ANDA

Business Litigation Report -- April 2013

by Quinn Emanuel Urquhart & Sullivan, LLP on 4/15/2013

In This Issue: - Firm News: DoJ Star Healthcare Fraud Prosecutor Joins Washington, D.C. Office; and Quinn Emanuel Wins Top Honors at the Inaugural U.S. Benchmark Annual Awards - Main...more

April 2013: Life Sciences Litigation Update: Will the Supreme Court Resolve Circuit Split on Settlement of ANDA Disputes?

by Quinn Emanuel Urquhart & Sullivan, LLP on 4/5/2013

On March 25, 2013, the U.S. Supreme Court heard oral argument in Federal Trade Commission v. Actavis, Inc. (Docket No. 12-416). The Actavis case centers around the debate over the type of antitrust analysis that should apply...more

Supreme Court Oral Argument in FTC v. Actavis

by Kevin E. Noonan | McDonnell Boehnen Hulbert & Berghoff LLP on 4/2/2013

The Supreme Court heard oral argument in Federal Trade Commission v. Actavis (the caption for what was Federal Trade Commission v. Watson Pharmaceuticals, Inc. in the 11th Circuit opinion below) last Monday, with Deputy...more

Court Report -- April 1, 2013

by Sherri Oslick | McDonnell Boehnen Hulbert & Berghoff LLP on 4/1/2013

In This Issue: Millennium Pharmaceuticals Inc. v. Fresenius Kabi USA LLC et al.; Trustee's of the University of Pennsylvania v. St. Jude Children's Research Hospital; and Pfizer Inc. et al. v. Lupin Ltd. et al.....more

Academic White Paper Rebuts FTC and S. 214

by Kevin E. Noonan | McDonnell Boehnen Hulbert & Berghoff LLP on 3/29/2013

Paul Bender, former Clinton-era Principal Deputy Solicitor General, and his colleagues Christopher A. Mohr and Michael Kippler at the University of Arizona Law School, published a White Paper entitled "S. 214's inappropriate...more

Case Brief: Federal Trade Commission v. Watson Pharmaceuticals

by Kwame Mensah | McDonnell Boehnen Hulbert & Berghoff LLP on 3/26/2013

[Ed. The Supreme Court heard oral argument today in Federal Trade Commission v. Watson Pharmaceuticals. While Patent Docs will provide analysis regarding the oral argument in a subsequent post, we provide the following...more

Senators Introduce Another Bill to Ban Reverse Payment Settlement Agreements

by Kevin E. Noonan | McDonnell Boehnen Hulbert & Berghoff LLP on 3/15/2013

Last week, Senator Al Franken (D-MN) was joined by Senators David Vitter (R-LA), Dick Durbin (D-IL), Jeanne Shaheen (D-NH), and Bernie Sanders (I-VT) in introducing S. 204, the "Fair and Immediate Release of Generic Drugs...more

In re Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litigation (Fed. Cir. 2013)

by Andrew Williams | McDonnell Boehnen Hulbert & Berghoff LLP on 3/1/2013

On the first day of February, the Federal Circuit rejected Impax's efforts to get out from under a preliminary injunction in a case captioned In re Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litigation. ...more

Par/Paddock Answers FTC Before Supreme Court

by Kevin E. Noonan | McDonnell Boehnen Hulbert & Berghoff LLP on 2/28/2013

Par PharmaceuticalPar/Paddock, one of the generic drug company defendants in FTC v. Actavis Inc. et al. (the "reverse payment" ANDA settlement case now before the Supreme Court) filed its reponsive brief last week. In it,...more

Federal Circuit Upholds Fentora Patents, But Affirms Non-Infringement

by Courtenay C. Brinckerhoff | Foley & Lardner LLP on 2/26/2013

In Cephalon, Inc. v. Watson Pharmaceuticals, Inc., the Federal Circuit reversed the district court’s finding that two Orange Book-listed patents for Cephalon’s FENTORA® product were invalid, but affirmed the district court’s...more

MBHB Snippets: Review of Developments in Intellectual Property Law - Winter 2013 - Volume 11, Issue 1: Federal Courts Debate Safe...

by Patrick Gattari, Nicole Grimm | McDonnell Boehnen Hulbert & Berghoff LLP on 2/19/2013

Patent protection is a critical driver of value for the biotech industry. One of the unique aspects of biotech patents, however, is that many otherwise infringing activities are exempt from claims of patent infringement when...more

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

by Kevin E. Noonan | McDonnell Boehnen Hulbert & Berghoff LLP on 2/15/2013

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

Court Report -- February 03, 2013

by Sherri Oslick | McDonnell Boehnen Hulbert & Berghoff LLP on 2/4/2013

In This Report: Purdue Pharma L.P. et al. v. Epic Pharma, LLC; Purdue Pharma L.P. et al. v. Impax Laboratories, Inc.; Santarus, Inc. et al. v. Mylan Pharmaceuticals Inc. et al.; Santarus Inc. et al. v. Mylan Inc. et al.;...more

Allergan, Inc. v. Barr Laboratories, Inc. (Fed. Cir. 2013)

by Michael Greenfield | McDonnell Boehnen Hulbert & Berghoff LLP on 1/30/2013

Those of you who dabble with chemical structures while prosecuting or litigating pharmaceutical patents may find Allergan v. Barr Laboratories, Inc., interesting. In this ANDA litigation brought by Allergan against Barr,...more

FTC Releases Another Report on Reverse Payment Settlement Agreements in ANDA Litigation

by Kevin E. Noonan | McDonnell Boehnen Hulbert & Berghoff LLP on 1/18/2013

As it has frequently in the past decade, the Federal Trade Commission on Thursday released a Report on the frequency of reverse payment settlement agreements in ANDA litigation between generic and branded drug makers,...more

Supreme Court to Hear AndroGel Reverse Payment Case

by Courtenay C. Brinckerhoff | Foley & Lardner LLP on 1/10/2013

The Supreme Court granted certiorari in Federal Trade Commission v. Watson Pharmaceuticals, Inc., to address whether and when “reverse payment” agreements made to settle ANDA litigation violate antitrust laws....more

In re Rosuvastatin Calcium Patent Litigation (Fed. Cir. 2012)

by Andrew Williams | McDonnell Boehnen Hulbert & Berghoff LLP on 1/10/2013

Late last year, in AstraZeneca v. Aurobindo (In re Rosuvastatin Calcium Patent Litigation), the Federal Circuit affirmed that a reissue patent covering the active ingredient of Crestor® was valid, enforceable, and infringed...more

Jumping the Line: Generic drug makers aren’t waiting until patents expire

by MoFo Tech on 12/4/2012

Since passage of the Hatch-Waxman Act in 1984, generic drug companies have used its Abbreviated New Drug Application (ANDA) process to bring cheaper versions of brand-name drugs to market after their patents expire. In the...more

FTC Moves as Amicus in Effexor Litigation, and Gets Its (Well-Earned) Comeuppance

by McDonnell Boehnen Hulbert & Berghoff LLP on 10/19/2012

The Federal Trade Commission, in an attempt to extend the scope of its signal (and sole) victory in its crusade against reverse payment settlement agreements in ANDA cases, In re K-Dur Antitrust Litigation, has moved for...more

FTC Asks Supreme Court to Play Favorites in Reverse Payment Settlement Agreement Cases

by McDonnell Boehnen Hulbert & Berghoff LLP on 10/17/2012

Reinvigorated by its triumph in convincing a three-judge panel of the Third Circuit to adopt its view that reverse payment settlement agreements in ANDA cases are presumptively illegal (in the K-Dur case, In re K-Dur...more

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