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Intellectual Property for Engineers

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Knobbe Martens attorneys Andrew Douglas and Shannon Lam presented "Intellectual Property for Engineers" on January 14, 2014 at the University of California, Irvine.

Knobbe Martens attorneys Andrew Douglas and Shannon Lam presented "Intellectual Property for Engineers" on January 14, 2014 at the University of California, Irvine.

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  • 1. knobbe.com Intellectual Property for Engineers January 14, 2014 UC Irvine
  • 2. 2© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. Overview 1. Background 2. Patent Quiz 3. Identifying IP 4. Protecting IP 5. Assessing 3rd Party Risk 6. Conclusions
  • 3. ©2012 Knobbe Martens, Olson & Bear, LLP all rights reserved.© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 3 BACKGROUND
  • 4. 4© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. Why have a patent system? • First Patent Law – 1790 • Stimulate Innovation • “Quid pro quo”  Give full, public disclosure  Receive exclusive rights • Patents are just one form of “Intellectual Property”  Intangible property rights
  • 5. 5© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. Who cares? • Inventors • Employers • Investors • Entrepreneurs Which is you?
  • 6. 6© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. Benefits • Often the most valuable assets of a start-up company. – Can be critical to obtain financing/investment • Allows idea sharing without risk of losing rights. – Publish papers and demonstrate prototypes • Protect Market – Enforce rights to prevent unauthorized use. • Injunction • Damages ($) • Source of revenue • Defensive purposes
  • 7. ©2012 Knobbe Martens, Olson & Bear, LLP all rights reserved.© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 7 PATENT QUIZ
  • 8. 8© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. Patent Quiz – True or False? • A patent application can be updated after it is filed to incorporate new features. • Liability for infringement can be avoided as long as you don’t intend to infringe. • Patent attorneys are always engineers or have some technical background.
  • 9. ©2012 Knobbe Martens, Olson & Bear, LLP all rights reserved.© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 9 IDENTIFYING IP
  • 10. 10© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. Identifying Intellectual Property • Patents - Right to exclude others from making, using, selling, etc.; can help you obtain exclusivity in your market niche (www.uspto.gov) – Does not give patent owner right to make, use or sell invention • Commonly patented features: – The device itself – Key components – Systems that include the device as well as other parts – Method of manufacturing – Method of using – Materials (drugs, biologics, alloys, plastics, etc.)
  • 11. 11© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. Identifying Intellectual Property • Trademarks - Right to prevent use of marks that are likely to confuse consumers; can greatly enhance marketing strategies (www.uspto.gov) • Copyrights - Right to prevent unauthorized copying, distribution, etc. of authorship works (www.copyright.gov) • Trade Secrets - Protect internal methods, materials; right to prevent unauthorized use (can protect against use of proprietary information)
  • 12. 12© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. Trademark Examples – Words and Names
  • 13. 13© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. Trademark Examples – Designs and Logos
  • 14. 14© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. Trademark Examples - Slogans
  • 15. 15© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. Trademark Examples - Colors “NEXIUM and the color purple as applied to the capsule are registered trademarks of the AstraZeneca group of companies.”
  • 16. 16© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. Where is the IP?
  • 17. 17© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. Your Novel Idea – A Coated Stent • Prior Art: Uncoated, bare metal stent • Problem to Solve: Preventing restenosis • Patentable Idea: Stent (100) having drug (or protein, etc.) deposits 106 on metal struts (102) to inhibit restenosis Prior Art Your Invention
  • 18. 18© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. Potential IP Protection • A new drug eluting stent – Patent – configuration of the drug eluting stent, drug itself, method of depositing the drug on the stent, method of deploying the stent in a body – Trademark – product name – “Guardian Stent” – Copyright – Instructions For Use, Product Literature, Training Video, software – Trade secret –method of manufacturing a kink- resistant introducer sheath
  • 19. 19© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. Patents vs. Trade Secrets Patents • Rights granted by U.S. Patent & Trademark Office • Expensive • Rights last only 20 years • Must fully disclose invention • Right to exclude others from practicing inventions – Regardless of whether copied or independently derived Trade Secrets • Rights easily obtained • Inexpensive • Rights last as long as information is maintained confidential • No public disclosure • Right to prevent misappropriation – Can’t stop copiers or independent derivation
  • 20. 20© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. Patents vs. Trade Secrets – How to Choose • Can invention be reverse engineered? • What if secret is leaked? • Will company seek private investment? • Most technology is protected with patents.
