As the Biologics market is predicted to be a $250 billion market in the next few years, it is not surprising that parties embroiled in biosimilar litigation go to the mat. Both Apotex and Sandoz filed cert petitions this year in their cases against Amgen. The issue? A provision in 2010’s Biologics Price Competition and Innovation Act (BPCIA) that requires a biosimilar product applicant to give a 180 day notice to the sponsor of the reference product. To date, that provision has been construed so that the 180 days only begins to run once the Food and Drug Administration (FDA) has already approved the biosimilar.
Other provisions in the BPCIA also provide exclusivity for the reference product, before the biosimilar is approved. For example, a biosimilar application cannot even be submitted until the reference product has been approved for four years. And the FDA cannot approve a biosimilar until the reference product has been approved for 12 years. 42 U.S.C. §262(k)(7)(A), (B). What import could an additional 180 day delay have? Plenty when you consider the economics. Biosimilars have been, on average, about 30 percent cheaper than their reference products (at least in Europe). The introduction of a cheaper biosimilar may have the effect of expanding the market for the therapy. And, for the innovators, even an additional six months of exclusivity can amount to billions of dollars.
Earlier this month the Court denied Apotex’s cert petition, but Sandoz’s petition is still pending, and has the support of the Solicitor General. The text of the statute itself permits notice before a biosimilar application has been approved:
(A) Notice of commercial marketing
The subsection (k) applicant shall provide notice to the reference product sponsor not later than 180 days before the date of the first commercial marketing of the biological product licensed under subsection (k).
42 U.S.C. §262(l)(8)(A) (emphasis added).
No other statutory language restricts how soon an applicant may provide notice. In fact, the statute’s next provision contemplates that notice will be provided before approval, so as to allow the innovator to seek a preliminary injunction before the biosimilar reaches the market:
(B) Preliminary injunction
After receiving the notice under subparagraph (A) and before such date of the first commercial marketing of such biological product, the reference product sponsor may seek a preliminary injunction prohibiting. . . the commercial manufacture or sale of such biological product until the court decides the issue of patent validity, enforcement, and infringement . . . .
42 U.S.C. §262(l)(8)(B) (emphasis added).
The government’s brief, as well as those of the parties, and several amici, may be found here.
Given the complexity of the BPCIA—described by the Federal Circuit as “a riddle wrapped in a mystery inside an enigma”—it is unlikely that 2016 will be the last time cert petitions are filed seeking clarity. To the contrary, we are just at the beginning.
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