The Federal Circuit held in Amgen v. Sandoz that the so-called “patent dance” is optional for applicants seeking approval of a biosimilar product under the abbreviated BPCIA pathway, as discussed here. Indeed, biosimilar applicants have in a number of cases chosen not to participate in the “patent dance.” This occurred, for example, in a recent lawsuit filed by Amgen against Hospira in connection with Hospira’s plan to bring a biosimilar version of Epogen to market, as described in an earlier post. In fact, until today I was personally unaware of any case in which a biosimilar applicant actually did participate in the patent dance with a reference sponsor, but that has changed with Amgen’s filing of a lawsuit against Apotex on October 2, 2015.
Amgen v. Apotex was filed in the Southern District of Florida, and alleges that Apotex has infringed, or will infringe, US Patent Numbers 8,952,138 and 6,162,427 by seeking approval under the abbreviated BPCIA pathway for a biosimilar version of filgrastim (which is sold by Amgen under the trade name Neupogen). The complaint is available here.
According to the complaint, Apotex participated in the exchange of information set forth in the BPCIA, i.e., the patent dance, which included providing Amgen with a copy of its abbreviated Biologic License Application (aBLA), and as a result of these exchanges the parties agreed to the inclusion of these two US patents in the lawsuit. The ‘138 patent “covers improved redox chemistry-based methodologies for efficiently refolding cysteine -containing proteins expressed in non-mammalian cells at high protein frustrations.” Presumably Amgen believes the patent will be infringed by the processes Apotex will use to manufacture the biosimilar filgrastim.
The ‘427 patent is directed towards a method that “employs a combination of G-CSF and a chemotherapeutic agent to mobilize stem cells more efficiently from the bone marrow to peripheral blood in a patient in need of a peripheral stem cell transplant.” Amgen alleges that if FDA approves the Apotex product for the same indications as Amgen’s Neupogen product (which is what FDA did with respect to Zarxio, Sandoz’s biosimilar version of Neupogen), or if FDA requires Apotex’s label to contain the same information as Amgen’s Neupogen, then this will induce infringement of the ‘427 patent. According to Amgen, “absent a legally cognizable and enforceable commitment by Apotex preventing Apotex from marketing its filgrastim product with a label that includes the same information regarding clinical trials, dosage and standard of care as Neupogen label… an actual controversy exists between the parties.”
The BPCIA also requires that biosimilar applicants “shall provide notice to the reference product sponsor not later than 180 days before the date of the first commercial marketing of the” biosimilar product. In Amgen v. Sandoz, the Federal Circuit interpreted this language as requiring that a biosimilar applicant “only give effective notice of commercial marketing after FDA has licensed its product.” According to the complaint, Apotex sent Amgen a letter purporting to be Apotex’s Notice of Commercial Marketing on April 17, 2015. Amgen seeks a declaratory judgment that the notice provided by Apotex on April 17, 2015 is invalid because at that time Apotex’s product had not been approved for licensure by FDA.
For its part, Apotex has reportedly taken the position, in a letter to Amgen dated August 24, 2015, that “because Apotex followed the pathway and provided Amgen with its application and manufacturing information, providing a notice of commercial marketing is not mandatory.” Significantly, the Federal Circuit decided Amgen v. Sandoz on July 21, 2015, i.e., prior to Apotex’s letter, and held that notice of commercial marketing after licensure is mandatory. I do not understand the basis for Apotex’s argument that notice of commercial marketing is not mandatory if the biosimilar applicant has participated in the patent dance, but it will likely be interesting to see how this plays out in the courts.