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  • Orange Book Blog is published for informational purposes only; it contains no legal advice whatsoever. Publication of Orange Book Blog does not create an attorney-client relationship. Orange Book Blog is Aaron Barkoff's personal website and it is intended for other attorneys. Orange Book Blog is not edited by McAndrews, Held & Malloy, Ltd. ("MHM") or its clients. No part of Orange Book Blog--whether information, commentary, or other--may be attributed to MHM or its clients. MHM represents many companies in the pharmaceutical and biotechnology industries, and therefore Orange Book Blog may occasionally report on news that relates to MHM clients. Orange Book Blog will always strive to be unbiased. All information on Orange Book Blog should be double-checked for its accuracy and current applicability. -- © Aaron F. Barkoff 2006-2017

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February 26, 2007

Comments

anon

Perhaps, after Medimmune, "reasonable apprehension" is probably not the right way to phrase the test.

I think the new test for the Fed. Cir. should be somewhere along the lines of "real controversy" v. "speculative controversy".

Medimmune involved a "real controversy", where one company was actually losing money, because it was being denied DJ relief.

But in the Teva and Apotex cases, it's mere speculation whether or not they are going to be sued. This is a case by case issue. The mere fact that a patent is listed in the OB, does not mean that it will be asserted. After all, the generic may have very well designed a wrok around (like in the Apotex case).

DePaul3L

I think that it really comes down to the fact that Medimmune is readily distinguishable from any of these HW-ANDA suits. Medimmune, as much as you want to talk about how it involved patents, really was a contracts case.

The Court has applied the DJA to contracts for around 70-80 years and when a term or condition arising out of the contract needs to be interpreted, it's proper for the Court to do so.

I think that the problem with the way that the CAFC has been handling its Art. III justiciability questions is that they have applied a test that is pretty good when you're talking about a vanilla infringement case, but it's horrible under a scheme like Hatch-Waxman which provides all sorts of benefits and loopholes for those who are not first in line. Whether that is a cognizable injury is a question that the court really has to decide.

But I don't know, I'm still a law student.

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