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.
Confirm Rx: Abbott Receives CE Mark for Smartphone Compatible ICM
Abbott recently announced the CE Mark and first use of what it claims is “the world’s first smartphone compatible” insertable cardiac monitor (ICM), as reported by a press release dated May 8, 2017.
According to the press release, Abbott produces the Confirm RxTM ICM, which is marketed as the slimmest ICM available. Pictured on the right, Abbott states that the Confirm RxTM is designed to continuously monitor a patient’s heart rhythm and proactively transmit information via the myMerlinTM mobile app, thereby allowing physicians to follow their patients remotely and accurately diagnose arrhythmias. As noted on the Confirm RxTM webpage, the ICM is placed by a physician under local anesthesia by making a small incision in the pectoral region, inserting the ICM under the skin using an insertion tool, and then closing the incision. “Patients can record symptoms directly on their smartphone without the need for a bedside transmitter or separate activator,” said Georg Nölker, M.D. in prepared remarks. Dr. Nölker was one of the first physicians to implant the Confirm Rx ICM after it received CE Mark approval.
According to Abbott, the myMerlinTM mobile app makes it easy for patients to stay connected to their physicians. A listing of the product features from the Confirm RxTM product website includes:
- Transmit nightly data reports automatically simply by being in range of the smartphone;
- Manually record patient symptoms on their own smartphone and specify events such as fainting or if they experience a fast heart rate;
- Confirm patient data was transmitted to their physician;
- Automatic alerts when they have missed a scheduled transmission;
- Offers secure transmission of patient data.
Mark D. Carlson, M.D., chief medical officer of Abbott’s cardiac arrhythmias and neuromodulation businesses, views these results as a step forward in ICM technology, stating:
Incorporating wireless technology directly into our devices enhances the quality of remote monitoring and patient compliance…The Confirm Rx ICM addresses a broad range of indications, such as syncope, palpitations and atrial fibrillation. The technology has been designed with robust data privacy and security measures to ensure peace of mind for both patients and providers.
Dr. Christopher Piorkowski, said to be one of the first physicians to implant the Confirm RxTM ICM, stated:
The Confirm Rx ICM will be particularly useful in monitoring for atrial fibrillation in my patients with paroxysmal AF, following AF ablation and with stroke of an unknown cause. It allows an objective way to quantify AF events to guide treatment decisions. The smartphone compatibility engages patients and allows better compliance to remote monitoring through a simple and intuitive user interface. This allows clinic staff to reduce follow-up burden and focus on reviewing transmitted data for AF.
As reported by the press release, the Confirm RxTM ICM is available in select European countries, with full European release expected during the second quarter of 2017. It further states that the device is currently under review by the U.S. Food and Drug Administration.
Potential Repeal of Medical Device Tax
With the upcoming Republican-dominated Presidency and Congress in 2017, the Affordable Care Act, or at least parts of it, look to be on the chopping block. One of the changes that may be forthcoming is a repeal of the 2.3% medical device excise tax. While currently being suspended through 2017, under the present law the medical device tax would be reinstated in 2018.
Some producers of medical devices hope that the tax is never reinstated. Mark Throdahl, president and CEO of OrthoPediatrics Corp., a northern Indiana based orthopedic company, has said that the suspension of the tax allowed the company to hire new workers and hopes for a full repeal after the Republican transition. According to Throdahl, the tax led to a hiring freeze, and suspension of the tax allowed for them to resume “an aggressive pace of hiring and investment.” Complaints from companies like OrthoPediatrics, as well as medical device associations like AvaMed, were what led to the initial temporary suspension of the tax.
Immediately after Donald Trump‘s election victory, AvaMed President Scott Whitaker wrote in a letter to Vice President-elect Mike Pence:
The medical device tax has been a significant drag on medical innovation, and resulted in the loss or deferred creation of jobs, reduced research, spending and slowed capital expansion.
According to some lawmakers, lobbyists, and industry executives, Trump and U.S. lawmakers will likely repeal the tax which could help some of the larger medical device manufacturers such as Medtronic, Boston Scientific, St. Jude Medical, and Johnson & Johnson. Senate Republican Leader Mitch McConnell has stated that repealing the Affordable Care Act will be one of the first order of business starting in January. Senator John Barrasso (R-Wyoming) has also stated that the medical device tax would likely be repealed.
