Posts Tagged: "public use"

On January 24, the Federal Circuit affirmed a jury’s finding that the defendant-appellant, Medtronic, induced surgeons to infringe two patents of plaintiff-appellee, Dr. Mark Barry, which were directed to methods of correcting spinal column anomalies, such as those due to scoliosis, by applying force to multiple vertebrae at the same time. Medtronic appealed on several grounds, “principally concerning the public-use and on-sale statutory bars, but also concerning prior invention, inequitable conduct, and induced infringement.” The majority of the panel rejected the appellant’s arguments, while Chief Judge Prost dissented and would have found that one of the patents was invalid due to either the public use or on sale bars of Section 102(b). Barry v. Medtronic, Inc., No. 2017-2463, 2019 U.S. App. LEXIS 2305 (Fed. Cir. Jan. 24, 2019) (Before Prost, Chief Judge, Moore and Taranto, Circuit Judges) (Opinion by Taranto) (Dissent by Prost).

The United States Patent and Trademark Office (USPTO) provides invalidity tools via inter partes review (IPR) and post-grant review (PGR), but which route is better? …  PGRs are estimated to cost more because of their broader discovery rules.  If cost is a major factor, IPRs are a less-expensive option due to restricted allowance of discovery, the most expensive aspect of patent litigation… If the invalidating arguments or art are not strong, an IPR may be a better option due to its lower threshold for institution.  The same prior art arguments that failed in a petition for a PGR may have succeeded in an IPR petition due to the lower standard.

The legal principles set out above, while seemingly straight-forward enough, leave ample room for case-specific interpretation and application when it comes to the question of whether the use of a claimed invention in connection with carrying out clinical trials will constitute an invalidating public use. Patent applications are typically filed early on in the process of developing and commercializing a pharmaceutical drug product. One reason for this approach is to secure the earliest possible filing date thereby pre-dating as much would-be prior art as possible. Such would-be prior art, however, is not limited to that published or otherwise emanating from others but also includes time bars such as the public use bar. The circumstances under which clinical trials involving administration of a drug product that occur prior to the critical date may constitute an invalidating public use is a murky area of the law and courts’ decisions in this area are highly dependent on the facts of the case before them.

Generally speaking the first step toward commercializing an invention and making money is typically to pursue the patent path. For those new to the industry it is important to understand that on the road to a patent there are many mistakes that inventors can make unwittingly, some of which will ultimately make it impossible to obtain a patent. With that in mind, here is a list of the top 5 mistakes inventors make, followed by discussion of what you should do to move your project forward in an appropriate and responsible way.