Medical Devices & Procedures
We are an undisputed leader in medical device IP Law, having filed over 40,000 patent applications in the medical device arts alone, helped over 100 medical device companies get acquired or go public, and successfully litigated numerous medical device IP cases, several through trial and appeal.
We’ve been active in the medical device industry almost from its inception—providing leading-edge counsel and representation for the entire spectrum of clients, including “garage” inventors, start-up companies, venture capitalists, medical device incubators, and established, publicly held-corporations.
Our team of attorneys provides guidance in all stages of development through capital formation, transactional due diligence, patent landscape (market clearance) evaluations, strategic patent prosecution, licensing and other IP agreements, trade secrets, third party patent evaluations, IP audits and, when necessary, IP litigation.
Our experience in the medical device industry encompasses a wide range of technical specialties, some examples of which include aesthetics, cardiac rhythm management, cardiovascular, dental, diabetes, ENT, gastrointestinal, monitoring/imaging, neurovascular, OB/GYN, ophthalmic, orthopedics/spine, prosthetics, peripheral vascular, pulmonology, and medical information technology applications.
Some of our attorneys serve or have served on the Boards of Directors of medical device companies, giving us an unparalleled perspective into the industry’s unique business issues and challenges.
Additionally, several of our attorneys have extensive engineering and R&D experience at medical device companies.
We also launched KnobbeMedical.com, a free cooperative portal that provides corporate, regulatory, legal, manufacturing, and other resources for entrepreneurs, executives, clinicians, researchers, investors, and corporate board members who are exploring a start-up, joint venture or spin-off in the medical device industry.
Our attorneys have experience in all areas of Medical Devices and Procedures, including:
Biocompatible Polymers & Coatings
Ear, Nose, & Throat
Hypertension Management Devices
Minimally Invasive & Endoscopic Procedures
Obesity Management & Bariatrics
Ophthalmology & Eye Care
Pacemakers & Electrical Stimulation Devices
Prosthetics & Orthotics
Sterile Field Devices
Urology & Incontinence
Vital Signs, Physiologic, & Hemodynamic Monitoring
Aesthetics & Implants
Cardiac Rhythm Management
Catheters & Probes
Glucose Monitoring & Insulin Infusion
Medical Informatics & Software Systems
Nephrology & Dialysis Equipment
Stents, Valves, & Loading Devices
AcousTx Corp (Therapeutic Ultrasound Devices)
AcuFocus (Intracorneal Inlays)
Advanced Ossius Technologies (Ultrasonic Hip Revision Tools)
Advanced Surgical Interventions (BHP Stents)
Alliance Medical Technologies (Heart Valves and Cardiovascular Devices)
Alphatec Spine (Spinal Implants)
Alure Medical (Cosmetic Implants)
Amsino Medical Group (Safety Catheters and Syringes)
Angiotrax (Medical Devices Used in Transmyocardial Revascularization)
Applied Technologies Holdings (Biometric Sensing and Analyzing Systems, Body Sensors for Rehabilitation and Sports Medicine)
Appriva Medical (ACQUIREfD by ev3) (Left Atrial Appendage Closure Devices)
ARO Medical (Spinal Implants)
ArtiVent Corporation (Respirators)
Atrionix (ACQUIRED by Johnson & Johnson) (Ablation Catheters for Treatment of Atrial Fibrillation)
Attenuex (Implants to Treat Urinary Incontinence)
Beckman Instruments (Medical Analytical Instrumentation)
Benvenue Medical (Orthopedic Spine)
Biogauge-Nordic Bioimpedence Research AS (Sweat Activity Monitor)
Biointerfaces (Bone Grafts, Implantable Prostheses)
Birsect (Autologous Breast Implants)
Buffalo Neurosurgery Group (Intracranial Devices)
CardiAQ Valve Technologies (Heart Valves)
Cardio Medical Solutions (Cardiovascular Devices)
