Intellectual property definition

Most of the equivalent patents are incorporated in the discussion, to give a sense of the international coverage to the reader. A summary of the main claim is included as a definition of the property subject matter. As could be seen the property subject matter of a World Intellectual Property Organization (WIPO) patent generally, is identical to one of the corresponding US patent (from the US Patent and Trademark Office, USPTO). However, in some instances a WIPO patent has more than one US equivalent patent. The equivalence between WIPO and US patents will be discussed for each particular case wherever relevant. 

When third parties are involved in process research and development work, agreements are needed to cover both the objectives of the joint program of work and definition of the ownership of intellectual property (patents) discovered by the third party. Such agreements benefit all parties. 

There is no guidance within the legislation regarding intellectual property rights apart from the definition of commercialisation, which includes ... 

Intellectual property issues need to be addressed more effectively. In the past, collaborations typically involved a company and a federal laboratory. Simple assignments of the patents or provisions for the company to license the technology were adequate. The DOE cooperative research and development agreement (CRADA) Subject Invention definition can confuse intellectual property ownership. Today, the collaborations may involve several partners, the results may be used by joint ventures, or even more-creative business structures may need access to the intellectual property developed by the collaboration. Increased flexibility on how this property is managed is a key issue for the future. 

The foundation of successful positioning is an optimal R D portfolio. Often R D portfolios are derived from an assessment of individual projects/therapeutic areas by the individual units, without a really comprehensive assessment across indications. In addition, the portfolio definition and management processes are often developed with insufficient involvement of all relevant functions, i.e., research, development, production, regulatory affairs, patents/intellectual property, marketing and sales. 

This chapter has merely surveyed some ways in which co-crystals may translate into new patents and commercial value and has discussed some considerations for accomplishing this. It is clear that the success of co-crystals in commercialization and as new patents is tied to their unique chemical composition, crystalline structure, and properties. Engineering pharmaceutical properties using co-crystals can create new commercial value for an API and extend its patent life. This value comes from the composition of the co-crystal as well as from its crystalline form. Patenting co-crystals captures that value in the form of intellectual property. Yet, co-crystal patents have their own unique aspects to be addressed as can be seen from the discussion of the definition of cocrystal , the patentability of co-crystals, and the information needed for... 

The typical patent application consists of the claim itself, a precise description of specifications, and the rationale for protection. In the specific field of EvoEng patents filed to date have claimed produced molecules with known function and utility, state-of-the-art production processes of molecules with known utility, or a selection process for useful traits in an already characterized strain. As explained in Fig. 3.1, the process of EvoEng consists of 3 steps amplification, diversification and selection. Protection claims may be directed towards the steps in the cycle, specific conditions of the cycle, or improvements to previous patents (e.g. the specific and defined mutation conditions used to obtain variation and/or definite selection with respect to flmess toward an EO). The penultimate example of EvoEng intellectual property is the SELEX technique (WO 91/19813), discussed in Sect. 3.3.1 and its follow-up patents regarding variations and improvements (Leimkiihler and Meyers 2004, 2005). 

The field of co-crystals has elicited significant interest in the pharmaceutical industry recently with the potential to utilize this technology as means of enhancing physicochemical properties such as solubility and dissolution in addition to enhancements to particle properties that could aid drug product development,. e.g. improving both chemical and physical stability and indeed as a method to induce crystallization of materials that traditionally would have been isolated as an oil or an amorphous material. There is also considerable ongoing debate as to the theoretical definition of a co-crystal, how a co-crystal can be reliably synthesized, manufactured and characterized, coupled with the intellectual properties ramifications therein. This presentation will outline some of our recent research efforts (in-house external) into the synthesis of co-crystals, and will outline different techniques that can be utilized to characterize co-crystals. 

When studying chemical properties of TAEs on the one-atom-at-a-time (per shift, day, week or month) level - which requires not only large intellectual and material efforts but also a lot of patience - the experimenters are inevitably tempted to draw more definite and numerous conclusions than the poor statistics actually permit. It is important to be aware of this danger and pay due attention to the statistical uncertainties of the obtained data, especially when counting is not free of background. 

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