Proprietary Perspectives: Post-Patent Pendency Inclemency: Trailblazing with Blindfolds

Examining strategies your company can employ when your patents are pending.

ByAnthony Almada, B.Sc., M. Sc.

Thanadophilus, Inc. (a fictitious entity) has developed a unique, heat-free method to kill live probiotic organisms and yet achieve even higher bioactivity after administration to humans (compared to heat-killed “bugs”), as demonstrated in some pilot clinical trials. Prior to disclosing their invention and offering it for sale they elect to file a non-provisional patent application—triggering the process of prosecution of the patent application at the U.S. Patent and Trademark Office (PTO). They elect to have their application published. They then commence marketing their patent pending product, and enjoy incremental success. (A patent does not mean potent or effective, and a patent pending does not allow its owner to exclude competitors from duplication. So what proprietary power tools can be employed, which have teeth and bite force?)

Almost two years later the patent application publishes. Two months later Necrodophilus, LLC (another fictitious entity), launches a “dead bugs” microorganism product, making the same efficacy claims as the Thanadophilus product. Competitive intelligence gathering (legally) orchestrated by Thanadophilus leads them to believe that Necro­dophilus is using the same method—as de­scribed in full in Thanadophilus’ patent application claims. Additionally, Necrodophilus does not appear to have any clinical trials on their marketed product. Discussion of this matter with their IP firm forces Thanadophilus to recognize that they have no ability to exclude Necrodophilus from practicing the same invention during the patent pending period (pendency) of the application, exacerbated by the acknowledgement that their patent may not issue for another 18-24 months. This measurable, perhaps even incremental loss of revenues over this duration, proved very distressing for the sales, marketing and management teams. Given these scenarios, what are their options?

It is noteworthy to assess what Thanadophilus has: 1) a published patent application; 2) clinical trials on the actual finished good; and 3) alleged active infringement on their invention. Three distinctive strategies can be employed. In relation to the assessment that their patent application claims are being in­fringed, Thana­dophilus faces up to two more years of being handcuffed and unable to exclude any competitor via patent infringement litigation. However, Thanadophilus can request accelerated examination of their patent application, which would yield them a grant/no grant decision from the PTO within 12 months. If the PTO elected to grant the patent they would then be able to proceed with attempting to secure a patent license from Necrodophilus or commence patent infringement litigation, if Necrodophilus is in­fringing.

A second path to pursue would be filing litigation in a federal district court, asserting Necrodophilus is in violation of the Lanham Act by making false claims (of efficacy) for their product. The merit of this approach would be further amplified if Necrodophilus was using Thana­dophilus’ own data—presented as scientific meeting abstracts—and attributing it to the Necro­dophilus product. Given that the two products are compositionally distinctive and different, Thanadophilus would have a fighting chance of prevailing and permanently stifling Necro­dophilus from making such claims and pirating (“borrowing”) their data (as achieved by Pharmanex in 1999 against another entity that was pirating Pharmanex’ red yeast rice data). This expensive tactic would, however, not require Necrodophilus to cease its alleged infringement of Thana­dophilus’ claims in its pending patent.



“Patent power tools do not come cheap and drain both human and financial capital. That said, prized possessions are worth fighting for.”




The final, and most unexplored tool to employ would be invoking a U.S. patent law [35 U.S.C. § 154(d)] that enables the owner of a pending patent application to put an alleged infringer on notice and obtain a “reasonable royalty” (NOT lost profits) spanning the duration of time between the publication of the patent application and the date the patent is granted. To invoke this rule, the following must transpire: 1) the owner/inventor of the patent application must provide actual notice of the patent application to the alleged infringer; 2) the patent application must be granted; and 3) the allegedly infringing invention must be “substantially identical” to what is claimed in the granted patent. This last requirement is of pivotal importance, as many patent claims have been changed or deleted be­tween the time of filing and the time of granting. Assume Thanadophilus originally claimed the use of any extract from any Cinnamomum (cinnamon), Origanum (oregano), or Rosmarinus (rosemary) species as the superior, heat-free method to kill probiotic organisms but the granted patent allowed only the claim of using any extract of Cinnamomum species. Assume Necrodophilus used an extract of Mediterranean oregano only. In this instance, Thanadophilus’ claim would be rendered more dead than its bugs.

Patent power tools do not come cheap and drain both human and financial capital. That said, prized possessions are worth fighting for.NW