“But we do it better” exclaimed Jan. “How is it possible that the Jackson lab can have a patent on this?”
Jan was looking quite perturbed. She had been searching Google patents and had unintentionally come across a newly published application. It was related to their work on assays for activity of the BXC drug and combinations with other therapeutics.
“Give Daniella a call and ask her if she can come by to discuss” advised Vijay. “In the meantime, let’s all go out for a beer or whatever your beverage of choice, and brainstorm about our presentation for the upcoming conference in Portland.” On that note, the group finished up its activities in the lab and set out to the pub they referred to as “the Local” just a few blocks away.
Daniella stopped by the next morning. “Ok,” she said, “I’ve had a look through this filing, but before I go through it in detail, tell me how you see it, how this relates to what you are working on.”
Jan jumped in “We have this assay for BXC to look at activity when it is in combination with other drugs.” She explained the outlines of the assay including the cell-based incubations, followed by the panels of RNA expression markers they had been using. Vijay filled in a few more details and explained the results they had achieved so far, including the identification of compounds that appeared to work synergistically with BXC.
Jan jumped back in again, her voice escalating in volume in frustration. “But the Jackson lab’s assay is no way as good as ours. In fact, I am pretty sure their assay doesn’t work at all. How could they get this patent?!”
Daniella signaled for calm. “First, this isn’t a patent. It’s just an application that’s published. A published application is no guarantee that a patent will issue or even if it does, that the claims will look anything like what exists in the application now.”
“When will we know?” asked Elle.
Daniella responded by illustrating the general process. First, she explained, essentially anyone can file a patent application. Whatever is filed usually publishes in 18 months. In the first period, the patent office hasn’t looked at the application or the claims, other than for formalities like filling out the proper paperwork and paying the required filing fees. “Once the patent office does take it up for examination,” Daniella further explained, “the back-and-forth with the applicant becomes public so we can see how the application is progressing. When the patent office issues a notice of allowance, the claims are generally set and then the granted patent publishes with the final claims under its new patent number.”
“And that’s that?” inquired Vijay. “How long will that be for the Jackson lab application?”
“Well on your first question, the patent grant isn’t always the end of the story. Patents can be challenged post-grant if there is a reasonable basis like lack of enablement, lack of novelty or for obviousness over the prior art.” Daniella answered. “And on the timing, it’s variable based on how the examination goes and how the applicant responds to the patent office. For instance, if the Jackson lab limits their claims to more narrow methods such as what they describe in their working examples, the patent may issue quicker than if they persist with these broader claims.”
“What do you suggest we do?” Vijay then asked.
“For now, just sit tight and we’ll keep an eye on this one. My prediction is that the claims will narrow and when they issue, the claims will cover their assay but not cover yours. Then there’s not a freedom-to-operate issue. And if, as you say, your assay works and theirs is not as good, that might be the end of the story.”
“What if it doesn’t come out that way?” Jan chimed in.
Daniella explained they would then have a number of options. These would options would depend on balancing factors such as the strength of the issued claims and the likelihood the claims would be upheld as valid, the relationship of CompanieBee and the patent owner and the potential for a license on reasonable terms, the ability to design-around the issued claims and so on.
“The relationship aspect isn’t going to be a point in our favor.” Elle chuckled. “Vijay and Dan Jackson are like oil and water. You two wouldn’t even sit next to each other at that MS conference lunch last month.”
“Lucky for you then that the licensing decision and the terms are not in Dan Jackson’s hands. He works for the university, so we would be dealing with the tech transfer office there. Also, didn’t you tell me that Dan Jackson isn’t interested in anything beyond academic research? He doesn’t have his own start-up, right?” Daniella posited.
“Yeah, that’s the situation as of now” Elle responded. “And besides” added Jan, “there’s no way we’d do that 2nd target step in their method ever.” Daniella looked quizzically at Jan and then back at the computer screen that displayed the Jackson lab’s application, and then asked her to point out the disfavored step.
“That one in claim 1” replied Jan. Daniella smiled broadly. “In that case” she said, “you may have no trouble with this application. All claims depend from claim 1 and therefore require that step. Provided that fact doesn’t change when the claims issue, it sounds like your method won’t ever incorporate that element. Since infringement requires performance of every step of the claimed method, your method won’t fall under the scope covered by the claims. Bottom line, is that you will not have a freedom-to-operate issue with this patent.”
On that pronouncement, the group visibly relaxed. Daniella spent a few more minutes catching up on some pending issues and then headed out.
If the second target step required by the claims in the Jackson lab’s patent application had not been the deciding issue, here are some questions for consideration:
- What should CompanieBee consider in designing around the patent claims?
- Could CompanieBee still get a patent on their BXC assay in view of the Jackson lab’s patent application?
- How might the patent landscape surrounding the BXC assay (including patents and applications from others) impact the licensing terms for the Jackson lab’s assay method?
The content of this blog is for informational purposes only and does not offer legal advice. Circumstances are fact-specific and you should consult an attorney for legal advice concerning your individual issues.