CardioVascular Dynamics (Angioplasty Catheters)
CardioVascular Technologies (Mitral Valve Repair for CHF)
Carnegie Mellon University (Joint Assessment and Diagnosis)
Carol Cole Company (Facial Toning and Stimulation Devices)
Carticept Medical (Orthopedic Devices)
Cayenne Medical (Knee Implants)
Cedars-Sinai Medical Center (Coronary Catheters)
Cenorin - Cenor (Medical Barriers, Sleeves, Straps, and Clasps)
Cercacor Laboratories (Patient Monitoring Devices)
Chestnut Medical Technologies (Neurovascular Stents)
Chicago Growth Partners
Chrontech Pharma (Injection Devices for Vaccine Delivery)
Cianna Medical (Soft Tissue Fixation Implants)
CMS Surgical (General)
CoreValve (ACQUIRED by Medtronic) (Percutaneous Heart Valves)
Cytori Therapeutics (Adipose-derived Stem Cell Isolation Device Used for Augmentations, Cardiovascular Repair, and Osteo-Prosthetic Implants)
D2SURG (Gastric Bypass)
Dendron GmbH (Cardiovascular)
Denmark Technical Institute
Dentatek Corporation (Root Canal Treatments)
DexCom (Glucose Monitors)
DFine (Spinal Vertoplasty Height Restoration/ Spinal Implants/ Bone Cutters)
Direct Flow Medical (Percutaneous Heart Valves)
Edge (Skin Aesthetics)
Edonetics (Sub mucosal Implants To Treat GERD)
EKOS (Neovascular, Peripheral Vascular, and Ultrasound Catheters)
Embrella Cardiovascular (ACQUIRED by Edwards Lifesciences) (Embolic Deflectors)
Endicor Medical (Cardiovascular, Rotational Artherectomy Catheters)
Endius (ACQUIRED by Zimmer Holdings) (Ortho/Spine)
Endoclear (Endotracheal Tube Cleaning Devices)
Endologix (Abdominal Aortic Aneurysm Grafts)
Entellus Medical (Chronic Sinusitis Therapy Catheters)
ETD-VDP (Vascular Devices)
eV3 (ACQUIRED by Covidien) (Vascular Treatment Devices, Cardiovascular, Catheters, and Stents)
Evera Medical (Cosmetic Implants)
Facet Solutions (Spinal Implants)
Flow Cardia (Endovascular Tools for Crossing Chronic Total Occlusions (CTOs))
Glaukos Corp. (Intraocular Implants and Devices to treat Glaucoma)
GluMetrics (Intravascular and Interstitial Fiber Optic Glucose Sensors)
GreenCut Industries (Surgical Saw)
Gynemed (Laboratory Devices for Cellular Sample Analysis)
Healthdyne (Home Care Electronic Monitoring and Diagnostic Devices)
Hudson Respiratory Care (Respirators, Nebulizers, Humidifiers and Related Electronics and Instrumentation)
ICU Medical (Infusion Devices and Connectors)
IDev Technologies (Vascular Treatment Devices)
I-Flow Corp. (ACQUIRED by Kimberly-Clark)(Drug Infusion Pump)
Image Analysis (CAT Scan Density Analysis Software and Instrumentation)
Imagyn Medical Systems (OB/GYN Devices)
IMD Group (Retractable Safety Syringes)
IMRA America (Photonics Fibers)
Infusion Systems (Ambulatory Patient Infusion Pumps)
InnerOptic (Image Guided Surgical Systems)
Innervision Medical Technologies (High Resolution Ultrasound)
Inogen (Oxygen Concentrator Device)
Interface Associates (Balloon Catheters)
Interlace Medical (Uterine Fibroid Catheters, Inflation Media)
Interventional Spine (Spinal Implants)
Intrinsic Therapeutics (Spinal implants)
Iradimed Corp. (MRI Infusion Pumps)
John Wayne Cancer Institute (Circulating DNA Detection)
Jotec GmbH (Stent Delivery)
Kai Medical (Physiologic Monitoring)
Kamøy Enterprises AS (Device for Non-invasive Laser Treatment of Varicose Veins)
KFx Medical (Bone Anchors)
Kinetic Surgical (Robotics)
Kona Medical (Formerly Therus) (Therapeutic Ultrasound)
Kringle Pharma Europe AB (Patch for Treatment of Diabetic Skin Ulcers)
Loma Linda University Medical Center (Minimally Invasive Surgical Devices and Proton Therapy Devices)
Lutonix (Drug Coated Stents)
Masimo Corp. (Patient Monitoring Devices and Systems)
Medicis (Liposculpture Devices)
Medscansonics (Acoustic Detection of Coronary Artery Disease)
Medstone International (Lithotripsy Devices)
Medtronic (Cardiovascular Devices)
MiCardia Corporation (Adjustable Annuloplasty Rings)
Micro Therapeutics (ACQUIRED by ev3) (Cardiovascular)
