WannaCry Malware and Medical Device Security
The WannaCry virus has infected and frozen computers in many industries around the world. According to a news source report, the virus has extorted doctors and hospital administrators for the keys to unlock and regain access to their systems in order to treat patients. The Telegraph reports that in the United Kingdom alone, up to 40 hospital trusts were hit by the WannaCry ransomware virus, which resulted in a wave of cancelled appointments and a general state of disarray. Recently, the BBC has stated that at least 16 of these hospitals are still facing issues. With the widespread damage associated with the WannaCry virus, many experts have advocated that the medical device industry should be on alert, now more than ever, regarding the cyber security of their medical devices.
Although the issues associated with medical device security have recently been discussed, some industry professionals believe there does not seem to be an adequate solution to the problem of device security. Tressa Springman, the CIO of LifeBridge Health, explains:
“There’s a lot of talk in healthcare about device security. Discussions about what we’re comfortable pushing as endpoint security and what we’re unable to do – because certainly, we don’t want to create any harm to patients. Many of these devices and the vendors who manage them, it’s very hard to go direct on patching and adding security.”
While medical devices are generally tested extensively for safety, some cybersecurity experts have observed the same cannot necessarily be said for security. Brian NeSmith, co-founder and CEO of cyber security company Arctic Wolf Networks, has stated:
“Medical devices, similar to many other IoT devices, were not designed with rigorous security in mind and are more vulnerable to being hacked. They also do not fall under normal security operations procedures since they are used as needed by the medical practitioners and not deployed and maintained by the IT department.”
Security experts are emphasizing the importance of security patches. Optimistically, Richard Staynings, the principal cybersecurity healthcare leader at Cisco’s Security unit, believes:
“This is going to cause a paradigm shift, at least for patching.”
Wright Medical To Sell Tornier Business to Corin for $33 Million
According to press releases, Wright Medical Group N.V. plans to sell its Tornier hip and knee business to Corin Orthopaedics Holdings Ltd. for about $33 million in cash. This deal comes shortly after Wright and Tornier merged in October 2015. Wright has sold assets in the hip and knee space in the past. In June 2013, Wright sold its OrthoRecon business to Hong Kong based MicroPort for $290 million.
In a statement, Robert Palmisano, president and chief executive officer of Wright, stated:
Our large joints business has excellent products and significant market share in key European markets with a loyal customer base. However, this business is not in line with our strategy to be the premier extremities and biologics company.
Stefano Alfonsi, chief executive officer of Corin, commented, “We are delighted with the acquisition of Tornier’s clinically proven portfolio of hips and knees.” The acquired portfolio is said to include hip and knee implants sold primarily in France and other European countries. The franchise brands include the Dynacup® and Meije Duo® hip implants and the HLS KneeTec® and HLS Noetos® knee implants.
Corin is a European Orthopaedic manufacturer based in Cirencester, England.
Wright Medical Group N.V. is a global medical device company that provides surgical solutions including for the upper extremities (shoulder, elbow, wrist, and hand), lower extremities (foot and ankle), and biologics markets.
Spineology Sues Wright Medical Technology
Spineology, Inc. sued Wright Medical Technology, Inc. (Wright Medical) in the United States District Court for the District of Minnesota . Spineology’s complaint alleges that Wright Medical’s X-REAM percutaneous expandable reamer infringes one or more claims of U.S. Patent No. RE42,757 (the ‘757 patent), which is entitled “Expandable Reamer” and was reissued on September 27, 2011. The suit includes claims for direct, induced, contributory, and willful infringement.
In support of its claim of willful infringement, Spineology alleges that it sold fifty of its own expandable reamers to Wright Medical in 2006, but did not convey any license to the ‘757 patent along with that sale. The complaint states that Spineology sent a cease-and-desist letter in 2014, which attached the ‘757 patent, requesting that Wright Medical stop selling its X-REAM product because the product was covered by the ‘757 patent. After Wright Medical continued selling its product, Spineology filed the current suit.
According to its website, Minnesota-based Spineology is focused on developing methods and products that not only treat spinal ailments, but also reduce the invasiveness of spine surgery for patients, aid the surgeon in overcoming the hurdles of minimally invasive surgery, and minimize the burden of healthcare expense.
According to its website, Tennessee-based Wright Medical is a specialty orthopaedic company that provides extremity and biologic solutions that enable clinicians to alleviate pain and restore their patients’ lifestyles.