There are still a number of decisions on how to approach the repeal of the medical device tax, whether in one single bill to repeal the Affordable Care Act or a number of smaller bills removing different parts of the Act. We should be receiving more clarity once President-elect Donald Trump officially takes office.
Repeal of the tax may remove approximately $2.5 billion of annual federal funding.
Med Device M&A Values Jump Nearly 50% in 1st Half of 2016
According to MergerMarket, the value of mergers and acquisitions in the medical device area jumped by nearly 50% to $74.5 billion in the first half of 2016 (H1 2016) compared with the first six months of 2015. The 45.5% surge in M&A cumulative value comes despite a 14.5% decrease in the total number of deals (394).
40% of the H1 2016 medical device M&A cumulative value came from a single blockbuster deal, the currently pending deal between Abbott Laboratories and St. Jude Medical. The market has responded favorably to the Abbott Laboratories acquisition, as the value of the combined entity has risen from $25 billion at the April announcement to almost $30 billion today.
In comparison, the pharmaceutical sector demonstrated declines in both the volume and cumulative value of H1 2016 M&A deals at -12.4% and -34.4% respectively. The pharmaceutical sector totaled 162 M&A deals, valued at an aggregate of $83.2 billion. In contrast, H1 2015 had 185 M&A deals valued at a total of $126.8 billion. As with the medical device space, a major deal accounted for a significant portion of the cumulative M&A value – the $35 billion acquisition of Baxalta International by the Irish headquartered Shire Plc.
Biotechnology M&A deals increased in both volume and cumulative value, rising to 75 deals worth $6.1 billion, an increase of 36.7% over H1 2015.
However, one notable deal collapsed – Pfizer’s $183.7 billion bid for Ireland-based Allergan was withdrawn following the introduction of new tax rules by the U.S. Treasury Department. Looking prospectively, the new April 2016 tax rules may have an impact on M&A deals in the 2nd half of 2016.
Abbott to Acquire St. Jude Medical for $25 Billion
A burst of potential acquisitions and consolidations occurred on April 28th in the medical device world, the largest being Abbott Laboratories‘ deal to acquire St. Jude Medical Inc. The deal is for $25 billion dollars and would bring together two of the leaders in cardiac-related medical devices. It allows Abbott to boost its medical-device sector to compete with competitors Medtronic PLC and Boston Scientific Corp.
In particular, according to press releases, St. Jude has a strong portfolio in heart failure devices, atrial fibrillation, and cardiac rhythm management which will complement Abbott’s portfolio of cardiac intervention devices and transcatheter mitral repair. Certain medical devices produced by both companies can be used to alleviate the burden of cardiovascular disease, where more than 40% of adults are expected to experience some sort of cardiovascular disease by 2030.
According to Abbott’s Chairman and CEO, Miles D. White,
“The combined business will have a powerful pipeline ready to deliver next-generation medical technologies and offer improved efficiencies for health care systems around the world.”
However, investors do not appears nearly as confident as Abbott’s stock fell by nearly 6 percent after the acquisition.
Abbott further has a pending deal to acquire the diagnostics company Alere Inc. for $5.8 billion. Other deals included Sanofi SA’s offer to purchase Medivation Inc. and AbbVie Inc.‘s offer to purchase Stemcentrx Inc. These consolidations appear to be attempts to improve negotiating power of the companies with hospitals.
First U.S. Implant of St. Jude’s First-to-Market “CRT-D”
St. Jude Medical, Inc. recently announced the U.S. launch and the first U.S. implant of its Quadra Assure MP™ cardiac resynchronization therapy defibrillator (CRT-D). The Quadra Assura MP™ features St. Jude Medical’s first-to-market MultiPoint™ Pacing (MPP) technology. The device received CE Mark Approval for MRI Compatibility in December 2015 and the MPP technology received U.S. FDA approval earlier this year. According to the press release, the first implant of the Quadra Assura MP™ took place at Saint Francis Hospital in Hartford, Connecticut.
