Blog Tag: Medtronic
Medtronic PLC recently announced its acquisition of Advanced Uro-Solutions, a Tennessee-based privately-held developer of neurostimulation products for treatment of bladder control issues. According to the Star Tribune, the terms of the acquisition, which closed in December 2014, were not disclosed.
Medtronic describes itself as a leader in the field of neuromodulation, the targeted and regulated delivery of electrical impulses and pharmaceuticals to specific sites in the nervous system. Medtronic states that its current portfolio includes implantable neurostimulation and targeted drug delivery systems for management of chronic pain, common movement disorders, spasticity, and urologic and gastrointestinal disorders.
Advanced Uro-Solutions manufactures a percutaneous tibial nerve stimulation system called the NURO™. The NURO is promoted for use in therapy that involves a small external stimulator and a single, reusable lead. It is described as providing temporary stimulation to the tibial nerve and treatment to patients with overactive bladder (OAB) and other urinary irregularities. According to the FDA’s 510(k) Premarket Notification Database, the NURO device was cleared by the FDA for the treatment of OAB as being substantially equivalent to a predicate device, the Urgent PC Stimulator (manufactured by Uroplasty, Inc.).
The USPTO Assignment database includes records for three patents and patent applications that have been assigned to Advanced Uro-Solutions LLC, including: U.S. Pat. Pub. No. 2014/0288613, U.S. Pat. No. 8,818,520, and U.S. Pat. No. 8,660,646. Each of these is entitled “Percutaneous Tibial Nerve Stimulator.” FIG. 2 of the ‘646 patent is shown to the left.
Medtronic states that it plans to implement the NURO system in the U.S. within the next 12 months, adding to its portfolio of urinary and bowel control therapies. Medtronic’s acquisition of Advanced Uro-Solutions follows shortly after its recent $49 Billion acquisition of Covidien.
The Patent Trial and Appeals Board (the “Board”) recently issued Final Written Decisions disposing of two inter partes reviews that NuVasive filed in mid-2013 regarding U.S. patent number 8,444,696 (the ’696 Patent). The ’696 Patent is entitled “Anatomic spinal implant having anatomic bearing surfaces” and, according to its abstract, “is directed to an interbody spinal implant having a structural configuration that provides for maintaining the normal anatomic relationship of two adjacent vertebrae of the spine.” According to the USPTO Assignment Database, the patent application that later became the ’696 patent was assigned on May 17, 2005 by its inventor to SDGI Holdings, Inc., then was assigned on April 28, 2006 by SDGI Holdings, Inc. to Warsaw Orthopedic, Inc.
In its recent Final Written Decision disposing of IPR2013-00395, the Board determined that NuVasive showed by a preponderance of the evidence that claims 1–6 of the ’696 Patent are unpatentable under 35 U.S.C. § 103(a) as obvious over the combination of three references, Michelson, Wagner, and Brantigan. In its recent Final Written Decision disposing of IPR2013-00396, the Board determined that NuVasive showed by a preponderance of the evidence that claims 7-12 of the ’696 Patent are unpatentable under 35 U.S.C. § 103(a) as obvious over a different combination of three references, including Steffee, Michelson, and Kim.
On August 17, 2012, Warsaw Orthopedic, Medtronic Sofamor Danek, Medtronic Puerto Rico, and Osteotech filed a complaint against NuVasive alleging infringement of U.S. patents numbers 8,021,430 and 5,676,146. In its two petitions for inter partes review, NuVasive stated that Warsaw Orthopedic asked the Court for permission to add the ’696 patent to the lawsuit. On July 24, 2013 Warsaw’s request was granted.
According to MedicalXpress, expansive data from a company’s medical device clinical trials will soon be made broadly available to medical device researchers for the first time. The Yale University Open Data Access (“YODA”) Project will make data from certain Johnson & Johnson (“J&J”) businesses available to outside researchers. YODA will act as an independent gatekeeper to access the data.
