Big Molecule Watch
June 29, 2023

Court Denies Motion for Preliminary Injunction in Biogen v. Sandoz Natalizumab BPCIA Litigation

As we previously reported, Biogen sued Sandoz and Polpharma (“Defendants”) in a BPCIA litigation related to Defendants’ natalizumab biosimilar. On October 19, 2022, Biogen filed a Motion for Preliminary Injunction and Motion to Strike, while Sandoz filed a Cross Motion to Strike. Oral argument was held on May 17, 2023. On June 20, 2023, in a sealed filing, the Court denied Biogen’s Motion for Preliminary Injunction and Motion to Strike, and also denied Sandoz’s Cross Motion to Strike. On June 27, 2023, the Court filed a redacted version of its order.

Regarding Biogen’s Motion for Preliminary Injunction, the Court found that Biogen did not satisfy its burden to show two requirements: (1) that it would suffer irreparable harm in the absence of an injunction and (2) that it would likely succeed on the merits. To demonstrate irreparable harm, Biogen pointed to harm in the form of (1) price erosion, (2) lost sales and market share, and (3) reputational harm. The Court held that all of these harms were “speculative and uncertain” and, as for price erosion, relied on Sandoz’s sources demonstrating that a biosimilar launch will not necessarily cause a price decline in the 12-18 months after a biosimilar launch. The Court also noted that Biogen’s own expert cited sources showing that, in the 12-18 months after biosimilar launch, the price of the biosimilar product remained stable. For similar reasons, the Court found Biogen’s arguments about loss of market share too speculative. The Court also noted that any harm could be remedied by money damages.

As for reputational harm, the Court held that it was also speculative, and that Biogen failed to show a causal nexus between that the asserted patents and the alleged harm caused by the infringement. More specifically, the Court noted that Biogen’s product, TYSABRI, is covered by several patents to the composition and methods of treatment, but none of those were asserted for purposes of the preliminary injunction. The Court noted that it was “not disputed that the PI patents do not cover the actual product, Tysabri – or its active ingredient – natalizumab.” Instead, the patents at issue for the preliminary injunction related to detecting antibodies, methods of assessing risk, and methods of manufacturing. The Court concluded that Biogen failed to show that consumers were buying TYSABRI because of these patented features, therefore it failed to demonstrate a causal nexus with any alleged harm.

As for the second requirement for a preliminary injunction, likelihood of success on the merits, the Court outlined the parties’ infringement arguments as to each patent. For one patent directed to an assay for detecting antibodies, Biogen asserted infringement only under the doctrine of equivalents, and the Court found that the accused product does not perform substantially the same function in substantially the same way to achieve substantially the same result. As for Biogen’s patents directed to methods of assessing risk, the Court found that Sandoz’s label, taken in its entirety, did not encourage, recommend, or promote infringement. Finally, as for Biogen’s manufacturing patents, the Court held that there was no evidence that the accused method practiced a certain claim element, and therefore Biogen failed to demonstrate a likelihood of success on the merits.

For the remaining hardships (balance of hardships and public interest), the Court found that the public interest in having lifesaving drugs that are accessible favored denying the motion, and declined to address balance of hardships.

Regarding the motions to strike, Biogen had sought to strike one of Defendants’ declarations because Polpharma had allegedly refused to provide adequate discovery as to the subject matter of the declaration or the declarant. The Court found that the evidence did not support that argument and denied the motion on that basis. As for the other declarations Biogen sought to strike, the Court did not rely on the objectionable paragraphs and therefore denied the motion as moot. Similarly, because the Court did not grant the preliminary injunction motion, it denied Sandoz’s cross motion to strike.

In the Court’s order, it also noted that it will “try its best to schedule a trial before April 2025.”

Stay tuned to Big Molecule Watch for further updates on this BPCIA litigation.

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