News & Analysis as of

Abbreviated New Drug Application (ANDA) Expert Testimony

Akin Gump Strauss Hauer & Feld LLP

Results from Phase I and II Clinical Trials and Pending Phase III Clinical Trial Insufficient to Render Obvious Method of Treating...

In an ANDA case in the District of Delaware, the court has rejected an obviousness challenge to a patented method of increasing survival in patients having prostate cancer. The court found that early clinical trial results...more

McDonnell Boehnen Hulbert & Berghoff LLP

Novartis Pharmaceuticals Corp. v. Accord Healthcare, Inc. (Fed. Cir. 2022)

When does the absence of evidence turn into evidence of absence, and when does such absence amount to an adequate written description of the absence of a step of a method claim?  This is a question that comes readily to mind...more

McDonnell Boehnen Hulbert & Berghoff LLP

Bracco Diagnostics Inc. v. Maia Pharmaceuticals, Inc. (Fed. Cir. 2020)

Stipulating to infringement after a contrary claim construction is a conventional stratagem for a losing party to have a final judgment that can be challenged before the Federal Circuit.  The risk of course, is that if the...more

McDonnell Boehnen Hulbert & Berghoff LLP

Cephalon, Inc. v. Watson Pharmaceuticals, Inc. (Fed. Cir. 2013)

Whether ANDA litigation has had a positive or negative impact on generic drug availability is an open question, in view of several recent reports looking at the effects such litigation has had on both branded and generic...more

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