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When the United States government decides to intervene in False Claims Act litigation after initially declining intervention, it is not “déjà vu all over again.”  Instead, as one court has recognized, the “government is getting on a moving train,”[1] and it can only be permitted to “intervene at a later date” if it can

On March 4, 2021, Brazil deposited with the United Nations its ratification of the Nagoya Protocol (“Protocol”) (see here the announcement of Brazil’s Ministry of Foreign Affairs).  This represents Brazil’s formal commitment to be bound by the Protocol.

On August 6, 2020, the Brazilian Senate passed a Decree that ratifies the Nagoya Protocol. The Protocol complements Brazil’s existing access and benefit sharing rules relating to Brazil’s genetic heritage and associated traditional knowledge (“ABS Framework”).  One important effect of this ratification is that other countries parties to the Protocol will have to ensure that users of Brazilian genetic heritage and associated traditional knowledge comply with the Brazilian ABS Framework.  However, the inverse is also true.  Brazil will need to ensure that Brazilian users of foreign genetic heritage and associated traditional knowledge comply with the access and benefit sharing regime of the country of origin.


Continue Reading Brazil Ratifies the Nagoya Protocol

On February 17, 2021, Senator Chuck Grassley (R-IA) and Brian Boynton, Acting Attorney General for the Department of Justice’s Civil Division, provided opening remarks at the Federal Bar Association’s annual Qui Tam Conference. Both emphasized the key role of the FCA in combating fraud against the Government, and noted an anticipated increase in FCA enforcement

On 25 November 2020, the European Commission published a proposal for a Regulation on European Data Governance (“Data Governance Act”).  The proposed Act aims to facilitate data sharing across the EU and between sectors, and is one of the deliverables included in the European Strategy for Data, adopted in February 2020.  (See our previous blog here for a summary of the Commission’s European Strategy for Data.)  The press release accompanying the proposed Act states that more specific proposals on European data spaces are expected to follow in 2021, and will be complemented by a Data Act to foster business-to-business and business-to-government data sharing.The proposed Data Governance Act sets out rules relating to the following:
  • Conditions for reuse of public sector data that is subject to existing protections, such as commercial confidentiality, intellectual property, or data protection;
  • Obligations on “providers of data sharing services,” defined as entities that provide various types of data intermediary services;
  • Introduction of the concept of “data altruism” and the possibility for organisations to register as a “Data Altruism Organisation recognised in the Union”; and
  • Establishment of a “European Data Innovation Board,” a new formal expert group chaired by the Commission.

Conditions for reuse of public sector data (Chapter II, Articles 3-8)

Chapter II of the Data Governance Act would impose conditions on public-sector bodies when they make certain protected data that they hold available for re-use.  These provisions apply to data held by public-sector bodies that are protected on grounds of commercial or statistical confidentiality, intellectual property rights, or personal data protection.  The Act does not impose new obligations on public-sector bodies to allow re-use of data and does not release them from their existing legal obligations with respect to data.  But if public-sector bodies do make protected data available for re-use, they must comply with the conditions set out in Chapter II.

Specifically, the Act prohibits public-sector bodies from granting exclusive rights in data or restricting the availability of data for re-use by entities other than the parties to such exclusive agreements, with limited derogations.  In addition, if a public-sector body grants or refuses access for the re-use of data, it must ensure that the conditions for such access (or refusal) are non-discriminatory, proportionate, and objectively justified, and must make those conditions publicly available. The Act also provides that public bodies “shall” impose conditions “that preserve the functioning of the technical systems” used to process such data, and authorizes the Commission to adopt implementing acts declaring that third countries to which such data may be transferred provide IP and trade secret protections that are “essentially equivalent” to those in the EU.

In addition, where specific EU acts establish that certain non-personal data categories held by public-sector bodies are  “highly sensitive,” such data may be subject to restrictions on cross-border transfers, as specified by the Commission through delegated acts.

Obligations on “providers of data sharing services” (Chapter III, Articles 9-14)

Chapter III of the Act introduces new rules for the operation of data intermediaries, termed “providers of data sharing services”.  Specifically, it would establish a notification and compliance framework for providers of the following data sharing services:

  • Intermediation services between data holders and data users, which include platforms or databases enabling the exchange or joint exploitation of data, such as industry data spaces;
  • Intermediation services between data subjects that seek to make their personal data available and potential data users; and
  • “Data cooperative” services that support individuals or SMEs to negotiate terms and conditions for data processing.

The Act set out several requirements that providers of these data sharing services would need to comply with, including:

  • Notifying the relevant EU Member State authority of its intent to provide such services;
  • Appointing a legal representative in one of the Member States, if the company is not established within the EU;
  • Not using the data collected for other purposes, and using any metadata only for the development of that service;
  • Placing its data sharing service in a “separate legal entity” from its other services;
  • Having in place adequate security safeguards; and
  • Imposing a fiduciary duty towards data subjects to act in their best interests.


Continue Reading The European Commission publishes a proposal for a Regulation on European Data Governance (the Data Governance Act)

Under the False Claims Act’s (“FCA”) first-to-file bar, “no person other than the Government may intervene or bring a related action based on the facts underlying the pending action.”  But can a relator amend her complaint to add, remove, or substitute relators without violating the first-to-file bar?  Recently, the Third Circuit in In re Plavix

The Trump Administration has released the much-anticipated executive order entitled “Lowering Drug Prices by Putting America First” (commonly referred to as the “Most-Favored-Nation” or “MFN” executive order). President Trump initially had announced the MFN executive order during his July 24, 2020 press conference highlighting four separate executive orders aimed at drug pricing. However,

Earlier this week, the Federal Circuit issued a decision in The Boeing Company v. United States that clears the way for resolution of Boeing’s substantive challenge to a controversial FAR provision that can give the government windfall recoveries in Cost Accounting Standards (CAS) matters.  The Federal Circuit decision is notable for three reasons.  First, in

Every four years, prosecutors at the Department of Justice (“DOJ”) train their sights on money spent to influence the outcome of the presidential election—and those who spend it.  While the Federal Election Commission (FEC) has exclusive jurisdiction to penalize and enforce civil violations of the Federal Election Campaign Act (FECA), 52 U.S.C. § 30101 et

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