By Limin Zheng, Ph.D., GCA Law Partners LLP
“Patent dance” refers to the elaborate exchange of patent information between a biosimilar applicant and a biologics sponsor under the Biologics Price Competition and Innovation Act (BPCIA) of 2009. It is intended to have the parties resolve any patent disputes expeditiously, preferably before the launch of the biosimilar product. Under the Act, within 20 days of FDA’s acceptation of an abbreviated biologics license application (aBLA), the biosimilar applicant “shall provide to the reference product sponsor a copy of the application ... and such other information that describes the process or processes used to manufacture the biological product that is the subject of such application.” This starts the dance.
After receiving the application and other information, the biologics sponsor must provide “a list of patents” for which it “believes a claim of patent infringement could reasonably be asserted.” The parties will then continue with more back-and-forth moves and counter-moves, culminating in a final short list of patents that the biologics sponsor can sue on in Phase I of the litigation. After the biosimilar applicant gives notice of commercial marketing — which must be provided “not later than 180 days before the date of the first commercial marketing” of the “licensed” biosimilar product under BPCIA — the biologics sponsor may, in Phase II of the litigation, seek a preliminary injunction with respect to other unresolved patents identified during the dance. Except for those issued after the dance, the patents that the biologics sponsor can assert in a lawsuit are limited to those identified during the dance.
In the Sandoz v. Amgen decision, issued in June, the U.S. Supreme Court held that despite the use of the word “shall” in the statute, an injunction is not available, at least under federal law, to force the biosimilar applicant to initiate the patent dance. The court also held that the commercial marketing notice may be provided by a biosimilar applicant before the FDA actually licenses the product, eliminating the possibility of an extra 180 days of exclusivity for the biologics sponsor. The Sandoz decision was clearly a win for biosimilar manufacturers.
In the Amgen v. Hospira decision, issued on Aug. 10, the U.S. Court of Appeals for the Federal Circuit gave a little more ammunition back to the biologics manufacturers (though on its face, it was a loss for Amgen), opining that the “could reasonably be asserted” language in the statute allows a biologics sponsor to initially include in the list any patent that it believes in good faith “could” reasonably be asserted, even if the belief is mistaken. If the biosimilar applicant fails to disclose information required under BPCIA pertinent to assessing infringement of a listed patent, the listing of the patent is deemed “reasonable.”
In December 2014, Hospira submitted to the FDA an aBLA for its biosimilar product to Amgen’s Epogen (epoetin alfa). Hospira notified Amgen the following February of the FDA’s acceptance of its aBLA, and provided Amgen with a copy of the application on March 3, 2015, triggering the patent dance.
During the dance, Hospira refused to provide information about the specific composition of its cell culture medium, claiming that it had provided sufficient information about both its product and the manufacturing processes in its aBLA. Unable to get this information, Amgen believed that it did not have a reasonable basis to assert its cell culture patents against Hospira, and consequently did not identify any cell culture patents during the patent dance.
The patent dance proceeded on other patents that Amgen identified. On Sept. 18, 2015, at the conclusion of the dance, Amgen sued Hospira in the U.S. District Court in Delaware for patent infringement under BPCIA. Because the lists exchanged during the patent dance did not include any cell culture patents, no such patents were asserted in the lawsuit.
During discovery, Amgen moved the court to compel Hospira to produce information about Hospira’s cell culture medium used for making the biosimilar product. Because no cell culture patent was at issue in the lawsuit, the district court denied Amgen’s motion, finding such information irrelevant to the case. Amgen appealed.
The Federal Circuit’s Opinion
In dismissing Amgen’s appeal, the Federal Circuit held that it lacked jurisdiction over the trial court’s discovery order. The Federal Circuit also denied Amgen’s request for a writ of mandamus because Amgen failed to show that it had “no other adequate means to attain the [desired] relief.”
Amgen argued that unless discovery of Hospira’s cell culture process were allowed, its patent enforcement rights afforded by BPCIA would be thwarted. According to Amgen, under BPCIA, it could only identify during the dance patents that it had a good-faith belief were infringed — or else it would face sanctions under the federal rules. By withholding information, Amgen argued, Hospira effectively prevented Amgen from asserting its cell culture patents.
The Federal Circuit disagreed. It held that BPCIA only requires that the sponsor list patents that it “believes . . . could reasonably be asserted,” and provides “no sanction for holding or asserting a mistaken belief in good faith.” According to the Federal Circuit, what Amgen should have done was to list the cell culture patents during the patent dance at the start, which would then have required Hospira, under BPCIA, to respond with “a detailed statement that describes, on a claim by claim basis, the factual and legal basis of the opinion of the [biosimilar] applicant that such patent is invalid, unenforceable, or will not be infringed.” Had Hospira failed to comply with its disclosure obligations, Amgen “would have a reasonable basis for asserting a claim of patent infringement.”
The Federal Circuit also clarified that its previous opinion that a sponsor “can access the required information through discovery” did not “purport to hold that the usual rules governing discovery do not apply in the BPCIA context.” That is, BPCIA does not supplant the pre-existing Federal Rules of Civil Procedure, which generally limit discovery to “nonprivileged matter that is relevant to any party’s claim or defense and proportional to the needs of the case” (emphasis added).
While the decision is unfavorable to Amgen, it is helpful to other biologics sponsors about to enter into a patent dance. It sets a low bar for how “a claim of patent infringement could reasonably be asserted” under BPCIA and allows a biologics sponsor to potentially identify more patents at the beginning of the dance than what it can reasonably assert at the end of the dance, after receiving additional information from the biosimilar applicant. It effectively penalizes a biosimilar applicant for withholding information relevant to the manufacturing process of its product — or at least takes away the incentives for doing so. However, it remains unclear whether a biologics sponsor can assert a patent in litigation without sufficient information for a good-faith assessment of infringement — something a patent owner would generally not be able to do in a regular patent infringement suit — where the missing information is in the control of a third party (as often is the case for the exact composition of cell culture medium).
While ambiguity still remains, the scheme outlined by the Federal Circuit is consistent with the congressional intent for the patent dance: “to ensure that litigation surrounding relevant patents will be resolved expeditiously and prior to the launch of the biosimilar product, providing certainty to the applicant, the reference product manufacturer, and the public at large.”
About The Author:
Limin Zheng is a litigation partner at GCA Law Partners LLP. She specializes in intellectual property and other complex technology litigation, with an emphasis on biotherapeutics, biotechnology, and medical devices. She can be reached at email@example.com.