Don't bank just yet on putting your marketing muscle behind the safe and effective off-label uses of your FDA-approved drugs, or defending your next mass consumer class action on First Amendment grounds. But you can start giving those multi-billion dollar prospects some serious thought, because constitutional winds are blowing through the Code of Federal Regulations ...
Myriad Genetics is known as a leader in the market for diagnostic testing of BRCA1 and BRCA2 gene mutations that have been linked to breast and ovarian cancer. These same diagnostic tests were recently in the celebrity press, as Angelina Jolie announced she had been tested positive for the mutations, resulting in her electing to have a preventative double mastectomy ...
Mining Industry 1. What is the nature and importance of the mining industry in your country?The mining industry accounts for 13 per cent of the GDP and 62.6 per cent of Chile’s total exports (US$49.3 billion). Chile is the largest producer of copper (31.9 per cent) in the world market and also produces other metals, such as silver and gold, and many non-metallic substances. The mining industry is mainly owned by private foreign and national companies ...
Governor Perry recently signed four bills into law designed to combat Medicaid fraud, waste, and abuse. The bills are a mixed bag of enhanced enforcement capabilities for the state and a few new protections for healthcare providers. Most notably, the legislature made several changes to the Texas Medicaid Fraud Prevention Act (TMFPA), bringing the statute more in line with the federal False Claims Act. Changes to the Medicaid Fraud Laws On the enforcement side, S.B ...
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) ...
On June 13, 2013, the West Virginia Supreme Court of Appeals (WVSCA) issued its decision in Faith United Methodist Church & Cemetery of Terra Alta, et al. v. Morgan, No. 12-0080, setting forth a clear definition of the term “surface” when used in deeds and other instruments of conveyance. This definition will weigh importantly on the state's shale gas industry ...
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 ...
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 ...
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 ...
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 ...
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 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”) ...
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 ...
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 ...
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 ...
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 ...
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) ...
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 ...
