In June 2017, the US Supreme Court ruled that the “patent dance” was not mandatory for biosimilar manufacturers. Since then, our discussion of the patent dance (not patent litigation) has been infrequent. The first wave of biosimilars tended to perform the dance (or did it not incompletely). Therefore, manufacturers of drugs like filgrastim, infliximab, epoetin, and others have already hit the dance floor or not. The patent litigation that has resulted or been headed off (less likely!) already occurred. Since the Supreme Court ruling, if you will, the music was still playing, but there were fewer spectators.
I hadn’t given the patent dance much thought since that time. I was under the impression that the majority of developers of new biosimilars would likely now avoid this process.
An excellent session at the ACI Biosimilar Summit this week in New York City focused the spotlight on the dance floor once again. The meeting itself was chockfull of attorneys—attorneys talking patents. Inevitably, this topic resurfaced. And it caused me to alter my perceptions.
CONTROLLING THE INFORMATION EXCHANGE
The exchange of information that takes place upon initiating the patent dance can still be advantageous to the biosimilar maker and the manufacturer of the innovator biologic. Irena Royzman, PhD, Partner at Kramer Levin, explained, “The patent dance gives control to the biosimilar applicant. It limits the number of patents the innovator can litigate. This is very powerful, especially when the innovator has [a multitude of patents].”
However, there could be advantages for the biosimilar applicant who decides not to participate. For instance, she said, the applicant can keep reference manufacturers from knowing what indications are being sought, unless these are released publicly. They can also shield such critical information as the manufacturing process.
TAPPING IN AND TAPPING OUT
Petra Scamborova, PhD, Director, Dispute Resolution, Regeneron Pharmaceuticals, pointed out that participating in the patent dance does not have to be a black and white decision. “There are several options,” Dr. Scamborova remarked, besides fully participating in the patent dance, which she believes is still the best option for biosimilar manufacturers. “It gets you the patent list early on,” she said, “which commits the innovator to asserting a specific set of patents that they will defend. It also gets you the reference manufacturing information prelitigation,” added Dr. Scamborova.
“If the innovator doesn’t abide by the rules of the dance fully,” she continued, the applicant will be at reduced risk, which may result in “a reasonable royalty only” should the biosimilar maker be on the losing end of a district court decision. Dr. Scamborova also commented that full participation in the patent dance avoids unnecessary litigation down the line.
Charles Klein, Partner, Winston & Strawn LLP, offered another option: “dancing partway,” that is, beginning the patent dance but electing to exit the process before completion. He thinks this may be a viable strategy if the reference product’s 12-year exclusivity is already expired. He noted, “It usually takes 6 to 9 months to get through the patent dance prior to litigation.” If a biosimilar maker intends to launch their product relatively soon after approval, delaying the litigation by 6 to 9 months can have a material effect on its ability to launch (e.g., 2 yr after approval).
However, undergoing the initial dance steps gains some of the important information during the exchange. “If you elect not to continue the dance,” Mr. Klein said, “the downside is that the biosimilar applicant loses control over the litigation. The sponsor could decide not to sue immediately (though not likely), which will delay resolution. You will also waive the statutory limitations on remedies.”
From the innovator’s perspective, a partial dance is better than no dance at all, Mr. Klein stated, “because you get a good deal of information from the applicant’s application. You control which patents to assert and when to assert them.”
GETTING IN AND OUT OF STEP, DEPENDING ON TIMING
What about option 3—no dance at all? The attorneys on the panel believe that decision again hinges on the timing of the 12-year exclusivity. Matthew Pearson, Partner at Akins Gump Strauss Hauer & Feld, pointed out that avoiding the patent dance altogether may be a good choice if, for instance, the applicant is not the first biosimilar for the innovator drug. “You may think you already know what patents will be asserted by the innovator.” In this scenario, the biosimilar applicant can keep its manufacturing information from the innovator company for some time.
Another important factor in deciding whether to engage in the patent dance relates to the new biosimilar maker’s belief as to whether it will infringe the innovator’s patents. If the biosimilar manufacturer believes it they will not infringe, and it does not have the first biosimilar for a particular biologic, he thinks it may make sense to avoid the patent dance completely.
What of the scenario when the opposite is true, where the biosimilar maker is faced with 70 patents and expects to infringe on some? The patent dance can then limit the number of patents that can be litigated. In the case of fewer potential patents at issue, the attorneys on the panel believe that the launch timing will play a role (along with the biosimilar maker’s willingness to accept risk). If sufficient time exists before potential launch, proceeding to the dance floor would make sense, they said.
Finally, in the case where the applicant knows only partially which patents will be asserted, but assumes it will not infringe upon any of these. Then, beginning the patent dance makes sense; the biosimilar maker can obtain the list of patents to be defended by the reference drug maker. It might then also make sense to stop the dance after confirming the patent list. Overall, they claim, the patent dance does present some benefits for biosimilar developers. The Supreme Court’s opinion did not strike down the process, only the fact that it was not mandatory. Based on the opinions of these experts in the process, it make still help smooth a still rough path through the litigation process.