Thesis (Ph.D. (Business Management))--North-West University, Vaal Triangle Campus, 2005.

Canada’s Patented Medicines (Notice Of Compliance) Regulations fail to achieve the intended purpose of balancing innovation with timely generic market entry. An examination of the inefficiencies created by the Canadian regulations reveals that key features of U.S. pharmaceutical law should be adopted to improve the disjointed regulatory system that impedes generic competition. Specifically, the regulations should be amended to consolidate multiple proceedings into one cause of action that evaluates patent validity. An economic incentive to challenge weak patents should also be introduced in Canada. These features encourage competition without deterring pharmaceutical research and development because only patents that are not truly inventive will be invalidated after a full inquiry. As such, the intellectual property laws will continue to satisfy Canada’s international intellectual property obligations and protect innovative medicines and allow recovery of costs and monopoly profits to new and useful pharmaceutical products.

We study the power series ring R= K[[x1,x2,x3,...]]on countably infinitely many variables, over a field K, and two particular K-subalgebras of it: the ring S, which is isomorphic to an inverse limit of the polynomial rings in finitely many variables over K, and the ring R', which is the largest graded subalgebra of R. Of particular interest are the homogeneous, finitely generated ideals in R', among them the generic ideals. The definition of S as an inverse limit yields a set of truncation homomorphisms from S to K[x1,...,xn] which restrict to R'. We have that the truncation of a generic I in R' is a generic ideal in K[x1,...,xn]. It is shown in <b>Initial ideals of Truncated Homogeneous Ideals</b> that the initial ideal of such an ideal converge to the initial ideal of the corresponding ideal in R'. This initial ideal need no longer be finitely generated, but it is always locally finitely generated: this is proved in <b>Gröbner Bases in R'</b>. We show in <b>Reverse lexicographic initial ideals of generic ideals are finitely generated</b> that the initial ideal of a generic ideal in R' is finitely generated. This contrast to the lexicographic term order. If I in R' is a homogeneous, locally finitely generated ideal, and if we write the Hilbert series of the truncated algebras K[x1,...,xn] module the truncation of I as qn(t)/(1-t)n, then we show in <b>Generalized Hilbert Numerators </b>that the qn's converge to a power series in t which we call the generalized Hilbert numerator of the algebra R'/I. In <b>Gröbner bases for non-homogeneous ideals in R'</b> we show that the calculations of Gröbner bases and initial ideals in R' can be done also for some non-homogeneous ideals, namely those which have an associated homogeneous ideal which is locally finitely generated. The fact that S is an inverse limit of polynomial rings, which are naturally endowed with the discrete topology, provides S with a topology which makes it into a complete Hausdorff topological ring. The ring R', with the subspace topology, is dense in R, and the latter ring is the Cauchy completion of the former. In <b>Topological properties of R'</b> we show that with respect to this topology, locally finitely generated ideals in R'are closed.

Canada’s Patented Medicines (Notice Of Compliance) Regulations fail to achieve the intended purpose of balancing innovation with timely generic market entry. An examination of the inefficiencies created by the Canadian regulations reveals that key features of U.S. pharmaceutical law should be adopted to improve the disjointed regulatory system that impedes generic competition. Specifically, the regulations should be amended to consolidate multiple proceedings into one cause of action that evaluates patent validity. An economic incentive to challenge weak patents should also be introduced in Canada. These features encourage competition without deterring pharmaceutical research and development because only patents that are not truly inventive will be invalidated after a full inquiry. As such, the intellectual property laws will continue to satisfy Canada’s international intellectual property obligations and protect innovative medicines and allow recovery of costs and monopoly profits to new and useful pharmaceutical products.

TRIPS strengthened international patent protection, particularly in relation to pharmaceutical patents. A compulsory license mechanism is one of the exceptions from patent protection available under TRIPS. This mechanism applies mainly to domestic market supply. Underdeveloped countries with insufficient pharmaceutical manufacturing capacities are unable to use this exception to import medicines in public health emergencies. To resolve this problem, the WTO General Council’s decision allows the export of generic versions of patented drugs under certain conditions. Canada’s Bill C-9 was the first statute to implement the decision. Bill C-9 bears both humanitarian and TRIPS-like provisions. The role of the Government is unjustifiably limited to participation in administrative and legislative processes, while the main operators in the scheme are the generic manufacturer and partly, the patent holder. This thesis proposes several different models to transform the Bill into a workable system for the export of drugs to underdeveloped countries afflicted with pandemics. / October 2006

Since the implementation of Directive 2004/48 EC on the Enforcement of Intellectual Property Rights in Sweden there is today a possibility for pharmaceutical companies holding a patent to issue interim injunctions against a generic company on the grounds of an attempt or preparation to a pharmaceutical patent infringement. It has been shown that one of the earliest steps in which a generic company may infringe a pharmaceutical patent is to offer the generic drugs onto the market. However, since the implementation of the attempt and preparation rule in the Swedish Patent Act questions have been raised as to in what stage interim injunctions may be issued against an attempt or preparation to offer generic drugs onto the market made by generic companies. This thesis has therefore intent to investigate at what stage interim injunctions may be applied for against a generic company on the grounds of an attempt or preparation to offer generic drugs. In the thesis the writer argues that in order for an attempt or preparation to offer generic drugs to exist an overall assessment must be made of the particular situation and that there is no specific principles to follow in order to determine either an attempt or a preparation to offer generic drugs. However, some guidance might be brought from Danish case law in order to establish a preparation to offer generic drugs in Sweden.

