Diagnostic testing of genetic disorders: limiting the scope of patent claims through disclosure requirements.

The breadth of claims in patents relating to genetic inventions has been controversial for some time. Possible adverse effects of broad claims include inhibiting research and higher costs, restricting patient access to genetic testing. The Australian Law Reform Commission's Report on Genes and Ingenuity--Gene Patenting and Human Health examined this issue, and concluded that the existing disclosure requirements contained in s 40 of the Patents Act 1990 (Cth) provide adequate mechanisms to control the breadth of claims. However, application of these requirements may be problematical in practice due to lack of relevant case law to provide guidance to patent examiners. It has been suggested that this deficit in direct judicial guidance can be obviated by developing appropriate analogies with other chemical systems in decided cases. This article focuses on gene-based diagnostic patents for human diseases, such as those held by Myriad Genetics for testing predisposition towards breast and ovarian cancer using the gene BRCA1. By examining the application of disclosure requirement by courts in genetic and non-genetic chemical inventions, it is possible to provide insight into how this might be applied by courts considering the validity of patent claims for diagnostic testing methods based on mutations in a gene such as BRCA1.

Quantifying missing annual emission sources of heavy metals in the United Kingdom with an atmospheric transport model.

An atmospheric chemical transport model was adapted to simulate the concentration and deposition of heavy metals (arsenic, cadmium, chromium, copper, lead, nickel, selenium, vanadium, and zinc) in the United Kingdom. The model showed that wet deposition was the most important process for the transfer of metals from the atmosphere to the land surface. The model achieved a good correlation with annually averaged measurements of metal concentrations in air. The correlation with measurements of wet deposition was less strong due to the complexity of the atmospheric processes involved in the washout of particulate matter which were not fully captured by the model. The measured wet deposition and air concentration of heavy metals were significantly underestimated by the model for all metals (except vanadium) by factors between 2 and 10. These results suggest major missing sources of annual heavy metal emissions which are currently not included in the official inventory. Primary emissions were able to account for only 9%, 21%, 29%, 21%, 36%, 7% and 23% of the measured concentrations for As, Cd, Cr, Cu, Ni, Pb and Zn. A likely additional contribution to atmospheric heavy metal concentrations is the wind driven re-suspension of surface dust still present in the environment from the legacy of much higher historic emissions. Inclusion of two independent estimates of emissions from re-suspension in the model was found to give an improved agreement with measurements. However, an accurate estimate of the magnitude of re-suspended emissions is restricted by the lack of measurements of metal concentrations in the re-suspended surface dust layer.

Treatment of septic common digital extensor tenosynovitis by complete resection in seven horses.

OBJECTIVE: To describe and evaluate a technique for radical resection of the entire intrathecal component of the common digital extensor tendon (CDET) in horses. STUDY DESIGN: Prospective clinical study. ANIMALS OR SAMPLE POPULATION: Seven client-owned horses. METHODS: Seven horses with wounds that resulted in septic tenosynovitis of the CDET sheath were treated by complete surgical resection of the affected tendon and ablation of the tendon sheath; 5 had previous surgery that was unsuccessful. Time from initial injury to complete resection was 1-22 weeks. In 6 horses, the wound was closed primarily using a closed suction (4 horses), penrose (1), or passive open drainage system (1). In 1 horse, the surgical wound healed by second intention. All horses had postoperative bandaging, antibiotic administration, and physiotherapy. RESULTS: Surgical wounds healed primarily in 6 horses and by second intention in 1 horse. Follow-up (mean, 26.4 months; range, 18-38 months) was available for 6 horses; all returned to their athletic performance level without lameness or gait abnormality. CONCLUSIONS: Complete resection of the CDET was an effective surgical technique for management of chronic septic tenosynovitis. CLINICAL RELEVANCE: Horses with infection of the CDET and its sheath may be returned to long-term soundness without gait abnormality after radical resection.