Diversity and Technology in Focus for Morgan Lewis's Incoming Chair
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Stefan Hankin on Online Harassment
What Does the Supreme Court Ruling in Alice v. CLS Mean to a Software Entrepreneur?
A Moment of Simple Justice - Revenge Porn
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How Fenwick Partners Caught the Tech Wave
How is Graphene Currently Used and What is the Hope for the Future?
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Two Tips for Inventors Filing Patent Applications
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Why Law Firms Are Starting to Think Like Media Companies
Schoenbrod: SCOTUS Ruling Helps EPA Deal With a "Stupid Statute"
Protecting and Enforcing Your High Technology Intellectual Property - Webinar Replay
Did the IRS Just Help or Hurt the Bitcoin Economy?
Legal Tech Startups: Separating Hype from Opportunity
Jail Time for Revenge Porn Offenses?
Polsinelli Podcast - Conducting Business in China
Rolling Out LPM Software at Akin Gump
Polsinelli Podcast - Generic Drugs to Market - What's the Climate in 2014?
On September 9, 2014, in Prevor v. Food and Drug Administration, the D.C. District Court held against FDA's interpretation of the definition of a medical device included in the Federal Food, Drug and Cosmetic Act (the act)....more
The Italian Communication Authority (AGCOM) published a new consultation on a draft regulation relating to the resolution of disputes between electronic communication operators....more
Earlier this month, a federal district court in California partially granted motions to dismiss a second amended complaint filed by the Center for Biological Diversity and the Pesticide Action Network alleging that the...more
In Center for Biological Diversity v. Environmental Protection Agency, No. 11-cv-00293-JCS, plaintiffs alleged that the Environmental Protection Agency (EPA) violated section 7 of the Endangered Species Act by failing to...more
In Tyco Healthcare Group LP v. Mutual Pharmaceutical Co., Inc., the Federal Circuit remanded-in-part for the district court to determine whether Tyco’s citizen petition to the FDA gave rise to antitrust liability. Judge...more
Mylan filed a complaint on April 25, 2014, challenging a letter decision by the FDA, addressing the marketing exclusivity eligibility of celecoxib Abbreviated New Drug Application applicants. Mylan then filed a motion for...more
Earlier this week HHS came out swinging in the latest round of its battle with the Pharmaceutical Research & Manufacturers of America (PhRMA) over the Affordable Care Act’s provisions on 340B and orphan drugs. HHS reasserted...more
According to a recent court filing by HHS, the agency should not be precluded from issuing interpretative guidance regarding a provision of the 340B Drug Pricing Program even though a federal district court previously vacated...more
On July 21, 2014, the U.S. Department of Health and Human Services (HHS) released an “Interpretive Rule” in response to a recent U.S. District Court decision that vacated the July 23, 2013, orphan drug rule on the grounds...more
On June 19, 2014, over 90 scientists sent a letter to EPA urging the Agency to move forward under its Tailoring Rule by "1) moving beyond the flawed assumption that bioenergy is inherently carbon neutral; 2) rejecting the...more
On June 23, 2014, the United States Supreme Court denied certiorari in Medtronic, Inc. v. Stengel, leaving in place the Ninth Circuit's en banc decision permitting a failure-to-warn claim against a pre-market approval (PMA)...more
A federal district court invalidated the first regulation published by the U.S. Department of Health and Human Services (HHS) addressing the 340B Drug Pricing Program (340B Program), on May 23, 2014, ruling that HHS had not...more
On June 20, 2014, the D.C. Circuit Court of Appeals vacated two FCC regulations on phone call captioning technology designed for the hearing impaired, holding that the rules were made arbitrarily and capriciously in violation...more
For over a year, participants in the 340B Drug Pricing Program (340B Program) and others have been waiting for the release of the so-called proposed “Mega-Rule” by the Department of Health and Human Services (HHS). The...more
HHS isn’t ready to throw in the towel in the fight over expansion of the 340B program under the Affordable Care Act (ACA). On Thursday HHS said in a court filing that it will appeal last month’s federal court ruling that...more
On May 27, 2014, almost a year following the promulgation of its final rule, the U.S. Department of Health and Human Services (HHS) had its rule vacated by the U.S. District Court for the District of Columbia under an...more
In the rapidly evolving landscape of the 340B Drug Discount Program, a recent court decision is the first to limit the rulemaking authority of the Health Resource and Services Administration (HRSA). This decision may...more
Braintree Laboratories, Inc. v. Breckenridge Pharmaceuticals, Inc.
Case Number: 1:12-cv-06851-AJN (Dkt. 69) -
Judge Nathan approved the parties’ proposal to maintain the case on administrative hold pending...more
In nearly identical decisions released on May 27, 2014, Sandoz Canada Inc v Canada, 2014 FC 501 (Sandoz) and ratiopharm Inc v Canada, 2014 FC 502 (ratiopharm), the Federal Court of Canada held that some licensees of patents...more
On May 23, Judge Contreras of the U.S. District Court for the District of Columbia (DC District Court) ruled that the Health Resources and Services Administration (HRSA) did not have the statutory authority to promulgate its...more
Companies that handle personal data may need to litigate an FTC enforcement action to its conclusion before a court will review the Commission's jurisdiction to commence the enforcement action in the first place....more
On May 23, 2014, the U.S. District Court for the District of Columbia issued a Memorandum Opinion in Pharmaceutical Research and Manufacturers of America v. United States Department of Health and Human Services, et al. At...more
In a blow to government efforts to regulate the 340B Drug Discount Program, U.S. District Judge Rudolph Contreras has ruled that HRSA lacks regulatory authority to promulgate regulations expanding access to 340B discounts for...more
Last Friday a federal district court invalidated a regulation that had authorized the 340B discount for critical access hospitals, sole community hospitals, rural referral centers and free-standing cancer hospitals when they...more
The FTC’s Claim -
A New Jersey federal judge has confirmed the Federal Trade Commission’s (“FTC”) authority to regulate data security and bring claims against companies suffering data breaches due to inadequate...more
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