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« FDA Publishes Draft Guidelines for Biosimilar Product Development | Main | John Marshall Law School 56th Annual IP Law Conference »

February 09, 2012


The relation between patented use and non-patented use and how those two aspects can be used by generic companies need guidelines from the FDA and clear court verdict.

Amazing that it took this long for the question of the efficacy of labeling carve-outs to come before the CAFC. Seems like a dumb suit, but hard to believe A-Z was dumb. Maybe desperate is the better explanation.


Very nice summary of case, including its implications.

The new FDA biosimilars draft Q and A clarifies that a biosimilar does not have to seek approval for all uses for which the reference molecule is approved. Thus, for biosimilars, there will be an inherent carve out. Let the games begin!

Dear Cranky,

I don’t think AstraZeneca was necessarily “dumb” to file this suit. I haven’t read the underlying briefs in this case, but it is very possible that AZ was relying on the phrase in latter part of § 271(e)(2): “the purpose of such submission it to obtain approval . . . to engage in the commercial manufacture, use, or sale of a drug . . . the use of which is claimed in a patent . . . .” Here, the focus could have been on the “purpose” of the submission, not the indication included on the proposed label. AZ could have been seeking the ability to conduct discovery to determine what the real “purpose” of the submission was. However, the district court shut them down before the even got a chance. And, because the Federal Circuit found the proposed label to be determinative, and therefore there could be no set of facts that would allow AZ to succeed, they affirmed. It would have been interesting to see how AZ would have conducted the case should it have been allowed to proceed. In any event, even though it may have looked like desperation on AZ’s part, I believe there was some logic in bringing this suit in the first place. Thanks for the comment.


Dear EG,

Thank you for the comment.


I see, so for Astra, the ANDA applicant is guilty per se inducing infringement by simply introducing the generic drug at the top of the distribution chain and having docs prescribe it for patented use, irrespecitve of what the ANDA applicant wants, intends, or desires. Seems like, as the court says, this is a perpetual monopoly after a composition of matter patent expires. If Astra can prove specific intent to induce, then it can win its infringement case.

Thank you for posting this information up about Crestor and the filers that aren't being included in the information that should be provided. I think this is all very important.

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