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Abilify®’s Saga Continues: Otsuka’s Eight-Day Streak of Generic-Free Competition Ends, For Now

On May 27, 2015, the U.S. District Court for the District of Maryland granted FDA and the Defendant-Intervenors summary judgment against Otsuka Pharmaceutical Co., Ltd. Otsuka Pharmaceutical Development and Commercialization,...more

Intact Vascular raises $39M in venture capital funding to further develop its Tack Endovascular System

Intact Vascular, Inc. is a Wayne, Pennsylvania-based developer of medical devices for treating patients with peripheral artery disease. According to its website, the privately-held company primarily develops minimally...more

MarkIt to Market - May 2015

The May issue of Sterne Kessler's MarkIt to MarketTM newsletter covers the negative impact of counterfeiting on e-commerce websites, recent changes in Russian trademark law, and an updated list of the Sunrise periods...more

Applicability of the Entire Market Value Rule in Hatch-Waxman Cases - AstraZeneca AB, et al. v. Apotex Corp., et al.

Addressing damages issues in the Hatch-Waxman context, the U.S. Court of Appeals for the Federal Circuit provided important guidance regarding the application of the entire market value rule to pharmaceutical sales, and the...more

Product Hopping and Antitrust: Mylan Court Dismisses Claims on Summary Judgment, Citing Need to Avoid Chilling Pharmaceutical...

A recent summary judgment opinion from the Eastern District of Pennsylvania breaks new ground in the developing antitrust law on “product hopping” claims. “Product hopping” refers to the practice of changing the form or...more

A Busy Summer Ahead for Some H-1B Employers: USCIS Instructs on H-1Bs with Worksite Changes

In a controversial ruling last month that changed years of established policy, the Administrative Appeals Office (AAO) issued an H-1B precedent decision. At issue was whether an employer is required to file not only a new...more

Four Security Gaps Cybercriminals Exploit in Your Business's Digital Storefront

Symantec, the American IT security company, recently released its 2015 Internet Security Threat Report that summarizes the number and types of threats and vulnerabilities seen in 2014. The report also analyzes trends and...more

Silk Road’s Ross Ulbricht Receives Life Sentence

On May 29, 2015, after a lengthy criminal investigation and multi-week trial, Ross Ulbricht, the mastermind behind Silk Road—one of the most famous enterprises to utilize Bitcoin currency—was sentenced to life in prison in a...more

3 Vetoes; 2 Hearing Rooms; 1 Month ‘Til Shutdown

Vetoed Gov. Mark Dayton vetoed two more budget bills (he vetoed E-12 last week) over the last weekend. The latest vetoes mean there are even more issues for legislators and the Governor to resolve in a Special Session. No...more

IP Newsflash - May 2015 #5

SUPREME COURT CASES - Invalidity is not a Defense to Infringement but a Defense to Liability - This week, on May 26, 2015, the Supreme Court held in Commil USA, LLC v. Cisco Systems, Inc. that a defendant’s...more

Court Report - May 2015 #4

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Tris Pharma Inc. v. Actavis Laboratories FL Inc. et al. 1:15-cv-00393; filed May 15, 2015 in the District Court of...more

Connecticut High Court Weighs in on CGL Coverage for Data Breach

In a highly anticipated May 26th decision, the Connecticut Supreme Court ruled that two CGL insurers, Federal Insurance Company and Scottsdale Insurance Company, are not required to cover losses in connection with the...more

Supreme Court Rules that Good-Faith Belief in Patent Invalidity is Not a Defense to Induced Infringement

The U.S. Supreme Court ruled that a defendant’s good-faith belief in the invalidity of a patent is not a defense to an induced infringement claim. The Court also affirmed its previous holdings that an induced infringement...more

Red Notice Newsletter - May 2015

Welcome to the May 2015 edition of Red Notice, a publication of Akin Gump Strauss Hauer & Feld LLP. This month on the anticorruption front, a German engineering firm tests Brazil's recently implemented anticorruption...more

EU E-commerce Probe to Target Online Restrictions for Physical Goods – Not Just Digital Content

The European Commission has recently launched an e-commerce sector inquiry. It will complement and inform its policy agenda for a Digital Single Market in Europe, which was announced on the same day. Companies contacted...more

New Jersey passes motor vehicle data privacy law

We have commented before that many consumers do not know or understand the amount of data their motor vehicle has concerning their driving habits, including erratic driving, speed, whether the radio or Bluetooth is being used...more

Patent Infringement in the Digital Age: How a Dispute About Tooth Aligners Led to a Fight About the ITC’s Jurisdiction over...

The International Trade Commission (“ITC”) is an “independent nonpartisan agency that investigates and reports to the President and Congress on matters concerning import trade, tariffs and trade agreements.” Shewmaker v....more

Five Employment, Labor, and Workforce Management Concerns Impacting Retailers

Retailers will be busy this summer attempting to conform their policies and procedures to various local, state, and federal laws, such as the spate of state and city sick leave laws, and analyzing proposed amendments by the...more

Fitbit IPO Cyber Risk Disclosures

Earlier this month, fitness-tracking company Fitbit, Inc. filed a Form S-1 Registration Statement for an IPO of up to $100 million that exhaustively disclosed potential cybersecurity risks with respect to the personal data...more

EPA Issues Proposal to Mitigate Exposure to Bees from Acutely Toxic Pesticide Products

The U.S. Environmental Protection Agency’s (EPA) Proposal to Mitigate Exposure to Bees from Acutely Toxic Pesticide Products published in the Federal Register on May 29, 2015, seeks comment on a proposal to adopt mandatory...more

Teva Agrees to Pay $1.2 Billion in FTC’s Pay-For-Delay Suit Against Cephalon

Recently, the FTC announced that it reached a settlement in its pay-for-delay lawsuit, FTC v. Cephalon Inc. in the U.S. District Court for the Eastern District of Pennsylvania, with Teva Pharmaceuticals Industries, Ltd.,...more

Permanent Injunction Against Medtronic

The Food and Drug Administration (FDA) first approved the Synchromed II Implantable Infusion Pump System manufactured Medtronic, Inc. in 2004. The pump infuses pain medication, Baclofen, through a catheter into a patient’s...more

Other Peoples’ (Adult) Content (Episode 15)

There are so many legal issues in Episode 15 that it’s hard to know where to begin, so I’m going to start at the end: porn. Pied Piper is competing against nemesis Endframe for a $15 million contract from the online porn...more

FTC and Cephalon Ink $1.2 Billion Settlement in Provigil "Pay-for-Delay" Litigation

On May 28, 2015, the FTC announced that it settled its longstanding antitrust suit against Cephalon, Inc., which is now owned by Teva Pharmaceutical Industries, Ltd. The FTC's suit alleged that Cephalon unlawfully protected...more

Need to Establish Criticality of Claimed Range to Avoid Anticipation by Broader, Overlapping Range - Ineos USA LLC v. Berry...

Addressing anticipation under pre-AIA § 102 in the context of a claimed numerical range and prior art disclosing a broader, overlapping range, the U.S. Court of Appeals for the Federal Circuit affirmed a lower court’s summary...more

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