Blog Tag: Litigation
Federal Circuit Upholds Lower Court Decision in Par Pharmaceutical, Inc. v. Eagle Pharmaceuticals, Inc.
By Rory Lootsma
(August 18, 2022) The Federal Circuit has affirmed that Eagle Pharmaceuticals, Inc. did not infringe Par Pharmaceutical, Inc. patents, easing Eagle’s path to market a generic competitor to Par’s Vasostrict®
product. Par had alleged that Eagle’s abbreviated new drug application (ANDA) infringed U.S. Patent Nos. 9,744,209 and 9,750,785, both titled “Vasopressin formulations for use in treatment of hypotension.” An example molecular structure is shown here:
Some of Par’s arguments had alleged that because the pH of Eagle’s products would be so close to Par’s claimed ranges for pH, inevitable drift in pH would occur over time, causing infringement. In affirming, Chief Judge Moore explained that the District Court had not committed clear error in finding otherwise. The infringement inquiry “begins and ends” with Eagle’s ANDA specification, so predicting future drift cannot show infringement.
Thus, the Federal Circuit upheld the District Court’s decision against Par Pharmaceutical and affirmed the finding of no infringement. The Federal Circuit’s decision is available here.
A medical device patentee has asked the U.S. Supreme Court to save his design patent, related to an introducer sheath handle, from invalidity based on application of the “on-sale” bar, which prohibits patenting an invention if it has been for sale for over one year prior to the patent filing.
On July 6, 2022, in Junker v. Medical Components Inc., inventor Larry Junker filed a petition for certiorari asking the Supreme Court to review the Federal Circuit’s finding of invalidity of his design patent under the on-sale bar. Mr. Junker alleged that Medical Components, Inc. and Martech Medical Products, Inc. (collectively “MedComp”) infringed U.S. Design Patent No. D450,839 (the “D’839 patent”), entitled “Handle for Introducer Sheath.” An introducer sheath is a device used to place catheters. The D’839 patent covered the design of the introducer sheath’s handle with rounded “Mickey-Mouse-shaped ears” that made the device easier to grasp when inserting the catheter and when peeling apart and removing the sheath. Figure 1 from the D’389 patent is reproduced below:
Mr. Junker and MedComp filed cross-motions for summary judgment debating whether the D’839 patent was invalid under the “on-sale bar” of 35 U.S.C. § 102(b) (pre-AIA). Under 35 U.S.C. § 102(b) (pre-AIA), a patent claim is invalid if “the invention was . . . on sale in this country, more than one year prior to the date of the application for patent in the United States.” The parties disputed whether a 1999 letter regarding a price quotation, sent more than one year before the D’839 patent was filed, constituted a commercial offer for sale. The letter was sent by a third party manufacturer to Boston Scientific.
The district court concluded that the letter was not a commercial offer for sale and accordingly granted Mr. Junker’s motion for summary judgment of no invalidity. After a bench trial, the court awarded Mr. Junker $1.25 million in damages. On appeal, the U.S. Court of Appeals for the Federal Circuit disagreed, finding that the letter contained sufficient terms to constitute a commercial offer for sale rather than a mere quotation.
In his petition for certiorari, Mr. Junker urges the Supreme Court to review the Federal Circuit’s ruling, arguing that the Federal Circuit misapplied contract law because the 1999 letter was sent by a third party who had no right to sell the invention, and the letter expressly stated it was a quotation rather than a price list.
Mr. Junker’s petition for certiorari is available here.
On April 11, 2022, Niazi Licensing Corporation (“Niazi”) succeeded in part in its appeal at the Federal Circuit in Niazi Licensing Corporation v. St. Jude Medical S.C. Inc. Niazi’s lawsuit alleged that St. Jude Medical S.C. Inc.’s (“St. Jude”) CPS telescoping catheter system infringed U.S. Patent No. 6,638,268, entitled “Catheter to Cannulate the Coronary Sinus” (the “‘268 patent”).
