Editor: Catherine Holland
On March 3, 2020, Exact Sciences announced completion of its acquisition of Paradigm Diagnostics, Inc. and Viomics, Inc., privately held companies based in Phoenix, AZ. According to Exact Sciences, Paradigm and Viomics together provide a differentiated late-stage therapy selection test and deep competencies in sequencing and biomarker discovery, extending Exact Sciences’ lab testing and research and development capabilities.
According to Kevin Conroy, Chairman and CEO of Exact Sciences:
The addition of these companies and their talented team members to Exact Sciences is another step forward in extending our leadership in advanced cancer diagnostics. Viomics’ research capabilities and the Paradigm therapy selection test and scalable clinical lab, combined with the powerful Exact Sciences commercial platform, allow us to provide patients with smarter, faster answers throughout the cancer continuum.
According to Paradigm Diagnostics, its core product, Paradigm Cancer Diagnostic (PCDx) test, can provide genomic and proteomic information about a patient’s cancer, allowing oncologists to personalize each patient’s course of treatment. The PCDx test can provide a comprehensive genetic result in three to five business days, often on specimens with a very limited amount of tumor.
According to AZBio, Viomics, Inc. was founded by David Mallery and Scott Morris, chief scientific officer. Viomics provides extensive sequencing capabilities and expertise in identifying unique biomarkers that can indicate presence of cancer in solid tissue or blood.
Exact Sciences describes itself as one of leading providers in cancer screening and diagnostic tests. Its products include Cologuard, a multitarget stool DNA test, that was FDA approved back in 2014 as recommended option for adults over the age of 50. In September of 2019, FDA expanded its previous approval for ages 50 or over by approving Cologuard for eligible average-risk individuals ages 45 or older. Since launch, Cologuard has screened over 2 million people, and detected over 10,000 early-stage cancers and over 70,000 pre-cancerous polyps, according to Exact Sciences.
Trademarks Require “Use in Commerce” – But What If You Need Regulatory Approval Before Selling Your Medical Device?
The U.S. Patent and Trademark Office (USPTO) allows for a trademark application to be filed on an “Intent to Use” basis to establish a priority date before the mark is actually “used in commerce.” However, such use in commerce must happen before the trademark application will register with the USPTO. If your company markets medical devices or related goods that require regulatory approval, the use in commerce requirement presents unique issues.
Typically, use in commerce is established when the goods affiliated with the trademark application are shipped between two states or to a foreign country, and with a label or packaging showing the trademark on the goods. For most industries, use of a trademark “in preparation” of sales will not suffice to satisfy the use in commerce requirement. Additionally, a trademark owner is only given three years to use the mark in commerce and provide evidence of such use after the USPTO determines the application is otherwise ready for registration. If the owner does not submit proof that it has used the mark by the deadline, the application is deemed abandoned. Three years seems like ample time for many trademark owners, but anyone who has needed regulatory approval for a product knows the process can stretch well beyond these three years. How does one deal with this conundrum?
You may think that you should wait to file your trademark application so that you don’t run out the three-year clock. But this may allow competitors to swoop in and file intervening trademark applications. If the USPTO believes your mark is confusingly similar to the mark in a competitors’ prior application or registration, it could prevent you from being able to register your mark.
With few exceptions, the best strategy is to file your trademark application as soon as possible. Fortunately, the law provides an accommodation for trademark registrants with goods and services that require regulatory approval. Legislators recognized the fact that “commerce” varies in different industries. For instance, while some companies can sell products as soon as they are ready for market, others must undergo testing to get a stamp of approval prior to marketing or selling their products. This latter group typically includes medical device companies. These and other devices may require pre-market approval (PMA) or a 510(k) clearance from the U.S. Food and Drug Administration (FDA), which can take many years.
