On July 11, 2018, then-U.S. Food and Drug Administration Commissioner Scott Gottlieb made a public statement about the agency’s efforts to advance the development of gene therapies.[1] Gottlieb pointed out that the FDA has approved three separate gene therapy products and the agency has issued six scientific guidance documents intended to serve as building blocks of a modern, comprehensive framework for how the FDA can advance the field of gene therapy ...
Proposition 65 is a 1986 California right-to-know law requiring businesses to provide “clear and reasonable” warnings of potentially harmful exposures to chemicals appearing on the growing list maintained by California’s Office of Environmental Health Hazard Assessment (“OEHHA”) ...
The Affordable Care Act ("ACA") is alive and well, despite renewed legal challenges and the elimination of the “individual mandate” beginning next year. While the Tax Cuts and Jobs Act reduced the tax penalty for individuals who don’t have health coverage to $0, effective for 2019, employers continue to be subject to penalties for failing to comply with certain ACA rules ...
The Communications Decency Act (CDA)—the law Congress enacted in 1996 and confirmed this past year to shield online publishers from responsibility for the speech of others—gives internet platforms the right to publish the ideas and opinions of third-party users without being held liable for that content or being forced to remove it.[1] In the closely watched case ofHassell v ...
In recent months a Customs Destination Certificate (CDA, in its Spanish acronym) will be required for medical devices1that do not have a sanitary registration to be imported into Chile. The CDA must be requested and obtained by the importer through the Institute of Public Health’s (ISP, id.) GICONA 2.0 electronic platform, and will require the payment of an official fee corresponding to the service code 4111027, “Customs Destination Certificate, law 18,164” ...
The Namibian Industrial Property Act, 2012 will finally come into effect on 1 August 2018 and will have far-reaching implications for the protection, use and enforcement of trade mark and other intellectual property rights in Namibia. This Act provides for the registration and protection and administration of patents, utility model certificates, industrial designs, trade marks, collective marks, certification marks and trade names ...
The release of Brand Finance South Africa 50 2018, a report on South Africa’s top brands (many of which are advised by ENSafrica’s IP team), gives all of us involved in brands and branding a chance to consider the commercial importance of our field.The report was produced by the company Brand Finance and mentions that over the past year, the value of South African brands grew by an impressive 8% to ZAR426-billion ...
Imagine listing this as one of a company’s major assets:“A sweet, slightly musky, vanilla-like fragrance, with slight overtones of cherry, and the natural smell of a salted, wheat-based dough.” That’s something Hasbro can do, certainly now that the US Patent and Trademark Office has accepted the company’s trade mark application for the smell of its Play-Doh product ...
“Use it or lose it”. It’s one of the fundamental principles of trade mark law – if a trade mark registration is not used, it’s liable to be lost. The principle makes perfect sense considering that a trade mark registration is effectively a monopoly (albeit one with limitations) to a name, logo or other form of branding. Monopolies should not and are not granted lightly ...
The European Court of Justice ("ECJ") recently came with important clarifications regarding the implementation of mergers before merger clearance, so called "gun jumping." The topic often arises in merger cases where the parties have "signed the deal" but are awaiting clearance by the relevant competition authority. What can be done by the parties before closing post signing, and what cannot be done prior to implementation? The judgment in case C-633/16 Ernst & Young P/S v ...
On June 28, 2018, Attorney General Jeff Sessions and Department of Health and Human Services (HHS) Secretary Alex M. Azar III announced the ninth year of the national health care fraud takedown. The takedown resulted in the largest government action against health care fraud, which involved more than 600 defendants from over 50 federal districts. The targeted fraud schemes accounted for more than $2 billion in false billings ...
Walking the tight rope between making strides for women’s rights and being too strident So, the Trump-Kim Summit has successfully concluded in Singapore, with the Leader of the Free World shaking hands with the Supreme Leader of one of its most coldblooded dictatorships. Looking at these two scions of privilege, it is hard not to be struck by how much they have in common, united not just by their comically bad hair, but also by their low regard for women ...
