OBB Newsletter

  • Enter your e-mail address below to subscribe to the Orange Book Blog newsletter. If a new post is added during the day, you'll receive it by e-mail the next morning.

Enter your email address:

Delivered by FeedBurner




  • 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

« Thailand's Compulsory Licensing of Pharmaceuticals Under TRIPS Stirs Controversy | Main | Astellas and Boehringer Ingelheim Defeat Ranbaxy in Flomax Case »

February 26, 2007



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).


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.

Verify your Comment

Previewing your Comment

This is only a preview. Your comment has not yet been posted.

Your comment could not be posted. Error type:
Your comment has been saved. Comments are moderated and will not appear until approved by the author. Post another comment

The letters and numbers you entered did not match the image. Please try again.

As a final step before posting your comment, enter the letters and numbers you see in the image below. This prevents automated programs from posting comments.

Having trouble reading this image? View an alternate.


Post a comment

Comments are moderated, and will not appear until the author has approved them.

Your Information

(Name is required. Email address will not be displayed with the comment.)