Generic Drugs Pharmaceutical Industry

News & Analysis as of

Seventh Circuit Knocks Out Claims Against Generic Manufacturer on Preemption Grounds

It is not often that we get the opportunity to discuss an opinion from a panel of judges including two former professors from our law school. Diane Wood is the Chief Judge of the 7th Circuit and taught us Civil Procedure at...more

Behind the Curtain: Shkreli was NOT the Big Story on the Hill Today

Congress’s complex relationship with prescription drugs was on display today in the House of Representatives. In the House Committee on Oversight and Government Reform (OGR), Martin Shkreli pleaded the 5th at a hearing...more

Cumberland Pharms., Inc., v. Mylan Institutional LLC

Case Name: Cumberland Pharms., Inc., v. Mylan Institutional LLC, Civ. No. 12-C-3846, 2015 U.S. Dist. LEXIS 134495 (N.D. Ill. Oct. 2, 2015) (Pallmeyer, J.)... Drug Product and Patent(s)-in-Suit: Acetadote®...more

Otsuka Pharm. Co., Ltd. v. Zydus Pharms. USA,

Case Name: Otsuka Pharm. Co., Ltd. v. Zydus Pharms. USA, C.A. Nos. 14-3168 (JBS/KMW),14-4671 (JBS/KMW),14-5878 (JBS/KMW),14-6398 (JBS/KMW),14-7252 (JBS/KMW), 2015 U.S. Dist. LEXIS 138853 (D.N.J. Oct. 13, 2015) (Simandle,...more

Final ACA Medicaid Drug Pricing Rule Published: Changes to 5i, Bundling, RCP and Other Provisions Leave a Lot for Manufacturers to...

On Thursday, January 21, the Centers for Medicare & Medicaid Services (CMS or “the Agency”) published its long-awaited final rule with comment period implementing the Medicaid pricing and reimbursement provisions of the...more

Cubist Pharms., Inc. v. Hospira, Inc.

Case Name: Cubist Pharms., Inc. v. Hospira, Inc., 2015-1197, 2015-1204, 2015-1259, 2015 U.S. App. LEXIS 19662 (Fed. Cir. Nov. 12, 2015) (Circuit Judges Wallach, Bryson, and Hughes presiding; Opinion by Bryson, J.) (Appeal...more

More on Patent Settlements Including Litigation at the European Courts

Last week I posted on the European Commission’s (EC) latest report into patent settlement agreements between originator and generic companies in the European Union (EU). The EC says each time it produces these reports that...more

The New One-Two Is Back

A couple of years ago the one-two punch was all the rage in prescription drug cases. “One-two punch” has been our moniker for decisions where plaintiffs ingested only generic drugs, but tried to hedge their bets, given the...more

CAFA Settlement Trap: States As Absent Class Members

Will a Class Action Fairness Act (CAFA) notice of settlement bind a state as an absent class member? A Pennsylvania federal district court recently offered guidance on this issue. The case involved allegations that the...more

Look before you leap: seeking to enforce your pharmaceutical patent may lead to unintended consequences

It may not be just generic manufacturers seeking compensation when their product launch is found to be delayed by an originator wielding what is ultimately found to be an invalid patent. An Australian court recently...more

Court Report - January 2016

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Spectrum Pharmaceuticals, Inc. et al. v. Amneal Pharmaceuticals LLC - 2:15-cv-01697; filed September 3, 2015 in the...more

Don't Blame Patents For High Drug Prices

Before his recent arrest, Martin Shkreli, the former CEO of Turing Pharmaceuticals, gained notoriety for increasing the price of the AIDS drug Daraprim® (pyrimethamine) from about $13.50 to about $750 per pill. He also was...more

Commonwealth a step closer to compensation for delayed PBS price drops

The Full Federal Court has held that the Therapeutic Goods Act 1989 (Cth) (TG Act) does not limit the Commonwealth’s ability to seek compensation for losses arising from the operation of an interlocutory injunction...more

