Testing And Characterizing Biosimilarity: Will The Hatch-Waxman Safe Harbor Apply?


[author: Michael Shuster]

Two recent conflicting Federal Circuit cases (Classenand Momenta) interpreting the Hatch-Waxman safe harbor provision (35 USC 271(e)(1)) have stirred debate in the biosimilars community. While the new biosimilars pathway (the Biologics Price Competition and Innovation Act) is different from Hatch-Waxman of course, and its interpretation by FDA is still evolving, the controversy emanating from the recent cases is drawing concern.

The Biologics Price Competition and Innovation Act ("BPCIA") has not yet led to an approved biosimilar, but one may not be far off. The FDA has conducted meetings with potential biosimilar sponsors and INDs (investigational new drug applications) for biosimilars have been filed. FDA's draft guidelines set forth detailed standard for 'biosimilarity' which must be met by the follow-on product.

The recent Momenta v. Amphastar case has led some in the biosimilars community to ask how an experimental safe harbor might work in the biological drug context, where we would likely see far more complex and sophisticated (and thus likely patented) compliance testing than what is typically found in the small molecule context.

If the Momenta case gets extrapolated to the biosimilars context, then the hard (and likely expensive) work of the first biosimilar candidate to figure out a method of testing and characterizing his large molecule will be used, legally and without compensation, by other follow-on candidates in order to test their own candidate molecules. On the other hand, if the reasoning in Momenta is rejected by the Supreme Court (assuming they grant certiorari, which appears increasingly likely) then whichever biosimilar candidate can come up with (and patent) an effective means of characterizing large molecules for purposes of establishing biosimilarity sufficient to meet FDA's standards will likely become the de facto exclusivebiosimilar competitor, as other competitors will be unable to satisfactorily characterize the biosimilarity of their candidate products without violating the patent.

Kevin Noonan, in the exceptional Patent Docs blog, has a comprehensive post on Judge Rader's dissent in Momenta. Judge Rader's various opinions on the topic of Hatch-Waxman safe harbor portend the problem of free-riding - "trespass" in the Judge's words - by competitor follow-on candidates, severely distorting incentives in the process.

We'll be looking for the Supreme Court to resolve the tension between Momenta and Classen and perhaps provide some guidance that can in turn be relied upon by the FDA.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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