Successfully reported this slideshow.
We use your LinkedIn profile and activity data to personalize ads and to show you more relevant ads. You can change your ad preferences anytime.
knobbe.com 
Paul Conover, Curtis Huffmire, Brent Babcock 
November 5, 2014 
Recent Developments in Patent Law for Medical ...
©2012 Knobbe Martens, Olson & Bear, LLP all rights reserved. 
© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserve...
3 
© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 
Federal Court System for Patent Infringement Lawsuits 
...
4 
© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 
Patent Law from Congress 
Patents should be awarded for...
5 
© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 
Alice Corporation PTY. LTD. v. CLS Bank International 
...
© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 
6 
Problem: 
There is no clear line between “inventions” a...
7 
© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 
Attorney’s Fees 
In the United States, each opposing si...
8 
© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 
Previous Rule from Court of Appeals 
“Clear and convinc...
9 
© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 
Octane Fitness, LLC v. Icon Heath and Fitness, Inc. 
Un...
10 
© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 
Patent Law from Congress 
Patents need to be sufficien...
11 
© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 
Previous Rule from the Federal Circuit Court of Appeal...
12 
© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 
New Rule from U.S. Supreme Court 
In Nautilus, Inc. v....
13 
© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 
Facts from Supreme Court Case: 
•Patent claim referred...
©2012 Knobbe Martens, Olson & Bear, LLP all rights reserved. 
© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserve...
15 
© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 
Applications Filed and Patents Granted Per Year 
*data...
16 
© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 
Medical Device Patents Granted 
*data from USPTO websi...
17 
© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 
2013 Medical Device Patent Owners 
*data from USPTO we...
18 
© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 
Medical Device Litigation Overview 
•In a review of pa...
19 
© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 
Medical Device Litigation Statistics (cont’d)
20 
© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 
Permanent Injunction – Legal Standard 
•35 U.S.C. §283...
21 
© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 
DePuy Synthes Products v. Globus 
•Synthes filed suit ...
22 
© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 
DePuy Synthes Products v. Globus 
•1) Suffered irrepar...
23 
© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 
Smith & Nephew v. Arthrex 
•Smith & Nephew created the...
24 
© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 
Smith & Nephew v. Arthrex – Factors 
•Irreparable Harm...
25 
© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 
How to Reconcile DePuy (not granted) with Smith & Neph...
26 
© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 
EW v. MDT/CoreValve – The Products 
Medtronic CoreValv...
27 
© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 
EW v. MDT/CoreValve - World-Wide Fight 
Year 
Patent 
...
28 
© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 
EW (Andersen) v. CoreValve - Timeline 
•11/13/2012: Fe...
29 
© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 
EW v. MDT/CoreValve - Settlement 
MDT will pay EW: 
•A...
30 
© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 
Masimo v. Philips (Delaware) 
•Irvine based Masimo Cor...
31 
© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 
Masimo v. Philips (Del.) – Trial 
•In a first trial, M...
32 
© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 
Masimo v. Philips (Del.) – Verdict 
•Jury found Masimo...
©2012 Knobbe Martens, Olson & Bear, LLP all rights reserved. 
© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserve...
34 
© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 
IPR Timeline
© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 
35
© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 
36
37 
© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 
Trials Institutions Overall 
Granted-All Claims60% Gra...
38 
© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 
Trial Institutions for Sep. & Oct. 2014 
Granted-All C...
39 
© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 
Trial Institutions for Sep. & Oct. 2014 (excluding 38 ...
40 
© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 
Rationales for Denial of Petition 
•Missing element 
•...
41 
© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 
Rationales for Denial of Petition 
•Procedural 
–Statu...
© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 42 
Written 
Decision 
31% 
Adverse 
Judgment 
10% 
Settled...
© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 43 
All Claims 
Unpatentable 
73% 
Some Claims 
Survived 
1...
44 
© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 
•Reasons provided: 
–Missing element 
•Petition argued...
45 
© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 
Considerations for Multi-Forum Proceedings 
•IPR and l...
46 
© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 
IPRs and Concurrent Litigation: Issues to Consider 
•P...
47 
© 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 
•Coordination with Litigation Counsel 
•Coordination w...
knobbe.com 
Orange County 
San Diego 
San Francisco 
Silicon Valley 
Los Angeles 
Seattle 
Washington DC 
Thank you! 
paul...
Upcoming SlideShare
Loading in …5
×

Recent Developments in Patent Law for Medical Device Companies

1,831 views

Published on

Paul Conover, Curtis Huffmire and Brent Babcock recently presented at the IN3 Medical Device Summit conference in San Francisco, CA. This presentation covers: recent patent cases from the supreme court, medical device patent statistics and cases, and USPTO Post-Grant Proceedings lessons learned after two years.

