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 ...
On June 13, 2013, the West Virginia Supreme Court of Appeals (WVSCA) issued its decision in Faith United Methodist Church & Cemetery of Terra Alta, et al. v. Morgan, No. 12-0080, setting forth a clear definition of the term “surface” when used in deeds and other instruments of conveyance. This definition will weigh importantly on the state's shale gas industry ...
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) ...
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 ...
Mining Industry 1. What is the nature and importance of the mining industry in your country?The mining industry accounts for 13 per cent of the GDP and 62.6 per cent of Chile’s total exports (US$49.3 billion). Chile is the largest producer of copper (31.9 per cent) in the world market and also produces other metals, such as silver and gold, and many non-metallic substances. The mining industry is mainly owned by private foreign and national companies ...
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) ...
Mining Industry1 What is the nature and importance of the mining industry in your country?The Philippines is rich in mineral resources and the mining industry plays a significant role in the country’s economy ...
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 response to solar industry concerns that its regulations were stifling the country’s solar energy development, the Federal Energy Regulatory Commission initiated a rulemaking on January 17 to amend its regulations applicable to the interconnection of facilities of 20 MW or less to the grid ...
On May 29, 2013, Alberta issued three regulations and two rules under the Responsible Energy Development Act (“REDA”). The new regulations and rules became operational on June 17, 2013, the same day that REDA came into force. With REDA, the regulations and the rules now in place, the new regulatory regime for energy development in Alberta has started to take shape ...
The $400 million package agreed by JP Morgan with the US federal energy regulator to settle its energy market abuse case against the firm, announced at the end of July, is a great example of the legal risks energy firms now run in exploiting loopholes in the frequently complex bidding rules governing energy wholesale markets ...
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 ...
Since our last update (in June 2013), progress has been made on the key outstanding issues we identified; namely, geology, taxation, community benefits and planning ...
I. Introduction The development of projects and business opportunities, particularly in the natural resource industries, requires government decision making, from the issuance of resource tenures, through environmental assessment of proposed works and activities, and through licences, permits and authorizations ...
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 ...
In 1956, the American Association of Professional Landmen (“A.A.P.L.”) published the first version of its model form Joint Operating Agreement (“JOA”), which it later revised in 1977, 1982, and 1989 (the “A.A.P.L. form”). Since that initial publication, the oil and gas industry has universally adopted the A.A.P.L. form as its standard JOA. The industry has also since adopted horizontal drilling and development as a popular method to recover hydrocarbons ...
