Never has there been a more controversial law in the past decade than the Reproductive Health Law (“RH Law”). After a long and contentious battle in Congress, the law was finally passed. But the fervent opposition by the so-called Pro-life groups (chief among them the Catholic Church) endures. Four days after the approval of the law’s Implementing Rules and Regulations (“IRR”), the Supreme Court on March 19, 2013, halted its implementation, issuing a 120-day status quo ante order ...
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 ...
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 ...
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) ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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) ...
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) ...
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 ...
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 ...
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 ...
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 ...
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 ...
