A 2010 law that created a fast track for approving biosimilar drugs just got a boost toward the U.S. Supreme Court. In early December, the solicitor general recommended that the high court review the Biologics Price Competition and Innovation Act (BPCIA).
The 2010 law established a complex series of disclosures, known as the patent dance, between branded biologic drugmakers and companies that want to market less expensive biosimilar versions. We asked Goodwin Procter partner Elaine Herrmann Blais (photo, below: Elaine Herrmann Blais of Goodwin Procter. Courtesy photo), editor of the firm's Big Molecule Watch blog, for an update.
Q. Why is this law important?
A. The BPCIA is important for pharmaceutical companies and for consumers because it establishes for the first time a pathway at [the U.S. Food and Drug Administration] for the approval of biosimilar products, and in the courts for resolution of related patent disputes. The goal of the BPCIA is to balance incentives for innovation with incentives for competition—with an eye towards lowering health care costs.
Q. When the U.S. Court of Appeals for the Federal Circuit ruled in Amgen v. Sandoz last year, the first case interpreting the law, it was kind of a mixed bag, right?
A. Yes. The case went up to the Federal Circuit with Sandoz having won two significant arguments at the district court level. The first was that the patent dance is optional and it is at the discretion of the biosimilar applicant. They also had won the argument with regard to notice—that biosimilars did not have to wait until they'd received notice of [FDA] approval to give notice of commercial marketing. You could give it whenever you want, so long as it's at least 180 days before you launched your product.
The Federal Circuit agreed that the patent dance is optional. But they disagreed with the district court and with Sandoz [on notice]. What they held is you can't give notice of commercial marketing until your aBLA application gets approved by the FDA. And so what that means is there's an extra 180-day waiting period after the 12 years [of marketing exclusivity] run.
Q. What's been the impact on the industry?
A. I don't think it changed the appetite of companies to compete in the biosimilars space. The dance being optional just gives the biosimilars companies more room to strategize how they want to proceed about patents. It gives you more control over your destiny with regard to patents. The extra 180 days, it's playing out in peculiar ways.
Q. How so?
A. In the Amgen v. Apotex case coming out of Florida, there are no patents that are preventing competition, but the 180 days [still applies]. The way the court has interpreted it, it's going to prevent competition for 180 days after FDA approval in all cases, even when there aren't patents in play.
Q. Is that likely to happen very often?
A. It could arise when there just are no patents. It could arise in litigation where you beat all the patents before you get approval. In both circumstances, if we were in the Hatch-Waxman world, we'd have immediate competition.
Q. What did the solicitor general recommend in the Sandoz case, and is it fair to say this increases the likelihood of Supreme Court review?
A. The solicitor general recommended that the Supreme Court grant Sandoz's cert petition and Amgen's conditional cross-cert petition. The SG's recommendation greatly increases the likelihood that the Supreme Court will grant review.
The SG also sided with Sandoz on the merits. With respect to the patent dance, the SG concludes that the only remedy available to the [brand] when the biosimilar applicant fails to engage in the dance is the filing of a patent infringement lawsuit. With respect to the 180-day notice of commercial marketing, the SG concludes that notice can be given prior to approval.
Q. BPCIA was part of the Affordable Care Act. Is there some jeopardy of it being repealed?
A. It's a really good question and it's one we've been thinking about. My hope is that the people who are intent on throwing out the Affordable Care Act have the good sense to look at what is involved and realize that it's not so simple. And that the BPCIA will not just be flushed away, but will instead be dealt with in a systemized way.
Of course, once they start tinkering with it, you start to wonder, what are the various interests going to ask for? You could see an effort to try to fix the notice of commercial marketing. You could see efforts by both sides to try to increase or decrease the period of exclusivity for the brand.
My instinct has always been that there wouldn't be much tinkering. Part of the reason was the win that the biosimilars got when the court held that the dance is optional was pretty good for them. And the brands wouldn't want to go back, because 12 years was a good win for them. At the time [of the legislation], there were lots of folks who had proposals for many fewer years than that, and so 12 years was quite a coup. But if we start tinkering with one piece, who knows?