CompanieBee was now a few months into its incubator term. This morning’s strategy/coffee session brought a new twist.
Vijay approached the table with a new face at his side. “Everyone, this is Alex. He joins our team at CompanieBee starting today.” Vijay explained that Alex would bring a new capability to the team. Alex specialized in applying artificial intelligence, specifically neural networks, to drug discovery methods. He would help the search for additional drug candidates for their existing multiple sclerosis target, as well as looks for new targets that could impact the disease.
Enthusiastic welcomes came from Elle and Jan and then the group settled down to its discussion with the usual compliment of morning caffeine and pastries.
“What’s happening with the BXC drug candidate?” Jan asked. “It’s just completing the pre-clinical tests, and so far, so good,” Vijay replied, “Phase I should start pretty soon.” BXC had been the lead that Vijay and Elle had worked on at the university. The university had partnered with the Tiajen drug company to test and hopefully commercially develop BXC, with the understanding that Vijay’s lab would continue to work on additional leads and the companion diagnostic assay. When CompanieBee was formed, Tiajen agreed to the move of the future leads and assay to the new start-up.
“On that note,” Jan piped up “we should discuss the current timeline for our assay.” Since this was Alex’s first morning session with the group, Jan provided some background. She explained that the assay would monitor the activity of the target in response to BXC. The idea would be to correlate the target activity in human patients to the effects on specific MS symptoms.
Alex looked interested. He wanted to know how the symptoms would be monitored and what other data would be collected in the trial.
Alex then asked about an assay for selecting patients in the trials. Elle explained the current plan. “We have a separate assay for 4 prominent candidate genes that are correlated as risk factors for MS. There are a number of different mutations and expression levels in MS populations and our assay can monitor them in the patient populations of the trials.” Following this overview, Jan and Elle showed the latest progress on the assays and what was left to do to be ready for Phase I testing of BXC.
“Sorry I’m late,” Daniella, the company’s IP attorney, stuck her head around the corner. She had already heard the latest assay data from Jan when they spoke by phone a day earlier. “Just in time,” Vijay said. “Let’s move on to where we stand with our patent applications and that Jackson lab article.” Daniella nodded and pulled out her notes. “Before we dive in this topic, I just want to remind everyone that we are going to have our first quarterly IP strategy review in 2 weeks. I will need information on your research timelines, current regulatory plans and don’t forget to make a list of what meetings you plan to present at, so we can sync all of this up. I’ll give you some more guidance later this week.”
Daniella turned back to the immediate topic at hand, the article on the Jackson’s lab assay. She explained how the publication came after CompanieBee’s filing of its patent application and on that score the article would not be prior art. She went on to explain, however, that the Jackson lab could have already filed their own patent application. “What then?” asked Jan, “how will we know if they filed?”
Daniella explained how US applications typically publish 18 months after filing. However, the Jackson lab could have filed a provisional application. She further explained that a provisional application is an initial filing that does not publish and is not examined by the patent office. Instead, the Jackson lab would have one year to convert this initial filing into a non-provisional application, the type that would then publish and be examined for patentability by the patent office. If the non-provisional claimed the filing date of the provisional application, then it would publish 18 months from this filing date.
“Remind me again,” Elle queried “what’s the purpose of the filing date?” “This is the date that sets a line between what came before and is prior art versus what is after and is not prior art, right?” quipped Vijay. Daniella nodded.
She also explained to the group one exception to publication, that the patent office offers a non-publication request option. This option, however, would not permit the Jackson lab to file for patents on the invention in other countries. Plus, given the research publication by the lab, it would be an unlikely option. “I’ll keep monitoring it” Daniella told them, “if something comes out you’ll be the first to know.”
Vijay introduced Alex to Daniella and explained Alex’s new role in the company. Daniella was intrigued. Alex jumped right in when he realized Daniella would be guiding their IP strategy. “I have a great idea for a clinical trial app to go along with CompanieBee’s companion assay for BXC and I also have some ideas for an AI approach to finding new targets.” Daniella nodded encouragingly and then noted that there would be some challenges as well as different strategies for IP protection in these areas. “Let’s talk about this again when I come by later in the week” she suggested.
Food for thought:
- What challenges does patenting in the area of AI and neural networks present?
- Can Alex patent his idea for a clinical trial app before he has completed its design? And if yes, should he do so?
- For CompanieBee’s upcoming IP strategy session with Daniella, what information should be considered in formulating an IP plan for the BXC diagnostic assays?