The world is on the cusp of a post-antibiotic period. A century ago, before the advent of antibiotics, bacteriophage therapy was the treatment of choice for bacterial infections. Although bacteriophages have yet to be approved as a treatment in Western medicine, researchers and clinicians have begun to anticipate phage therapy. Bacteriophages are viruses that depend on bacterial cell metabolism to multiply. They offer a promising alternative to the use of antibiotics and an excellent antibacterial option for combating multidrug resistance in bacteria. However, not every phage is suitable for phage therapy. In particular, prophages should not be used because they can lysogenize host cells instead of lysing them. To offer adequate therapeutic options for patients suffering from various infectious diseases, a wide selection of different phages is needed. While there is no evidence of direct toxicity induced by phage particles, it is crucial to study mammalian cell-phage interactions. This requires phage preparations to be free of bacterial cells, toxins and other compounds to avoid skewing host responses. Negative staining of purified viruses and electron microscopy remain the gold standard in the identification of bacteriophages. Interestingly, genomics has greatly changed our understanding of phage biology. Bacteriophage genome sequencing is essential to obtain a complete understanding of the bacteriophages\' biology and to obtain confirmation of their lifestyle. Full genetic sequencing of bacteriophage will enable a better understanding of the phage-encoded proteins and biomolecules (especially phage lytic enzymes) involved in the process of bacterial cell lysis and death. Mass spectrometry can be used for the identification of phage structural proteins. The use of lytic phages as biocontrol agents requires the most appropriate and standard methods to ensure application safety. This review pursues recent research and methods in molecular biology for the isolation and characterization of phages to facilitate follow-up and implementation of work for other researchers. Patents related to this topic have been mentioned in the text.

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An analysis of US Federal Circuit decisions shows strategies for designing around patents.

Patents of innovator biopharmaceutical products, such as epoetin, are expiring, and biosimilar versions of these products may soon enter European and American markets. Copies of these products, termed biosimilars or follow-on biologics, are not truly equivalent and cannot gain market approval through the procedure typically applied to generic drugs. We evaluated literature reports of both analytic and clinical studies conducted with biosimilar epoetin products currently marketed outside the United States and Europe in light of recently implemented European Medicines Evaluation Agency guidelines. The analytic studies reported that products differed widely in composition, did not always meet self-declared specifications, and exhibited batch-to-batch variation. Although several clinical studies demonstrated correction of anemia with biosimilar epoetins by using an open-label or placebo-controlled study design, only 4 of 22 studies were competitor controlled. Most of the studies were small (median 41 patients, range 18-1079 patients) and of short duration (median 12 wks, range 6 wks-1 yr). Clinical experience with epoetin shows that the dosage required to achieve similar hemoglobin levels varies among patients, making it impossible to demonstrate bioequivalence without a comparator. The analytic reports did not demonstrate comparability of biosimilar epoetin products with innovator epoetin alfa, and the clinical studies were not rigorous enough to show equivalent safety and efficacy of a biopharmaceutical product. The variation between products illustrates the challenge in replicating and consistently producing biopharmaceutical proteins. Immunogenic reactions with epoetin indicate that large, long-term studies are needed to adequately monitor safety.

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The authors postulate that, as the number of university-industry cooperative research programs increases, the potential for problems arising from the inherent differences between the two types of organizations will increase as well. They maintain that success in such relationships can be promoted by anticipating problems and developing guidelines for averting or dealing effectively with them. Ten such guidelines are presented, concerning publication rights, patent ownership, copyright, confidentiality agreements, research units, faculty consultants and entrepreneurs, international agreements, sharing of personnel and equipment, and model research agreements.