Discovering the Undiscoverable: Patent Eligibility of DNA and the Future of Biotechnical Patent Claims Post-\u3ci\u3eMyriad\u3c/i\u3e

In June 2013 the Supreme Court held that naturally occurring human DNA cannot be patented, but synthetically created DNA is patent-eligible. Though a major victory for patients’ rights, the holding of Association for Molecular Pathology v. Myriad Genetics appears to be the latest in a series of restrictions on patents and the human body, much to the annoyance of biotechnology companies. However, this case should not be viewed as the final word in patenting “natural phenomena.” Patent claims of genetic material are still viable when the claim details a new and useful improvement on the naturally occurring product or an application of the product to a process. Furthermore, the Myriad Court noted that extending the natural products rule too far would be against public policy, giving litigators room to explore the contours of this rule. This Article examines the limits of the Supreme Court’s decision and the avenues that potential patent seekers still have for making eligible patent claims on naturally occurring products and phenomena, as well as the processes for identifying such products and phenomena. It highlights the areas where the courts are likely to take a hard stance against patent eligibility and where opportunities still exist to claim a valid patent in three areas. First, though discovery of a natural process in its naturally-occurring state is now un-patentable, the Myriad holding signals that a variation on this natural state, no matter how slight, could make the product eligible for a patent under the “new and useful improvements” rule. Second, the “application of new processes” rule is unchanged by this case. Third, a public policy argument on the importance of protecting medical and genetic discoveries may be more relevant in light of Myriad’s broad holding

Energy recovery and efficiency improvement for an activated sludge, agro-food WWTP upgrade

Abstract Wastewater treatment's primary purpose is to protect surface water quality, aquatic life, beneficial and recreational uses of waterways, and primarily comply with local water emission standards. Lately, additional requirements were added for these facilities, concerning minimization of a series of sidestream environmental impacts (i.e., odours, generated waste by-products, etc.), air emissions, including CO2, methane and nitrogen greenhouse gases (GHGs), and mitigation of various other likely impacts resulting from energy and chemical use in treatment processes. This paper describes a case study in Northern Europe, where critical analysis of an industrial wastewater treatment plant's present conditions, during an evaluation of upgrade possibilities to improve regulatory compliance, led to a sustainable intervention proposal. According to the formulated proposal, process improvement, energy recovery, and overall savings and GHG emissions reduction could be simultaneously achieved with a series of relatively simple interventions

Crisaborole Ointment Improves Quality of Life of Patients with Mild to Moderate Atopic Dermatitis and Their Families.

IntroductionThe impact of crisaborole ointment, a nonsteroidal phosphodiesterase 4 inhibitor for the treatment of mild to moderate atopic dermatitis (AD), on quality of life (QoL) was assessed in two identically designed phase 3 studies (AD-301: NCT02118766; AD-302: NCT02118792, both at http://www.clinicaltrials.gov ).MethodsIn both studies, patients aged ≥ 2 years with mild to moderate AD per the Investigator's Static Global Assessment were randomly assigned 2:1 to receive crisaborole or vehicle twice daily for 28 days. QoL was assessed using the Children's Dermatology Life Quality Index (CDLQI) (2-15 years), the Dermatology Life Quality Index (DLQI) (≥ 16 years), and the Dermatitis Family Impact Questionnaire (DFI) (parents/caregivers/family of patients aged 2-17 years). Established QoL score severity bands provided clinical context.ResultsGreater mean improvement in QoL was observed in crisaborole-treated patients than in vehicle-treated patients at day 29 [mean change from baseline (∆BL), CDLQI: - 4.6 vs. - 3.0; P < 0.001; DLQI: - 5.2 vs. - 3.5; P = 0.015]. At baseline, more than half the patients had a "moderate effect" or higher of AD on QoL. At day 29, there was a trend toward more crisaborole- than vehicle-treated patients having "small effect" to "no effect", The QoL of parents/caregivers/family improved more for crisaborole-treated than for vehicle-treated patients (∆BL, DFI: - 3.7 vs. - 2.7; P = 0.003).ConclusionCrisaborole treatment results in clinically meaningful improvement in QoL for patients and their parents/caregivers/families.Trial registrationAD-301: http://www.clinicaltrials.gov , NCT02118766; AD-302: http://www.clinicaltrials.gov , NCT02118792.FundingAnacor Pharmaceuticals, Inc., a wholly owned subsidiary of Pfizer Inc., New York, NY

