Hatch-Waxman Act. Legal news and articles for September 24 - 30, 2014

Lex Machina Out With Legal Analytics for Big PharmaCanada Wants to get Tough on Pay-to-Delay Deals30 Years Of GenericsLex Machina Out With Legal Analytics for Big PharmaActavis confirms generic Butrans patent challengeOp-ed: Reid's obstruction hurts Senate's productive historyPTAB proceedings – the most stay-friendly district courtsPTAB proceedings – the most stay-friendly district courtsActavis Confirms Generic Butrans® Patent ChallengeActavis (ACT) Confirms Butrans Patent ChallengeActavis Confirms Generic ButransB. Patent ChallengePTAB proceedings – the most stay-friendly district courtsCelebrating 30 years of easier access to cost-saving generic drugsFDA goes purple on biologics and biosimilars: composes a variation on a theme ...A Big Change in the ANDA Litigation Paradigm: Lex Machina's Legal Analytics

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"FTC Doubles Down in Challenge to Pharmaceutical Settlement"
JD Supra (press release)September 11, 2014

The pharmaceutical regulatory environment, specifically the Hatch-Waxman Act, incentivizes generic patent challenges while providing patent holders with an opportunity to seek legal redress in court against potential infringers before the generic ...more »

Teva sues Dr Reddy's, two others on patent
mydigitalfc.comSeptember 22, 2014

Israeli drugmaker Teva has sued Indian generics company Dr Reddy's along with two others, Sandoz and Momenta, for 'inten-ding to violate' the patent of its brand Copaxone. The drug, used to treat multiple sclerosis, has been a favourite for a handful ...more »

Hatch-Waxman Act. News and Stories

Lex Machina Out With Legal Analytics for Big Pharma
Law Technology NewsSeptember 30, 2014

The Hatch-Waxman Act amended the Federal Food, Drug, and Cosmetic Act and established an abbreviated new drug application (ANDA) process that requires generic manufacturers to demonstrate a generic drug is “bioequivalent” to an approved brand ...more »

Canada Wants to get Tough on Pay-to-Delay Deals
Wall Street Journal (blog)September 29, 2014

Pecman raised another point: There is no Canadian equivalent to the Hatch-Waxman Act, the 1984 law that ushered in the modern-day model for generic competition and, specifically, provides 180 days of market exclusivity to the first generic drug maker ...more »

30 Years Of Generics
The Biological SCENESeptember 29, 2014

In September 1984, the Drug Price Competition & Patent Term Restoration Act, commonly known as the Hatch-Waxman Act for its congressional sponsors' names, was signed into U.S. law. By creating a new regulatory path for generic medicines and ...more »

Lex Machina Out With Legal Analytics for Big Pharma
Law Technology NewsSeptember 29, 2014

The Hatch-Waxman Act amended the Federal Food, Drug, and Cosmetic Act and established an abbreviated new drug application (ANDA) process that requires generic manufacturers to demonstrate a generic drug is “bioequivalent” to an approved brand ...more »

Actavis confirms generic Butrans patent challenge
pharmabiz.comSeptember 27, 2014

The lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Actavis' ANDA for up to 30 months from the date the plaintiffs received notice of Actavis' ANDA filing or until final resolution of the ...more »

Op-ed: Reid's obstruction hurts Senate's productive history
Salt Lake TribuneSeptember 27, 2014

The 30th anniversary of the Hatch-Waxman Act—which revolutionized prescription drug regulation in the U.S.—provides an appropriate occasion to observe the unfortunate contrast between a time when Congress accomplished difficult and meaningful work, ...more »

PTAB proceedings – the most stay-friendly district courts
Managing Intellectual Property (subscription) (blog)September 26, 2014

Pharmaceutical companies, and generic producers in particular, who may wish to invalidate a patent more quickly than is possible in most district courts, are likely to ramp up their filings. Second-filer generics that enjoy no Hatch-Waxman exclusivity ...more »

PTAB proceedings – the most stay-friendly district courts
Managing Intellectual Property (subscription) (blog)September 25, 2014

Pharmaceutical companies, and generic producers in particular, who may wish to invalidate a patent more quickly than is possible in most district courts, are likely to ramp up their filings. Second-filer generics that enjoy no Hatch-Waxman exclusivity ...more »

Actavis Confirms Generic Butrans® Patent Challenge
SYS-CON Media (press release)September 25, 2014

The lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Actavis' ANDA for up to 30 months from the date the plaintiffs received notice of Actavis' ANDA filing or until final resolution of the ...more »

Actavis (ACT) Confirms Butrans Patent Challenge
StreetInsider.com (subscription)September 25, 2014

The lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Actavis' ANDA for up to 30 months from the date the plaintiffs received notice of Actavis' ANDA filing or until final resolution of the ...more »

Actavis Confirms Generic ButransB. Patent Challenge
CNNMoneySeptember 25, 2014

The lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Actavis' ANDA for up to 30 months from the date the plaintiffs received notice of Actavis' ANDA filing or until final resolution of the ...more »

PTAB proceedings – the most stay-friendly district courts
Managing Intellectual Property (subscription) (blog)September 25, 2014

Pharmaceutical companies, and generic producers in particular, who may wish to invalidate a patent more quickly than is possible in most district courts, are likely to ramp up their filings. Second-filer generics that enjoy no Hatch-Waxman exclusivity ...more »

Celebrating 30 years of easier access to cost-saving generic drugs
FDA.gov (blog)September 25, 2014

Thirty years ago today, President Ronald Reagan signed into law the Drug Price Competition and Patent Term Restoration Act of 1984, better known today as the Hatch-Waxman Amendments. This law, championed by Senator Orrin Hatch and Representative ...more »

FDA goes purple on biologics and biosimilars: composes a variation on a theme ...
Lexology (registration)September 24, 2014

Devotees of the Orange Book will not, however, find in the Purple Book the detailed information on patents that is required under the 1984 Drug Price Competition and Patent Term Restoration Act ("Hatch-Waxman"), for the simple reason that, unlike with ...more »

A Big Change in the ANDA Litigation Paradigm: Lex Machina's Legal Analytics
IPWatchdog.comSeptember 24, 2014

Likewise, we often relayed information to our clients about opposing counsel based on the premise that the particular attorney we were facing would act more in line with reputation of their firms, then as they may actually act as an individual attorney ...more »

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