Heart failure patients frequently experience ventricle contraction or beating that is out of sync. CRT synchronizes the ventricle contraction. According to the press release, the first-to market MPP technologies allow physicians to pace multiple locations on the left side of the patient’s heart. According to the American Heart Association, “heart failure (HF) is a chronic, progressive condition in which the heart muscle is unable to pump enough blood through to meet the body’s needs for blood and oxygen.” The condition affects over 5.8 million in the USA and over 23 million worldwide. Despite the success of CRT, according to a recent study, one third of the HF patients fail to respond to CRT. The same study shows that MPP optimizes the response of such non-responsive patients to CRT. According to St. Jude, MPP is also featured on St. Jude Medical’s Quadra Allure MP™ CRT-pacemaker (CRT-P) and two new Quartet™ Quadripolar LV Leads.
Regarding the first implant, Dr. Mark D. Carlson, Chief Medical Officer and Vice President, Global Clinical Affairs, at St. Jude Medical, stated:
St. Jude Medical developed and established a new standard of care for CRT with quadripolar pacing. We are excited to bring the next-generation MultiPoint Pacing technology to market, giving physicians additional options to improve patient response.
Dr. Neal Lippman, electrophysiologist with Arrhythmia Consultants of Connecticut, added:
We are now able to offer St. Jude Medical’s new MultiPoint Pacing technology for our patients whose heart failure condition is difficult to manage. It is important for us to have this option to individualize patient care and help improve response to therapy.
According to its website, St. Jude Medical is a global medical device manufacturer, headquartered in St. Paul, Minnesota and focuses on six key treatment areas: heart failure, arrhythmias, vascular disease, structural heart, chronic pain, and neurological diseases.
St. Jude Medical Completes Acquisition of Thoratec
St. Jude Medical, Inc. recently announced that it has completed its acquisition of Thoratec Corporation. In July 2015, St. Jude Medical announced its offer to buy Thoratec shares at $63.50 per share. The transaction is valued at about $3.3 billion.
Prior to the acquisition, St. Jude Medical’s heart failure portfolio included its CardioMEMS heart failure (HF) monitoring device, which received a limited FDA approval in 2014 specifically for use “in New York Heart Association (NYHA) Class III heart failure patients who have been hospitalized for heart failure in the previous year.” Acquiring Thoratec augments that portfolio with Thoratec’s HeartMate II and Heartmate 3 LVADs (Left Ventricular Assist Devices), the CentriMag and PediMag Blood Pumps, and the Thoratec PVAD (Paracorporeal Ventricular Assist Device). The HeartMate II received FDA approval in 2008 for use in “patients awaiting further, perhaps more complex treatment, such as transplants” and in 2010 for use in “severe heart failure patients who are not acceptable candidates for heart transplantation.” Thoratec’s Heartmate 3 is a chronic mechanical circulatory support (MCS) device currently being considered for a CE Mark in Europe.
Regarding the acquisition, St. Jude Medical’s Chief Operating Officer and incoming President and Chief Executive Officer, Michael T. Rousseau stated:
St. Jude Medical is excited to bring together two companies that are considered heart failure therapy leaders and build on our established franchise that is now uniquely positioned to offer physicians and patients innovative solutions across the heart failure continuum. We believe this acquisition represents a tremendous opportunity and we welcome Thoratec’s employees as we look forward to changing the way the world views the treatment of this expensive epidemic disease.
According to its website, St. Jude Medical is a global medical device manufacturer, headquartered in St. Paul, Minnesota and focuses on six key treatment areas: heart failure, arrhythmias, vascular disease, structural heart, chronic pain, and neurological diseases.
Thoratec is a Pleasanton, California-based company focusing on mechanical circulatory support therapies for heart failures.
St. Jude Medical Acquires Spinal Modulation, Inc.
St. Jude Medical recently announced that it has completed the acquisition of Spinal Modulation, Inc. In June of 2013, St. Jude invested $40 million in Spinal Modulation for which it received an exclusive option (now exercised) to purchase the company for a maximum of $300 million, plus milestone payments. According to St. Jude Medical’s earlier press release, St. Jude Medical agreed to pay Spinal Modulation $175 million upon closing with milestone payments due upon FDA approval of Spinal Modulation’s Axium Neurostimulator System.
