The Patented Medicines (Notice of Compliance) Regulations: An Examination of the Decision Making Patterns in these Cases at the Supreme Court of Canada

Abstract Generic drug approval cases involving Canada’s Patented Medicines (Notice of Compliance) Regulations are adjudicated at the Federal Court through the judicial review process. The European Union alleges that this abbreviated process is unfair to litigants who hold patents on medicines, since it does not encompass all of the features of a trial, nor is it an actual suit for patent infringement. In addition, the process has unequal appeal rights for the patent holder and the patent challenger, where the generic challenger can appeal a decision at Federal Court, but the patent holder cannot. When examining the pattern of decision making in Patented Medicines (Notice of Compliance) Regulations cases at the Supreme Court of Canada, there is little evidence to suggest that the Supreme Court Justices are making wrong or unfair decisions because the lower court cases were decided through the judicial review process. The decision making pattern is very similar to the pattern in the Supreme Court patent cases, and to Supreme Court jurisprudence overall, so there is little reason to think that wrong decisions on these cases are being made because of the abbreviated process. In addition, the pattern of decision making in the Patented Medicines (Notice of Compliance) cases is much different than the Supreme Court jurisprudence on copyright, an area of law that has been through a period of significant change due to issues surrounding digital music. The copyright cases are quite comparable to the Patented Medicines (Notice of Compliance) cases, in that the original adjudication of both case types was through the process of judicial review. However, the decision making pattern in the copyright cases contrasts the pattern in the Patented Medicines (Notice of Compliance) cases, in that there are few concurring opinions in the Patented Medicines (Notice of Compliance) cases and a high proportion of concurring opinions in the copyright cases, which indicates that the interpretation of the Patented Medicines (Notice of Compliance) Regulations is not creating divided opinions amongst the Justices, nor is the abbreviated process of judicial review from the lower court contributing to significant judicial disagreement. This study therefore provides evidence that a full trial for patent infringement in these cases would not necessarily change the outcomes in these cases

Asymptotically good homological error correcting codes

Let $\Delta$ be an abstract simplicial complex. We study classical homological error correcting codes associated to $\Delta$, which generalize the cycle codes of simple graphs. It is well-known that cycle codes of graphs do not yield asymptotically good families of codes. We show that asymptotically good families of codes do exist for homological codes associated to simplicial complexes of dimension at least $2$. We also prove general bounds and formulas for (co-)cycle and (co-)boundary codes for arbitrary simplicial complexes over arbitrary fields

Biological characteristics and mortality of western butterfish (Pentapodus vitta), an abundant bycatch species of prawn trawling and recreational fishing in a large subtropical embayment

The western butterfish (Pentapodus vitta) is numerous in the bycatch of prawn trawling and recreational fishing in Shark Bay, Western Australia. We have thus determined crucial aspects of its biological characteristics and the potential impact of fishing on its abundance within this large subtropical marine embayment. Although both sexes attained a maximum age of 8 years, males grow more rapidly and to a larger size. Maturity is attained at the end of the first year of life and spawning occurs between October and January. The use of a Bayesian approach to combine independent estimates for total mortality, Z, and natural mortality, M, yielded slightly higher point estimates for Z than M. This result indicates that P. vitta is lightly impacted by fishing. It is relevant that, potentially, the individuals can spawn twice before recruitment into the fishery and that 73% of recreationally caught individuals are returned live to the water

The Development of an Expectations Theory of Patent Law by Creating a Nexus with John Locke\u27s Theory of Private Property