The district court determined that the terms “resilient” and “pliable” in the claims rendered all but one claim of the ‘268 patent indefinite and, therefore, invalid. However, the Federal Circuit reversed the district court’s holding and instead found that, although the terms may be broad, they are not uncertain. The Federal Circuit held that intrinsic record and extrinsic evidence are sufficient to inform a skilled artisan of the meanings of the terms with reasonable certainty. The court sent the case back to the district court to resolve any outstanding questions of whether St. Jude infringed the claims and whether St. Jude’s remaining invalidity defenses are applicable.
The Federal Circuit’s complete decision is available here.
Becton Dickinson’s PureWick Wins Patent Infringement Suit Against Stryker’s Sage Products Related To Female External Catheters
PureWick Corp., a Becton Dickinson company, succeeded in its infringement lawsuit PureWick Corp. v. Sage Products LLC. PureWick’s lawsuit alleged that Sage Products infringed U.S. Patent Nos. 10,226,376; 10,390,989; 10,376,407, which relate to a female external catheter that purports to reduce catheter-associated infections and other issues with traditional medical equipment.
The Delaware jury determined that Sage Products, a Stryker company, infringed all of PureWick’s claims with its competing product, and rejected Sage’s non-infringement and invalidity counterclaims. The jury awarded PureWick $26.2 million in lost profits resulting from the infringement, and $1.8 million as a royalty for Sage Products’ sale of the infringing product. The jury also determined that Sage Products willfully infringed two of the three patents.
(Mar. 31, 2022) Last Friday, ImmunoGen won an appeal at the Federal Circuit in ImmunoGen, Inc. v. Hirshfeld. The lawsuit is a civil action to order the granting of U.S. Application No. 14/509,809 (‘809), titled “Anti-FOLR Immunoconjugate Dosing Regimens”:
A federal judge in Virginia ruled it unpatentable, but the Federal Circuit overturned that decision.
The ‘809 application relates to dosing for the cancer drug mirvetuximab, an immunoconjugate. Generally, immunoconjugates include (1) an antibody portion typically targeting a cell of interest, and (2) a drug coupled to the antibody through a chemical linker. The antibody portion of mirvetuximab targets a folate receptor often overexpressed in ovarian and peritoneal cancer cells.
Early clinical trials for mirvetuximab were mixed. The drug was effective, but caused ocular toxicity if dosage exceeded a certain threshold. The ‘809 application claimed dosing below this threshold: “a dose of 6 milligrams (mg) per kilogram (kg) of adjusted ideal body weight (AIBW) of the patient.” AIBW accounts for a patient’s sex, total body weight, and height.
The district court had ruled on summary judgment that the ‘809 application was indefinite and obvious. However, the Federal Circuit held this violated proper procedure by resolving factual disputes against ImmunoGen, the non-moving party.
In one such dispute, the district court had found the ‘809 application indefinite partly because “for example” preceded the AIBW formula in the specification. It held this example did not fall within the claims and declined to hear expert testimony regarding whether a skilled artisan would use the formula. But the Federal Circuit pointed to a particular claimed dosing regimen for a specific immunoconjugate, reasoning this could lead one of skill in the art to choose a specific corresponding AIBW formula. This undermined the district court’s finding of indefiniteness.
In another factual dispute, the district court had held the claims obvious because based on prior art, a skilled artisan would have known to use AIBW dosing to address mirvetuximab’s side effects. The district court found ocular toxicity was a known side effect of immunoconjugates, even though there was no directly supportive expert testimony. The Federal Circuit pointed to contrary evidence in the record: that side effects were not well understood and that it is difficult to generalize the pharmacological effects of immunoconjugates.
Accordingly, the Federal Circuit overturned the indefiniteness and obviousness findings and sent the case back to the district court. Now ImmunoGen has another opportunity to pursue grant of the ‘809 application.
Rasmussen Instruments, LLC (“Rasmussen”) won a $20M jury verdict against DePuy Synthes (“Depuy”), a part of Johnson & Johnson Medical Devices Companies. Rasmussen asserted Patent Nos. US 9,492,180 (‘180 patent) and US 10,517,583 (‘583 patent), both titled “Arthroplasty systems and methods for optimally aligning and tensioning a knee prosthesis,” against DePuy’s “Balanced Sizer” product for its Attune® Knee System.
