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 ...
In a January 13, 2013 blog post, the Federal Trade Commission’s Bureau of Consumer Protection’s Business Center Blog highlighted the FTC’s recent groundbreaking settlement for violations of the Fair Credit Reporting Act (“FCRA”) in the mobile app context ...
With a law enacted on 17 December 2012, the Finnish parliament moved forward on the longstanding plan to house intellectual property rights disputes in the Market Court. This legislative reform has a significant impact for all companies operating in Finland. The Market Court will start to hear these disputes in the autumn of 2013 ...
As we embark upon the season of goodwill, those wishing to embrace the Christmas cheer may wish to consider settlement of an ongoing commercial dispute bringing peace and goodwill to all - besides saving their business time and money in the process.Should you settle? Parties settle disputes for a variety of reasons ...
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 ...
A Polish company enters into a contract with a German company. Which country’s law will govern the contract? Monika Hartung: To start with, under Art. 3 of the Rome I Regulation (Regulation 593/2008 of 17 June 2008 on the law applicable to contractual obligations), the parties themselves may select the law governing the contract. The previous version of Poland’s Private International Law required the existence of a link, e.g ...
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 ...
FAQ on the Belgian Pre-Contractual Information in the Framework of Commercial Co-operation Agreements Act of 19 December 2005.Belgium has a specific legal regime protecting the economically weaker party in certain commercial partnership agreements (i.e. the Pre-Contractual Information in the Framework of Commercial Co-operation Agreements Act of 19 December 2005 – “the Act”) ...
The General Medical Council has issued definitive guidance on doctors' duties when they fear a child in their care is suffering from abuse. The GMC's 2012 Guidance on Child Protection came into effect on 3 September 2012 after a two-year working group - chaired by a senior family court Judge, the Right Honourable Lord Justice Thorpe - listened to evidence given by child protection experts ...
On 15 October 2012, the Federal Government announced the appointment of an expert panel to review pharmaceutical patents in Australia (Review). The Review will focus particularly on the extension of term provisions in Chapter 6, Part 3 of the Patents Act 1990 (Cth). Those provisions currently allow the extension of pharmaceutical patents up to five years beyond their standard 20-year term ...
On Aug. 31, 2012, the United States Court of Appeals for the Second Circuit issued its decision in In re Charter Communications Inc., (2d Cir. Aug. 31, 2012), expressly adopting an abuse of discretion standard for reviewing equitable mootness determinations ...
Over the course of 2012, on at least three occasions the Federal Circuit has found anticipation in a situation in which previously the invention would have merely been viewed as obvious:(1) where the prior art merely proposes the steps of the method, without knowledge of whether those method steps will achieve any result, much less the result claimed in the therapeutic method; (2) where the prior art discloses a broader range without providing a “pattern of preference” for a later-claimed narrow
Currently a large part of politicians, economists and lawyers are working hard to ensure that a recent Lithuania’s bank bankruptcy story would not repeat itself. Sometimes people still associate the term “bank” with instability, possibility to lose something or lack of transparent governing. Maybe this is the reason why there are no biobanks in Lithuanian which are widespread in the EU and other countries of the world ...
On September 17, 2012, the Department of Health and Human Services (“HHS”) announced a $1.5 million settlement with the Massachusetts Eye and Ear Infirmary and Massachusetts Eye and Ear Associates Inc. (“MEEI”) for potential violations of the HIPAA Security Rule ...
While arbitration offers an excellent means for parties to get their disputes settled faster than in traditional courts, how you draft the arbitration clause in a document is critically important for a positive outcome – should a dispute arise. Legal agreements often have a clause indicating that parties agree to settle any disputes arising from the arrangement in arbitration ...
In Sir Arthur Conan Doyle’s short story Silver Blaze, Sherlock Holmes noticed that the guard dog for a famous racehorse did not bark on the night that the horse disappeared and its trainer was found murdered on the moor. 1. Holmes correctly deduced from this that the dog must have known the killer. 2 Inspector Gregory of Scotland Yard overlooked the same clue when he earlier accused a stranger of the murder ...
On January 24, 2011 the Attorney General of the Federal Republic of Brazil signed a document restricting the powers of ANVISA (Brazil’s regulatorybody) in the examination of pharmaceutical applications, giving the rights to the Brazilian PTO to do so without any interference of ANVISA. The dispute between ANVISA and the Brazilian PTO in the examination of pharmaceutical applications had apparently been solved ...
On 20 June 2012, the Court of First Instance (in proceedings brought by the Securities and Futures Commission ("SFC")) ordered Hontex International Holdings Company Ltd ("Hontex") to make a repurchase offer to about 7,700 investors who had subscribed for Hontex shares in the initial public offering in December 2009 or purchased them in the secondary market during the 3 months after its shares were listed (by then the present action was taken by the SFC) ...
New amendments to the Regulation on Health Conformity of Dietetic Products have entered into force on 28 May 2012. Here are some of the most significant changes that are prescribed by these amendments to the Regulation. As a reminder, this is a regulation that introduced the obligation of the registration of dietetic products (including supplements) in July 2010, and is a regulation that regulates the issues of labelling and the composition of these products in details ...
The provision of gifts and hospitality to public officials has recently been the subject of a number of news stories in the Serbian media, covering not only the official reports on the variety of protocol gifts received by the high ranking officials from the leaders of other countries, but also the alleged corruption affairs involving the potential bribing of various lower-level officials by companies and individuals seeking an unfair advantage in the market ...
Three recent decisions bolster a generic manufacturer’s ability to challenge Orange Book listings and obtain ANDA approval through section viii “carve-outs.” In Caraco v. Novo Nordisk1 the U.S. Supreme Court unanimously held Caraco could use the Hatch-Waxman’s counterclaim provision to correct Novo’s overbroad use code. In AstraZeneca v. Apotex, the U.S ...
In Greek mythology, Prometheus stole fire from Zeus to give to mankind. It seems that Zeus is now reclaiming some of that fire in the guise of Mayo Collaborative Servs. v. Prometheus Labs., Inc., No. 10-1150 (U.S. Mar. 20, 2012), the Supreme Court’s latest decision addressing patent-eligible subject matter. But a practical analysis of Prometheus reveals strategies one can use in drafting patent claims to keep those claims burning ...
