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Mund, Claudia --- "Patenting biosimilars" [2017] ELECD 802; in Matthews, Duncan; Zech, Herbert (eds), "Research Handbook on Intellectual Property and the Life Sciences" (Edward Elgar Publishing, 2017) 3

Book Title: Research Handbook on Intellectual Property and the Life Sciences

Editor(s): Matthews, Duncan; Zech, Herbert

Publisher: Edward Elgar Publishing

ISBN (hard cover): 9781783479443

Section: Chapter 1

Section Title: Patenting biosimilars

Author(s): Mund, Claudia

Number of pages: 12

Abstract/Description:

The title chosen for the present chapter might be surprising to some skilled experts and IP professionals. The two terms ‘patenting’ and ‘biosimilars’ are hardly ever used within the same context and it seems to be a contradiction in itself. True, the ‘classic’ approach to the concept of biosimilars is one of follow-on drugs or generics, which profit from the fact that patent protection of the original drug has already expired, and from simplified procedures for market authorization. This approach does not include any patent-related issues such as the scope of a patent claim, patent infringements, or the risk of being copied at all. However, patent-related questions do arise by slightly shifting the perspective and questioning whether a biotechnological invention, in which the pioneer manufacturer has invested high research costs, could – with minor changes or amendments – be brought to the market as a new product by an imitating competitor. The following chapter investigates this broader understanding of ‘biosimilars’ and presents some thought-provoking points without claiming to provide a final response to all the questions raised. When defining and delimiting biosimilars from other conventional drugs or generics, it is essential to take a brief look at pharmaceutical history. Some centuries ago, most drugs and medications were composed of small molecules that were not too complex in their chemical structure. The pharmaceutical industry took advantage of patent protected drugs by being the exclusive holder of the intellectual property rights for up to twenty years.After the drugs went off patent, other players began to enter the market by selling copies of the original chemical products at a lower price. These so-called ‘generic drugs’ are identical copies of the chemical molecular structure of the innovator product. They contain the same quantity of active substancesas the reference medicine. They are used in the same dosage to treat the same diseases and have an identical effect on the human body by being identical or nearly identical in their composition and manufacturing technology.Therefore, they are bioequivalent, which means the effects of the original chemical product and the generic product, with respect to both efficacy and consumer safety, can be expected to be essentially the same. Generic drugs are interchangeable and substitutable with the innovator product. They are, in general, cheaper than their originals since generic drug manufacturers do not develop a drug from scratch, meaning research costs can be reduced. In addition, most regulatory drug authorities apply a simplified authorization procedure for a medical product with known active pharmaceutical ingredients if the product meets the requirements for quality, safety and efficacy. These abbreviated approval procedures do not require the generic manufacturer to repeat costly clinical trials on ingredients or dosage forms that have already been approved for safety and effectiveness. Incremental development costs can be kept comparatively low. In this way, generic products can significantly contribute to reducing health care costs.Most regulatory authorities for drug market approval, such as the Food and Drug Administration (FDA)in the US or the European Medicines Agency (EMA),apply abbreviated drug application procedures for generic drugs.