It was late in the afternoon when Vijay and Jan took a break from their lab experiments to sit down at the communal table. Jan opened her laptop and looked at the red-lined patent application Daniella had sent over. As CompanieBee moved forward, Jan had become tasked as the primary company contact for IP issues. This was not to say that the full team had disengaged from the process. But as things moved forward, each of CompanieBee’s members had taken a lead role in some area – IP, regulatory, technical development, general operations and so on.
Vijay peered at Jan’s screen. They were looking at a draft claim set for the BXC assay patent application. “I don’t get it,” Vijay exclaimed. “I thought we explained to Daniella that we were the first to discover the set of mutations that predict response to the drug. So why are these DNA sequences not claimed here?” He reached over and scrolled down the page and then back up to the top. “And what about the assay, why don’t we have claims to a PCR assay amplifying the BXC gene?”
Jan grimaced. “Apparently, it’s not that straight-forward.” She began laying out the reasoning Daniella had provided to her in their last meeting. But Vijay just looked something between perplexed and miffed. “Look,” she finally said, “let’s call Daniella on FaceTime now. I know she’s available and she’s much better at explaining it. She even made a diagram for me which sort of explained why older patents we see have these types of claims, but we can’t get them now.”
“Okay.” Vijay agreed. “Let me just grab some strong coffee first. I think I am going to need a boost to make sense of all of this.”
When Vijay returned to the table, Jan already had Daniella on the screen. “Wow, you’re always available!” Vijay exclaimed. “I wouldn’t say always.” Daniella replied. “I’d prefer to stay away from the 3 am calls. But I do try to be there for you as a virtual team member.”
Daniella then moved on to the point of the call. “So, I understand you want to walk through the rationale for the claim set. I’ll go through some background first that will help give some context to where we are now. The diagnostics space can be a tough one, but not an impossible one for patenting.”
Daniella then proceeded to explain how court cases about diagnostic tools and assay patents had changed the landscape. She began with a description of a case which she referred to as Prometheus versus Mayo. The assay in this case monitored the level of a metabolite of a drug and then increased or decreased dosage based on the result. The court reasoned that because the assay simply monitored the conversion of the drug to the metabolite, which it labeled as a natural phenomenon, the claims to the assay were not patent-eligible.
Daniella moved onto a series of cases concerning Myriad’s identification of breast-cancer associated DNA sequences. She explained how isolated DNA sequences like genomic DNA, as well as primers and probes, were generally not on their own patent-eligible after these court decisions. Daniella described the rationale as a 2-part test. Question 1 concerned whether the claims concerned an abstract idea, a natural product or natural phenomenon. The answer to this is usually yes for the nucleic acids, because things like the mutations in a gene occur in nature. Question 2 then asks whether the patent claim adds something more that would move the subject matter into the patent-eligible territory. As Daniella explained it, standard techniques like PCR without something else would not cut it.
“Ugh” interjected Vijay. “This just doesn’t seem fair! Is anything left or are we doomed?” Jan chuckled and patted Vijay on the shoulder. “It’s not that bad.” Daniella concurred. “It’s not mission impossible, but there are limitations and it does take some creativity to get something both patentable and enforceable.”
“What do you mean by getting something enforceable?” Jan asked. Daniella chuckled. “It’s kind of a rock and a hard place when we are talking about methods claims.” She went on to explain a concept she called “divided infringement.” In this circumstance, the method claim has multiple parties that carry out different steps of the method. The example she gave was a diagnostic assay where a lab would perform a PCR analysis to test for gene mutations, but then using the results, a physician would prescribe and administer a specific type of drug. As Daniella explained it, if the lab did not control the doctor’s prescribing decision, the lab would likely not be found to infringe the patent claim. Yet, on the other hand, just a standard PCR assay for the gene mutations would not be patent-eligible as Daniella had run through with them earlier. “That’s why we give it some thought and design specific types of claims likes the ones I sent you in the draft.” Daniella concluded.
“Got it” Vijay and Jan said almost simultaneously. The three then revisited the draft claims with their new understanding. After a spirited discussion and some tweaks to the existing draft, Jan suggested a taking break and inviting the others for a beer at the local pub down the street. She went in search of Elle, who was in the lab room next door and Alex, who did not seem to be in their space.
Just as the 4 were about to give up on Alex, he came through the door with someone in tow. It was Greg from downstairs. Greg was a member of a small company that has just moved into the incubator. Usually a relaxed guy, Greg appeared rather perturbed, to put it mildly. He was holding a piece of paper in his hands, which Alex then took and handed to Daniella. “Daniella, can you look at this for him? It says something about cease and desist and goes on about infringement, and licensing and other stuff. What does this mean?” . . . to be continued.
Food for thought:
- Are there other areas of CompanieBee’s product development that might encounter issues with patent eligibility or divided infringement?
- What are the implications for a cease and desist letter? What actions should Greg’s company consider?
- Are Greg’s discussion with Daniella about the cease and desist letter shielded by the attorney-client privilege?
This blog is for general information purposes and is not intended to be and should not be taken as legal advice.