Intellectual Property - Patent Drafting and Expert Witness assistance

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Patent Preparation Expert Witness

New Product Acquisition Drug Delivery Systems

Preformulation Formulation and Process Design Analytical Method Development and Validation Feasibility and Stability Quality By Design IND CMC Documentation Bioavailability Reverse Engineering of Pharmaceucial Formulation

Quality By Design Process Optimization Scale-Up and Clinical Manufacture Analytical Methods Regulatory Stability Process Validation Technical Transfer Bioequivalence Testing NDA CMC Documentation

Quality By Design for Excipients Excipient Safety Regulatory Alternate Sources Quality Management Systems

Excipients Drug Delivery Systems Clinical Trial Supplies Medicinal Products

Two major aspects of Intellectual Property must be considered for formulations; the drafting of patents, and avoidance of patent infringement during the formulation and development of generic versions of a medicinal product.

Many generic companies lose their cases, not because they necessarily deliberately infringe a patent, but because they do not understand the difference between science and case law, and that case law will prevail regardless of the science.

For the innovator companies, properly qualified expert witnesses are equally important. Very often the litigation focuses on what a person of ordinary skill in the arts would/could have known at the time of the patent was filed.

FinnBrit Consulting has the necessary experience to advise pharmaceutical companies formulation patents from drafting it to acting as an Expert Witness.

All information published throughout www.finnbrit.com is intended for information only, and does not contain any warranties, implied or otherwise.

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