Lawmakers revised the definition of “use in commerce” to state that such requirement:
be interpreted to mean commercial use which is typical in a particular industry. Additionally, the definition should be interpreted with flexibility so as to encompass various genuine, but less traditional, trademark uses, such as those made in test markets, infrequent sales of large or expensive items, or ongoing shipments of a new drug to clinical investigators by a company awaiting FDA approval (Senate Judiciary Committee Report on S. 1883, S. Rep. No. 100-515, p. 44-45 (Sept. 15, 1988))
This expanded meaning of “use in commerce” has been generally adopted by the USPTO and the courts. Therefore, shipments across a state line that include use of the mark for testing, investigation, studies, and similar efforts may satisfy the “use in commerce” requirement within industries that require regulatory approval. This may be true even if regulatory approval and sales to customers are many years down the road.
A key factor is whether the use is genuine. A token “use” just to obtain a trademark registration will not suffice for any industry. But if there are legitimate efforts being undertaken for getting a product ready for the market, and your company falls within one of these regulatory carve-outs that provide for earlier use in commerce, you should consider using your company’s mark as soon as possible in connection with all pre-approval activities. Whether such use is sufficient to constitute “use in commerce” under the law will depend on the particular facts of each situation. Even if you are unable to submit evidence of use prior to the USPTO deadline, however, you will have prevented others from registering confusingly similar trademarks during the pendency of your application. In addition, you may file a new application for the same mark prior to the expiration of the first application. This will give you additional time to begin using the mark in commerce. You should consult with legal counsel for guidance with your particular facts.
Wearable fitness products company Fitbit Inc. announced Friday it entered a definitive agreement to be acquired by Alphabet Inc.-owned Google for $7.35 per share in cash, valuing the company at approximately $2.1 billion. James Park, co-founder and CEO of Fitbit, said of the deal: “Google is an ideal partner to advance our mission. With Google’s resources and global platform, Fitbit will be able to accelerate innovation in the wearables category, scale faster, and make health even more accessible to everyone.” The deal is expected to close in 2020.
Founded in 2007, Fitbit launched its step-counting Fitbit Tracker at the end of 2009. The wearables market has grown rapidly in the past decade. According to IDS, Apple leads the wearables market with 16.2 million devices sold in the 4Q18, followed by Xiaomi, Huawei, Fitbit, and Samsung. Google’s presence in wearables includes WearOS.
“This move should put the eHealth market on alert—Google just acquired 25-30 million active users who care about monitoring their health. This is exactly the demographic that eHealth is designed to reach. And I would say that ‘preventative health’ within eHealth just got more competitive.” – Michael Luther, Co-Founder and CEO of MX3 Diagnostics
This year Fitbit sought to diversify its income stream by working with health care companies and offering subscription-based services. Some analysts see the Fitbit acquisition as a data play on Google’s part. Tom Taulli of InvestorPlace notes: “Google is a global leader in AI and this technology will likely prove extremely useful in transforming the healthcare industry.” Omri Shor, CEO of Medisafe notes: “Quality AI is predicated on an abundance of validated data, the tools to analyze that data in a meaningful way, and the ability to drive action. Google and FitBit together certainly have the potential to develop groundbreaking AI.” D.A. Davidson’s Tom Forte agrees and said in a note to clients “We see Google as a natural acquirer for the company that would leverage Fitbit’s: 1) data, 2) hardware and 3) brand into a larger ecosystem that would allow Google to further penetrate the healthcare sector and the smartwatch category.”
The U.S. Food and Drug Administration (FDA) has issued two new guidance documents related respectively to an “abbreviated” and a “special” approach to the typical 510(K) process for medical devices.
The FDA describes the usual 510(K) process as “a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device…that is not subject to premarket approval.” According to the FDA, “Each person who wants to market in the U.S., a Class I, II, and III device intended for human use, for which a Premarket Approval application (PMA) is not required, must submit a 510(k) to FDA unless the device is exempt from 510(k) requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) .”
