ANDA

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Court Report -- Part II: November 2014

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Par Pharmaceutical, Inc. v. Glaxosmithkline LLC et al. 2:14-cv-06627; filed November 19, 2014 in the Eastern District of...more

Comments Sought by December 19th on the FDA's Proposed Criteria for "First Generic" Applications

This morning, the Food and Drug Administration (FDA) opened a public docket and requested comments on its proposed criteria for expedited review of "first generic" Abbreviated New Drug Applications (ANDAs). The comment period...more

FDA's Final Guidance on Determination of Five-Year NCE Exclusivity for Certain Fixed-Combination Drug Products Under Federal FDCA

The U.S. Food and Drug Administration (FDA) recently published its final Guidance for Industry detailing circumstances under which a fixed-combination drug product (FCD) may be entitled to five-year new chemical entity (NCE)...more

Court Report - November 2014

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Teijin Ltd. et al. v. Unimark Remedies Ltd. 1:14-cv-01356; filed November 4, 2014 in the District Court of...more

Lex Machina Looks at ANDA Cases

Lex Machina, a commercial venture spinning out of the "quantitative statistics" trend in patent scholarship popularized by Mark Lemley, Kimberly Moore, David Schwartz, and others, has released a Report on ANDA litigation that...more

Judge Sheridan Dismisses More Plaintiffs in Lipitor Antitrust Case

Late last week, District Court Judge Peter Sheridan (D.N.J.) dismissed with prejudice the complaint for antitrust injury by the so-called "End Payor Class Purchasers" against the parties in previous ANDA litigation in the...more

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

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

United Therapeutics Corp. v. Sandoz, Inc.

Nature of the Case and Issue(s) Presented: UTC claimed that Sandoz induced infringement of the ’007 patent by instructing physicians to dilute its product for use intravenously. The asserted claim required a particular...more

Hospira, Inc. v. Burwell

Nature of the Case and Issue(s) Presented: Precedex is commonly used as a sedative. Specifically, the FDA has approved Precedex for two uses: (i) sedation of initially intubated and mechanically ventilated patients during...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

Ferring B.V. v. Watson Labs., Inc.—Florida (I)

Nature of the Case and Issue(s) Presented: The issue of infringement in this case relates entirely to dissolution rates. Apotex sought to market its generic product by designing around Ferring’s Lysteda. In its 2010 ANDA,...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

Court Report - October 2014

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Shire LLC v. Amerigen Pharmaceuticals Ltd. 1:14-cv-06095; filed October , 2014 in the District Court of New Jersey....more

Sham-Wow! Antitrust Liability May Attach to Sham Administrative Petitions

Addressing whether the “sham” exception to Noerr-Pennington immunity is limited to sham litigation in courts, the U.S. Court of Appeals for the Federal Circuit vacated a lower court’s summary judgment of no antitrust...more

BioPharma Patents Quick Tips and News

THREE NEW CASES FROM THE FEDERAL CIRCUIT - UNEXPECTED RESULTS - 1. In Allergan v. Apotex, 754 F.3d 952 (Fed. Gir. 2014). claims to method of growing eyelashes by administering a broad genus encompassing...more

Court Report - September 2014 #6

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Cadence Pharmaceuticals Inc. et al. v. InnoPharma Licensing LLC et al. 1:14-cv-01225; filed September 24, 2014 in the...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

IS THE A IN ANDA BEGINNING TO MEAN ANTITRUST? [Video]

The Abbreviated New Drug Application (ANDA) process is one of the hottest areas of intellectual property disputes among companies today. But the Federal Circuit’s recent decision in Tyco Healthcare v. Mutual Pharmaceutical is...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

Allergan, Inc. v. Apotex, Inc. (Fed. Cir. 2014)

In a not particularly well-written opinion that breaks no new ground, the Federal Circuit considered a consolidated appeal of two patents directed to methods of promoting hair growth, including, in particular, eyelash hair...more

Federal Circuit Finds Apotex ANDAs Do Not Infringe Lysteda Patents

In two decisions issued under the same name (Ferring B.V. v. Watson Laboratories, Inc.), the Federal Circuit upheld the validity of the Orange Book-listed patents for Lysteda®, but found that they were not infringed by either...more

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

In the second of a pair of decisions issued last Friday, styled Ferring B.V. v. Watson Laboratories, Inc., the Federal Circuit affirmed a finding by the District Court that the generic ANDA challenger had not shown the...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

Federal Circuit Upholds Validity of Lysteda Patents

In two decisions issued under the same name (Ferring B.V. v. Watson Laboratories, Inc.), the Federal Circuit upheld the validity of the Orange Book-listed patents for Lysteda®, but found that they were not infringed by either...more

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