Medical Device Litigation

At Knobbe Martens, our litigators offer a proven ability to persuade judges and juries alike regarding the value, efficacy and originality of each client’s medical device technology. Our lawyers understand far more than just the law, including a myriad of technologies, the language of engineers, KOLs, a variety of business models, the product development lifecycle, business finance and ROI.

We have decades of experience representing medical device companies in IP and technology litigation, from start-up to Fortune 500 companies and everything in between. Our clients know how to clear the clinical and regulatory hurdles to bring their medical device technology to market, and we know how to succeed in the courtroom. Notably, we have over $1 billion in judgments and settlements collected for our medical device clients with an equal amount of defense victories since 2000.

We deliver the bandwidth to handle bet-the-company litigation with more than 60 litigators focusing on technology disputes in the medical device industry. All of our medical device litigators have backgrounds as engineers or scientists and can quickly devise a winning strategy within a cost-effective budget. Our experience includes all areas of the medical device industry, such as implantable devices, surgical planning, wearables and diagnostics. Whether proprietary technology has been stolen or a client is accused of doing so, we bring the requisite breadth and depth of skill and legal acumen needed to realize the right result in even the most critical or difficult disputes.

Our litigators have triumphed in courtrooms nationwide, as well as in arbitration, in coordination with foreign litigation, and in administrative proceedings before the ITC and PTAB, among other venues. Our unique blend of industry knowledge and legal savvy enables us to develop the litigation strategy that best fits our clients’ business needs. We remain dedicated to successfully and expeditiously executing the right strategy and approach to problem solving — whether in court, before the Patent Office, or at the negotiating table.

Successes

​​​​​​​Prosecution

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.  

CardiAQ Valve Technologies, Inc. v. Neovasc Inc.
Won a $70 million jury verdict for our client, CardiAQ. CardiAQ designed a transcatheter mitral valve replacement device that was the first ever to be placed in a human and hired Neovasc to help assemble prototypes under a non-disclosure agreement. Neovasc's lead engineer began designing a directly competing device while working on CardiAQ's prototypes, but decided not to tell CardiAQ as their relationship continued for six more months, during which time CardiAQ shared numerous confidential designs. After the judge enhanced damages and awarded interest, the judgment totaled $112 million, which our client collected in full.

Masimo Corp. v. Philips Electronics North America Corp. and Philips Medizin Systeme Boblingen GmbH
Won 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. The parties settled before appeal, with Philips agreeing to pay $300 million and integrate Masimo technology in its patient monitors.

KFx Medical Corp. v. Arthrex, Inc.
Won a $29 million jury verdict for our client, KFx Medical Corporation. A jury found that Arthrex willfully infringed all three KFx patents directed to improved methods for attaching soft tissues to bone. 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.

Applied Medical Resources Corp. v. United States Surgical Corp.
Won a jury verdict of $43.5 million for our client, Applied Medical. The jury also found that Tyco’s U.S. Surgical division had willfully infringed Applied Medical’s patent. The court upheld the verdict, enhanced the damages, and entered a $64.5 million judgment, all of which were affirmed on appeal.

Mallinckrodt, Inc. v. Masimo Corp.
Won a $134.5 million jury verdict for our client, Masimo, on four patents involving read-through-motion pulse oximeters. The jury found that Tyco’s Nellcor division had willfully infringed the four patents, while also finding that our client had not infringed a Tyco patent. The appellate court affirmed the $164.5 million judgment and ordered the entry of a permanent injunction. The case settled for $330 million and future royalties.

I-Flow Corp. v. Apex Medical Technologies
Won a $10 million jury verdict for our client, I-Flow, on patent, trade secret, breach of confidence and unfair competition claims.

Defense

Otto Bock Healthcare LP v. Össur HF
Successfully opposed a motion to enjoin our client, Össur, at the beginning of a patent litigation. Otto Bock filed the motion to attempt to remove Össur’s Unity product of vacuum suspension prosthesis despite Össur having invested substantial resources to bring its product to market. We successfully convinced the district court that Otto Bock was unlikely to prevail on the merits of any of its claims and the district denied the preliminary injunction. The Federal Circuit affirmed.

Masimo Corp. and Cercacor v. Dominion Assets
Successfully obtained early dismissal of a multi-patent infringement lawsuit on behalf of our clients, Masimo and Cercacor. We were able to show that the non-practicing entities lacked standing to bring the suit.

Applied Medical Resources Corp. v. Tyco Healthcare Group LP d/b/a Covidien
Won an inventorship dispute for our client, Applied Medical. As part of a long patent infringement battle between Applied Medical and Covidien over single incision laparoscopic surgery devices, Covidien purchased the disputed license rights in Applied Medical’s patents and sued Applied Medical to add additional alleged inventors to Applied Medical’s patents. After a bench trial, the district court ruled in Applied's favor on all claims and held that no individuals associated with Covidien are inventors on any of the five Applied patents at issue.

United States v. Masimo Corp.
Successfully defended Masimo against former employees who alleged that Masimo submitted false claims to the government in connection with Masimo’s “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. We won a motion for summary judgment, which gave Masimo a complete victory without having to go to trial.

