IP and Equivalence

Under a recent court ruling, device manufacturers' 510(k) submissions may be fodder for invalidation of U.S. patents.

Linda E. Alcorn

Can information about substantial equivalence provided to FDA in a premarket notification (510(k)) submission be used to invalidate a patent? In a recent decision by the United States Court of Appeals for the Federal Circuit, the answer was a resounding yes.

When applying to the U.S. Patent and Trademark Office (PTO) for a patent, applicants owe a “duty of candor and good faith.” A breach of this duty can arise from a failure to disclose information material to patentability, coupled with an intent to deceive or mislead the patent office. Intent can be inferred if the withheld information is highly material to patentability. A breach of the duty of candor, often referred to as inequitable conduct, can render a patent unenforceable and in some cases can subject the patent holder to a judgment requiring it to pay the accused party's attorneys fees.

All of these elements came into play in the case of Bruno Independent Living Aids Inc. v. Acorn Mobility Services Ltd. and Acorn Stairlifts Inc., which was recently decided in the Federal Circuit.1 The court upheld an award of attorney's fees to the accused infringer because the patent holder, during procurement of its patent, failed to disclose to the PTO information from an FDA submission regarding “substantially equivalent” devices.¹

Background