Now, two recent guidance documents issued by the FDA allow for altered 510(K) approaches for certain medical devices. The first guidance, issued September 13, 2019, is for a “Special 510(K) Program.” The FDA describes this program as “an optional pathway for certain well-defined device modifications where a manufacturer modifies its own legally marketed device, and design control procedures produce reliable results that can form, in addition to other 510(k) content requirements, the basis for substantial equivalence (SE).” The guidance is intended to clarify “the types of technological changes appropriate for review as Special 510(k)s.” The new guidance also supersedes prior FDA guidance from 1998 regarding Special 510(k) policy in “The New 510(k) Paradigm: Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications.”
This MDDI article purports to offer a “handy checklist” to determine “if changes made to your medical device can be reviewed under the [Special 510(K)] program.” Some of the questions listed on the article’s checklist include the following:
- Is it a change to the manufacturer’s own device?
- Are performance data needed to evaluate the change?
- Is there a well-established method to evaluate the change?
- Can the data be reviewed in a summary or risk analysis format?
The second FDA guidance, also issued September 13, 2019, is for the “Abbreviated 510(K) Program.” The FDA describes the program as “an optional approach that may be used to demonstrate substantial equivalence in premarket notifications (510(k)s)” and that “uses guidance documents, special controls, and/or voluntary consensus standards to facilitate FDA’s premarket review of 510(k) submissions.” The guidance is “intended to facilitate 510(k) submission preparation by manufacturers and review by FDA.”
A copy of the guidance for the Special 510(K) Program can be found here, and a copy of the guidance for the Abbreviated 510(K) Program can be found here. The FDA currently states that comments on either guidance may be submitted at any time. Public comments on the guidance for the Special 510(K) Program may be submitted here and for the Abbreviated 510(K) Program here.
On June 11, 2019, the U.S. Patent and Trademark Office Patent Trial and Appeal Board (PTAB) instituted inter partes review (IPR) of U.S. Patent No. 6,306,141, assigned to Medtronic Vascular, Inc. The Decision instituted the IPR based on two obviousness grounds, including that “Petitioner has made an adequate showing at this stage that at least claim 1 would have been obvious over Cragg, Pops, and Tanaka.”
As previously reported on KnobbeMedical, the petition that led to institution of the IPR was filed on November 9, 2018 by Cook Medical LLC. The status of the proceeding can be examined by searching for the patent on the Patent Trial and Appeal Board website.
The ‘141 Patent is entitled “Medical Devices Incorporating SIM Alloy Elements.” The ‘141 Patent states that it relates to “a medical device containing a shape memory alloy element.” The ‘141 Patent claims priority to a 1983 filing. The USPTO’s Certificate Extending Patent Term for the ‘141 patent indicates that it will expire on April 15, 2022.
The ‘141 patent discloses using stress to restrain a metal alloy in a stressed state (“stress induced martensite” or “SIM”). The alloy expands to its unstressed shape after being released from its restraint due to a phase change from martensite to austenite without a change in temperature. In one example, the ‘141 Patent describes that the disclosed device enables doctors to treat damaged or diseased heart valves with a less invasive transcatheter heart valve procedure. Figures 3 and 4 of the ‘141 Patent, shown below, illustrate a “side elevation view of a partial section of a catheter” in stressed (Figure 3) and unstressed (Figure 4) configurations.
This is not the first time that the ‘141 patent has been subject to a petition for inter partes review, but it is the first time that an IPR has actually been instituted. On January 17, 2014, Edwards Lifesciences Corporation filed a petition with the Patent Trial and Appeal Board requesting inter partes review of all claims of the ‘141 Patent. According to a Medtronic press release, on May 20, 2014, Medtronic and Edwards reached a “global settlement agreement” to “dismiss all of the pending litigation matters and patent office actions between them.”