  • 21. 21© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 2008 Berkeley Patent Survey Percentage of Start-Up Companies Holding U.S. Patents & Applications 39% 24% 82% 67% 76%75% 94%97% 0% 20% 40% 60% 80% 100% All respondents Biotechnology Medical Devices Software/Internet Overall population of companies (D&B) Venture-backed companies Berkeley Technology Law Journal, vol. 24:4, pp. 1255-1328, April 16, 2010.
  • 22. 22© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 2008 Berkeley Patent Survey Average Number of U.S. Patents & Applications Held By Start-Up Companies 9.7 18.7 4.7 15 1.7 5.9 25.2 34.6 0 10 20 30 40 All respondents Biotechnology Medical Devices Software/Internet Overall population of companies (D&B) Venture-backed companies Berkeley Technology Law Journal, vol. 24:4, pp. 1255-1328, April 16, 2010.
  • 23. 23© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. Patent Rights • What right does a utility patent confer? – The right to exclude others from making, using, selling or importing the invention – For 20 years from earliest filing date • Patents do not provide a right to practice! – Never say, “We don’t have any risk of getting sued because we own the patent on our product.”
  • 24. 24© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. Consider the Patented Improvement Stent Nickel- Titanium Stent Covered Nickel- Titanium Stent Drug Eluting, Covered, Nickel-Titanium Stent     Patent 1 Patent 2 Patent 3 Your Patent
  • 25. ©2012 Knobbe Martens, Olson & Bear, LLP all rights reserved.© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 25 PROTECTING IP
  • 26. 26© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. Protecting IP and Product Development • Public Disclosure Can Prevent Patentability – U.S. – One Year Grace Period – Everywhere Else – Must File Beforehand • Non-Disclosure Agreement • Always better to file before disclosing
  • 27. 27© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. Deadlines for Filing Patents Public Disclosure Deadline to File Patent Application 1 year Public Disclosure = Deadline to File Patent Application U.S. Rest of World
  • 28. 28© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. Protecting IP and Product Development • First-to-Invent* vs. First-to-File – U.S. changed to a First-Inventor-to-File system 3/16/2013 • Keep detailed lab notebooks • Complete invention disclosure forms • Save and date prototypes (or photographs)
  • 29. 29© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. Requirements for Patentability Invention as claimed must be (a) Novel, and (b)Non-obvious with respect to the “prior art.” Prior art includes earlier patents and printed publications How do you know what is in the “prior art”?
  • 30. 30© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. Searching – Why Bother? • Searching is not required, but helps: – Assess patentability – Assess freedom-to-operate (risk) – Identify key competitors – Develop design arounds
  • 31. 31© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. Searching Strategies • Key word searching – www.google.com/patents – patft.uspto.gov – www.delphion.com – Key words – “coated stent restenosis” or “drug eluting stent” • Competitor / assignee searching • Journals / literature • Hire a professional
  • 32. 32© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. Contents of a Utility Patent • Cover Page (title, abstract, searching classification, prior art, etc.) • Figures • Description – The patent must be written in full, clear, concise terms to enable one of ordinary skill in the art to make or use the invention. – The patent must describe the best mode contemplated by the inventor for practicing the invention (time of filing). • Claims
  • 33. 33© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. Claims What is claimed is: 1. A drug eluting prosthesis, comprising: a stent comprising an expandable substrate adapted for implantation in a vessel of a body; and a layer of drug eluting compound fixed to an outside surface of said stent; wherein: said layer of drug eluting compound is uniformly deposited about the outside surface of said stent. 2. The drug eluting prosthesis of Claim 1, wherein the expandable substrate is made from a nickel-titanium alloy. 3. The drug eluting prosthesis of Claim 1, wherein the drug eluting compound comprises a drug configured to prevent restenosis.
  • 34. ©2012 Knobbe Martens, Olson & Bear, LLP all rights reserved.© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 34 ASSESSING 3RD PARTY RISK
  • 35. 35© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. Survey Competitive Landscape • Patents only provide a right to exclude, not a right to practice • How to identify possible risk: – Searching – Patent marking on competitor products and labeling – Receiving a letter from a competitor • It is best to identify problem patents early, before product design is frozen!
  • 36. 36© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. Survey Competitive Landscape • Who is likely to conduct initial risk assessment? YOU!