Applied Medical Resources Corp. v. Tyco Healthcare Group LLP
Successfully defended Applied Medical against claims of patent infringement in the Eastern District of Texas. The Texas jury found that all four patents were invalid and not infringed.

AngleFix Tech, LLC v. Smith & Nephew, Inc.
Successfully stayed a district court infringement action filed by a non-practicing entity against our client, Smith & Nephew, pending inter partes review (IPR). Upon institution of the IPR, our client favorably settled the suit relating to variable angle bone plates and screws for use in orthopedic surgery.

Kinetic Concepts, Inc. v. Smith & Nephew, Inc.
Represented Smith & Nephew in the negative-pressure wound therapy (NPWT) war with Kinetic Concepts. We won a major battle when, after trial, the judge overturned the jury verdict and ruled the patents KCI had asserted were invalid. Following that ruling, KCI (the patent licensee) and Wake Forest University (the patent owner) parted ways and Smith & Nephew ultimately reached a favorable settlement with Wake Forest.

Kinetic Concepts, Inc. v. Blue Sky Medical Group
On appeal, we obtained affirmance of a jury verdict that a gauze-based system for negative pressure wound therapy does not infringe patents.

Nobel Biocare AB v. Materialise, N.V.
Won a summary judgment of non-infringement for Nobel Biocare’s dental implant surgical planning software in a declaratory judgment action in the Central District of California. The summary judgment ruling resulted in the favorable resolution of U.S. and foreign litigation between the parties.

Koepnick Medical & Educ. Research Found, L.L.C. v. Alcon Labs., Inc. et al.
Successfully represented Bausch & Lomb before the district court and on appeal. We secured a favorable claim construction and won a judgment of no infringement against the patent owner alleging that LASIK eye surgery infringed the asserted patent.

PTAB Trials

Smith & Nephew, Inc. v. ConforMIS, Inc.
Obtained final written decisions of unpatentability of all the challenged claims in ConforMIS’s foundational patent and three additional patents involving patient-specific instruments for knee replacement surgery. These IPRs constitute the first set in a series of IPRs Smith & Nephew filed against ConforMIS patents. We also successfully obtained a stay of the district court litigation upon institution of the first IPR.

Instradent USA, Inc. v. Nobel Biocare Services
Defeated the institution of an IPR petition challenging the validity of Nobel’s pioneering medical device patent for dental implants. The IPR challenge was brought by a competitor after the patent had been found infringed upon in a co-pending ITC action.

ITC Actions

In the Matter of Certain Dental Implants
Successfully represented Nobel Biocare (the complainant) in an investigation asserting patents directed at dental implant design against two respondents. After defeating a motion for summary determination of invalidity, the case proceeded to trial where we secured multiple victories for Nobel. The Administrative Law Judge (ALJ) found one patent valid and infringed, but found another invalid as anticipated. We successfully petitioned the commission to reverse the ALJ’s determination of invalidity, and the commission reversed. The respondents appealed the commission’s reversal to the Federal Circuit. The Federal Circuit affirmed.

In the Matter of Certain Sleep-Disordered Breathing Treatment Mask Systems
Represented Fisher & Paykel (the respondent) in an investigation involving patents directed at masks for treating sleep apnea. The complainant withdrew the complaint after we obtained a favorable and significant evidentiary ruling.

Arbitration

Zimmer Inc. v. Nobel Biocare, USA, Inc.
Successfully defended Nobel in an arbitration involving a dental implant patent dispute. Zimmer asserted that two of Nobel's popular product lines infringed Zimmer’s patent and sought an injunction and $100 million in past damages. The patent had been previously enforced against over a dozen companies in the dental implant industry, resulting in settlements and payments of millions of dollars in royalties. The panel found that Nobel did not infringe and awarded Nobel over $2 million in attorneys’ fees and expenses.

Flex Foot v. CRP, Inc.
Successfully represented Flex Foot, a prosthetic limb manufacturer-patentee, in a patent arbitration before the AAA relating to prosthetic feet. The arbitration panel found that CRP infringed Flex Foot’s patent and awarded patent damages and arbitration fees to Flex Foot. All arbitrated issues were confirmed by the district court and affirmed by the Federal Circuit.

Medical Device Client
Secured a stay of a foreign lawsuit brought against a medical device client in favor of a U.S. arbitration before the ICDR of the American Arbitration Association (AAA). The foreign lawsuit was dismissed after we won a favorable arbitration ruling. We also secured a consent judgment of no infringement in co-pending patent litigation in U.S. District Court.

Medical Device Client
Won a non-infringement ruling in a confidential arbitration conducted by the International Institute for Conflict Prevention and Resolution (CPR) before a panel selected from the specialized "Technology" panel of CPR's Panel of Distinguished Neutrals.

IRVINE, Calif., February 28, 2024 – Knobbe Martens is pleased to announce that the firm and two of its partners have been shortlisted in eight categories for the 2024 Managing IP Americas awards. The...
PTAB sides entirely with Spectrum in IPR proceeding against DNA Genotek IRVINE, Calif., February 20, 2024 – A team from Knobbe Martens led by Ali Razai secured another victory for Spectrum Solutions...
The Orange County Business Journal honored Knobbe Martens partners Joseph Re and Steve Jensen as Orange County Businesspeople of the Year for their work on behalf of Irvine, California-based medical...