Blog Tag: Boston Scientific

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.

Boston Scientific Buys Venous-Stent Maker VENITI

Boston Scientific recently announced an agreement to acquire privately-held VENITI, Inc. for $160 million. According to the press release, VENITI submitted a pre-market approval application with the U.S. Food and Drug Administration in June 2018 for the VICI stent system for treating obstructive venous disease. The VICI stent system received CE Mark approval in 2013.

According to the press release, venous obstructive disease affects more than 1.1 million people in the United States and Western Europe annually. Jeff Mirviss, Senior Vice President and President of Peripheral Interventions at Boston Scientific, commented:

Along with our leading AngioJet thrombectomy platform and venous product pipeline, we look forward to meeting the needs of physicians treating both chronic and acute venous disease.

According to the Worcester Business Journal, Boston Scientific announced over $1.5 billion in acquisitions this year alone. Other notable Boston Scientific acquisitions in 2018 include Millipede ($540m), NxThera ($306m), nVision Medical Corporation ($275m), Claret Medical ($270m), and Cryterion Medical ($202m).

Boston Scientific expects the acquisition of VENITI to be immaterial to adjusted earnings per share (EPS) in 2018 and 2019, and accretive thereafter. Nonetheless, shares of Boston Scientific opened trading the day of the announcement up more than 3 percent.

Boston Scientific Announces Acquisition of EMcision

Boston Scientific Announces Acquisition of EMcision

On March 5, 2018, Boston Scientific announced its acquisition of EMcision, a privately held company in the United Kingdom and Canada. According to Boston Scientific, this acquisition will expand its range of medical devices in the field of minimally invasive endoluminal procedures as alternatives to conventional surgery. According to Art Butcher, Senior Vice President and President of the Endoscopy Division of Boston Scientific:

As we continue to search for ways to treat pancreaticobiliary cancers, we also seek to improve the quality of life for patients living with a cancer diagnosis today. We are committed to exploring innovative options to help increase the chance of earl diagnosis, improve treatment and advance the ability to remove cancers located in challenging areas of the gastrointestinal tract.

According to EMcision, EMcision was founded by an internationally renowned surgeon and medical device inventor, Professor Nagy Habib, and has developed proprietary medical devices utilizing RF technology for applications such as percutaneous procedures, and open, laparoscopic, vascular, and endoscopic surgeries. EMcision’s devices help patients with advanced cancers located in challenging areas of the gastrointestinal tract for whom surgery is not an option.

EMcision’s website states that EMcision’s flagship product, the Habib™ EndoHPB, is a novel endoscopic bipolar radiofrequency (RF) probe that was the world’s first endoscopic device for tumour ablation via ERCP. The Habib™ EndoHPB has been cleared by the U.S. Food and Drug Administration (FDA) and received CE mark from the EU. EMcision devices are currently being sold in 38 countries around the world and used in most of the top cancer centers in the United States.

With regards to the acquisition, Cherif Habib, EMcision’s outgoing CEO, stated: “By partnering with Boston Scientific, we will continue delivering on our mission of improving the quality of life of cancer patients on much larger scale. Boston Scientific has the resources and the know-how to further improve our technology, expand clinical indications and make it available to may more patients.” According to Yahoo Finance, Boston Scientific’s Endoscopy division revenues rose 14.8% year over year to $436 million in the last reported quarter.

Boston Scientific Announces Agreement for Investment & Acquisition Option with Transcatheter Annuloplasty Ring Developer Millipede, Inc.

Global medical device company Boston Scientific has announced on January 24, 2018, an agreement to make a $90 million investment in privately-held medical device company Millipede, Inc.  Millipede has developed a non-invasive solution for repair of the heart’s mitral valve.  According to the press release, the agreement includes an option for Boston Scientific to acquire all remaining shares of Millipede, upon completion of a clinical study, for an additional $325 million in cash, with an extra $125 million in payments upon completing a commercial milestone.

