January 2018

On January 9, 2018, Department of Defense (“DoD”) issued Class Deviation 2018-O0009, designed to reduce barriers to entry for innovative entities through streamlining the awards process for research and development contracts. This Class Deviation allows for the use of simplified acquisition procedures and excuses certain procurement obligations when DoD awards contracts and subcontracts valued…

Last week, President Trump nominated four new commissioners to the Federal Trade Commission (“FTC”):  Joseph J. Simons, an antitrust attorney, as Chairman; Noah Joshua Phillips, chief counsel for Senate Majority Whip John Cornyn (R-Texas), for the second Republican seat; Christine Wilson, an executive for Delta Air Lines, for the third Republican seat; and Rohit Chopra,…

On January 25, 2018, the Court of Justice of the European Union (“CJEU”) handed down a ruling permitting consumer privacy actions to be brought in the consumer’s home jurisdiction — as opposed to the jurisdiction in which the defendant data controller has its main establishment — but not permitting consumer privacy class actions to be…

Federal contractors may be subject to a slate of new regulations in 2018, including rules that increase cyber reporting burdens, expand small business competition, and change the procedures for competitively awarding IDIQ contracts.

Among the proposed rules, announced in the Semiannual Regulatory Agenda of the FAR Council and the General Services Administration (“GSA”), are changes…

Technology companies widely use open source software (“OSS”), which carries with it many potential benefits.  It can reduce the time and cost of development, and, to the extent that the code has been vetted by numerous other developers, may contain fewer bugs.  OSS can also reduce dependency upon third party vendors and associated pricing risks.…

The U.S. Government has recently taken a number of steps to reinvigorate its support of medical countermeasure development. In particular, by pursuing new methods of contracting, updating regulatory frameworks, and establishing additional incentives for capital investment, the U.S. Government has confirmed that countermeasure development remains a critical component of public health preparedness.

Now, over the…

On January 19, 2018, FDA announced the availability of a new draft guidance, titled “Material Threat Medical Countermeasure Priority Review Vouchers.” FDA’s publication of the draft guidance, which was issued by FDA’s Office of Counterterrorism and Emerging Threats (OCET) without a statutory mandate – reflects the commitment of FDA leadership to the development and…

By Dr. Dr. Adem Koyuncu, Covington & Burling LLP

In the EU, drug companies are not allowed to publicly promote prescription-only medicines. As courts also apply a broad interpretation of the term “promotional”, nearly all public statements that mention a prescription drug are likely to be qualified as illegal advertising. In certain circumstances, this…

On 23 January 2018, Germany’s Federal Supreme Court (Bundesgerichtshof – BGH) handed down its judgment on alleged anti-competitive requests for preferential rebates and conditions by food retailers (case KVR 3/17 – not yet published).  This is an important judgment as it removes a major roadblock to antitrust enforcement in the food retail sector in Germany,…

On January 2, 2018, the Standardization Administration of China (“SAC”) released the final version of the national standard on personal information protection, officially entitled GB/T 35273-2017 Information Technology – Personal Information Security Specification (GB/T 35273-2017 信息安全技术 个人信息安全规范) (hereinafter “the Standard”).  The Standard will come into effect on May 1, 2018.As highlighted in our previous coverage…