  • 37. 37© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. Survey Competitive Landscape • What can you do if you find a problem patent? – Design-around – License – Document internal analysis – Opinion of counsel (noninfringement, invalidity) – Challenge the patent – Wait – Drop the project
  • 38. 38© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. Reading Claims • Assess risk of infringing competitor’s patents • Claims consist of a series of limitations or elements • All limitations (or, in some cases, equivalents thereof) must be present for infringement • All limitations must be performed or provided by the same entity (with exceptions) • Compare competitor’s patent’s claims to your product
  • 39. 39© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. How to Read a Claim What is claimed is: 1. A drug eluting prosthesis, comprising: a stent comprising an expandable substrate adapted for implantation in a vessel of a body; and a layer of drug eluting compound fixed to an outside surface of said stent; wherein: said layer of drug eluting compound is uniformly deposited about the outside surface of said stent. Your Invention Does your invention infringe Claim 1?
  • 40. 40© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. How to Read a Claim What is claimed is: 1. A drug eluting prosthesis, comprising: a stent comprising an expandable substrate adapted for implantation in a vessel of a body; and a layer of drug eluting compound fixed to an outside surface of said stent; wherein: said layer of drug eluting compound is uniformly deposited about the outside surface of said stent. Your Invention
  • 41. 41© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. How to Read a Claim What is claimed is: 1. A drug eluting prosthesis, comprising: a stent comprising an expandable substrate adapted for implantation in a vessel of a body; and a layer of drug eluting compound fixed to an outside surface of said stent; wherein: said layer of drug eluting compound is uniformly deposited about the outside surface of said stent. Your Invention
  • 42. 42© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. How to Read a Claim What is claimed is: 1. A drug eluting prosthesis, comprising: a stent comprising an expandable substrate adapted for implantation in a vessel of a body; and a layer of drug eluting compound fixed to an outside surface of said stent; wherein: said layer of drug eluting compound is uniformly deposited about the outside surface of said stent. Your Invention
  • 43. 43© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. How to Read a Claim What is claimed is: 1. A drug eluting prosthesis, comprising: a stent comprising an expandable substrate adapted for implantation in a vessel of a body; and a layer of drug eluting compound fixed to an outside surface of said stent; wherein: said layer of drug eluting compound is uniformly deposited about the outside surface of said stent. Your Invention
  • 44. 44© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. How to Read a Claim What is claimed is: 1. A drug eluting prosthesis, comprising: a stent comprising an expandable substrate adapted for implantation in a vessel of a body; and a layer of drug eluting compound fixed to an outside surface of said stent; wherein: said layer of drug eluting compound is uniformly deposited about the outside surface of said stent. Your Invention
  • 45. 45© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. How to Read a Claim What is claimed is: 1. A drug eluting prosthesis, comprising: a stent comprising an expandable substrate adapted for implantation in a vessel of a body; and a layer of drug eluting compound fixed to an outside surface of said stent; wherein: said layer of drug eluting compound is uniformly deposited about the outside surface of said stent. Your Invention XTherefore, no literal infringement of Claim 1!
  • 46. ©2012 Knobbe Martens, Olson & Bear, LLP all rights reserved.© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 46 CONCLUSIONS
  • 47. 47© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. What to Expect • Maintain accurate and dated records of invention • Use agreements when working with consultants and contractors. • File applications before making public disclosures • Understand patent landscape and analyze risk early • Your patent attorney can help!
  • 48. © 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 48
  • 49. 49© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. Inventor Notebooks • Complete, sign and witness everyday • Fill in every page • Attach drawings, photos, data directly to lab notebook page and sign across borders • Include things to try in the future • Use care when describing competitor products or patents – what you say could be used against you later!
  • 50. 50© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. Invention Disclosure Form • Title • Contributors • Has invention been disclosed outside of the organization?
  • 51. 51© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. • Background • Problem being solved • Known Prior Art • Description of invention • Include drawings, photos, copies of lab notebook, engineering drawings, flow charts Invention Disclosure Form
  • 52. 52© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. • Advantages • Why would invention be important to competitors? • Possible modifications and additional uses • Signature of contributors and witnesses Invention Disclosure Form
  • 53. 53© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. Medical Device Claim Strategies w Apparatus claims to protect the device or consumable An endoluminal prosthesis for treating a diseased blood vessel,comprising: a stent body having a plurality of struts and a plurality of openings between said struts,said prosthesis having a restenosis inhibiting agent adhered thereto. w Claims to instrumentation used to deliver the device A delivery device comprising an outer sheath,an inner core advanceable relative to said outer sheath,and a lumen for receiving a guidewire therein,wherein said inner core is configured to support a prosthesis thereon. w System claims for the combination of components A system comprising: an endoluminal prosthesis having a restenosis inhibiting agent adhered thereto; and a delivery device for delivering the prosthesis to a deployment site within a medical patient.
