Panel: Should Biologics Manufacturers Have to Disclose More About Their Patents?

Editor's note: This is part 1 of a series on biologics patents and biosimilars.

The biosimilars pathway in the Biologics Price Competition and Innovation Act (BPCIA) was created to address the needs of biosimilar applicants and speed their products to market for the benefit of patients, but is the pathway working?

Panelists at the Festival of Biologics USA meeting said some tinkering may be necessary to optimize the patent resolution process (aka patent dance) in the BPCIA, particularly when it comes to understanding processes and intellectual property related to manufacturing.

The BPCIA was created in 2010 by legislative fiat, but “whether it’s working or not depends on what expectations you have of the system and how you expected it to work over time,” said Hans Sauer, vice president for Intellectual Property at the Biotechnology Innovation Organization. “The BPCIA as it’s currently interpreted and implemented is perhaps not quite what I and others expected when it was first passed.”

Compared with the 1984 Hatch-Waxman Act for simple molecule chemical compounds (generics), there are more moving parts to the BPCIA. During the patent dance, biosimilar developers and originator companies come to the fence to decide where potential intellectual property infringements may occur and attempt to resolve those issues prior to the biosimilar being launched. It’s one of the vital organs of the BPCIA.

“The patent dance is working for people who chose to use it, right? And it’s not working if litigants make different choices. Does that mean it’s a train wreck? I don’t know,” Sauer said. “I think we see a greater diversity of corporate behavior, of litigation behavior, than certainly what we see in the small molecule space. If you have an expectation that this is supposed to work like the Hatch-Waxman system for small molecules, it does not. It’s certainly working for litigants who have come out on top and who end up getting out of the system what they want, but for the other guys, it’s usually not working.”

The beauty of the patent dance is its flexibility, said Timothy “Tim” J. Shea Jr, biotechnology intellectual property expert and director of Sterne Kessler Golstein and Fox of Washington, DC. “It’s not a one-size-fits-all, as maybe we are more likely to see under Hatch Waxman, and so we see a lot of different strategies in terms of the patent dance and other aspects of the statute.” The BPCIA allows biosimilar applicants to choose the order of battles that are most important to them. “If there are certain patents that are going to drive the decision of whether to launch or when to launch, being able to focus on those early on, I think, is very positive,” he said.

Value of Disclosure

But would more information on manufacturing patents and processes, disclosed earlier, help biosimilar applicants get more products to market faster and with less trouble? Legislation has been drafted to prompt more disclosure from reference product manufacturers to improve clarity and, ultimately, to make the marketplace more competitive. And in December 2020, the Biological Product Patent Transparency Act was signed into law, requiring originator product companies to promptly share relevant patent information with the FDA. Starting in June 2021, this disclosed information would automatically be entered in the Purple Book reference guide for the biologics industry.

However, the risk is that manufacturers burdened with greater disclosure requirements would be fearful of sharing manufacturing secrets and become less willing to innovate, panelists said. “These innovations are extremely valuable, not just to the biosimilar applicant but to the whole industry, and we want to encourage that,” Shea said. “I don’t like the idea of a kind of a draconian provision that just says all this must be disclosed.”

It’s also possible that disclosure requirements could make the process more confusing for the originator product companies, besides too revealing, Sauer said. “If I sit on a portfolio of alternative resins for chromatography columns, columns for purification, or alternative cell culture media that could be used, or others, which do I disclose? The ones that I use may not be the ones the biosimilar company ends up using."

Legislation has raised the specter that companies that fail to sufficiently disclose the patents they hold may lose the right to enforce those patents in the event of infringement. “List it or lose it propositions that we’ve seen throughout these bills have been our greatest concern,” Sauer said. Another reason originator manufacturers may be leery of disclosure laws is that the intellectual property may pertain to multiple products the company produces. Revealing information about one product may compromise another.

Simply Start Sooner

One way to enhance the information exchange might be to start the patent discussion earlier in the application process, even several years before anticipated approval and launch of a biosimilar, said Bruce Leicher, moderator of the panel and a strategic law advisor and adjunct processor in Biotechnology Law at the University of New Hampshire Franklin Pierce School of Law.

For that to work, the timing has to be right, said panelist David Korn, vice president of Intellectual Property and Law with PhRMA, a pharmaceutical industry trade association. “Is it that, at some point, it becomes too early to actually engage the full process and the back and forth, and if there are any changes after that, then it would seem like the whole thing needs to be restarted in order to get a true picture of the patents that are relevant to that particular biosimilar.”

Shea agreed that the timing should be worked out so that discussions over intellectual property occur when it’s relevant to have them. “I think you do want to be at a point where the process is fixed enough that it just really makes sense, otherwise it opens up all sorts of cans of worms in terms of being premature.” But an earlier discussion of relevant patents has the potential to “reduce the surprise element for the biosimilar applicant,” he said.

Ultimately, biosimilar developers ought to have a good sense of what information is needed to understand where infringements may lie, Sauer said. After all, they have developed their own manufacturing processes by the time they apply to the FDA for approval. “To my mind, the biosimilar developer is best positioned to know what to look for in the published patent literature and published application literature,” he said.

“Why is it that we so persistently hear concern about the uncertainty that’s being caused by manufacturing patents?" he asked. "Is it that manufacturers keep getting new patents to improve manufacturing technology that pop out of the system when it’s too late? Is it that biosimilars are genuinely locked into a limited range of technologies, and they discover that all of this ends up being patented by someone?”