Dutfield - Intellectual Property Rights and the Life Science Industries
Aus Leowiki
“From the 1960s and 1970s, developed-country intellectual property regimes began to undergo radical changes which tend to suit the interests of rights-owners. These trends, which appear to be continuing, were of three kinds. The first of these was the widening of protectable subject matter and the narrowing of limitations and exceptions. […] In patents, examples include the application of patent protection to cover business methods, computer programs, life forms, cell lines and DNA sequences, and the removal of exclusions on product patents for drugs. The second change was the creation of new rights, such as plant breeders’ rights in the early 1960s and rights to layout-designs of integrated circuits two decades later. The third change was the progressive standardization of the basic features of intellectual property rights. […] These developments in intellectual property law, all of which began in Europe and North America, are spreading to the rest of the world, and at an accelerating pace.” (p. 36)
“By ‘strong’, I refer to the extent of enforceability of the rights and the absence – or at least relative lack – of exceptions to patentability by subject matter or technological field.” (p. 37)
“Patent systems have been highly successful in accommodating both the long-established assumption that individuals invent and the apparently conflicting reality that corporate invention is inherently collective and the achievement of research teams.” (p. 39)
“Patents are winner-take-all systems.” (p. 43)
“Some apparently anti-competitive practices are described approvingly (and even enthusiastically) by Rivette and Kline[2000]. According to the authors, ‘clustering’ means ‘building a patent wall around a product,’ preferably consisting of a large quantity of interlocking patents. ‘Bracketing’ means surrounding a competitor’s key patent with so many of one’s own that it cannot be commercialized. Grandstrand [1999] describes six different patent strategies: (i) ad hoc blocking and ‘inventing around’, (ii) strategic patent searching, (iii) ‘blanketing’ and ‘flooding’, (iv) ‘fencing,’ (v) ‘surrounding,’ and (vi) comination into patent networks.” (p. 47)
“Strong intellectual property rights may involve costs as well as benefits for many firms. […] Even large firms have to figure out how to balance their interests as patent owners with their interests in licensing those held by other institutions, and in navigating through what may be a veritable jungle of patents held by competitors, some of which may be extremely broad in scope and even doubtful in validity.” (p. 50)
“The development of commercial biotechnology was driven mostly by discoveries coming out of universities arising usually from research funded by the State rather than by the public sector.” (p. 157)
“Alternatively, biotechnologies my be classified by generation. Thus, the first generation includes traditional technologies like beer brewing and bread making. These go back at least to the Sumerians of ancient Mesopotamia. The second begins with the microbiological applications developed by Pasteur and continues with the mass production by fermentation of the antibiotics. Tissue culture and modern plant and animal breeding also fall within this generation. The third generation includes techniques like recombinant DNA, monoclonal antibodies, polymerase chain reaction (PCR), and animal cloning, whose emergence was triggered by post-Second World War advances in molecular biology.” (p. 158)
“The last three decades have seen the establishement of a growing number of small science-based firms seeking to develop or take advantage of new biological technologies. Their ability to remain in business, raise funds and grow is heavily reliant on patents.” (p. 167)
“The biotechnology revolution has its roots in an invention and the setting up of a company to exploit it. The invention is Stanley Cohen’s and Herbert Boyer’s recombinant DNA technique (often shortened to ‘rDNA’). […] The technique, which enables foreign genes to be inserted into microorganisms and passed on to others through cell division, was patented by Stanford and licensed widely, earning over $200 million in royalties between 1975 and 1997, when the patent expired. […] One wonders how long the revolution might have been delayed had Stanford opted to grant exclusive rather than non-exclusive licenses.” (p. 167)
“Key to the success of biotechnology company initial public offerings (IPOs) was the possession of patents protecting important technologies and promising products in the making.” (p. 169)
“So, although there are more dedicated biotechnology firms in Europe than in the USA, they tend to be smaller, employ fewer scientists, and their market capitalization is far lower.” (p. 171)
“[T]he ownership of a key patent or a large portfolio of patents may serve as a signal to a larger company that the dedicated biotechnology firm would make a good purchase. […] Dedicated biotechnology firms have also kept their independence by entering into strategic alliances with other dedicated biotechnology firms and the bigger, longer-established firms, and by forming extensive research, development and marketing networks containing dedicated biotechnology firms, large firms, and (albeit to decreasing extent) government and university research institutions.
“The biotechnology and genomics revolutions created completely new commercial opportunities, and spawned four types of business.These were (i) the technology providers that manufactured the DNA sequencing machines and other equipment (for example, Applied Biosystems and Amersham Biosciences); (ii) the information providers (such as Incyte and Celera) that collected and organized sequencing information; (iii) the research firms, consisting mainly of the dedicated biotechnology firms that generally did the upstream research but lacked the resources or the ambition to do the downstream product development and marketing; and (iv) the health, agricultural and industrial biotechnology firms.” (p. 174; Anm.: insbesondere Typ (iii) scheinen besonders attraktive Fälle für unsere Studie zu sein.)