As rapid technological changes in the 21st century continue to expand the types and volume of private electronic information, the Fourth Amendment’s privacy protections are evolving. Originally, “Fourth Amendment jurisprudence was tied to common-law trespass” and provided protections against searches of property. See, United States v. Jones, 565 U.S. 400, 405 (2012) ...
In a unanimous vote on June 28, 2018, California lawmakers enacted a landmark, first-of-its-kind data privacy law that is intended to give consumers greater control over how their personal information is collected, stored, and sold by companies with whom they do business ...
After not disturbing the Third-Party Doctrine for more than 40 years, the Supreme Court created a significant exception to it inCarpenter v. United States. Slip Op., 16-402 (Jun. 22, 2018). Under the Third-Party Doctrine, individuals who voluntarily provide personal information to third parties are deemed to relinquish their legitimate reasonable expectation of privacy in that information ...
Artificial intelligence technologies are extremely promising in healthcare.1 By examining, cross-referencing and comparing a phenomenal amount of data.2 AI lets researchers work more quickly at a lower cost3 and facilitates doctors’ decision-making with regard to diagnosis, treatment and choice of prescription. The integration of AI into the healthcare field can take various forms:4 Management of electronic medical records (e.g ...
Earlier this year the U.S. Supreme Court released its much-anticipated opinion inSouth Dakota v. Wayfair, Inc., in which it held that physical presence within a State is no longer a prerequisite to the imposition of liability on out-of-state sellers to collect and remit sales taxes. In doing so, the Court overruled two of its own earlier cases—National Bellas Hess, Inc. v. Department of Revenue of IllinoisandQuill Corp. v. North Dakota ...
Ferdose al-Taie, Dallas-based senior counsel in Dykema’s Commercial Litigation group, authored the article “Anonymous Whistleblowers Make Millions for Reporting Their Own Companies to Federal Regulators,” forFOCUS, the quarterly newsletter of the Association of Corporate Counsel (ACC) South Central Texas Chapter. In the article, al-Taie shines a light on the ins and outs of Dodd-Frank Whistleblower awards and who is eligible for consideration ...
InLagos v. United States, 584 U.S. ___ (2018), the Supreme Court issued a unanimous ruling that limits the ability of corporate victims of fraud to seek reimbursement of legal fees for internal investigations. The case began when GE Capital discovered that Sergio Lagos falsified numerous invoices for his company, which he used as collateral to obtain tens of millions of dollars in loans from GE Capital ...
On June 21, 2018, the United States Supreme Court, in South Dakota v. Wayfair, Inc., held that a state can now require companies not physically present in that state to collect tax on internet sales made to its residents. The explosive growth of e-commerce combined with the states’ eroding tax base convinced the Supreme Court to turn back a half century of jurisprudence ...
This week, the U.S. Department of Labor (DOL) issued final rules to expand access to “Association Health Plans” for small businesses that are unaffiliated, but are in the same line of business or geographic area. An “Association Health Plan” or “AHP” is a group health plan adopted by members of an employer group or association to provide health coverage for their employees ...
It has been long-established by the classic fundamental principles of corporate law that companies are separate and distinct persons from their shareholders, directors and officers. From this flows the general principle that it is the company, and the company alone, that can be liable for its obligations ...
On June 5, I wrote about the suspension of the California End of Life Option Act (“EOLOA”) in the wake of Ahn v. Hestrin and several related court proceedings in May. On Friday, June 15, the Fourth District Court of Appeal determined that the EOLOA will in fact remain enforceable pending further proceedings. Thus, eligible Californians who have requested end-of-life drugs in accordance with the EOLOA may continue with the process described in that law ...
In the Loop: With the Hanson Bridgett Government Group Many of us have had to request reimbursement from our company for an expense, which can be a pretty complicated process. For members of a legislative body, these rules can be even more specific. We'll think about Buddy, who sits on city council. Not long ago, the City gave Buddy a city-owned tablet to allow him to do his job remotely ...
How to strike the right balance between (i) the business need to take preparatory steps in view of integrating the target in M&A deals and (ii) the legal requirement to comply with the standstill obligation under merger control rules? ...
