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Bank Regulators Issue Notice of Proposed Rulemaking on Enhanced Cyber Risk Management Standards

Three federal banking regulatory agencies have approved an advance notice of proposed rulemaking (ANPR) inviting comment on a set of potential enhanced cybersecurity risk-management and resilience standards that would apply...more

Anonymous or Not: Court of Justice Issues Ruling on IP Addresses

On October 19, 2016, the Court of Justice of the European Union (CJEU) issued a ruling on the question of whether IP addresses constitute personal data. The ruling has direct implications on the general question of when data...more

Johnson and Johnson Insulin Pump Potentially Vulnerable to Cyber Attack

Johnson & Johnson recently warned its customers of a cybcersecurity issue with one of its insulin pumps, potentially leaving thousands of users vulnerable.  According to Johnson & Johnson’s letter, “a cybersecurity issue with...more

An Inflectra Update -- Pfizer Announces Launch of REMICADE® Biosimilar

On April 5, 2016, the FDA approved Celltrion's application to market a biosimilar to Janssen Biotech Inc.'s REMICADE® (infliximab) anti-TNF-a antibody (see "FDA Approves Inflectra - Celltrion's REMICADE® Biosimilar"). ...more

Advertising Law - October 2016 #3

YouTube Adds Sponsored Content Notification Feature - To help influencers achieve compliance with the necessary disclosures about their relationships with advertisers, YouTube has unveiled a new tool to provide notice to...more

Department Of Defense Issues Final Cyber Incident Reporting Rule

On October 4, 2016, the Department of Defense (“DoD”) published a final rule implementing mandatory cyber incident reporting requirements for DoD contractors and subcontractors. The rule, which is effective as of November 3,...more

SEC Fines Fantasy Stock Market App Developer

The Securities Exchange Commission (“SEC”) recently fined New York-based Forcerank LLC (“Forcerank”) $50,000 in connection with charges that Forcerank’s fantasy stock market mobile app illegally offers complex derivative...more

3D Printing Quarterly Report: Q3 - 2016

Study offers plan to make Northeast Ohio region the Silicon Valley of 3D printing - A report from the Youngstown Business Incubator and America Makes in Youngstown and Team NEO and Magnet in Cleveland offers a plan to...more

Economic Times of India: Report Suggests that Indian Biosimilars Market May Reach $40 Billion USD by 2030

The Economic Times of India has reported on a study of the Indian biosimilars market conducted by the Jawaharlal Nehru Institute of Advanced Studies (JNIAS). The study reports that the Indian biosimilars industry was...more

New Tool in Calif. AG’s Privacy Enforcement Efforts: Consumers

California Attorney General Kamala Harris is enlisting new enforcers in her efforts to get companies to comply with the state’s privacy policy requirements: members of the public. On October 14, Harris released an online...more

New Round of Cuba Sanctions Changes Expand Opportunities for Health Sector

Key Points - - OFAC’s latest changes expand opportunities for U.S. persons to engage in medical research with Cuban nationals, authorize U.S. persons to obtain FDA approval of Cuba-origin pharmaceuticals, and market...more

Attorney General Kamala D. Harris Provides New Online Tool to Report California Online Privacy Protection Act (CalOPPA) Violations

It’s time for a compliance check on those website or mobile app privacy policies, before the California Attorney General comes knocking. Attorney General Kamala D. Harris has announced the release of a new tool for...more

PTAB Denies Institution on Biogen’s Tysabri® Patent

On October 17, the PTAB denied institution of IPR2016-000912, IPR2016-00915, IPR2016-00916. The Petitions in these cases were filed by Swiss Pharma International AG on U.S. Patent Nos. 8,815,236; 8,349,321; and 8,900,577,...more

California Attorney General 'Crowdsources' Reporting of Privacy Policy Violations

This initiative by the Attorney General is effective immediately and is just the latest example of California’s effort to increase enforcement of laws aimed at protecting the privacy and data security of individual consumers....more

Hot Pocket: Samsung Galaxy Note 7 Recall Highlights Risk of Lithium Batteries During Air Transportation

Air transportation of lithium ion batteries recently garnered significant attention due to events following reports of the Samsung Galaxy Note 7’s batteries overheating, catching fire, and even exploding. See Samsung Recalls...more

AliceStorm Update for October 2016

The Federal Circuit's recent decision in McRO has been interpreted by many in the patent community as a further signal that the so-called "pendulum" is swinging back to a more favorable position for patentees. There is some...more

Fintech in Hong Kong: Where There’s a Will, There’s a Way, or Hong Kong’s Measures To Become the Fintech Capital of Asia

Hong Kong is putting substantial focus on financial technology, or fintech, to compete with Singapore and Tokyo as the fintech capital of Asia. In April 2015, the Hong Kong Government (the “Government”) established the...more

Cybersecurity Requirements Proposed for New York Financial Companies

The New York Department of Financial Services has proposed new cybersecurity regulations “designed to promote the protection of customer information as well as the information technology systems of regulated entities...more

Feds Propose Enhanced Cyber Standards for Nation’s Largest Banks and Their Boards

Bank regulators are continuing to demand more accountability from corporate leaders when it comes to compliance with cybersecurity safeguards. In an advance notice of proposed rulemaking issued yesterday, federal...more

New Cybersecurity Regulations for Financial Services Companies in New York State

Action item: Banking, insurance, and other financial services companies in New York State must be aware of new comprehensive cybersecurity regulations proposed by the Department of Financial Services that will require covered...more

Sixth Circuit: Substantial Risk of Harm and Mitigation Costs Sufficient to Confer Standing in Data Breach Case

On October 12, 2016, the U.S. Court of Appeals for the Sixth Circuit denied a petition for an en banc rehearing of its September 12 decision in Galaria, et al. v. Nationwide Mutual Insurance Company (Nos. 15-3386/3387). In...more

PTAB Upholds Lialda Patent Over Kyle Bass IPR Challenge

The USPTO Patent Trial and Appeal Board (PTAB) has issued a final written decision upholding Shire’s Lialda® patent over the Inter Partes Review (IPR) challenge brought by Kyle Bass and his Coalition for Affordable Drugs. The...more

The Supreme Court’s Decisions Not to Hear Patent Cases Leaves Federal Circuit Decisions on Key Questions Intact

The Supreme Court recently declined to hear several patent cases, thus leaving the decisions by the Federal Circuit intact. Issues that were not taken up by the Supreme Court include (1) whether performing patented methods...more

NIOSH Presentation on Engineering Controls for Nanotechnology Now Available

On September 27, 2016, the National Institute for Occupational Safety and Health (NIOSH) Board of Scientific Counselors (BSC) met, and its discussion included engineering controls and nanomaterials. Kevin H. Dunn, Sc.D.,...more

ECJ Declares IP Addresses are Personal Data

Today, the European Court of Justice (ECJ) issued its long-awaited decision in Breyer v. Germany. Breyer addresses the question of whether IP addresses are “personal data” for purposes of EU data protection law. As is...more

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