This year marks the 30th anniversary of the passage of the Hatch-Waxman Amendments to the Federal Food, Drug and Cosmetic Act (FD&C Act). Considered to be one of the most successful pieces of legislation ever enacted, the Hatch-Waxman Amendments created the modern generic drug industry, which is responsible for dramatically increasing the availabilty of low-cost generic drugs and saving the U.S. healthcare system billions of dollars ...
The numbers have been crunched and we have a winner! The United States District Court for the Eastern District of Virginia — known nationally as the “Rocket Docket” — had the fastest trial docket in the country in 2013. Once again. For the sixth year in a row. The median time interval to trial for the 12-month time period ending March 31, 2013, (the most recently released data) is 11.1 months. That’s 11 ...
A recent decision by the Florida Supreme Court is raising eyebrows among businesses and practitioners because it regards what constitutes a valid agreement to arbitrate, specifically, whether an arbitration clause written in English can be enforced against parties who do not speak the language. Given Florida’s diverse population, the opinion causes concern as some interpreted it to go against long-standing law that binds a signatory to a contract even if they did not fully understand it ...
An application to register the word mark BIMBO DOUGHNUTS as a Community Trade Mark (CTM) has been successfully opposed in the European courts. The ECJ upheld the General Court’s earlier decision that there is a likelihood of confusion between the word mark BIMBO DOUGHNUTS and a registered Spanish word mark, DOGHNUTS. (Bimbo SA v OHIM, Case C-591/12 P) ...
LabMD, Inc. renewed its argument that the FTC lacks authority to regulate the data security practices of HIPAA covered entities by appealing the dismissal of its case for lack of jurisdiction (see our coverage here) to the Eleventh Circuit. LabMD also filed an emergency motion seeking expedited briefing and requesting an order enjoining the administrative proceedings until the appellate court rules on the merits of its argument ...
The healthcare industry will have to wait for a court to answer the question of whether the United States Federal Trade Commission (the “FTC”) has authority to regulate data security practices of entities covered by the Health Insurance Portability and Accountability Act (“HIPAA”). On Monday, a federal district judge dismissed LabMD, Inc.’s case without reaching the merits, declining to disrupt the underlying administrative proceeding ...
Regional governments in Sweden are increasingly looking to leverage their purchasing power in order to secure discounts and rebates on the list prices of branded drugs. However, as noted by Elizabeth Eklund, Partner at leading commercial law firm Delphi, such agreements risk running foul of both Swedish and European Union (EU) law ...
The U.S. Supreme Court again unanimously reversed the U.S. Court of Appeals for the D.C. Circuit, this time in two cases relating to attorney fees for patent infringement: Octane Fitness v. Icon Health & Fitness, No. 12-1184, and Highmark v. Allcare Health Mgmt. Sys., No. 12-1163. The Federal Circuit is now 0-3 in cases before the court so far this term, and it has persuaded a grand total of zero justices to support affirmance in any of those cases. See Medtronic v ...
Negotiations are part of our daily lives from an early age. From haggling with teachers over homework to agreeing terms for a new job – we all negotiate regularly throughout our lives. So why then can it be difficult to get some parties to start negotiating when it matters? Parties are unlikely to negotiate if they believe that they can force a better result at a lower cost ...
Judges sitting in the Inner House of Scotland’s supreme civil court, the Court of Session, will no longer wear wigs and judicial robes when hearing civil appeals. Where this is the case the court will not insist that counsel should appear with wig and gown or that solicitors with rights of audience should appear with gowns. Where the court intends to wear wigs and judicial robes, for example at ceremonial sittings, practitioners will be informed accordingly ...
On April 1, 2014, the Superior Court issued an interesting decision respecting consent to care1. The Quebec City CHU petitioned the Superior Court in order to be authorized to provide care for a 60‑day period to a patient despite the refusal of her parents. On March 14, the 22 years old patient suffered cardiac arrest following an intravenous drug overdose ...
