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 Major Transport Projects Facilitation Amendment (East West Link and Other Projects) Bill 2013 ('the Bill') was commended to Victoria's Legislative Assembly on 13 June 2013. The Bill principally amends the existing Major Transport Projects Facilitation Act (Vic), which governs the assessment, approval and delivery of major transport project infrastructure ...
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 ...
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 ...
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 ...
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 ...
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) ...
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 ...
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 ...
Physicians in Texas can receive up to $160,000 for the repayment of medical school loan debt through a state program that received a significant increase in funding earlier this year. To be eligible, physicians need to apply by Nov. 30, 2013 and agree to provide four consecutive years of service in a federally designated Health Professional Shortage Area ...
When does title in the ship pass from the shipbuilder to the shipowner? Can the parties agree to change when title will pass? Usually shipbuilding contracts are negotiated on standard forms such as the SAJ form produced by the Shipbuilders’ Association of Japan and the AWES form produced by the Association of European Shipbuilders and Shiprepairers. South African law generally recognises freedom of contract and accordingly parties to a contract are entitled to vary the terms by agreement ...
In a statement issued by the National Regulatory Agency, Control and Surveillance (ARCSA), drugs that are sold in Ecuador must have labels stating the words 'generic', otherwise it can not be marketed as of January 24, 2014 ...
On October 18, 2013, the Centers for Medicare & Medicaid Services (CMS) published Survey & Certification Letter 14-01-NM, which clarified the obligations of a skilled nursing facility (SNF) or nursing facility (NF) (collectively “nursing homes”) to provide cardiopulmonary resuscitation, or CPR, to its residents ...
Starting in January 2014, everyone will be required to purchase health insurance. If you are someone whose company already provides you with insurance, you can probably skip this article. But if you are elderly, purchase your insurance privately, or are one of the 24.2 percent of Texans without health insurance, you might want to read on ...
The Colombian government, aware of the need to improveinfrastructure in order to reduce logistical costs and thereby promote the country’s growth and development, is currently in the process of selecting contractors for the fourth generation road concessionprogram, which envisages the award of approximately 25 concession contracts, with total investment of close to €18,300 million ...
The 83rd Texas Legislature passed legislation to simplify the process by which physicians supervise and delegate to Physician Assistants (PAs) and Advance Practice Registered Nurses (APRNs). This article summarizes the rules recently adopted by the Texas Medical Board (TMB) to implement SB 406 (83R) ...
Physician-owned distributorships (PODs) and other physician-owned entities (POEs) have emerged as a favored vehicle to reduce costs, but the popularity of PODs and POEs has led to increased scrutiny by federal regulators. In June 2011, the United States Senate called on the Office of Inspector General for the U.S. Department of Health and Human Services (OIG) and Centers for Medicare & Medicaid Services to investigate the proliferation of PODs and corresponding utilization practices ...
The Swedish court of appeal (hovrätten över Skåne och Blekinge) decided in May this year that the party ordering a transport service also is liable for payment of such service; regardless of if the parties have agreed that the receiver of the goods or any other party shall be the receiver of the invoice. In this case a seller of goods has agreed with a carrier that the freight should be invoiced the receiver of the goods ...
St. Luke’s Health System’s 2012 acquisition of Saltzer Medical Group, Idaho’s largest independent multi-specialty physician practice group, violated federal and state antitrust laws according to a U.S. District Court holding issued on Friday, January 24, 2014. The Court ordered divestiture of the practice. The FTC and the Idaho Attorney General filed the Complaint seeking to block the sale on March 12, 2013. In response, St ...
The Affordable Care Act, in a largely overlooked provision, bestowed broad powers on the Centers for Medicare and Medicaid Services (CMS) to impose a moratorium on the enrollment of new Medicare or Medicaid providers, including whole categories of providers in certain geographic locations ...
CMS recently announced yet another delay to the full implementation of “two midnight rule,” which revises its longstanding guidance to hospitals and physicians relating to when hospital inpatient admissions are deemed to be reasonable and necessary for payment under Medicare Part A. Specifically, this latest “delay” is the result of CMS’s extension of the “Probe & Educate Period,” a period of partial non-enforcement for the two midnight rule requirements, until September 30, 2014 ...
