Document(s) published by this organization: 476
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|180-Day Notice of Commercial Marketing Mandatory Even When Biosimilar Applicants Do the "Patent Dance"|
A. Patricia Campbell, Jennifer J. Chheda, Pablo D. Hendler, Timothy J. (Tim) Heverin, Janet M. McNicholas; Jones Day;
August 3, 2016, previously published on July 2016On July 5, 2016, the Federal Circuit issued another important decision regarding the meaning of certain provisions of the Biologics Price Competition and Innovation Act of 2009 ("BPCIA"). See Amgen Inc. v. Apotex Inc., Fed. Cir. Case No. 2016-1308 (Fed. Cir. July 5, 2016). The court held...
|U.S. DOJ Obtains Record Fine Against Activist Investor for Failing to Make HSR Premerger Filing|
Michael H. (Mike) Knight, Bevin M.B. Newman; Jones Day;
August 3, 2016, previously published on July 2016This week the Department of Justice obtained a record $11 million fine for an investor's failure to comply with the premerger notification and waiting period requirements of the Hart-Scott-Rodino (HSR) Act. DOJ challenged hedge fund ValueAct's reliance on the "investment-only" exemption...
|SEC Adopts Final Resource Extraction Disclosure Rules|
Bradley C. (Brad) Brasser, Rory T. Hood, Robert (Bob) Joseph, Joel T. May, Michael J. (Mike) Solecki; Jones Day;
August 3, 2016, previously published on July 2016On June 27, 2016, the Securities and Exchange Commission ("SEC") adopted final rules requiring disclosure by resource extraction issuers of payments made to governments for the commercial development of oil, natural gas, or minerals. Specifically, issuers must disclose payments of...
|EEOC Issues Final Wellness Plan Regulations and Immediately Asserts Retroactive Effect|
Fred W. Alvarez, Eric S. Dreiband, Michael J. Gray, Matthew W. (Matt) Lampe, Blake Pulliam; Jones Day;
August 3, 2016, previously published on July 2016On May 16, 2016, the Equal Employment Opportunity Commission (“EEOC”) finalized highly anticipated regulations that purport to define the extent to which the Americans with Disabilities Act (“ADA”) and the Genetic Information Nondiscrimination Act (“GINA”) permit...
|Italian Competition Authority Closes Sector Inquiry on Vaccines Competition|
Francesco Liberatore, Cristiana Spontoni, Mario Todino; Jones Day;
August 3, 2016, previously published on July 2016Over the last few years the pharmaceutical industry in Italy has attracted increasingly intensive antitrust scrutiny. Last month the Italian Competitive Conspiracy (ICA) concluded an important sector inquiry on vaccines for human use, just after the conclusion of two other high profile antitrust...
|Second Circuit Limits Territorial Reach of U.S. Government to Domestically Stored Data|
Theodore T. (Ted) Chung, Daniel J. (Dan) McLoon, Mauricio F. Paez, Gregory P. Silberman, John A. Vogt; Jones Day;
August 3, 2016, previously published on July 2016In a highly anticipated decision, the Second Circuit ruled on July 14, 2016, that the United States cannot compel Microsoft Corp. ("Microsoft") to disclose certain customer emails stored in Ireland because Congress did not intend the warrant provisions of the Stored Communications Act...
|Post-Spokeo Decisions Rejecting "No Injury" Lawsuits|
J. Todd Kennard, Brandy Hutton Ranjan, John A. Vogt; Jones Day;
August 3, 2016, previously published on July 2016Multiple recent decisions have applied the U.S. Supreme Court's injury-in-fact analysis from Spokeo, Inc. v. Robins, 136 S. Ct. 1540 (2016), to dispose of claims based on lack of standing. In Spokeo, plaintiff Robins alleged that Spokeo, which operates a web service that compiles general background...
|New York Reins In "Common Interest" Doctrine|
William J. (Bill) Hine, Sevan Ogulluk; Jones Day;
August 3, 2016, previously published on July 2016In June 2016, New York's highest court reversed an important 2014 decision by an intermediate appellate court that had expanded the application of the common interest doctrine to commercial transactions, such as mergers, where litigation was neither pending nor anticipated. In Ambac Assurance...
|The EU-U.S. Privacy Shield Approved|
Jonathon Little, Giuseppe Mezzapesa, Mauricio F. Paez, Elizabeth A. (Liz) Robertson, Undine von Diemar; Jones Day;
August 3, 2016, previously published on July 2016After months of criticism from various EU bodies and institutions, the much-anticipated EU-U.S. Privacy Shield finally has been approved by the European Commission, paving the way for self-certifying U.S. organizations to transfer legally EU personal data across the Atlantic. The adoption of this...
|New Zealand Authorities Impose Fine for Real Estate Agency Price Fixing|
Prudence Smith, Nick Taylor; Jones Day;
August 3, 2016, previously published on July 2016New Zealand's High Court has fined a real estate agency that engaged in price fixing and other anticompetitive conduct in the Manawatu real estate market. Unique Realty Limited had entered into an agreement with at least 10 other agencies to pass on to home sellers, rather than to absorb, listing...