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 March 28, 2013, the Environmental Protection Agency (EPA) issued the final National Pollutant Discharge Elimination System (NPDES) Vessel General Permit (VGP). The 2013 VGP, issued under the Clean Water Act (CWA), replaces the 2008 VGP and regulates discharges incidental to the normal operation of commercial vessels greater than or equal to 79 feet in length.1 The 2013 VGP will be effective on December 19, 2013, when the current 2008 VGP expires ...
Just as it seemed that the South African Government’s appetitefor introducing the carbon tax was waning we were informed by the Minister of Finance that the long awaited carbon tax policy paper will be released by the end of March 2013. The carbon tax policy paper is expected to be an update of the carbon tax discussion paper that was published for comment in December 2010 ...
A March 7, 2013 piece on Morning Edition, the morning news program from National Public Radio, raised a lot of questions. “In A Grain Of Golden Rice, A World Of Controversy Over GMO Foods” told the story of golden rice, a beautiful yellow rice enhanced with beta-carotene, or Vitamin A. This rice was ostensibly developed to be grown in developing countries, where foods high in Vitamin A either are uncommon or are expensive ...
An interview with Weronika Pelc, the partner in charge of the Energy Law Practice at Wardynski & Partners, and Michal Barlowski, the partner in charge of the Bankruptcy and Restructuring practices at Wardynski & Partners, about shale gas projects in Poland. You recently visited Houston at the invitation of the law firm of Haynes and Boone for a seminar on shale gas mining in Poland ...
A federal court jury in Illinois found that nursing home operator Momence Meadows fraudulently billed Medicare and Medicaid for “worthless services” and falsely certified compliance with health care laws and regulations, resulting in $28 million in damages to the government. United States ex rel. Absher v. Momence Meadows Nursing Ctr., Inc., No. 2:04-cv-02289 (C.D. Ill. Feb. 8, 2013) ...
On February 5, 2013, the United States District Court for the Middle District of Pennsylvania granted Tennessee Gas Pipeline Co. LLC’s (“TGPC”) motion for an emergency preliminary injunction preventing Pennsylvania’s Environmental Hearing Board (“EHB”) from reviewing permits issued by Pennsylvania’s Department of Environmental Protection (“DEP”) to TGPC associated with its Northeast Upgrade Project (“Project”) ...
It took thirteen years, four months, and five days of heated debates and passionate protests before the country’s first reproductive health law was passed. Four days shy of Christmas last year, President Aquino finally signed the 24-page bill into law. It is now Republic Act No. 10354 or The Responsible Parenthood and Reproductive Health Act of 2012 (RH Law). The passing of the RH Law, however, does by no means close this chapter of Philippine history ...
One of the provisions of the West Virginia Horizontal Well Control Act passed in December 2011 increased the permit fees for horizontal wells from $400 to $10,000. At the time this legislation was under consideration, West Virginia Department of Environmental Protection Secretary Randy Huffman told the legislature that the increased permit fee would allow him to nearly double the Inspection and Enforcement staff within the Office of Oil and Gas, which at that time numbered 17 ...
The new Waste Act of 14 December 2012 went into force on 23 January 2013. It introduces major changes in the waste management system in Poland. The prior Waste Act of 27 April 2001 will continue to apply in certain areas, however. The new Waste Act was enacted primarily in order to implement the Waste Framework Directive (2008/98/EC) into Polish law. The deadline for transposing the directive was 12 December 2010 ...
On January 16, 2013, the Environmental Protection Agency (EPA) submitted the final 2013 Vessel General Permit (VGP) to the White House Office of Management and Budget (OMB) for review. The 2013 VGP, which will be issued under the Clean Water Act (CWA), will replace the 2008 VGP and will regulate discharges incidental to the normal operation of commercial vessels greater than or equal to 79 feet in length. See 76 Fed. Reg. 76,716 (Dec. 8, 2011) ...
Sixteen years since the enactment of Law No. 7 of 1996 regarding Food (“the 1996 Food Law”), the Government issued the new Food Law (ie Law No. 18 of 2012) (“Food Law”) on 18 October 2012, two days after World Food Day. The Food Law replaces The 1996 Food Law. The Food Law covers three significant areas which were not governed by the 1996 Food Law, ie imports of food; the halal requirement; and the establishment of a new non-ministerial agency in-charge of food matters ...