Wright Medical Technology Files for Inter Partes Review of Orthophoenix Patents
On June 6, 2014, Wright Medical Technology, Inc. (“WMT”) filed first and second petitions with the Patent Trial and Appeal Board requesting inter partes review of both U.S. Patent No. 6,440,138 (“the ‘138 Patent”) to Reiley et al., and U.S. Patent No. 6,863,672 (“the ‘672 Patent”) to Reiley et al. According to the ‘672 Patent’s New Application Transmittal at page 9, the ‘672 Patent is a divisional of the ‘138 Patent.
According to the U.S. Patent and Trademark Office assignment database, the ‘138 and ‘672 Patents were previously assigned to Kyphon Inc., which was acquired by Medtronic in 2007 for $3.9 billion. The database also includes a recorded assignment, executed on April 25, 2013, from Medtronic, Inc., Kyphon SARL, and Warsaw Orthopedic, Inc. to Orthophoenix, LLC. Orthophoenix’s signatory was Erich Spangenberg (listed as the CEO). Spangenberg is also the owner and founder of IPNav, according to IPNav’s website. IPNav describes itself as a patent monetization firm.
The ‘138 Patent is entitled “Structures and Methods for Creating Cavities in Interior Body Regions.” According to the ‘138 Patent, it relates to tools that carry structures that are deployed inside bone and, when manipulated, cut cancellous bone to form a cavity. Figure 1 of the ‘138 Patent, described as a side view of a rotatable tool having a loop structure capable of forming a cavity in tissue, with the loop structure deployed beyond the associated catheter tube, is shown below left:
The ‘672 Patent is also entitled “Structures and Methods for Creating Cavities in Interior Body Regions.” According to the ‘672 Patent, it relates to tools that carry structures that are deployed inside bone and, when manipulated, cut cancellous bone to form a cavity. Figure 27 of the ‘672 Patent, described as a side view of a vertebra with the tool deployed to cut cancellous bone by moving the blade structure in a linear path to form a cavity, is shown below right:
The petition regarding the ‘138 Patent relies on a single prior art reference: U.S. Patent No. 5,015,255 to Kuslich, which the petition alleges was not before the Examiner during prosecution of the ‘138 patent. The petition seeks review of Claims 1-26 (all claims) of the ‘672 Patent and requests cancellation of each Claim. By contrast, the petition regarding the ‘672 Patent relies on two separate prior art references: U.S. Patent No. 5,439,464 to Shapiro and U.S. Patent No. 6,371,968 to Kogasaka et al. The petition alleges that neither prior art reference was before the Examiner during prosecution of the ‘672 Patent. The petition seeks review of Claims 1-12 (all claims) of the ‘138 Patent and requests cancellation of each Claim.
The petitions disclose that Orthophoenix has sued WMT in the U.S. District Court for the District of Delaware. Orthophoenix, LLC v. Wright Medical Tech., Inc., Civil Action No. 13-10007-LPS (D. Del.). Orthophoenix filed its complaint on June 5, 2013 alleging direct and indirect patent infringement of both the ‘138 and ‘672 Patents (the “Patents in Suit”) by WMT.
AngleFix Tech, LLC Sues Wright Medical Technology, Inc.
On June 10, 2013, AngleFix Tech, LLC sued Wright Medical Technology, Inc. in the Western District of Tennessee. AngleFix’s complaint alleges that Wright Medical’s plate and screw systems for bone fixation infringe U.S. Patent No. 6,955,677 entitled “Multi-Angular Fastening Apparatus and Method for Surgical Bone Screw/Plate Systems.” The accused systems include the Claw, Claw II, Charlotte Claw, Ortholoc, Ortholoc 3Di, and Ortholoc 3Di2.
The complaint states that the ‘677 Patent was the result of the inventor’s “desire to capture bone fragments during orthopedic surgery that would otherwise evade locking screws set at a single fixed angle.” The Abstract of the ‘677 Patent describes an apparatus including a fastener and a fastener receiving member that “enables the fastener to be affixed to the fastener receiving member at a variable insertion angle selected by the user.” Figure 3 from the ‘677 Patent is shown below:
AngleFix is based in North Carolina and holds an exclusive license to the ‘677 Patent from the University of North Carolina. AngleFix sued NuVasive, Inc. on the same patent in the Southern District of California earlier this year.
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