The decision of the Indian Supreme Court to deny Novartis’s application for patent protection for an improved version of its patented Glivec drug – the culmination of a seven-year battle - has certainly made the headlines. There are a number of reasons for this. First, Glivec is a well-known drug – described by some as a ‘wonder drug’ – that’s used to combat cancer, including leukaemia and gastro-intestinal cancer ...
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 ...
Following the dissolution of BP Migas, SKK Migas has taken over all upstream oil and gas business activities until the new law on oil and gas is enacted. The Minister of Energy and Mineral Resources recently issued Regulation No. 9 of 2013 on the duties and organizational structure of SKK Migas ...
By October 1, 2013, the North Carolina Mining and Energy Commission (“N.C. MEC”) must report its findings and recommendations for hydraulic fracturing to the Joint Legislative Commission on Energy Policy and the Environmental Review Commission. One of the issues being considered by the N.C. MEC is whether the state will permit forced pooling by oil and gas companies ...
The County Commission in Doddridge County, West Virginia is currently considering amendments to its Floodplain Ordinance as a result of a December 17, 2012 decision by the Circuit Court of Doddridge County. (Comments to the amended floodplain ordinance were due by March 25, 2013.) The facts and procedural posture of the Doddridge County case are convoluted ...
On April 24, 2013, the Pennsylvania Supreme Court issued its highly anticipated decision in the Butler v. Charles Powers Estate case. The Supreme Court decided to maintain the status quo in Pennsylvania by reaffirming the application of the Dunham Rule, meaning that there will not be a sea change in the Commonwealth regarding the interpretation of oil and gas conveyances ...
As discussed in Part I, the North Carolina Mining and Energy Commission (“N.C. MEC”) will present its report on hydraulic fracturing to the Joint Legislative Commission on Energy Policy and the Environmental Review Commission by October 1, 2013. One of the many issues up for debate is whether the state will permit forced pooling and if so, what approach the state will adopt for nonconsenting landowners ...
On 20 March 2013, the Finnish government issued its much-awaited proposal for a new Electricity Market Act and an amended Natural Gas Market Act. It also sent to the parliament a separate supervision act. The proposal implements the European Union’s third Electricity and Natural gas Directives to the Finnish legislation. It also includes numerous nationally prepared amendments and changes ...
Today the HHS Office of Inspector General (OIG) issued an Updated Special Advisory Opinion addressing the recommended scope and frequency of exclusion checks of employees and contractors. The Advisory Opinion provides important and practical guidance to assist healthcare providers seeking to protect their businesses against the risk of employing or contracting with excluded individuals and entities ...
Following a month-long retrial, a South Carolina jury has concluded that Tuomey Healthcare System, Inc. (Tuomey) violated the Stark Law and the False Claims Act by illegally paying referring physicians. The jury found that Tuomey’s compensation arrangements with referring physicians were impermissible under the Stark Law, resulting in almost 22,000 false claims and more than $39 million in overpayments ...
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) ...
Earlier this month, the United States Department of Justice (“DOJ”) filed a suit against Vitas Hospice Services, L.L.C. and its subsidiary entities (“Vitas”) alleging that Vitas submitted false claims for hospice services which were excessive, unnecessary, or not provided, and also alleging that Vitas admitted patients to hospice who were not terminally ill ...
On April 12, 2013, the N.C. Supreme Court stepped into the ongoing dispute regarding the 7.2 percent rate increase sought by Duke Energy and approved by the North Carolina Utilities Commission (NCUC) in January 2012. Duke initially sought a 12 percent rate increase, but eventually entered into a settlement with the North Carolina Public Staff, setting the rate at 7.2 percent. Duke contended that it needed the higher rates to cover $4 ...
The Budget. The 83rd Texas Legislative Session convened on January 8th with news of a better-than-anticipated revenue estimate, an unusually high number of new and second-term legislators, and less controversy and fanfare than observers have come to expect at the start of the biennial, 140-day process. In mid-March, only days before the bill became due, lawmakers passed and the Governor signed legislation to fill the $4 ...
The draft law governs the organization and functioning of the natural gas sector, rules and conditions for carrying out energy activities in this sector, planning and development of the natural gas market, market regulation, "unbundling" of activities, third party access to natural gas systems ...
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 ...
On April 12, 2013, the West Virginia Legislature passed Senate Bill 243 which contained, among other West Virginia Department of Environmental Protection (“DEP”) rules, the Rules Governing Horizontal Well Development 35-8 (“Rule”). The Rule was developed to provide further direction in the implementation and administration of the Natural Gas Horizontal Well Control Act that became effective on December 14, 2011 (“Act”) ...
An intermediate appellate court in New York recently affirmed that a local government has the authority to enact zoning ordinances banning all oil and natural gas activities within municipal limits. In 2011, the Town of Dryden amended its zoning ordinance to ban “all activities related to the exploration for, and the production or storage of, natural gas and petroleum within its borders ...
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 ...
In the last legislative session (2011–12), bills that would have imposed severe restrictions or even an outright moratorium on hydraulic fracturing (HF) were narrowly defeated in the California legislature. Earlier this year, we issued an alert regarding draft regulations that had been issued by the Division of Oil, Gas, and Geothermal Resources ...
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 ...
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 ...
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 ...