According to the complaint filed in 2020, Dr. G. Lynn Rasmussen is an orthopedic surgeon based in Murray, Utah, with over 40 years of experience in reconstructive orthopedic surgery and is the sole member and owner of Rasmussen. Both the ‘180 patent and ‘583 patent claim priority to a provisional application filed in 2005 by Dr. Rasmussen. The complaint alleges that the ‘180 patent and ‘583 patent “describe and claim . . . a device for maintaining the tension in the ligaments of a knee joint and/or adjusting the alignment of a knee joint during knee replacement surgery.”
According to the complaint, from 2012 to 2014, Dr. Rasmussen discussed licensing the patented technology with DePuy, but after the negotiations broke down, Rasmussen initiated litigation against DePuy. After a trial in March of 2022, the jury decided that DePuy’s “Balanced Sizer” product infringed the ‘180 patent but did not infringe the ‘583 patent. The jury also decided that DePuy’s infringement of the ‘183 patent was willful and that Rasmussen’s damages were therefore $20 million. The jury also held that the ‘180 patent and the ‘583 patent were not invalid.
The case is No. 1:20-CV-11807-WGY in the U.S. District Court for the District of Massachusetts, Eastern Division.
Find additional information and resources for the medical device community at Knobbe Medical.
Federal Circuit Reverses PTAB’s Invalidation of Patent Claims for an Artificial Heart Valve (Snyders vs St. Jude)
On October 5, 2021, the U.S. Federal Circuit reversed a finding of invalidity by the Patent Trial and Appeal Board (PTAB) for patent claims related to an “artificial valve for repairing a damaged heart valve.” St. Jude Medical LLC (“St. Jude”) filed for an inter partes review (IPR) at the PTAB for U.S. Patent No. 6,821,297, entitled “Artificial Heart Valve, Implantation Instrument and Method Therefor,” owned by Snyders Heart Valve LLC (“Snyders”).
In invalidating the claims, the PTAB interpreted the patent claim limitation of a “frame sized and shaped for insertion between the upstream region and the downstream region.” The PTAB found that the limitation also covers a frame that fits in place after removal of a damaged heart valve. The cited prior art allegedly also disclosed a valve insert sized to fit the valve after the damaged native valve was removed. Therefore, the PTAB found that the prior art anticipated the claims.
The Federal Circuit held that the PTAB erred in determining that the “sized and shaped” limitation “does not require the frame be sized and shaped for insertion into a damaged heart valve,” but “only that the frame is sized and shaped for insertion in a position between the upstream region and the downstream region.” The Federal Circuit reasoned that the PTAB’s construction was incorrect because “it covers frames sized and shaped for installation with the native valve removed, rather than only with the native valve in place.” The Federal Circuit cited language in the patent specification allegedly stressing that the disclosed artificial heart valve can be inserted without removing the native valve, an alleged express improvement on the prior art.
The Federal Circuit’s decision is available here.
The Washington State Supreme Court recently released its decision in Taylor v. Intuitive Surgical, Inc. where it held that Washington law requires medical device manufacturers to warn hospitals that purchase their products of dangers associated with those products. According to Bloomberg BNA, Washington is the first state to impose such a requirement. As a result, the decision may have a significant effect on medical device manufacturers and their practices. SciPol reports that industry groups, such as the Medical Device Manufacturers Association and the National Association of Manufacturers, believe that the decision may increase the risk for device manufacturers to introduce new products and may lead to reduced innovation in the medical device space.
The case involved Intuitive Surgical‘s da Vinci robotic surgical system, which Intuitive explains enables surgeons to perform delicate and complex operations through a few small incisions. da Vinci is powered by robotic technology that allows the surgeon’s hand movements to be scaled, filtered and translated into precise movements of the EndoWrist instruments working inside the patient’s body.
