BackgroundFollowing much anticipation on the part of health care industry members, CMS released its long-awaited final rule on the Physician Payment Sunshine Act in February 2013, supplying clarification and guidance on new financial disclosure requirements governing pharmaceutical and medical device manufacturers. The rule includes extensive and potentially time-consuming mandates for drug and device companies, including reporting of annual payments to physicians and teaching hospitals ...
The insolvency of one or other of the parties to a dispute has become commonplace in recent times, particularly in construction related disputes. Practitioners are becoming increasingly knowledgeable about the implications of insolvency on procedure and the potential remedies available ...
In Novozymes A/S v. DuPont Nutrition Biosciences APS, 2012-1433 (Fed. Cir. July 22, 2013), the Federal Circuit affirmed the district court’s grant of DuPont’s post-trial motion for judgment as a matter of law holding that Novozymes’ U.S. Patent No. 7,713,723 (“the ’723 patent”), directed to a variant of alpha-amylase, was invalid under 35 U.S.C. § 112, first paragraph, for failing to satisfy the written description requirement.2 (Slip op. at 18) ...
Internal investigations are a central part of the crisis management response, and whilst the form and structure of the investigation will depend on the type of crisis, investigations will generally focus on identifying root causes and those with responsibility for the crisis ...
Statute of limitations for appeal of public auction contractsThe Higher Commercial Court recently clarified several issues relating to the statute of limitations for appeals of public auction contracts. (Higher Commercial Court of Ukraine Resolution 10 ("On Certain Practical Issues of Statute of Limitation Application"), May 29 2013 ...
Minister of Health Regulation No. 30 of 2013 on The Inclusion of Information on Sugar, Salt, and Fat Content, and Health Impact Messages for Processed and Fast Foods is aimed at lowering the exposure of the public to the risk of non-contagious disease such as hypertension, stroke, diabetes and heart attacks, which can be caused by the excessive consumption of processed or fast foods ...
The Minister of Health has issued Regulation No. 28 of 2013 on Affixing Health Warnings and Information on Tobacco Product Packaging which came into force on 12 April 2013, as a further implementation of Government Regulation No. 109 of 2012 on Control of AddictiveSubstances in the Form of Tobacco Products. The Regulation requires tobacco producers and importers to affix pictorial health warnings and health information on their tobacco products packaging ...
The Head of the National Drug and Food Control Agency (Badan Pengawas Obat dan Makanan – “BPOM”) recently issued Regulation No. 27 of 2013 on The Supervision of Drugs and Food Imports into Indonesian Territory which came into effect on 28 May 2013. This Regulation repeals and replaces the previous regulations on Imports of Processed Foods, Cosmetics and Drugs ...
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. The text for this clause is frequently supplied by a local arbitration institute ...
Don't bank just yet on putting your marketing muscle behind the safe and effective off-label uses of your FDA-approved drugs, or defending your next mass consumer class action on First Amendment grounds. But you can start giving those multi-billion dollar prospects some serious thought, because constitutional winds are blowing through the Code of Federal Regulations ...
Myriad Genetics is known as a leader in the market for diagnostic testing of BRCA1 and BRCA2 gene mutations that have been linked to breast and ovarian cancer. These same diagnostic tests were recently in the celebrity press, as Angelina Jolie announced she had been tested positive for the mutations, resulting in her electing to have a preventative double mastectomy ...
Legal succession of banksUkrainian legislation prescribes a special reorganisation procedure for banks that, among other things, requires banks to:• develop a reorganisation plan;• obtain approval for internal statute changes from the National Bank of Ukraine; and• conduct an audit to ensure the correctness of transfers (for mergers and acquisitions) or the demerger balance sheet (for spin-offs and transfers) ...
Governor Perry recently signed four bills into law designed to combat Medicaid fraud, waste, and abuse. The bills are a mixed bag of enhanced enforcement capabilities for the state and a few new protections for healthcare providers. Most notably, the legislature made several changes to the Texas Medicaid Fraud Prevention Act (TMFPA), bringing the statute more in line with the federal False Claims Act. Changes to the Medicaid Fraud Laws On the enforcement side, S.B ...
Insurers often have a duty to settle underlying claims against their insureds. While that duty generally requires insurers to accept reasonable settlement offers, insurers and insureds alike face many other issues regarding settlement of the underlying case ...
In Wyeth and Cordis Corp. v. Abbott Laboratories, 2012-1223, -1224 (Fed. Cir. June 26, 2013), the Court of Appeals for the Federal Circuit affirmed the district court’s grant of summary judgment in favor of the defendants, holding method of treatment claims invalid under 35 U.S.C. § 112(a) (2012) as not being enabled for their full scope. (Slip op. at 3) ...
The US Court of Appeals for the Second Circuit recently held that excess insurance policies are triggered when the payment of losses exceed the attachment point rather than when the policyholder’s loss obligations exceed the attachment point. Ali v. Fed. Ins. Co., No. 11-5000-cv, 2013 WL 2396046 (2d Cir. June 4, 2013). The decision is another reminder that outcomes in insurance disputes may depend on subtle differences in the wording of insurance policies ...
On June 14, 2013, Governor Rick Perry signed legislation, which for the first time authorizes domestic captive insurers in Texas. The bill, known as SB 734, allows Texas businesses to realize the advantages, including tax benefits, of forming and operating a “pure” captive insurance company without the burden and cost associated with an out-of-state captive ...
IntroductionIn the course of implementing the visa liberalisation regime with the European Union, Parliament recently passed several anti-corruption laws, including the Law on Criminal Liability of Legal Entities. The law introduced amendments to the Criminal Code, the Code of Criminal Procedure, the Law on Principles of Prevention and Combating Corruption and the Law on Ensuring the Safety of Those Involved in Criminal Proceedings ...
On June 13, 2013, in the highly anticipated decision for Ass’n for Molecular Pathology v. Myriad Genetics, Inc., the Supreme Court shed some light on the future of genetic patenting to companies and scientists working in the personalized medicine and genetics industry. The personalized medicine industry seeks to revolutionize patient care by using genetic sequencing and testing to predict disease likelihood, severity, progression, and/or treatment response ...
In a decision that will likely have a significant impact on the pharmaceutical industry (and possibly broader implications for patent, antitrust, and high technology), the Supreme Court yesterday refused to exempt so-called reverse payment (or "pay for delay") patent settlements from antitrust scrutiny. Prior to yesterday’s ruling in FTC v. Actavis, Inc., 570 U.S. ___ (2013), most of the circuit courts to have considered the issue (i.e ...
The Supreme Court has unanimously upheld an arbitrator’s ruling that a contract that required arbitration of "any dispute" constituted an agreement to class-wide arbitration. The Court’s narrow ruling turns on the parties’ express agreement to allow the arbitrator to decide whether their contract, which contained an arbitration provision but did not mention class proceedings, authorized class arbitration ...
As discussed in our previous Alert, the French government has imposed Sunshine-like obligations on the pharmaceutical industry. Article 2 of Law No 2011-2012 of 29 December 2011 on the Strengthening of Health Protection for Medicinal and Health Products ("loi relative au renforcement de la sécurité sanitaire du médicament et des produits de santé" or "Loi Bertrand") inserted Articles L. 1453-1 in the French Code of Public Health ("Code de la santé publique" or "CSP"). Article L ...
Here are select March 2013 rulings of the Philippine Supreme Court on legal and judicial ethics:Attorney; a lawyer shall not assist in the unauthorized practice of law. Atty. Bancolo admitted that the Complaint he filed for a former client before the Office of the Ombudsman was signed in his name by a secretary of his law office ...
