By Orion Armon, IP Litigation practice group, Cooley LLP

Until now, the mHealth industry has experienced relatively few patent infringement conflicts, and little or no litigation instituted by non-practicing entities. But these trends may be disrupted within the next few years.  Companies in the medical device, computer, networking, and communications industries are all patenting in the mHealth space, and the likely result will be a thicket of overlapping patents on mHealth products and their components. As the patent thicket grows, patent infringement conflicts likely will increase—especially as mHealth technologies mature and winners within the industry emerge.

To help you navigate the patent thicket, this article discusses the current patent landscape in the mHealth industry and concludes with recommendations that mHealth companies could pursue to manage their intellectual property more effectively and reduce patent infringement risk.

Summary of Findings

• The number of mHealth patents issued by the Patent Office has increased steadily since 2000 (when the number of mHealth patent applications was negligible), and will continue to surge until at least 2014.
• Large companies are winning the mHealth patent race by obtaining the vast majority of newly-issued mHealth patents.
• Intellectual Ventures, a non-practicing patent aggregator, is patenting aggressively in the mHealth space.  Licensing demands and litigation from IV (and possibly other NPEs) are sure to follow.
• Almost half of the top twenty mHealth patent holders are not mHealth companies, or even medical device developers.
• The incidence of mHealth patent infringement conflicts likely will increase as companies become more profitable and patent portfolios mature.  To manage patent infringement risk, companies should consider the following options:
  • If you have never been sued, consider purchasing insurance;
  • Properly structure IP indemnification rights and obligations;
  • Build-out your patent portfolio—even ancillary improvements in the mHealth space may become critical if they are widely adopted by your competitors;
  • Streamline  your internal invention disclosure, review, and patent filing processes, and where appropriate, use the USPTO’s Track 1 process to accelerate examination of key patent applications;
  • Monitor competitors’ patent filings and patent portfolios, and consider making pre-issuance submissions of prior art during prosecution of competitors’ patents;
  • Proactively cross-license patents with key IP owners to expand your freedom to operate—or utilize commodity components from major companies who will indemnify you for their use; and
  • If competitors are infringing, consider enforcing your patents before your competitors’ patent portfolios mature.

So Far, No Significant Uptick in mHealth Litigation Activity

The mHealth industry has seen a few patent infringement lawsuits this year, including the following notable cases:

• CardioNet filed lawsuits against MedNet Healthcare, MedTel 24, Rhythm Watch, AMI Cardiac Monitoring, ScottCare, and Ambucore Health Solutions;
• Robert Bosch Healthcare filed lawsuits against ExpressMD, MedApps, Waldo Health, and Cardiocom; and
• BodyMedia filed a lawsuit against Basis Science.

The volume of patent litigation in the mHealth industry is low relative to related industries such as the computer, smartphone, and medical device industries. The following factors likely play a role in damping the amount of patent litigation in the mHealth industry:

• The difficult funding environment and poor economy make the expense of litigation unpalatable;
• The industry is rapidly evolving and it is unclear which technologies and solutions will be profitable “winners”; and
• Many companies are still in the process of building their patent portfolios.

The influence of these factors will wane as the economy stabilizes, the mHealth industry matures, and companies obtain more patents on mHealth technologies. Some mHealth companies are already becoming more aggressive about defending their intellectual property rights.

For example, AirStrip, a company that offers a mobile patient monitoring platform, announced in September 2012 that it obtained a patent (U.S. Patent No. 8,255,238) on technology for sending and displaying physiologic data on a mobile device.  In an interview with MobiHealthNews, AirStrip’s President and Chief Medical Officer, Dr. Cameron Powell, claimed that his company’s patents cover “taking any type of physiologic data—whether that’s from a sensor in the shoe, a home monitor, a blood pressure cuff, or a monitor in the hospital—and then re-rendering it on a native or HTML5 application on a mobile device.” At the time, Powell noted that, “[t]he message here to the industry is not that we are issuing this press release to stop every company out there who is doing this, [but], who knows, there may be a few fringe players who we have an issue with.” More recently, on October 18, 2012, AirStrip filed a lawsuit against mVisum, Inc. in the Southern District of New York alleging that mVisum’s CCS, Live Stream, OB, and onDemand products infringe AirStrip’s ‘238 patent. As is typical in such lawsuits, AirStrip’s Complaint requests an injunction barring future infringement, treble damages, and attorneys’ fees.

Similarly, after filing several lawsuits against competitors in the home health monitoring field, Robert Bosch Healthcare’s spokeswoman declared that “[w]e feel it is important to demonstrate that IP is important, and not just to our company. Bosch Healthcare Systems, like most high-tech companies, values its intellectual property as an essential asset of its business. Bosch is open to working with those companies that are interested in securing this technology through a licensing agreement, and we are in discussion with numerous companies in this regard.”

Patent owners in many industries tout their patent rights and use their patents to attack alleged infringers. AirStrip’s and Robert Bosch Healthcare’s actions are notable because they seem to indicate that mHealth companies are becoming more assertive about their patent rights. Loudly advertising patent rights and filing patent infringement lawsuits tends to create insecurities in competitors that may spark patent arms races or precipitate business disputes that result in additional litigation.