Previously, only pharmaceutical data from J&J was available through the YODA program. Under the extended program that now includes data related to medical devices and diagnostics, clinical trial results from the Medical Devices and Diagnostics divisions of J&J will be made available. As with the J&J pharmaceutical data requests, YODA will review the requests for device/diagnostic patient data, which has been sanitized of patient identifying information. However, the agreement only covers products approved since early 2014 and thus excludes many products currently on the market. One device for which data will be available is J&J’s Thermocool Smarttouch catheter, a device used to treat atrial fibrillation that received approval in 2014 .
“advocates for the responsible sharing of clinical research data” and “is committed to open science and data transparency, and supports research attempting to produce concrete benefits to patients, the medical community, and society as a whole.”
Medical device giant Medtronic, Inc. has also partnered with YODA, albeit currently only with regard to Medtronic’s recombinant human bone morphogenetic protein-2 (rhBMP-2) data. Medtronic has previously shared medical device clinical trial data with the YODA Project for a single product, a bone formation product called “Infuse.” Given J&J’s expansion of its available data, other industry leaders, such as Medtronic, may well follow suit and make available additional data.
Med Device Online reports that Medtronic has been cleared by the Federal Trade Commission (“FTC”) and EU’s European Commission to merge with Covidien. Also according to Med Device Online, the companies had to agree that Covidien would sell Stellarex, its drug-coated balloon stent business division, to Spectranetics for $30M USD in order to obtain FTC and European Commission approval for the merger.
The FTC originally issued an administrative complaint against the merger. The FTC noted in its complaint that C.R. Bard, Inc. is currently the only supplier of drug-coated balloon catheters indicated for the femoropopliteal artery. In addition, Medtronic and Covidien are the only two companies seeking FDA approval for drug-coated balloon catheters indicated for the femoropopliteal artery (both companies are now in clinical trials). Therefore, in its complaint the FTC held that without the sale of Stellarex, Medtronic’s acquisition of Covidien would likely create an unfair and anti-competitive advantage for the companies in that market space. On Nov. 26, 2014, following the companies’ agreement to sell Stellarex, the FTC cleared the merger on unanimous approval.
The European Commission noted that Stellarex, which recently obtained promising results from its first clinical trials, competes directly with Medtronic’s leading drug-coated balloon device, the “In.Pact.” Therefore, despite (or perhaps due to) there being few active competitors in that market, the European Commission found it likely that Covidien would have competitively constrained Medtronic and that the acquisition would remove a credible future competitor from an already-dense market, thereby reducing innovation in the field of drug-coated balloon catheters. Following the FTC’s lead, the European Commission gave its approval of the merger on Nov. 28, 2014.
According to Medtronic, the deal is scheduled to close in early 2015.
According to its website, Medtronic is headquartered in Minneapolis, Minnesota, and operates in more than 140 countries. Medtronic is the world’s 3rd largest medical device company, developing and manufacturing devices and therapies to treat more than 30 chronic diseases, including: heart failure, Parkinson’s disease, urinary incontinence, Down’s syndrome, obesity, chronic pain, spinal disorders, and diabetes.
According to its website, Covidien is headquartered in Dublin, Ireland, and also operates globally. The company, which was spun off from Tyco International in 2007, develops and manufactures medical devices and supplies, for varied applications, including: vascular therapy, airway and inhalation therapy, oximetry and medical monitoring, soft tissue repair, and general surgery.
On April 25, 2014, Medtronic, Inc. and Medtronic Vascular, Inc. (“Medtronic”) filed a second petition (the ’695 Petition) with the Patent Trial and Appeal Board requesting inter partes review of U.S. Patent No. 5,593,417 (“the ’417 Patent”). Medtronic concurrently filed a motion requesting joinder of the ’695 Petition and Medtronic’s previously filed first petition requesting inter partes review of the ’417 Patent (the ’100 Petition).
