News & Analysis as of

Pharmaceutical Industry

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

IPR Updates

by Goodwin on

Here are some updates since our last IPR update: HUMIRA - On November 6, 2017, Sandoz filed an IPR Petition challenging AbbVie’s U.S. Patent No. 9,187,559 (IPR2018-00156). ...more

Unknown Problem Plus Nonobvious Solution Cannot Render Patent for Sublingual Formulation of Asenapine Obvious

by McDermott Will & Emery on

The District Court for the District of Delaware found Forest Labs’ patent for sublingual or buccal compositions of asenapine and methods of using such compositions to treat mental disorders, including schizophrenia and mania,...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

The State AG Report Weekly Update

by Cozen O'Connor on

AG Elections- Democrat Justin Nelson Launches Campaign for Texas Attorney General- Democrat Justin Nelson declared his candidacy for Texas AG seeking to unseat incumbent Republican AG Ken Paxton, who is running for...more

FTC Advisory Opinion Says Hospital’s Proposed Prescription Program for Affiliated Entity Employees is Exempt from Robinson-Patman...

by Foley & Lardner LLP on

On November 7, 2017, the Federal Trade Commission (FTC) released an advisory opinion confirming that a non-profit hospital in New York may sell discounted prescription drugs to the employees of an affiliated medical practice...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

Sandoz Announces New Data For Its Adalimumab And Rituximab Biosimilars

by Goodwin on

On November 14, 2017, Sandoz announced data from four clinical trials comparing its proposed adalimumab and rituximab biosimilars to their reference drugs, Humira® and Rituxan®. We previously reported that the Sandoz...more

Wake-Up Call: Admissibility of Damages Calculations in Narcolepsy Drug Case

by McDermott Will & Emery on

Addressing a motion by defendants Mylan and Ranbaxy to exclude damages testimony by plaintiff Apotex’s expert, the US District Court for the Eastern District of Pennsylvania admitted one and denied two proposed damages...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

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

FDA Announces New Draft REMS Guidance

by Goodwin on

Last week, FDA Commissioner Scott Gottlieb announced new draft guidance on risk evaluation and mitigation strategies (REMS) programs. The draft guidance provides for a single shared Drug Master File submission for all...more

Price-Fixing Allegations Against Generic Drug Manufacturers Broaden as State Attorneys General Seek Amended Complaint

by Arnall Golden Gregory LLP on

On October 31, 2017, the Attorneys General of forty-five states and the District of Columbia (the “State AGs”) moved to amend a December 2016 complaint alleging a broad price-fixing scheme among key players in the generic...more

Fresh From the Bench: Precedential Patent Cases From the Federal Circuit

In Sanofi v. Watson Labs., the Circuit affirms a determination of induced infringement of one patent and direct infringement of another, thus assuring Sanofi another 12 years of exclusivity as to its Multaq® atrial...more

Pharma and Biotech: Key Trends and Legal Risks

by Latham & Watkins LLP on

How to thrive amid uncertainty? This was the question we explored at the 35th FT Global Pharmaceutical and Biotechnology Conference. Here are five key industry trends and corresponding practical legal tips to help companies...more

Brexit Bill - Impact on patents

by Hogan Lovells on

The UK government’s draft EU Withdrawal Bill (the “Brexit Bill“) aims to incorporate EU directives and regulations into UK domestic law in their current form immediately following Brexit (“Retained EU Law“).  This article...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

NJ Court Grants Exceptional Case Fees Based on Speculative Infringement Suit

by McDermott Will & Emery on

The US District Court for the District of New Jersey awarded Luitpold more than $210,000 in fees and costs under 35 USC § 285 after granting its motion for judgment on the pleading under Fed. R. Civ. P. 12(c) (ANDA Update,...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

Generic Defendants Shed No Tears after Winning Motion to Add Incorrect Inventorship Defense

by McDermott Will & Emery on

The US District Court for the Eastern District of Texas granted defendants' motion to amend their pleadings after the deadline for amending had passed. Allergan v. Teva Pharmaceuticals USA, No. 15-1455-WCB, 2017 WL 1512334...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

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