Cost-effective removal of COD in the pre-treatment of wastewater from the paper industry

The present paper reveals results of research for cost-effective removal of chemical oxygen demand (COD) contained in industrial paper mill effluent. Not only process efficiency but also wastewater treatment costs are discussed. Different pre-treatment processes are applied aiming to investigate the COD removal before discharge to the municipal sewage network. The objective of this paper is to find the optimal operating conditions for the coagulation process. The effects of key operational parameters, including the type of coagulant, initial pH, temperature and coagulant dose, on COD percentage removal were investigated. The laboratory experiments confirmed the high efficiency of chemically enhanced mechanical treatment towards COD. The data obtained show that even low dose of chemicals provides sufficient COD reduction. The initial pH of the wastewater had a significant impact on the COD removal. Under the optimal operational conditions (pH = 7.5, T = 18 °C) the treatment of wastewater from paper industries by coagulation has led to a reduction of 70% COD for wastewater discharged. In terms of the investigated paper industry wastewater, polyaluminium chloride appears to be most suitable for treatment of high COD concentration. However, in an economic evaluation of requirements for wastewater treatment, operating costs and associated saving were such that PAX was more favourable.Fil: Boguniewicz Zablocka, Joanna. Opole University Of Technology; PoloniaFil: Klosok Bazan, Iwona. Opole University Of Technology; PoloniaFil: Naddeo, Vincenzo. Universita di Salerno; ItaliaFil: Mozejko, Clara Alexandra. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Córdoba. Instituto de Estudios Avanzados en Ingeniería y Tecnología. Universidad Nacional de Córdoba. Facultad de Ciencias Exactas Físicas y Naturales. Instituto de Estudios Avanzados en Ingeniería y Tecnología; Argentin

Emollient enhancement of the skin barrier from birth offers effective atopic dermatitis prevention

BackgroundAtopic dermatitis (atopic eczema) is a chronic inflammatory skin disease that has reached epidemic proportions in children worldwide and is increasing in prevalence. Because of the significant socioeconomic effect of atopic dermatitis and its effect on the quality of life of children and families, there have been decades of research focused on disease prevention, with limited success. Recent advances in cutaneous biology suggest skin barrier defects might be key initiators of atopic dermatitis and possibly allergic sensitization.ObjectiveOur objective was to test whether skin barrier enhancement from birth represents a feasible strategy for reducing the incidence of atopic dermatitis in high-risk neonates.MethodsWe performed a randomized controlled trial in the United States and United Kingdom of 124 neonates at high risk for atopic dermatitis. Parents in the intervention arm were instructed to apply full-body emollient therapy at least once per day starting within 3 weeks of birth. Parents in the control arm were asked to use no emollients. The primary feasibility outcome was the percentage of families willing to be randomized. The primary clinical outcome was the cumulative incidence of atopic dermatitis at 6 months, as assessed by a trained investigator.ResultsForty-two percent of eligible families agreed to be randomized into the trial. All participating families in the intervention arm found the intervention acceptable. A statistically significant protective effect was found with the use of daily emollient on the cumulative incidence of atopic dermatitis with a relative risk reduction of 50% (relative risk, 0.50; 95% CI, 0.28-0.9; P = .017). There were no emollient-related adverse events and no differences in adverse events between groups.ConclusionThe results of this trial demonstrate that emollient therapy from birth represents a feasible, safe, and effective approach for atopic dermatitis prevention. If confirmed in larger trials, emollient therapy from birth would be a simple and low-cost intervention that could reduce the global burden of allergic diseases