Alabama No Longer An Outlier State: Legislature Says “No” To Innovator Liability

I. Introduction - Since the United States Supreme Court’s decision in Pliva, Inc. v. Mensing, the plaintiffs’ bar has been feverishly searching for an alternate theory of recovery when the claimant took a generic...more

New Law Remedies Partial Loss of Drug Marketing Exclusivity Period Caused by U.S. DEA Scheduling Delays

When a new drug is first approved by the U.S. Food and Drug Administration (FDA), the drug is entitled to a period of market exclusivity. For a subset of these new drugs, the FDA will determine that the product has the...more

Generic Preemption Prevails in Testosterone MDL

What? You were expecting another of our insensitive blogpost headlines? Nope, we’re playing this one straight down the middle. In In re Testosterone Replacement Therapy Products Liability Litigation, 2015 WL 6859286...more

New Preemption Decisions That We Can't Discuss Quite Yet

As lawyers, we have to get client approval before we can discuss their litigation substantively. Here are a couple just-in decisions where we’re doing that, but that are important enough our readers would want to know about...more

Warnings Causation Sinks "Failure to Update" Claim

This post is not from the Dechert side of the blog. “Failure to update” claims have multiple problems. You probably already know what we are referring to. Federal law requires that generic drug manufacturers...more

Novartis Pharm. Corp. v. Zydus Noveltech Inc.

Case Name: Novartis Pharm. Corp. v. Zydus Noveltech Inc., Civ. No. 14-cv-1104-RGA, 2015 U.S. Dist. LEXIS 103708 (D. Del. Aug. 7, 2015) (Andrews, J.) - Drug Product and Patent(s)-in-Suit: Exelon® (rivastigmine); U.S....more

Endo Pharms. Inc. v. Amneal Pharms. LLC

Case Name: Endo Pharms. Inc. v. Amneal Pharms. LLC, Civ. Nos. 12 Civ. 8115 (TPG), 12 Civ. 8060 (TPG), 12 Civ. 8317 (TPG), 12 Civ. 8985 (TPG), 13 Civ. 435 (TPG), 13 Civ. 436 (TPG), 13 Civ. 3288 (TPG), 13 Civ. 4343 (TPG), 13...more

Millennium Pharms., Inc. v. Sandoz Inc.

Case Name: Millennium Pharms., Inc. v. Sandoz Inc., Civ. No. 12-1011-GMS (consolidated), 2015 U.S. Dist. LEXIS 110099 (D. Del. Aug. 20, 2015) (Sleet, J.) - Drug Product and Patent(s)-in-Suit: Velcade® (bortezomib); U.S....more

Will Purple Reign, as a Color Trademark?

Today, we’re not talking about that Purple Rain, that Color Purple, or those Purple People Eaters, and we’re especially not talking today about Purple Gloves, Purple Bags, Purple Jackets, Purple Candy Wrappers, or Purple...more

Eli Lilly & Co. v. Nang Kuang Pharm.Co., Ltd.

Case Name: Eli Lilly & Co. v. Nang Kuang Pharm.Co., Ltd., 1:14-cv-1647-TWP-DKL, 2015 U.S. Dist. LEXIS 11510 (S.D. Ind. Aug. 24, 2015) - Drug Product and Patent-in-Suit: Alimta® (pemetrexed disodium); U.S. Patents Nos....more

ANDA Update - October 2015

Federal Circuit Interprets Statutory Requirements for Biosimilar Regulatory Pathway - Amgen Inc., v. Sandoz Inc., (Fed. Cir. July 21, 2015): In a case of first impression, the U.S. Court of Appeals for the Federal...more

Eli Lilly & Co. v. Teva Parenteral Medicines, Inc.

Case Name: Eli Lilly & Co. v. Teva Parenteral Medicines, Inc., Civ. No. 10-cv-1376-TWP, 2015 U.S. Dist. LEXIS 112221 (S.D. Ind. Aug. 25, 2015) (Pratt, J.) - Drug Product and Patents-in-Suit: Alimta® (pemetrexed...more

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