I joined millions of Americans who took to the road and skies last week—not to celebrate the nation’s founding—but to attend my third symposium by the American Conference Institute on Innovative Biologics and Biosimilars. The differentiating feature of this meeting is that its primary focus is on the evolving patent and intellectual property (IP) arena in biosimilar commercialization and the largest segment of the audience comprises attorneys specializing in these areas. This is the only meeting throughout the year with these two characteristics.
The sessions delved into several areas both directly affecting IP and tangential to it. All of these, however, are of real interest to the biosimilar community. The next series of articles will cover key takeaways from the sessions.
Pending in Congress
With the third Biosimilars User Fee Act (BsUFA) being debated in Congress today, a panel commented on some of its many provisions. The current BsUFA authorization ends on September 30, and passage prior to this is imperative, said Karin Hessler, Assistant General Counsel for the Association for Accessible Medicines. “It includes a focused effort to advance the development of interchangeable products,” she reported.
Hans Sauer, Deputy General Counsel and Vice President of IP, BIO, believes that the impact of those interchangeability provisions will be felt sooner than later. “Most of the discussion so far around interchangeability [in practice] has involved the insulins.” With the adalimumab biosimilars launching in 2023, “it will be a big year. I think two will launch as interchangeable. The dynamics of how they compete against each other and gain marketshare will be interesting,” he said.
Several other BsUFA proposed changes were discussed, including more detail on the filing of supplemental biosimilar applications and faster timelines for FDA review; the need for more communication and guidance from FDA during the biosimilar development meeting stage with the drug maker; addressing issues with plant inspections prior to receiving an approval decision from the FDA; and the need to hire and retain top-flight scientists at FDA for the review process.
Citizens Petitions are a primary route through which pharmaceutical companies can communicate with FDA about scientific, label, and other issues, said David Korn, Vice President, IP and Law, PhRMA. However, there is considerable concern over the use of Citizens Petitions to stall FDA through “sham” filings by industry. As a result, two pieces of legislation were introduced in 2021 and are still circulating in the Senate. The first, S.1425, appropriately named the Stop STALLING Act, would “enable the Federal Trade Commission (FTC) to deter filing of sham citizen petitions to cover an attempt to interfere with approval of a competing generic drug or biosimilar, to foster competition, and facilitate the efficient review of petitions filed in good faith,” according to the bill’s text. The second, S.562, the Ensuring Timely Access to Generics Act, also depends on the FTC to take action on companies filing petitions that do nothing but delay application decisions. We’ll have more on the subject of the FTC in a later post. Mr. Korn expressed doubts that these proposals would pass a First Amendment test of free speech. Mr. Sauer added that he was unsure of the utility of this legislation.
Product hopping is another anticompetitive concern. The practice occurs when an innovator company creates follow-on products and then attempts to switch patients to those new agents to avoid loss of revenue from older agents at the end of their patent lives (e.g., AbbVie switching patients from Humira® to Skyrizi® prior to the launch of biosimilar versions of adalimumab). Senate bill 1435 and H.R.2873 both deal with product hopping, in addition to other patent-related issues. Little action on these has occurred since they were introduced by the summer of 2021. These bills would also rely on the FTC to sue in court or institute proceedings against the offending organization. Mr. Sauer said that “this is one of the most frustrating bills that we have dealt with. There are huge definitional uncertainties.” He explained that this legislation could have significant negative implications for manufacturers who are thinking of improving their existing products.
As we reported last year, both S.1435 and H.R.2884 seek to streamline the famous “patent dance,” by limiting the number of patents a reference manufacturer can assert to 20 (with patents granted within 4 yr of FDA approval being permitted outside of this cap). Ms. Hessler, Assistant General Counsel for the Association for Accessible Medicines, argued that there are several loopholes within the bills for reference manufacturers. She explained, “At a high level, this reflects what District Courts have been ruling for a while—you can’t have an efficient system with no patent caps.” Mr. Sauer added that method-of-use patents (which are granted for each drug indication) are not subject to the cap, “because they were not considered to necessarily block market entry of a biosimilar.” That is, a biosimilar maker could apply for approval with a skinny label.
In our next article, we’ll report on attorneys’ take on the approval of skinny labels for biosimilars, based on patent considerations.