Published in: Law

Recent Developments in Patent Law for Medical Device Companies

  1. 1. knobbe.com Paul Conover, Curtis Huffmire, Brent Babcock November 5, 2014 Recent Developments in Patent Law for Medical Device Companies IN3 Medical Device Summit San Francisco
  2. 2. ©2012 Knobbe Martens, Olson & Bear, LLP all rights reserved. © 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 2 RECENT PATENT CASES FROM THE SUPREME COURT Paul Conover
  3. 3. 3 © 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. Federal Court System for Patent Infringement Lawsuits U.S. SUPREME COURT discretionary U.S. COURT OF APPEALS FOR THE FEDERAL CIRCUIT appeal as of right FEDERAL DISTRICT COURT
  4. 4. 4 © 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. Patent Law from Congress Patents should be awarded for “any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof.” (35 U.S.C. § 101) Supreme Court long ago created an exception: No patents for “laws of nature, natural phenomena, and abstract ideas”
  5. 5. 5 © 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. Alice Corporation PTY. LTD. v. CLS Bank International •Unanimous decision by Justice Clarence Thomas (July 2014) •Alice owns a patent for using a computer system to mitigate risk in a financial transaction with an intermediary. Supreme Court Ruling: (a) This financial transaction is just an abstract idea (b) Merely using a computer to perform it does not make it worthy of patent protection
  6. 6. © 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 6 Problem: There is no clear line between “inventions” and “abstract ideas” Example from Supreme Court of patent-worthy invention: Computerized method of manufacturing rubber that used a ”thermocouple”
  7. 7. 7 © 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. Attorney’s Fees In the United States, each opposing side in a lawsuit is normally responsible for its own attorney’s fees, regardless of who wins or loses Exception to This Rule: The loser in a patent infringement case must pay the attorney’s fees of the opposing party “in exceptional cases” •(35 U.S.C. § 285)
  8. 8. 8 © 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. Previous Rule from Court of Appeals “Clear and convincing” evidence of: (a) Material inappropriate conduct (b) Objectively baseless case (c) Brought in subjective bad faith
  9. 9. 9 © 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. Octane Fitness, LLC v. Icon Heath and Fitness, Inc. Unanimous decision by Justice Sotomayor (April 2014) Now much lower standard for getting attorney fees: •An exceptional case in one that stands out from others in the “strength of a party’s litigation position” (facts or law); or the “unreasonable manner in which the case was litigated” •Also, no special level or proof required
  10. 10. 10 © 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. Patent Law from Congress Patents need to be sufficiently clear to enable the public to know what types of products are covered, or not covered, by a particular patent. Patent Law from Congress: Patents must “particularly point out and distinctly claim the subject matter which the applicant regards as [the] invention” (35 U.S.C. § 112 ¶ 2)
  11. 11. 11 © 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. Previous Rule from the Federal Circuit Court of Appeals •Claims were considered unclear only if they were “insolubly ambiguous” (Relatively easy standard to satisfy)
  12. 12. 12 © 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. New Rule from U.S. Supreme Court In Nautilus, Inc. v. Biosig Instruments, Inc.: Unanimous decision by Justice Ginsberg (April 2014) •A patent must “inform, with reasonable certainty, those skilled in the art about the scope of the invention” (More difficult standard to satisfy)
  13. 13. 13 © 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. Facts from Supreme Court Case: •Patent claim referred to two electrodes that are “mounted…in space relationship with each other.” •This language was held invalid as not sufficiently specific.
  14. 14. ©2012 Knobbe Martens, Olson & Bear, LLP all rights reserved. © 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 14 MEDICAL DEVICE PATENT STATISTICS AND CASES Curtis Huffmire
  15. 15. 15 © 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. Applications Filed and Patents Granted Per Year *data from USPTO website (as of December 31, 2013)
  16. 16. 16 © 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. Medical Device Patents Granted *data from USPTO website (as of December 31, 2013)
  17. 17. 17 © 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 2013 Medical Device Patent Owners *data from USPTO website (as of December 31, 2013) TOP TEN (tie)
  18. 18. 18 © 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. Medical Device Litigation Overview •In a review of patent litigations identified by KnobbeMedical filed between August 2013 & October 2014: –67 litigations were filed relating to medical device technology –46 involved a litigation in which both parties were practicing entities –21 involved a litigation involving an NPE/PAEs
