Medical device innovations and IP: A strategy is everything.
Bringing a medical device to market relies on a broad understanding of IP, explain Sabing Lee and Kregg Koch of Knobbe Martens.
The medical device industry is driven by innovation, where great ideas are developed into successful businesses and products to improve patient care and outcomes. As patent attorneys, we witness many different pathways to innovation and guide IP strategies for innovators of all types. From garage start-ups that become global industry leaders to incubators and university-funded research programs, innovation has no common starting point.
One certainty exists, though. A properly executed IP strategy, tailored to the medical device industry, is critical for protecting innovation, creating company value and ultimately supporting the commercialization of products that will benefit patients.
Sources of Medical Device Innovation
One common starting point for medical device innovation is the physician. Many new innovations start from individual practitioners, such as a surgeon or other specialist who works first-hand with the types of devices that he or she improves upon.
Whether orthopedic, cardiovascular, neurological, or other, physicians with first-hand experience in the causes of medical conditions, the outcomes from devices and treatments, and the implementation of the devices and treatments are often the best equipped to recognize a need for improvement and to foster innovation. This is the reason why a significant number of medical devices come from or are developed in consultation with physicians.
Medical device innovation is an iterative process, and a significant amount of engineering work is needed to translate an initial concept into a viable product. Some physicians are garage inventors themselves, building prototypes using household parts or buying and assembling components into something that can be tested in trials.
Frequently, physicians seek out partnerships with engineers who can assist in this process, and many important medical technologies have resulted from the physician-engineer collaboration. Engineers themselves are also often inspired by new medical ideas and will seek out the clinical perspectives of a physician to refine and improve upon these ideas.
Protecting IP is especially important to the solo inventor, who often starts with only an idea and needs to secure some degree of protection, typically with a provisional patent application, before disclosing the idea to others.
Solo inventors and early-stage companies should also take care in securing ownership rights to their inventions when seeking the help of others. Non-disclosure agreements, while helpful in maintaining confidentiality, do not typically include IP assignment clauses. Without an IP assignment agreement, the solo inventor runs the risk that one of their collaborators improves upon the invention and claims ownership of the improvement for themselves.
While many innovations are the result of spontaneous inspiration, incubators, who form another important group of innovators, follow a more structured process. Incubators are organizations, including university-sponsored entities (sometimes called biodesign programs), that usually comprise individuals having orthogonal skill sets and backgrounds that form a multi-disciplinary team.
Incubators often include physicians, engineers, scientists, and business professionals. Some incubators study the industry, look for unmet patient needs, and brainstorm ideas. Innovation is a primary focus.
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.
Cancer Drug Patent Not Dead Yet
(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.
Technology
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.
Case Details
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.
Surgeon wins $20M jury verdict against DePuy Synthes for Infringement of Knee Prosthesis Patents
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.
Researchers Develop Face Mask for Detection of SARS-CoV-2
According to an article published in Nature Biotechnology, Harvard and MIT researchers invented a face mask for detecting SARS-CoV-2, the virus that causes COVID-19, via a user’s breath. Instead of relying on a lab, the personal device uses sensors that use wearable freeze-dried cell-free (wFDCF) technology. This technology contains the same molecules that cells use to recognize and manipulate nucleic acids and proteins. According to MedGadget, unlike previous iterations of this technology which store living cells in “tiny aquariums”, wFDCF technology prevents any issues with leakage due to breakage.
To use the mask, a user presses a button on the mask to release water onto reactive wFDCF sensors. MedGadget reports that results are given within 90 minutes and can be displayed on the inside of the mask for privacy purposes. According to the scientific article, the wFDCF technology first cleaves viral particle samples in order to release the viral RNA. Next, target genes located in the viral RNA are amplified via reverse transcription–recombinase polymerase amplification, in order to amplify the sequence that encodes for the spike protein. A lateral flow assay strip is then used to display visual results similar to a pregnancy test.