Miramar Labs (Microwave-Based Treatments on Tissue)
MitraLife (ACQUIRED by ev3) (Coronary Sinus Implants)
MP Biomedicals (Various Macromolecular Extraction Devices)
NAS Medical Technologies (Pedicle Screw)
Neoguide (Advanced Internal Access)
NeoMatrix (Breast Cancer Screening)
NIH (Laparoscopic Morcellation Device)
Nobel Biocare, USA (General, Dental Implants, and Prosthetic Dentistry)
Nobles Medical (Suturing Devices)
Novalign Orthopaedics (Intermedullary Bone Fixation, Ortho/Spine)
Optiscan Biomedical Corp. (Noninvasive Spectroscopic Glucose Monitor, and Measurement)
Orthalign (Surgical Orientation Devices)
OrthoScan (ACQUIRED by Aton GmbH) (Radiographic Imaging)
Oslo Universitetssykehus HF (Tumor monitoring system, needle positioning)
Osseon Therapeutics (Vertebroplasty)
Össur hf (Prosthetic Limbs, Orthotics)
Pacesetter (ACQUIRED by St. Jude Medical, Cardiac Rhythm Management Division) (Pacemakers and Defibrillators)
Panadent (Dental Articulators)
PeriOptix (Surgical and Dental Loupes)
Pharmacia-Upjohn (Ophthalmic Devices Including Intraocular Lenses and Glaucoma Shunts)
PhotoMedex (Dermatology Devices, Laser Therapies)
PhotoThera (Devices for Providing Phototherapy)
Pilot Cardiovascular Systems (ACQUIRED By U.S.C.I.) (Steerable Guide Wires and Angioplasty Catheters)
QuantuMDx Group Limited (Handheld PCR Devices)
Radiance Medical (Intravascular Brachytherapy)
Resolution Biomedical (Laboratory Solutions for Cellular Sample Analysis)
Reva Medical (Intravascular Slide-and-Lock and Absorbable Stents)
Rigshospitalet (Double-wire Non-trapping Angioplasty Catheter)
Sapheon Therapeutics (Saphenous Vein Closure)
Savacor (ACQUIRED by St. Jude Medical, Cardiac Rhythm Management Division) (Implantable Cardiac Pressure Sensors, Pacemakers and Rhythm Management Systems)
Scope Medical (Angiographic Guide Catheters)
Seattle Children’s Hospital Research Institute (Ventilators and Bubble CPAP Devices)
Shoulder Innovations (Glenoid Replacement Implants)
Siesta Medical (Sleep Apnea implants)
SmartDisc (Artificial Spinal Disk)
Smith & Nephew Orthopaedics (Orthopedics, Hip/knee Implants)
Smith & Nephew (Wound Therapy)
Solace Therapeutics (Implants to treat Urinary Incontinence, SUI Implants)
Spinal Elements (Orthopedic Spine implants)
Spinal Kinetics (Total Spinal Disc Replacement)
Spinal USA (Spinal Implants)
SpineOvations (Micro particle Implant Material for Spinal Disk Bulking)
Sterilis (Sterilization Devices)
Surgilight (Presbyopia Treatment)
SynergEyes (Hybrid Contact lenses)
TD.JAM Medical Technologies (Vascular Devices)
Telesis Research (Absorbable Vascular Stents)
Thoratec Corporation (Circulatory Assist Devices)
Toshiba Medical Systems Company
TranS1 (Spinal Fusion Implants, Orthopedic Spine)
Triage Medical (Bone Fracture Fixation Screws)
Tryton Medical (Bifurcation Stents)
Ulthera (Aesthetics, Cosmetic Ultrasound)
UROS Corp. (Urinary Tract Infusers)
ValenTx (Endolumenal Gastric Bypass)
Vascular Device Partners (Vascular Devices)
Venetec (ACQUIRED by C.R. Bard) (Securement Devices)
Vertelink Corp (Spinal Implants)
Vesica Medical (SUI Suspension Systems)
Vesta Medical (Medical Waste Sorting Systems)
Visiogen (ACQUIRED by Abbott Medical Optics) (Intraocular Lenses, Accommodating IOLs and IOL Injectors)
VNUS Medical Technologies (ACQUIRED by Covidien) (Vein Closure & Varicose Vein Removal)
Long-time firm client ev3 was acquired by Covidien, a leading global provider of healthcare products, for $2.6 billion. Knobbe Martens represented ev3 and its affiliated companies for many years, helping them to develop a robust patent portfolio in the vascular disease market.
Firm client CoreValve was acquired by Medtronic for $700 million plus additional contingent milestone payments. Knobbe Martens served as intellectual property prosecution, diligence, and litigation counsel for CoreValve, the developer of a transcatheter aortic valve replacement.
