News & Analysis as of

Medtronic

Medtronic Receives Regulatory Approval for Surgical Navigation Device

by Knobbe Martens on

According to Medtronic news release, the company recently received 510(k) clearance from the U.S. FDA and a CE mark from the E.U. for its StealthStation™ ENT surgical navigation system. The system will assist surgeons...more

Minnesota Supreme Court Rejects Delaware Test for Direct Versus Derivative Action

In a case arising out of the inversion transaction where Medtronic merged with Coviden, the Minnesota Supreme Court spoke on the proper test of determining when an action is derivative or direct in In re Medtronic, Inc....more

Medtronic's Recent Interactions with the FDA

by Knobbe Martens on

It has been a busy couple of months between Medtronic and the Food and Drug Administration (FDA), with Medtronic experiencing both recalls and approvals from the government agency. Below is a brief summary of some recent of...more

FDA Approves Medtronic Melody TPV For Implantation in Failed Pulmonary Heart Valves

by Knobbe Martens on

Medtronic recently announced that its Melody® Transcatheter Pulmonary Valve (TPV) is the first transcatheter pulmonary valve to receive FDA approval for implantation in patients with failed surgical bioprosthetic pulmonary...more

FDA Approval for Medtronic’s Reveal LINQ ICM with TruRhythm Detection

by Knobbe Martens on

On March 13, 2017, Medtronic announced FDA 510(k) clearance for its Reveal LINQ Insertable Cardiac Monitor (ICM) with TruRhythm Detection. Previously, Medtronic received Ministry of Health, Labor and Welfare approval for the...more

PTAB Life Sciences Report -- Part II - March 2017

About the PTAB Life Sciences Report: Each month we will report on developments at the PTAB involving life sciences patents....more

Infringement of Method Claim Still Requires Performance of Every Claimed Step

by McDermott Will & Emery on

Addressing the issue of divided infringement, the US Court of Appeals for the Federal Circuit upheld the district court’s dismissal of patent owner’s claims of infringement because not all steps of the claim were performed,...more

Reconsideration of Institution Decisions Is Also “Final and Nonappealable”

by McDermott Will & Emery on

In an opinion addressing whether a decision by the Patent Trial and Appeal Board (PTAB or Board) to reconsider a decision on institution is “final and nonappealable,” the US Court of Appeals for the Federal Circuit reaffirmed...more

In re NuVasive Brings the Administrative Procedure Act to IPRs

NuVasive owns US 8,187,334, which claims certain spinal implants. Medtronic filed a petition challenging various claims of the ‘334 patent as obviousness over US 2002/0165550 (Frey) in view of US 5,860,973 (Michelson). ...more

Medtronic v. Robert Bosch – Has the Federal Circuit closed the door on reviewing IPR institution decisions?

by Knobbe Martens on

On October 20, 2016, the Federal Circuit issued yet another opinion finding that the Patent Trial and Appeal Board’s decisions related to the institution of an inter partes review (IPR) are not subject to judicial review. ...more

Federal Circuit Patent Updates - October 2016

by WilmerHale on

Medtronic, Inc. v. Robert Bosch Healthcare (No. 2015-1977, -1986, -1987, 10/20/16) (Lourie, Dyk, Hughes) - Dyk, J. Denying petition for rehearing and confirming the Court's earlier order. “The Board's vacatur of its...more

PTAB Vacating Its Initial Institution Decision is Not Appealable, Federal Circuit Says

The Federal Circuit reaffirmed last week that the Patent Trial and Appeal Board’s (PTAB’s) decision to discontinue inter partes review (IPR) proceedings is not reviewable on appeal. In Medtronic, Inc. v. Robert Bosch...more

Federal Circuit Confirms Cuozzo Does Not Disturb § 314(d) Bar on Appellate Review of PTAB Reconsideration of IPR Institutions

by K&L Gates LLP on

The Federal Circuit’s recent decision in Medtronic, Inc. v. Robert Bosch Healthcare Systems, Inc., addressed the effect of the Supreme Court’s decision in Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131 (2016), on the issue...more

Medtronic, Inc. v. Robert Bosch Healthcare Systems, Inc. (Fed. Cir. 2016) - Federal Circuit Denies Petition for Rehearing in...

One of the aspects of inter partes review that differed from other post-grant review proceedings before the Board of Patent Appeals and Interferences (succeeded by the Patent Trial and Appeal Board) is a requirement for...more

Congress Made a Rock So Heavy that the Courts Can’t Pick it Up

In Medtronic, Inc. v. Robert BoschHealthcare Systems, Inc., [2015-1977, 2015-1986, 2015-1987] (October 20, 2016), the Court of Appeals for the Federal Circuit reaffirmed its earlier order that the PTAB’s vacatur of its...more

First FDA Approval of Closed-Loop Insulin Pump

by Knobbe Martens on

Medtronic’s MiniMed 670G system was recently approved by the FDA – this marks the first-ever FDA approval of a hybrid closed-loop insulin delivery system. Medtronic explains that the system uses a computer algorithm in...more

“World’s Smallest Pacemaker” Experiences Sizeable Success

by Knobbe Martens on

Medtronic recently announced continued success with what it describes as “the world’s smallest pacemaker.” The Micra® Transcatheter Pacing System (TPS) is less than one-tenth of the size of traditional pacemakers (examples...more

California Court Clears The Way For Express Preemption

by Reed Smith on

Not everyone sees eye to eye on federal preemption, including judges. Take for example the conflicting opinions from the California Court of Appeal applying the express preemption provision of the Medicare Prescription Drug,...more

Arm’s Length Royalty Rates Save Medtronic from $1.36 Billion Tax Deficiency

by McDermott Will & Emery on

Addressing whether certain intercompany technology license agreements were negotiated at arm’s length, the US Tax Court rejected the Internal Revenue Service’s (IRS’s) alleged $1.36 billion tax deficiency and determined that...more

FDA Approves Medtronic Prestige LP Cervical Disc for 2-Level Use

by Knobbe Martens on

The FDA recently approved the Medtronic Prestige LP Cervical System for treating degenerative disc disease at two adjacent vertebral levels (between C3 and C7). The device is said to be Medtronic’s third clinically-proven...more

Medtronic Acquires HeartWare for $1.1 Billion

by Knobbe Martens on

Medtronic PLC has announced it has agreed to acquire HeartWare International Inc. for $1.1 billion in cash. According to the press release, the acquisition will expand Medtronic’s portfolio of diagnostic tools and treatments...more

Examples of Brexit Disclosures in SEC Filings

As Broc Romanek noted on the TheCorporateCounsel.net, a number of SEC filings discussing Brexit have been made. I have noted some of the disclosures below, focusing on those that have been made since the vote result was...more

Smith & Nephew Sells Its Gynecology Business for $350 Million

by Knobbe Martens on

Smith & Nephew recently announced that it will sell its gynecology business to Medtronic for $350 million. As part of the sale, Medtronic will obtain Smith & Nephew’s key gynecological surgical solution, called the TRUCLEAR...more

Supreme Court Ruling on at Least Five Patent-Related Cases

To date, the Supreme Court has granted certiorari (commonly referred to as cert) to five patent-related cases this term, which will result in three oral arguments likely to be decided before the end of the term. Two of the...more

Federal Circuit Tasked With Analyzing Evidence For Proof That Defendant Had the State of Mind Necessary For Induced Infringement

by BakerHostetler on

On January 19, 2016, the Supreme Court issued a grant-vacate-remand order in a dispute between rival medical device companies Medtronic and NuVasive. The order directs the Federal Circuit to revisit its decision in light of...more

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