The ’417 Patent is entitled “Intravascular Stent With Secure Mounting Means,” and lists a single inventor, Valentine J. Rhodes. The ’417 Patent states that it relates to “expandable grafts and methods of use for opening restrictions therein, e.g., revascularizing stenotic arteries.” Figures 1-3 from the ’417 Patent are shown below:
The ’695 Petition seeks review of claims 1, 2, 9, 10, and 13 of the ’417 Patent, the same claims challenged by the ’100 Petition. The ’695 Petition discloses that one or more claims of the ’417 Patent have been asserted against Medtronic by Endotach LLC (“Endotach”) in a lawsuit filed in the U.S. District Court for the Northern District of California. Endotach’s first amended complaint, filed on October 22, 2013, alleges that Acacia Patent Acquisition LLC assigned its rights in the ‘417 Patent to Endotach. The complaint further alleges that “at least the Endurant AAA Stent Graft and Endurant II AAA Stent Graft. . .” infringe “at least claims 1, 2, and 13 of the ’417 Patent. . . .” On April 24, 2014, the lawsuit was stayed by order of the court pending final resolution of the inter partes review proceedings.
According to the ’695 Petition, Endotach is also asserting the ’417 Patent against Cook Medical Inc. in Endotach LLC v. Cook Medical Inc., No. 1:13-cv-1135 (S.D. Ind.) and W.L. Gore & Associates, Inc. in Endotach LLC v. W.L. Gore & Associates, Inc., No. 3:12-cv-00308 (N.D. Fla.).
On April 11, 2014, according to a press release, the U.S. District Court for the District of Delaware issued a preliminary injunction barring Medtronic, Inc. from selling its CoreValve TAVI product to most new customers in the U.S. This ruling is the latest installment in a patent dispute between Medtronic and Edwards Lifesciences Corp. involving transcatheter heart valve technology. According to Bloomberg, this developing market is expected to reach $3 billion a year. In 2011, Edwards received FDA approval for its Sapien transcatheter aortic valve, which was the first approved transcatheter aortic valve in the U.S. until the CoreValve system was approved in January 2014.
In 2010, a jury found that the CoreValve device infringed Edwards’ U.S. Pat. No. 5,411,552 to Andersen et al. (the “Andersen patent”) and awarded Edwards $73 million in damages. The verdict was upheld on on appeal, and last October the U.S. Supreme Court declined to review that decision. In December 2011, Edwards filed an application for patent term extension on the Andersen patent. Edwards’ petition noted that the patent was due to expire on May 2, 2012, and requested an extension of 1,757 days based on the FDA regulatory review period of the Sapien valve, such that the new requested extended expiration date would be February 22, 2017. The USPTO has not yet made a final determination of the length of the patent term extension, but has granted multiple interim patent term extensions, the latest of which extends the Andersen patent’s term until May 2, 2015.
A NASDAQ article states that although the court believed that “CoreValve ‘is a safer device’ and produces ‘better outcomes with a lower risk of death,’” patients’ needs must be balanced against the public interest in enforcing patent rights. The article states, however, that Medtronic will still be allowed to sell the CoreValve for patients who are not candidates for Edwards devices. The injunction is scheduled to go into effect seven business days from the April 11th ruling. Medtronic has already filed a Notice of Appeal.
(March 6, 2014) Medtronic, Inc. announced in a press release that the European Patent Office (EPO) has invalidated European Patent Number EP2055266B1 (“the ’266 Patent”) assigned to Edwards Lifesciences PVT, Inc. The ’266 Patent, entitled “Implantable Prosthetic Valve,” states that the invention “relates to a valve prosthesis for cardiac implantation or for implantation in other body ducts.” Figure 1 of the ’266 patent is illustrated below:
According to the press release, the ’266 Patent was the basis for an August 26, 2013 injunction prohibiting sales of Medtronic’s CoreValve® System in Germany. The EPO stated that the oral proceedings resulted in “[t]he European patent [being] revoked because at least one ground for opposition prejudices the maintenance of the European patent.” The EPO file is available here.
