“Yum!” exclaimed Elle as she saw the box of scones, brioche and other goodies that Daniella, CompanieBee’s IP attorney, had brought along for the meeting. “Where did you get these?” Elle asked. “In the Inner Sunset District, at a bakery called Arizmendi.” The other members of CompanieBee, Vijay, Alex and Jan, joined them around the table with steaming mugs of coffee and tea.
Daniella opened her laptop and projected a list onto the screen behind the conference table. “These are some of the issues we are going to run through today,” she explained “this will help us with syncing the IP strategy with your research and product development plans.” She then advanced to a slide with a timeline across the top. Daniella explained that this was a high-level view of their product development and IP filings based on their initial discussions. Now they were going to break it down into more detail and update it with recent events and plans.
They started with the R&D plan for the BXC assay. Jan set out the milestones. Testing of the finalized assay in the lab would be complete by Q4 2017. Then there were the submissions for the IDE which would allow them to use the assay with clinical trials, and then subsequent milestone points for the clinical testing and evaluation. “What about the timeline for Tiajen’s testing of the BXC drug?” Tiajen, a large pharma company, was spearheading the development of the BXC drug based on Vijay and Elle’s work at the university prior to starting CompanieBee.
“With the original formulation or Vijay’s new formulation?” asked Elle. Daniella replied that they should map out both, so Elle provided the planning information she had received from the last meeting she had participated with their collaborators at Tiajen.
Daniella then referred back to the timeline with the current patent filings, including those started at the university, applications already filed by CompanieBee and also applications planned but not yet filed by the team. She explained how the yellow arrow indicated when their first patent on the BXC assay was filed. This was the one that they had filed while Vijay and Elle were still at the university. It was licensed to CompanieBee. Daniella explained that the length of the line represented the lifespan of the patent. Then she pointed to a separate arrow for the new patent application CompanieBee had filed on an improvement to the assay, and also the other arrows that indicated filed and planned applications for the drug, its administration and formulations. Next, she overlaid this onto the R&D timeline.
“What’s the purpose of this diagram?” asked Alex, “It just makes me think we have a lot of work to do!” Daniella laughed. “That’s one way to see it, or you have a lot of exciting times ahead!” She replied and then continued, “But my purpose for this diagram is to work with the team to coordinate these activities and your IP strategy. Some key goals for my part are making sure that your innovations are protected by patent filings before you start putting them out in the public and working with others outside the company. I also want to look in detail at the components and methods you will be using and eventually commercializing to see if there are any issues with 3rd party IP that we should address.”
Daniella returned the discussion to the first point, the coordination of CompanieBee’s activities with the IP. She asked Vijay to summarize the plan for research publications and presentations at scientific conferences. Vijay went through the plan for the upcoming year. He also mentioned that Dr. Reins, one of his former university colleagues, wanted to work on a joint publication and would be stopping by next week to map out the joint research plan.
“Let’s come back to the issue of your work with Dr. Reins after we finish with the current tasks” Daniella noted. “I want to address some issues about trade secrets and joint work before you embark on that meeting.”
“Ok,” Daniella paused and then highlighted several points on the timeline. “Each of these is a point where you will be communicating about the company’s work – either to collaborators, regulators or at meetings.” She went on to explain that at a reasonable time before each of these points they needed to review what patents had been filed and assess whether it made sense to file on any new developments. She then highlighted another group of points in a different color. These, she explained, represented points in the R&D plan where aspects of the assay, drug formulation and other details would become fixed. “Well before these points we will want to look for any relevant 3rd party IP.”
“What 3rd party IP are we looking at?” asked Elle. Daniella explained that they would talk about that topic in more detail, but that in a nutshell, the team would map out the various components for the assay and the drug formulation, and then she would do some searching to see if other individuals, companies or institutions had filed patents in these areas. They would then look more closely at what had been filed and what had issued to decide next steps. “What next steps would you recommend?” inquired Jan. “That will depend on what we find,” explained Daniella. “In some cases, you might want to design-around what has already been patented, in some instances licensing is an option, and in others we might find that the patent claims are unlikely to be upheld as valid and just go forward. The attractiveness of each option might also depend on who owns the patent at issue.”
Food for thought:
- What should Vijay and the group consider related to trade secret protection before the visit of Dr. Reins?
- What issues of inventorship and ownership might arise if Vijay and Dr. Reins embark on a joint research project?
- What are the challenges in filing patents on the BXC assay and its combination with the BXC drug?