U.S. Court Ruled in Favor of Sandoz Inc. & Against Biogen for Failing to Show Irreparable Harm in a Patent Infringement Case

U.S. Court Ruled in Favor of Sandoz Inc. & Against Biogen for Failing to Show Irreparable Harm in a Patent Infringement Case

The U.S. District Court for the District of Delaware has denied Biogen’s motion for preliminary injunction and Motion to Strike, and also denied Sandoz’s Cross Motion to strike.

Biogen had filed a lawsuit against 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.

The case dates back to 2019, when Sandoz Inc., had agreed with Polpharma Biologics SA to develop, globally supply, and sell a biosimilar, natalizumab, a widely used MS treatment.

Sandoz sought U.S. Food and Drug Administration (FDA) approval in May 2022.

Thereafter, Biogen sued the company in September 2022, alleging patent infringement and filed a preliminary injunction bid to prevent the launch and sale of the Sandoz product.

The Judge Gregory B. Williams regarding Biogen’s Motion for Preliminary Injunction, found that Biogen did not satisfy its burden to show two requirements:

(i) That it would suffer irreparable harm in the absence of an injunction and;

(ii) That it would likely succeed on the merits.

To establish irreparable harm, Biogen demonstrated the harm in the form of firstly, price erosion, secondly, lost sales and market share, and thirdly, 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 referred to the statement of Biogen’s own expert quoting sources estimating that, in the 12-18 months after biosimilar launch, the price of the biosimilar product remained stable.

Likewise, the Court found Biogen’s arguments about loss of market share were too speculative. The Court also noted that any harm could be remedied by money damages.

With respect to the issue of reputational harm, the Court held that it was also speculative, and that Biogen failed to demonstrate the causal nexus between that the asserted patents and the alleged harm caused by the infringement.

The Court noted that Biogen’s product, TYSABRI, was 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 acknowledged 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.

Thus, the Court held that Biogen failed to show that consumers were buying TYSABRI because of these patented features, it had failed to establish a causal nexus with any alleged harm.

Next the second requirement for a preliminary injunction is related to the likelihood of success on the merits.

In this regard the Court after hearing the parties’ infringement arguments as to each patent, observed that 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.

Apropos to Biogen’s patents which directed to methods of assessing risk, the Court found that Sandoz’s label, taken in its entirety, did not encourage, recommend, or promote infringement.

As for Biogen’s manufacturing patents, the Court was of the considered view that there was no evidence that the accused had used method practice for a certain claim element, and therefore Biogen failed to demonstrate a likelihood of success on the merits.

Therefore, in the balance of hardships and public interest), the Court found that the public interest in having lifesaving drugs that are accessible was in favor for denying the motion. In this view the Court refused to address the concern related to balance of hardships.

Lastly, 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 avowed that the evidence did not support that argument and denied the motion on that basis. The Judge did not place reliance 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.

Accordingly, the Court issued an order denying the injunction, finding Biogen failed to show irreparable harm or a likelihood of success on the merits.

The Court clarified that Sandoz may supply and sell its biosimilar natalizumab product following receipt of its pending FDA application.