US Launch: Five litigation strategies European biosimilar developers should know

Authors: Joshua Whitehill is a counsel in Goodwin's Litigation Department and a member of the Intellectual Property group. Natasha Daughtrey is a partner in Goodwin's Intellectual Property Litigation group.

Timing can be everything when it comes to successfully launching a biosimilar product in the United States.  The timeline for launch of such products is controlled in part by the Biologics Price Competition and Innovation Act (BPCIA).  The BPCIA outlines an abbreviated regulatory pathway for FDA-approval of biosimilar products and a litigation framework for patent disputes between reference product sponsors (RPS) and biosimilar applicants.  The complex interplay between the BPCIA’s regulatory and litigation schemes can create potential stumbling blocks for a biosimilar developer’s commercialization plans.  Below we highlight five key litigation strategies that any newcomer to the U.S. biosimilar market should consider as they develop a biosimilar for the U.S. market.

1. Patent Dance Strategy

The BPCIA outlines a unique series of pre-litigation disclosures and negotiations between the parties following the FDA’s acceptance of a biosimilar application—this process is commonly referred to as the “patent dance.”  If an applicant opts to engage in all steps of the patent dance, it typically takes about 8 months to complete before the filing of a complaint in federal district court.  Therefore, a biosimilar applicant needs to determine whether it will engage in a full patent dance, opt out of it, or something in between.  Each strategy comes with its own potential benefits and risks and should be assessed based on the specific circumstances.

2. Patent Defense Strategy

Unlike typical generic drug patent litigation under the Hatch-Waxman Act, litigation under the BPCIA may involve several dozen patents pertaining to a wide variety of different subject matters.  U.S. law does not currently provide a mandatory listing of patents, akin to the FDA’s Orange Book, that an RPS could assert against a biosimilar applicant.  Instead, a biosimilar applicant may receive such a listing from the RPS through the patent dance procedures.  Accordingly, an applicant may need to engage in considerable due diligence prior to FDA-submission to identify all patents owned or licensed by the RPS and develop defensive positions against each patent. 

3. IPR Strategy

A biosimilar applicant may decide to file one or more petitions for inter partes review (IPR) to challenge the validity of the RPS’s patents before the Patent Trial and Appeals Board.  Biosimilar applicants commonly file IPR petitions before or concurrent with BPCIA litigation.  IPR proceedings have different rules and strategies than district court litigation.  If instituted, an IPR proceeding typically takes around 18 months from the time of filing the petition to a final written decision on the merits.  IPR proceedings can impact an applicant’s litigation position or settlement leverage, so applicants should determine early on which patents to challenge via IPR, and when. 

4. "Notice of Commercial Marketing" Strategy

The BPCIA requires that an applicant provide the sponsor with “notice of commercial marketing” (NCM) at least 180 days before the applicant’s first commercial marketing of the biosimilar.  NCM timing is critical both because it is a prerequisite to any launch, and because it can trigger a preliminary injunction proceeding and litigation over additional patents.  Providing NCM early on in a case or later in a case may be preferable, depending on the applicant’s goals.

5. Preliminary Injunction Strategy

Under the BPCIA, a biosimilar applicant may face preliminary injunction proceedings when it provides its NCM to the RPS.  The entry of a preliminary injunction that blocks the launch of a product pending the outcome of the full litigation can be a major setback for an applicant.  Thus, a biosimilar applicant needs to identify the evidence, experts, and arguments to defend against these proceedings early.

Final thoughts

Developing a strategy for these areas is critical, but in no way exhaustive of the large number of other legal, regulatory, and market considerations that a biosimilar applicant must consider before and during litigation.  It is important to reevaluate and reassess these strategies throughout a case to maximize the chance of a successful commercial launch.