10 Jul Non-Disclosure Agreement or Provisional Patent Application or Both?… by Shilpa G. Ghurye
With the changes in patent law after implementation of the America Invent Act, entrepreneurs/innovators routinely face a dilemma when it comes to protecting their intellectual property when talking to collaborators or investors. It is because this act grants a person or an entity who files a patent application priority to receive the patent for that technology over a person or an entity who invents the technology. So, what is the best way to protect your IP rights? Non-disclosure Agreement or Provisional Patent Application, or both?
A case worth discussing is Hexagon Health, Inc. et al v. Medtronic Plc et al, a lawsuit filed in the U.S. District Court for the District of Delaware, in which the founder of Hexagon Health, Dr. Shirin Towfigh (“Dr. Shirin”) has alleged patent infringement of hernia mesh device by Medtronic.
What is the origination of this lawsuit?
Dr. Shirin, a practicing surgeon in Beverly Hills founded Hexagon Health to develop technologies that would address complications related to hernia care that her patients encountered. Her device comprised a textile mesh with fin-like shape to address these complications. This design could benefit both male and female patients. For instance, in men with inguinal hernias, she found that her mesh would address unwanted complications such as painful intercourse and testicular pain that resulted from using traditional inguinal hernia mesh. In women with femoral hernia, she found that her design offered improved coverage in the femoral space. Hexagon Health filed patent applications for its novel design in 2015 and has since been granted several patents covering this design (US Patent Nos. 11, 207,169; 11, 219, 619; and 11,324,579). Around 2015, Dr. Shirin began discussions with Medtronic to seek their help in getting her mesh device in the market. They even signed a non-disclosure agreement prior to these discussions. However, Dr. Shirin discovered later that Medtronic filed a patent application for its hernia mesh product, Dextile, in 2017. Medtronic’s mesh incorporated a similar fin-like shape to Dr. Shirin’s mesh and boosted similar benefits as her device. To make matters worse, Medtronic marketed its product as an original product without recognizing Dr. Shirin’s contributions. Dr. Shirin filed a patent infringement lawsuit against Medtronic and is not only seeking financial damages for willful infringement by Medtronic but also wants Medtronic to add her as an inventor in their patents related to this mesh device and the court to prohibit Medtronic from further marketing their product in its current form.
What are the takeaways from this lawsuit?
Dr. Shirin did everything that was necessary before she began her discussions with Medtronic. Yet, she had to file this infringement lawsuit against Medtronic. However, since she had taken the necessary precautions, she has a better standing against Medtronic than someone who may not have taken these precautions. As we await the court’s decision in this matter, there are many takeaways from this lawsuit for young entrepreneurs who need industry help to bring their product to the market. Firstly, make sure that you have a strong non-disclosure agreement signed with the third party. It is always best to engage an attorney to draft the non-disclosure agreement and review edits from the opposing party instead of using mere templates that are available. Secondly, engage an attorney to draft and file a provisional patent application. It is essential to include as much information regarding the technology as possible in the specification of the provisional application including modifications contemplated by the inventor. This helps if there is a lawsuit like Dr. Shirin’s lawsuit because the filing date of the provisional application will establish a priority date for the invention which is later used in a non-provisional or utility application to determine the effective filing date of the invention. Thirdly, be very smart when discussing their technology with third parties and share only what is necessary with the third party.
References:
https://medcitynews.com/2024/12/medtronic-lawsuit-hernia-patent-infringement/
By Shilpa G. Ghurye, Senior Attorney at KMD Law