Author: Bawa, Raj

Source: Nanomedicine, Volume 2, Number 3, June 2007 , pp. 351-374(24)

Publisher: Future Medicine

Abstract:

Big pharma's business model, which relies on a few blockbusters to generate profits, is clearly broken. Patent expiration on numerous blockbusters in recent years is already altering the drug landscape. Drug companies are also facing other challenges that necessitate development and implementation of novel R&D strategies, including those that focus on nanotechnology and miniaturization. Clearly, there is enormous excitement and expectation regarding nanomedicine's potential impact. However, securing valid and defensible patent protection will be critical. Although early forecasts for nanomedicine commercialization are encouraging, there are numerous bottlenecks as well. One of the major hurdles is an emerging thicket of patent claims, resulting primarily from patent proliferation as well as continued issuance of surprisingly broad patents by the US Patent and Trademark Office (PTO). Adding to this confusion is the fact that the US National Nanotechnology Initiative's widely cited definition of nanotechnology is inaccurate and irrelevant from a nanomedicine perspective. It is also the cause of the inadequate patent classification system that was recently unveiled by the PTO. All of this is creating a chaotic, tangled patent landscape in various sectors of nanomedicine where the competing players are unsure of the validity and enforceability of numerous issued patents. If this trend continues, it could stifle competition and limit access to some inventions. Therefore, reforms are urgently needed at the PTO to address problems ranging from poor patent quality and questionable examination practices to inadequate search capabilities, rising attrition, poor employee morale and a skyrocketing patent application backlog. Only a robust patent system will stimulate the development of commercially viable nanomedicine products that can drastically improve a patient's quality of life and reduce healthcare costs.

Keywords: commercialization; drug delivery; nanomedicine; nanoparticles; National Nanotechnology Initiative; nonexclusive licensing; patent classification; patent thickets; US Patent and Trademark Office

Document Type: Research article

DOI: http://dx.doi.org/10.2217/17435889.2.3.351

Affiliations: 1: 1Bawa Biotechnology Consulting, LLC, 21005 Starflower Way, Ashburn, Virginia 20147, USA

Publication date: 2007-06-01

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• Nanomedicine is a uniquely medicine-focused journal in nanotechnology, addressing the important challenges and advances in medical nanoscale-structured material and devices, biotechnology devices and molecular machine systems, and nanorobotics.
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