“We have essentially shrunk an entire diagnostic laboratory down into a small, synthetic biology-based sensor that works with any face mask, and combines the high accuracy of PCR tests with the speed and low cost of antigen tests,” said researcher Peter Nguyen. “In addition to face masks, our programmable biosensors can be integrated into other garments [e.g., lab coats] to provide on-the-go detection of dangerous substances including viruses, bacteria, toxins, and chemical agents.”
MIT News reports that the device can also swap in sensors for other pathogens, including influenza, Ebola, and Zika, or sensors they have developed to detect organophosphate nerve agents.
Genetic Engineering and Biotechnology News reports that the research team is “actively searching for manufacturing partners who are interested in helping to enable the mass production of the face mask diagnostic for use during the COVID-19 pandemic, as well as for detecting other biological and environmental hazards.” The article reports that the authors have already submitted provisional patent applications for the technology.
The original article was published in Nature Biotechnology on June 28, 2021, and is available here.
Strategies for Protecting Intellectual Property (IP) on a Reduced Budget
Shutdown orders due to the COVID-19 virus pandemic have created economic disruption, causing companies to scale back on intellectual property (IP) expense. This creates an opportunity to move ahead of the competition. This is especially true because the U.S. patent system, and many others around the world, reward the first inventor to file.
Below are some suggestions for protecting your IP on a reduced budget. This is not an exhaustive list. It is also not right for everyone. You should consult with legal counsel about your IP and what is right for your company.
Further, obtaining the best protection for your IP may involve filing for a utility patent, which is a long process. It involves, for example, understanding the client’s business and its goals; studying the technology; meeting with the inventors; discussing the invention, its genesis, and design alternatives; identifying target concepts to protect; meticulously drafting the claims and the written description; preparing the figures; and reviewing and revising the draft documents many times until they are right, among many other tasks.
By most measures, a pandemic is not an ideal time for many things, including companies trying to protect their IP. Consider discussing the following options with IP counsel to see if any of these might be right for you. For fuller discussion of these and other techniques, see this webinar presented to the Association of Corporate Counsel.
1. Get your place in line – On a reduced budgetThe U.S. and many non-U.S. patent systems reward the first inventor to file. It is therefore important to stake your place in line before the competition. Below are some suggestions for reserving your place in line – your “priority date” – while keeping expenses down.
A. Consider a U.S. provisional patent application filing.
A U.S. provisional patent application holds your place in line at the Patent Office for up to one year. The government filing fee is currently 280 USD (potentially discounted for “small entities” or “micro entities”).
Provisional applications do not require the same level of formality as a non-provisional application. For example, a sketch, a slide deck, or an informal set of notes from an inventor can be filed as a provisional application. While you will only get credit, for priority purposes, for the amount of detail you file, it may be beneficial to file something rather than nothing.
Within one year of the first provisional application filing, you can supplement it with one or more “follow-on” provisional filings. This may be useful, for example, to file a follow-on later when IP budgets are subsequently increased.
All of the filed provisional applications within that one year can then be “rolled up” into a single non-provisional application. If you ultimately decide to do nothing with the one or more filed provisional applications, they will never publish.
B. Consider “coaching” preparation of the patent application.
While ideally a patent attorney will draft your application, this involves additional expense. One option may be to have your attorney “coach” you through the preparation process.
BioArctic Announces Patent Allowance Entitled Spinal Cord Devices and Methods for Promoting Axonal Regeneration
BioArctic AB, a public Swedish biopharma company, recently announced that they received allowance of a patent application directed to a method of promoting axonal regeneration using a biodegradable spinal cord device. The medical device is said to be a component of BioArctic’s SC0806 product for treatment of complete spinal cord injury. The allowed claims are directed toward “selecting a spinal cord device” having certain geometric characteristics, “positioning peripheral autologous nerves in … through channels,” and implanting the device in an injured spinal cord. The device is said to be soakable in a solution of FGF1 growth factor prior to implantation. BioArctic reports to have received corresponding patents in China and Australia.
According to BioArctic, despite considerable research into bridging spinal cord gaps, no product is yet available on the market. BioArctic states that the SC0806 spinal cord product is currently undergoing Phase 1/2 clinical trials in Sweden and was granted orphan drug status in the European Union and the United States, qualifying the product for 10 and 7 years of market exclusivity, respectively. The product received funding from the European Union’s Horizon 2020 Research and Innovation Program, the EU’s largest public investment program for research and innovation, comprising an €80 billon investment over 7 years, culminating in 2020.
