US Biotechnology Research Articles

Strategic Considerations for Innovation and Commercialization in the US Biotechnology Sector

This paper examines the importance of alliances as an innovation strategy utilized by US biotechnology firms. In doing so, the role of alliances with universities vis-à-vis alliances with industrial companies is emphasized. The biotechnology sector is dominated by few large and many small firms. The small firms are research focused or technology developers. Several large firms are now integrated biopharmaceutical companies. Very few small firms can survive without strengthening their relationships with universities, biotechnology or pharmaceutical or other large companies. These relationships range from licensing agreements, export–import connections to various forms of alliances for R&D, product development and marketing. Large firms supplement in-house R&D by acquiring research products and/or new technologies from small firms as well as universities. A survey of US biotechnology companies is used to show the emergence of alliance relationships, which continue to highlight university linkages, emphasize connections of biotechnology firms with other biotechnology entrepreneurs, and an ongoing effort to build a synergistic relationship with pharmaceutical or other large companies. Most linkages are not confined to the local area; the main locational attribute is the science base or the labour market.

The External Sourcing of Technological Knowledge by US Pharmaceutical Companies: Strategic Goals and Inter‐organizational Relationships

This study of the organization of the discovery function by large US pharmaceutical companies (LPCs) examines an important knowledge acquisition strategy—external sourcing of compounds and technologies. Through a critical examination of the “capabilities” thesis in strategic management and of the theoretical conceptualization in organization studies of innovation networks, we undertake an in‐depth qualitative analysis of the network relationships LPCs establish with biotechnology firms/public research laboratories. We additionally examine the motivations and degree of strategic intent of R&D managers involved in external knowledge sourcing. The paper identifies the tensions and contradictions in network relationships and indicates how these lead to changes in knowledge sourcing. This qualitative analysis is placed in its industry and technology context. This reveals both the pressures towards and the trends in external knowledge sourcing, as compared with in‐house discovery. Extensive interviews with US LPCs and biotechnology firms provide a rare glimpse of how some of the most important actors in global innovation networks handle a significant new innovation strategy.

An analysis of firm-level innovation strategies in the US biotechnology industry

This study examines factors that may affect innovation strategies and performance of firms in the biotechnology industry. Specifically, differences between factors common to firms with high R&D intensity and those to firms with low R&D intensity are investigated. Biotechnology firms with relatively higher levels of R&D intensity attribute their innovation performance to research-based innovation factors and strategies such as strengthening their own research capabilities, entering into research collaborations with universities, industry leaders and other biotech firms, and licensing their technology. These strategies can be summarized as alignment within the industry. Firms with relatively lower R&D intensity have a hybrid focus—they invest in R&D but may also have products on the market. These firms attribute their innovation performance more so to production-based innovation factors and strategies such as gaining market access and maintaining connections with customers. Their strategy focuses on competitiveness, marketing, and distribution channels, while not ignoring the importance of a strong research base and the need to advance technologically. In a sense, strategies employed to achieve successful innovation reflect the stage of innovation in which a firm is operating for a particular product or process.

BIO reaches adolescence

Recent turnover of the staff at the US Biotechnology Industry Organization following the appointment of a politician to head it up suggests a new role for the organization. How does the industry view these changes? Jeff L. Fox investigates.

Patents on Human Gene Sequences in Germany: On Bad Lawmaking and Ways to Deal With It

Whether patents should be granted on human genes or gene sequences is highly controversial, both ethically and politically; not only in Germany but throughout Europe and in most parts of the world. Proof of this has been the attention created by US biotechnology company Myriad Genetics, which, in 2001, obtained European patents for human gene sequences indicating an increased risk of certain types of cancer. In Germany the Bundestag has recently addressed the issue: the core of a newly introduced provision of the German Patent Statute (PatG) is Paragraph 1a Sec. 4 PatG, which limits the scope of patent protection available for human gene sequences or parts thereof. If the subject of an invention is a human gene sequence, Paragraph 1a Sec. 4 PatG requires disclosure of not only the sequence but also at least one application. Without such disclosure a human gene sequence is not patentable under German Patent Law. This is remarkable, because under the Directive of the European Parliament and the Council on the Legal Protection of Biotechnological Inventions, the so-called Biotechnology Directive of 1998, a piece of European Union legislation, the situation is different.

Current topics in biotechnology patent law: The written description requirement

Universities and medical research institutions are as interested in securing patent protection for their biotechnological inventions as pharmaceutical and biotechnology companies. Obtaining adequate patent protection by universities and research institutions has been hampered by the 'embryonic' nature of its inventions. This problem is particularly noticeable in the fields of biotechnology and molecular medicine. This paper focuses on recent court cases in US biotechnology patent law and analyses the effects of the legal decisions on the effort by universities and research institutions to secure meaningful legal protection for biotechnological inventions.

