Overview
We are an undisputed leader in medical device IP Law, having filed more than 5,000 patent applications in the medical device arts alone, helped over 50 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.
Representative Experience
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 Million 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.
ev3
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.
CoreValve
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.
VNUS Medical Technologies
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.
Visiogen
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.
C.R. Bard
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.
EKOS
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.