Kramer Levin Naftalis & Frankel LLP attorneys discuss the direction of biosimilar litigation from recent federal court rulings. They also look at trends in patent litigation and what to expect in 2021 and beyond.

The Biologics Price Competition and Innovation Act (BPCIA) turned 10 this year, making it a good time to look at recent litigation trends and assess what’s ahead for 2021.

U.S. biosimilar litigation continues to take shape, although most cases have resolved without a decision on the merits. The U.S. Court of Appeals for the Federal Circuit has provided guidance on the requirements for the BPCIA’s 180-day notice of commercial marketing and biosimilar injunctions.

Manufacturing patents protecting all aspects of the manufacture of biologics continue to play a central role in biosimilar litigation, as biosimilar makers are obtaining patents to protect their products and gain a competitive edge.

By looking at recent litigation, we can examine trends that will impact biosimilar makers.

Makers Provide One Notice of Commercial Marketing

The BPCIA requires biosimilar makers to provide notice to innovators at least 180 days before commercially marketing their biosimilars, allowing innovators to assert their patents and seek injunctive relief. The U.S. Supreme Court has clarified that biosimilar makers may give such notice before or after receiving Food and Drug Administration approval.

An open question, however, remained as to whether biosimilar makers that supplement their regulatory applications after giving initial notice of commercial marketing have to provide new 180-day notices. In July, the Federal Circuit made clear that they do not.

In a litigation involving Amgen’s biosimilar of Genentech’s Avastin, an important cancer therapy, Genentech argued that Amgen could not launch its biosimilar product because it had not provided a new 180-day notice of commercial marketing after supplementing its regulatory application. The Federal Circuit, affirming the district court, explained that the BPCIA provides only a single timing requirement for providing commercial notice and a biosimilar maker is only required to provide one notice for each product.

Going forward, with one notice of commercial marketing sufficient, combined with the fact that it can be provided long before FDA approval, innovators can be in the dark as to when a biosimilar product will actually launch.

Innovators Take Swift Action for Biosimilar Injunctions

In Genentech’s recent litigation over Amgen’s biosimilar version of Genentech’s blockbuster Herceptin, a treatment for breast cancer, the district court denied a request for a preliminary injunction to prevent Amgen’s biosimilar from launching. The court did not rule on the merits and found no irreparable harm due to Genentech’s delay in seeking an injunction.

Key to the court’s decision was the fact that Genentech had waited 14 months after receiving Amgen’s 180-day notice of commercial marketing, three months after receiving Amgen’s biosimilar launch date through discovery, and nearly one month after FDA approved Amgen’s biosimilar product to seek a preliminary injunction.

The district court explained that Genentech’s delay was undue, particularly when the BPCIA’s 180-day notice of commercial marketing is designed to provide time to obtain injunctive relief. The Federal Circuit affirmed.

Going forward, innovators seeking injunctive relief will undoubtedly act more quickly, even when a biosimilar maker provides its 180-day notice well in advance of commercial launch.

Manufacturing Patents Play a Central Role

The composition and activity of biologic medicines is tied to how they are manufactured. As a result, it is typical for patents protecting a biologic to cover all stages of its manufacture. These manufacturing patents have come to play a major role in biosimilar litigation. In fact, innovators assert manufacturing patents in almost every litigation.

In a litigation involving Sandoz’s biosimilar of Amgen’s Enbrel, Amgen preserved an additional five months of exclusivity based on infringement of its manufacturing patent. In many litigations, manufacturing patents are the only patents in the lawsuit or make up more than half of the patents litigated. This trend will continue into 2021 and years to come.

Biosimilar Makers Sue One Another for Infringement

Biosimilar makers are focusing on the same blockbuster biologic medicines and competing with each other. Some biosimilar makers are trying to gain a competitive edge by obtaining their own manufacturing and formulation patents.

For example, a number of biosimilar makers, including Coherus Biosciences, Amgen, and Fresenius Kabi, have developed biosimilars of AbbVie’s Humira (adalimumab), a blockbuster treatment for Crohn’s disease and rheumatoid arthritis. Coherus, a biosimilar maker with an approved biosimilar of adalimumab, obtained several patents covering adalimumab formulations.

In 2019, Coherus sued Amgen for infringement of its formulation patents. Coherus claimed that Amgen infringed its patents by making an adalimumab biosimilar in the U.S. for sale in foreign markets. The case ultimately settled.

Fresenius Kabi, another biosimilar maker that sells a biosimilar of AbbVie’s Humira ex-US and with plans to market an adalimumab biosimilar in the U.S., filed a petition for post-grant review (PGR) challenging one of the patents that Coherus asserted against Amgen. Coherus argued that the claims were not patentable. The Patent Office did not institute the PGR, finding that Fresenius Kabi was not more likely than not to invalidate the claims.

Coherus’s lawsuit and the PGR petition highlight that biosimilar makers are obtaining patents of their own and enforcing them against competition. Fresenius Kabi’s petition for PGR also shows that biosimilar makers are relying on proceedings before the Patent Trial and Appeal Board not only to challenge patents held by innovators but those developed by their biosimilar maker competitors.

The number of patent proceedings between biosimilar makers will increase as more biosimilar makers compete for market share.

This column does not necessarily reflect the opinion of The Bureau of National Affairs, Inc. or its owners.