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Apobiologix Continues To Move Forward With FDA Review Process

Supreme Court indicates that there will be no differentiation between companies following the patent dance and those that do not

December 13, 2016

Toronto, ON — Apobiologix, a division of the Apotex Group focused on biologics innovation, today announced that in response to a Petition for Certiorari filed by the company, the US Supreme Court has decided not to hear the company's case regarding appropriate timing for the currently-required 180-days' notice to brand companies from biosimilar companies who have followed the patent dance. The patent dance is a formal procedure with strict timing and sequencing requirements for resolving patent disputes between the biosimilar company and the company marketing the reference product.

"While we believed that the court would see a distinction between companies who had followed the 'patent dance' and those that have not, we are hopeful that the court will see the overall importance of bringing biosimilars to patients and physicians sooner," said Steve Lydeamore, president, Apobiologix. "We support the Sandoz effort to petition the court to clarify the broader timing of the 180-days' notice as it will allow biosimilars to reach the market sooner."

Last week, the Office of the Solicitor General (OSG) submitted a brief recommending that the Supreme Court review the appeals court's decision on the petition filed by Sandoz questioning the timing of the 180-days' notice for companies regardless of if they had participated in the "patent dance" or not. The OSG's brief also rejected the appeals court's holding that the notice of commercial marketing period can be enforced by an injunction. By contrast, and as advocated by Apotex previously on appeal, the OSG's brief stated that if an applicant (the biosimilar company) fails to provide the notice of commercial marketing, the sole recourse of the sponsor (the company marketing the reference product) is to commence a patent-infringement action, and may not seek a separate injunction to enforce compliance.

The filing by Apobiologix requested the Supreme Court consider if a biosimilar applicant, which has followed the patent dance, may provide "notice of intent to market a biosimilar" prior to securing FDA approval for their product(s). The petition challenged the Federal Circuit Court of Appeal's ruling that the company may not launch Grastofil (filgrastim) and Lapelga (pegfilgrastim) until after providing 180-days' notice following regulatory approval by the U.S. Food and Drug Administration (FDA) despite having participated in the "patent dance". The court's decision clarifies the Biologics Price Competition and Innovation Act (BPCIA) regarding the 180-days' notice requirement.

The Apobiologix Petition for Certiorari was filed to the Supreme Court in September following an unprecedented positive court decision by Judge Cohn of the Southern District of Florida who ruled that the manufacturing process for both Grastofil (filgrastim) and Lapelga (pegfilgrastim) did not infringe, either literally or by equivalents, on Amgen's US Patent No. 8,952,138.

Of the more than 7,000 requests for cases made of the Supreme Court each year, Supreme Court Justices make decisions on only about 130 of these cases; of these 130 cases, the justices decide to hear only about 80 of these cases and make decisions on about 50 others without hearing arguments.

The FDA is actively reviewing the applications for Grastofil and Lapelga.

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