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 saw an opportunity to bring the gold-standard surgical approach to repairing the mitral valve to an underserved population of severe MR patients with transcatheter techniques, and are excited Boston Scientific also sees the unique abilities of the IRIS transcatheter ring” – Joe Cunningham, MD, Chairman of the Board, Millipede, Inc. and Managing Director of Santé Ventures.

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 over 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.

Boston Scientific closes acquisition of TAVI device company, Symetis

On March 30, 2017, Boston Scientific announced an agreement to acquire Symetis SA, a privately-held Swiss company focused on minimally-invasive transcatheter aortic valve implantation (TAVI) devices, for $435 million in cash.

The acquisition expands Boston Scientific’s structural heart portfolio and Symetis will join the Boston Scientific Interventional Cardiology division. According to the press release, Boston Scientific will begin selling the ACURATE TA™ and ACURATE neo™/TF™ valve systems in Europe and in other geographies outside of the United States.

ACURATE valves are marketed as replacement valves delivered via a transcatheter percutaneous delivery system.  As noted in the press release, the ACURATE valves along with Boston Scientific’s LOTUS Valve System platform “are designed to treat patients suffering from severe and symptomatic aortic valve stenosis, who are considered at high risk for surgical valve replacement.” As stated on the Symetis website with reference to the ACURATE TA™ valve system

“[t]he most distinctive aspects of the bioprosthesis design are the self-seating and self-sealing features that allow for optimal positioning of the valve, promote sealing, and reduce paravalvular leak. Combined with the two-step deployment technique of the delivery system, these properties provide outstanding ease-of-use throughout the procedure.”

The ACURATE neo™/TF™ valve system is described as including the same self-seating and self-sealing features and stepped deployment technique.

The executive vice president and global chief medical officer of Boston Scientific, Ian Meredith, M.D., stated:

“Adding the ACURATE family of valve products to our structural heart portfolio presents us with the opportunity to provide two distinctly different but complementary TAVI platforms enabling implanting physicians and hospitals to treat the broadest range of patients and aortic valve anatomies.”

Boston Scientific Announces Worldwide EMBLEM™ Study

Boston Scientific recently announced that it is launching a worldwide study for its EMBLEM™ MRI Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) device.  According to the press release, a multicenter trail of the device will focus on a group of patients who are above 65 years old with a history of prior heart attack, diabetes, and moderately reduced left ventricular ejection fraction, considered to be at higher risk of sudden cardiac arrest but unsuitable for implantable cardiac defibrillators. The study, according to Boston Scientific, is designed to evaluate whether the company’s EMBLEM MRI S-ICD System improves the survival rate in the target group of patients in comparison to patients continuing with their present treatment. Boston Scientific indicates that it is also seeking parallel approvals for a new indication from the FDA and the Center for Medicare & Medicaid Services for use of the device in treating the target group of patients.

Commenting on the study, Senior VP and Chief Medical Officer of Global Health Policy and Rhythm Management Dr. Kenneth Stein, stated:

“In addition to the knowledge we hope to gain from this population of patients with diabetes, we are excited for the opportunity to improve the broad applicability of the [multicenter] trial results by increasing the enrollment of women in this study. Moreover, the trial emphasizes our continued commitment to expanding access to all patients who may benefit from this proven technology.”

Dr. Valentina Kutyifa, principal investigator and research assistant professor of cardiology at the University of Rochester Medical Center, also stated:

“Our hypothesis is that the S-ICD device may reduce all-cause mortality in this high-risk cohort of cardiac patients with diabetes. The value of eliminating unnecessary patient complications by implanting a defibrillator which does not require intracardiac leads was an important factor in our decision to utilize the S-ICD device when designing this trial.”

Boston Scientific previously reported acquiring the S-ICD technology from Cameron Health in 2012.

NeuroTronik Closes $23.1 million Series B Round

NeuroTronik Closes $23.1 million Series B Round

NeuroTronik, a North Carolina based subsidiary of NeuroTronik LTD of Dublin, announced that it recently closed a $23.1 million Series B funding round. The press release noted that the round was led by contributions from Boston Scientific, Synergy Life Science Partners, and several venture capital firms.  NeuroTronik was quoted in the release as aiming to improve patient outcomes, shorten hospital stays, and reduce hospital recidivism rates.