The ’469 Patent is entitled “Audio Instructions for Appliances,” and the sole listed inventor is Stephen J. Brown. The ’469 Patent states that it relates to “communication systems for remote monitoring of individuals, and in particular to a networked system for remotely monitoring individuals and for communicating information to the individuals through the use of script programs.” Figure 5 from the ’469 Patent is shown below:
The petition seeks review of all 22 of the ’469 Patent’s claims. The petition discloses that the ’469 Patent has been asserted by Robert Bosch Healthcare Systems, Inc. (“Bosch Healthcare”) against Cardiocom, LLC (“Cardiocom”), a wholly-owned subsidiary of Medtronic, in a lawsuit filed in the U.S. District Court for the Eastern District of Texas. The complaint, filed on April 26, 2013, states the ’469 Patent is assigned to Bosch Healthcare. The complaint alleges that the “Cardiocom Telehealth system, which includes, but is not limited to, the Commander Flex Device, the Commander Device, the Telescale Device, the LinkView Device, the Attentiv Device, the NetResponse product, the TeleResponse product, and the Omnivisor Management System” infringes the ’469 Patent and five other patents.
The petition further states that there is a second patent infringement lawsuit “involving related patents,” and also that several of the related patents are also being challenged in USPTO proceedings. The complaint for this second case, filed by Bosch Healthcare against Cardiocom on July 24, 2012 in the Northern District of California, is available here.
United States Supreme Court Reverses Federal Circuit Decision in Medtronic, Inc. v. Mirowski Family Ventures, LLC
(January 22, 2014) A unanimous Supreme Court reversed the Federal Circuit and held that, when a licensee seeks a declaratory judgment against a patentee to establish that there is no infringement, the burden of proving infringement remains with the patentee.
According to the opinion, Mirowski Family Ventures, LLC (“Mirowski”) owns patents (U.S. Reissue Patents Nos. RE38,119 and RE39,897) relating to implantable heart stimulators. Figure 1 of U.S. Reissue Patent No. RE38,119 is illustrated below:
By way of background, Mirowski entered into a licensing agreement that permitted Medtronic, Inc. (“Medtronic”) to practice certain Mirowski patents in exchange for royalty payments. Mirowski notified Medtronic of its belief that several of Medtronic’s new products infringed the licensed patents, and thus royalty payments relating to those product were owed. Medtronic then brought a declaratory judgment action asserting that their products did not noninfringe the Mirowski patents. The district court concluded that Mirowski, as the party asserting infringement, had the burden of proving infringement and that Mirowski had not met that burden. The Federal Circuit disagreed. It acknowledged that a patentee normally bears the burden of proof, but concluded that where the patentee is a declaratory judgment defendant and, like Mirowski, is foreclosed from asserting an infringement counterclaim by the continued existence of a licensing agreement, the party seeking the declaratory judgment, namely Medtronic, bears the burden of persuasion.
The Supreme Court reversed the decision of the Federal Circuit and held that, “when a licensee seeks a declaratory judgment against a patentee to establish that there is no infringement, the burden of proving infringement remains with the patentee.” The case was remanded for further proceedings.
According to a Medtronic press release, Medtronic is acquiring TYRX, Inc. for an initial payment of $160 million plus potential future milestones. According to TYRX’s website, TYRX is the developer and manufacturer of “innovative, implantable, combination drug+device products that utilize novel biomaterials.”
According to TYRX’s website, the company has developed the recently FDA-cleared AIGISRx® R Fully Resorbable Antibacterial Envelope, designed to reduce surgical site infections associated with cardiac implantable electronic devices, such as AICDs. Additionally, TYRX’s website also describes their AIGISRx® N Antibacterial Envelope, for use with spinal cord neurostimulators.
“While the risk of infection from an implanted pacemaker or defibrillator is low for most patients, repeated operative procedures after the initial device implant are associated with a substantial incremental risk of infection. This is estimated to cost the U.S. healthcare system more than $1 billion per year . . . . TYRX has developed an innovative, proven technology to reduce infection risk, making the procedure safer for patients and removing significant costs from the healthcare system.”
The press release also quotes TYRX President and CEO Robert White: “We look forward to joining Medtronic as part of a combined portfolio that can positively impact outcomes for patients by reducing implant-related infections, and bring value to our customers.”
Since its passage as part of the Affordable Care Act in 2010, the medical device tax has been hotly debated. The 2.3% excise levied on total revenues may effectively preclude new entrants while hindering the growth of established companies. While industries have turned to outsourcing for a number of years as a way to cut costs, the medical device industry may increasingly consider outsourcing in the coming years as a means to offset the effects of this tax. While outsourcing may help U.S. medical device companies, it may adversely affect Americans currently working in this sector.
