ANDA Pharmaceutical Industry

News & Analysis as of

AstraZeneca AB v. Apotex Corp. (Fed. Cir. 2015)

Earlier this month, the Federal Circuit rendered a decision on damages in what may be the last of a long-running series of ANDA cases involving AstraZeneca's Prilosec® (omeprazole) franchise. As set forth in the opinion,...more

Otsuka’s Pediatric Labeling Dispute Seeks to Expand Orphan Drug Exclusivity

On April 13, 2015, the U.S. District Court for the District of Maryland issued an Order granting Otsuka Pharmaceutical Co., Ltd. Otsuka Pharmaceutical Development and Commercialization, Inc., and Otsuka America...more

Amgen Receives No Help from the FDA -- A Biosimilar Update

Near the end of last month, the U.S. Food and Drug Administration ("FDA") denied a citizen petition filed by Amgen in which it requested that action be taken to ensure that biosimilar applicants comply with the disclosure and...more

Apotex Inc. v. Daiichi Sankyo, Inc. (Fed. Cir. 2015)

Can a Federal district court ever have subject-matter jurisdiction to hear a declaratory judgment action of non-infringement for a disclaimed patent? Of course, the Federal Circuit explained this week in the Apotex Inc. v....more

FDA Denies Amgen’s Citizen’s Petition Awaiting Guidance from the Courts

As we have discussed before, the first generation of biosimilar litigation under the Biologics Price Control and Innovation Act (BPCIA) addresses whether the BPCIA’s patent dispute resolution procedures – the “patent dance” –...more

Safety Labeling: Public Meeting Later This Month and Comment Period Extended – Key Dates Coming Up

On March 27, 2015, FDA plans to hold a public meeting entitled, “Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products”. The meeting was announced in a Federal Register Notice posted...more

Direct Purchasers and End Payors Accuse Brand Pharma of Delaying Generic Entry

Americans want access to inexpensive pharmaceutical drugs. This demand must be balanced with the fact that brand-name, innovator pharmaceutical companies typically invest tremendous resources to research and develop new...more

The Medicines Co. v. Mylan Inc.

Case Name: The Medicines Co. v. Mylan Inc., Civ. No. 1:11-cv-1285, 2014 U.S. Dist. LEXIS 152433 (N.D. Ill. Oct. 27, 2014) (St. Eve, J.) (Generic drug manufacturer was liable for patent infringement as a matter of law when the...more

FDA Revisits Its Proposed Rule Regarding Generic Drug Labeling

On February 18, 2015, the FDA announced that it is reopening the comment period for its proposed rule that would allow ANDA holders to unilaterally update their generic drug product labels prior to the NDA holder doing so....more

Warner Chilcott Co, LLC v. Teva Pharms. USA, Inc

Case Name: Warner Chilcott Co, LLC v. Teva Pharms. USA, Inc., Nos. 2014-1439, 2014-1441, 2014-1444, 2014-1445, 2014-1446, 2014 U.S. App. LEXIS 21946 (Fed. Cir. Nov. 18, 2014) (Circuit Judges Lourie, Reyna and Taranto...more

Supreme Court Takes a Pass on Generic Drug Labeling Appeal

In the watershed case of PLIVA, Inc. v. Mensing, the United States Supreme Court determined that federal law preempts state law failure-to-warn claims against generic pharmaceutical manufacturers. More specifically, Mensing...more

Court Report - January 2015 #2

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Tris Pharma Inc. v. Par Pharmaceutical Inc. et al. 1:15-cv-00068; filed January 21, 2015 in the District Court of...more

Court Report - January 2015

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Sanofi-Aventis U.S. LLC et al. v. Breckenridge Pharmaceutical, Inc. 9:15-cv-80056; filed January 15, 2015 in the...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

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

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

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

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

91 Results
|
View per page
Page: of 4

All the intelligence you need, in one easy email:

Great! Your first step to building an email digest of JD Supra authors and topics. Log in with LinkedIn so we can start sending your digest...

Sign up for your custom alerts now, using LinkedIn ›

* With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name.
×