On July 5, the Federal Circuit ruled in favor of Amgen against Apotex in a case clarifying the so-called patent dance.
What is the patent dance?
Since the enactment of the Biologics Price Competition and Innovation Act (BPCIA) in 2010, biologics patent owners and biosimilars patent applicants have grappled with the particulars of the patent dance.
The BPCIA established a two-stage litigation process, whereby the source patent holder (in this case, Amgen) and the party applying for a Biologics License Application (in this case, Apotex) exchange information, the intent being to narrow the patents the applicant might attempt to get, and the volume of litigation triggered by the process.
The BPCIA has been the subject of a number of incongruent interpretations, and, because it is still quite new, litigation in cases like this one have been the primary vehicle for clarification and specification of the Act.
Dance partners: Apotex and Sandoz
This decision functions as a complement to Amgen v Sandoz, which established that the first stage of information sharing of the patent dance is not legally required of a biosimilar applicant. However, when the applicant does not elect to share this information, it is still required to provide the 180 days’ notice to the reference product maker before its biosimilar becomes available on the market.
Amgen v Apotex then established two related precedents: a biosimilar applicant that does elect to participate in the informational exchange stage of the patent is also required to provide the source 180 days’ notice of launch, and that this notice may only be given after the biosimilar has been approved by the FDA.
Giving the notice of launch at the time the biosimilar receives an FDA license should simplify the second stage of patent dance litigation, particularly for source drug patent owners. Instead of having to counter each iteration and change the applicant makes to its patents, source owners will now only need to expend resources to address a biosimilar once its exact nature, use and manufacturing processes are fixed.
If the biosimilar applicants “make the product one way it might infringe patent A; if they make it a different way, it might not,” said Dominick Conde of Fitzpatrick, Cella, Harper & Schinto. “It’s unfair to try to shoot at a target that’s always moving,” he added.
Apotex – like Sandoz had before it, when up against Amgen – also argued that the Court’s application of Section 8(A) of the BPCIA gave the reference product a de facto six month extension of its 12 year exclusivity period. The Court replied in its decision that the 12-year mark is “an earliest date, not a latest date, on which a biosimilar license can take effect.” It also emphasized the likelihood that, as more and more biologics will be approved and sold in the future, biosimilar applicants can begin their development, patenting and FDA-approval processes well within the exclusivity period, ensuring to give notice of launch to the reference drug-maker six months before the 12 year period ends.
Endorsement for tentative approval
In his opinion, Federal Circuit Judge Richard Taranto wrote that the Court found no legal reason that the FDA could not issue licenses to biosimilar applicants that would not become effective until the end-date of the 12-year exclusivity period for the reference drug.
This approach would be “akin to what happens with the Hatch-Waxman Act” for branded versus generic pharmaceutical litigation, said Peter Armenio, co-chair of Quinn Emmanuel Urquhart & Sullivan’s life sciences practice group.
The early days of the BPCIA’s trajectory have tracked closely with those of the Hatch-Waxman act.
“I think what the Federal Circuit is projecting is that [what happened with] that regime will also come to pass in the biologics act,” said Armenio, “but there will be a whole lot of litigation between now and then.”
Guidance from the FDA itself and this litigation will, over time, determine if the FDA has the reach to issue these tentative licenses. The Amgen v Apotex case, coupled with this likely continuation of litigation and FDA participation should streamline and clarify the timing issues that have plagued patent dance and to “set the rules of the road,” said Armenio.
Ultimately, he said: “once Congress sees how [the BPCIA] is being interpreted, and if it’s how they intended, they may seek to adjust it.”