Firm client VNUS Medical Technologies, a developer of medical devices for minimally invasive treatment of venous reflux disease, was acquired by Covidien for $440 million.
Firm client Visiogen, an ophthalmic start-up developing innovative intraocular lenses, was acquired by Abbott Medical Optics for $400 million. In addition to representing Visiogen in acquisition diligence, Knobbe Martens was involved with building the client's patent portfolio.
Knobbe Martens represented firm client C.R. Bard in its acquisition of SenoRx, the developer of minimally invasive devices for the treatment of breast cancer. SenoRx was acquired for about $213 million. The firm conducted extensive target diligence on SenoRx, analyzing over 1200 patents in under 3 weeks in advising C.R. Bard on the transaction. The firm also represented C.R. Bard in performing target due diligence for its acquisition of Medivance, a leader in the field of products for therapeutic hypothermia to treat critically ill patients. Medivance was acquired for $250 million.
Knobbe Martens client EKOS Corporation was acquired by BTG (a British pharmaceutical company) for $180 Million and up to $40 million in additional payouts if milestones are met. EKOS is a medical device company that makes ultrasound catheters that use advanced ultrasound excitation to precondition blood clots for rapid clot removal. Knobbe Martens has been the sole IP counsel for EKOS since 2002.
Masimo Corp. v. True Wearables Inc.
Represented Masimo in a trade secret case involving technology for noninvasively measuring blood oxygen saturation. In addition to trade secrets, the case also included claims for breach of contract and breach of fiduciary duty. Masimo prevailed, and the Court issued a permanent injunction barring the defendants from selling their product that used Masimo’s trade secrets.
Masimo Corp. v. Philips Electronics North America Corp. and Philips Medizin Systeme Boblingen GmbH
Obtained a jury verdict of over $466 million for lost-profits damages against Philips for infringing two Masimo patents. The jury also rejected Philips’s infringement claims seeking $169 million.
AngleFix Tech, LLC v. Smith & Nephew, Inc.
Knobbe Martens obtained a stay pending inter partes review (IPR) on behalf of client Smith & Nephew, Inc. from the district court for the Western District of Tennessee. The motion effectively halted litigation in the patent infringement case brought by non-practicing entity, AngleFix LLC, relating to variable angle bone plates and screws for use in orthopedic surgery. Smith & Nephew subsequently obtained a favorable settlement.
St. Jude Medical, Inc. v. Access Closure, Inc.
Knobbe Martens Partner Joseph Re achieved an appellate victory for AccessClosure, Inc., a medical device company that develops products to address challenges in the cardiovascular and peripheral vascular markets.
A jury had found that AccessClosure infringed patents of competitor St. Jude Medical, Inc. and awarded damages. The district court then entered an injunction. Mr. Re was then hired to handle the appeal, and persuaded the U.S. Court of Appeals for the Federal Circuit that the patent was invalid under the rarely used “double patenting” doctrine. The Federal Circuit overturned the district court’s injunction, and also denied St. Jude’s petition for rehearing en banc. Free from any injunctive threat, AccessClosure was able to successfully sell the company to healthcare giant Cardinal Health for $320 million.
Applied Medical Resources Corp. v. Tyco Healthcare Group LP d/b/a Covidien
In March 2014, Knobbe Martens secured a victory on behalf of Applied Medical Resources, Corp. in an inventorship dispute filed by Covidien and Gaya Ltd. In September 2011, Applied Medical sued Covidien for patent infringement and alleged that Covidien’s SILS Port products, which are used in single incision laparoscopic surgery, infringed one of Applied Medical’s patents. Covidien thereafter purchased disputed license rights in that patent and other Applied Medical patents from Gaya Limited, who claimed to have invention and ownership rights in the patents. Covidien and Gaya then filed a lawsuit against Applied Medical in which they requested that the inventorship of five Applied Medical patents be corrected to name Gaya personnel as inventors. On July 11, 2014 the Central District Court of California ruled in Applied Medical’s favor on the inventorship claims and found that no individuals associated with Gaya should be named as inventors on any of the Applied Medical patents at issue.
United States v. Masimo Corp.
The firm successfully represented Masimo in its defense against a group of former employees who alleged Masimo caused false claims to the government in connection with its “Pronto” line of medical devices. These devices non-invasively measure total hemoglobin in the blood. Relators claimed the devices were worthless and doctors who used them should not have received any governmental reimbursement.
