ANDA

News & Analysis as of

Ranbaxy Labs., Ltd. v. Burwell

Case Name: Ranbaxy Labs., Ltd. v. Burwell, 14-cv-1923 BAH, 2015 U.S. Dist. LEXIS 29459 (D.D.C. Mar. 11, 2015) (Howell, J.). Drug Products and Patents-in-Suit: Nexium® (esomeprazole) and Valcyte® (valganciclovir);...more

Eli Lilly & Co. v. Mylan Pharms., Inc.

Case Name: Eli Lilly & Co. v. Mylan Pharms., Inc., Civ. No. 14-cv-00389-SEB-TAB, 2015 U.S. Dist. LEXIS 30175 (S.D. Ind. Mar. 12, 2015) (Barker, J.). Drug Product and Patents-in-Suit: Effient® (prasugrel hydrochloride);...more

Court Report - April 2015 #4

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Medicis Pharmaceutical Corp. v. Taro Pharmaceuticals U.S.A., Inc. et el. 3:15-cv-02841; filed April 22, 2015 in the...more

Magistrate Recommends Dismissing Certain Induced Infringement Claims

The disputed technology relates to carvedilol, initially patented 20 years ago for the treatment of hypertension, and now for the treatment of chronic heart failure. Defendants filed ANDAs for generic versions of the drug...more

Senju Pharm. Co., Ltd. v. Metrics, Inc.

Case Name: Senju Pharm. Co., Ltd. v. Metrics, Inc., Civ. No. 14-3962-JBS/KMW, 2015 U.S. Dist. LEXIS 41504 (D.N.J. Mar. 31, 2015) (Simandle, J.) ....more

Apotex Inc. v. Daiichi Sankyo, Inc.

Case Name: Apotex Inc. v. Daiichi Sankyo, Inc., 2014-1282, -1291 2015 U.S. App. LEXIS 5134 (Fed. Cir. Mar. 31, 2015) (Circuit Judges Taranto, Mayer, and Clevenger presiding; Opinion by Taranto, J.) (Appeal from N.D. Ill.,...more

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

InSite Vision Inc. v. Sandoz, Inc. (Fed. Cir. 2015)

The Federal Circuit showed once again the importance of a district court's factual findings (and the deference the appellate court gives those findings, particularly when supported by expert testimony), in InSite Vision Inc....more

Exela Pharma Sciences LLC v. Lee (Fed. Cir. 2015)

Late last month, the Federal Circuit handed Exela Pharma Sciences its latest defeat in litigation relating to its ANDA filing on Cadence Pharmaceuticals' injectable acetaminophen-based drug Ofirmev®, in Exela Pharma Sciences...more

Claim Construction Opinion Issues In ANDA Case

Andrews, J. Court issues a claim construction opinion in ANDA case regarding terms from nine patents. The disputed technology relates to the administration of testosterone. The following terms were construed...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

Threshold Issues: IPR Not Derailed by Unidentified D/B/A Name or Prior ANDA Certification - Metrics, Inc. v. Senju Pharmaceutical...

Addressing threshold jurisdictional issues of a petition for inter partes review (IPR), the U.S. Patent and Trademark Office’s (USPTO) Patent Trial and Appeal Board (PTAB or Board) determined that a d/b/a name does not create...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

Senju Pharmaceutical Co., Ltd. v. Lupin Ltd. (Fed. Cir. 2015)

Senju PharmaceuticalEarlier this month, the Federal Circuit affirmed a District Court judgment of obviousness in ANDA litigation under the Hatch Waxman Act having a long provenance of earlier litigation, in Senju...more

Claim Construction Opinion Issues In ANDA Rufinamide Litigation

Stark, C. J. The court issues claim constructions regarding 7 terms from 3 patents. The following terms were construed...more

Court Denies Generic Drug Manufacturer’s Motion to Dismiss Hatch-Waxman Patent Infringement Action on Jurisdiction Grounds

On March 12, the United States District Court for the Southern District of Indiana joined the District of Delaware and Eastern District of Texas as the first courts to consider a generic drug manufacturer’s motion to dismiss...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

Magistrate Recommends Denying Motion To Dismiss Based On Lack Of Personal Jurisdiction

Burke, M.J. Magistrate recommends denying defendant’s motion to dismiss for lack of personal jurisdiction in a Report and Recommendation....more

Glenmark Generics Ltd. v. Ferring B.V.,

Case Name: Civ. No. 3:14-cv-422-HEH, 2014 U.S. Dist. LEXIS 146528 (E.D. Va. Oct. 14, 2014) (Hudson, J.) (Where patent holder disclaims patent and asks FDA to delist, but patent remains in Orange Book, declaratory judgment...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

Takeda Pharms. USA, Inc. v. West-Ward Pharm. Corp.,

Case Name: Takeda Pharms. USA, Inc. v. West-Ward Pharm. Corp., Civ. No. 14-1268-SLR, 2014 U.S. Dist. LEXIS 155981 (D. Del. Nov. 4, 2014) (Robinson, J.) (Given statements made in the accused product’s proposed labeling,...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

147 Results
|
View per page
Page: of 6

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.
×