 

According to NeuroTronik, the therapy, known as CANS Therapy, utilizes a neuromodulation device designed to stimulate the cardiac autonomic nerve via a catheter. NeuroTronik describes the device as less invasive than currently used implantable defibrillators, providing an alternative to drug-based treatments. According to the company, NeuroCatheterTM is temporarily placed in a vein just above the heart and is controlled via an external NeuroModulatorTM that can be positioned bedside.

“Physicians need better therapy tools to treat Acute Heart Failure in the hospital. With the achievement of our Series A milestones and through subsequent work, our team has demonstrated that NeuroTronik CANS Therapy™ holds considerable promise to be a unique and valuable tool for physicians for use in this clinical setting,” said Fred McCoy, CEO and Director, NeuroTronik LTD in a prepared statement.

NeuroTronik stated that it plans to use the Series B funding to obtain regulatory approval to market its CANS Therapy device in Europe. After obtaining European approval, NeuroTronik plans to bring the treatment to the United States.

Previous news sources state that NeuroTronik closed a $13.1 million Series A round in May of 2013, and was spun out of a medical technology incubator called Synecor in 2012.

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.

Boston Scientific Acquires Cosman Medical

Boston Scientific Corporation announced today that it has acquired Cosmon Medical, Inc. for an undisclosed amount.

Cosman Medical is a privately held manufacturer of radiofrequency ablation (RFA) systems used to treat patients with chronic pain, the leading cause of disability for adults in the United States. According to the press release, RFA has been used over the last 50 years as a procedure for providing relief for patients with chronic pain by applying heat to small areas of nerve tissue to interrupt pain signals.

According to Boston Scientific, the Cosman Medical team and products will become part of Boston Scientific’s Neuromodulation business, which currently offers Spinal Cord Stimulator (SCS) systems to treat patients with chronic pain. Spinal cord stimulation involves sending electrical signals to the spinal cord in order to mask pain signals from reaching the brain. Some patients find effective relief from RFA, whereas other patients turn to SCS to manage pain. Thus, the acquisition of Cosman Medical adds to Boston Scientific’s portfolio of non-opioid solutions for chronic pain.

Boston Scientific is headquartered in Marlborough, Massachusetts, and the company is a worldwide developer, manufacturer and marketer of medical devices. The company states that its products are used in a range of interventional medical specialties, including interventional radiology, interventional cardiology, peripheral interventions, neuromodulation, neurovascular intervention, electrophysiology, cardiac surgery, vascular surgery, endoscopy, oncology, urology and gynecology.

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.

Boston Scientific Files IPR Petitions Against Nevro

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.”

Boston Scientific Files Second IPR Petition Against UAB Patent

Boston Scientific Files Second IPR Petition Against UAB Patent

Boston Scientific Corporation (“Boston Scientific”) filed a petition with the Patent Trial and Appeal Board on April 10, 2015 requesting inter partes review of U.S. Patent No. 6,266,563 (“the ’563 Patent”).  The petition states that the ’563 Patent is owned by the UAB Research Foundation.  The petition has been assigned Case No. IPR2015-01038.

The ’563 Patent is entitled “Method and Apparatus for Treating Cardiac Arrhythmia,” and lists as inventors Bruce H. KenKnight, Raymond E. Ideker, Robert S. Booker, III, and Stephen J. Hahn.  The ’563 Patent states that it “relates to methods and an implantable apparatus for treating cardiac arrhythmia, particularly ventricular fibrillation.”  Figure 1 from the ’563 Patent is shown below.

The petition seeks review of all twenty of the ’563 Patent’s claims “as obvious under 35 U.S.C. § 103 based on U.S. Patent No. 5,181,511 (‘Nickolls’), U.S. Patent No. 5,433,729 (‘Adams’), and the knowledge of a person of ordinary skill in the art.”