In May 2013, Lombard Medical filed a petition for inter partes review of Claims 1-10 and 18-22 of the ‘141 Patent. Lombard Medical’s products, according to its website, include the AORFIX™ endovascular stent graft. According to a Lombard press release, on October 17, 2013, Lombard was granted a non-exclusive license by Medtronic to the ‘141 Patent, and Lombard formally requested a withdrawal of its inter partes review petition with the USPTO.
The ‘141 Patent has also been previously litigated. The ’141 Patent, among others, was previously asserted by Medtronic against W.L. Gore & Associates, Inc. in 2006; Gore’s EXCLUDER® AAA, TAG, and VIABAHN SFA® endoprosthesis devices were at issue. The parties entered into a confidential settlement in 2009.
Medtronic also previously asserted the ’141 Patent, among others, against AGA Medical in 2007. AGA’s AMPLATZER® Septal Occluder, Duct Occluder, and Vascular Plug devices were at issue. The parties entered into a settlement in 2010 in which AGA received a non-exclusive license to patents including the ’141 Patent in exchange for $35 million. AGA Medical was subsequently purchased by St. Jude Medical in October 2010 for $1.3 billion. St. Jude was in turn acquired by Abbott in 2016 for $25 billion.
In July 2018, Citroën, the French car manufacturer, unveiled glasses that aid in alleviating motion sickness. The “Seetoën” glasses, developed by Boarding Ring, purports to eliminate motion sickness symptoms within about 10 minutes of putting them on. According to Boarding Ring, the Boarding Ring technology includes four rings filled with blue liquid.
With the increase of use of smartphones and tablets, motion sickness has been affecting more people as more people look at screens while being transported around. Motion sickness affects up to 66% of the passengers depending on the vehicle. Motion sickness is thought to be caused by a mismatch between the visual information and the balance system’s perceptions. This situation can trigger motion sickness symptoms.
Currently, common remedies for motion sickness include focusing your eyes on the horizon, choosing your seat wisely to minimize motion (e.g., front or driver’s seat in a car, center of a boat, over the wings on a plane), avoiding alcohol and fatty foods, and taking medications such as Dramamine. But these remedies are not necessarily a complete fix. According to the Smithsonian, “some examples include a pair of blinders to block out visual information, a head mounted projection device meant to make visual information line up with sensory information, and shutter glasses that open and close rapidly, meant to prevent the visual slippage associated with motion sickness.”
As explained by Autoevolution, the lens-less glasses “create an artificial horizon line in the front and sides, which allows the resynchronization of sight and inner-ear, and thus ‘cures’ motion sickness. Put them on and look at a fixed object, such as tablet or phone or book, and you should be able to remove them after 10 minutes[.] [Afterwards,] your motion sickness symptoms [will be] all gone.” The glasses use a concept that is similar as looking at the horizon when experiencing motion sickness at sea. The horizon provides a stable reference point for our brains to focus on, thus alleviating the confusion that other senses create when sending confusing information to our brains. Alleviating motion sickness can be performed by putting on the Seetoën glasses as soon as symptoms start to occur. The Seetroëns can be worn over prescription lenses. Once symptoms disappear, one can simply remove the glasses and enjoy the rest of their trip.
However, there are critics who remain skeptical of the effectiveness of the glasses. Thomas Stoffregan, a professor of kinesiology at the University of Minnesota states that “[p]eople have been trying to use an artificial horizon in the context of motion sickness for several decades, at least since the 1970s …It’s never worked. My question to this company is ‘what’s different about your virtual horizon?’” In response, Boarding Ring’s CEO Antoine Jeannin says the Boarding Glasses are unique because they bring an artificial horizon to the peripheral vision—that’s why the glasses have four lenses—unlike other products, which only engage the central vision.
The glasses were invented by the father of Antoine Jeannin, Hubert Jeannin. According to the Smithsonian, “Hubert Jeannin patented his innovation in 2004 (the ’237 Patent) and tested the Boarding Glasses prototypes with the French navy, and, although the exact results are confidential, his son says it was extremely successful—some 95 percent of users found the glasses helpful within 10 minutes. Father and son now run the company together, with father handling innovation and son handling business.” According to Autoblog.com, early reviews of the spectacles come from boating magazines, and the specs received a special mention at the marine-focused 2013 DAME Awards.” Eventually, Citroën’s called upon Parisian design studio 5-5 to redesign the glasses with a fresh, simple, and ergonomic style.”