In October, 2013, the litigation team won a motion for summary judgment, claiming a total victory in this false claims action. Judge Carney found that Masimo was aware of studies showing that the performance of the Pronto devices “was at least as good as, and sometimes better than” the performance of other hemoglobin measuring devices. Additionally, the district court held that Masimo presented “overwhelming evidence of its good faith belief in the medical value of the Pronto Devices as well as their value to members of the medical community.”
Ruhe v. Masimo Corp.
A team of Knobbe Martens attorneys succeeded in persuading a California district court to vacate an arbitration award of over $5,000,000 in punitive damages. The award was based on former Masimo employees’ claims of constructive wrongful discharge because of pressure to sell allegedly defective medical devices. Masimo convinced the court that the arbitrator should have disclosed that the arbitrator’s brother had represented Masimo’s main competitor in an antitrust suit and patent suit filed by Masimo in which Masimo was awarded hundreds of millions of dollars. The team then challenged that the arbitrator be disqualified. The district court found that the arbitrator did not follow Judicial Arbitration and Mediation Services (“JAMS”) rules by refusing to allow JAMS to hear the disqualification challenge. In contrast to what the arbitrator characterized as “abusive litigation tactics,” Judge Carney found that the team “zealously represent[ed] their client.”
$330 Million Settlement for Masimo Corporation
The firm represented Masimo in a patent infringement case involving pulse oximeters. After trial and appeal, Masimo settled the case and received $330 million and additional future royalties. In addition to handling the litigation, Knobbe Martens also continues to build and manage Masimo's extensive intellectual property portfolio.
$64.5 Judgment for Applied Medical Resources Corporation
In a jury trial, the firm represented medical-device maker Applied Medical Resources Corporation in obtaining a verdict of $43.5 million and a finding that Tyco’s U.S. Surgical Unit had willfully infringed patent. The Court confirmed the verdict, enhanced the damages, and entered a $64.5 million judgment. The appellate court affirmed the judgment in its entirety and the judgment has since been satisfied.
Kinetic Concepts, Inc. v. Smith & Nephew, Inc.
Knobbe Martens successfully defended Smith & Nephew in a case in which Kinetic Concepts asserted several patents on negative pressure wound therapy (NPWT). NPWT is the treatment of difficult-to-heal open skin wounds with negative pressure. After a jury trial, the Court granted JMOL of invalidity due to obviousness based on evidence presented at the trial by the Knobbe team. In view of this ruling, clinicians and patients now have a choice when selecting NPWT products.
KFx Medical Corp. v. Arthrex, Inc.
Knobbe Martens secured a decisive victory on behalf of client KFx Medical Corporation. The KFx patents at issue are directed to improved methods for attaching soft tissues to bone, which are widely used in rotator cuff repair. After a liability trial in August 2013, a jury found all three KFx patents were valid and willfully infringed by Arthrex. In October 2013, the same jury awarded $29 million in damages for the infringement. The district court granted additional damages and interest, bringing the total award to $35 million. The Federal Circuit summarily affirmed the district court judgment and the U.S. Supreme Court subsequently denied certiorari. Hundreds of thousands of rotator cuff surgeries are performed each year in the United States utilizing KFx’s patented technique.
Otto Bock Healthcare LP v. Össur HF
Össur is a global company active in the development and distribution of products in the fields of non-invasive prosthetics, medical braces and supports. After Össur invested substantial resources to bring to market its Unity product of vacuum suspension prosthesis, Otto Bock filed a motion for a preliminary injunction seeking to enjoin Össur.
We vigorously opposed the motion on Össur's behalf. The district court denied Otto Bock’s motion, and concluded that Otto Bock was unlikely to prevail on the merits of any of its claims. The Federal Circuit affirmed the district court’s decision in favor of Össur and concluded that Otto Bock is unlikely to establish infringement of the asserted claims.
New Enterprise Associates (NEA)
Knobbe Martens client New Enterprise Associates (NEA) led the financing of Relievant Medsystems, Inc., a privately held medical device company pioneering the therapeutic use of basivertebral nerve ablation for the treatment of chronic axial low back pain. The company secured $30 million in a Series D equity financing to advance and expand the Company’s worldwide clinical development programs.
Justin Klein, M.D. “Relievant’s early clinical results indicate that Intracept has the potential to be a highly effective, durable, safe, and minimally invasive procedure to address a multi-billion dollar market. As important, we believe the Company’s dedication to demonstrating the benefits of Intracept through a rigorous, randomized controlled trial—working in close partnership with its clinical advisors and the FDA—is exactly the right approach to providing a therapy that addresses the needs of patients, spine surgeons and interventionalists, and payors.” The firm represented NEA in the IP diligence of Relievant.