News & Analysis as of

Prescription Drugs

FTC Hosts Workshop – “Understanding Competition in Prescription Drug Markets: Entry and Supply Chain Dynamics”

by Mintz Levin on

On Wednesday, November 8, 2017 the Federal Trade Commission (FTC) hosted a workshop seeking to explore the general question of why the cost of prescription drugs has risen greatly in recent history. The Workshop was framed...more

Opioid Litigation Over Insurance Coverage – Coming to a Jurisdiction Near You

by Nexsen Pruet, PLLC on

A very recent appellate ruling in California provides a roadmap for opioid litigation over insurance coverage that is about to ramp up all over country. In Travelers Prop. Cas. Co. of Am. v. Actavis, Inc. et al, 2017 WL...more

Ferring Pharms. Inc. v. Par Pharm., Inc.

by Robins Kaplan LLP on

Case Name: Ferring Pharms. Inc. v. Par Pharm., Inc., Civ. No. 1:15-cv-173-RGA, 2017 U.S. Dist. LEXIS 106491 (D. Del. July 11, 2017) (Andrews, J.). Drug Product and U.S. Patent: Prepopik® (sodium picosulfate, magnesium...more

De-Bunking the Opioid Litigation Epidemic

by Kelley Drye & Warren LLP on

If you type ‘opioids’ into a search engine, chances are you’ll be greeted with headlines like: “Opioid abuse is in everyone’s backyard”. The Washington Post writes: “Even this puppy wasn’t safe from America’s opioid crisis”;...more

The Opioid Epidemic: Are We Headed Toward a Tipping Point?

by Burr & Forman on

Health care law and policy occupy a prime place in the current news cycle. Much of the attention revolves around the actions or inactions of Congress and the White House, particularly with regard to their impact on the future...more

K&L Gates Triage: 340B Update: CMS Finalizes 340B Program Reimbursement Cut on Part B Drugs

by K&L Gates LLP on

In this episode, Richard Church and Ryan Severson discuss the recent decision by the Centers for Medicare and Medicaid Services (CMS) to substantially decrease reimbursement under the Outpatient Prospective Payment System...more

Pfizer Inc. v. Mylan Pharms. Inc.

by Robins Kaplan LLP on

Case Name: Pfizer Inc. v. Mylan Pharms. Inc., No. 15-79-GMS, 2017 U.S. Dist. LEXIS 125634 (D. Del. Aug. 9 2017) (Sleet, J.). Drug Product and Patent(s)-in-Suit: Toviaz® (fesoterodine fumarate extended-release tablets);...more

IP considerations in the early stages of drug development – how to pick your moment

by FPA Patent Attorneys on

The step of identifying an initial lead drug candidate is the cornerstone of the drug development process and is also usually the point at which actions are taken to protect the associated intellectual property (IP). However,...more

DOT Amends Employee Drug Testing Requirements

by Seyfarth Shaw LLP on

Seyfarth Synopsis: On November 13, 2017, the Department of Transportation amended its drug testing program regulation which, among other things, adds certain semi-synthetic opioids to its drug testing panel. ...more

White Collar Courier: Delivering News and Providing Guidance in White Collar Matters

by Burr & Forman on

Before joining Burr & Forman, I was a federal prosecutor for a little over a decade focusing on health care fraud and general white collar matters. In that role, I was a member of a prosecution team that secured guilty...more

How to Pay the Piper: FDA Issues New Guidances for PDUFA VI and GDUFA II

by Arnall Golden Gregory LLP on

FDA recently issued two draft guidances: Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017 (PDUFA VI) and Assessing User Fees Under the Generic Drug User Fee Amendments of 2017 (GDUFA II), which...more

New rules for expanded access in Italy

by Hogan Lovells on

Fast track for orphan diseases and rare forms of cancers - By Ministerial Decree of 7 September 2017 (DM 7 September 2017), published in the Italian Official Journal on 2nd November2017, the Ministry of Health enacted new...more

Reckitt Benckiser LLC v. Amneal Pharms. LLC

by Robins Kaplan LLP on

Case Name: Reckitt Benckiser LLC v. Amneal Pharms. LLC, Nos. 15-2155 (RMB/JS), 15-4524 (RMB/JS), 2017 U.S. Dist. LEXIS 133998 (D.N.J. Aug. 22 2017) (Bumb, J.). Drug Product and Patent(s)-in-Suit: Mucinex® (guaifenesin);...more