The Plaintiff in the case, Mr. Taylor, claimed to have suffered complications during and as a result of surgery in which the da Vinci surgical system was used. As a result of those complications, Mr. Taylor sued his surgeon and his medical practice and Intuitive Surgical on various theories including “product defect, breach of warranty, breach of contract, violation of Washington’s Consumer Protection Act . . . , negligence, and product liability.” Mr. Taylor claimed that Intuitive Surgical had a duty to warn the hospital about the dangers that are associated with the da Vinci System. However, during trial, the court refused to instruct the jury that Intuitive Surgical had any such duty to warn the hospital. Mr. Taylor appealed the jury’s verdict for Intuitive Surgical.
On appeal, the Washington Supreme Court did not decide the merits of many of Mr. Taylor’s claims. Instead, it held that, pursuant to the Washington Product Liability Act (“WPLA”), manufacturers have a duty to warn hospitals about the dangers of their products and that, as such, the lower court erred when it did not instruct the jury on that duty. According to the Court, warnings must be provided to the purchaser of a product, which in Mr. Taylor’s case was the hospital. The Court vacated and remanded the case for further consideration consistent with its holdings.
The ruling has been met with mixed reactions. According to Mr. Taylor’s attorney, the decision “brings the law in line with the reality of modern medicine.” But, as Bloomberg notes, both the Medical Device Manufacturers Association and the National Association of Manufacturers cautioned that adopting a new warning requirement could chill medical innovation and harm patients overall. It remains to be seen whether other states will adopt similar rules.
On February 14, 2017, U.S. District Judge Michael Mosman of the United States District Court, District of Oregon granted a Joint Stipulated Motion for Dismissal with Prejudice submitted by Plaintiffs Smith & Nephew, Inc. and John O. Hayhurst, M.D. (inventor) and Defendant Arthrex, Inc. subject to the terms of a Settlement and License Agreement. Information about the settlement terms is not publicly available.
This agreement ends a 12-year long dispute between Smith & Nephew and Arthrex over Smith & Nephew’s U.S. Patent No. 5,601,557, which is directed to a method and apparatus for anchoring cartilage within a joint.
In 2004, Smith & Nephew sued Arthrex and alleged that certain products of Arthrex’s SutureTak® and PushLock® suture anchor families infringed the ‘557 patent (case number 3-04-cv-00029). According to the United States Court of Appeals for the Federal Circuit’s opinion of March 18, 2015, the parties had gone through three jury trials and two previous appeals. The third jury trial in 2011 produced a verdict of willful infringement and damages awards. Arthrex moved for Judgment as a Matter of Law (JMOL) of noninfringement, which was granted by the district court without an opinion. The Federal Circuit reversed and remanded the JMOL and reinstated the verdict in its S&N II opinion in 2013.
We previously reported the district court’s entering of judgment in favor of Smith & Nephew on remand, awarding a total of $88 million in damages and granting a permanent injunction against Arthrex. The judgment was affirmed by the Federal Circuit in its March 18, 2015 opinion. In June 2015, Smith & Nephew reported receiving a $99 million patent infringement payment from Arthrex.
In 2008, Smith & Nephew also sued Arthrex and alleged that different products from the same SutureTak® and PushLock® families infringed the ‘557 patent (case number 3:08-cv-00714). Judge Mosman granted in-part Smith & Nephew’s motion for summary judgment of infringement and denied Arthrex’s motions for summary judgment as of non-infringement. He also granted Smith & Nephew’s motion for summary judgment as to reasonable royalty damages.
According to the court’s public record, a jury trial was set for February 13, 2017 for the remaining issues in the lawsuit filed in 2008. On February 10, 2017, Judge Mosman vacated the jury trial, followed by the parties’ Joint Stipulated Motion for Dismissal with Prejudice.
Smith & Nephew and Arthrex filed a similar Joint Stipulated Motion for Dismissal with Prejudice in the 3-04-cv-00029 case, and in another lawsuit in the Eastern District of Texas relating to Arthrex’s patents (case number 2:15-CV-1047). The motion was granted by the Eastern District of Texas court, but denied as moot in the 3-04-cv-00029 case, which was closed when the September 2013 judgment was entered.
A federal jury found in favor of CardiAQ in a lawsuit filed against former service provider, Neovasc. The jury found that Neovasc breached the non-disclosure agreement between the parties, misappropriated CardiAQ’s trade secrets, and breached its duty of honest performance to CardiAQ. The jury awarded $70 million in damages for trade secret misappropriation.
