention • Identity of owner • Abandonment 40
41. Summary • Patents are important business tools and add value to the company • Choose a patent strategy that fits your business aims, the market and the nature of the invention • The best enforcement strategy is to have a broad and strong patent drafted and prosecuted by a patent attorney 41
42. Questions? Cantab LLP VBox 881846 Singapore 919191 mail@cantab-ip.com www.cantab-ip.com Copyright 2008-2013 Khoo C-Y 42