According to BioArctic, in addition to developing treatments for complete spinal cord injury, its research focuses on disease modifying treatments and reliable biomarkers and diagnostics for neurodegenerative diseases, such as Alzheimer’s disease and Parkinson’s disease, for which AbbVie has agreed to develop and commercialize BioArctic’s Parkinson’s antibody portfolio. European Biotechnology rated BioArctic’s €71.8 million IPO as one of Europe’s most successful in 2017.
FDA Approves “First-of-its-kind” Infant Medical Device
The U.S. Food and Drug Administration (FDA) recently authorized the use of what it described as a “first-of-its-kind” medical device to treat infants for a birth defect called esophageal atresia, in which the upper esophagus is disconnected from the lower esophagus and the stomach. According to the FDA, babies with this condition require a feeding tube until surgery can be performed to connect the esophagus to the stomach.
According to Cook Medical, its pediatric esophageal atresia anastomosis device, called Flourish™, uses magnets to pull the upper and lower esophagus together, closing the gap and allowing food to enter the stomach. Dr. Mario Zaritzky, a pediatric radiologist at the University of Chicago Medical Center and one of the joint inventors listed on the patent on this technology (U.S. Patent No. 9,168,041), states:
“The idea was to create a minimally invasive procedure that could possibly be an alternative to surgery in selective pediatric cases. Any procedure that can potentially replace major thoracic surgery with a less invasive method should be considered before deciding to go to the operating room.”
Cook Medical’s press release notes that each of the 16 infant patients treated using this device had a successful joining of their esophagus with no remaining gap, within 3‑10 days after receiving the device.
According to the Cook Group, Cook Medical is a company that engages in “medical research and product development in minimally invasive medical device technology for diagnostic and therapeutic procedures.”
Positive Clinical Results for Using Myriad’s BRACAnalysis CDx® for Identifying Breast Cancer Patients for Treatment with Lynaparza
Myriad Genetics recently announced clinical results showing that its BRACAnalysis CDx® test was able to identify patients with HER2-negative metastatic breast cancer who had improved response with Lynparza (olaparib), AstraZeneca’s PARP inhibitor. The results are based on a collaborative effort between Myriad Genetics and AstraZeneca for identification and treatment of patients with metastatic breast cancer and underlying BRCA 1/2 mutations.
In 2014, the FDA approved the use of BRACAnalysis CDx to identify patient with advanced ovarian cancer that would benefit from treatment with olaparib. Jonathan Lancaster, the chief medical officer of Myriad Genetics stated that, “we believe the results of the OlympiAD trial support use of BRACAnalysis CDx test to help inform treatment decisions in the metastatic breast cancer setting and will expand the patient population who can benefit from BRCA testing.”
The recent announcement is the first report of data from a Phase 3 Clinical Trial (the OlympiAD trial) that compares treatment options in Metastatic Breast Cancer Patients with Germline BRCA1/2 Mutations. The treatments compared the responses to Lynparza and so-called physician’s choice chemotherapy, where the investigators will choose Capecitabine, Vinorelbine, or Eribulin. Mydriad’s BRACAnalysis CDx test was used to identify patients with germline BRCA 1/2 mutations and these patients showed a statistically-significant improvement of progression-free survival when treated with olaparib compared to treatment with a chemotherapy of the physician’s choice. Information about the clinical trial can be obtained here: https://clinicaltrials.gov/ct2/show/NCT02000622.
According to Myriad, BRACAnalysis CDx is an in vitro diagnostic device that detects and classifies variations of BRCA1 and BRCA2 in both protein coding and intron/exon junctions regions of the genes. The device analyzes genomic DNA obtained from whole blood. Small genetic variations including single nucleotide polymorphisms (SNPs) are identified using PCR with Sanger sequencing. Larger genetic variations, including large deletions and duplications, are detected using multiplex PCR.
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.
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.
