Courtenay Brinckerhoff on Patent Cap in Drug Pricing – ‘Hard to predict if this will make a difference’

Foley & Lardner LLP partner Courtenay Brinckerhoff discussed a recent bill passed in the U.S. Senate aimed at lowering drug prices by limiting the number of patents that can be asserted in cases over biosimilars in the Law360 article, “Patent Cap In Drug Pricing Bill Seen As Having Muted Effect.”

Brinckerhoff, who is vice-chair of Foley’s Intellectual Property Department, said the bill seems to be targeted to help biosimilars makers resolve cases sooner, so they “can be on the marketplace without patent litigation holding that up,” but “it’s hard to predict if this will make a difference.”

The legislation only counts certain patents toward the cap, including those that have a filing date more than four years after a biologic drug’s approval. Brinckerhoff said that the four-year window appears to be “getting at the perceived problem of companies mining their earlier patent applications for additional subject matter and continuing to get new patents off of the same original patent application.”

The bill also does not have any limits on patent assertions after a biosimilar drug is launched. Brinckerhoff noted that while companies sometimes do file new patent suits after a biosimilar or generic drug is approved, typically, settlements reached before a launch are broad enough to preclude further disputes.

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