Sandoz asks Supreme Court to nix 'exclusivity windfall' delaying biosimilar launches

Novartis' ($NVS) Sandoz unit rolled out its biosimilar version of Amgen's ($AMGN) Neupogen last fall after waging a months-long battle in court--and waiting out an injunction imposed under the Biologics Price Competition and Innovation Act.

Next time, Sandoz doesn't want to stand by to watch the clock tick through a 180-day notice period. The company has asked the Supreme Court to review the appeals court ruling that forced the delay, in hopes that it will interpret the BPCIA differently.

At issue is a ruling from the U.S. Federal Circuit, which set out its definition of the 180-day notice stipulated by the BPCIA. The law says the biosimilar developer has to give the branded drugmaker a 180-day heads up before launching its product. Just when that notice can be given is a key point--and the Federal Circuit decided that it has to wait until after the biosim has FDA approval in hand.

Sandoz first gave notice of its plans to commercially market Zarxio before the FDA had approved the drug. Amgen argued that notice was ineffective because the law requires notice of a "licensed" product--and a product is only licensed when it's FDA-approved. The district court agreed with Sandoz, but the appeals court ruled for Amgen.

Now, Sandoz argues that forcing biosim makers to delay till the FDA has approved their product in essence gives the branded product an additional 180 days of exclusive hold on the market--an "exclusivity windfall," is how the company's petition put it.

If the circuit court's decision is allowed to stand, it "will delay the availability of all biosimilars for 180 days more than Congress intended--even if the sponsor has no valid patent claims and even if the sponsor already has had the opportunity to pursue any valid claims," the company argues.

Sandoz also contends that allowing 180-day notice only after FDA approval interferes with the intended framework for patent disputes. The maker of the original product--the "reference product," as styled by the law--can't sue to defend some patent rights until after the notice happens. That sequence of events is "entirely inconsistent with a statute structured to maximize the chance that any patent disputes will be resolved before FDA approval."

The question is such a basic one for biosimilar drug development and marketing that the National Law Review sees a good chance that the U.S. high court will take it up. "The Supreme Court may be inclined to hear this case, since it involves an important provision of the BPCIA, and because the decision in effect delays the commercial availability of less expensive biosimilar products that the BPCIA was enacted to provide," the review noted Thursday.

The rules for how and when biosimilar products can hit the market are critical for both sides of the equation. Makers of the original products of course would like to hold off biosimilar copies as long as possible; biologic knockoffs aren't expected to hit the original brands as hard or as quickly as small-molecule generics do to their brand targets, but the pain will be real.

On the other hand, biosim drugmakers have to invest a lot of money and time into testing their versions of biologic blockbusters like Neupogen. Biosimilars must undergo clinical trials, unlike small molecule generics, and so their makers would like to start recouping their R&D costs posthaste.

- see the National Law Review piece
- check out the Sandoz petition (PDF)

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