AbbVie to High Court: Notice of Biosimilar Release Is Mandatory

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By John T. Aquino

The owner of a biologic patent must receive 180-days notice of the planned release of a biosimilar for the biosimilar statute to do its job, AbbVie Inc. told the Supreme Court March 17 ( Sandoz, Inc. v. Amgen, Inc. and Amgen, Inc. v. Sandoz, Inc. , U.S., Nos. 15-1039 and 15-1195, 3/17/17 ).

AbbVie filed a brief in support of the patent owner in the high court’s review of the U.S. Court of Appeals for the Federal Circuit’s first interpretation of the biosimilar statute, known as the Biologic Price Competition and Innovation Act (BPCIA).

The life sciences industry, physicians and patients are awaiting the Supreme Court’s ruling in this dispute, which will likely determine how quickly these lower cost biologic drugs can come to market and how long the patent owner can exclusively sell its product.

AbbVie Supports and Sues Amgen

The BPCIA provides an abbreviated approval pathway for biosimilars that partly relies on data submitted for FDA approval of the original biologic. A biosimilar applicant can submit an abbreviated biologic license application (aBLA) to the Food and Drug Administration under the BPCIA. A biosimilar is a biologic that is highly similar to an FDA-approved biologic.

The high court will review two conclusions reached by the Federal Circuit in a single ruling. First, the appeals court concluded that the exchange of patent and manufacturing information specified in the BPCIA between the biologic patent owner and the maker of a biosimilar is optional. Second, it held that the biosimilar maker must give 180-days notice to the patent owner that it plans to release the biosimilar commercially. That notice is mandatory, and can be given only after the FDA approves the biosimilar for market, the ruling said.

Amgen, the owner of the biologic Neupogen (filgrastim) for the treatment of the effects of chemotherapy, is asking the court to reverse the Federal Circuit’s first ruling, and Sandoz, a division of Novartis Inc. and the maker of Zarxio, a biosimilar of Neupogen, is asking the court to reverse the second ruling, stating that the Federal Circuit’s interpretation of the statute will delay the release of all biosimilars.

AbbVie is in a unique position to comment on the dispute. Like Amgen, it is the owner of an original biologic for which a biosimilar has been approved by the FDA. AbbVie owns the patents covering Humira (adalimumab), which treats rheumatoid arthritis, psoriasis and Crohn’s Disease. AbbVie also is suing Amgen, the maker of Amjevita, a biosimilar of AbbVie’s Humira, contending the Amgen biosimilar infringes its patents. Amgen has estimated that AbbVie’s litigation could delay its release of Amjevita until 2019 ( 10 LSLR, 11/11/16 ).

AbbVie’s is the only brief posted that was filed in support of Amgen’s position by the court’s March 17 deadline. Nine briefs were filed in support of Sandoz’s position, including one from the U.S. government, by the court’s Feb. 17 deadline ( 11 LSLR, 3/3/17 ).

Congress Wanted Transparent Process

AbbVie asked the court to uphold the Federal Circuit’s decision that the 180-days notice requirement is mandatory and reverse the appeals court’s holding that the BPCIA’s exchange of information between the parties is optional.

“Congress plainly intended there to be a more transparent, informed, and streamlined approach to early patent litigation,” AbbVie wrote, stating the BPCIA contemplates and provides for two phases of patent litigation: in the first phase, the parties identify patent claims that can meaningfully be adjudicated or otherwise resolved before the FDA determines what will be licensed, and in the second, the parties can litigate the remaining patent claims.

“Sponsors need the 180-day notice window to compare the approved product to the aBLA, identify any remaining patent disputes, and (if needed) to file a preliminary injunction [stopping release of the biosimilar],” AbbVie stated.

Noting that Sandoz wanted to issue the notice of commercial marketing once the FDA approved the aBLA for review, AbbVie criticized Sandoz’s argument that the FDA’s approval for review is itself a notice that the biosimilar will be commercially marketed. AbbVie noted that things can and do change between the filing of the aBLA and the approval of the final product.

“If biosimilars could launch immediately upon FDA approval, there would be no time to litigate patent infringement issues implicated by the approved biosimilar but not apparent from the face of the aBLA submitted many months, if not years, prior,” AbbVie wrote.

Leave Enforcement for Another Day

AbbVie stated its own experience with Amgen’s biosimilar of Humira provides a useful example of the work to be done during the 180-day notice period: AbbVie identified more than 60 patents during the BPCIA patent exchange process; Amgen then limited the initial litigation to just 10 patents; and now AbbVie must wait until Amgen provides notice of commercial marketing to bring suit on the remaining patents. “Once Amgen provides that notice, AbbVie will need the 180 days to seek, if necessary, a preliminary injunction,” Amgen stated.

AbbVie concluded its brief by addressing the argument of Sandoz and those who filed a brief in support of Sandoz’s position that the Supreme Court should hold that, when an applicant violates the BPCIA’s notice-and-exchange provisions, there is no federal private right of action to enforce the statute. “But that question is not presented here: Amgen, Inc. brought only state-law claims to enforce the BPCIA. Thus, the only salient question that could be before the Court is whether Amgen’s state-law claims are preempted by the BPCIA,” AbbVie wrote.

Sandoz expressly disavowed any preemption defense, which leaves the court “with an exceedingly unsuitable vehicle to resolve the enforcement question,” AbbVie wrote. “To the extent the Court wishes to decide the issue at all, preemption is the correct framework and Amgen’s state-law claims are not preempted. But the more prudent course would be to affirm Amgen’s interpretation of the statute and leave the means of enforcement for another day.”

The AbbVie’s brief was filed by Latham & Watkins LLP, Washington.

To contact the reporter on this story: John T. Aquino in Washington at jaquino@bna.com

To contact the editor responsible for this story: Randy Kubetin at RKubetin@bna.com

For More Information

AbbVie's amicus brief is at http://src.bna.com/nag.

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