Disputes, resolution

T. Arnold, Patent Alternative Dispute Resolution Handbook, Clark Boardman Co., Ltd., New York, 1991. 

The first steps include holding scientific workshops with key stakeholders, re-examining and clarifying the scope and interpretation of Part 11 (see Section 9.6.3), developing technical dispute resolution processes, and harmonizing inconsistencies between the different centers of the FDA. 

Eormal Dispute Resolution Seientifie and Teehnieal Issues Related to Pharmaceutical cGMP... 

Establishes dispute resolution mechanisms for the resolution of scientific controversies relating to new drugs. 

The effects of evolution on regulation are generally positive. Vague requirements are clarified with example, dispute resolution, and dissemination of interpretation. Differences of opinion are debated, discussed, and S3mthesized. Guidelines are issued, investigators are trained, and examples are provided. 

Australian Trade Minister and U.S. Trade Ambassador Chapter 17 (Intellectual Property Rights) and Chapter 21 (Dispute Resolution Procedures) (Faunce 2005c). All of these in different ways have the capacity to impact on pharmaceutical cost-effectiveness pricing (Faunce et al. 2005). Chief amongst them, however, is Annex 2C. 

The constructive ambiguities in Annex 2C may be definitively settled only under the AUSFTA dispute resolution chapter 21, by an unelected panel of three nominated trade lawyers (Article 21.7). Perhaps of great importance for the PBS in this context is Article 21.2(c). This is what is known in international trade law as an NVNB clause. NVNB provisions allow dispute resolution proceedings to be commenced where only the "spirit" of the treaty had been broken or, more technically, the "legitimate expectations" have been nullified or impaired (no technical violation) by a "measure" of the other party. 

Treaty with mandatory international arbitration clauses, and no right to block the transit during dispute resolution (for example ECT, WTO)... 

The next steps are clearly confrontation in varying degrees of severity. For most divisions and groups to which a submission is directed, there is a formal appeals process (see Chapter 6). If not, or as a step beyond that appeals channel, the FDA Office of the Ombudsman has a dispute-resolution procedure. Finally, it is possible to bring suit against the FDA in Federal Court. 

Communications between the FDA and applicants Dispute resolution Drags with potential for abuse Approval of an application and an abbreviated application... 

Technology transfer specialists, in contrast, are more focused on business aspects. They need to be able to work closely with and understand the work of the industrial property people, to help them check on the patent applications filed by the institution. But they also, and more importantly, must follow market trends involving the portfolio of patents and applications, orient the preparation of technical cooperation, detect and contact potential partners for future technology transfers, negotiate and draft contractual instruments applicable to each case, monitor the partnerships formed, deal with external law offices specializing in intellectual property, and act in cases of breach of contractual clauses. In relation to this last item, when a contractual infraction or other compliance problem is noted, a choice must be made as to what action to take. Will it be by judicial action or some form of alternative dispute resolution ... 

There is a range of alternative dispute resolution (ADR) methods. Among the most common are arbitration and mediation, although conciliation and direct negotiation are also possible. 

Dispute resolution is an important process for business, since it permits a quick, fair, and economic way to solve conflicts, without the need for prolonged litigation. Hence, it is possible to obtain a more satisfactory outcome and often to preserve a suitable commercial relationship. 

ADR AUTM EPC IDA IFN-alpha INPI mAb alternative dispute resolution Association of University Technology Managers European Patent Convention irnationally recognized depositary authority Interferon-alpha Brazilian National Institute of Industrial Property Monoclonal antibody... 

Establish expedited dispute resolution processes for distributed generation project proposals. 

In the United States, this is a civil action brought in the federal courts. The specific federal district court in which a patent owner can sue an infringer is governed by federal law. Patent litigation is very expensive and time-consuming. For this reason, it is not entered into without careful consideration of the consequences and analysis of all options available. In recent years, various alternative dispute-resolution proceedings have been used more often. 

See, e.g., Brunda, "Resolution of Patent Disputes by Non-litigation Procedures," 15 AIPLA Q. J. 73 (1987) Arnold, "Alternative Dispute Resolution in Intellectual Property Cases," 9(1) AIPLA Seleeted Legal Papers 289 (July 1991). 

Draft Guidance for Industry Formal Dispute Resolution Scientific and Technical Issues Related to Pharmaceutical CGMP. Food and Dmg Administration Rockville MD, 2004. 

This activity includes information on contractual arrangements with suppliers and points of contact, relationship history (orders, fulfillments, disputes, resolutions), business evaluations, and technical evaluations of products and capabilities, including certifications for specific materials. For specific materials (or product families), there are approved supplier lists that identity supphers from whom the organization may order that material, often with preference ranking or ranking criteria. 

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