News & Analysis as of

Infringement Abbreviated New Drug Application (ANDA)

Knobbe Martens

Going down With the Ship: Non-infringing Indications Are Barred When Listed in the Same ANDA as Infringing Indications

Knobbe Martens on

SALIX PHARMACEUTICALS, LTD. v. NORWICH PHARMACEUTICALS., INC. Before Lourie, Chen, and Cunningham.  Appeal from the District of Delaware Summary: The Federal Circuit ruled that an ANDA listing an infringing indication cannot...more

McDermott Will & Emery

Claim to Gel Formulation Not Obvious Over Prior Art Liquid Formulation

McDermott Will & Emery on

Addressing the issue of whether a topical gel with an increased concentration of active ingredient would have been obvious over a prior art liquid product, the US District Court for the District of New Jersey concluded that...more

McDermott Will & Emery

New Jersey Court Rules That a Parent Company Is Still on the Hook for Divested Subsidiary’s ANDA Filing

McDermott Will & Emery on

Addressing a motion to dismiss for lack of subject matter jurisdiction, a New Jersey district court held that Merck could maintain a Hatch-Waxman lawsuit against Actavis, Inc. n/k/a Allergan Finance LLC (Actavis), despite...more

McDonnell Boehnen Hulbert & Berghoff LLP

G.D. Searle LLC v. Lupin Pharmaceuticals, Inc. (Fed. Cir. 2015)

Over seven years ago, the Federal Circuit delivered a mixed ruling against Pfizer in litigation against Teva) relating to the pain medication Celebrex® (celocoxib) (where "celocoxib" is...more

McDonnell Boehnen Hulbert & Berghoff LLP

Court Report - December 29, 2013

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Janssen Pharmaceuticals Inc. et al. v. Alkem Laboratories Limited 1:13-cv-09227; filed December 26, 2013 in the Northern...more

Foley & Lardner LLP

Federal Circuit Finds LUNESTA Patent Infringement Based on ANDA Product Description Not Avoided by Other Certifications

Foley & Lardner LLP on

In Sunovion Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc., the Federal Circuit reversed the district’s holding of no Lunesta® patent infringement that was based on a certification submitted to the court, and found...more

McDonnell Boehnen Hulbert & Berghoff LLP

Research Foundation of State University of New York v. Mylan Pharmaceuticals Inc. (Fed. Cir. 2013)

When assessing the validity of a patent, you cannot ignore the dependent claims. That was the main takeaway from the recent Federal Circuit case, Research Foundation of State University of New York v. Mylan Pharmaceuticals...more

Foley & Lardner LLP

Federal Circuit Finds “Molecular Weight” to Be Insolubly Ambiguous

Foley & Lardner LLP on

In Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., the Federal Circuit invalidated a number of claims directed to a polymer defined by its “molecular weight” because the term was ambiguous, and Applicants’ conflicting...more

McDermott Will & Emery

IP Update, Vol. 16, No. 7, July 2013

McDermott Will & Emery on

“Reverse Payment” Settlements Face Greater Antitrust Scrutiny Following U.S. Supreme Court Ruling in FTC v. Actavis: Federal Trade Commission v. Actavis, Inc. - Resolving a split among the U.S. Courts of Appeals, the...more

McDonnell Boehnen Hulbert & Berghoff LLP

Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc. (Fed. Cir. 2013)

A claim term that can have different meanings or values depending on the method used to measure it renders the claim indefinite because it is impossible for a potential infringer to discern the boundaries of the claim. This...more

McDonnell Boehnen Hulbert & Berghoff LLP

Court Report -- July 28, 2013

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Cornerstone Therapeutics Inc. et al. v. Exela Pharma Sciences LLC et al. 1:13-cv-01275; filed July 24, 2013 in the...more

McDonnell Boehnen Hulbert & Berghoff LLP

Supreme Court Denies Certiorari in Momenta Case

The Supreme Court on Monday declined to grant certiorari in Momenta Pharmaceuticals v. Amphastar Pharmaceuticals, a case involving a split in authority that has arisen among Federal Circuit judges regarding the scope of the...more

McDonnell Boehnen Hulbert & Berghoff LLP

Court Report -- June 23, 2013

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Alza Corp. et al. v. Par Pharmaceutical Inc. et al. 1:13-cv-01104; filed June 19, 2013 in the District Court of Delaware...more

McDonnell Boehnen Hulbert & Berghoff LLP

Court Report -- April 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

Foley & Lardner LLP

Federal Circuit Upholds Fentora Patents, But Affirms Non-Infringement

Foley & Lardner LLP on

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

McDonnell Boehnen Hulbert & Berghoff LLP

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

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

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

McDonnell Boehnen Hulbert & Berghoff LLP

Court Report -- February 03, 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

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