TAKEAWAY: The USPTO has requested public comment on the Experimental Use Exception, and patent practitioners should be on the lookout for the USPTO’s findings.
The U.S. Patent and Trademark Office (USPTO) recently solicited public feedback on the current state of the experimental use exception to patent infringement. The agency is evaluating whether legislative action should be considered to codify the exception consistent with its efforts to promote innovation.
By statute, a party infringes on a patent when it, without authority, makes, uses, offers to sell, or sells a patented invention within the United States during the term of the patent. 35 U.S.C. § 271. However, under common law, courts have long held that parties should not be punished for practicing a patented invention when their actions and motivations fall within the experimental use exception.
Since the seminal case Whittemore v. Cutter setting forth the experimental use exception in 1813, courts have refined the contours of this defense to patent infringement. Whittemore v. Cutter, 29 F. Cas. 1120 (C.C.D. Mass. 1813) (Case No. 17,600). Most recently, in 2002, the U.S. Court of Appeals for the Federal Circuit clarified the exception in Madey v. Duke University, holding that “regardless of whether a particular institution or entity is engaged in an endeavor for commercial gain, so long as the act is in furtherance of the alleged infringer’s legitimate business and is not solely for amusement, to satisfy idle curiosity, or for strictly philosophical inquiry, the act does not qualify for the very narrow and strictly limited experimental use defense.” 307 F.3d 1351 at 1361-1362 (Fed. Cir. 2002). The Madey decision reflects current jurisprudence.
Some innovators may view the narrower reading of the experimental use exception provided by Madey as a boon, increasing the likelihood of a successful patent infringement claim against competitors. However, other innovators may view the limited scope of the defense having a chilling effect on innovation. Congress outlined a safe harbor provision in 35 U.S.C. § 271(e)(1) for infringing uses that employ specific genetic manipulation techniques, but legislative initiatives seeking to codify the experimental use exception more broadly have not been successful.
The USPTO concluded the public feedback period on September 26, 2024. Interested parties should remain on alert for potential changes or further guidance in this area of patent law.