The life sciences industry and the changing IP landscape

2013 ◽  
Vol 19 (3) ◽  
Author(s):  
Gareth Williams

This article looks at the findings of Marks & Clerk’s 2013 Life Sciences Report, launched in April 2013. Of interest to both R&D/IP experts and professionals in strategic positions within biotechnology companies, it explores many of the issues facing the biotechnology industry and is informed by an industry survey of over 330 international life sciences professionals. Topics explored include the financial climate, growing markets in Asia, IP reforms in the US and Europe, biosimilars and personalised medicine.

1969 ◽  
Vol 15 (4) ◽  
Author(s):  
J Leslie Glick

Venture capital (VC) funding of US biotechnology companies was analysed relative to total VC investments placed in US companies from 1995 to 2007. During those years, except for a spike because of the dot-com bubble from 1999 to 2001, VC funding of US biotechnology companies grew at a faster rate percentagewise than total VC funding of US companies, with respect to annual dollars invested, number of deals closed and the mean dollar investment. Start-up and early-stage VC funding of US biotechnology companies also grew at a faster rate percentagewise, with respect to all three parameters, than total start-up and early-stage VC funding of US companies. It was further observed that long-term trends in the availability of VC for biotechnology do not appear to be affected by perturbations in the financial markets and short-term fluctuations in the availability of VC. It was concluded that the biotechnology industry should continue to attract VC over the long run particularly because of the emerging impact of personalised medicine and the coming of age of bioenergy.


1969 ◽  
Vol 17 (4) ◽  
Author(s):  
David J Dykeman ◽  
Danielle T Abramson

As a result of the global recession that began in 2008, life sciences companies face a groundswell of new business and regulatory pressures that includes health care and patent reform, increased pricing pressures, and diluted markets. Bringing new products from discovery to market is becoming more expensive and unpredictable. In the pharmaceutical sector, some predict that the age of the blockbuster drug has ended as generics present a growing threat to the pharmaceutical giants. Further, with a large number of key patent expirations looming through 2014, analysts expect that large pharmaceutical companies will lose over US$150 billion of revenues of brand name drugs.In response to declining sales and rising R&D costs, the life sciences industry is pursuing new market opportunities by expanding beyond the developed markets of the United States, Europe and Japan, and into emerging markets such as China and India. Despite market uncertainties, however, venture capital funding in the life sciences sector (including pharmaceuticals and medical devices) is on the rise with $2.1 billion going into 206 deals during the second quarter of 201l, an increase of 37 per cent in dollars and 12 per cent in deal volume. To survive – and thrive – in these tumultuous times, both large and small life sciences companies face pressure to develop new products and technological advancements.Patents are pivotal to the life sciences industry. In order to succeed, life sciences companies must distinguish themselves from their competitors through their intellectual property portfolios. A successful patent portfolio represents a well-reasoned business strategy, where each patent is a single strategic building block in a larger portfolio that reflects present and future business objectives. A strong patent portfolio is also important in the current life sciences investment climate, where venture capital funding is often dependent on whether a company has secured its intellectual property assets, thereby validating a company's technology and demonstrating its commercial potential. Although building and maintaining a strong patent portfolio is important for all life sciences companies, it is most critical for early-stage companies. Patent portfolios are often the driving force for major events in the life cycle of a life sciences company, including mergers and acquisitions, public offerings, venture capital investment, strategic collaborations, joint ventures and litigation.As a result of recent measures taken by the US Congress, the US Patent and Trademark Office (USPTO) and the US Supreme Court to reform the current US patent system, life sciences companies must respond with strong patent strategies that address these reforms without sacrificing the company's competitive edge in the marketplace. Such comprehensive technology strategies must maximize patent coverage of a company's current core technology and future improvements, monitor the patent landscape and explore ways to patent white space, and consider cross-licensing opportunities with competitors. With these strategies in place, life sciences companies can withstand patent reform and ensure their success in today's competitive and rapidly evolving global commercialization landscape.


Subject The US life sciences sector. Significance The US pharmaceutical company Gilead purchased rights and shares in the Belgian-Dutch firm Galapagos with a 5.1-billion-dollar agreement in mid-July. The move illustrates a trend in the life sciences industry (pharmaceuticals, biotechnology and other sectors based on biological knowledge): the effective outsourcing of research functions through mergers and acquisitions (M&A). Gilead pursued Galapagos, according to reports, for access to its drugs in development and those in its pipeline. However, there are questions about whether this strategy is sufficient for the sector long-term. Impacts Laws or rulings on data or genetic privacy will affect medical-data-reliant life sciences firms, posing shocks. This is less likely in the United States, where the industry has considerable lobbying power. A major EU data decision could bifurcate the life sciences industry.


