A trio of pending congressional bills is proposing regulation that would create a new industry for generic versions of biologics, a class of medicines created from living tissues or organisms that have much larger molecules than pharmaceutical drugs.
A regulatory path that would allow companies to produce generic versions of biologics, which are known as biosimilars or follow-on biologics, would spawn a new patent counseling and litigation arena for life sciences lawyers.
Chad Landmon, an intellectual property litigation partner in the Hartford, Conn., office of New York’s Axinn, Veltrop & Harkrider, spoke with The National Law Journal about the pending legislation and the legal impact of regulating biosimilars.
NLJ: How would the regulatory approval pathway for biosimilars likely differ from the process for generic pharmaceutical drugs?
CL: Currently there isn’t an approval pathway for biosimilars, but from legislation and commentators we have a good idea of what it’s going to look like. Generic drugs don’t have to do clinical tests. It appears a biosimilar will need to do a limited amount of clinical tests.
NLJ: There are three proposed bills for biosimilar regulation in the U.S. Senate and the U.S. House of Representatives. Are there major differences in the bills?
CL: There are really two competing bills, the one sponsored by [Representative Henry] Waxman [D-Calif] and the one by [Senator Charles] Schumer [D-N.Y.]. The Senate bill is identical to the bill introduced by [Representative Anna G.] Eshoo [D-Calif.]. The main issue is what period of market exclusivity the innovator [branded biologic] company will get. Innovator companies say it takes a lot of money to research these products, so they need to justify the investment and need to be on the market for a period of time. The Waxman bill [proposes] five years of patent exclusivity for the innovator company. The Eshoo bill has 12 to14 years.
NLJ: How likely is some form of legislation to pass in the near future?
CL: There will be legislation. Earlier this year, I though it would definitely be this year. The Obama administration has been pushing it, and people in Congress have as well. It’s more a matter of how intense the debate is going to be over the exclusivity period.
NLJ: What would be the legal impact of an approval process for biosimilars?
CL: It would create a tidal wave of patent litigation in the area, a whole host of patent litigation between the follow-ons [biosimilar creators] and the brand companies. It [would] essentially create a whole industry that is aimed at avoiding a brand company’s patents, a follow-on or biosimilar industry. For most projects you’d see companies try to design around or invalidate [the patents of] the patent innovator companies. Eventually, [it would be] similar in scope to what we see in the pharmaceutical space.
NLJ: Once regulation is in place, would the time period of patented exclusivity for a biosimilar affect the level of patent litigation?
CL: Certainly. If there’s a longer period of exclusivity, there’s likely to be somewhat less, maybe not a lot less, of patent litigation.
NLJ: What kinds of legal issues are companies preparing to make biosimilars grappling with now?
CL: There are two different things we’ve talked to the industry about. On the innovator side, they’re preparing their patent portfolios to be ready for the patent applications that are going to be filed, and there are a whole host of regulatory issues. [Other companies are] getting ready to launch patent challenges.
Sheri Qualters can be reached at [email protected].
