The new abbreviated regulatory approval pathway for “biosimilar” and “interchangeable” types of biologic drug products was implemented in the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) as part of the Patient Protection and Affordable Care Act of 2010. The details about the use of this pathway were left for further development through Food & Drug Administration (“FDA”) action ...
On November 15, 2011, existing facilities subject to the federal Spill Pollution Control and Countermeasure Rule (“SPCC Rule”), 40 C.F.R. Part 112, were required to finalize and implement a plan—known as an “SPCC plan”—detailing the equipment, workforce, procedures and steps to be taken to prevent, control and provide adequate countermeasures to a discharge of oil to navigable waters of the United States or adjoining shorelines ...
2011 saw significant developments in the courts in relation to the issue of directors’ liability for the costs of remediation of waste sites, an issue which is particularly crucial where the company which disposed of the waste is not in a position to pay ...
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EPA recently made an announcement of interest to those in the oil field services sector as well as in the energy sector itself. On November 23, the agency announced that it was granting in part a petition by Earthjustice to initiate rulemaking under the Toxic Substances Control Act (TSCA), relating to chemical substances and mixtures used in oil and gas exploration or production ...
The Joint Select Committee on Marcellus Shale (the “Committee”) reported a 121 page bill governing horizontal wells that utilize 210,000 gallons of water or more per month or that involve surface disturbance of 3 acres or more. The final version of the bill was posted to the West Virginia Legislature’s website on November 18, 2011 (the “Bill”) ...
November 8, 2011- The Minister of Finance and Economic Development delivered his Budget Speech on the 4th of November 2011. The Budget aims at providing for innovative measures to support key economic sectors (such as ICT/BPO, Tourism, Financial Sector...) and new markets (renewable energies...). The Budget also provides for a National Resilience Plan to support the economy in a global economic downturn ...
President Obama recently sent to Congress proposed legislative language and analyses of his proposed deficit-reduction plan. Among the proposed legislative changes is a change to the formula used for calculating the cap on the amount that the federal government will reimburse federal contractors for executive compensation ...
The long anticipated America Invents Act (the “Act”) was signed into law today. However, given that certain provisions of the Act are now in effect while others do not come online until March 16, 2013, innovating companies and individuals should consider the impact and timing of those provisions on their overall patent strategy. Below is a link to some practice pointers and strategic tips you may want to consider when operating under the Act ...
The government has recently published a consultation document seeking views in relation to its proposals for business rate retention ("BRR") in England and options for enabling local authorities to carry out Tax Increment Financing ("TIF") within the business rates retention system. The business rates consultation may interest developers, the public sector and those involved in renewables or regeneration, particularly those considering Tax Increment Financed projects ...
The aim of the recent freedom of information (FOI) reforms was to encourage a pro-disclosure culture, and to provide additional assistance and guidance to both the applicant and agencies in processing FOI requests. However, since the commencement of those reforms, maintaining the balance between the philosophy and the practical operation of the FOI Act has presented challenges for agencies in meeting their statutory FOI obligations ...
Introduction A plant variety right (PVR) is an IP right which rewards breeders of new plant varieties for their efforts in creating those varieties. The current PVR law dates back to 1975 and is based on the 1961 International Convention for the Protection of New Varieties of Plants. The convention has since been amended several times, most recently and radically in 1991 ...
In order to comply with a court-ordered schedule, EPA Administrator Lisa Jackson on July 28 signed a 604-page package that proposes to subject additional oil and gas operations to regulation under the New Source Performance Standards (NSPS) and National Emission Standards for Hazardous Air Pollutants (NESHAPS) programs and to impose new and amended requirements under both programs. This proposed rulemaking has significant ramifications for the oil and gas industry ...
As you will be aware, 1 January 2012 is the go live date for OHS harmonisation. A new OHS Act, Regulation and Codes of Practice will commence in the Commonwealth and in each State and Territory at this time. The new package of OHS legislation will be based on model legislation, so will be substantially similar in each jurisdiction. For detailed information about the state of play in relation to OHS harmonisation, see our HR&IR Update of 22 June 2011 ...
Following the introduction of the Tertiary Education Quality and Standards Agency Bill 2011 (Bill) and the Tertiary Education Quality and Standards Agency (Consequential Amendments and Transitional Provisions) Bill 2011 (Transitional Bill) into the Commonwealth Parliament (as reported in our news alert of 23 March 2011), the Senate referred the Bill and the Transitional Bill to the Senate Education, Employment and Workplace Relations Legislation Committee (Commi
On June 20, 2011, Justice Ginsberg delivered the unanimous opinion of the U.S. Supreme Court in American Electric Power Company, Inc. v. Connecticut, holding that the Clean Air Act and EPA action under it displaced the federal common law nuisance claims against CO2 emitters that plaintiffs sought to pursue. Plaintiffs had sued four private power companies and the TVA, asking for a decree setting CO2 emission limitations at defendants’ power plants, with the limitations to be reduced annually ...
1. International anti-corruption conventions To which international anti-corruption conventions is your country a signatory? Chile is a signatory to and has ratified the Inter-American Convention against Corruption, the OECD Convention on Combating Bribery of Foreign Public Officials in International Business Transactions, and the United Nations Convention against Corruption. 2 ...
The new Immigration Bill was passed by the Indonesian Parliament on 7 April 2011. It will pass into law on the day it is signed by the President or within 30 days of its passage, whichever occurs earlier.The bill covers a range of basic matters relating to immigration, including entry to and exit from the Indonesian territory, travel documents, visas, stay permits, etc ...
Are donations of counterfeit goods to charities socially acceptable? - Despite calls for seized counterfeit goods to be donated to charity, a number of conditions should be met in order to protect both IP rights holders and those receiving the goods Nobody would dispute that in today’s world, the social and environmental impacts of our actions must be taken into consideration whenever we make a decision ...
On April 4, 2011, the U.S. Patent and Trademark Office (USPTO) issued a Final Rule implementing the prioritized examination track (“Track I”) of its new examination timing control procedures.1 Under Track I, patent applicants can accelerate examination of certain patent applications that are filed on or after May 4, 2011 ...
The USPTO has declared that the aftermath of the March 11, 2011 earthquake and tsunami in Japan constitutes an “extraordinary situation” under 37 C.F.R. §§ 1.183 and 2.146 that justifies certain measures of relief from patent regulations. While the PTO cannot declare this extraordinary situation a “postal emergency” to grant stronger relief, it has elected to recognize the difficulties of its innovation customers in the affected areas of Japan ...
On February 23, 2011, IOGA hosted a comprehensive day-long informational and training seminar on the United States Environmental Protection Agency’s (“USEPA”) mandatory greenhouse gas (“GHG”) reporting rule for the oil and gas industry, Subpart W of 40 C.F.R ...
It's that time of year when municipalities send out tax accounts to their citizens. In certain cases, they may contain a very unpleasant surprise. For citizens living in municipalities whose property assessments are for the years 2010 to 2012, now is the time to do some double-checking ...