Generics has recently been adopted to many mainstream object oriented languages, such as C# and Java. As a particular design choice, generics in C# and Java use a sub-typing relation to constraint type parameters. Failing to encapsulate type parameters within generic interfaces and inability to encapsulate type constraints as part of an interface definition have been identified as deficiencies in the way this design choice has been implemented in these languages. These deficiencies can lead to verbose and redundant code. In particular, they have been reported to affect the development of highly generic libraries. To address these issues, extending object oriented interfaces and sub-typing with associated types and constraint propagation has been proposed and studied in an idealized small-scale formal setting. This thesis builds on this previous work and provides a design and implementation of the extensions in full C#. We also present a proof of soundness of the Featherweight Generic Java (FGJ) formalism extended with interfaces. This property was assumed in a proof of type safety of associated types and constraint propagation, but no proof for the property was provided.

Reusing code from software libraries can reduce the time and effort to construct software systems and also enable the development of larger systems. However, the benefits that come from the use of software libraries may not be realized due to limitations in the way that traditional software libraries are constructed. Libraries come equipped with application programming interfaces (API) that help enforce the correct use of the abstractions in those libraries. Writing new components and adapting existing ones to conform to library APIs may require substantial amounts of "glue" code that potentially affects software's efficiency, robustness, and ease-of-maintenance. If, as a result, the idea of reusing functionality from a software library is rejected, no benefits of reuse will be realized. This dissertation explores and develops techniques that support the construction of software libraries with abstraction layers that do not impede efficiency. In many situations, glue code can be expected to have very low (or zero) performance overhead. In particular, we describe advances in the design and development of active libraries - software libraries that take an active role in the compilation of the user's code. Common to the presented techniques is that they may "break" a library API (in a controlled manner) to adapt the functionality of the library for a particular use case. The concrete contributions of this dissertation are: a library API that supports iterator selection in the Standard Template Library, allowing generic algorithms to find the most suitable traversal through a container, allowing (in one case) a 30-fold improvement in performance; the development of techniques, idioms, and best practices for concepts and concept maps in C++, allowing the construction of algorithms for one domain entirely in terms of formalisms from a second domain; the construction of generic algorithms for algorithmic differentiation, implemented as an active library in Spad, language of the Open Axiom computer algebra system, allowing algorithmic differentiation to be applied to the appropriate mathematical object and not just concrete data-types; and the description of a static analysis framework to describe the generic programming notion of local specialization within Spad, allowing more sophisticated (value-based) control over algorithm selection and specialization in categories and domains. We will find that active libraries simultaneously increase the expressivity of the underlying language and the performance of software using those libraries.

We investigate the genericity of measure-preserving actions of the free group Fn, on possibly countably infinitely many generators, acting on a standard probability space. Specifically, we endow the space of all measure-preserving actions of Fn acting on a standard probability space with the weak topology and explore what properties may be verified on a comeager set in this topology. In this setting we show an analog of the classical Rokhlin Lemma. From this result we conclude that every action of Fn may be approximated by actions which factor through a finite group. Using this finite approximation we show the actions of Fn, which are rigid and hence fail to be mixing, are generic. Combined with a recent result of Kerr and Li, we obtain that a generic action of Fn is weak mixing but not mixing. We also show a generic action of Fn has sigma-entropy at most zero. With some additional work, we show the finite approximation result may be used to that show for any action of Fn, the crossed product embeds into the tracial ultraproduct of the hyperfinite II1 factor. We conclude by showing the finite approximation result may be transferred to a subspace of the space of all topological actions of Fn on the Cantor set. Within this class, we show the set of actions with sigma-entropy at most zero is generic.

Fix an algebraic curve X. We study the problem of parametrizing geometric data over X, which is only generically defined. E.g., parametrizing generically defined maps from X to a fixed target scheme Y. There are three methods for constructing functors of points for such moduli problems (all originally due to Drinfeld), and we show that the resulting functors are equivalent in the fppf Grothendieck topology. As an application, we obtain three presentations for the category of D-modules “on” \(B(K)\backslash G (\mathbb{A}) /G (\mathbb{O})\) and combine results about this category coming from the different presentations. / Mathematics