CardiAQ co-founder J. Brent Ratz said in a press release that the company worked for years to develop and create the CardiAQ transcatheter mitral valve, which provides an alternative to open heart surgery. Ratz stated that:
We are proud of this foundational work and grateful that the jury recognized these contributions to the developing field of transcatheter mitral valve replacement.
According to the press release, CardiAQ hired Neovasc in 2009 to provide services for its transcatheter mitral valve replacement (TMVR) program and Neovasc signed a non-disclosure agreement. While working for CardiAQ, Neovasc started its own TMVR program without notifying CardiAQ. After discovering a Neovasc patent publication in late 2011, CardiAQ initiated this litigation in 2014 regarding Neovasc’s transcatheter mitral valve technology, including the Tiara.
According to the press release, the jury also issued advisory findings that Neovasc engaged in unfair or deceptive practices and that CardiAQ’s founders, Ratz and Dr. Arshad Quadri, contributed to the conception of Neovasc’s U.S. Patent No. 8,579,964. The judge is expected to rule later on causes of action under Massachusetts Gen. Law Ch. 93A and patent inventorship.
Fitbit, Inc., a manufacturer of wearable health technology, is involved in a national class action lawsuit filed on January 5, 2016 in the Northern District of California over two of its wristbands, the Charge HR and the Surge, based on their “PurePulse” LED-based technology used for tracking heart rates. Generally, the lawsuit alleges that the heart-rate monitor used in those wristbands, advertised under the now amusing tag line “every beat counts,” does not monitor heart beats correctly. This allegedly especially occurs during times of intensive exercise.
In a statement to ArsTechnica responding to the lawsuit, a Fitbit spokesperson wrote, “We do not believe this case has merit. Fitbit stands behind our heart rate technology… [b]ut it’s also important to note that Fitbit trackers are designed to provide meaningful data to our users to help them reach their health and fitness goals, and are not intended to be scientific or medical devices.” Further, Fitbit released another statement after the lawsuit saying that “PurePulse provides better overall heart rate tracking than cardio machines at the gym.”
Acumed LLC recently sued Skeletal Dynamics LLC in the United States District Court for the District of Oregon. Acumed’s complaint alleges that Skeletal Dynamics’s REDUCT Headless Compression Screw infringes one of Acumed’s patents. The patent at issue, U.S. Patent No. 6,030,162 (the ‘162 Patent), titled “Axial Tension Screw,” issued on February 29, 2000. The ‘162 Patent contains 78 claims, 6 of which are independent. In its complaint, Acumed did not identify which claims it asserts Skeletal Dynamics infringes; rather, it merely alleges that “Skeletal Dynamics has infringed and is infringing the ‘162 patent by making, using, selling, offering to sell, and/or importing the Skeletal Dynamics REDUCT Headless Compression Screws.”
The ‘162 Patent’s abstract states that the patent relates to: “A screw having a root and threads formed on the root. The screw is configured to generate and/or maintain axial compression between threads formed in leading and trailing sections of the screw either by virtue of pitch differential in the threads or the way in which the screw is installed.” Figure 1 of the ‘162 Patent is shown to the right.
A screenshot from Skeletal Dynamics’s REDUCT YouTube video is shown to the left. The video was published on September 3, 2015, shortly after Acumed filed suit, and states in its description that the REDUCT Headless Compression Screw is “[t]he first headless compression screw that allows for controlled compression using a proprietary “clutch” that is incorporated into the screw design.”
According to its website, Acumed is headquartered in Hillsboro, Oregon and develops orthopedic implants and surgical devices. Miami, Florida-based Skeletal Dynamics describes itself as being focused on designing innovative solutions that have not been addressed by other manufacturers.
Four Mile Bay, LLC recently sued Zimmer Holdings, Inc. in the United States District Court for the Northern District of Indiana. The complaint alleges that Zimmer Holdings’ hip implants, such as the “Trabecular Metal Primary Hip Prosthesis,” infringe U.S. Patent Nos. 8,506,642 and 8,821,582, which issued in 2013 and 2014, respectively. Both patents are entitled “Hip Implant with Porous Body.”