Under the Patient Protection and Affordable Care Act (“PPACA”), an employer that employs an average of at least 50 full-time and full-time equivalent employees (a “Large Employer”) during 2013 may be subject to a penalty in 2014 if the Large Employer fails to offer “minimum essential coverage” to all but 5 percent (or, if greater, five) of its full-time employees (“No Coverage Penalty”) ...
Total Maximum Daily Loads, or TMDLs, serve a profoundly important function under the federal Clean Water Act. They provide regulators with a systematic and comprehensive mechanism for identifying all sources and causes of water quality impairment, and then calculating the reductions needed to address the impairment in an equitable manner. But for TMDLs to be effective, they must be derived in a legally and technically defensible manner ...
The wait is over. On January 17, 2013, the Department of Health and Human Services’ ("HHS’") Office for Civil Rights ("OCR") released its long-anticipated megarule ("Omnibus Rule") amending the HIPAA Privacy, Security, Breach Notification and Enforcement Rules. These amendments implement and expand on the requirements of the Health Information Technology for Economic and Clinical Health ("HITECH") Act and the Genetic Information Nondiscrimination Act of 2008 ...
The long awaited Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security Regulation amendments (the “Changes”) to incorporate the changes made by Health Information Technologyfor Economic and Clinical Health (HITECH) in 2009 as part of the American Recovery and Reinvestment Act and by the Genetic Information Nondiscrimination Act (“GINA”) were recently released ...
On December 5, 2012, EPA issued revised enforcement guidance to assist agency personnel in exercising enforcement discretion regarding the treatment of tenants under Superfund’s bona fide prospective purchaser (BFPP) defense. (See here.) The revised guidance supersedes guidance the agency had issued on January 14, 2009 and expands some of the protections ...
If you have ever had a project on land on which wetlands or other “waters of the U.S.” were present, you know that project was more expensive because of the costs of permitting and mitigation for wetland losses, or the presence of wetlands may have resulted in abandonment or significant revision of the project to minimize losses of wetlands or other waters of the U.S. In their prior two “waters of the U.S.” decisions, Solid Waste Agency of Northern Cook Cty. v. Army Corps of Engineers, 531 U ...
Grid Code amended In December of last year, the Serbian Transmission System Operator amended the Grid Code. These amendments did not substantially change the code, but did introduce changes in: - technical conditions for connecting to the grid, including specific conditions for connecting generating units, and - access to the grid. The amendments are published in the Official Gazette of the Republic of Serbia no. 02/12 ...
On Oct. 22, 2012, the U.S. Court of Appeals for the Ninth Circuit ruled that the Bureau of Land Management and the U.S. Fish and Wildlife Service (FWS) violated the Endangered Species Act (ESA) by granting a right of way for the Ruby Pipeline project. Center for Biological Diversity v. Bureau of Land Management, No. 10-72356 (9th Cir. Oct. 22, 2012) ...
The U.S. District Court for the Eastern District of Virginia recently overturned the United States Patent & Trademark Office ("USPTO") interpretation of the patent term adjustment ("PTA") statute in Exelixis, Inc. v. Kappos. Similar to Wyeth v. Kappos, where a previous USPTO interpretation of the PTA statute was overturned, the Exelixis decision promises to add months and even years to the patent term of many patents ...
Narrow Construction of Food & Drug Act Undermines FDA Regulation, Class Actions A divided panel of the Second Circuit Court of Appeals in New York overturned on First Amendment grounds the conviction of a pharmaceutical sales representative for conspiracy to introduce a misbranded drug into interstate commerce, an offense more commonly referred to as off-label marketing. The decision, United States v. Caronia, No. 09-5006-cr (2d Cir. Dec ...
On October 15, 2012, Spilman Thomas & Battle, PLLC filed suit in the D.C. Circuit Court of Appeals on behalf of the Independent Petroleum Association of America (“IPAA”) and six other state-level oil and gas associations (PA, WV, OH, KY, IL, IN), (referred to herein as “the Associations”) challenging the U. S. Environmental Protection Agency’s (“EPA”) New Source Performance Standards (“NSPS”) promulgated for the oil and natural gas industry on August 16, 2012 ...
On November 26, 2012, the Department of Health and Human Services’ Office of Civil Rights (“OCR”) published guidance on the two methods for de-identifying protected health information (“PHI”) in accordance with the HIPAA Privacy Rule ...
The rapid growth of the hospice industry has attracted the attention of Congress and federal and state healthcare regulatory and enforcement agencies. The Patient Protection and Affordable Care Act (the “ACA”), signed into law by President Obama on March 23, 2010, included several provisions aimed at hospice providers ...
