The 3-year patent infringement suit against Medtronic Inc. has likely come to its end resulting in a $23.5 million damage award against the medical technology development company. The suit, filed by Mark A. Barry, MD, in early 2014 alleged that the CD Horizon Legacy spine surgery system infringed the claims of U.S. Patent Nos. 7,670,358, 7,776,072 and 8,361,121. The patents are related and directed to systems and methods for ameliorating spinal column abnormalities, particularly scoliosis.
The specifications of the three patents show a pedicle screw cluster derotation (ie, manipulation) tool coupled to the pedicles of the vertebrae via pedicle screws. The patents disclose that the derotation tool is designed to “simultaneously and safely derotate multiple vertebrae of an affected spinal segment (as well as likewise apply balancing forces to other group(s) of vertebrae which are lateral to the affected segment(s)).”
Paul S. Mazzola
Figure 1 of the patents shows the pedicle screw cluster derotation tool, labeled generally as reference numeral 30. Handles 34 of pedicle screw wrenches 32 are coupled together by a linking member 42 such that the coupled wrenches move in unison during use. A cross-linking member 40 may be provided to couple the linking members 42 disposed on opposite sides of the spine.
The ‘072 patent claims the surgical system including the pedicle screw cluster derotation tool itself, whereas the ‘358 and ‘121 patents claim methods of using the tool. The jury’s finding of induced infringement was limited to the claimed methods of the ‘358 and ‘121 patents. The methods involved rotating pre-contoured spinal rods initially loosely engaged with the pedicle screws to a desired orientation “to achieve a substantial correction of the scoliosis in the first two of three axes.” Thereafter, manual manipulative forces are applied to the pedicle screw cluster derotation tool(s) to move the pedicle screw clusters to correct the scoliosis along the third axis.
The claims of a patent define the scope of the invention, and a patent claim includes a series of so-called “limitations.” In the context of a method claim, for example, the limitations are typically a series of steps that must be performed by a device or by an individual to infringe the patent. Although in many cases it is the surgeons performing the steps that result in the infringement of the patent, it is common for the patent owner to seek damages from the medical device company that supplies the surgeons with the device(s) that induce infringement of the method claims.
It is important to note that proving induced infringement (and contributory infringement) of a patent requires an underlying showing of literal infringement of the same. Literal infringement requires the allegedly infringing device or process to include each and every limitation recited in the claim(s) of the patent. As applied to the Medtronic case, the jury found the CD Horizon Legacy spine surgery system induces doctors to perform all of the steps recited in at least one of the method claims of the ‘358 and ‘121 patents.
The jury award included $17.7 million for actively inducing patent infringement. The presiding judge also awarded a 20% enhancement for the jury’s finding that the infringement was willful given the evidence of copying by the company. Further, the judge awarded prejudgment interest of $2.4 million. However, because the patent owner failed to mark two of the three surgery systems as patented, the judge denied pre-suit damages on those devices. –
Mark BARRY, M.D., v. MEDTRONIC, INC., 1:14-cv-104 (E.D. Texas, Beaumont Division)
U.S. Patent No. 7,670,358 (issued Mar. 3, 2010); U.S. Patent No. 7,776,072 (issued Aug. 17, 2010); U.S. Patent No. 8,361,121 (issued Jan. 29, 2013).
Paul S. Mazzola, JD, an intellectual property associate with Howard & Howard Attorneys PLLC, can be reached at email@example.com.
Disclosure: Mazzola reports no relevant financial disclosures. This article is for informational purposes, and is not intended to constitute legal advice.
Editor’s note: When contacted by Healio/Orthopedics, Medtronic supplied the following comment in response to the ruling: “Medtronic disputes the allegations in this case, and while not entirely unexpected, we were disappointed with the ruling. We believe the facts in this case support our position and look forward to vigorously defending this case in the appellate court.”