Last year, Indiana Intellectual Property Law News reported on another suit filed by Four Mile Bay against Zimmer in the Northern District of Indiana. In its complaint, Four Mile Bay alleged that Zimmer infringed U.S. Patent No. 8,684,734, entitled “Dental Implant with Porous Body.” The case is still pending.
Four Mile Bay seeks a judgment of infringement, reasonable royalties, and both pre-judgment and post-judgment interest in both cases.
USPTO Assignment Database records show that all of the ‘642, ‘582, and ‘734 patents were assigned by the inventor (and IP attorney), Philip Lyren, to William Lyren on November 1, 2013. William Lyren then assigned the patents to Four Mile Bay, LLC on February 1, 2014. According to the USPTO search page, Philip Lyren is a listed inventor on a number of patents and applications having broadly varying subject matter, including:
- Home appliance that can operate in a time range (Pat. No. 8,954,199)
- User Agent with Personality (Pat. Pub. No. 2014/0359439)
- Displaying Targeted Advertisements to Users (Pat. Pub. No. 2014/0330649)
- Determine a Product from Private Information of a User (Pat. Pub. No. 2014/0316853)
- Cover for Handheld Portable Electronic Device (Pat. Pub. No. 2014/0313551)
- Peer-to-Peer Data Storage (Pat. Pub. No. 2014/0297742)
- Methods and apparatus for generating recommendations for gifts (Pat. No. 8,577,741)
- Marketing and selling feature length movies over networks (Pat. No. 8,521,601)
- Portable electronic device for receiving and playing feature length movies (Pat. No. 8,424,048)
According to its website, Zimmer designs and manufactures a variety of joint replacement products. Zimmer states that the “Trabecular Metal Primary Hip Prosthesis” uses a material with a “highly porous, strut configuration nature” and “open pore-configuration” to enable biological growth. According to the complaint, Four Mile Bay is a Nevada limited liability company having its principal place of business in Wadsworth, Ohio. Nevada Business Entity records indicate that William J. Lyren is the sole officer of the company.
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.
(January 20, 2015) KFx Medical Corp.’s $35 million patent infringement award against Arthrex, Inc. was upheld by the Federal Circuit. KFx’s lawsuit alleged that Arthrex’s SutureBridge and SpeedBridge devices infringed U.S. Patent No.7,585,311, 8,109,969, and 8,100,942, each entitled “System and method for attaching soft tissue to bone.” Figure 1 from the ‘311 patent is reproduced below:
The Federal Circuit upheld the Southern District of California court’s dismissal of Arthrex’s motion for a new trial after a jury found that Arthrex had infringed the KFx patents, and awarded KFx $29 million in damages. The district court judge later awarded additional damages and pre-judgment interest. The Federal Circuit’s decision is available here, and a press release from KFx is available here.
Federal Circuit Vacates $176 Million Damages Award to Covidien relating to Ethicon Harmonic Ultrasonic Cutters
The United States Court of Appeals for the Federal Circuit vacated a $176 million district court damages award to Covidien, formerly known as Tyco Healthcare Group LP, in a patent infringement suit against Ethicon Endo-Surgery, Inc., a subsidiary of Johnson & Johnson. Covidien’s lawsuit alleged that Ethicon’s Harmonic ultrasound cutting devices infringed U.S. Patent Nos. 6,682,544; 6,063,050; and 6,468,286. According to the Federal Circuit, “the asserted patents generally disclose a surgical device… that employs ultrasonic energy to cut and coagulate tissue in surgery.” Figure 12 from U.S. Patent No. 6,063,050 is illustrated below:
The Federal Circuit held that the claims Covidien asserted against Ethicon were invalid as obvious. The opinion stated that “the district court improperly held that the Ethicon Prototype could not be considered prior art under 35 U.S.C. § 103, and erred in finding that the… claims would not have been obvious.”
Bonutti Skeletal Innovations, LLC brought a patent infringement suit against Globus Medical, Inc. in the Eastern District of Pennsylvania on November 19, 2014. The lawsuit alleges that several of Globus Medical’s spinal spacer products and related instruments infringe Bonutti Skeletal patents.
