Intellectual Property Considerations During Product Development
 

Intellectual Property Considerations During Product Development

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On Saturday, April 28, 2012, Knobbe Martens Partner Agnes Juang presented "Intellectual Property Considerations During Product Development" at the Sino-American Biomedical & Pharmaceutical ...

On Saturday, April 28, 2012, Knobbe Martens Partner Agnes Juang presented "Intellectual Property Considerations During Product Development" at the Sino-American Biomedical & Pharmaceutical Professionals Association (SABPA) 7th Annual Biomedical Forum, which was held at the McDonnell Douglas Engineering Auditorium at UC Irvine.

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Intellectual Property Considerations During Product Development Intellectual Property Considerations During Product Development Presentation Transcript

  • Intellectual Property Considerations During Product Development April 28, 2012 Agnes Juang SABPA 7th Annual Biomedical ForumThe recipient may only view this work. No other right or license is granted.
  • 1. Patent Quiz2. Identifying IP3. Protecting IP4. Assessing 3rd Party Risk
  • 1. Patent Quiz2. Identifying IP3. Protecting IP4. Assessing 3rd Party Risk
  • Patent Quiz – True or False? • A patent grants the inventor the right to make, use, sell, and import his or her invention? – False • The person who pays for the inventing owns the patents. – False • A method of performing a medical procedure may be patented. – True© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 4
  • Patent Quiz – True or False? • Improvements to old technologies may be patented. – True • A patent application can be updated after it is filed to incorporate new features. – False • Liability for infringement can be avoided as long as you don’t intend to infringe. – False© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 5
  • 1. Patent Quiz2. Identifying IP3. Protecting IP4. Assessing 3rd Party Risk
  • Your Novel Idea – A Coated Stent Prior Art Your Invention • 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© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 7
  • Potential IP Protection • A new drug eluting stent • Patent Configuration of the drug eluting stent, drug itself, delivery system, 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© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 8
  • Patents vs. Trade Secrets • Patents • Trade Secrets – Rights granted by U.S. Patent – Rights easily obtained & Trademark Office – Inexpensive – Expensive – No public disclosure – Must fully disclose invention – Rights can last forever – Rights last only 20 years • But rights are lost as – Right to exclude others from secrecy lost practicing inventions – Right to prevent • Regardless of whether misappropriation copied or independently • Can’t stop copiers or derived independent derivation© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 9
  • 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. – 94% of venture-backed start-ups own patent or application – Venture-backed start-up holds in average 25 patents & applications© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 10
  • Consider the Patented Improvement Drug-eluting Covered Covered Nitinol Stent Nitinol Stent Nitinol Stent Stent     Patent 1 Patent 2 Patent 3 Your Patent© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 11
  • 1. Patent Quiz2. Identifying IP3. Protecting IP4. Assessing 3rd Party Risk
  • Protecting IP and Product Development • Use non-disclosure agreements • Keep detailed inventor notebooks and assignments with third parties • Complete an invention disclosure form • Secure ownership with employee • Save and date prototypes (or contracts and consulting photographs) agreements • Involve the IP team at this stage© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 13
  • Protecting IP and Product Development • File before public disclosure – U.S. provides a one-year grace period. 1 year Public Disclosure Deadline to File – Most countries bar patent upon public disclosure. Public Disclosure = Deadline to File – Public disclosure before filing can lead to lost rights.© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 14
  • Requirements For Patentability Invention as claimed must be (a) Novel, and (b) Non-obvious with respect to the “prior art.” How do you know what is in the “prior art”? Why would you care?© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 15
  • Searching – Why bother? • Searching is not required, but helps: – Assess patentability – Assess freedom-to-operate (risk) – Identify key competitors – Develop design arounds • Types of searches – Do-it-yourself (Internet, Google Patents, Trade Journals, Medical Databases) – Professional searching (former Examiners) – Industry searching for marked products© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 16
  • 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.”© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 17
  • 1. Patent Quiz2. Identifying IP3. Protecting IP4. Assessing 3rd Party Risk
  • 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!© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 19
  • 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© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 20
  • Reading Claims • Assess risk of infringing competitor’s patents • Compare competitor’s patent’s claims to your product • Claims consist of a series of limitations or elements – All limitations (or, in some cases, their equivalents) must be present for infringement – All limitations must be performed by the same entity (with exceptions)© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 21
  • How To Read A ClaimWhat 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; Your Invention wherein: said layer of drug eluting compound is uniformly deposited about the outside surface of said stent. Does your invention infringe Claim 1?© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 22
  • How To Read A ClaimWhat 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; Your Invention wherein: X said layer of drug eluting compound is uniformly deposited about the outside surface of said stent. Therefore, no literal infringement of Claim 1!© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 23
  • Take Home Points • Maintain accurate and dated records of invention • Use agreements with consultants, contractors, and employees • File applications before public disclosure • Understand patent landscape and analyze risk early • Monitor IP and product development trajectories • Consider all forms of IP protection • Your IP attorney can help!© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 24
  • © 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 25
  • Agnes Juang, Ph.D., J.D.Thank You! Agnes.Juang@knobbe.com