I wanted to share with you another interesting post by Kurt Karst at FDALawBlog.com. This one discusses a recent court ruling on patents that has implications for FDA regulated industries. The decision, in part, states
“Whoever marks upon, or affixes to, or uses in advertising in connection with any unpatented article the word “patent” or any word or number importing the same is patented, for the purpose of deceiving the public; or Whoever marks upon, or affixes to, or uses in advertising in connection with any article the words “patent applied for,” “patent pending,” or any word importing that an application for patent has been made, when no application for patent has been made, or if made, is not pending, for the purpose of deceiving the public – Shall be fined not more than $500 for every such offense.”
Each offense is then defined as each article that includes the false patent claim. The ruling goes on to state, “Any person may sue for the penalty, in which event one-half shall go to the person suing and the other to the use of the United States.” As a result of this, several lawsuits have been filed.
Many of our clients are surprised by the detailed regulations governing product labeling. This is yet another label detail to bear in mind. We stand ready to help you with your labeling and other FDA regulatory needs and welcome your call (303-432-1605) or email.
Read the entire FDA Law Blog post here.