Over the past 20 years, the number of patent infringement disputes filed annually at the U.S. International Trade Commission (ITC) has more than tripled.  Although typically associated with smartphones and semiconductor chips, the ITC has also seen quite a few disputes involving medical devices.  Important trends are emerging in medical device patent litigation at the ITC.

This post is part of a three-part series that will explain why medical device companies should stay on top of trends in this fast moving and high stakes forum for litigation, to avoid being caught unprepared.  This Part presents basic information about section 337 and how it has been used in cases involving medical device patents.  Part II will describe the key issues addressed in proving or disproving a violation of section 337 involving a medical device.  Finally, Part III will look at the track record of medical device cases at the ITC including trials, settlements, and remedies.

Section 337 of the Tariff Act of 1930 allows U.S. intellectual property (IP) owners to seek exclusion orders barring the importation into the United States of articles that infringe their patents or other IP rights.  If a patent owner proves a respondent has violated section 337, U.S. Customs and Border Protection will block infringing products at the border — even new versions of infringing products developed after the exclusion order goes into effect.  This powerful, prospective remedy, along with section 337’s speedy procedures, attract patent owners to the ITC to protect IP rights and market share.

Since 1996, there have been twenty section 337 investigations involving infringement of medical device patents instituted by the ITC — about 4 percent of the total.  In the past few years, cases involving medical devices have been instituted at nearly twice that rate, with almost one case in every ten featuring a medical device.  The cases surveyed represent a wide range of products and technologies, including hospital and medical equipment (CPAP machines, incubators for premature infants), surgical equipment (dissection balloons for laparoscopic hernia repair), drug delivery devices (insulin pens), and diagnostic and testing equipment (tumor locators for guiding radiation treatment, HIV test kits).

While section 337 complaints can target infringement of all types of intellectual property as well as other forms of unfair competition, medical device cases have focused almost exclusively on patent infringement, with one case claiming both trademark and patent infringement.  Nearly half the time, a medical device section 337 complaint alleges infringement of a single patent, although a few patentees have asserted 7 or 8 patents in a single complaint.  Multi-patent complaints are far more common in section 337 litigation involving information and communications technology products.

Because the remedy under Section 337 is prospective, many complainants file parallel district court litigation seeking damages for past infringement.  Among medical device cases, complainants brought district court complaints against the same parties with respect to one or more of the same patents 65 percent of the time, which is consistent with the overall rate of parallel ITC/district court patent litigation

Although a section 337 complaint can be filed at any point before complainant’s patent expires, many medical device complaints get filed at one of two times.  For products that require FDA marketing approval, it is common to see a complaint filed by the company that was first to market shortly after the FDA grants marketing approval to a competing product.  For products that do not require FDA marketing approval, a complaint may be filed when a new competitor begins importing a rival product to the U.S. in commercial quantities, or even by imports for use at trade shows or in patient trials.

Look for our next post in this series, which will look at what happens once a section 337 complaint is filed.