Blog Tag: Litigation

Medical Device Manufacturers’ Duty to Warn Expands

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.

Smith & Nephew, Arthrex Settled Suture Anchor Patent Dispute Before Trial

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.

CardiAQ Wins $70 Million in Trade Secrets Suit

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.

Edwards Lifesciences Corporation, based in Irvine, Calif., acquired CardiAQ in 2015.

CardiAQ was represented in the litigation by Knobbe Martens LLP, including lead partners John B. Sganga, Jr.  and Christy G. Lea.

Class Action Lawsuit Filed Against Fitbit

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.”

Fitbit is also involved in another class action lawsuit filed in May 2015 regarding its sleep tracking data, and is also involved in several suits against rival wearable-device maker Jawbone.

Acumed Sues Skeletal Dynamics For Patent Infringement

Acumed Sues Skeletal Dynamics For Patent Infringement

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 Sues Zimmer Holdings

Four Mile Bay Sues Zimmer Holdings

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)
The suits against Zimmer are not the first time Mr. Philip Lyren’s patents have been litigated.  In 2014, Arstechnica published “Meet the ‘inventor’ of the week: Patent troll owns pre-release digital movies,” which prominently featured Mr. Lyren.

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 Sues Wright Medical Technology

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.

Federal Circuit Upholds $35 million Infringement Award to KFx Medical

Federal Circuit Upholds $35 million Infringement Award to KFx Medical

(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

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 Sues Globus Medical

Bonutti Skeletal Innovations Sues Globus Medical

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.

 

Wright Medical Technology Files for Inter Partes Review of Orthophoenix Patents

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. 

I.C. Medical, Inc. Sues ConMed Corporation

I.C. Medical, Inc. Sues ConMed Corporation

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

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.”

Federal Circuit Reverses BPAI Reexamination Decision; Finds Synthes Patent Invalid

Federal Circuit Reverses BPAI Reexamination Decision; Finds Synthes Patent Invalid

On July 9, 2013, the Federal Circuit reversed the Board of Patent Appeals and Interferences’ decision that certain claims of U.S. Patent No. 7,128,744 were not invalid due to obviousness. The ‘744 Patent, owned by Synthes, Inc., is entitled “Bone Plating System” and issued on October 31, 2006. Figure 7 of the ‘744 Patent is shown below:

Smith & Nephew PLC filed a request for inter partes reexamination of the ‘744 Patent in 2009. Smith & Nephew’s request for reexamination alleged that all 55 claims of the ‘744 Patent were obvious. The patent examiner agreed and rejected all 55 claims as obvious.

Synthes appealed the examiner’s decision to the BPAI. The BPAI upheld the rejection of claims 24-31 and 33-55, but reversed the rejections of claims 1-23 and 32. Smith & Nephew then appealed the BPAI’s decision that claims 1-23 and 32 were not invalid due to obviousness.

The Federal Circuit reversed, finding that claims 1-23 and 32 were obvious. The Federal Circuit explained:

While the ‘substantial evidence’ standard of review for the board’s factual findings makes Smith & Nephew’s burden on appeal a heavy one, we are satisfied, after careful review, that Smith & Nephew has met that burden and has shown that the claims at issue would have been obvious.

Knobbe Martens attorneys Joe ReChristy Lea, and Jared Gardner represented Smith & Nephew in the successful appeal.

Synthes and Smith & Nephew have been in litigation over Synthes’ bone plate technology since 2003, when Synthes filed a complaint against Smith & Nephew in the U.S. District Court for the Eastern District of Pennsylvania for infringement of U.S. Patent No. 5,053,036.

Smith & Nephew filed a request for reexamination of the ‘036 Patent in 2003, and that request was granted. During reexamination, Synthes amended four of the ‘036 Patent claims and added new claims. In 2007, the PTO issued a reexamination certificate, indicating that two of the original ‘036 Patent claims, the four amended claims, and the newly-added claims were patentable.

Synthes filed an amended complaint against Smith & Nephew in 2006, alleging infringement of the ‘744 Patent, the ‘036 Patent, and U.S. Patent No. 6,623,486.

In addition to Smith & Nephew’s request for reexamination of the ‘744 patent, Smith & Nephew also filed requests for inter partes and ex parte reexamination of the ‘486 Patent in 2009. Both of Smith & Nephew’s requests for reexamination of the ‘486 Patent were granted, and the two ‘486 Patent reexamination proceedings were consolidated on July 10,  2009.

The U.S. District Court for the Eastern District of Pennsylvania case was stayed on July 13, 2009, pending reexaminations of the ‘744 Patent and the ‘486 Patent. The ‘486 Patent reexamination is still pending.

 

Smiths Medical ASD, Inc. Sues Rocket Medical plc on Embryo Replacement Catheter Technology

Smiths Medical ASD, Inc. Sues Rocket Medical plc on Embryo Replacement Catheter Technology

On July 3, 2013, Smiths Medical ASD, Inc. sued Rocket Medical plc in the United States District Court for the District of Massachusetts.  Smiths Medical’s complaint alleges that Rocket Medical’s embryo replacement catheters infringe U.S. Patent No. 8,092,390 entitled “Medico-Surgical Devices.”

The Abstract of the ‘390 Patent describes a catheter in which “[g]as bubbles of a diameter in the range of 5µ to 10µ are incorporated into the thickness of the wall of the shaft by adding gas during extrusion.  The bubbles are selected to increase the visibility of the catheter under ultrasound imaging whilst still enabling material flowing along the catheter to be seen.”  Figure 2 from the ‘390 Patent is shown below:

Smiths Medical is a division of Smiths Group plc, which is headquartered in London.  According to their website, Smiths Medical supplies a variety of medical devices for hospital and home use.  Rocket Medical is also headquartered in the UK, and according to their website manufactures a range of single use medical devices.  The complaint and patent at issue are available here.

