Once their compound patents have expired many blockbuster drugs remain protected by secondary 'method of treatment' patents. The validity and enforceability of these secondary patents can be less certain in many jurisdictions. In Sanofi-Aventis Australia Pty Ltd v Apotex Pty Ltd (No ...
The Florida Agency for Health Care Administration (“AHCA”) earlier this month fined Humana $3.4 million for failing to promptly report suspected cases of Medicaid fraud and abuse by others, as required by statute and Humana’s Medicaid HMO contract. Though many states have similar laws or regulations, this appears to be the first enforcement action of its kind in the nation ...
International trade sanctions are becoming an increasingly high profile issue for both practitioners and clients in Australia. Major reforms to Australia's sanctions system will have implications for global companies with any Australian connections ...
The Internal Revenue Service has proposed guidelines detailing how tax-exempt hospitals can conduct a Community Health Needs Assessment (CHNA), as required in the 2010 Patient Protection and Affordable Care Act (PPACA). Although this new requirement is not effective until taxable years commencing after March 23, 2012, the IRS issued its guidance now because hospitals may choose to start the process of conducting CHNAs and implement strategies in advance of the effective date ...
On June 22, 2011, the Securities and Exchange Commission (the “SEC”) adopted final rules and amendments under the Investment Advisers Act of 1940, as amended (the “Advisers Act”), designed to implement various provisions of the Dodd-Frank Wall Street Reform and Consumer Protection Act (the “Dodd-Frank Act”) ...
Texas health care providers, health insurers and health clearinghouses face new mandates and increased penalties over the use of electronic health records (EHR) as a result of HB300, which was passed in the 2011 Texas legislative session and signed into law by Governor Rick Perry. The Texas legislation expands privacy rights of patients beyond that contained in federal HIPAA legislation ...
On July 1, the Texas Supreme Court handed down an opinion that has the potential to impact any case where medical or health expenses are at issue. In the wake of the Court’s ruling, a plaintiff may not recover medical expenses for amounts that the plaintiff’s health providers bill but have no right to be paid. In addition, the Court held that such bills are inadmissible - including to show pain and suffering. Case Background and Issues Presented Haygood v ...
During the 2011 legislative session that just ended, Texas Governor Rick Perry signed into law a bill that allows rural hospitals to employ physicians, known as the “corporate practice of medicine,” despite the state’s long-standing ban on such practices. This legislation, along with similar recent legislation, signals that Texas might eventually do away with its ban on corporate employment of physicians altogether ...
Asters Law Associates Oles Kvyat and Oleksandr Mozheiko talk today about the terms and procedures of the Initial Public Offering on the Ukrainian Stock Exchange The Ukrainian market grows in line with global markets. When global markets decline, the Ukrainian equity market suffers correction as well. The recent financial turmoil experienced by the world in 2009 - 2010 adversely affected the Ukrainian equity market ...
The Ministerial Decree of the Italian Minister for the Economic Development dated May 11, 2011 (the “Decree”) has at long last implemented in Italy the administrative procedure for opposition against Italian and International trademark applications ...
Chinese authorities may soon make another significant step in China’s shift from being the global manufacturing hub to becoming the world’s biggest consumers market. During a press conference held in Beijing last 15 June, Yao Jian, the spokesperson of China’s Ministry of Commerce (MOFCOM) announced the upcoming reduction of import duties on luxury goods ...
On June 16, 2011, the Supreme Court issued an opinion in Smith v. Bayer allowing a plaintiff to pursue class certification in a state court action after a federal court had denied certification in a substantially similar case. The Court held that it was improper for the federal court to enjoin the state proceeding under the “relitigation exception” of the Anti-Injunction Act because the issues were not identical and the state court plaintiff was not a party to the federal lawsuit ...
A bipartisan U.S. Senate committee has asked both the Centers for Medicare & Medicaid Services (CMS) and the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services to study the proliferation of physician owned distributorships (PODs), citing a lack of regulatory guidance on how these arrangements square with existing federal law ...
On May 25, 2011, the en banc Federal Circuit announced its decision in Therasense, Inc. v. Becton, Dickinson & Company regarding the appropriate standards for succeeding with an inequitable conduct defense ...
The Office for Civil Rights (OCR) of the Department of Health and Human Services today proposed an expansion of the rights of individuals to obtain reports from health providers and insurers about how their protected health information (PHI) is used.1 The draft regulations will require health providers and insurers (called “Covered Entities”) to provide more data faster and in a variety of formats as requested by individuals ...
Abstract:Following the provisions of the TRIPS agreement, the Brazilian Industrial Property Law affords special protection to famous (highly renowned) trademarks in all fields of activity ...
The Brazilian industry appears to be fully recovered from the world crisis of 2008, at least as regards Intellectual Property aspects. According to a recent official announcement made by the Brazilian Trademark Office, the number of trademark filings in Brazil raised considerably in 2010, from an estimate 111.724 applications in 2009 to a total of 129.620, which corresponds to a 16% growth ...
It seems to have avoided the worst effects of the 2009 financial crisis that shook much of the developed world, as domestic demand, government stimulus and rising commodity prices helped pull the economy out of recession faster than most countries. Indeed, the good economic momentum that catapulted Brazil forward over the past 10 years has helped 30% of the population to rise out of poverty and become consumers of products and services ...
The Centers for Medicare and Medicaid Services (CMS) announced the creation of so-called “Pioneer ACOs” on May 17 in an attempt to blunt heavy criticism over the draft regulations on Accountable Care Organizations (ACOs) issued on March 31, 2011 (the “Draft Regulations”).1 The Draft Regulations have been criticized due to their burdensome data collection requirements, large start-up costs, uncertain savings, possible losses and troublesome governance mandates ...
Southwest Health Alliance (“Southwest”), an independent practice association with approximately 900 member-physicians, has agreed to a proposed order recently entered by the Federal Trade Commission (“FTC”) settling charges that it engaged in anticompetitive conduct in its dealings with insurers and other payors for the provision of physician services (collectively, “insurers” or “payors”) ...
A former GlaxoSmithKline attorney, Lauren Stevens, was acquitted on May 10 of all criminal charges stemming from her response to an FDA investigation. The acquittal, ordered by U.S. District Judge Roger W. Titus, is a stunning defeat for the government’s anti-fraud enforcement measures. The judge also severely rebuked the government’s efforts in the matter, stating the case should never have been prosecuted. Had she been convicted, Stevens would have faced a prison term of up to 60 years ...
Early last year, the State Administration for Industry and Commerce (“SAIC”) and the Ministry of Public Security of the People’s Republic of China (“PRC”) jointly issued a Circular on Further Strengthening Administration of the Registration of Resident Representative Offices (“RO”) of Foreign Enterprises (“Circular”) ...
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 ...
In a letter dated April 8, 2011, to the President of the North American Securities Administrators Association (“NASAA”),1 Robert Plaze, Associate Director of the Division of Investment Management of the Securities and Exchange Commission (the “SEC”), stated that the SEC is expecting to adopt final rules implementing various provisions of the Dodd-Frank Wall Street Reform and Consumer Protection Act (the “Dodd-Frank Act”) applicable to investment advisers by July 21, 2011 ...
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 ...