Current topics in biotechnology patent law: The written description requirement

Universities and medical research institutions are as interested in securing patent protection for their biotechnological inventions as pharmaceutical and biotechnology companies. Obtaining adequate patent protection by universities and research institutions has been hampered by the 'embryonic' nature of its inventions. This problem is particularly noticeable in the fields of biotechnology and molecular medicine. This paper focuses on recent court cases in US biotechnology patent law and analyses the effects of the legal decisions on the effort by universities and research institutions to secure meaningful legal protection for biotechnological inventions.

US biotechnology companies and foreign nationals: the changing dynamics of access to H-1B visas

Recent changes in the H-1B visa program have left biotech employers shorthanded and confused.

The Canadian environment for innovation and business development in the biotechnology industry: a firm‐level analysis

This paper is an empirical study of firm‐specific characteristics in the Canadian biotechnology sector. The research context examines the national system of innovation and regional infrastructure in place for the biotechnology industry. Literature on the Canadian biotechnology industry is not as extensive as studies on the US biotechnology industry. The current analysis shows that the Canadian sector is innovative and outward looking. One group of firms is more research oriented and the other is more product/process oriented. The first group emphasises the need to expand their science base through increased funding including inward foreign investment. The second group emphasises organisational needs such as improved feedback from product development and manufacturing to R&D; the development of manufacturing capabilities; the need to find new Canadian buyers; and the internationalisation of R&D through outward foreign direct investment. Place‐specific characteristics matter to the process of innovation and commercialisation for both groups: firms with high levels of R&D intensity seek access to scientists, universities, pharmaceutical companies and funding. Firms with low levels of R&D intensity seek access to manufacturing facilities and customers. An analysis of geographic or sectoral variation in strategies could not be accomplished due to data limitations. However, the results show the importance of Canadian participation in the internationalisation of innovation and commercialisation of biotechnology products. Such a trend needs to be considered in Canada's international negotiations pertaining to policies and regulations of international trade and investment (both inward and outward foreign direct investment) in biotechnology products.

The US Biotechnology Industry: Industry Dynamics and Policy

The inseparability of the biotechnology industry and the state is a central theme in the analysis of the location and performance of biotechnology industry in the US and elsewhere. This paper reports on the results of a survey of US biotechnology companies looking particularly at their assessment of needs, barriers, strategies, and government programs. The paper shows that although there is an increasing level of federal and state intervention, there are considerable barriers faced by biotechnology firms, which may or may not be resolved in the near future because of the nature of the business of biotechnology, which involves uncertainties at every stage of innovation and commercialisation.

Firm-specific characteristics of R&D collaborators and non-collaborators in US biotechnology clusters and elsewhere

This study examines the difference between collaborators and non-collaborators, in clusters and elsewhere, in the US biotechnology industry. In doing so, the relationship among R&D intensity, collaboration, innovation, and location is examined. Particular attention is given to R&D strategies of these firms, with regard to university-based collaborations and the importance of location for collaboration. Firms with higher levels of R&D intensity are more intent on engaging in R&D alliances, especially research collaborations with universities. Many alliances occur with scientists located outside of the local area, including other countries. More firms located in defined clusters of the biotechnology industry engage in collaborative R&D than do firms located elsewhere. University scientists are the main research partners (although not necessarily locally based) and the main purpose of collaboration by a cluster firm is access to basic research. One of the main purposes of such collaborations for a non-cluster firm is product development. Firms engaged in collaborative R&D exhibit better innovation performance. Location continues to be important for start-up companies. Locational inertia is important for established firms, who acknowledge the importance of reputation and networks, as well as factors like nearness to universities, venture capitalists, and the supply of skilled labour, in the process of innovation.

Presages to the Coming War over Generic Biologics

There are sufficient legal and scientific precedents to support positions ranging from arguments against the approval of any ‘generic’ biologic to arguments that support the position that existing Food and Drug Administration (FDA) precedents permit the approval of a generic biologic. While it seems highly likely that at some point there will be a legally and scientifically acceptable construct for the approval of generic biologics, given the diverse opinions and varied interests of the US Congress, the FDA, the pharmaceutical and biotechnology industries, health service providers, insurers, consumers and the scientific community with regard to generic biologics, it is difficult to determine what such a construct will entail, or when it might be implemented. The only certainty is that there are presently no absolutes regarding this issue, either legally or scientifically. This paper seeks to trace past and current events that are quickly culminating to set the stage for a war over generic biologics, and which may offer some insight into the agency's thinking on their uncertain future.

