Genentech's Misfire on Kanjinti Creates Opening

Timing is important in biosimilars as in everything else. Genentech found this out last year when it missed a key opportunity to block a trastuzumab biosimilar from coming to market.

This error in timing may have implications for how litigants in biosimilar disputes map out their strategies and initiate court proceedings in the coming years under the Biologics Price Competition and Innovation Act (BPCIA), Ted Mathias, a patent law attorney with Axinn, Veltrop & Harkrider of Hartford, Connecticut, said.

Under the BPCIA, patent litigants enter a period of discovery known as the patent dance, during which they exchange key information about biosimilars that a company wants to bring to market and the patents that the originator company asserts may be transgressed by the biosimilar. Also under the act, the companies must resolve these issues as part of the business of clearing a biosimilar for marketing.

The patent dance may stretch over many months, and it is punctuated somewhere in the middle by the filing of a notice of commercial marketing by the biosimilar applicant, which customarily has been followed by a preliminary injunction filing by the originator company. The preliminary injunction, if accepted by the court, preserves the status quo, meaning the biosimilar could not come to market until patent issues are resolved.

Waiting too Long to File

In the case of Genentech, the company waited too long to file the preliminary injunction motion after Amgen served a commercial marketing notice for its trastuzumab biosimilar (Kanjinti). Amgen filed the notice in May 2018, but Genentech did not file the injunction motion until July 10, 2019, a month after Amgen got its FDA approval for Kanjinti. Usually, such a motion would have been filed before the FDA approval.

“That was the principal reason the district court denied Genentech’s motion for a preliminary injunction,” Mathias said in a presentation at the recent World Biosimilar Congress USA 2020 at the Festival of Biologics USA in San Diego, California.

Amgen was then able to launch its trastuzumab product “at risk” of litigation, but it became the first trastuzumab biosimilar on the US market and began to carve into the $2.9 billion US market for Herceptin, the reference product.

It has not been uncommon for originators to wait before filing a preliminary injunction motion. The type of patent information exchanged after such a motion represents a second line of defense against a biosimilar applicant.

During this phase, the originator company can assert any remaining patents that were not litigated during the first phase, prior to the notice of commercial marketing.

“What was happening was that the originators were receiving early notices of commercial marketing but holding off on seeking preliminary injunctions until FDA approval drew closer. Genentech actually waited too long to seek preliminary injunction. It knew by April 2019 that Amgen was planning to launch in July 2019, but it waited until almost a month after Amgen got approval in June 2019 before filing for the preliminary injunction,” Mathias said.

Lessons Learned

Knowing how the court ruling went for Genentech, originator companies are liable to start filing these motions much earlier in the process, which could serve the interests of biosimilar companies, Mathias said.

If the preliminary injunction comes earlier in the patent dance, the biosimilar company gets the benefit of more information sooner that may expose vulnerabilities in the originator company’s legal position. “Some applicants may welcome that early preliminary injunction motion. They’re likely to see the originator’s best arguments right away and be able to assess the weaknesses in their own position,” Mathias said.

In addition, some biosimilar applicants may not be expecting an FDA decision on their application for many months. With an early preliminary injunction motion, they could take their time about entering the litigation process until they know better how the FDA is likely to respond. This would spread out the cost of litigation and allow a biosimilar developer to assess the strength of its FDA application for biosimilar approval before committing to a potentially costly fight over the preliminary injunction.

“So, we can expect some changes and, specifically, some more varied approaches to litigation based on what we saw last year with trastuzumab,” Mathias said.

As a footnote, Genentech appealed the lower court ruling by the US District Court for the District of Delaware on the preliminary injunction. In early March, the US Court of Appeals for the Federal Circuit upheld the lower court’s ruling.

In the meantime, the underlying patent litigation involving Kanjinti continues, and 4 other trastuzumab biosimilars have come to market, all of them within the past 5 months.