As in past years, chemical, pharmaceutical and biotechnology patent cases in 2013 offered a combination of the predictable and the unpredictable. On the predictable end of the spectrum, the US Supreme Court offered no surprises ...
The federal Endangered Species Act is designed to prevent the taking of endangered species and imposes a regulatory program geared toward the protection and conservation of federally listed species and their critical habitat ...
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 ...
On Thursday, November 7, 2013, the United States Food and Drug Administration (FDA) announced measures to definitively eliminate all the artificial trans fats from processed products in the United States. The purpose of the proposal, which is released for public comments for a 60-day period, is to remove trans fats from the “generally recognized as safe” (“GRAS”) category, which would allow these products to be commonly used in food products ...
THE 1979 STATUTE It is well known that, under the legal regime for the protection of agricultural lands, the acquisition of agriculturally zoned lands with a surface area of four hectares or more by a person not residing in Quebec is subject to the authorization of the Commission de protection des terres agricoles. This is the object of the Act respecting the acquisition of farm land by non-residents (CQLR chapter A-4.1) (the “Act”), which has been in force since December 21, 1979 ...
Purchasers and lessees of commercial or industrial properties know to obtain Phase I environmental site assessments to identify the presence of contamination - so-called recognized environmental conditions (RECs) - because of the very substantial liabilities these conditions may create. And their lenders generally require them. The industry standard for Phase I’s is based on EPA regulations that flesh out Superfund’s “all appropriate inquiry (AAI)” standard ...
Introduction Last week, the federal government took a big step toward bringing the Fisheries Act (Canada) and its application into line with the federal government’s responsible resource development plan ...
The European Parliament’s Auken Report made it clear that Spain is coming up short as far as protecting its coastline is concerned. Application of Coastal Law 22/1988, of July 28, 1988, fast-tracked in recent years, not only brought with it no little confusion for all concerned, it also failed to contribute to the protection of the coastline, which clearly leaves a great deal to be desired along certain stretches of the Spanish coast ...
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 ...
On 3 October 2013, DG Environment of the European Commission published its final report following the public consultation on ‘Unconventional fossil fuels’ (e.g. shale gas). Since this is an important stage in the legislative process, the purpose of this note is to provide you with a brief outline of its findings and follow up. Importantly, the European Commission has announced that in December 2013 the impact assessment will follow ...
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 17th, 2013, the Supreme Court of Canada released its long-awaited decision in Castonguay Blasting, commonly referred to as the fly-rock case. To summarize, Castonguay was doing some blasting work and rock was unexpectedly projected outside the work site, landing on someone’s property and damaging a home and a vehicle. No one was hurt and there was no environmental damage ...
In the innovativeness of its economy, Poland ranks 4th from last in the European Union, but greater support is planned for highly innovative projects that show promise for implementation and commercialisation in Poland. At a session of the Polish Parliament’s Innovation and New Technology Committee on 19 June 2013, the Ministry of Regional Development presented the guidelines for operational programmes Smart Growth 2014–2020 and IT & Telecommunications 2014–2020 ...
In September 2013, the Texas Commission on Environmental Quality updated its guidance on the use of the Texas Environmental, Health, and Safety Audit Privilege Act to reflect changes recently made by the 83rd Texas legislature to allow prospective purchasers of facilities to take advantage of the protections afforded by the Act ...
In June 2013, the Land and Environment Court handed down a judgment in a case concerning parent company liability for environmental pollution caused by a subsidiary, (Case No. M 11429-12). Initially, we give a brief description of the term operator followed by an account of the judgment in question ...
Denmark has a large life science sector, including a number of biotech and pharmaceutical companies and research activities. The sector is highly regulated and covered by extensive and complicated statutory requirements, executive orders and ethical standards. Denmark has incorporated most of the EU regulation and Danish law is thus to a large extent in conformity with the general EU regulation and practice of, for example, the European Medicines Agency (‘EMA’) ...
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 ...
On 13 June 2013, the Supreme Court of the United States handed down its unanimous decision in the ongoing case of Association for Molecular Pathology et al v Myriad Genetics, Inc. et al 12-398, 569 US __ (2013). This case is the first brought in the US directly challenging the patentability of human genes and for that reason is extremely important to any entity involved in the biotechnology industry which relies on human genetics research as part of innovation strategy ...
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 ...
he designation of critical habitat under the Endangered Species Act (ESA) can result in significant and costly consequences for landowners, industry, government, and other entities—often with little if any evidence of a commensurate benefit to the species involved. In Critical Habitat and the Challenge of Regulating Small Harms, Professor Dave Owen provides a valuable contribution to assessing the role of critical habitat during consultation on federal agency actions under ESA section 7 ...
One way to change the law fast is to amend or repeal statutes in budget legislation. That is what the federal government of Canadadid in 2009, 2010 and 2011. Federal programs, staff positions and budgets for environmental science, conservation and protection have been eliminated. That leaves a lot of responsibility with the provinces and territories, and many open questions for industry. This article describes what has happened and identifies what to look out for ...
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) ...
