Biopatent Law: Patent Strategies and Patent Management by Andreas Hübel

By Andreas Hübel

Patents preserving biotechnological invention have gotten ever extra vital. simply because biotechnology has many ameliorations with admire to different applied sciences, classes discovered in different fields of expertise can't easily be transferred to undertake an appropriate process for facing biotechnology innovations.

In this quantity, normal facets of biopatent legislations may be mentioned. This consists of questions of patentability, together with moral matters and problems with technicality, in addition to questions of patent exhaustion in circumstances have been reproducible material, like cells or seeds, is secure. in addition, lively and passive patent techniques are addressed. additional, perception can be given into patent lifetime administration and extra protecting measures, like supplementary safeguard certificate and information exclusivity. the following, concepts are mentioned how marketplace exclusivity might be prolonged so long as attainable, that's rather very important for biopharmaceutical medicinal drugs, which create excessive R&D costs.

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Under many jurisdictions, the individual prescription of a given drug for a given indication, as effected by a physician, qualifies as exempt from patent protection. Under this privilege, a physician can legally prescribe the biosimilar version of a biopharmaceutic for which compound protection has expired, for treatment of a given disease, even if said indication is subject of second or higher medical indication patent. However, this privilege applies only for prescription on an individual, patient-focused basis.

In case a patent application describes, and claims, a new protein that may play a physiological role in the human body, it is common to also draft a claim related to a theoretical antibody against said protein. 18 In both cases, the rationale behind this position was that the provision, and correct specification, of a novel protein X enables a skilled person to produce an antibody against said protein. Therefore, it is considered a fair reward for the applicant of protein X to be granted a claim related to a theoretical antibody against said protein.

European Patents, in contrast, expire 20 years after filing [Article 63(1) EPC], which may amount to an effective period of 21 years as well in case a priority has been claimed. Similar terms apply to patents in most other industrialized countries. 2 Patent Term Adjustment While there is no way to extend the actual lifetime of a European Patent, the USPTO grants day-for-day supplements to the normal patent term to compensate potential delays in prosecution caused by the USPTO under 35 USC 154 (b).

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