Abstract This thesis reviews the Lockean justification of private physical property as an explanation for patent “property,” identifies its weaknesses, and modifies it to create a new theory of patent law based on expectations. After describing the characteristics of technical information, that description is applied to three different interpretations of the Lockean condition which demonstrate a strain in defining technical knowledge as property. The technical information paradigm is then applied to an expectations theory, which demonstrates a broad connection to the Lockean conditions, but maintains a fit within a wider patent law interpretation. The expectations theory also creates an avenue for reintroducing utility assessments of patents and setting flexible patent terms. An example of a new medicine is used to test the various forms of the Lockean condition and the expectations model. The historical development of modern patent law is reviewed then separated into two periods, which are subsequently generalized. While the early period prioritized utility assessments, working requirements and the individualization of patent terms, the later period minimized the importance of utility and working requirements, but prioritized inventiveness. The three different Lockean conditions, along with the expectations theory, are applied to the generalized form of each historical era. While each form of the Lockean condition illustrates a unique relationship to the patent law eras, the expectations model provides an encompassing explanation because of its fitness with the definition of technical information. The analysis demonstrates that patent law can be categorized as either strong form patent law or weak form patent law, based on what can be expected from it. While the strong form creates an expectation of a societal benefit from a patent beyond simply disclosing it, the weak form does not. The utility assessments of patents in the first era, along with the individualization of patent terms meant that the first era exhibited strong form patent law. The loss of utility assessments, working requirements, and adjustable patent terms during the second era characterize it as weak form. While nonobviousness narrowed the scope of patent to things that were truly innovative in the second era, it was not a sufficient basis for ensuring that a Lockean bargain was achieved. The modified expectations model is then applied to Canada’s pharmaceutical patent law history to demonstrate how Canada’s patent law with respect to pharmaceuticals changed from strong form to weak form once it relinquished its compulsory licensing provisions, leaving few expectations from foreign-registered pharmaceutical patents by the early nineties. The pharmaceutical patent law history of Canada also illustrates the difference in competitors that a modified Lockean theory of patent law creates – close competitors who can act upon each other’s patented information and far competitors, where one competitor cannot act upon the other’s patented technological information that it patents. The closest competitors need not rely on any mechanisms like working requirements or compulsory licenses to achieve the patent bargain because their ability to use the patented information arises in a reciprocal fashion, as suggested by Locke’s original enough and as good condition. With far competitors, however, the patent bargain is not as easily attainable because of the inability of the patent grantor to use the patented information to extend the knowledge or employ it after patent expiry. Overall, the close competitor/far competitor distinction reveals the specificity of patent “property” (technical knowledge) that makes it challenging to transfer it to others, in contrast from Locke’s general physical property model, which easily transfers interchangeable land from person to person. The thesis concludes with a practical application of an expectations model to demonstrate its use beyond macro-analysis to the micro-analysis of patents. Employing a Canadian patent case adjudicated at the Federal Court and the Federal Court of Appeal, the analysis demonstrates the use of utility parameters in evaluating patents, creating patent score cards which can eventually be used as a database for evaluating the utility of future patents and setting patent terms accordingly

Transduction Efficiency of AAV 2/6, 2/8 and 2/9 Vectors for Delivering Genes in Human Corneal Fibroblasts

In the present study, cellular tropism and relative transduction efficiency of AAV2/6, AAV2/8 and AAV2/9 vectors have been tested for the cornea using primary cultures of human corneal fibroblasts. The AAV6, AAV8 and AAV9 serotypes having AAV2 ITR plasmid encoding for alkaline phosphatase (AP) gene were generated by transfecting HEK293 cell line with pHelper, pARAP4 and pRep/Cap plasmids. Primary cultures of human corneal fibroblasts were exposed to AAV infectious particles at two different doses (1×105 and 2×105 MOI). Cytochemistry and enzyme assays were used to measure delivered transgene expression in samples collected at 4 and 30 hours after AAV infection by counting AP-stained cells or quantifying AP enzyme activity. Cellular toxicity of AAVs was evaluated with TUNEL and trypan blue assays. All three AAV serotypes transduced human corneal fibroblasts. The order of transduction efficiency was AAV2/6\u3e\u3e\u3eAAV2/9\u3eAAV2/8. The transduction efficiency of AAV2/6 was 30-50 fold higher (p \u3c0.001) for the human corneal fibroblasts compared to the AAV2/8 or AAV2/9 at two tested doses. The level of transgene expression at 4 hrs was considerably low compared to 30 hrs suggesting that the transgene delivery did not reach its peak at 4 hrs. Cultures exposed to any of the three AAV serotypes showed more than 97% cellular viability and less than 5 TUNEL positive cells suggesting that tested AAV serotypes do not induce significant cell death and are safe for corneal gene therapy