Boston Scientific Files IPR Petitions Against Nevro
Boston Scientific filed two petitions with the Patent Trial and Appeal Board on May 14, 2015 requesting inter partes review of Nevro’s U.S. Patent No. 8,359,102. The petitions were assigned Case Nos. IPR2015-01203 and IPR2015-01204. The ‘102 Patent, which is entitled “Selective High Frequency Spinal Cord Modulation for Inhibiting Pain with Reduced Side Effects, and Associated Systems and Methods,” issued on January 22, 2013. Figure 1 of the ‘102 Patent is shown below.
The first petition seeks review of Claims 1, 2, 11-15, 17-23, 25, and 26 of the ‘102 Patent as obvious based on six different grounds: 1) Claims 1, 2, 11-14, 17-22, 25, and 26 were challenged as being anticipated by MacDonald (U.S. Pat. No. 5,776,170); 2) Claims 1, 2, 15, 17-18, and 25-26 were challenged as being anticipated by Sluijter (U.S. Pat. No. 6,246,912); 3) Claims 1, 2, 17-23, 25 and 26 were challenged as being anticipated by Royle (U.S. Pat. Pub. No. 2006/0009820); 4) Claims 1, 2, 11-15, 17-23, 25, and 26 were challenged as being obvious over MacDonald, either alone or in view of De Ridder (U.S. Pat. Pub. No. 2011/0184488), Sluijter, and/or Royle; 5) Claims 1, 2, 11-15, 17-23, 25, and 26 were challenged as being obvious over Sluijter, either alone or in view of De Ridder, MacDonald and/or Royle; and 6) Claims 1, 2, 11-15, 17-23, 25, and 26 were challenged as being obvious over Royle, either alone or in view of De Ridder, MacDonald and/or Sluijter.
The second petition seeks review of the same claims, though on only two different grounds: 1) Claims 1, 2, 17-22, 25, and 26 were challenged as being anticipated by Knudson (U.S. Pat. Pub. No. 2007/0073354); and 2) Claims 1, 2, 11-15, 17-23, 25, and 26 were challenged as being obvious over Knudson either alone or in view of De Ridder and/or MacDonald.
The petitions state that there is no related litigation.
Days before Boston Scientific filed the petitions, Nevro announced that its Senza spinal cord stimulation system received FDA approval. Nevro states that it “intends to vigorously defend its intellectual property in this matter.”
Shift Labs Continues Trend Toward Consumer Wireless Healthcare Devices
The medical device market is expanding into more private healthcare products in hopes of bringing healthcare directly to the user. For example, the increase in popularity of wearable diagnostic devices, such as FitBit, and Apple’s recently released ResearchKit, turning iPhones into medical devices, illustrate that users are ready to look after their own health.
According to founder Koji Intlekofer:
The places where healthcare is growing fastest is outside of traditional hospital settings.
Shift Labs aims to pioneer a new “middle class” of medical device offerings, and provide products outside the hospital setting. According to founder Beth Kolko,
There is no reason why we can’t make products for nurses and medical practitioners that they enjoy using. But no one is building products for the people who are going to be providing the care.
According to its website, Shift Labs’s first product is the DripAssist, a simple, low-cost take on an infusion pump for monitoring IV drips, which runs on a single AA battery. By contrast to typical infusion pumps, which can cost anywhere from $5,000 to $15,000, this patent-pending pump has a suggested retail price of only $225. The DripAssist does not pump fluid in the conventional sense. Instead, it monitors the rate of an IV drip and sounds an alarm if the pace is outside particular threshold values.
The DripAssist is currently being sold in select international markets and for veterinary usage. Shift Labs is still in the process of securing FDA clearance to sell the DripAssist in the United States. USA Today reports that Shift Labs’s next projects in the pipeline are an oxygen monitor, a cooling system for vaccines, and a device to pasteurize breast milk.
Shift Labs states that it received initial startup capital from Y Combinator, which provides seed funding and mentorship for early-stage startups. Other notable companies seeded by Y Combinator include Reddit, Airbnb, Hipmunk, and Dropbox.
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)
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.
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
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, 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
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
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.
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