The U.S. Court of Appeals for the Federal Circuit, which hears all U.S. patent infringement appeals, issued an order on April 26, 2010 requesting briefs from the parties in Therasense, Inc. v. Becton, Dickinson, and Co. (appeal no. 2008-1511) to consider en banc the standards by which courts should find “inequitable conduct ...
The United States Patent and Trademark Office (“USPTO”) is seeking public comment on a proposed three-track patent examination initiative that would provide applicants with greater control over the speed at which their applications are examined. The proposed initiative aims to reduce overall pendency of patent applications by providing applicants with alternative timing systems for the examination of their patent applications ...
Most patent applicants can now accelerate the examination of a select number of patent applications in exchange for abandoning an equal number of unexamined, pending applications, according to an announcement issued by the U.S. Patent and Trademark Office (“PTO”) on June 24, 2010 ...
The U.S. Department of Health and Human Services, the U.S. Department of Labor and the U.S. Department of Treasury have released another set of interim final regulations (the “IFR”) regarding the coverage of preventive care without cost sharing. As with all guidance, the IFR cannot be considered in isolation ...
Spotlight on Corporate Governance One of the impacts of the global financial crisis on the United Arab Emirates (UAE) has been an increased spotlight on corporate governance standards in the UAE. The Ministry of Economy published Ministerial Resolution No. 518 of 2009 (MR 518) which provides for enhanced corporate governance rules and discipline standards for UAE Public Joint Stock Companies (PJSC) ...
The hospital has lost lengthy legal proceedings about the uninsured patients from the governments of the Netherlands Antilles and Curaçao. The governments are not obligated to write a “blank check”, as it were, for the costs Sehos had to incur for uninsured persons that cannot be recovered, according to judge Van Schendel yesterday ...
Hunton & Williams announced today the launch of its new website — the Hunton & Williams Health Care Reform Center, huntonhealthcarereform.com ...
Recent Federal Circuit Decision on Section viii Carve Outs and Inducement By C. Kyle Musgrove, Partner On November 1, 2010, a divided 2-1 panel of the Federal Circuit issued a decision in AstraZeneca LP v. Apotex, Inc. that addresses inducement of infringement in the context of a Section viii "carve out" under 21 U.S.C. § 355(j)(2)(A)(viii) and 21 C.F.R. § 314.92(a)(1) ...
On April 28, 2005, the Chambre des notaires du Québec filed a petition to declare unconstitutional and of no force and effect requirements issued by the Canada Revenue Agency (CRA) under sections 231.2 and 231.7 as well as subsection 5 of section 232(1) of the Income Tax Act, R.S.C. 1985, c. 1 (5th Supp.) (ITA) to obtain documents or information prima facie protected by professional secrecy ...
KSB partner Martin Šolc, who specializes in advisory on transactions in the field of mergers and acquisitions, has also been performing professional activities for a long time with the International Bar Association (IBA), a leading organization of international legal practitioners, bar associations and law societies, bringing together more than forty thousand attorneys and one hundred and ninety-seven chambers of attorneys on all continents ...
After decades of debate, US healthcare reform became a reality in 2010 when President Obama signed the Patient Protection and Affordable Care Act (ACA) in March. Yet public opinion remains sharply divided on the merits of this sweeping legislation, both in terms of its ability to address the problems of access to, and the rising cost of, healthcare services and in terms of the financial burden on the federal and state governments of implementing ACA ...
In Sweden, the directive has been implemented through amendments to the Medical Devices Act (1993:584), and through the regulation which the Medical Products Agency has issued in connection with this Act and the directive. The revised directive contains some clarifications but also some news ...
As part of the Medicare hospital outpatient prospective payment system and ambulatory surgery center payment system final rule for calendar year 2011 (the “Final Rule”), the Centers for Medicare and Medicaid Services (CMS) recently issued final regulations that implement the changes that were made to the whole hospital exception by the Patient Protection and Affordable Care Act and the Health Care Education and Reconciliation Act of 2010 (collectively, the “Acts
On January 18, 2011, the West Virginia Supreme Court of Appeal decided State ex rel. West Virginia Citizens Action Group, et al. v. Earl Ray Tomblin, et al., Docket No. 101494. In this case, the Citizens Action Group and others were seeking an order from the court to compel Earl Ray Tomblin, et al ...
HARMONIZATION OF CLINICAL RESEARCH CONTRACTS IN QUEBEC OLGA FARMAN and MARIE-ÈVE CLAVET [email protected] [email protected] Over the past few decades, a high-quality system of research and innovation has been built in the Province of Quebec. The contractual research conducted by university-affiliated health-care institutions in Quebec has become a fundamental scientific, economic and social activity ...
A ‘Battle of the Forms’ commonly arises where each of the parties, in the course of the negotiation process, forwards to the other its own standard form of contract, with the aim of getting the other party to adopt such terms and conditions. The question as to which set of terms and conditions constitute the contract often depends on the ‘last shot’ – that is, which form of contract was the one last ‘fired’ to the counter-party ...
In a recent decision of the court of appeal, the Honourable Pierre J. Dalphone confirmed that a secured creditor may ust its debt to acquire the assets which are charged with its security interests in the context of a sale process monitored by the court under the companies creditors arrangement act (CCAA) background. White Birch Paper Inc. and several of its subsidiaries (collectively, the “White Birch Group”February 24, 2010)obtained an initial order under the CCAA ...
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 ...
The Office for Civil Rights (OCR) of the U.S. Department of Health and Human Services has recently announced two significant enforcement actions against health care providers for violating the HIPAA Privacy Rule. In the first matter, Cignet Health Care of Prince George’s County, MD was fined $4.3 million for failure to provide patients with access to their health records and for failing to cooperate with the ensuing OCR investigation ...
How is health care in your jurisdiction organised? The basic principles of the organisation of the health-care system are governed by Act CLIV of 1997 (the Health-care System Act), more specifically by sections 141 et seq. Pursuant to section 141, the state is ultimately responsible for the state of health of the population, and for the creation of a system that protects, promotes and – if necessary – restores it ...
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 ...
Accountable Care Organizations (ACOs) will face large start-up costs under proposed rules issued on March 31, 2011 by the Centers for Medicare and Medicaid Services (CMS), with an uncertain outlook for savings and even possible losses. An ACO is an organization of health care providers that agrees to be accountable for cost, quality and the overall care of Medicare beneficiaries who are assigned to it ...
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 ...
As we stated in our bulletin last week, on March 31st, the federal government outlined proposed actions relating to Accountable Care Organizations (ACOs), a key component of the healthcare reform legislation (the Affordable Care Act, or ACA) enacted in March 2010. In this bulletin, we provide some additional information regarding each of the March 31st releases ...
On April 18, 2011, the Centers for Medicare and Medicaid Services (CMS) began the attestation phase under its $27 billion Medicare EHR Incentive Program. Incentive payments for the meaningful use of electronic health records (EHR) will begin in May 2011 and will continue over the next several years. Eligible professionals (i.e ...
