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Cardiovascular ip landscape webinar
1.
The Cardiovascular IP
Landscape October 12, 2020 Adam Gilbert, Shannon Lam, Christy Lea, Sabing Lee, Rabi Narula Knobbe Martens
2.
© 2020 Knobbe
Martens Introductions & Overview 2 Litigation Trends and Statistics & Recent Litigation and PTAB Filings Sabing Lee Rabi Narula Recent Litigation Decisions Christy Lea
3.
© 2020 Knobbe
Martens Introductions & Overview 3 IP Related Transactions Adam Gilbert USPTO Update Shannon Lam
4.
© 2020 Knobbe
Martens 4 Litigation Trends and Statistics
5.
© 2020 Knobbe
Martens Litigation Is On The Rise (But Maybe Not For Medical Devices) 5 Data through 10/4/2020 Source: Docket Navigator 0 1000 2000 3000 4000 5000 6000 7000 8000 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 All Technologies USDC PTAB ITC 0 100 200 300 400 500 600 700 800 900 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 Technology Center 3700 USDC PTAB ITC
6.
© 2020 Knobbe
Martens Increase in Trade Secret Litigation 6 0 200 400 600 800 1000 1200 1400 1600 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 Trade Secret Case Filings 2010 to 2019 w/o DTSA DTSA 6
7.
© 2020 Knobbe
Martens Trends at the Patent Trial and Appeal Board (PTAB) • New procedures implemented in 2012 with America Invents Act • Viewed as efficient mechanism to challenge patents outside of the litigation process • Significant initial interest as many patent challengers were successful • Current statistics show that PTAB challenges may postpone litigation, but do not avoid it completely • Ongoing challenges to the constitutionality of these procedures 7
8.
© 2020 Knobbe
Martens Observations on Institution Rates (September 2012 – July 2020) • 11,845 PTAB proceedings have been filed since creation of procedure • Rates of institution have declined over time 8 https://www.uspto.gov/patents-application-process/patent-trial-and-appeal-board/statistics
9.
© 2020 Knobbe
Martens Recent Outcomes at the PTAB Favor Patent Owner 9 Source: LexMachina Outcomes Since January 2018 for 1242 petitions NO INSTITUTION (55.6%) ALL CLAIMS UPHELD (8.0%) AMENDED CLAIMS (0.2%) MIXED FINDINGS (8.8%) ALL CLAIMS CANCELLED (27.5%) No Institution 55.6% (690) All Claims Cancelled 27.5% (342) All claims upheld 8.0% (99)
10.
© 2020 Knobbe
Martens 10 Recent Litigation Filings and Settlements – Heart Valves
11.
© 2020 Knobbe
Martens • Patents formerly owned by • Complaint filed March 13, 2020 in District of Delaware • 5 patents asserted against CoreValve and Evolut products • Medtronic alleged to have met with Direct Flow in 2006 and 2007 v.Speyside Medical 11
12.
© 2020 Knobbe
Martens • Complaint filed May 4, 2020 in Central District of California • 2 patents asserted against CoreValve and Evolut products • Colibri alleged that it met with Medtronic in 2014 and discussed its TAVI system and patent applications • Medtronic filed IPR petitions on September 2, 2020 • Edwards filed IPR petition against one of the patents on September 18, 2020 v. 12
13.
© 2020 Knobbe
Martens • Features claimed • Delivery system with pusher and moveable sheath • Deploying distal portion of replacement heart valve and restraining the replacement heart valve to allow for recovery • Stent that flares at both ends v. 13
14.
© 2020 Knobbe
Martens v. PASCAL Transcatheter Valve Repair System• Initial complaint filed by Abbott in January 2019 • Abbott asserted 5 patents in District of Delaware • Edwards asserted 3 patents in Central District of California • Both sides filed IPRs • Litigations also in the UK, Switzerland, Germany, Italy, Ireland 14
15.
© 2020 Knobbe
Martens • Preliminary injunction denied by Delaware court in June 2019 • Settled July 2020 • Edwards paid Abbott $368 million plus ongoing payments for sales of Pascal through May 2024, as well as potential sales milestone payment in 2026 • No patent litigation disputes in the field of transcatheter mitral and tricuspid repair and replacement products for 10 years • Injunctions (UK and Switzerland) against Edwards’ PASCAL device were lifted 15 v. PASCAL Transcatheter Valve Repair System
16.