1998 ◽  
Vol 12 (2) ◽  
pp. 77-83
Author(s):  
Paul M. Kelley

The author briefly describes what venture funders do and how they do it to illuminate the process of high-tech business formation and development. By way of illumination, he gives two short histories of successful university spin-outs that his company, Zero Stage Capital, has helped launch. He then examines how this firm's knowledge and experience may apply in the context of the Scottish university and financial climate, and bearing in mind the goals of Scotland's Technology Ventures strategy. Finally, he discusses the US government support initiatives for small business, the Small Business Investment Company (SBIC) Program. He suggests an approach for its application in increasing the birth-rate of fast-track technology-based ventures in Scotland or in other countries that have the infrastructure to support and enhance the process.


Author(s):  
Paige Clayton ◽  
Maryann Feldman

We review the literature on entrepreneurial team formation with a focus on data to study academic teams and summarize our empirical work on the life sciences industry. We consider how academics form teams to start new companies and the implications of various configurations on firm behavior with regards to patenting, survival and firm growth. We present several empirical challenges facing research on academic teams and conclude with suggestions for future research.


1969 ◽  
Vol 16 (1) ◽  
Author(s):  
Yali Friedman

In the relatively short history of the biotechnology industry, new business models have emerged every few years. Some have been little more than short-lived marketing or investment-attraction devices, whereas others have had endured as viable options. Given the dramatic changes in the economic climate and potentially the regulations affecting biotechnology, is it time for a new business model?A SHORT HISTORYFirst there was the FILCO, or fully integrated life science company, business model. This model, employed by some of the first biotechnology companies, positioned firms to capture the revolutionary advances of biotechnology and to build large vertically-integrated companies. Companies like Amgen and Genentech were able to fulfill this endpoint, but many other companies were not so fortunate. Another early model was to improve existing products, rather than to build an entire franchise around discovering and commercializing new ones. This model is exemplified by Alza, which was founded to improve medical treatment through controlled drug delivery and focused on improving existing drugs rather than developing new ones. This same model is still employed today, and shares some similarity with the technology platform business model, where companies focus on developing technologies that can be sold to other R&D firms, rather than independently developing consumer applications.Newer business models did not replace the older ones, but rather enabled new firms to focus on the unique environment in which they were founded. Examples include the hybrid model that combined product development with a technology platform, which could be sold or licensed to others, and the no research, development-only model that as a derivative of the specialty pharmaceutical model, saw newly founded companies buying drug leads off of other companies to complete late-stage clinical trials. These models enabled new firms to meet the respective needs of risk-averse and cash-rich investors.WHERE ARE WE NOW?I've previously written that the global economic crisis has been (and still is) transformative for the biotechnology industry. The aforementioned biotechnology business models rose to prominence in conditions that favored them. For example, the hybrid model emerged in a funding drought and was favored as it enabled companies to build internal revenue streams while still maintaining the possibility to realize the upside of product sales.What are the factors influencing biotechnology companies today? In the United States, beyond the general economic climate there are still unresolved questions about the availability of early stage financing, the ability to recruit foreign workers, and – post-commercialization – data exclusivity, generic biologics and the potential for price controls. Internationally, some nations are still undergoing dramatic economic reorganizations, while others are making significant investments in building biotechnology R&D capacity.So, the question remains: Is the biotechnology industry ready for a new business model, and is there a business model that can accommodate the myriad domestic challenges faced by many countries while addressing the increasing globalization of activities?


Author(s):  
Yoosuf Cader

The 2005 global revenues of publicly traded biotechnology companies have grown by 18.1% to $63.1 billion (Donn, 2006). Many countries are now investing in research and development in the biotechnology industry as it is believed this 30 year-old industry is moving toward profitability. The stock value in this industry has outperformed the average stock value in many countries. In the pre-genomic era, a typical life sciences company would have marketed diagnostic kits, assays, chemicals, measuring equipment, and research products to name a few. In the genomic era, a new range of products is marketed focusing on molecular medicine. Among these new products are bioinformatics software solutions, storage systems, biotechnology systems, and solutions researching into genes and proteins, tools for analysis of genetic sequence data, integrated systems and solutions for disease research, and new drug discovery (Cader, 2004). The need for biotechnology portals is now more than justified and will be a useful information and knowledge source.


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