The petition states that the ’563 Patent has been asserted by the Board of Trustees of the University of Alabama at Birmingham and the UAB Research Foundation against Boston Scientific and Cardiac Pacemakers, Inc. in a lawsuit filed on September 22, 2014 in the U.S. District Court for the Northern District of Alabama.  The complaint alleges that Boston Scientific and Cardiac Pacemakers, Inc., a wholly owned subsidiary of Boston Scientific, infringe the ’563 Patent by making, using, offering to sell or selling cardiac resynchronization therapy defibrillators (“CRT-Ds”), “including but not limited to the Incepta, Enrgen, Cognis, and Livian CRT-Ds . . . .”

The petition also states that Boston Scientific previously filed a petition requesting inter partes review of the ’563 Patent, alleging that all twenty claims were invalid as anticipated under 35 U.S.C. § 102(b) by U.S. Patent No. 5,797,967 to KenKnight.  The prior petition was filed on March 23, 2015, and was assigned Case No. IPR2015-00918.

Boston Scientific Files Petitions for Inter Partes Review of Three VSI Patents

Boston Scientific Files Petitions for Inter Partes Review of Three VSI Patents

On May 15 and 16, 2014, Boston Scientific Corporation and Boston Scientific Scimed, Inc. (collectively, “Boston Scientific”) filed a total of five petitions with the Patent Trial and Appeal Board requesting inter partes review of three U.S. Patents.  The first petition (the ’759 Petition) seeks review of U.S. Patent No. 8,142,413 (“the ’413 Patent”).  The second and third petitions (the ’760 Petition and the ’761 Petition) seek review of U.S. Patent No. 8,048,032 (“the ’032 Patent”).  The fourth and fifth petitions (the ’762 Petition and the ’763 Petition) seek review of U.S. Patent No. 8,292,850 (“the ’850 Patent”).  The petitions state that “all three patents are closely related and directed generally to the same subject matter,” and request that the petitions be assigned to the same Board.

All three patents are entitled “Coaxial Guide Catheter For Interventional Cardiology Procedures,” and list as inventors Howard Root, Greg Sutton, Jeffrey M. Welch, and Jason M. Garrity.  According to the patents, the ’850 Patent issued from an application that was a divisional of the application that issued as the ’413 Patent, which was a divisional of the application that issued as the ’032 Patent.

The ’413, ’032, and ’850 Patents state that they relate to “methods and apparatus for increasing backup support for catheters inserted into the coronary arteries from the aorta.”   Figure 7 from the patents is shown below:

The ’759 Petition seeks review of claims 1, 4, 9, 10, and 13 of the ’413 Patent on various grounds.  The ’760 Petition seeks review of claims 1-4, 8, 11, 13, and 17 of the ’032 Patent on various grounds, and the ’761 Petition seeks review of claims 1-4, 8, 11, and 13 of the ’032 Patent on alternative grounds.  The ’762 Petition seeks review of claims 1-4, 8, 12, 14, and 18 of the ’850 Patent on various grounds, and the ’763 Petition seeks review of claims 1-4, 8, 12-14, and 18 of the ’850 Patent on alternative grounds.

The petitions disclose that one or more claims of the ’413, ’032, and ’850 Patents have been asserted against Boston Scientific by Vascular Solutions, Inc. (“VSI”) in a lawsuit originally filed on May 16, 2013 in the U.S. District Court for the District of Minnesota.  VSI’s first amended complaint, filed on May 28, 2013, alleges that Vascular Solutions is the owner by assignment of the  ’413, ’032, and ’850 Patents.  The complaint further alleges that “VSI’s cause of action arises directly from Boston Scientific’s infringing actions by manufacturing, marketing and selling the infringing Guidezilla™ product in the State of Minnesota. . . .”

Boston Scientific to acquire the Interventional Division of Bayer AG

According to a Boston Scientific Corp. press release from May 15, 2014, the company has entered into a definitive agreement to acquire the Interventional Division of Bayer AG for $415 million. The transaction is expected to close in the second half of 2014. The press release notes that “[i]n 2013, Bayer Interventional generated sales of approximately $120 million.”