The Boarding Ring site has had the glasses available for preorder at a price of around $80 (£60, AU$107) with a shipping date of December 2018.
Boston Scientific Exercises Option to Acquire Transcatheter Annuloplasty Ring Developer Millipede Inc.
Global medical device company Boston Scientific has announced on December 27, 2018, that it exercised its option to acquire remaining shares of privately-held medical device company Millipede, Inc. upon its recent successful completion of a first-in-human clinical study. Boston Scientific previously announced on January 24, 2018, an agreement to make a $90 million investment in Millipede. The current press release states the prior agreement included an option for Boston Scientific to “acquire [Millipede’s] remaining shares for $325M at closing, with a $125M payment becoming available upon achievement of a commercial milestone.”
Millipede has developed a non-invasive solution for repair of the heart’s mitral valve. According to Millipede’s website, Millipede’s IRIS Transcatheter Annuloplasty Ring System reshapes the mitral valve annulus of the heart to treat severe mitral regurgitation (MR). MR is caused by a leaking mitral valve, which causes blood to flow backward from the left ventricle into the left atrium. Over time, MR can lead to or accelerate heart failure and rhythm problems. Millipede’s website describes the IRIS system as providing the gold standard in surgical heart valve repair – a complete annuloplasty ring implant. The implant reshapes and reduces the mitral valve annulus opening, enabling return of leaflet coaptation and reduction of MR.
According to Millipede, the implant is delivered via catheter, for example through a small cut in the patient’s leg. This allows patients to avoid invasive open heart surgery, which is necessary for implantation of conventional annuloplasty rings. Millipede describes the transcatheter ring as repositionable and retrievable.
“We are very satisfied with the early results of our clinical program and are excited to see this technology further leveraged by Boston Scientific to expand the mitral repair solutions for patients around the world.” – Randy Lashinski, CEO, Millipede Inc.
Millipede is based in Santa Rosa, California and was founded in 2012 by majority investor Santé Ventures and Steve Bolling, MD, and has been led by CEO Randy Lashinski since 2014.
Boston Scientific describes itself as a worldwide developer, manufacturer and marketer of medical devices, providing a broad range of high performance solutions that address patient needs and aim to reduce the cost of healthcare.
Millipede is a client of intellectual property and technology law firm Knobbe Martens. With close to 275 lawyers and scientists nationwide, Knobbe Martens dedicates its practice to all aspects of intellectual property law including litigation and is consistently ranked among the top intellectual property firms worldwide.
A new study based on a novel implantable weight loss device that was published in Nature, has shown that it was able to help rats shed almost 40 percent of their body weight. This implant device developed by engineers at the University of Wisconsin–Madison could offer a promising new weapon for the battle against obesity. More than 700 million adults and children worldwide are obese, according to a 2017 study that called the growing number and weight-related health problems a “rising pandemic.”
According to articles, the device itself is minuscule – measuring less than 1 centimeter across. The devices are said to be safe for use in the body and implantable via a minimally invasive procedure and is powered by the stomach’s natural churning motion. The devices are also said to generate a gentle electric pulse to the vagus nerve, which links the brain and the stomach, and signals to the brain that the stomach is full even after a small snack.
According to the University of Wisconsin –Madison, “[u]nlike gastric bypass surgery, which permanently alters the capacity of the stomach, the effects of the new devices are reversible. When Wang and his collaborators removed the devices after 12 weeks, the study’s rats resumed their normal eating patterns and weight bounced right back on.”
