On January 13, 2014, the Food and Drug Administration ("FDA" or "the Agency") announced the availability of a much-anticipated draft guidance on its intended regulation of product promotion conducted via social media, titled Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics ...
A New York appellate court affirmed in Syracuse Univ. v. National Union Fire Ins. Co., CA 13-01056, (N.Y. Sup. Ct. App. Div. Dec. 27, 2013), that an insurer must pay the costs incurred by its policyholder to comply with subpoenas issued to the policyholder as part of a criminal investigation, even where formal charges are not filed ...
Sierra Club v. Bostick (W.D. Oklahoma) In June 2012, environmental groups filed suit in the US District Court for the Western District of Oklahoma challenging the US Army Corps of Engineers’ issuance of Nationwide Permit (NWP) 12 for utility line projects, and use of NWP 12 for the Keystone Pipeline Gulf Coast Project.Sierra Club v. Bostick, 5:12-cv-00742-R (W.D. Oklahoma) ...
In Ass’n For Molecular Pathology v. Myriad Genetics, Inc., the Supreme Court held that "a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but that cDNA is patent eligible because it is not naturally occurring." 133 S. Ct. 1207 (2013). Further, fragments that are "indistinguishable from natural DNA" are not statutory subject matter. Id., 2119 ...
Getting ready for your next compliance examination? Well, it may be time to take a fresh look at your institution’s Regulation B compliance. The Equal Credit Opportunity Act ("ECOA"), as implemented by Regulation B, is not a new concept. First adopted in 1974, Regulation B is understood by most institutions to include a focus on what information and what signatures can be obtained with respect to the family member of an applicant ...
On January 2, the Antitrust Division of the US Department of Justice (DOJ) announced its first civil enforcement action of 2014 — a consummated merger challenge and settlement resulting from Heraeus Electro-Nite’s (Heraeus’s) $42 million acquisition of Midwest Instrument Company Inc. (Minco). The enforcement action is the latest DOJ challenge to a merger not required to be reported to the US antitrust agencies under the Hart-Scott-Rodino Act ...
Why Proportionality Should Be Considered As Part of the Preservation Parties have a general duty to preserve and produce relevant electronically stored information (ESI). This duty, however, is bounded by a proportionality requirement because e-discovery should not be allowed to be the tail that wags the dog. Courts and parties have been adept at applying proportionality requirements to the production of ESI, but they have struggled to apply proportionality to the preservation of ESI ...
As in past years, chemical, pharmaceutical and biotechnology patent cases in 2013 offered a combination of the predictable and the unpredictable. On the predictable end of the spectrum, the US Supreme Court offered no surprises ...
A recently unsealed decision from the United States District Court for the District of Maryland demonstrates that insurers cannot hide behind the attorney-client privilege and work-product doctrine to shield claim files from discovery. The court made clear that involving counsel in claim handling does not operate to make either doctrine automatically apply. Charter Oak Fire Ins. Co. v. Am. Capital Ltd., No. 8:09-cv-100 (D. Md. Nov. 6, 2013) ...
On 22 November 2011, the Court of Justice of the European Union (CJEU) rendered two very important rulings in the Medeva (C-322/10) and Georgetown (C-422/10) cases. Those rulings however raised new issues that national patent courts quickly referred back to the Court. Yesterday, the CJEU decided on three Medeva follow-up cases. The new rulings brought more clarity about the conditions under which an SPC may be granted ...
A Pennsylvania appellate court in Indalex, Inc. v. National Union Fire Ins. Co., No. 612 WDA 2012 (Dec. 3, 2013), found that a general liability insurer must defend a window and door manufacturer against claims alleging that defects in the manufacturer’s windows and doors caused damage to property and bodily injuries ...
Institutional Shareholder Services ("ISS") recently announced its updated voting policies for the 2014 proxy season. The policies will become effective for shareholder meetings held on or after February 1, 2014. We have summarized below four policy updates relating to corporate governance matters that may be of particular interest to US corporations. Simplified Pay-for-Performance Executive Evaluation ISS revised its policy relating to executive pay-for-performance evaluations ...
More than three years after first announcing that it was considering issuing regulations applying the Americans with Disabilities Act to websites, the US Department of Justice (DOJ) appears on the verge of announcing its proposed rules for website accessibility. While the DOJ originally stated that it anticipated issuing its Title II website accessibility rules for websites operated by state and local governments by November 2013, it now expects to issue these rules by the end of the year ...
Negotiation of the proposed EU Data Protection Regulation has faltered. While there is still a possibility that the Regulation could be passed before the May 2014 European elections, that looks increasingly remote. The main stumbling block appears to be the difficult issue of the ‘one stop shop’, which has produced deadlock within the Council of Ministers. The ‘one stop shop’ proposal is inherently difficult, but until now has been referenced in somewhat superficial terms ...
A recent court order in favor of the Commodity Futures Trading Commission (or CFTC) and new rules issued by CFTC establish a standard of liability for depository institutions that fail to fulfill their customer funds protection obligations under the Commodity Exchange Act (or CEA) and, thus, requires them in certain circumstances to monitor the activities of clients that are registered with CFTC as futures commission merchants (or FCMs), commonly known as commodity brokers ...
On December 2, 2013 the US Supreme Court will hear oral arguments in BG Group v. Argentina, addressing for the first time the applicable rules when a US court reviews an international arbitral award made under a bilateral investment treaty. This case has earned the attention of the international arbitration community, given its potential impact on future arbitral practice in the United States and abroad ...
On October 25, 2013, the Standing Committee of the National People’s Congress of the People’s Republic of China passed an amendment to the P.R.C. Law on the Protection of Consumer Rights and Interests (the “Amendment”) ...
On October 22, 2013, the National Institute of Standards and Technology (“NIST”) issued the Preliminary Cybersecurity Framework (the “Preliminary Framework”), as required under Section 7 of the Obama Administration’s February 2013 executive order, Improving Critical Infrastructure Cybersecurity (the “Executive Order”). The Preliminary Framework includes standards, procedures and processes for reducing cyber risks to critical infrastructure ...
