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Practice Industry: Dispute Resolution, Government & Public Sector, Healthcare & Pharmaceuticals
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One of the more stirring reforms in the past two decades in the field of education is Republic Act 10533, or the Enhanced Basic Education Act of 2013 (“Enhanced Basic Education Act”) ...

The UK Information Commissioner’s Office (the “ICO”) experienced a surprising setback recently after the Information Rights Tribunal (the “Tribunal”) ruled that a fine of £250,000 issued by the ICO in relation to a breach of the Data Protection Act 1998 (the “DPA”) by Scottish Borders Council (the “Council”) was excessive ...

Hunton Andrews Kurth LLP | August 2013

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 ...

Haynes and Boone, LLP | July 2013

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) ...

Lawson Lundell LLP | July 2013

An American organization that finds itself involved in litigation in Canada, or an American attorney advising such an organization, will find most aspects of the Canadian civil justice system to be familiar. The legal systems of the two countries are comparable in many respects, they share common historical antecedents, and their core values are the same ...

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 ...

Asters | July 2013

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 ...

Makarim & Taira S. | July 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 ...

Makarim & Taira S. | July 2013

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 ...

Makarim & Taira S. | July 2013

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 ...

Makarim & Taira S. | July 2013

Two years after the issuance of Law No. 6 of 2011 on Immigration (“Immigration Law”), its implementing regulation i.e. Government Regulation No. 31 of 2013 on The Implementation of Law No. 6 of 2011 on Immigration (“Reg. 31/2013”), was issued in order to provide further details on certain Articles of the Immigration Law. Reg. 31/2013 came into effect on 16 April 2013. Visas There are four types of visas under Reg ...

Krogerus | July 2013

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 ...

Asters | July 2013

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) ...

ENSafrica | July 2013

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 ...

Haynes and Boone, LLP | July 2013

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 ...

By a vote of seven justices, with three inhibiting, one absent, and four dissenting, the Supreme Court – in a decision penned by J. Perez and promulgated last June 25, 2013 – dismissed this petition for certiorari assailing the earlier Resolutions of public respondent COMELEC which ordered the cancellation of petitioner’s Certificate of Candidacy (CoC) for the position of Representative of the lone district of Marinduque ...

Haynes and Boone, LLP | June 2013

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) ...

Haynes and Boone, LLP | June 2013

IntroductionGovernment contractors often use teaming agreements to combine the services of two or more contractors to offer the most persuasive bid for a government contract. The prime contractor typically agrees with the other team members that if the prime wins the bid, it will allocate some of the contractual work to the other member(s) ...

PLMJ | June 2013

The various plans and the range of measures included in them that have been described have produced practical results, particularly an increase in the applications for registration of patents, trademarks and protection by copyright, specifically for property such as software.  In terms of applications for patents registered in 2011, China came in first place above the USA and Japan ...

PLMJ | June 2013

The Court of Justice of the European Union recently issued a judgment in Case C-1/12, following a reference for a preliminary ruling submitted by the Lisbon Court of Appeals, in the dispute between the Order of Chartered Accountants (OTOC) and the Portuguese Competition Authority ...

Asters | June 2013

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 ...

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