Meet the Presenters. Luke Dohmen 25 years of corporate IP experience Former Chief Patent Counsel of Boston Scientific

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2 Meet the Presenters Luke Dohmen 25 years of corporate IP experience Former Chief Patent Counsel of Boston Scientific Tyler Nasiedlak Principal at Schwegman w/ 20+ years of IP experience Former VP, GC and CPC of Guidant and BSC Divisions

3 Freedom to Operate What is Freedom to Operate (FTO)? What is a Clearance Opinion? What rights does a patent give to an owner?

4 Why Conduct FTO Patent Infringement may be the single largest potential liability facing a seller Gain knowledge of the art in the field Use knowledge to design around known patents License necessary patents Generate IP with an eye toward settling future litigation Provide evidence for state of mind Avoid willful infringement in future litigation

5 FTO Process Clearance search Compare device/process to claims Review file wrapper of target patents Review validity of target patents Must be done by a patent attorney per CAFC No privilege if done by a non-attorney

6 When to conduct FTO Prototype Stage Design Freeze First US manufacture, use, sell Promptly after receiving cease and desist letter After litigation starts

7 Willful Infringement 35 U.S. 284:.In either event the court may increase the damages up to three times the amount found or assessed SCT Halo Case Standard: o Awards of enhanced damages are not to be meted out in a typical infringement case, but are instead designed as a punitive or vindictive sanction for egregious infringement behavior. The sort of conduct warranting enhanced damages has been variously described in our cases as willful, wanton, malicious, bad-faith, deliberate, consciously wrongful, flagrant, or indeed characteristic of a pirate. o Culpability is measured by reference to the knowledge of the actor at the time of the challenged conduct, so defenses developed after infringement do not insulate conduct from an award of enhanced damages Preponderance of the evidence standard Decisions reviewed for abuse of discretion Much lower standard than under Seagate Companies receiving written opinions much more frequently now

8 Indirect Infringement Unlike direct infringement, which is a strict liability offense, indirect infringement (inducement or contributory) requires both actual knowledge that the induced acts constitute patent infringement and intent. The knowledge element requires the accused infringers knowledge of the patent-insuit as well as knowledge that its actions contributed or induced direct infringement of the patent-in-suit. A noninfringement opinion may not only avoid a finding of willfulness and an award of attorneys fees, but may also provide a substantive defense against liability for indirect infringement As an opinion negates the defendant s knowledge of direct infringement, the opinion can be used affirmatively to avoid liability for indirect infringement. Recently, the Supreme Court in Commil tacitly acknowledged that an opinion of noninfringement may be a substantive defense to liability for indirect infringement while eliminating the defense of good-faith belief in the invalidity of the patent.

9 Best Practices At project kick-off, conduct a landscape search Work with design team to design around known patents Conduct clearance search prior to design freeze Get oral opinion at design freeze Obtain written opinion before first US make, use, or sell Review OUS counterparts of relevant patents Opinion should be from outside counsel patent attorney Reference your clearance procedure in Operating Procedures Bottom line: By designing around known patents, you are minimizing the risk once product launches

10 Considerations Can be expensive To save money: o Review labeling and websites of competitive products o Only search for competitor s patents o Clear major features of products o Limit review to US patents o THIS MAY NOT BE REASONABLE FOR YOUR CIRCUMSTANCES If launching a follow-on product, only clear the new features Start-Ups: Many investors will require an FTO before investing Useful for both willful analysis and for contributory/induced infringement

11 Benefits of a Virtual In-House Counsel In-House counsel can: o Work with design team to suggest design around opportunities o Provide feedback and guidance to design team and other in-house teams o Develop plan for licenses or IP trades o Identify features for patenting Can assist on question of whether an opinion is needed or not Can assist management with risk assessment Can identify design around options

12 Discussion & Questions Luke Dohmen Tyler Nasiedlak

13 IP Punch List Webinar Series PLEASE JOIN US FOR OUR NEXT PRESENTATION: April 27, PM (Central)