Articles have stated that the new device also has several advantages over existing devices that stimulates the vagus nerve for weight loss. That existing unit, “Maestro,” approved by the Food and Drug Administration in 2015, administers high-frequency pulses to the vagus nerve to block all communication between the brain and stomach. The Maestro device also require batteries which frequently must be recharged. In contrast, “Wang’s device contains no batteries, no electronics, and no complicated wiring. It relies instead on the undulations of the stomach walls to power its internal generators. That means the device only stimulates the vagus nerve when the stomach moves.”
NAMSA, which describes itself as “the world’s only Medical Research Organization (MRO) that accelerates medical device development through integrated laboratory testing, clinical research and regulatory consulting services,” has announced the acquisition of Reimbursement Strategies, LLC.
According to Mass Device, “NAMSA is a medical device firm that “offers integrated laboratory testing, clinical research and regulatory consulting services.” According to NAMSA, Reimbursement Strategies is a consultancy “focused on reimbursement, health economics and market access for the international life science industry” which “places a significant concentration on providing clients efficacious and timely development outcomes through the organization’s expertise in reimbursement strategy, health economics, medical policy research and coverage advocacy.”
Christopher Rupp, VP of NAMSA’s global marketing and commercial operations stated that the acquisition of Reimbursement Strategies “will allow clients to proactively address the largest challenges of bringing novel devices to the global marketplace—securing appropriate coverage and payment for new and existing technologies.” Rupp continued to state that “We look forward to delivering device manufacturers faster, more cost-effective commercialization results through our comprehensive, full-service development solution.”
The former President of Reimbursement Strategies, LLC, Edward Black, stated, “We are very pleased to join the NAMSA Team as we work together to provide clients the most critical services required to navigate our industry’s complicated global reimbursement landscape.” Black, who is now NAMSA’s Director of Global Reimbursement Strategy, asserted that, “It is more important than ever for device manufacturers to assess reimbursement challenges early so they may fully integrate this planning into regulatory and clinical research pathways to achieve resource efficiencies and expedite market commercialization.”
According to Business Wire, “NAMSA’s MRO® Approach plays an important role in translational research, applying a unique combination of disciplines—consulting, regulatory, reimbursement, preclinical, toxicology, microbiology, chemistry, clinical and quality—to move clients’ products through the development process, and continue to provide support through commercialization to post-market requirements anywhere in the world.” Business Wire also reports that, “NAMSA operates 13 offices throughout North America, Europe, the Middle East and Asia, and employs nearly 1,000 highly-experienced laboratory, clinical and consulting Associates.”
Garmin and ActiGraph Collaborate to Explore Health and Activity Monitoring Solutions on Wearable Devices
Garmin International, Inc. recently announced a collaboration with ActiGraph to create health and activity monitoring solutions for academic research, clinical trials, and remote patient monitoring. The collaboration will combine Garmin wearables with ActiGraph‘s CentrePoint data analytics platform to achieve these goals.
Travis Johnson, Garmin Health global product lead, stated that “[c]ombining the sensor data from Garmin wearables with the data capture and analytical expertise of the ActiGraph platform creates a powerful solution for many different patient monitoring applications.”
ActiGraph chief technology officer Jeremy Wyatt expressed similar praise for ActiGraph’s new partner, stating that “Garmin wearables produce high resolution, accurate data streams that are ideal for scientific analysis and can provide additional, novel endpoints to the ActiGraph software platform.”
Garmin International, Inc. is a subsidiary of Garmin Ltd. Garmin is known for developing a variety of products, such as handheld GPS devices and wearable fitness trackers. On the other hand, ActiGraph offers a variety of activity monitors and also software platforms to analyze data collected by such monitors.
Both Garmin and ActiGraph acknowledge the growing importance of wearable devices as potential health and medical tools. By partnering with ActiGraph, Garmin has indicated its interest in the future development of wearable devices with medical applications. Likewise, the partnership allows ActiGraph to utilize Garmin’s experience in developing wearable devices to apply and hone its data monitoring and management systems.