In Wyeth and Cordis Corp. v. Abbott Laboratories, 2012-1223, -1224 (Fed. Cir. June 26, 2013), the Court of Appeals for the Federal Circuit affirmed the district court’s grant of summary judgment in favor of the defendants, holding method of treatment claims invalid under 35 U.S.C. § 112(a) (2012) as not being enabled for their full scope. (Slip op. at 3) ...
Many employers are wary of hiring applicants with criminal records because they fear exposing themselves to potential negligent hiring or negligent supervision claims, but they also have concerns imposed by the EEOC’s aggressive interpretation of Title VII that a blanket rule against hiring persons with criminal convictions is a violation of the law ...
On June 13, 2013, in the highly anticipated decision for Ass’n for Molecular Pathology v. Myriad Genetics, Inc., the Supreme Court shed some light on the future of genetic patenting to companies and scientists working in the personalized medicine and genetics industry. The personalized medicine industry seeks to revolutionize patient care by using genetic sequencing and testing to predict disease likelihood, severity, progression, and/or treatment response ...
In a decision that will likely have a significant impact on the pharmaceutical industry (and possibly broader implications for patent, antitrust, and high technology), the Supreme Court yesterday refused to exempt so-called reverse payment (or "pay for delay") patent settlements from antitrust scrutiny. Prior to yesterday’s ruling in FTC v. Actavis, Inc., 570 U.S. ___ (2013), most of the circuit courts to have considered the issue (i.e ...
On Friday June 14, 2013, the Supreme Court of Canada released its eagerly-awaited decision, Communications, Energy and Paperworkers Union of Canada, Local 30 v. Irving Pulp & Paper, Ltd., 2013 SCC 34, a case concerning random alcohol testing at a paper mill operation in Saint John, New Brunswick ...
The Supreme Court has unanimously upheld an arbitrator’s ruling that a contract that required arbitration of "any dispute" constituted an agreement to class-wide arbitration. The Court’s narrow ruling turns on the parties’ express agreement to allow the arbitrator to decide whether their contract, which contained an arbitration provision but did not mention class proceedings, authorized class arbitration ...
As discussed in our previous Alert, the French government has imposed Sunshine-like obligations on the pharmaceutical industry. Article 2 of Law No 2011-2012 of 29 December 2011 on the Strengthening of Health Protection for Medicinal and Health Products ("loi relative au renforcement de la sécurité sanitaire du médicament et des produits de santé" or "Loi Bertrand") inserted Articles L. 1453-1 in the French Code of Public Health ("Code de la santé publique" or "CSP"). Article L ...
On May 28, 2013, the US Food and Drug Administration (FDA) published a draft guidance entitled "Contract Manufacturing Arrangements for Drugs: Quality Agreements."1 The draft guidance describes FDA’s views on defining, establishing and documenting the responsibilities of parties that are involved in the contract manufacturing of drugs that are subject to current good manufacturing practice (cGMP) requirements ...
After the Netherlands, Slovakia, and the UK, it is now France’s turn to impose Sunshine-like obligations on the pharmaceutical industry. Soon, similar obligations will apply to all EU countries, after EFPIA, the European trade association for the pharmaceutical industry, adopts a code of conduct on disclosure of transfers of value between pharmaceutical companies and health care professionals or institutions ...
In 2012, the National Labor Relations Board (NLRB) set the business community atwitter when an administrative law judge in American Red Cross decided that an at-will disclaimer in an employee handbook violated the National Labor Relations Act (NLRA) by being overly broad ...
America’s high school and college students will soon be finishing another school year, and employers across the country are gearing up to welcome many of these young adults as interns for the summer. Interns are staples in many organizations and often provide valuable benefit to a business. As employers strive to keep costs down, including that of labor, many use unpaid summer help where possible ...
On February 25, 2013, the Department of Health and Human Services (HHS) released its final rule (the Final Rule) setting forth standards for health insurance issuers under the Patient Protection and Affordable Care Act (the Affordable Care Act). Specifically, the Final Rule outlines exchange and issuer standards related to coverage of essential health benefits, minimum value and actuarial value ...
Last month, the United States Supreme Court (Supreme Court) provided an unexpected gift to entities facing collective actions under the Fair Labor Standards Act (FLSA) by holding that defendants may moot such a case by making an offer of judgment pursuant to Rule 68 of the Federal Rules of Civil Procedure. This ruling could have application to the more common vehicle for multiple plaintiff claims, class actions under Rule 23, but that has yet to be tested ...
Because of recently-enacted changes to the West Virginia Wage Payment and Collection Act, West Virginia employers will have more time to pay final wages to discharged employees. Prior to this change, the Wage Payment and Collection Act required that employers pay discharged employees within 72 hours of termination ...
Last week, a federal jury in South Carolina found that Tuomey Healthcare System, Inc. violated the Stark Law and the False Claims Act by submitting false claims for reimbursement to the United States, resulting in $39 million in damages to the government. United States ex rel. Drakeford v. Tuomey Healthcare Sys., Inc., No. 3:05-2858-MBS (D.S.C. May 8, 2013) ...
1. OverviewIn accordance with theWorld Football Association’s, FIFA’s requirements, (consistent) time periodsfor the transfer of players have been established within the Union of EuropeanFootball Associations (UEFA). These time periods exist to ensure that the transferwindows of individual Football Associations coincide with each other and inturn to guarantee equal opportunities for each individual club ...
On April 24, 2013, WorkSafeBC announced the approval of new Occupational Health and Safety Workplace Bullying and Harassment Policies, which come into effect on November 1, 2013 ...
If your company utilizes temporary workers supplied by a staffing agency, you may be a target of OSHA. On April 29, 2013, the Deputy Assistant Secretary of OSHA, Richard Fairfax, issued a memorandum to its Regional Administrators, entitled “Protecting the Safety and Health of Temporary Workers.” Mr ...
On April 8, 2013, the Occupational Safety and Health Review Commission (“OSHRC” or the “Review Commission”) reversed an administrative law judge’s (“ALJ’s”) decision vacating a lockout/tagout (“LOTO”) citation issued to Otis Elevator Company (“Otis”). See Secretary of Labor v. Otis Elevator Company, OSHRC No. 09-1278 (Apr. 8, 2013) ...
The National Labor Relations Board (NLRB) has become active in scrutinizing and striking down employers’ social media policies. Three times in the last year, the NLRB issued Operations Management Memoranda providing employers with direction on drafting and applying social media policies. The NLRB specifically evaluated social media policies to determine whether they violated the employee bill of rights in Section 7 of the National Labor Relations Act (NLRA) ...
On April 16, 2013, in a 5-4 opinion, the United States Supreme Court decided whether an offer of judgment that fully satisfies the named plaintiff’s individual claim in a Fair Labor Standards Act (“FLSA”) action moots the plaintiff’s collective action claim. In Genesis HealthCare Corporation v ...
After the recent change in the practice of the authorities with respect to protection offered to pregnant definite term employees from having their employment terminated, which gained much media attention and resulted in significant public reaction, the Serbian Parliament has adopted the Law on Amendments of the Labour Law at the beginning of April 2013 ...
On April 17, 2013, the Health and Human Services Office of Inspector General (OIG) released an Updated Provider Self-Disclosure Protocol (SDP), which replaces the original SDP published in 1998. The SDP is used by providers and suppliers to voluntarily disclose violations of the fraud and abuse laws. According to the OIG, it has received more than 800 disclosures since the SDP’s inception, resulting in more than $280 million in recoveries ...