St. Jude Medical describes the Axium system (shown to the right) as a form of spinal cord stimulation (SCS) that targets a neural structure within the spine called the dorsal root ganglion (DRG). The DRG contains the primary sensory neurons that transmit pain signals from the peripheral nerves to the brain. The system uses an implantable medical device to deliver mild electrical pulses to the DRG. These pulses mask or interrupt pain signals as they travel to the brain.
According to St. Jude,
[w]ith the closing of the acquisition, St. Jude Medical has become the only medical device manufacturer in the world to offer radiofrequency ablation (RFA), spinal cord stimulation (SCS) and dorsal root ganglion (DRG) stimulation therapy solutions for the treatment of chronic pain.
According to its website, St. Jude Medical is a global medical device company, headquartered in St. Paul, Minnesota, offering a wide array of products in diverse fields.
Spinal Modulation, Inc., headquartered in Menlo Park, California, focuses on providing treatment options for patients suffering severe chronic pain.
First Flexible Tip Ablation Catheter To Receive FDA Approval
St. Jude Medical, Inc. recently announced that the U.S. Food and Drug Administration (FDA) has approved its FlexAbility Ablation Catheter for use by electrophysiologists to treat cardiac arrhythmia.
The new catheter provides a unique bendable irrigated catheter tip that allows the catheter to better conform to the cardiac anatomy and more effectively form lesions during operation. According to St. Jude Medical, the FlexAbility catheter also has an improved handle and shaft that enhance maneuverability, allowing electrophysiologists to reach challenging anatomical locations with less hand fatigue.
St. Jude’s new catheter could provide benefits to an estimated 10.4 million people in the United States who suffer from some type of cardiac arrhythmia. According to Dr. Andrea Natale, executive medical director at the Texas Cardiac Arrhythmia Institute:
“The FlexAbility catheter is the only ablation catheter with a flexible tip available to electrophysiologists in the United States today. For the past several years we’ve been looking for a catheter that provided a gentler, more optimal approach to ablation. The FlexAbility catheter addresses this need and provides me with another safe treatment option for my patients”
MarketWatch reports that the FDA approval of the FlexAbility catheter, which received its CE Mark in Europe last year, bolsters St. Jude Medical’s expanding ablation portfolio, which includes various patents such as U.S. Pat. No. 8,790,341, and expands the ability of physicians to treat patients battling abnormal heart rhythms.
St. Jude Medical Acquires Endosense
On August 19, St. Jude Medical, Inc. announced the acquisition of Endosense SA. The press release notes that St. Jude Medical has made an initial payment of approximately $170 million with additional cash payments of up to $161 million contingent on achievement and timing of regulatory milestones.
According to the press release, Endosense SA, a Switzerland-based company, “has pioneered contact-force measurement in catheter ablation.” The press release notes that Endosense’s TactiCath irrigated ablation catheter provides physicians a real-time, objective measure of the force applied to the heart wall during a catheter ablation procedure.
Frank J. Callaghan, president of the Cardiovascular and Ablation Technologies Division of St. Jude Medical stated:
This transaction significantly accelerates our timeline to providing an irrigated ablation catheter that incorporates force sensing in both international and U.S. markets, and has potential future applications across other St. Jude Medical technology platforms as well.
The press release states that St. Jude Medical can incorporate the force sensing technology for use with their technologies including offering a “MediGuide-enabled force-sensing ablation catheter and to incorporate force sensing data into the company’s EnSite Velocity™ Mapping System.”
St. Jude Medical Announces First Patient Implant in Clinical Trial of Cardiac Plug
St. Jude Medical, Inc. issued a press release today announcing the first patient implant in a clinical trial of the company’s AMPLATZER™ Cardiac Plug (ACP), a device designed to prevent stroke in patients with non-valvular atrial fibrillation. According to the press release, the ACP is
[a] self-expanding occlusion device constructed from nitinol mesh, and delivered via catheter [and] is designed to completely seal the [left atrial appendage (LAA)] (a tubular-shaped, muscular appendage connected to the left atrium of the heart) at its opening, and minimize blood clots from forming in the LAA and migrating into the bloodstream.
The press release states that the trial will compare the safety and efficacy of the device to the traditional treatment option of using long-term, blood-thinning medication.
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