Showing all posts written by Bryan Wahl
HeartWare International announced in a press release earlier this week that they acquired CircuLite, Inc. for $30 million, as well as possible additional payments up to $320 million subject to regulatory and commercial milestones.
According to its website, CircuLite has developed the CE Mark-approved SYNERGY miniature ventricular support system, a minimally invasive implant for the treatment of refractory chronic congestive heart failure. CircuLite describes the system as comprised of a micro-pump, inflow cannula and outflow graft, a percutaneous lead connected to a wearable external controller, and a lightweight, rechargeable dual battery back system implantable via a mini-thoracotomy incision.
Publicly-traded HeartWare has, according to its website, received FDA PMA approval for its HEARTWARE Ventricular Assist System for use as a bridge to cardiac transplantation in patients at risk of death from refractory congestive heart failure.
The press release notes that “IDEV Technologies’ products include SUPERA Veritas®, a self-expanding nitinol stent system with CE Mark in Europe for treating blockages in blood vessels due to peripheral artery disease (PAD). . . . In the U.S., SUPERA Veritas is cleared only for the treatment of biliary strictures (narrowing of a bile duct) related to cancer. It is currently being reviewed under a Premarket Approval Application (PMA) by the U.S. Food and Drug Administration (FDA) for treatment of the superficial femoral artery (SFA), which is the main artery in the thigh that supplies blood to lower extremities, and is not currently approved in the U.S. for that use.” According to IDEV’s website, they also are marketing the SUREPATH™ guidewire “combining the flexibility of nitinol with the strength of stainless steel.”
Abbott’s press release also states that the transaction is expected to close by the end of the year and “will not impact Abbott’s ongoing full-year 2013 earnings-per-share guidance. The transaction is subject to customary closing conditions, including antitrust clearances.”
Lombard Medical has filed a petition earlier this month with the Patent Trial and Appeal Board for inter partes review of Medtronic’s U.S. Pat. No. 6,306,141 to Jervis. Lombard Medical’s products include the AORFIX™ endovascular stent graft.
The ‘141 patent is entitled “Medical Devices incorporating stress-induced martensite (SIM) alloy elements” and lists a priority claim back to October 14, 1983. The ‘141 patent’s abstract states that “[m]edical devices which are currently proposed to use elements made from shape memory may be improved by the use of stress-induced martensite alloy elements instead. The use of stress-induced martensite decreases the temperature sensitivity of the devices, thereby making them easier to install and/or remove.”
Lombard’s petition seeks review of Claims 1-10 and 18-22 of the ‘141 patent, alleging that those claims are invalid for either anticipation, obvious, and/or obviousness-type double-patenting. The associated exhibits can be found by visiting the Board’s website, entering the patent number 6306141, and clicking on the Search button.
Of note, the ‘141 patent, among others, was previously asserted by Medtronic against W.L. Gore & Associates, Inc. in 2006; Gore’s EXCLUDER® AAA, TAG, and VIABAHN SFA® endoprosthesis devices were at issue. The parties entered into a confidential settlement in 2009.
Medtronic also previously asserted the ‘141 patent, among others, against AGA Medical in 2007. AGA’s AMPLATZER® Septal Occluder, Duct Occluder, and Vascular Plug devices were at issue. The parties entered into a settlement in 2010 in which AGA received a non-exclusive license to patents including the ‘141 patent in exchange for $35 million. AGA Medical was subsequently purchased by St. Jude Medical in October 2010 for $1 billion.
Atrium Medical filed four petitions with the Patent Trial and Appeals Board for inter partes review of C.R. Bard’s U.S. Patent No. 7,785,334. The ‘334 patent, entitled “Implantable Prosthesis” issued on August 31, 2010. According to the ‘334 patent, the patent relates to an “implantable prosthesis for repairing an anatomical defect, such as a tissue or muscle wall hernia” and “includes a patch and/or plug having a body portion that is larger than a portion of the opening or weakness so that placement of the body portion against the defect will cover or extend across that portion of the opening or weakness.” Figure 1 from the ‘334 patent is shown below:
Two of the four petitions are currently publicly available, seeking review of Claims 24-49 and Claims 99-126. The exhibit titles can be seen by visiting the Board’s website, searching for the ‘334 patent, and clicking on the Case Number link.
According to Atrium’s website, Atrium’s ProLite™ and ProLite Ultra™ brand polypropylene surgical mesh products are commonly used for soft tissue and hernia repair and employ Atrium’s C-QUR™ Mesh technology, which utilizes a proprietary, pharmaceutical grade Omega 3 Bioabsorbable Oil Fatty Acid (O3FA) coated surgical mesh.
Boston Scientific has prevailed in the appeal of its lawsuit against Cordis Corporation. Boston Scientific alleged in the lawsuit that Cordis’ 2.25 mm Cypher Sirolimus DES coronary stent infringed U.S. Pat. No. 5,922,021, entitled “Intravascular Stent”. Figure 1A from the ‘021 Patent is shown below:
In a per curiam decision, the Federal Circuit affirmed, without further comment, the District Court’s March 2012 decision, which awarded Boston Scientific enhanced damages based on a finding of willful infringement of the ‘021 patent. The total award to Boston Scientific was approximately $42 million. A 32% royalty rate was assessed on sales of Cypher stents not included in the judgment.
The ‘021 patent was previously subject to ex parte re-examination, and a re-examination certificate issued on April 17, 2012. According to a Cordis press release, Cordis discontinued manufacturing Cypher and Cypher Select Plus Sirolimus-Eluting Coronary Stents at the end of 2011.
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.
AngioDynamics is going ahead with the purchase of microwave ablation technology from Microsulis Medical, Poststar reports. According to the story, AngioDynamics plans to incorporate the microwave ablation technology into its own technology “in an all-in-one device that offers a full spectrum of ablation technologies on the same cart, called the ‘total ablation solution.’” The story summarizes the terms of the deal:
AngioDynamics will pay $10 million cash initially, to be followed by a $5 million cash payment at the end of 2013, according to a statement issued Wednesday. The Latham-based firm will also assume up to $1 million of liabilities on Microsulis’ books.
According to the story, AngioDynamics President and CEO Joseph DeVivo said that he expects the Microsulis technology to improve a thermal ablation business that generated $23 million in 2012.