The Lab Manager's Role in Preparing Patent Applications
Lab managers can play an important role in the process of filing patent applications on staff members' inventions. The stakes are often high when patenting a new product or process. So it's important to get everything right. Nowhere is this truer tha
Lab managers can play an important role in the process of filing patent applications on staff members' inventions. The stakes are often high when patenting a new product or process. So it's important to get everything right. Nowhere is this truer than in the pharmaceutical industry where average costs to develop a new drug now exceed $1 billion.
Getting a patent is a complex process impacted by both regulations and court decisions. For example, the March 29 issue of C&EN carried a report (page 17 of the print edition) that a U.S. federal appeals court ruled in favor of Eli Lilly & Company in its patent litigation with Ariad Pharmaceuticals. Ariad had claimed that two commercial Lilly drugs, Evista (for treating osteoporosis) and Xigris (for treating sepsis) had violated its own patent covering methods of treating disease by regulating cell-signaling activity. In 2007, a U.S. district court had ruled in favor of Ariad and ordered Lilly to pay Ariad $62.5 million in damages plus future royalties on sales of the two drugs. Lilly appealed the decision and the appeals court overturned it. The reason? The appeals court decided that Ariad had failed to adequately describe its invention. Therefore, the court declared the patent claims were invalid.
According to Lawrence M. Green, a patent attorney at Boston law firm Wolf, Greenfield & Sacks, this federal appeals court decision indicates the importance of including legally solid, well-written descriptions and support for any invention when filing a patent application. Inventors need to give careful thought to the applications of fundamental discoveries before filing a patent on them.
The lab manager's role
This is often difficult for inventors to do because they are emotionally involved in the conception and development of an invention. Patent attorneys are sometimes ill equipped to do so themselves despite having science or engineering degrees. This is because they were not involved in creating the invention. To remedy this, the inventor's supervisor or team leader should be involved in this process. The supervisor, whatever his/her job title, should combine a fairly detailed knowledge of the invention, which the patent attorney may lack, with the emotional detachment the inventor may lack. The supervisor can help define and explain the invention when writing the patent application. It should be noted that this is this author's opinion and others may disagree.Being involved in the process means the supervisor should give careful thought to the staff member's invention disclosure before it is submitted to the patent department or outside law firm whose lawyers will draft the patent application. Later a final review of the patent application with the inventor and patent attorney can help assure that critical points are covered in both the claims and patent teachings. Another essential point is that the patent examples must support the claims. It also is important that the background and description of the invention be written correctly when submitting the application to the U.S. Patent and Trademark Office. Lab managers can contribute to making sure the description and background of the invention satisfy company interests and requirements. With greater knowledge of corporate strategies than their staff members have, lab managers may have useful contributions to make in helping draft patent specifications. This includes a description of the invention that may be broader than what is defined in the claims.