© 2020 Knobbe
Martens v. • Boston multi-front attack (April 2016) • 1 Boston patent asserted against Sapien 3 in Delaware • 8 Boston patents asserted against Sapien delivery system and crimper in Central District California • Suits in Germany, UK, Ireland, and France • Edwards counterattack • 3 Edwards patents asserted against Lotus in Delaware • 2 Edwards patents asserted against Watchman in separate suit in Delaware (August 2018) • Suits in Canada and Germany Lotus Watchman LAA implant 16 Sapien 3
17.
© 2020 Knobbe
Martens v. • March 2018: PTAB held Boston patent unpatentable • Dec. 2018: Jury found Boston patent valid and infringed and Edwards patents not infringed • Jan. 2019: Settled; Edwards paid Boston $180 million, but no ongoing royalty • Parties will not litigate patent disputes related to current portfolios of transcatheter aortic valves, certain mitral valve repair devices, and left atrial appendage closure devices • Injunctions (UK and Germany) lifted 17 Lotus Watchman LAA implant Sapien 3
18.
© 2020 Knobbe
Martens 18 Recent Litigation & PTAB Filings (catheters and other non-heart valve technology)
19.
© 2020 Knobbe
Martens • Complaint filed July 2, 2019 in District of Minnesota • 5 patents asserted against Medtronic’s Telescope Guide Extension Catheter • Patents directed to: • Guide catheter and extension catheter that includes a tubular flexible tip portion and a substantially rigid proximal portion • Guide extension catheter with a substantially rigid segment coupled to more flexible tubular structure • Methods of forming such a device • Medtronic filed 12 petitions for IPR in November 2019 (most instituted and still pending) • July 7, 2020 case stayed pending final resolution of IPR’s v. 19
20.
© 2020 Knobbe
Martens • In December 2018, CSI filed IPRs against 3 Shockwave’s patents directed to balloon angioplasty catheters that produces shockwaves to treat calcified lesions • No co-pending litigation • In July, 2020, final decisions were issued • 1 claim survived • Shockwave issued a press release touting that a key claim was found valid • Continuations are pending v. 20
21.
© 2020 Knobbe
Martens v. Apple Watch Patent directed to a method of detecting atrial fibrillation comprising (a) detecting irregular pulse rhythms from a succession of time intervals each corresponding to a respective interval of time between successive pulse beats of a sequence of the pulse beats; (b) analyzing the detected irregular pulse rhythms to make a determination of possible atrial fibrillation; and (c) indicating the possible atrial fibrillation from the determination. • 2017: Dr. Weisel sent Apple notice letters • December 2019: Dr. Weisel sued Apple Watch for patent infringement • September 2020: Apple filed IPR petition 21 Dr. Joseph Weisel
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Martens Trends in Medical Device IP Litigation 22 1. More patent eligibility (§ 101) challenges against medical device patents 2. Remedies for sales outside the United States 3. Decreased ability to forum shop
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Martens 23 Trend #1 – More patent eligibility (§ 101) challenges against medical devices
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Martens U.S. – Patent Eligible Subject Matter 24 §101 provides: Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor.... Supreme Court (1980): “Anything under the sun made by man”
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Martens Supreme Court Limited Patent Eligibility Over Past Decade 25 Natural Laws (Mayo - 2012) Natural Phenomena (Myriad - 2013) Abstract Ideas (Alice - 2014)
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Martens 26 v. • May 2015 - CardioNet sued InfoBionic on 6 patents in field of Mobile Cardiac Telemetry • Patents invalid or not infringed • March 2017 – CardioNet sued InfoBionic on 1 patent • District Court: Patent invalid, subject matter not eligible under § 101 • Federal Circuit: REVERSED US market estimated at $1.4B
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Martens 27 Telehealth - Abstract Idea? Do claims focus on specific improvements to the relevant technology or Are they directed to a result that is the abstract idea and merely invoke generic machinery?”
