News & Analysis as of

Generic Drugs

Generic drugs taking hold in the Asian marketplace: STAT News interview

by Hogan Lovells on

Aging populations and rising healthcare costs across Asia — particularly in Japan — have created new market opportunities for generic drug makers operating in the region. For originator drug manufacturers, that means...more

Trump Administration: 2017 Recap and 2018 Outlook

On January 20, 2017, businessman Donald J. Trump was sworn in as the 45th President of the United States following a contentious and unconventional 2016 presidential election. Republicans also successfully maintained control...more

FDA 2017 Year in Review

by McDermott Will & Emery on

The US Food and Drug Administration’s (FDA’s) 2017 regulatory agenda was marked by inactivity in the months following the presidential inauguration. Since FDA Commissioner Scott Gottlieb’s Senate confirmation in May 2017, the...more

Rx IP Update - 2017 Highlights in Canadian Life Sciences IP

by Smart & Biggar on

The year 2017 was one of the most significant years for Canadian Life Sciences IP and Regulatory Law in Canada’s history. The year saw major developments in patent linkage, patent term, and substantive patent issues. As we...more

State Of Louisiana, As Absent Class Member, Escapes CAFA Settlement Trap

by Carlton Fields on

The Third Circuit Court of Appeals affirmed a Pennsylvania district court decision holding the Eleventh Amendment to the United States Constitution prevented a private party from enjoining the state of Louisiana from bringing...more

FDA Announces “New Steps to Facilitate Efficient Generic Drug Review to Enhance Competition, Promote Access and Lower Drug Prices”

by Locke Lord LLP on

The FDA has taken action to accelerate the approval of Abbreviated New Drug Applications (“ANDAs”). With a goal of reducing the number of review cycles needed to reach approval, the FDA will save generic drug companies money...more

French Competition Authority Fines a Pharmaceutical Laboratory EUR 25 Million for Anti-Generic Practices

by McDermott Will & Emery on

On 20 December 2017, the French Competition Authority (the FCA) imposed a EUR 25 million fine on a pharmaceutical laboratory, for delaying entry onto the market of the generic version of Durogesic, and for hindering its...more

Comment Deadline Approaches for CMS’s Proposed Changes to Medicare Advantage and Part D Programs for CY 2019 – Part 2: Beneficiary...

by Epstein Becker & Green on

On November 28, 2017, the Centers for Medicare & Medicaid Services (“CMS”) issued a proposed rule titled “Medicare Program; Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan,...more

Allergan’s Mohawk Gambit May Be Doomed – PTAB Rethinks the Scope of Sovereign Immunity

by Pepper Hamilton LLP on

A few months ago, the Irish drug company Allergan moved to shield its key patents on its dry-eye drug Restasis from challenge at the Patent Trial and Appeal Board (PTAB) of the U.S. Patent Office by assigning these patents to...more

California Supreme Court Recognizes “Innovator Liability”

Last week, the California Supreme Court in T.H. v. Novartis Pharmaceuticals Corp., became the first state high court to recognize the doctrine of “innovator liability,” unanimously holding that brand-name prescription drug...more

Breaking News: TH v. Novartis – California Supreme Court Recognizes New Tort Duties as Traditional Limits Slide into the Sea

by Reed Smith on

We posted our 2017 “Worst 10 decisions” list a day too soon, because the California Supreme Court issued its anticipated decision in TH v. Novartis, No. S233898, slip op. (Cal. Dec. 22, 2017) today, and if it is not the worst...more

Worldwide Bolar-type Provisions*

Please see full chart for Bolar Excemption rules in foreign countries regarding Clinical Trials, New Drugs, Biosimilars and Foreign Jurisdiction issues. ...more

Bolar Exemption in Europe and Asia

Bolar exemption in Europe - The Bolar exemption is governed by European Directive 2001/83/EC on the Community Code relating to medicinal products for human use. Article 10(6) excludes from infringement of patent rights or...more

Bolar Exemptions in North America

Bolar Exemptions in the U.S. Because approval by the U.S. Food and Drug Administration (FDA) is a long, sometimes arduous process, U.S. law provides a research or experimental use exemption with respect to regulated...more

FDA 2017 Year In Review: Therapeutic Products Energized by Cures Act, Bold Leadership

As is the tradition here at Health Law & Policy Matters, towards the end of the year we take stock of what transpired in our respective industries and highlight important legal, regulatory, and business developments. For...more

Jury Verdict Overturned in Pepcid® Dispute After Court Finds Insufficient Evidence of Infringement

Last year, a jury awarded Brigham and Women’s Hospital (“BWH”) approximately $10 million after it found that defendant Perrigo Company’s (“Perrigo”) generic version of Pepcid® Complete® willfully infringed BWH’s patent. After...more

Innovator Liability – A Word to the Wise

by Reed Smith on

A lot of us attended the annual ACI Drug & Medical Device Litigation Conference in New York City last week. One of the messages sent loud and clear from the initial client round table panel is that our clients don’t like...more

Hatch-Waxman Venue: The New Narrow?

by Robins Kaplan LLP on

The issue of venue—where geographically a case can be brought—and jurisdiction are a pair of principles to determine in which forum a case can properly be brought. Jurisdiction in personam concerns whether a particular party...more

FDA Commissioner Announces Plans to Streamline Approval Process for Headline-Grabbing Products

by Dorsey & Whitney LLP on

Last week, Dr. Scott Gottlieb, Commissioner of the FDA, touched on two issues that have frequented headlines in the past two years. First, in remarks made on November 28, 2017, Commissioner Gottlieb expanded on plans to...more

Eleventh Circuit Affirms Preemption of HRT Complaint

by Reed Smith on

Today, December 1, 2017, is the birthday of Gilbert O’Sullivan, who scored a hit back in 1972 with “Alone Again, Naturally,” the saddest song we can think of this side of Albinoni’s Adagio. That is fitting, given our...more

The Latest Trends in Drug Monopolies

by Zelle LLP on

Brand-name pharmaceutical companies employ a variety of strategies to preserve and extend their branded drug products’ monopolies. Challenges by generic drug manufacturers and consumers to those efforts as allegedly...more

CMS Releases Major MA/Part D Proposed Rule

by Hogan Lovells on

CMS released the first major MA/Part D rulemaking in several years, proposing a number of significant changes to the Part D program, including required pass-through of pharmaceutical company rebates to lower patient...more

CMS Releases CY 2019 Proposed Rule for Medicare Advantage and Part D

Last Thursday, November 17, 2017, the Centers for Medicare & Medicaid Services (CMS) released its proposed contract year 2019 Medicare Advantage and Part D regulations. The proposed rule is scheduled to be published in the...more

Ready to Release a New Pharmaceutical? What to Think About When Selecting Your Drug Name

by Foley & Lardner LLP on

Pharmaceutical name clearance in the United States can be complicated. This post aims to provide insight into the regulatory safety review process and the trademark registration process for candidate drug names. This...more

In re Sebela Patent Litigation

by Robins Kaplan LLP on

Case Name: In re Sebela Patent Litigation, 14-6414 (CCC) (MF), 2017 U.S. Dist. Lexis 128258 (D.N.J. Aug. 11, 2017) (Cecchi, J.). Drug Product and Patents-in-Suit: Brisdelle® (paroxetine mesylate); U.S. Patents Nos....more

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