Blog Tag: Catheters

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.

Cuba an Untapped Market for Medical Device Exports

Cuba an Untapped Market for Medical Device Exports

The United States is the world’s largest medical device exporter, according to reports accounting for $45 billion of over $140 billion in global exports in 2014.  This is not surprising since it also produced the largest share of medical devices in the same year, contributing to nearly a fifth of the $340 billion global industry. Yet, the United States and other large markets are largely saturated with annual growth rates of only 3 to 5 percent.

For these reasons, Cuba displays a potential high-growth opportunity for American medical device manufacturers, according to a recent report in the Cuba Journal. According to the report, Cuba’s expenditures on healthcare in 2014 were nearly 10 percent of its GDP. Yet, Cuba’s domestic production of medical devices is limited largely to low margin goods such as surgical dressings, optical lenses, and dental supplies. Thus, Cuba is greatly dependent on medical device imports, including both low-end goods such as syringes and catheters as well as high-end goods like imaging equipment and orthopedic devices.

However, the share of imports to Cuba from the United States is dwarfed by other countries. According to the report, Europe makes up over 40 percent of Cuban imports while China and Japan combine for nearly 30% of the country’s imports, as of 2014. The United States, on the other hand, provides less than 1 percent of Cuba’s medical devices. Even Mexico exports twice the share of Cuban medical devices the United States does.

Meanwhile, similarly sized markets received far greater attention from U.S. manufacturers. For most of the period from 2005-2014, U.S.  exports to regional countries with a per capita GDP comparable to Cuba’s, such as the Dominican Republic and Colombia, have been more than 200 times greater than that of Cuba, according to the report

Fortunately, medical device exports to Cuba from the United States are on the rise. In 2015, U.S. exports to Cuba jumped by more than 600 percent compared to 2014 even though exports to Cuba dropped overall by 40 percent in the same period.

Notwithstanding the above, few companies have taken advantage of the Cuban market. This may be due in part to unfamiliarity with the law as well as delays and difficulties in complying with it. However, the U.S. Office of Foreign Assets Control has relaxed some of the barriers, and an exception for medicines and medical devices to the general policy of denial for exports already exists. This, combined with a greater awareness of the trade opportunities in Cuba and the greater openness between the United States and Cuba, have made Cuba a potentially attractive destination for U.S. medical devices. But, at present, the Cuban market remains largely untapped.

Cardinal Health to Acquire Cordis for $2 Billion

(March 2, 2015) Johnson & Johnson announced that Cardinal Health has made a binding offer to acquire Cordis, a Johnson & Johnson company, for $1.99 billion.  The press release indicates that the sale price includes $1.944 billion in cash and $46 million in net receivables.  According to Cardinal Health’s announcement regarding the acquisition, it expects the deal to close by the end of 2015. Highlights of the deal can be found here.

According to its website, Cordis manufactures cardiovascular and endovascular products, for example stents, catheters, guidewires, and vena cava filters. According to news articles, Cordis was acquired by Johnson & Johnson in 1996 for about $1.8 billion.

According to its website, Cardinal Health is a health care services company that distributes pharmaceuticals and medical products to healthcare providers and pharmacies. Cardinal Health also manufactures various medical products. Last year, Cardinal Health acquired AccessClosure for $320 million.


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.



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. . . .”

AngioLight Forms Partnership With MTIA

Interventional cardiology medical device company AngioLight announced today that it has formed a partnership with Medical Technologies Innovation Asia (MTIA).  According to AngioLight’s press release, MTIA will perform safety, animal and clinical studies of AngioLight’s diagnostic catheter in exchange for equity in AngioLight.  AngioLight’s newly appointed president, Gary Saxton, will oversee the partnership.

In the press release, AngioLight’s president states:

While the worldwide market potential for our device is clear, we see a uniquely high growth opportunity in China, where the patient need exists and an advancing healthcare system is moving towards improved standards of care. Our collaboration with MTIA will allow us to capitalize on this opportunity with expert, on-the-ground resources who can help move our technology through the development phase and into the hands of physicians.

According to the press release, AngioLight has developed a light-based diagnostic catheter to improve proper stent sizing and placement.  AngioLight is based in Medford, Massachusetts.  MTIA is a medical device company headquartered in Hong Kong, with manufacturing and sales facilities throughout China.  AngioLight’s press release is available here.

Federal Circuit Upholds Lower Court Decision in Edwards Lifesciences v. CoreValve

Edwards Lifesciences succeeded in its appeal at the Federal Circuit in the lawsuit Edwards Lifesciences v. CoreValve.  Edwards’ lawsuit asserted that the Medtronic CoreValve ReValving system infringed U.S. Patent No. 5,411,552, entitled “Valve Prosthesis for Implantation in the Body and a Catheter for Implanting Such Valve Prosthesis”.

The Federal Circuit upheld the District Court’s decision in favor of Edwards Lifesciences and sent the case back to the District Court to reconsider its decision to deny an injunction.  The Federal Circuit’s decision is available here.