September 9, 2016
Toronto, ON — Announcing an unprecedented positive court decision in its patent Infringement litigation against Amgen concerning its Grastofil (filgrastim) and Lapelga (pegfilgrastim) products, Apobiologix also indicates that the company today filed a Petition for Certiorari with the US Supreme Court. The new petition challenges the Federal Circuit Court of Appeal's ruling that the company may not launch its products until after providing 180-days' notice following regulatory approval by the FDA.
"The court decision against Amgen brings us one critical step closer to making these innovative biologics available in the U.S.," said Steve Lydeamore, President, Apobiologix.
This decision represents the first occasion in which a biosimilar applicant proceeding under the Biosimilar Price Competition and Innovation Act (BPCIA) has achieved a district court victory. The ruling was made on September 6 by Judge Cohn of the Southern District of Florida, who ruled that the manufacturing process for both products did not infringe, either literally or by equivalents, Amgen's US Patent No. 8,952,138, which expires on July 29, 2031.
"Our patent infringement victory underscores the urgent need for the Supreme Court to rule that biosimilar applicants can provide their notice of intent to market prior to securing FDA approval for their products, as intended by the BPCIA," added Lydeamore.
The petition submitted to the US Supreme court states: "In this instance, the Circuit's bar will operate only to keep a non-infringing, cost-saving FDA-approved biosimilar product out of the hands of consumers for an additional six months."
This is the second petition filed this year asking the Supreme Court to address the question. Earlier this year, the Supreme Court asked the US Solicitor General to weigh in on this issue.
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