Included in the transaction are Bayer Interventional technologies designed to treat coronary and peripheral vascular disease. These technologies include “the AngioJet® Thrombectomy System and the Fetch® 2 Aspiration Catheter, which use endovascular techniques to remove blood clots from blocked arteries and veins, and the JetStream® Atherectomy System, a minimally invasive device used to remove plaque from diseased peripheral arteries.”

According to the press release, “[t]he acquisition is expected to improve Boston Scientific’s access to a number of attractive segments in the peripheral space, including the growing atherectomy and thrombectomy categories.”

Jeff Mirviss, president, Peripheral Interventions, Boston Scientific describes the effects of the transaction saying:

The addition of Bayer Interventional will expand our commercial footprint and enhance our ability to provide physicians and healthcare systems with a complete portfolio of solutions to treat challenging vascular conditions, . . . We believe this acquisition will accelerate the growth of our Peripheral Interventions business and strengthen our position as a global leader in peripheral therapies.

Mirowski Family Ventures Files Lawsuit Against Boston Scientific

Mirowski Family Ventures Files Lawsuit Against Boston Scientific

Last week, Mirowski Family Ventures, LLC filed a lawsuit against Boston Scientific Corp. and its wholly-owned subsidiaries Cardiac Pacemakers, Inc., Guidant LLC, and Guidant Sales LLC. According to the complaint, the defendants breached exclusive license agreements to patents relating to implantable cardioverter defibrillators and cardiac resynchronization therapy. The complaint also asserts claims for breach of the implied covenant of good faith and fair dealing, unjust enrichment, constructive fraud, disgorgement of profits, and negligence.

The NIH describes an implantable cardioverter defibrillator as an implantable device, similar to a pacemaker, that “uses electrical pulses or shocks to help control life-threatening arrhythmias, especially those than can cause sudden cardiac arrest.”

The patents identified in the complaint include U.S. Patent Nos. 4,316,4724,407,288RE38,119, and RE39,897. Figure 1 from the ‘119 patent is shown below:

The lawsuit seeks over $570 million in damages for the defendants’ actions. The lawsuit was initially filed on September 10, 2013 in the Circuit Court For Montgomery County, and was subsequently removed by the defendants to the U.S. District Court for the District of Maryland.

Fighting Fire with Fire – the Medical Device Tax and Outsourcing

Fighting Fire with Fire – the Medical Device Tax and Outsourcing

Since its passage as part of the Affordable Care Act in 2010, the medical device tax has been hotly debated.  The 2.3% excise levied on total revenues may effectively preclude new entrants while hindering the growth of established companies.  While industries have turned to outsourcing for a number of years as a way to cut costs, the medical device industry may increasingly consider outsourcing in the coming years as a means to offset the effects of this tax.  While outsourcing may help U.S. medical device companies, it may adversely affect Americans currently working in this sector.

OrbusNeich Sues Boston Scientific In Ireland

OrbusNeich Sues Boston Scientific In Ireland

OrbusNeich Medical Inc. and its subsidiary, Orbus International B.V., announced on Friday a lawsuit against Boston Scientific Corp. in Ireland for alleged patent infringement.  According to the press release, the lawsuit alleges that Boston Scientific’s coronary stent systems, including the PROMUS Element™, PROMUS Element Plus™, OMEGA™, TAXUS™, SYNERGY™, and Promus PREMIER™ lines of stents, infringe European Patent No. 2,311,412 and European Patent No. 1,341,482, both entitled “Stent having helical elements,” granted on August 9, 2012 and September 23, 2010, respectively.  Figure 11 from the ‘412 patent is shown below:

In February, OrbusNeich filed suit against Boston Scientific for patent infringement in Germany and the Netherlands.  A patent infringement suit filed by OrbusNeich against Boston Scientific in the U.S. in 2009 was stayed pending reexamination of the patents by the U.S. Patent and Trademark Office.  The asserted European patents are available at EP 2,311,412 and EP 1,341,482.