AngleFix Tech, LLC Sues Wright Medical Technology, Inc.

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.

Cardiocom files for Inter Partes Review of University of Rochester’s Patient Monitoring and Treatment Patent

Cardiocom files for Inter Partes Review of University of Rochester’s Patient Monitoring and Treatment Patent

Cardiocom, LLC, filed a petition last Friday with the Patent Trial and Appeal Board requesting inter partes review of claims 1-9 of University of Rochester’s U.S. Patent No. 6,612,985.

The ‘985 patent is entitled “Methods and System for Monitoring and Treating a Patient.”  The patent specification states that the patent relates to “a method and system for monitoring and treating a patient who has one or more diagnosed conditions and is located at a remote location from a treatment processing system.”

The ‘985 patent is the subject of a lawsuit filed in the U.S. District Court for the Eastern District of Texas by University of Rochester and purported licensee My Health, Inc. against Cardiocom.  The complaint refers to Cardiocom’s use of allegedly infringing “sales of products incorporating the University’s technology[,]” including “a unique technology that assists healthcare providers in monitoring and treating patients.”

AGA Medical Wins Septal Closure Appeal at the Federal Circuit

On Monday, June 3, 2013, the Federal Circuit affirmed the judgments of non-infringement and invalidity in a lawsuit filed by the University of Minnesota against AGA Medical. The opinion was authored by Judge Dyk.

The University of Minnesota alleged that AGA infringed two patents, U.S. Pat. Nos. 6,077,291 and 6,077,281, directed to  “devices and methods for occluding septal defects or shunts in the heart or the vascular system.” Following claim construction, the District Court of Minnesota granted summary judgment that the ‘291 patent was not infringed, and the ‘281 patent was anticipated. On appeal to the Federal Circuit, the University of Minnesota argued that the district court had incorrectly construed the claims of the ‘291 patent, and incorrectly found the ‘281 patent invalid.

The Federal Circuit affirmed, holding that the District Court properly construed the ‘291 patent’s claim language, correctly held that AGA’s device did not infringe the asserted claims of the ‘291 patent, and correctly held that the ‘281 patent was invalid in view of the prior art.

ResMed Sues APEX Medical for Patent Infringement Relating to Respiratory Masks

ResMed Sues APEX Medical for Patent Infringement Relating to Respiratory Masks

ResMed Incorporated has filed a new lawsuit against APEX Medical Corporation and other defendants.  The lawsuit alleges infringement of several patents, including U.S. Patent No. 7,159,587, entitled “Respiratory Mask Having Gas Washout Vent And Gas Washout Vent Assembly For Respiratory Mask.”

According to the Abstract, the ‘587 Patent relates to “a vent assembly suitable for use with a respiratory mask of the type used in CPAP treatment. In one embodiment the vent is made of a thin air permeable membrane.”  Figure 1 from the ‘587 Patent is shown below:

According to the ‘587 Patent, Figure 1 illustrates a “gas washout vent constituted by an opening 26 in the shell 12 across which extends a thin air permeable membrane 28.”  ‘587 Patent, col. 4, lines 41-43.  The ‘587 Patent states that, “[l]ocating the vent in the mask shell results in an improvement in the minimization of CO2 retention within the mask compared to locating the vent as an inline mask component.”  ‘587 Patent, col. 7, lines 5-7.

ResMed alleges that APEX Medical’s WiZARD branded masks infringe the ‘587 Patent.  The complaint and asserted patents are available here.

NuVasive Files 2 Petitions for Inter Partes Review of Warsaw Orthopedic Patent

NuVasive Files 2 Petitions for Inter Partes Review of Warsaw Orthopedic Patent

San Diego-based NuVasive, Inc. filed two petitions last Friday with the Patent Trial and Appeal Board for inter partes review of Medtronic subsidiary Warsaw Orthopedic, Inc.’s U.S. Pat. No. 8,251,997. The sole listed inventor of the ‘997 patent is Dr. Gary Michelson.

The ‘997 patent is entitled “Method for Inserting an Artificial Implant Between Two Adjacent Vertebrae Along a Coronal Plane” and “relates generally to instrumentation and methods of performing surgical procedures on the human thoracic and lumbar spine along the lateral aspect of the spine and from a true lateral or anterolateral approach, and specifically to the surgical correction of thoracic and lumbar disc disease and spinal deformities where concomitant fusion is desired.” Figure 13 from the ‘997 patent is shown below:

NuVasive’s first and second petitions collectively seek review of all 30 of the claims of the ‘997 patent, asserting the claims are obvious over a number of references. The associated exhibits can be found by visiting the Board’s website, entering the patent number 8251997, and clicking on the Search button.

Medtronic and NuVasive have a history of spinal patent infringement litigation. In 2008, Medtronic filed a patent lawsuit against NuVasive relating to spinal implants, and NuVasive filed patent infringement counterclaims. The first phase of this litigation went to trial in 2011, where Medtronic won $101 million in damages and NuVasive won $660,000, and is still ongoing.

Of note, the ‘997 patent, among others, was asserted by Warsaw against NuVasive in another pending patent infringement lawsuit originally filed in the Northern District of Indiana. The case has since been transferred to the Southern District of California. Warsaw’s alleged infringement contentions against NuVasive with respect to the ‘997 patent can be found here.