Inter partes review proceedings for biosimilar products are soaring. Biosimilar makers are taking advantage of IPR proceedings to challenge patents protecting some of the world's most important biologic medicines due to the advantages that these proceedings offer: no standing requirement, no presumption of validity, a lower burden of proof and potentially broader claim construction. More than half of the IPR petitions challenging these patents were filed in fiscal 2017 ...
The Sixth Circuit Court of Appeals recently affirmed dismissal of an FCA complaint that failed to meet the FCA’s stringent pleading requirements. See United States ex rel. Ibanez v. Bristol-Myers Squibb Co., No. 16-3154, 2017 U.S. App. LEXIS 21328 (6th Cir. Oct. 27, 2017) ...
Californians diverting water should take notice of new measurement and reporting requirements with quickly approaching deadlines. Water right holders diverting between 10 and 100 acre-feet per year have until January 1, 2018, to either (1) install and maintain a measurement device, (2) employ a measurement method capable of measuring the rate of diversion, or (3) submit an alternative compliance plan ...
The term “dawn raid” refers to an unanticipated visit to commercial premises by a regulatory authority. Examples of this could include a squad of policemen entering a warehouse, a team from a financial-services regulator checking trading records at a bank, or an official from the UAE Ministry of Human Resources and Emiratisation entering your office to check the work permits of all employees present there (an increasingly common practice) ...
The revised Phase 2 Requirements of Participation for long-term care facilities will go into effect November 28, 2017. While multiple provider groups have requested a delay of some of the rule's provisions to allow time for additional revisions, officials at the Centers for Medicare and Medicaid Services ("CMS") have indicated that they will not act on those requests at this time and plan to move forward with the November 28, 2017, implementation date for Phase 2 ...
The California Office of Environmental Health Hazard Assessment (OEHHA) announced on November 9, 2017 that it was adding two widely used perfluorinated chemicals to the Proposition 65 list of chemicals known to cause reproductive toxicity: perfluorooctanoic acid (PFOA) and perfluorooctane sulfonate (PFOS) ...
How retailers can harness technology to beat e-commerce at its own game. “It's official: Singapore malls are dead, as occupancy reaches its lowest level in 10 years,” screams one headline. “At some suburban malls, retailers confront the sound of silence,” another chimes in. As e-commerce takes hold, shoppers are eschewing brick and mortar in favour of the convenience of point and click ...
Simonsen Vogt Wiig and lead counsel Anders Thue represented Fosen-Linjen AS (a ferry operator) against AtB AS before the EFTA Court. AtB organises the public transportation in one of the Norwegian counties. In its judgment delivered earlier this year (in Case E-16/16), the EFTA Court replied to questions referred to it by the Frostating Court of Appeal (Frostating lagmannsrett) ...
A common question our Education Law Group receives is, “Can an employee rescind his or her written resignation that has been submitted to the superintendent and is waiting on approval from the board of education?” Unfortunately the question often arises frequently in situations where the employee is not the “best employee” and administration feels thankful upon receipt of the resignation ...
On Oct. 6, 2017, during a speech at New York University School of Law, Deputy Attorney General Rod Rosenstein explained the Department of Justice (DOJ) is reexamining current DOJ policy as part of an effort to streamline and centralize internal guidance. As of now, DOJ policies span multiple sources, including internal manuals, memoranda, speeches and articles interpreting policies ...
The Slovenian National Assembly adopted the Class Action Law, which will implement an important institute to the Slovenian legal system, i.e. mechanism of class action. This mechanism is already applied in the UK, Belgium, Netherlands and Sweden, but is yet to be implemented in numerous EU member states. The new mechanism of class action will provide for the injured parties, both natural and legal persons, to file a compensation claim in case of mass harm situations ...
In less than 4 months the Priips-Kid regulation will come into force. The exercise of ensuring compliance with this regulation is not an easy one ...
Yesterday, U.S. Attorney General Jefferson Sessions issued new guidance reversing the federal government’s former position that gender identity is protected under Title VII. In a memo sent to the heads of all federal agencies and the U.S. attorneys, the attorney general stated that as a matter of law, “Title VII does not prohibit discrimination based on gender identity per se ...
After weeks of headlines dominated by Equifax’s cyber breach affecting 143 million consumers and the breach of the SEC’s own EDGAR system, the SEC recently announced the creation of (i) a Cyber Unit to target cyber-related misconduct and (ii) a Retail Strategy Task Force to strengthen its protection of retail investors ...
Noble Group continues to draw fire from Iceberg Research more than two years after the short-selling firm first accused the listed commodities trader of questionable accounting practices. In August this year, Iceberg renewed its criticism of the group, but expanded its crosshairs to include Singapore's regulators ...
On June 30, 2017, Governor Kasich signed the workers’ compensation budget bill. House Bill 27, which funds the Bureau of Workers’ Compensation, also made several important changes significant to Ohio employers. The changes are effective September 29, 2017. The most impactful portions of House Bill 27 involve a modification in the injury statute of limitations for filing a claim, reducing the filing from two years of the date of injury to one year ...
The District Court for the Southern District of New York recently rejected the notion of a “holistic” approach to materiality, instead zeroing in on the government’s continued payment of claims despite knowledge of non-compliances as proof positive those non-compliances were not material. In United States ex rel. Kolchinsky v. Moody’s Corp ...
On Friday, September 22, 2017, the Department of Education, Office of Civil Rights (OCR) officially withdrew two guidance documents issued under the Obama administration regarding implementation of Title IX on school campuses. In place of these guidance documents, the OCR issued new interim guidance documents regarding how schools should handle sexual assaults. The OCR indicated official guidance and directives will be issued after a formal notice and comment period ...
In line with the state policy set out in the Philippines Constitution to recognise the indispensable role of the private sector in national growth, encourage private enterprise and provide incentives to attract needed investment, the Philippine government has long resorted to public-private partnerships (PPPs) to address problems of national interest ...
The Second Circuit Court of Appeals recently granted a petition for interlocutory review to decide whether a violation of the FCA’s first-to-file rule can be cured by filing an amended pleading. Both the D.C. Circuit and Fourth Circuit1 recently addressed this issue, concluding that the plain language of the first-to-file rule precludes amending around the rule ...
Yesterday, Education Secretary Betsy DeVos addressed the public regarding a controversial and difficult issue – Title IX. In her statements, she announced the new administration will change the way colleges and universities handle incidents of sexual assault on campus ...
In its flagship report entitled Global Economic Prospects released in January, the World Bank observed: “The Philippines is particularly weak with regard to transport and trade-related infrastructure … with particularly low rankings for the quality of its seaports and airports. About one-quarter of the population remains without electricity.” Yet growth in the Philippines is projected to accelerate to 6 ...
After getting the knowledge of GPA Model and PPP Model, the bidders need to know how to make preparation during the pre-bid stage. Following are the responses to some most frequently asked questions regarding bidding qualifications, based on which the foreign bidders can make its preparation plan ...
In the wake of Hurricane Harvey, franchisors should take action to avoid potential liability for price gouging committed by franchisees in affected areas. Price gouging occurs when a seller increases prices of goods, services or commodities to a level that is exploitive and unethical. Texas law explicitly prohibits price gouging following a natural disaster, and fines for price gouging can be up to $20,000 per violation ...
It is rare that FCA defendants have their legal defenses paid for, and rarer still that DOJ must bear the expense. In United States ex rel. Wall v. Circle C Construction, the Sixth Circuit held that the government must pay roughly $500,000 in legal fees and expenses the defendant incurred as a result of the government’s unreasonable litigating position ...
