Ha Kung Wong: The FDA's Biosimilar Action Plan


Ha Kung Wong, JD, partner at Fitzpatrick, Cella, Harper and Scinto, discusses key features of the Biosimilar Action Plan.


As a litigator, one of the things that particularly caught my attention was the FDA’s commitment to enhancing the Purple Book to make it more useful. Currently, unlike the Orange Book for small-molecule drugs, the Purple Book doesn’t list any of the patents that cover the biologic products. This has created a challenge for biosimilar manufacturers, as they have to attempt to determine the entire scope of patents protecting any drugs they are developing essentially through their own internal analysis.

With the Orange Book and small-molecule drugs, FDA guidance pursuant to 21 C.F.R. § 314.53(b)(1) is clear that applicants may list “drug substance (or active ingredient) patents, drug product (or formulation and composition) patents, and method-of-use patents.” Applicants, however, may not list process patents, patents claiming packaging, patents claiming metabolites, and patents claiming intermediates.

It’s unclear from the limited information that the FDA has given whether they will able to include similar patent information in the enhanced Purple Book, but if that were to be included, it could change litigation strategies going forward.

For example, more patents may see IPR (or inter partes review) challenges as the biosimilar manufacturer wouldn’t need to wait to go through the [Biologics Price Competition and Innovation Act, BPCIA] patent dance procedure to identify all of the patents relevant to a biosimilar drug and could start bringing the challenges earlier.

It may also decrease the incentive to use the BPCIA patent dance as the patents that could be involved would already be identified. From an innovator’s perspective, identifying all the patents that could be infringed by biosimilar manufacturers could be difficult without knowing the manufacturing methods they are using. And perhaps more importantly, if innovators are unable to list process patents in the Purple Book, similar to what’s in place for the Orange Book, there could be a significant loss of efficiency on both sides, as process patents tend to be much more important and unique for biologics than they are for small molecules.

From the perspective of an innovator, anything the FDA does to speed up the approval process will make litigation that much more important for protecting their products from biosimilar competition once any regulatory exclusivities have ended. Earlier approvals could cause us to see more biosimilar manufacturers attempting at-risk launches and cause us to see more related legal procedures such as requests for temporary restraining orders and preliminary injunctions.

The FDA said that it will be creating updated guidance for biosimilar manufacturers that are seeking approval for fewer conditions than the reference product is approved for. More guidance informing this practice could change both innovator and biosimilar manufacturers’ assessments of the strength of patent portfolios, as method of treatment patents may become less valuable in protecting biologic drugs from competition.

The FDA also noted that they will be working together with other government partners to take corrective action if they see evidence of practices that create an imbalance between innovation and competition that is contrary to statutory intent. This may mean we will see extra scrutiny of litigation and IPR settlements that are interpreted to potentially delay biosimilars from reaching the market.

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