The High Court, County Court and the Magistrates Court have jurisdiction to hear civil matters in England and Wales, with the High Court dealing with the most complex and high value disputes. The County Court hears lower value debt, personal injury and contract claims as well as some technology, construction and patent cases. Until 22 April a claimant could choose to bring their claim in the High Court providing the figure claimed for was over £25,000 ...
Clients unfamiliar with patent prosecution are often surprised to learn that few patent applications receive a first-action allowance, or FAA. There are even rankings of law firms that receive the most FAAs each year. But what does an FAA signify? Is it a cause to celebrate, or to conduct a post-mortem? The answer is, of course, “it depends ...
In 16 January 2014, the Constitutional Court (“MK”) granted the request for a judicial review of Article 335 of the Criminal Code (“KUHP”) and removed the phrase, “offensive act” from Article 335 of the KUHP. The reason for removing the phrase, “offensive act” is that it allows investigators and public prosecutors to act arbitrarily against certain people ...
On 6 April 2014, the historic remedy of distress ceased to exist. The tool that landlords have used for centuries has been replaced by the Commercial Rent Arrears Recovery (‘CRAR’) regime.Tenants have welcomed this development as CRAR prevents bailiffs from simply turning up unannounced at the tenant’s address in order to seize goods. Landlords on the other hand are now faced with a more complex process and the loss of the element of surprise ...
If all’s fair in love and war, and business is war, it must follow that all is fair in business. We should therefore not concern ourselves with fairness in our business dealings, but focus on maximising our personal gain, irrespective of the impact of our decisions on others. Adopting the above approach is not only likely to harm you but also your business. People are social beings and have evolved to reward cooperation and punish avarice. Take two individuals - Mr Smith and Mr Jones ...
A decision of the Court of Justice of the European Union (CJEU) in 2011 appeared to limit the options for large television companies seeking to prevent unlicensed viewing. It was held in that case, involving the Football Association Premier League Ltd, that the use of foreign decoders to broadcast Sky television in public places could not be prevented because of EU competition rules ...
Westshield Limited v David and Lisa Whitehouse [2013] 3576 EWHC (TCC); Akenhead J, 18 November 2013Executive SummaryIn this decision the TCC considered the impact of a CVA ("Company Voluntary Arrangement") on an adjudication decision and confirmed that challenges to the enforcement of adjudicators' decisions are not necessarily limited to jurisdictional or breach of natural justice arguments ...
As you no doubt already know, the Pharmaceutical Industry in Argentina is a strictly controlled industry. Said control is held by the ANMAT Administración Nacional de Medicamentos, Alimentos y Tecnología Médica) and it spreads from the first authorisation of a laboratory to act as such in the country, moving through the authorisations to commercialise products, up to pharmacovigilance of products that have already been commercialised ...
In one of the few decisions of its kind, the UK High Court recently assessed the damages to be paid to a generic pharmaceutical company under a cross-undertaking in damages. While some aspects of the decision are specific to the UK pharmaceutical reimbursement scheme, the judgment will be a useful reference point for parties involved in similar litigation in Australia ...
On February 21, 2014, the Federal Circuit’s 6-4 majority en banc ruling in Lighting Ballast Control vs. Philips Electronic North America retained the standard of de novo appellate review of district court claim construction rulings, whereby the scope of the patent grant is reviewed as a matter of law ...
There are many famous cases where trademarks and passing off come into contact with unofficial merchandising and the right holder has been unsuccessful. They range from the fictional character Tarzan, to the rock band Linkin Park, to Diana Princess of Wales. There is no such thing as a matter of UK law as a free standing general right by a famous person (or anyone else) to control the reproduction of their image ...
On March 5, 2014, the US Supreme Court rendered a 7-2 decision reinstating a $185 million arbitration award in favor of the BG Group against Argentina under the UK-Argentina bilateral investment treaty (BIT). The Supreme Court held that the Court of Appeals for the DC Circuit erred in deciding de novo, and without deference to the tribunal’s award, the issue of the arbitrators’ jurisdiction ...