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Martens Cardionet v. InfoBionic (Fed. Cir. 2020) 28 District court: Not patent eligible – automating known techniques Federal Circuit: Reversed. Patent eligible. • Improved cardiac monitoring device that • detects beat-to-beat timing of cardiac activity • detects premature ventricular beats • determines relevance of beat-to-beat timing • Specification touts advantages of improved device “The 101 patent-eligibility inquiry is only a threshold test.”
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Martens 29 Trend #2 – Remedies for sales outside the United States
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Martens Damages for Foreign Sales 30 §271(f) provides: Whoever supplies from the United States component(s) of a patent invention for combination outside the United States in a manner that would infringe if such combination occurred in the United States shall be liable as an infringer Supreme Court (2018): Lost profits from foreign sales are recoverable for infringement of US patent
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Martens 31 May 2008: Maquet acquired patents-in-suit (but does not practice them) Dec. 2015: Maquet sent cease & desist letter to Abiomed attaching a draft complaint § Impella heart pump Jan. 2016: Abiomed responded with claim charts May 2016: Maquet responded demanding a license and threatening litigation May 2016: Abiomed filed complaint (D. Mass.) seeking declaratory judgment on 6 patents V.
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Martens Maquet’s Counterclaims for Infringement Do Not Include § 271(f) 32 • Direct Infringement § 271(a) • Indirect Infringement § 271(b) and (c) • No infringement based on foreign sales § 271(f)
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Martens Maquet Sought Discovery of Foreign Sales But Never Amended Complaint 33 • Maquet requested discovery of Abiomed’s foreign sales • Abiomed objected because infringement counterclaims limited to US activities (making, selling, importing) • Maquet never amended counterclaims
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Martens 34 Trend #4 – Decreased ability to forum shop
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Martens The Rise of the Western District of Texas NEW HOTSPOT Knobbe Headquartered 2020 expected – 779 cases; 22% District Cases (2019) Percent (2019) Cases (2020) Percent (2020) W.D.Tex. 288 8.07% 658 21.59% D.Del. 1,000 28.03% 548 17.98% E.D.Tex. 333 9.34% 302 9.91% C.D.Cal. 344 9.64% 241 7.91% N.D.Cal. 235 6.59% 185 6.07% D.N.J. 145 4.07% 123 4.04% U.S. District Judge Alan D. Albright Data through 10/4/2020 Source: Docket Navigator 35
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Martens 36 USPTO Update
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Martens Top 10 Countries for Cardiovascular Treatment Device Publications (2019-20) 37 Source: Derwent Innovation
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Martens Top 10 Countries for Cardiovascular Diagnostic Device Publications (2019-20) 38 Source: Derwent Innovation
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Martens Trends in U.S. Cardiovascular Publications & Filings 39 Source: Derwent Innovation Publication Year Priority Year
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Martens 0 200 400 600 800 1000 1200 1400 1600 1800 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 Year Trends in U.S. Cardiovascular Publications 40 Cardiovascular Diagnostic Devices Prostheses in Heart Valves Source: Derwent Innovation Prostheses in Blood Vessels
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Martens 50% of Cardiovascular U.S. Patents Granted Within 3 to 4 Years 41 50% of Treatment Devices Granted 3 Yrs. After Filing 50% of Diagnostic Devices Granted 4 Yrs. After Filing Sources: USPTO; PatentBots 3774 3791
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Martens 42 IP Related Transactions
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Martens Three Very Successful Cardiovascular IPOs 43 Acutus Medical (AFIB) $158.8M Inari Medical (NARI) $156M Shockwave Medical (SWAV) $75M $18 $42 $36 Up 55% Up 54% Up 108% IPR Decision
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Martens Breaking: Medtronic to Acquire Avenu Medical 44
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Martens Breaking: CryoLife acquired Ascyrus Medical for $200M 45
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Martens Philips Acquired Intact Vascular for $275-360M 46
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Martens Terumo Acquired Quirem Medical for $45M 47
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Martens LeMaitre Vascular Acquired Artegraft for $90M 48
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Martens Keystone Heart Acquired 510 Kardiac Devices for $90M 49
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Martens AngioDynamics Acquired Eximo Medical for $66M 50
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Martens Siemens Acquired Corindus Vascular Robotics for $1.1B 51
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