  19. 19. 19 © 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. Medical Device Litigation Statistics (cont’d)
  20. 20. 20 © 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. Permanent Injunction – Legal Standard •35 U.S.C. §283 –May grant “in accordance with principles of equity to prevent violation of any right secured by patent, on such terms as the court deems reasonable” •Burden on requesting party to show: –1) Suffered irreparable injury; –2) Remedies at law are inadequate to compensate for injury; –3) Remedy in equity is warranted based on balance of hardships between plaintiff and defendant; and –4) Public interest not disserved by permanent injunction.
  21. 21. 21 © 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. DePuy Synthes Products v. Globus •Synthes filed suit against Globus for infringement of 3 patents •Patents related to “inter-vertebral implants” and methods of implanting between adjacent vertebrae in spinal fusion procedure •Jury verdict found Synthes’s patents valid and infringed 7,875,076 “Intervertebral Implant”
  22. 22. 22 © 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. DePuy Synthes Products v. Globus •1) Suffered irreparable injury - NO –Globus offered evidence showing consumers use their (infringing) products for reasons other than the patented features –Lost sales alone are insufficient to prove irreparable harm –Also rejected argument that patented products are “door openers” to other new products –No basis to conclude Globus would not be able to pay the more than $16 million reasonable royalty damages –Thus, Synthes will be adequately compensated •2) 3) and 4) –Court did not address Factors 2-4 because factor 1) was not met
  23. 23. 23 © 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. Smith & Nephew v. Arthrex •Smith & Nephew created the plastic, push-in suture market •Arthrex executives – including its President – were aware of SNN’s patent •Arthrex took a large portion of the market, and credited its infringing plastic, push-in suture (in place of the metal, screw-in suture they previously used) –Two of Arthrex’s top three largest selling suture anchors were infringing products US 5,601,557 “Anchoring and Manipulating Tissue”
  24. 24. 24 © 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. Smith & Nephew v. Arthrex – Factors •Irreparable Harm: Yes – Directly compete in a portion of the market that Smith & Nephew created and that Arthrex took over through its infringement •Adequate Monetary Relief: No – Difficult to quantify damages. Does not typically license. •Balance Hardships – SNN – Willful infringement, Arthrex sells other products, won’t go out of business •Public Interest – SNN – Substantial public interest in enforcing valid patents. Acceptable alternatives on the market to meet health needs.
  25. 25. 25 © 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. How to Reconcile DePuy (not granted) with Smith & Nephew (granted)? •Desire for infringing product driven by patented features? –DePuy: disconnect affirmatively shown by Globus –Smith & Nephew: link not discussed explicitly by court, but said “identity of form and function” between infringing product and patentee’s product covered by the patent •Is willfulness a factor? –Arthrex: knowledge of patent and no opinion of counsel •Pioneer v. commodity? –Smith & Nephew: able to show lost sales correlating with Arthrex’s introduction of infringing product; substantial R&D investment related to patented products; Smith & Nephew heavily-invested in field as a pioneer in plastic, push-in suture market •Patentee bears burden of proving entitlement to injunction
  26. 26. 26 © 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. EW v. MDT/CoreValve – The Products Medtronic CoreValve Edwards Sapien
  27. 27. 27 © 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. EW v. MDT/CoreValve - World-Wide Fight Year Patent Jurisdiction Plaintiff Defendant Outcome 2009 Andersen UK Edwards CoreValve Not Infringed 2008 Andersen Germany (Infrin’t) Edwards CoreValve Not Infringed Affirmed on appeal 2010 Andersen Germany (Invalidity) CoreValve Edwards Not Invalid 2010 Andersen Delaware Edwards CoreValve Infringed - $83M 2012 Seguin California MDT Edwards Invalid 2013 Spenser Germany (Infrin’t) Edwards MDT Infringed (injunction) 2014 Spenser EPO (Invalidity) Edwards MDT Invalid 2014 Cribier California Edwards MDT Infringed - $392M 2014 Andersen Delaware Edwards CoreValve Prelim. Injunction
  28. 28. 28 © 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. EW (Andersen) v. CoreValve - Timeline •11/13/2012: Federal Circuit –Affirms willful infringement –Remands denial of permanent injunction •11/25/2013: Edwards files motion for preliminary injunction to enjoin CoreValve post approval launch •01/17/2014: FDA approves CoreValve Generation 3 •04/15/2014: District Court grants-in-part motion for preliminary injunction •04/21/2014: Federal Circuit grants emergency stay of preliminary injunction •05/20/2014: Medtronic announces settlement agreement
