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Our Dublin-based lawyers work closely with those in our other European offices and around the world to support foreign companies doing business in Ireland or assisting national businesses with their expansion into new markets. We deliver commercially minded advice that takes into account the increasingly complex global regulatory and reporting regimes that affect businesses' strategy and operating structures.
We offer expertise in the life sciences, digital health, technology, and consumer brands industries, together with sophisticated and integrated knowledge of Irish, EU, and other international laws and regulations. Our lawyers on the ground in Ireland work closely with Covington’s international public policy, anti-corruption, export controls, international tax, and global dispute resolution practices to develop comprehensive solutions for clients on a variety of challenging cross-border transactional, regulatory, compliance, enforcement, and litigation matters.
Litigated Successful Constitutional Challenge
On behalf of Microsoft, successfully challenged a gag order statute that allows courts to forbid technology companies from telling their customers about demands for their data under the Electronic Communications Privacy Act (ECPA). The lawsuit resulted in nationwide reform of the government's practices under the statute. See Microsoft Corporation v. United States Department of Justice, No. 2:16-cv-00538-JLR (W.D. Wash.).
Significant Privacy Case Before the Irish High Court
The Irish High Court referred the validity of the Standard Contractual Clauses used as a basis to transfer data and specifically whether they are compatible with the EU treaties to the EU Court of Justice. This is an amicus brief where we will appear on behalf of our client alongside the U.S. Government in making submissions before the EU Court of Justice.
Advice to Numerous Life Sciences Companies on Regulatory Compliance and Infrastructure
Advice to numerous pharmaceutical and medical technology companies on compliance with with pharmaceutical and medical device regulations. For pharmaceutical companies, this has included compliance with manufacturing and supply chain rules, pharmacovigilance, and other “GxP” requirements. We have advised device manufacturers on borderline, classification, conformity assessment and other quality system requirements, including in the digital health space. In both industries, we have advised extensively on the impact of, and preparations for Brexit.
NICE Challenge for Irish Biopharmaceutical Company
Advised the wholly owned Irish subsidiary of a major U.S. biopharmaceutical company on a negative recommendation from the UK's NHS reimbursement from the National Institute of Health and Care Excellence (NICE) on a treatment for obesity and an appeal against it.
Microsoft Ireland Case
Representing Microsoft before the U.S. Supreme Court in its challenge to the government’s attempt to compel disclosure of customer emails stored in Ireland using a search warrant. The case set Irish and European privacy law and national sovereignty against U.S. law enforcement needs and raised a whole host of issues relating to demands for data by government agencies from another country.
Representation of Microsoft in Landmark Case Involving Data Stored Abroad
Successfully challenged U.S. government warrant seeking data stored in Ireland. After a favorable decision from the Second Circuit—and while the Supreme Court was reviewing the case—Congress enacted the CLOUD Act, a modernized framework for cross-border data requests. See United States v. Microsoft Corporation, No. 17-2 (U.S.).
EU and U.S. Food Regulatory Requirements and Approvals
Advising a range of Irish companies on EU and U.S. food regulatory requirements and compliance.
Product Recall Matter in Ireland
Advising on a product recall and related regulatory and consumer issues.
Case Challenging a Negative Reimbursement Decision before the Irish High Court
Advised U.S. pharmaceutical company PTC Therapeutics on the first ever challenge on a negative reimbursement decision by the Health Executive Ireland relating to ultra-orphan drug, Translarna.
November 15, 2018
The proposed withdrawal agreement between the European Union and the United Kingdom was published by the European Commission on November 14 (see here). The text runs to 585 pages, and represents a tentative agreement reached between the UK and EU negotiating teams. It is accompanied by an eight-page outline of the proposed political declaration on the future ...
British Irish Chamber calls for State supports to Brexit-proof Ireland’s agri-food sector
September 5, 2018, Irish Examiner
Maree Gallagher is quoted in the Irish Examiner regarding Brexit’s impact on Ireland’s agri-food sector. Ms. Gallagher, also Chair of the British Irish Chamber of Commerce Agri-Food Committee, says, “The agri-food sector is Ireland’s largest indigenous industry employing around 250,000 people enabling €12.6bn in exports a year.” Ireland, who is a major source of ...
June 5, 2018, The Irish Times
Sir Michael Leigh and Lord Francis Maude recently participated in a roundtable with The Irish Times to discuss Brexit developments. Commenting on the status of finding a solution to the Irish Border issue, Leigh and Maude said that they do not envisage a solution to maintain an invisible border being agreed until there is a deal on the future EU-UK trading ...
May 22, 2018, The American Lawyer
Michael Labson is quoted by The American Lawyer in an article regarding Covington's presence in Ireland. "We were focused on whether it’s a strategic fit with the firm’s overall strengths,” says Labson. “With Brexit, we saw the Irish office would be of growing importance. A lot of large pharmaceutical companies have significant operations in Ireland and large ...
Practices
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Regulatory and Public Policy