The field of bioinformatics is flourishing, and strong growth is only projected to continue. Like any cutting edge technology, bioinformatics requires an integrated IP strategy involving patent, trade secret, and copyright laws. The patent system in particular can be a powerful protection for commercializing bioinformatics inventions as long as a corresponding patent application meets certain patent law standards. Recently, the most rapidly evolving of these patent law standards—patent eligibility—came to a crescendo last year when the Supreme Court in Alice v. CLS Bank introduced a two-step test for determining whether computer-implemented inventions are patent-eligible. Since then, other courts and the USPTO have applied the test on inventions implemented on a computer and/or using the Internet with fact-dependent results. Here, we discuss how these decisions relate to bioinformatics inventions. We then analyze bioinformatics patents that have recently issued post-Alice. While the law remains relatively underdeveloped, it becomes clear that relying on a general purpose computer to perform routine or conventional steps in a claim will not infuse patent-eligibility into a claim. However, bioinformatics inventions remain patentable, especially when the patent prosecution team properly and persuasively presents the technical improvements and commercial embodiments.
As a small biotech company embarks on a drug development program, there is a tendency for management to focus on a well-defined set of issues. Is the science behind the drug valid? Does it solve an interesting problem or unmet need? What are the prospects that the medical community and patients will embrace it as a valuable new solution? And what is the range of indications the drug is conceived as addressing? These are all valid questions, but a small biotech can do even more to prepare itself for the drug development process, which is a journey that can take many years and cost a significant amount of money.
America deserves access to high-quality health care without avoidable medical errors and complications. This achievable goal begins with harnessing and using the power of information. And that begins with clear, accurate, and usable labeling.The Americ…
Historically, innovation in the biotechnology sector has relied to a large extent on the expensive infrastructure provided by universities or large pharmaceutical companies. This prohibitive start-up expense is the basis of why garage-style biotechnolo…
As in the medical biotechnology area some decades ago, the fast technological development within industrial biotechnology (IB) has caused numerous new ventures. Venture capital (VC) has become a major capital source for these companies and VC investors…
The Brazilian human health biotechnology sector was analyzed according to its spacial and sectorial distribution of the following aspects: (i) the scientific production; (ii) dependence of companies on governmental funding for research and development;…
Specialty biologics are the fastest growing class of bio/pharmaceutical products in terms of the number of new brand launches and rates of health care spending in the U.S. and globally. Innovative biologics meant to treat a range of hitherto untreatable conditions in oncology, inflammation, CNS, endocrinology and other chronic conditions seek to offer radical improvements in efficacy and patient well-being. Such products can command premium prices, often costing over $100K per year per patient – triggering a raft of challenges to ensuring that eligible patients have adequate access.
This article outlines important trends impacting market access to specialty biologics in the U.S. and globally. Particular importance is placed on evolving methods for managing specialty product utilization and reimbursement toward ensuring appropriate access. The reshaping of the specialty product market access landscape in the U.S. through the availability of oral biologic formulations distributed to patients via high-touch, high-involvement specialty pharmacies is examined. The rising role of risk sharing between specialty product manufacturers and insurers as a way to balance rewards of access with the risks inherent in radical new specialty therapeutics is discussed. Challenges posed by specialty biosimilars to traditional ways of ensuring market access and fair reimbursement are outlined. The impact of health care reforms on market access for specialty biologics in the U.S. is discussed in the context of the growing need for comparative outcomes research and the application of the principles of health technology assessments – adapted, in part from their apparent success in ensuring equitable and cost-effective access to biologics in the E.U.
Advances in commercial application of biotechnology worldwide over the past two decades have led to the development of a bioeconomy, whereby substantial economic outputs are from the development and use of biological materials. Bioeconomy encompasses all industries and economic sectors based on the values implicit in biological materials that can be translated into new sources of income, environmental sustainability and social well-being.
Malaysia, one of the most competitive biotechnology hubs in the Asia-Pacific region, has also taken critical early steps to coordinate and intensify national efforts to harness the potential of the bioeconomy. Most significantly, the Bioeconomy Transformation Programme (BTP) was launched in October 2012, making the country only the second in Asia, after China, and the first in ASEAN, to establish its own national bioeconomy initiative.
The BTP is in line with the Government’s objective to develop Malaysia into a high-income nation by the year 2020. The BTP aims to achieve this by focusing on bio-based industries in Malaysia, a sector that has been identified as having enormous potential to further develop the nation due to the abundance of natural resources available.
With the introduction of the BTP, Malaysia is now unlocking even greater opportunities in the local and regional biotechnology industry, and enhancing the participation of the private sector. Through effective execution strategies from the Government and BiotechCorp, the biotechnology sector is now directly contributing towards efforts to drive Malaysia towards a high-income and knowledge-based economy by year 2020.
The purpose of this paper is to provide an update and report the current status of the cross-campus University of Colorado Denver program in bioinnovation and entrepreneurship, details of which were first reported in the Journal of Commercial Biotechnology in 20125. The paper outlines the joys and challenges of implementing an inter-campus program that attempts to marry cutting-edge biotechnology innovation with a solid business foundation. The tremendous value offered by such a program, particularly to biotechnology and life-science researchers, is outlined. Operationalization and process issues such as differential tuition rates, distance between campuses, and class timing issues are considered, and solutions are offered. Finally, recommendations are provided for other business schools considering a similar program.
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