Federal Circuit Affirms $42 Million Award in Boston Scientific v. Cordis Corporation

Federal Circuit Affirms $42 Million Award in Boston Scientific v. Cordis Corporation

Boston Scientific has prevailed in the appeal of its lawsuit against Cordis Corporation.  Boston Scientific alleged in the lawsuit that Cordis’ 2.25 mm Cypher Sirolimus DES coronary stent infringed U.S. Pat. No. 5,922,021, entitled “Intravascular Stent”.  Figure 1A from the ‘021 Patent is shown below:

In a per curiam decision, the Federal Circuit affirmed, without further comment, the District Court’s March 2012 decision, which awarded Boston Scientific enhanced damages based on a finding of willful infringement of the ‘021 patent.  The total award to Boston Scientific was approximately $42 million.  A 32% royalty rate was assessed on sales of Cypher stents not included in the judgment.

The ‘021 patent was previously subject to ex parte re-examination, and a re-examination certificate issued on April 17, 2012.  According to a Cordis press release, Cordis discontinued manufacturing Cypher and Cypher Select Plus Sirolimus-Eluting Coronary Stents at the end of 2011.

New Suit Targets Rex Medical’s Vena Cava Filter

New Suit Targets Rex Medical’s Vena Cava Filter

EVM Systems, LLC has filed a new lawsuit targeting Rex Medical, L.P. and Argon Medical Devices, Inc.  The lawsuit alleges infringement of U.S. Patent No. 8,052,670, entitled “Medical Device With Slotted Memory Metal Tube.”  According to the ’670 Patent, the patent “generally relates to an instrument which uses a slotted memory metal tube to perform or assist in various medical procedures.”  ’670 Patent, col. 1, lines 17-19.  Figure 1A from the ’670 Patent is shown below:

According to the ’670 Patent, Figure 1A illustrates a “memory metal tube 11 with four slots 12 near the distal end.  The slots 12 create a balloon-shaped structure which can be used as a retrieval basket for small particles 14, with a closure around the caught particle due to the concave shape of the inner wall of the memory metal tube 11.”  ’670 Patent, col. 3, lines 32-37.

EVM Systems alleges that Rex Medical’s Option™ Vena Cava Filter infringes the ’670 Patent.  EVM Systems is a subsidiary of Acacia Research Corporation and has sued a number of medical device companies in the past several years, including Boston Scientific, Cordis Corporation, and Abbott Laboratories.  According to the complaint, Rex Medical is based in Pennsylvania, and Rex Medical’s distributor, Argon Medical Devices, is based in Texas.  The complaint and asserted patents are available here.

New Suit Targets C.R. Bard

C.R. Bard, Inc., and Bard Peripheral Vascular, Inc., are the latest targets of a series of lawsuits brought by LifeScreen Sciences LLC.  LifeScreen filed a patent infringement lawsuit in the District of Delaware on January 30 accusing C.R. Bard and Bard Peripheral of patent infringement.  LifeScreen Sciences and LifePort Sciences have recently filed patent infringement suits against Cook, Inc., Cordis Corporation, Medtronic Corp., W.L. Gore & Associates Inc. and Endologix, Inc.

LifeScreen’s latest lawsuit alleges that C.R. Bard’s Meridian vena cava filter infringes several patents, including U.S. Patent No. 6,468,290, entitled “Two-Planar Vena Cava Filter With Self-Centering Capabilities,” which issued in 2002.  The patent relates to a two-plane filter with filter wires with extensions that are applied against the wall of a vein and compel the filter “to adopt a position with its axis generally coincident with the axis of the vein…”   The ‘290 patent was originally assigned to SciMed Life Systems, Inc.

LifeScreen’s other lawsuits have targeted similar technologies.  For example, on January 23, 2013, LifeScreen filed lawsuits in Delaware and Texas alleging infringement of U.S. Patent No. 6,214,025, entitled “Self-Centering, Self-Expanding and Retrievable Vena Cava Filter,” a patent originally assigned to Boston Scientific.

The complaint and asserted patents in LifeScreen Sciences v. C.R. Bard are available here.