„Biotechnology was and continues to be a high risk and extremely research intensive activity, and for dedicated biotechnology firms especially, it has always been crucial to be able to secure large amounts of investment capital just to stay in business. Patent portfolios, and not products, of which there are likely to be none for some time after firms have been established, are a magnet for outside investors – which also include larger science-based firms. Strong portfolios attract the most interest from investors, indicating that this company may have genuine potential for growth. […] Research decisions in many companies can depend as much, if not more, on the advice of patent lawyers as on the opinions of the scientists. Will this research lead to patentable inventions? Is that line of research going to run into another company’s patents? And if so, can we invent around their patents in case they won’t give us a license? Or had we better look into another area? Naturally, companies have a strong interest in securing patents that encompass the broades possible scope and whose claims are drawn in ways that seek to anticipate future scientific and commercial developments. No doubt also, the strength of competitors’ patent positions helps companies to decide which research not to pursue.” (pp. 193-194, Herv. i. Orig.)
Definition of “dedicated biotechnology firms”: “Dedicated biotechnology firms typically invest the equivalent of over 50 percent of sales revenues in research and development.” (p. 229)
“Even company representatives express frustration that so much basic genetic information is being privatized by other companies through the patent system. Typically, the complainers are from the pharmaceutical and life science firms, while those being criticized are dedicated biotechnology firms.” (p. 217)
“Three situations have arisen that should be of major concern to regulators and policymakers. First, a disproportionately large quantity of patents I being granted in relation to the number of commercial products based upon them. […] Second, the scope of a patent can sometimes be drawn so broadly as to allow monopoly protection to cover a range of possible products including many unforeseen by the applicant. […] Third, there is a consolidation of patent ownership and global market shares in the hands of a small number of corporate life science giants.” (p. 218; Anm.: darunter dann Verweis auf Heller/Eisenberg (1998) und deren Anticommons-These)
“According to Arti Rai of Duke University, the history of patent pools does not give cause for optimism in this regard. First, some of the best known pools were set up only after protracted litigation. Second, past patent pools were sometimes deemed anti-competitive and therefore illegal under antitrust law. Third, in the biotechnology case, the partners would include a diversity of organizations such as universities, government research agencies, small firms and transnationals. Past experience suggests, in her view, that patent pools have most often come about among homogeneous partners that have previous experience of collaborating.” (p. 219)
“Companies may well be interest in joining such a consortium if they see a commercial advantage in agreeing to treat raw data generation as being a ‘pre-competitive’ activity. […] In 1999, a group of companies together with the Wellcome Trust, then the world’s largest medical charity, established the SNP [single nucleotide polymorphisms] Consortium with the aim of jointly contributing to a publicly available SNP map. Funding came from the Trust and the member companies: APBiotech, AstraZeneca, Aventis, Bayer, Bristol-Myers Squibb, Hoffmann-La Roche, Glaxo Wellcome, IBM, Motorola, Novartis, Pfizer, Searle, and SmithKline Beecham. […] Such collaborative approaches and licensing schemes are not a rejection of intellectual property rights per se. But they do emphasise and seek to encourage collaboration of the kind that aggressive assertion of patent and other intellectual property claims would certainly preclude. Indeed, intellectual property protection may be necessary for ‘open source’ collaborative models to work. The assertion of intellectual property rights is the most obvious sanction against those who acquire data and who may not be bound by any license.” (p. 220)
“With respect to the third problem, biotech-related patent ownership is becoming concentrated in the hands of a small number of very large companies. The question is, does patent ownership merely reflect such concentration, or does it also reinforce it? […] Evidently, patents appear to encourage or facilitate consolidation, which leads to a concentration of relatively large firms. But they also support the preservation of small firms and the formation of corporate alliances and networks.” (p. 222)
“Patents are extremely important for pharmaceutical companies. Monopoly protection of a commercially successful drug provides huge returns that more than make up for the required investment in discovery and developemnts. Several surveys indicate that pharmaceuticals are one of the few industrial sectors in which patents are effective means to capture returns from research and development. This effectivenessis enhanced by the ways – sometimes highly questionable – in which these companies use the patent system. It is important in this context to understand that drugs are not usually protected by single patents whose expiry allows anybody to aproduce a drug. […] Thus, pharmaceutical companies use patents (and also trade marks) strategically in order to restrict competition, in some cases for several years beyond the 20-year patent duration. ‘Evergreening’ or ‘line extentions’ are terms used to refer to the use of intellectual property rights and marketing strategy in order to extend the monopoly or at least market dominance of a drug beyond the life of the original patent protecting it, or else to shift patients onto a very similar follow-on product.” (p. 304 f.)
“Indeed, it seems quite reasonable to argue that major breakthroughs are more likely to be achieved in universities than companies because of the different ways that research is done in each kind of institution.” (p. 328)
“Two further complaints important to consider are made about the patent system. First, it is claimed that too much corporate research and development has been aimed at molecular manipulation that can be profitable but not very creative and not necessarily all that beneficial for patients. Patents are accused of failing to stimulate truly original research with man ‘new’ products coming on the market being variants of, or slight improvements upon, existing ones rather than radically novel drugs, and others providing only modest therapeutic gains. Second, patents are blamed for distorting research priorities by encouraging research on treatments for relatively trivial ailments like baldness or dealing with diet-related health concerns of affluent societies such as obesity and high cholesterol, on chronic problems such as high blood pressure that do not cure patients but that need to be taken continually for many years, and on the various other concerns of the ‘worried well’ that medication supposedly ‘cure’.” (p. 332 f.)
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