Ropes & Gray LLP

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Boston, MA 02199-3600, United States

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Federal Agencies Release New Volcker Rule Guidance for Non-U.S. Banking Entities and Fund Sponsors Seeking to Rely on the “SOTUS” Covered Fund Exemption, Clarifying that the U.S. Marketing Restriction Does Not Apply to Third Parties

On February 27, 2015, the Board of Governors of the Federal Reserve System (the “Federal Reserve”), the Office of the Comptroller of the Currency, the Federal Deposit Insurance Corporation, the Securities and Exchange Commission…more
| Administrative Law, Commercial Law & Contracts, Finance & Banking, Securities Law

Federal Court Decision Demonstrates Ongoing Challenges Faced by Plaintiffs in Data Breach Litigation

On February 11, 2015, the U.S. District Court for the Southern District of Texas dismissed a class action complaint against the St. Joseph Health System arising out of a data security breach that occurred after hackers allegedly…more
| Civil Procedure, Constitutional Law, Health, Privacy, Science, Computers, & Technology

Mutual Fund Adviser Sanctioned for Deficiencies in Custody of Funds’ Derivatives Collateral and Directed Brokerage Compliance

On February 12, 2015, the SEC announced that Water Island Capital LLC (“Water Island”) agreed to settle enforcement proceedings arising from alleged violations of the Investment Company Act of 1940 (the “1940 Act”) found during…more
| Finance & Banking, Securities Law

Eleventh Circuit Upholds the U.S. DOJ’s Expansive Approach to Anti-Corruption Enforcement

On February 9, 2015, the Eleventh Circuit affirmed Jean Rene Duperval’s convictions for money laundering and conspiracy to commit money laundering, approving the U.S. Department of Justice’s (“DOJ”) expansive approach to…more
| Antitrust & Trade Regulation, Communications & Media Law, Criminal Law, International Law & Trade, Government Contracting

Clinical Trial and Medicare Provider Quality Improvement Provisions in House Committee 21st Century Cures Discussion Draft

On January 27, 2015, the House Energy & Commerce Committee (“Committee”) released a discussion draft of comprehensive medical innovation reform legislation as part of its 21st Century Cures Initiative. According to supporting…more
| Health, Privacy, Science, Computers, & Technology

Orange Book Patent Listing and Patent Certifications: Key Provisions in FDA’s Proposed Regulations Implementing the Medicare Modernization Act of 2003

On February 6, 2015, the United States Food and Drug Administration (FDA) issued long-awaited proposed regulations to implement portions of the Medicare Modernization Act of 2003 (MMA). Consisting of almost one hundred pages in…more
| Administrative Law, Health, Intellectual Property, Science, Computers, & Technology

UK Home Affairs Committee – Evaluating the National Crime Agency

On 17 February, the House of Commons Home Affairs Committee published its report on the architecture of policing in the United Kingdom. This report follows a period of five years of restructuring and reshaping policing at the…more
| Administrative Law, Criminal Law, Finance & Banking, International Law & Trade

China Announces Revised Good Clinical Practices for Public Comments

The China Food and Drug Administration (“CFDA”) recently released its proposed revisions to Good Clinical Practices (“GCP”) for pharmaceutical clinical studies for public comments. The proposed revisions, if eventually…more
| Health, Science, Computers, & Technology

FDA Issues Final Guidance Eliminating Regulatory Controls on Medical Device Data Systems, Imaging Storage Devices, and Imaging Communications Devices

On February 9, 2015, the United States Food and Drug Administration (FDA) issued a final guidance document describing the Agency’s intention not to enforce regulatory controls applicable to medical device data systems (MDDS),…more
| Administrative Law, Health, Science, Computers, & Technology

In First Appeal Decision from a PTAB Final Written Decision, Federal Circuit Holds PTAB IPR Institution Decisions Not Appealable, Broadest Reasonable Interpretation Standard Proper for IPR Proceedings

On February 4, 2015, the Federal Circuit issued its first opinion addressing an appeal from a final written decision of the new Patent Trial and Appeal Board (“PTAB” or “Board”) in post-grant proceedings under the America…more
| Civil Procedure, Intellectual Property, Science, Computers, & Technology

The Cure for the Common FDA Reform Legislation? House Committee Releases 21st Century Cures Discussion Draft

On January 27, 2015, the House Energy & Commerce Committee (“E&C Committee”) released a long-awaited discussion draft of comprehensive medical innovation reform legislation as part of its 21st Century Cures Initiative. Launched…more
| Health, Science, Computers, & Technology

Eleventh Circuit Clarifies Scope and Effect of the FCA’s Public Disclosure Bar

The Eleventh Circuit has recently issued an opinion clarifying the 2010 amendments to the False Claims Act (“FCA”) and its “public disclosure bar,” which prohibits suits based on information already publicly disclosed. In United…more
| Health, Government Contracting

The Ropes Recap: Mergers & Acquisitions Law News - January 2015

In this issue: - News from the Courts - Delaware Supreme Court Clarifies Fiduciary Duties in Sale Context and Overturns Judicial Imposition of Auction in Deal with Passive Market Check - Illinois Court…more
| Civil Procedure, Finance & Banking, Business Torts, Mergers & Acquisitions, International Law & Trade

FDA Draft Guidances on General Wellness Products and Device Accessories Continue Risk-Based Approach to Health IT

On January 20, 2015, the United States Food and Drug Administration (FDA) issued two new draft guidance documents, announcing the agency’s plans not to regulate “general wellness products” (including certain software programs)…more
| Administrative Law, Health, Science, Computers, & Technology

New Year, New Potential for UK and European Private Placements

Week two of the New Year marked a significant step in the development of the European Private Placement Market: The Loan Market Association (LMA) launched template documents for use in European private placement transactions…more
| Business Organizations, Finance & Banking, International Law & Trade, Securities Law
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