Roche lawsuit blasts Amgen for 'about-face' on biosimilar patent fights

Biosimilars have yet to generate really big dollars for developers, but they are certainly generating them for lawyers. In the latest legal battle, Roche’s Genentech has sued Amgen for not giving up the info Genentech experts need to mount a patent infringement attack on Amgen’s biosimilar for Avastin, its $6.8 billion blockbuster.

If it doesn’t get that data ASAP, Genentech argues the “consequences are potentially disastrous.”

A complaint filed Wednesday in U.S. District Court in Delaware, says Roche wants the court to force Amgen to cough up all the data it says it needs, allow Roche to have experts evaluate it and then reset the deadlines for resolving any patent disputes. It asks the court to block Amgen from selling its biosimilar to Avastin until this legal fight has played out.

Roche says the so-called “patent dance” requirements that Amgen must follow are laid out in the Biologics Price Competition and Innovation Act (BPCIA). The law was established to hasten cheaper biosimilars to market by allowing developers to rely on much of the development work done by the original drug developer but also provide drug originators ways to assert their patent rights.

The law says in one pathway to approval, once the FDA accepts an Abbreviated Biologic License Application for the biosimilar, the applicant has 20 days to provide the drug’s originator the aBLA and “such other information that describes the process or processes used to manufacture the biological product.” Then the originator, Genentech in this case, has 60 days to review it with experts and say what patents it believes might be infringed and how. The clock started to tick Jan. 4 when the FDA accepted Amgen’s application.

But Roche says Amgen has provided only its aBLA, claiming that satisfied its obligation and should be all Roche needs to do its evaluation. It also blasts Amgen in the filing for an “about-face.”  It points out that Amgen had a different attitude when one of its own drugs was under attack by a biosimilar.

When “Hospira, produced only its aBLA after applying for FDA approval for a biosimilar of Amgen’s blockbuster Epogen —exactly the same conduct Amgen has engaged in here—Amgen sued Hospira in this district for noncompliance with the BPCIA....” the filing says.

In that case, Amgen argued "a patent owner cannot fully protect itself as Congress intended if the applicant only produces its aBLA, because many important details about the product are normally omitted,” Roche declares in its filing.

Roche is hoping to get a hearing and a ruling ASAP, since time is running short for it to fight Amgen’s application.

Biosimilars are still new in the U.S., with the FDA having only approved the first, a biosimilar of Amgen’s Neupogen, two years ago. It has approved three others since. Given that this is new territory, and with billions of dollars in drug sales at stake, legal challenges are expected until the courts help the industry interpret what is required.

One case has already made its way to the Supreme Court. That case involves Amgen and Novartis’ Sandoz unit, but differs from the fight Amgen is now having with Roche. The Supreme Court will decide whether a biosimilar applicant can opt out of the BPCIA information exchanges altogether and if so what its obligations are for providing info to an originator about its biosimilar. 

One issue in that case is a six-month waiting period required after a biosim company notifies the original developer about its would-be rival drug—and when, exactly, that notification can take place. A federal appeals court had previously ruled that biosim companies must have an FDA approval in hand before they can officially notify of a launch.

Sandoz argues biosim makers should be able to provide that notice earlier in the development process. Otherwise, the court's interpretation creates an “exclusivity windfall” for the originator company that Congress did not intend to grant, the company says.