President’s Opioid Commission Issues Final Recommendations: Implications for Health Care Stakeholders

by K&L Gates LLP on

In late October, President Trump declared the nation’s opioid addiction crisis a public health emergency. Less than a week later, the President’s Commission on Combating Drug Addiction and the Opioid Crisis (the “Commission”)...more

California Enacts Limitations on Copayment Coupons

by Arnall Golden Gregory LLP on

As prescription drug pricing continues to dominate political headlines, state legislatures are taking action intended to lower drug prices for health plans and patients. Despite industry opposition, California has enacted a...more

Preparing for the Opioid Litigation Epidemic

by Kelley Drye & Warren LLP on

One of the newer symptoms of this so-called “Opioid Epidemic,” is a rash of litigation targeting pharmaceutical manufacturers and distributors. Currently, there are actions underway in Texas, West Virginia, Alabama, Ohio,...more

Supernus Pharms., Inc. v. TWi Pharms., Inc.

by Robins Kaplan LLP on

Case Name: Supernus Pharms., Inc. v. TWi Pharms., Inc., 15-369 (RMB/JS), 2017 U.S. Dist. LEXIS 154446 (D.N.J. Sept. 21, 2017) (Bumb, J.). Drug Product and Patent(s)-in-Suit: Oxtellar XR® (oxcarbazepine); U.S. Patents Nos....more

Louisiana Adopts Price Reporting Law

by Kelley Drye & Warren LLP on

A new law in Louisiana requires drug manufacturers to report wholesale acquisition cost (WAC) information directly to the state. Louisiana law defines WAC as “the manufacturer’s list price for the pharmaceutical drug or...more

Top Takeaways for Medicare Physician and Hospital Payments in 2018

by Holland & Knight LLP on

The Centers for Medicare & Medicaid Services (CMS) on Nov. 1, 2017, released the Medicare Hospital Outpatient Prospective Payment System (OPPS) and the Medicare Ambulatory Surgical Center (ASC) Payment System Final Rule for...more

OCR Clarifies Privacy Rule for Sharing PHI on Opioid Overdoses

In the wake of the national opioid overdose crisis, the Office for Civil Rights (OCR) has provided clarification on when covered entities are permitted to disclose patient information during opioid emergencies....more

Dutch Supreme Court hands down landmark decision on infringement of second medical use patents

by Hogan Lovells on

On 3 November 2017, the Dutch Supreme Court (Hoge Raad) handed down a landmark decision on the infringement of second medical use patents in the Merck Sharp & Dohme Corp. (“MSD”) v. Teva Pharma B.V. and Pharmachemie B.V....more

Allergan, Inc. v. Teva Pharms. USA, Inc.

by Robins Kaplan LLP on

Case Name: Allergan, Inc. v. Teva Pharms. USA, Inc., No. 2:15-CV-1455-WCB, 2017 U.S. Dist. LEXIS 136445 (E.D. Tex. Aug. 25, 2017) (Bryson, C.J.). Drug Product and Patent(s)-in-Suit: Restasis® (cyclosporine); U.S. Patents...more

CMS Finalizes Reimbursement Cuts for 340B Hospitals

by Foley & Lardner LLP on

In a striking blow to 340B hospitals, the Department of Health and Human Services, Centers for Medicare and Medicaid Services (CMS) released a final Medicare Outpatient Prospective Payment System (OPPS) rule adopting its...more

CMS Announces New Policy for Biosimilars Payments Under Part B

by Goodwin on

As we previously reported, the Centers for Medicare and Medicaid Services (“CMS”) has been considering comments on a proposed rule regarding biosimilar payment policies. On Thursday, CMS issued a final rule for the 2018...more

Allergan Sales, LLC v. Teva Pharms. USA, Inc.

by Robins Kaplan LLP on

Case Name: Allergan Sales, LLC v. Teva Pharms. USA, Inc., Civ. No. 2:15-cv-01471-FRG-RSP, 2017 U.S. Dist. LEXIS 127886 (E.D. Tex. July 25, 2017) (Payne, M.J.). Drug Product and U.S. Patent: Delzicol® (mesalamine); U.S....more

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