IP Litigation Remains Active in the Orthopedic and Spine Industries
The orthopedic industry traditionally sees significant levels of intellectual property litigation activity, and this year has been no different. One source of this activity comes from Conformis who has continued to assert patents directed towards surgical planning and patient specific instruments and implants. In 2021, Conformis filed three new complaints, settled one case, and continued another litigation. These cases have involved various companies, including DePuy Synthes, Exactech, Bodycad, Wright Medical, and Medacta.
Decisions and settlements have also been reached in several additional lawsuits relating to diverse technologies, such as bone plates, knee implants, and pedicle screws. TriMed, Arthrex, Medacta, and Zimmer are some of the companies that have been parties to these lawsuits. Alternative forums, including the use of Inter Partes Review, have also continued to play significant roles for both patent holders and challengers.
Several attorneys from Knobbe Martens – including Andrew Douglas, Jessica Achtsam, Michael Christensen, Kregg Koch, Christy Lea and Sabing Lee – presented a webinar on August 26, 2021, to discuss notable decisions from recent orthopedic and spine intellectual property litigations. The webinar was prepared in anticipation of the 2021 Annual Meeting of the American Academy of Orthopaedic Surgeons and the 36th Annual Meeting of the National Association of Spine Specialists and included topics such as:
- an analysis of claim types asserted by Conformis against patient specific implant and instrument technologies and how these claims have been enforced against and challenged by many prominent orthopedic companies;
- how statements made by a patent holder can limit the scope of their claims in litigation;
- how small companies can leverage their patents to derive licensing revenue;
- trade secret issues that can arise at industry meetings;
- how prolific doctor inventors have built and enforced large patent portfolios;
- remedies for IP disputes outside the United States; and
- strategies for using patents defensively as part of a countersuit strategy.
The full webinar is available for viewing at this web link.
Isto Holdings Acquires Arteriocyte To Form Isto Biologics
Isto Holdings, the parent company of Isto Technologies, has acquired Massachusetts based Arteriocyte Medical Systems Inc. and the two companies will be combined under the name Isto Biologics under the current CEO of Isto Technologies, George Dunbar.
According to its website, Isto Technologies is a medical device company involved with bone and cartilage repair and regeneration. Public records indicate that there are several pending patent applications listing Isto as the applicant. According to its website, Arteriocyte focuses on improving surgical outcomes and there are several patents and applications listing Isto as the applicant covering a number of technologies, such as centrifuge systems and autologous fibrin sealants, to name a few.
Accordingly, Isto Biologics’s expanded product portfolio will now include Arteriocyte’s MAGELLLAN autologous platelet separator with Isto’s bone-growth and cell therapy products including InQu bone graft extender and substitute, Influx natural bone-grant material, and CellPoint concentrated bone marrow aspirate system.
Thompson Street Capital Partners, which acquired the commercial operations of Isto in June of this year, provided capital for the transaction. According to Anthony Chambers, Director at Thompson:
We’re excited to bring together two great organizations under the Isto umbrella and build upon their leading biologics platforms.
At this time, the terms of the acquisition deal have not been disclosed. While the combined company will be headquartered in St. Louis under CEO George Dunbar, Isto’s base of operations, they will maintain operations in Massachusetts.
Life Spine Announces FDA Clearance of PROLIFT Expandable Interbody System
The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to the PROLIFT Expandable Interbody System of Life Spine. Accordoing to its website, Life Spine is a medical device company based in Huntley, Ill., that designs, develops, manufactures and markets products for the surgical treatment of spinal disorders.
According to press releases, the PROLIFT system is the latest addition to the company’s platform of expandable interbody technologies. According to Life Spine, PROLIFT is an all-titanium system restores disc height, in-situ, for minimally invasive Posterior Lumbar Interbody Fusion (PLIF), Transforaminal Lumbar Interbody Fusion (TLIF) and oblique approaches. Once implanted, the system can expand cephalad to caudal to accommodate disc height ranges from 8mm to 16mm for varying patient anatomy.
According to Life Spine, “When paired with the CENTERLINE™ Midline Thoracolumbar Screw System, PROLIFT creates the optimal hyper-minimally invasive solution.” “The PROLIFT Expandable Interbody System allows for simplified, contracted insertion with minimal anatomical disruption and retraction,” said Rich Mueller, Chief Operating Officer of Life Spine.
Life Spine plans to launch a limited release of the PROLIFT system in the second quarter of 2016, and full product release is expected later in the year.
NuVasive Receives First-Ever 510(k) Clearance for a Cervical Corpectomy Cage
Spinal device specialist NuVasive recently received section 501(k) FDA clearance for its X-Core Mini Cervical Expandable VBR System, a titanium vertebral-body replacement device used in the cervical spine to replace vertebral bodies damaged by tumors, fractures, or osteomyelitis.
According to NuVasive’s FDA filing, the X-Core Mini system can also be used for reconstruction following a corpectomy or to restore the integrity of the spinal column without resorting to spinal fusion in patients that have short life expectancies due to advanced-stage tumors involving the cervical spine. The X-Core Mini system is available in a variety of sizes and shapes to accommodate differences in individual patients’ physical characteristics and pathology.
NuVasive states that the X-Core Mini must be used with supplemental fixation that has previously been cleared by the FDA for use in the cervical spine, which includes NuVasive’s new Archon Reconstruction Corpectomy plate. This plate is designed to increase rigidity and to resist screw pullout.
In a company news release NuVasive’s President and Chief Operating Officer, Pat Miles, stated:
The assembly of best-in-class cervical products into a cohesive procedural offering further reinforces NuVasive’s commitment to providing single-source, integrated procedural solutions to our customers. Combining X-Core Mini VBR and Archon Reconstruction plate provides another excellent example of defining the components necessary to properly address an unmet market need as NuVasive remains focused on becoming number one in spine.
According to Fierce Medical Devices, NuVasive became the third-largest competitor in the spinal device market last year. NuVasive maintains an active patent portfolio to help protect its market share: the USPTO Assignment Database lists NuVasive as the Assignee of 325 patents and patent applications dating from 1999 to the present.
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