The U.S. Supreme Court held earlier this year in Commil USA v. Cisco Systems that a mistaken but good faith belief that a patent is invalid is not a defense to a claim of induced infringement. This ruling is particularly important for medical device companies since liability for infringement of medical method patents must often be found through a theory of inducement rather than by direct infringement.
Medical device companies often pursue both apparatus claims and method claims when filing patent applications covering their devices. Apparatus claims, which can cover items such as disposables, durable devices, systems, components, implants, instrumentation and surgical kits themselves, tend to provide stronger patent protection than method of use or method of manufacture claims covering the same technology. However, method claims can also add valuable protection, particularly when a company’s device is similar to other devices known in the prior art but is being used or made in a different manner. Method claims may also include fewer structural limitations than the corresponding device claims, affording them a broader scope of protection.
A drawback to medical method claims is that they typically are not directly infringed by competing medical device companies selling similar devices as those described in the patent. Rather, medical method claims are infringed by entities such as surgeons, hospitals, or end users. Even if companies holding medical method patents want to sue their own potential customers, section 287(c) of the US patent code provides a safe harbor for medical practitioners and their health care entities so that these entities can provide the best care to patients without apprehension of patent infringement lawsuits. For the owner of a medical method patent to go after a competing medical device company that is supplying medical devices used in the patented method, a charge of indirect infringement such as inducement or contributory infringement must be used.
Proof of inducement requires a showing by the patent holder that the inducer had a certain level of intent to cause the infringement. Prior to the ruling in Commil, it was unclear whether a good faith belief of patent invalidity (such as one supported by a written legal opinion) was sufficient to defeat this intent requirement and avoid liability for induced infringement, at least until a point in time when the belief of patent invalidity is proved incorrect. The Supreme Court has now made clear in Commil that a belief of patent invalidity does not support a defense to induced infringement. The Court has also reaffirmed that induced infringement requires knowledge that the induced acts constitute patent infringement (as opposed to merely having knowledge of the patent.)
The Commil opinion strengthens patents having method claims by confirming that written opinions of invalidity alone are insufficient to shield a defendant from liability for induced infringement.
I hope you find this update useful and informative. If you have any questions regarding IP strategies, please feel free to reach out to me at email@example.com. For further background on Shay Glenn and our IP expertise, visit www.medtechbriefs.com. The site has recently been upgraded and additional medical device resources continue to be added.
Doug Limbach is a registered patent attorney in Silicon Valley representing early stage medical device companies, the entrepreneurs who found them and the investors who fund them. He has represented more than 50 such companies, including TheraSense (acquired by Abbott Laboratories), Archus Orthopedics (acquired by Facet Solutions), Facet Solutions (acquired by Globus Medical), Novare Surgical (acquired by a major robotic-assisted surgery company), Aragon Surgical (acquired by Aesculap), Tibion (acquired by AlterG) and Xlumena (acquired by Boston Scientific). Mr. Limbach has been working in patent law since 1991.