Source: https://www.pbwt.com/aron-fischer/biologics-blog-2/
Timestamp: 2019-04-25 23:58:57+00:00

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On June 12, 2017, the Supreme Court decided Amgen v. Sandoz, the landmark case about the meaning of the Biologics Price Competition and Innovation Act (BPCIA). First, the Supreme Court held that no federal injunction is available to force biosimilar applicants to participate in the BPCIA’s patent dispute resolution procedures (a/k/a the patent dance); but it remanded to the Federal Circuit to address whether such an injunction is available under state law. Second, the Court held that under the BPCIA, a biosimilar applicant may provide 180-day notice of commercial marketing before the biosimilar product is licensed, meaning that as a practical matter, the 180-day notice period need not affect the timing of the biosimilar product’s launch.
Today, Judge Gregory Sleet of the U.S. District Court of Delaware orally dismissed Genentech’s lawsuit against Amgen alleging violations of the BPCIA. Judge Sleet did not issue a written opinion, but his order states that the case is dismissed without prejudice for lack of subject matter jurisdiction in light of Amgen v. Sandoz, 794 F.3d 1347 (Fed. Cir. 2015).
On Wednesday, February 15, 2017, the Patent Trial and Appeal Board (“PTAB”) ruled in favor of the Broad Institute of MIT and Harvard in a closely watched patent fight with UC Berkeley over the breakthrough CRISPR genome-editing technology. The PTAB concluded that the Broad Institute’s later-filed patents for using CRISPR in eukaryotic cells did not interfere with Berkeley’s earlier-filed patent application that disclosed the use of CRISPR technology in vitro and claimed the use of CRISPR technology in general.
Last week, the Solicitor General submitted its brief in Amgen v. Sandoz, arguing that the Supreme Court should review and decide in Sandoz’s favor both questions presented by the parties’ cross-petitions for certiorari. Two days later, however, the Supreme Court denied cert in Amgen v. Apotex, which raised similar issues.
Among the first generation of biosimilar litigation under the Biologics Price Competition and Innovation Act (BPCIA) is a dispute between Amgen and Apotex over Apotex’s proposed biosimilar versions of Amgen’s Neupogen (filgrastim) and Neulasta (pegfilgrastim). That dispute has resulted in the first final judgment in a BPCIA lawsuit. Earlier this month, Judge James Cohn of the Southern District of Florida ruled after a consolidated bench trial addressing both products that Apotex’s biosimilar applications did not infringe Amgen’s sole remaining patent, U.S. Patent No. 8,952,138 (the ‘138 patent). Meanwhile, Apotex, which remains subject to an injunction prohibiting it from marketing its biosimilar products for 180 days after they are approved, has filed a petition for a writ of certiorari to the United States Supreme Court challenging that injunction.
Yesterday the Federal Circuit granted Amgen’s motion for an injunction pending appeal in Amgen v. Sandoz, the first appeal to squarely address the patent litigation provisions of the Biologics Price Competition and Innovation Act (BPCIA). While this is an interim decision without a substantive opinion, it indicates that the court is taking Amgen’s arguments seriously.
Amgen v. Sandoz, the first full-fledged dispute under the Biologics Price Reduction and Innovation Act, is headed to the Federal Circuit on an expedited briefing schedule, with oral argument to be held on June 3. The Federal Circuit’s decision is likely to answer basic questions about how the statute operates.
Although the most recent challenge to the Affordable Care Act does not affect the Biologics Price Competition and Innovation Act (BPCIA), it calls to mind the first round of Obamacare litigation, in which the BPCIA, while not directly challenged, briefly became collateral damage.
In the first reported cases on the BPCIA patent provisions, biosimilar makers have sought to bring declaratory judgment actions before engaging in the statutory “patent dance.” The courts have unanimously dismissed these actions as non-justiciable.

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