News & Analysis as of

Takeda Pharm. Co., Ltd. v. Mylan Inc.

Nature of the Case and Issue(s) Presented: The issue here concerns whether the owner of a pharmaceutical patent may simultaneously assert a claim for infringement under § 271(e)(2), and a claim pursuant to the Declaratory...more

GPhA Issues Statement Regarding Proposed IP Provisions of Trans-Pacific Partnership Agreement

The Generic Pharmaceutical Association (GPhA) issued a statement today regarding ongoing talks between major Pacific Rim countries (including the U.S.) related to the proposed Trans-Pacific Partnership Agreement. This trade...more

Depomed, Inc. v. Actavis Elizabeth LLC

Nature of the Case and Issue(s) Presented: Depomed sued Actavis for infringing seven patents related to a dosage form capable of being retained in the stomach, allowing for the delayed-release of gabapentin in the small...more

Fresenius Kabi USA, LLC v. Dr. Reddy’s Labs., Ltd.

Nature of the Case and Issue(s) Presented: Plaintiff filed suit alleging infringement of claims 1, 16, 36, and 37 of each of the patents-in-suit. The patents-in-suit all claim pharmaceutical compositions containing propofol...more

Apotex Inc. v. UCB, Inc.

Nature of the Case and Issue(s) Presented: Apotex appealed the district court’s finding that the ’556 patent was unenforceable due to inequitable conduct. The ’556 patent describes a method for making moexipril tablets used...more

Silence of ANDA with Respect to a Claim Limitation Does Not Constitute Infringement

Ferring B.V. v. Watson Labs., Inc. - In Hatch-Waxman litigation that involved Abbreviated New Drug Applications (ANDAs) that were silent as to certain claimed limitations, the U.S. Court of Appeals for the Federal...more

In re Lipitor Antitrust Litigation (D.N.J. 2014)

In the lastest instance of a plaintiff attempting to extend the Supreme Court's holding in FTC v. Actavis that "reverse payment" settlement agreements in ANDA litigation could be anticompetitive and violate the antitrust...more

Intellectual Property and Technology News - Issue 23, Q3 2014

In This Issue: - Substitution Allowed? State Biosimilar Laws Are Evolving - Patent Wars: Can The Energy Industry Avoid Them? - Surviving A Trademark Opposition Challenge: Do You Have A True...more

Emerging Impact of Inter Partes Review on Hatch Waxman Litigation – A Primer

Hatch-Waxman Litigation in a Nutshell - Hatch-Waxman litigation refers to pharmaceutical patent litigation between a brand drug manufacturer and a generic drug manufacturer under the Hatch-Waxman Act (“Act”). The Act...more

Court Report - September 2014

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. UCB Inc. et al. v. Watson Laboratories Inc. (NV) et al. 1:14-cv-01083; filed August 21, 2014 in the District Court of...more

Ferring B.V. v. Watson Laboratories, Inc. (I) (Fed. Cir. 2014)

In the first of a pair of decisions issued last Friday, Ferring B.V. v. Watson Laboratories, Inc., the Federal Circuit affirmed a finding by the District Court that a generic company could moot ANDA litigation by amending its...more

IP Newsflash - August 2014 #4

DISTRICT COURT CASES - Showing of a Substantial Case of Irreparable Harm to Losing Plaintiff Justifies Injunction Against Defendant During Appeal - Following a bench trial, but before the court issued a...more

Court Report -- Part III

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Cubist Pharmaceuticals Inc. v. Fresenius Kabi USA LLC 1:14-cv-00914; filed July 11, 2014 in the District Court of...more

Contractual Duty to Deal Does Not Equal Antitrust Duty to Deal

Addressing for the first time whether a patent holder under a contractual duty to deal is also subject to an antitrust duty to deal, the U. S. Court of Appeals for the Second Circuit upheld dismissal of a putative antitrust...more

An Unsuccessful Reach for the STELARA, Written description of generic biomolecule claims

AbbVie owns US 6,914,128 (’128), which covers a variety of anti-IL12 monoclonal antibodies. AbbVie markets an anti-IL12 monoclonal (viz. Humira®) as a treatment for a variety of auto-immune disorders, including psoriasis....more

Generic Drug Company Licensees Avoid Patented Medicines Price Oversight

In nearly identical decisions released on May 27, 2014, Sandoz Canada Inc v Canada, 2014 FC 501 (Sandoz) and ratiopharm Inc v Canada, 2014 FC 502 (ratiopharm), the Federal Court of Canada held that some licensees of patents...more

What Is “a Patient?”

Braintree Labs, Inc. v. Novel Labs, Inc. - On appeal from summary judgment, the U.S. Court of Appeals for the Federal Circuit construed “a patient” to mean “a population of patients,” overturning the district court’s...more

Jumping Into The Actavis Briar Patch — Insight Into How Courts May Structure Reverse Payment Antitrust Proceedings And The...

In This Issue: - INTRODUCTION - WHAT ARE REVERSE PAYMENT SETTLEMENT AGREEMENTS? ..The Basic Framework of Hatch-Waxman Litigation ..The Federal Trade Commission’s View of Reverse Payment Settlements and Its...more

A Combination of References Need Only Provide a “Reasonable Expectation of Success”

Hoffmann La-Roche Inc. v. Apotex Inc. - Addressing the validity of a dosing regimen patent in Abbreviated New Drug Application (ANDA) litigation, the U.S. Court of Appeals for the Federal Circuit affirmed a lower...more

Federal Circuit Vacates Infringement of Braintree SUPREP Patent

In a divided opinion issued in Braintree Labs., Inc. v. Novel Labs., Inc., the Federal Circuit reversed the district court on one of two challenged claim construction issues and vacated the district court’s finding of...more

Federal Circuit Expands Doctrine of Double Patenting

Gilead Sciences, Inc. (Gilead) owns United States Patent No. 5,763,483 and United States Patent No. 5,952,375. The patents feature common inventors and disclose similar material in the field of anti-viral compounds. Natco...more

FTC Asks Court to Reverse Payment Decision

On May 2, 2014, the Federal Trade Commission (FTC) filed an amicus brief with the U.S. Court of Appeals for the Third Circuit requesting that the court reverse the district court’s decision in Lamictal Direct Purchaser...more

Federal Circuit Find Fractures in Roche Boniva Patents

In Hoffman-LaRoche, Inc. v. Apotex, Inc., the Federal Circuit affirmed the district court’s summary judgment that two Roche Boniva patents are invalid as obvious. The conclusion of obviousness is not particularly remarkable...more

Shire Development, LLC v. Watson Pharmaceuticals, Inc. (Fed. Cir. 2014)

Claim construction in patent cases, and the propensity for the Federal Circuit to disagree with a district court's conclusions regarding the scope and meaning of claim terms, remains one of the most vexing aspects of patent...more

Endo Pharmaceuticals Inc. v. Actavis, Inc. & Endo Pharmaceuticals Inc. v. Roxane Laboratories, Inc. (Fed. Cir. 2014)

The Federal Circuit's decision in the consolidated appeals of Endo Pharmaceuticals Inc. v. Actavis, Inc. and Endo Pharmaceuticals Inc. v. Roxane Laboratories, Inc. amply demonstrates the concept that you should be careful...more

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