Multi-level Science Policy and Regional Innovation: The Case of the Munich Cluster for Pharmaceutical Biotechnology

Knowledge-based industries tend to develop within regional or local clusters that allow for knowledge spillovers, the generation of a critical mass of complementary competencies and skills as for spatial proximity to academic organizations out of which many highly innovative firms have been founded. The prototype of that development certainly is the biotechnology industry which has emerged since the 1970s first in the US where especially small and medium-sized research companies have been established around leading science bases. Following the example of the US biotechnology industry, public policies in many industrialized countries aimed at stimulating cluster formation in biotechnology. This holds true especially for member states of the European Union (EU) where public policy initiatives have been initiated at different territorial levels. This article refers to the Munich pharmaceutical biotechnology cluster and applies institutional and organizational indicators that have been developed in various systemic analyses of technological development and innovation. It will be shown that reforms of the institutional environment in which the innovative organizations are embedded were crucial for the commercialization of biotechnological research in Germany. These reforms have occurred mostly at the regional and national level, whereas the EU played a role especially in establishing the regulatory framework for the biotechnology industry. Organizational indicators will be applied in order to assess the modes of knowledge production within the cluster.

Preemptive patenting, human genomics, and the US biotechnology sector: balancing intellectual property rights with societal welfare

Within the biotechnology sector of the US economy, aggressive patenting, i.e. preemptive patenting, of human genomic research results are practiced by private-sector firms, the academic community, and non-profit organizations. Preemptive patenting has traditionally been practiced by the private sector as a competitive strategy, being driven by economic considerations. Recently, academics and patients/consumers have instituted preemptive patenting strategies as a way of ensuring access to genomic sequences for, respectively, research study purposes and life-enhancing access to diagnostic gene testing. To reduce this non-economic motivation for preemptive patenting by these nontraditional competitors, it is recommended that the biotechnology industry initiate a strategy of its own which will: (1) relax firm patent enforcement of genomic sequences that are essential for academic researchers to use in their studies; and (2) provide for a ‘means-test’ approach that incorporates a ‘staggered’ fee-schedule for academic researchers to charge their subjects, i.e. patients, for gene tests and diagnostic results.

New immigration laws affect US biotechnology.

A host of new agencies, increased processing times and stricter enforcement of current regulations may hamper the hiring of foreign workers.

Patents and public health. European institutions are challenging Myriad Genetics's patent monopoly on the brca1 gene.

An increasing number of international research and governmental institutions are challenging several gene patents, arguing that the patent holders’ absolute control of diagnostic methods is not in the public's best interests. Most notably, the Institut Curie, a cancer research centre in Paris, is leading the fight against Myriad Genetics, a US biotechnology company that plans to install a monopoly on all genetic work associated with the breast and ovarian cancer predisposition gene brca1 . The critics of Myriad's wide‐ranging patent rights maintain that the company's absolute control not only prohibits further research on the diagnosis of and therapies against breast cancer, but also has a detrimental effect on public health. Physician examining mammographs. ![][1] > Critics of Myriad's wide‐ranging patent rights maintain that it not only prohibits further research on diagnostics and therapies but also has a detrimental effect on public health Since the European Commission adopted a directive allowing human genes to be patented in July 1998, many such patents have been granted and indeed challenged, including the battles over the insulin, relaxin and hematopoietin genes. In 2001, seven years after Myriad Genetics first identified the sequence of brca1 , the European Patent Office (EPO) granted the company three patents covering all potential diagnostic and therapeutic applications based on the gene's sequence. Several European research centres and associations quickly contested the first two patents in an attempt to fight Myriad's monopoly. More recently, in August 2002, the Institut Curie, the Institut Gustave‐Roussy, the Assistance‐Publique‐Hopitaux de Paris together with almost all European genetics societies and many scientific institutions and governments turned up the heat and filed a joint opposition notice to the third patent. As this protects the isolated gene and the corresponding protein, and includes all imaginable future therapeutic uses, such as gene therapy and screening of drugs or transgenic animals, … [1]: /embed/graphic-1.gif

The role of foreign worker scientists in the US biotechnology industry.

Recent surveys show that US biotechnology companies are recruiting the majority of skilled foreign workers out of US universities.

Governance inseparability and the evolution of US biotechnology industry

This paper explores mechanisms through which a party’s choice of governance mode for a focal transaction is constrained by the governance choices it made for other, prior transactions. We argue that this condition of “governance inseparability” plays an important role in determining the differential organizational costs incurred by various firms when undertaking the same new activity, and is therefore important for theories aimed at predicting what kinds of firms will undertake such an activity. We develop these arguments by showing how governance inseparability conditions help explain the persistent fragmentation of the US biotechnology industry.

The US biotechnology industry: the importance of workforce quality in the maintenance of corporate competitive advantage

The US biotechnology industry: the importance of workforce quality in the maintenance of corporate competitive advantage

The US biotechnology industry: the importance of workforce quality in the maintenance of corporate competitive advantage

The US biotechnology industry: the importance of workforce quality in the maintenance of corporate competitive advantage