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.
DePuy Synthes Acquires Medical Enterprises Distribution LLC’s Orthopedic Assets
DePuy Synthes, a part of the Johnson & Johnson Medical Devices Companies, announced recently that it has signed a definitive agreement to acquire the assets of Medical Enterprises Distribution, LLC, which includes the automated ME1000™ Surgical Impactor tool used in hip replacement surgery. The two companies had previously formed an exclusive agreement to co-market the hip application of the ME1000™. The financial terms of the acquisition are not being disclosed. The transaction is expected to close in the second quarter of 2018.
According to Medical Enterprises, the ME1000™ delivers constant, stable energy that is designed to automate bone preparation, implant assembly and positioning in total hip arthroplasty (THA). DePuy Synthes said that the company plans to develop and broaden the surgical impactor technology for a range of orthopaedic surgery procedures.
“The acquisition of assets of Medical Enterprises Distribution is a key example of going beyond the implant to provide complete solutions to achieve better outcomes.” – Ciro Roemer, Company Group Chairman of DePuy Synthes
The hip replacement global market was $6.5 billion in 2015 and is predicted to reach $9.1 billion by 2025. The global market for all joint replacements is expected to reach $30 billion by 2025. Other companies in the joint replacement markets include Zimmer Biomet, Smith & Nephew, and Stryker.
In the recent press release, DePuy Synthes also announced an exclusive marketing agreement with JointPoint Inc. to co-market a hip navigation system for analysis of implant selection during THA. Earlier this year, DePuy Synthes announced the acquisition of Orthotaxy, a privately-held developer of software-enabled surgery for total and partial knee replacement. In discussing the Orthotaxy acquisition, Ciro Roemer, Company Group Chairman of DePuy Synthes, said “Our goal is to bring to market a robotic-assisted surgery technology that is an integral part of a comprehensive orthopedics platform, delivering value to patients, physicians and healthcare providers across the episode of care.” Other companies in the joint replacement market are likely seeking to create comprehensive orthopedic platforms as well.
Zimmer Biomet Buys LDR Holding for $1 Billion
Warsaw, Indiana-based Zimmer Biomet Holdings Inc. recently announced it will purchase LDR Holding Corp. for approximately $1.0 billion. PR Newswire notes that Zimmer Biomet will commence a tender offer to acquire all outstanding shares of LDR at a price of $37 per share, a 64% premium over LDR’s trading price prior to the announcement (however, as Bloomberg notes, LDR’s shares lost 49% in the last 12 months). The companies expect to complete the transaction in the third quarter of 2016.
According to it’s website, Zimmer Biomet designs, manufactures, and markets orthopedic reconstructive products for musculoskeletal healthcare, including knee, hip, surgical, spine, and dental franchises. LDR describes itself as a global medical device company focused on the development of innovative technology for spinal procedures.
Zimmer Biomet’s 2015 annual report notes that the spine segment is one of the company’s smallest franchises, accounting for only about 7% of total sales. Analysts predict Zimmer Biomet’s acquisition of LDR will increase the company’s share of the global spine market from about 5 to 7%, moving Zimmer Biomet from No. 6 to No. 5 in that sector. Regarding the acquisition, David Dvorak, Zimmer Biomet President and CEO, said:
This highly strategic and complementary transaction will enhance Zimmer Biomet’s innovation leadership in musculoskeletal healthcare by adding a premier spine platform to our portfolio of solutions.
We are confident that the combination of Zimmer Biomet’s Spine division and LDR will create a Spine company with the scale, talent and technology portfolio to become a leader in the $10 billion global Spine market.
The LDR acquisition comes merely one year after Zimmer completed its combination with Biomet in a cash and equity transaction valued at over $14 billion. At least some analysts believe that Zimmer Biomet’s purchase of LDR signals that the recently-combined company has wrapped up the integration and moved on to growing the company via M&A using its sizeable cash reserves.
Zimmer files for Inter Partes Review of Knee Replacement Patent
On October 30, 2013, Zimmer Holdings, Inc. and Zimmer, Inc. filed a petition with the Patent Trial and Appeal Board requesting inter partes review of U.S. Patent No. 7,837,736, assigned to Bonutti Skeletal Innovations, LLC.
The ‘736 Patent is entitled “Minimally Invasive Surgical Systems and Methods.” The ‘736 Patent states that it relates to a method “for performing a total knee arthroplasty.” Figure 90 from the ‘736 Patent, described as “a schematic illustration of a tibial component of a knee implant[,]” is shown below:
The petition seeks to review claims 15-28 and 31-36 of the ‘736 Patent. The petition discloses that Bonutti Skeletal has accused Zimmer of infringing the ‘736 Patent in a lawsuit filed in the U.S. District Court for the District of Delaware. Bonutti Skeletal filed an amended complaint in that lawsuit on January 15, 2013. In addition to the ‘736 Patent, the amended complaint also alleges infringement of U.S. Patents 6,702,821, 7,749,229, 7,806,896, 7,959,635, and 8,133,229.
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