Peanut allergy:effect of environmental peanut exposure in children with filaggrin loss-of-function mutations

BackgroundFilaggrin (FLG) loss-of-function mutations lead to an impaired skin barrier associated with peanut allergy. Household peanut consumption is associated with peanut allergy, and peanut allergen in household dust correlates with household peanut consumption.ObjectiveWe sought to determine whether environmental peanut exposure increases the odds of peanut allergy and whether FLG mutations modulate these odds.MethodsExposure to peanut antigen in dust within the first year of life was measured in a population-based birth cohort. Peanut sensitization and peanut allergy (defined by using oral food challenges or component-resolved diagnostics [CRD]) were assessed at 8 and 11 years. Genotyping was performed for 6 FLG mutations.ResultsAfter adjustment for infantile atopic dermatitis and preceding egg skin prick test (SPT) sensitization, we found a strong and significant interaction between natural log (ln [loge]) peanut dust levels and FLG mutations on peanut sensitization and peanut allergy. Among children with FLG mutations, for each ln unit increase in the house dust peanut protein level, there was a more than 6-fold increased odds of peanut SPT sensitization, CRD sensitization, or both in children at ages 8 years, 11 years, or both and a greater than 3-fold increased odds of peanut allergy compared with odds seen in children with wild-type FLG. There was no significant effect of exposure in children without FLG mutations. In children carrying an FLG mutation, the threshold level for peanut SPT sensitization was 0.92 μg of peanut protein per gram (95% CI, 0.70-1.22 μg/g), that for CRD sensitization was 1.03 μg/g (95% CI, 0.90-1.82 μg/g), and that for peanut allergy was 1.17 μg/g (95% CI, 0.01-163.83 μg/g).ConclusionEarly-life environmental peanut exposure is associated with an increased risk of peanut sensitization and allergy in children who carry an FLG mutation. These data support the hypothesis that peanut allergy develops through transcutaneous sensitization in children with an impaired skin barrier

Patterns of Clinical Management of Atopic Dermatitis in Infants and Toddlers: A Survey of Three Physician Specialties in the United States

ObjectiveTo describe atopic dermatitis (AD) management patterns in children ≤36 months old as reported by pediatricians, dermatologists, and allergists in the US.Study designA nationally-representative survey was administered to pediatricians (n = 101), dermatologists (n = 26), and allergists (n = 26). Main outcomes included referrals to health care professionals, suggested/ordered laboratory tests, management approach (dietary, pharmacologic, or combination of both) by age, AD location, and severity.ResultsSignificant differences were observed in referrals to healthcare professionals (P < .001). Pediatricians more frequently referred to dermatologists than allergists in mild (52.4% vs 32.0%) and moderate/severe (60.6% vs 38.1%) cases. Dermatologists referred to allergists less frequently for mild (9.1%) than moderate/severe (40.7%) AD cases. Pediatricians (59%), allergists (61.5%), and dermatologists (26.9%) reported treating at least some of their patients with AD with dietary management (infant formula change) alone (with or without emollients). Soy-based formulas were often used. For mild AD, the most commonly reported first-line pharmacologic treatments included topical emollients, topical corticosteroids, and barrier repair topical therapy/medical devices. Over 80% of physicians used a dietary and pharmacologic combination approach. Dermatologists were most likely to manage AD symptoms with a pharmacologic-only approach. AD lesion location influenced pharmacologic treatment in >80% of physicians.ConclusionsSignificant and distinct differences in AD treatment approach exist among physicians surveyed. Most pediatricians and allergists use formula change as a management strategy in some patients, whereas dermatologists favor a pharmacologic approach. This diversity may result from inadequate evidence for a standard approach. Consistent methods for managing AD are needed