San Diego-based NuVasive, Inc. filed two petitions last Friday with the Patent Trial and Appeal Board for inter partes review of Medtronic subsidiary Warsaw Orthopedic, Inc.’s U.S. Pat. No. 8,251,997. The sole listed inventor of the ‘997 patent is Dr. Gary Michelson.
The ‘997 patent is entitled “Method for Inserting an Artificial Implant Between Two Adjacent Vertebrae Along a Coronal Plane” and “relates generally to instrumentation and methods of performing surgical procedures on the human thoracic and lumbar spine along the lateral aspect of the spine and from a true lateral or anterolateral approach, and specifically to the surgical correction of thoracic and lumbar disc disease and spinal deformities where concomitant fusion is desired.” Figure 13 from the ‘997 patent is shown below:
NuVasive’s first and second petitions collectively seek review of all 30 of the claims of the ‘997 patent, asserting the claims are obvious over a number of references. The associated exhibits can be found by visiting the Board’s website, entering the patent number 8251997, and clicking on the Search button.
Medtronic and NuVasive have a history of spinal patent infringement litigation. In 2008, Medtronic filed a patent lawsuit against NuVasive relating to spinal implants, and NuVasive filed patent infringement counterclaims. The first phase of this litigation went to trial in 2011, where Medtronic won $101 million in damages and NuVasive won $660,000, and is still ongoing.
Of note, the ‘997 patent, among others, was asserted by Warsaw against NuVasive in another pending patent infringement lawsuit originally filed in the Northern District of Indiana. The case has since been transferred to the Southern District of California. Warsaw’s alleged infringement contentions against NuVasive with respect to the ‘997 patent can be found here.
A new patent infringement suit has been filed against Medtronic and CoreValve targeting percutaneous aortic valve implantation technology. The lawsuit was brought by a cardiologist, Troy Norred, and alleges infringement of Norred’s United States Patent No. 6,482,228 (“the ’228 patent”) entitled, “Percutaneous Aortic Valve Replacement.” The ’228 Patent relates to a balloon catheter with an inverted umbrella shaped valve with frame members or ribs that move between a folded position and an unfolded position.
The lawsuit alleges that the ’228 patent is infringed by Medtronic’s CoreValve ReValving System. In November of last year, Edwards Lifesciences succeeded in the appeal of its patent infringement lawsuit targeting Medtronic’s CoreValve ReValving System.
The complaint and the asserted patent in Norred v. Medtronic are available here.
C.R. Bard, Inc., and Bard Peripheral Vascular, Inc., are the latest targets of a series of lawsuits brought by LifeScreen Sciences LLC. LifeScreen filed a patent infringement lawsuit in the District of Delaware on January 30 accusing C.R. Bard and Bard Peripheral of patent infringement. LifeScreen Sciences and LifePort Sciences have recently filed patent infringement suits against Cook, Inc., Cordis Corporation, Medtronic Corp., W.L. Gore & Associates Inc. and Endologix, Inc.
LifeScreen’s latest lawsuit alleges that C.R. Bard’s Meridian vena cava filter infringes several patents, including U.S. Patent No. 6,468,290, entitled “Two-Planar Vena Cava Filter With Self-Centering Capabilities,” which issued in 2002. The patent relates to a two-plane filter with filter wires with extensions that are applied against the wall of a vein and compel the filter “to adopt a position with its axis generally coincident with the axis of the vein…” The ‘290 patent was originally assigned to SciMed Life Systems, Inc.
LifeScreen’s other lawsuits have targeted similar technologies. For example, on January 23, 2013, LifeScreen filed lawsuits in Delaware and Texas alleging infringement of U.S. Patent No. 6,214,025, entitled “Self-Centering, Self-Expanding and Retrievable Vena Cava Filter,” a patent originally assigned to Boston Scientific.
The complaint and asserted patents in LifeScreen Sciences v. C.R. Bard are available here.