The asserted Bonutti Skeletal patents include U.S. Patent No. 6,099,531, entitled “Changing Relationships Between Bones,” which issued on August 8, 2000. The patent discusses the use of a wedge member in a joint to alter the relative positioning of a patient’s bones.
Specifically, Bonutti Skeletal alleges that Globus Medical’s CALIBER, CALIBER-L, COALITION, COLONIAL, CONTINENTAL, FORGE, FORTIFY, FORTIFY I PEEK, FORTIFY I-R, INDEPENDENCE, INTERCONTINENTAL, MONUMENT, NIKO, RISE, SIGNATURE, SUSTAIN ARCH, SUSTAIN LARGE, SUSTAIN MEDIUM, SUSTAIN-O, SUSTAIN SMALL, and TRANSCONTINENTAL spinal spacer products each infringe various Bonutti Skeletal patents.
According to the Complaint, Bonutti Skeletal has been built on the work of Dr. Peter M. Bonutti, an orthopedic surgeon that has performed over 20,000 orthopedic surgical procedures and been the inventor or co-inventor on over 150 U.S. patents.
Globus Medical’s website states that “Globus Medical, Inc. is a leading musculoskeletal implant manufacturer and is driving significant technological advancements across a complete suite of spinal products.”
The complaint and asserted patents are available here.
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.
On January 6, 2014, I.C. Medical, Inc. filed a lawsuit against ConMed Corporation in the United States District Court for the District of Arizona. The complaint alleges that ConMed’s GoldVac® electrosurgical pencils infringe U.S. Patent Nos. 7,935,109 (“the ‘109 Patent”) and 8,414,576 (“the ‘576 Patent).
The ‘109 Patent is entitled “Multifunctional Telescopic Monopolar/Bipolar Surgical Device and Method Thereof” and was issued on May 3, 2011. The Abstract states that “a multifunctional telescopic monopolar/bipolar electrosurgery pencil is disclosed for use with an electrosurgery unit (ESU). . . . The monopolar/bipolar electrosurgery pencil is capable of functioning as both a monopolar and bipolar device and can be used for open and closed laparoscopic and endoscopic procedures.” Figure 3c of the ‘109 Patent is reproduced below:
The ‘576 Patent is entitled “Swivel Device for Electrosurgery Pencil and Surgical Smoke Evacuation” and was issued on April 9, 2013. The Abstract explains that “a swivel device for connection to an ESU pencil, an exhaust port of an ESU pencil with an integrated smoke evacuation system, or an exhaust port of an ESU pencil smoke evacuation shroud attachment includes a fixed member attached to a rotating member. The rotating member allows an electrical cord and/or vacuum tube to twist and coil freely during operation of an ESU pencil with or without the smoke evacuation system.” Figure 3 of the ‘576 Patent is reproduced below:
I.C. Medical’s’s website states that I.C. Medical is a privately owned company based in Phoenix, Arizona that focuses on surgical smoke collection. According to ConMed’s website, ConMed offers products in areas such as patient monitoring, endomechanical instrumentation, advanced energy, gastroenterology and pulmonology, advanced visualization, and orthopaedics.
Federal Circuit Affirms Rejection of Claims Directed to a System for Detection of Blood Within a Body Lumen
On July 19, the Federal Circuit affirmed a decision of the Board of Patent Appeals and Interferences that the claims of U.S. Patent Application No. 10/097,096 were obvious over a combination of prior art references. The ‘096 application states that it relates to “a method and system for detection of colorimetric abnormalities in vivo, and specifically within the gastrointestinal (GI) tract.” Figure 3 of the ‘096 application is shown below:
The Federal Circuit held that the Board’s affirmance of the Examiner’s rejection of all claims as obvious was “supported by substantial evidence.” The Federal Circuit found that the claims at issue were a “predictable variation of the combination of [the prior art references].” The Federal Circuit also rejected the Applicant’s argument that the Board relied on new grounds in reaching its decision, stating: “[w]hile the Board’s explanation may go into more detail than the examiner’s, that does not amount to a new ground of rejection.”