  29. 29. 29 © 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. EW v. MDT/CoreValve - Settlement MDT will pay EW: •A one-time payment of $750 million •Royalties through April 2022, not less than $40 million annually The parties agreed to: •Dismiss all of the pending litigation matters and patent office actions between them •Grant each other broad releases to patent litigation claims. •not sue each other “for patent matters anywhere in the world for eight years in the field of aortic and all other transcatheter heart valves.”
  30. 30. 30 © 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. Masimo v. Philips (Delaware) •Irvine based Masimo Corporation alleged infringement of a family of patents directed to “pulse oximetry” technology that can provide accurate measurements in the presence of patient motion Sensor Cable Monitor
  31. 31. 31 © 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. Masimo v. Philips (Del.) – Trial •In a first trial, Masimo asserted two patents •Shortly before trial, Philips admitted infringement. Philips challenged validity and the amount of damages
  32. 32. 32 © 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. Masimo v. Philips (Del.) – Verdict •Jury found Masimo’s patents valid and awarded damages
  33. 33. ©2012 Knobbe Martens, Olson & Bear, LLP all rights reserved. © 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 33 USPTO POST-GRANT PROCEEDINGS: LESSONS LEARNED AFTER 2 YEARS Brent Babcock
  34. 34. 34 © 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. IPR Timeline
  35. 35. © 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 35
  36. 36. © 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 36
  37. 37. 37 © 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. Trials Institutions Overall Granted-All Claims60% Granted - Some Claims17% Denied23% Petition Institution
  38. 38. 38 © 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. Trial Institutions for Sep. & Oct. 2014 Granted-All Claims61% Granted - Some Claims15% Denied24% Petition Institution
  39. 39. 39 © 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. Trial Institutions for Sep. & Oct. 2014 (excluding 38 Zond decisions) Granted-All Claims52%Granted - Some Claims19% Denied29% Petition Institution
  40. 40. 40 © 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. Rationales for Denial of Petition •Missing element •Insufficient showing of inherency •No reason to combine •No expert declaration or insufficient reasoning in expert declaration •Failure to establish reference as prior art •Publication not established •§ 102(e) basis not sufficiently supported
  41. 41. 41 © 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. Rationales for Denial of Petition •Procedural –Statutory 1-year bar from service of Complaint –Filed Declaratory Judgment (DJ) action first –Real Party-in-Interest (RPI) not identified –No joinder –Redundancy –§ 325(d) (previously presented) •Discretionary •PTAB’s invocation is on the rise
  42. 42. © 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 42 Written Decision 31% Adverse Judgment 10% Settled 59% “Disposals”
  43. 43. © 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 43 All Claims Unpatentable 73% Some Claims Survived 12% All Claims Survived 14% Amendment Granted 1% Written Decisions Final Written Decisions
  44. 44. 44 © 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. •Reasons provided: –Missing element •Petition argued inherency –No reason to combine •Battle of the experts –Reference successfully antedated •Motion to Amend –Only one motion granted, and that was an unopposed Motion to Amend Rationales for Claims Surviving Final Decision
  45. 45. 45 © 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. Considerations for Multi-Forum Proceedings •IPR and litigation proceeding simultaneously –Most IPRs/CBMs prompted by litigation –Stays are common, but by no means certain •Multiple IPRs –Attack different claims of same patent –Propose different unpatentability grounds •IPR and continuations/reissues/ex parte reexams –Common strategies to seek new claims
  46. 46. 46 © 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. IPRs and Concurrent Litigation: Issues to Consider •Protective Order –USPTO default Protective Order –Can be modified by stipulation with supporting rationale •Prosecution Bar –Limited to participation with Motion to Amend? –Covers all USPTO activity? •Confidential Information –Will be disclosed if PTAB deems necessary
  47. 47. 47 © 2014 Knobbe, Martens, Olson & Bear, LLP all rights reserved. •Coordination with Litigation Counsel •Coordination with Prosecution Counsel •Discovery –Very limited in PTAB •Claim Construction –Broadest Reasonable Interpretation (BRI) v. Phillips •Expert Choice/Preparation –Technical background –Litigation experience IPRs and Concurrent Litigation: Issues to Consider
  48. 48. knobbe.com Orange County San Diego San Francisco Silicon Valley Los Angeles Seattle Washington DC Thank you! paul.conover@knobbe.com curtis.huffmire@knobbe.com brent.babcock@knobbe.com (949) 721-6356 (949) 721-7628 (949) 721-2920

×