  • 54. 54© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. Medical Device Claim Strategies w Method claims to protect how it’s used in the IFU A method for repairing a portion of a diseased vascular tissue comprising: advancing a delivery catheter to a diseased portion of a patient’s vasculature, retracting an outer sheath of said delivery catheter,and expanding a prosthesis against a vessel wall in said diseased portion. w Method of manufacturing claims A method for manufacturing a drug eluting stent,comprising: laser cutting a hollow cylinder comprising Nitinol to form a plurality of struts and openings in said hollow cylinder; depositing a restenosis inhibiting agent on one or more of said plurality of struts.
  • 55. 55© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. How To Read A Claim What is claimed is: 1. A method of treating a vascular occlusion, comprising: i) applying a drug eluting coating to a stent; ii) loading the stent onto a catheter; iii) inserting the catheter into a patient’s vasculature; iv) advancing the catheter to a vascular occlusion; v) deploying the stent at the vascular occlusion; and vi) removing the catheter from the patient’s vasculature. Who infringes Claim 1?
  • 56. 56© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. How To Read A Claim What is claimed is: 1. A method of treating a vascular occlusion, comprising: i) applying a drug eluting coating to a stent; ii) loading the stent onto a catheter; iii) inserting the catheter into a patient’s vasculature; iv) advancing the catheter to a vascular occlusion; v) deploying the stent at the vascular occlusion; and vi) removing the catheter from the patient’s vasculature. Who infringes Claim 1?
  • 57. 57© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. Joint Infringement • Where actions are performed by separate entities, but one entity acts under direction and control of the other. – Examples: • Contractual obligation • One entity acts as the agent of the other. • May be very difficult to show Clinician and Manufacturer are joint infringers. • Divided infringement = no infringer
  • 58. 58© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. How To Read A Claim What is claimed is: 1. A method of treating a vascular occlusion, comprising: i) applying a drug eluting coating to a stent; ii) loading the stent onto a catheter; iii) inserting the catheter into a patient’s vasculature; iv) advancing the catheter to a vascular occlusion; v) deploying the stent at the vascular occlusion; and vi) removing the catheter from the patient’s vasculature. Divided Infringement
  • 59. 59© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. How To Read A Claim What is claimed is: 1. A method of treating a vascular occlusion, comprising: i) providing a catheter, the catheter having a stent mounted near the catheter’s distal end; ii) inserting the catheter into a patient’s vasculature; iii) advancing the catheter to a vascular occlusion; iv) deploying the stent at the vascular occlusion; and v) removing the catheter from the patient’s vasculature. Who infringes Claim 1?
  • 60. 60© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. Direct vs. Indirect Infringement • Direct Infringement – Entity performing steps is the direct infringer. – Clinicians may be shielded (pure medical methods). – Manufacturer generally preferred target. • Indirect Infringement – Does one entity provide a product that has no substantial use except to infringe? – Does one entity induce the other to infringe?
  • 61. 61© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. Indirect Infringement • Contributory Infringement – Are there substantial non-infringing uses for product used to perform method? • Inducement – What is evidence that company knowingly induces infringement with specific intent to infringe? • User manuals, training materials, videos, web sites, sales people, marketing materials • Would method constitute an off-label use? • Notify inducers to establish knowledge and intent.
  • 62. 62© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. How To Read A Claim What is claimed is: 1. A method of treating a vascular occlusion, comprising: i) providing a catheter, the catheter having a stent mounted near the catheter’s distal end; ii) inserting the catheter into a patient’s vasculature; iii) advancing the catheter to a vascular occlusion; iv) deploying the stent at the vascular occlusion; and v) removing the catheter from the patient’s vasculature. Does Company induce Clinician to infringe?
  • 63. knobbe.com Orange County San Diego San Francisco Silicon Valley Los Angeles Seattle Washington DC Andrew Douglas andrew.douglas@knobbe.com (949) 721-7623 Shannon Lam shannon.lam@knobbe.com (949) 721-6366