Biosimilars: The Next Chapter

Amgen and Sandoz received a decision from the U.S. Court of Appeals for the Federal Circuit in Washington last week. PharmExec spoke with legal and biosimilar experts for their initial reactions.

Novartis’ biosimilar and generics unit scored a significant judgment from the U.S. Court of Appeals for the Federal Circuit in Washington last week. Whether the decision means Sandoz will be marketing the first biosimilar for the US market, Zarxio, a copy of Amgen’s cancer treatment Neupogen, in the Fall is not entirely clear as appeals are likely. Tuesday’s ruling allows for a September 2 launch date.

The court upheld Sandoz disinclination to participate in the “patent dance”, outlined in Biologics Price Competition and Innovation Act (BPCIA) of 2009. Sandoz decided not to tango, seeing the choreographed steps as optional, as well as a stall mechanism, simply delaying its date with the US market.

The BPCIA calls for the interchange so that the branded drug manufacturer, Amgen in this case, can review the biosimilar’s application and assess potential manufacturing patent infringements.

The BPCIA’s dance was an attempt to resolve the patent issues before the 12-year exclusivity period had expired for an innovator’s biologic, explained Joseph Fuhr, Professor of Economics, Widener University. The BPCIA was not intended for a case like Amgen v Sandoz where the patent was claimed to be valid after the 12 years had expired. “So, it makes sense in this case as well as others not to have the patent dance be mandatory,” he concluded.

The first fact from this ruling is that it’s a win for Sandoz in the sense that it provides initial legal precedence that they don’t have to participate in patent dance, stated to Siegmund Gutman, chair of the Life Sciences Patent practice with Proskauer.

Additionally, the court decided in favor of Sandoz saying that the 180-day notice prior to marketing the biosimilar was correctly given upon FDA approval, and not prior to the drug being licensed. As Courtenay Brinckerhoff, a partner and intellectual property lawyer with Foley & Lardner blogged, “Sandoz first gave notice of its plans to commercially market Zarxio before the FDA had approved its application. Amgen argued that notice was ineffective because the statute requires notice of a “licensed” product, which only can be given once the product is approved. The district court agreed with Sandoz on this issue, but the Federal Circuit agreed with Amgen.” So, the initial pre-market notice was ineffective, but the one given on the day of FDA approval, March 6, is effective, and thus, we may see the biosimilar come to market on September 2.

Will Sandoz launch Sept 2?

However, there’s a good chance that the September 2 date will come and go without the first biosimilar coming to market, noted a life science patent law expert. Even if the date sticks and Sandoz brings Zarxio to market, it doesn’t mean there is a clear resolution of the issues, he said. So taking the biosimilar to market by the chosen date, Sandoz would be doing so at risk, because other manufacturing patent issues will not necessarily be resolved.

Given that there are still patent issues to be resolved the question that Sandoz now faces is whether they will launch at risk and be subject to payments if Amgen’s patents are valid or infringed, agreed Fuhr.

Unwrapping the BPCIA riddle

Not surprising, but significant was that the court said the language of the BPCIA is opaque and would need clarification, noted James Langley, chair of the Healthcare and Life Sciences Practice at The Mead Consulting Group. The court acknowledges that it was perplexed by the language and not above dispute, he added.

“In footnote 1, the Federal Circuit characterizes the BPCIA as ‘a riddle wrapped in a mystery inside an enigma.’  This confirms that this decision will likely be followed by many others that interpret various aspects of the BPCIA,” noted Gutman.

The federal circuit viewed the statute as difficult to interpret, but it did interpret it in some ways, commented the patent law expert. So we have more guidance today than the day before.

All legal experts agreed that legal disputes were far from over with the life science patent law expert advancing the possibility that one or both parties will appeal to the Supreme Court. The decision was a mixed bag for both sides, and the Supreme Court would likely recognize the importance of the biosimilar issue for healthcare and public policy. Congress was trying to balance the interests of many different parties when it wrote in BPCIA, therefore the high court could ultimately have a say in balancing these interests, he said.

Looking forward – will biosimilar makers ever choose to dance?

How companies will proceed in the future is certainly a good question. This court’s ruling was one data point, but there are still many questions that remain. There is discussion in congress to force the FDA to give more guidance and many think clarity will come in 2015.

As things stand, Brinckerhoff is doubtful that anyone will opt in to BPCIA because all biosimilar cases to date have involved applicants trying to avoid the patent dispute resolution procedures. “Some say that many biosimilar applicants will want to resolve the patent issues early in the approval process, and so will avail themselves of these procedures even if it means sharing their biosimilar applications.” Though she adds that she is not convinced that this will be the case, quoting Judge Chen who wrote, “Why would any biosimilar applicant opt for the path that requires it to disclose highly confidential information and engage in the complicated biosimilar patent “dance””.

Langley thinks that it is a matter of timelines. For Zarxio and Neupogen, every week delayed is a week without a biosimilar competitor. But for future cases where six to nine months of dancing may not delay your overall entry time, it’s unclear how companies will treat the dance requirements. “A company with a biosimilar may decide to go through the patent dance. One reason to do so could be that the exchange of information may give the biosimilar manufacturer a better sense of the potential patent litigation that the branded biologic company may use against them.”