Secrecy and publication

14.45 While scientific research necessarily involves a period of non-publication for testing and developing the relevant hypotheses, scientific research is built on a tradition of peer review and replication of studies—which are dependent on the critical analysis of published research.

This public exposure has two main functions. One is to maintain high standards of quality control through peer review. This is through both the refereeing process and the later replication of the research. The other function is to promote rapid advances in critical research areas.^[63]

14.46 It has been suggested that the commercialisation of research, and the consequent obligations on researchers and links with industry partners, may have the potential to constrain this tradition by delaying publication or placing restrictions on sharing of data.^[64] A 2002 report from the Organisation for Economic Co-operation and Development, Genetic Inventions, Intellectual Property Rights and Licensing Practices: Evidence and Policies (OECD Report) found that:

There is some evidence in the biomedical sciences that research delays (before the publication of research results) are increasing … The withholding of data, research materials and research results is reputed to be more common in genetics and especially in human genetics than in other fields.^[65]

14.47 The Report stated that ‘the effect of increased secrecy might be to slow the pace of research, by making it impossible to confirm published research and by increasing duplicate research efforts’.^[66]

14.48 Scientists who perform research with private funding may be required to delay publication of research outcomes, at least until the commercial partner has had time to evaluate an invention.^[67] In the United States, the National Institutes of Health (NIH) recommends that universities allow commercial partners to prohibit publication for no more than one or two months.^[68] However, survey evidence indicates that much longer delays may be common. A 1994 study found that 58% of 210 life science companies that sponsor research required delays of more than six months before publication.^[69]

14.49 Problems with the withholding of research results in human genetics may extend beyond the time at which research results are published. A 2000 survey found that 47% of geneticists who had asked other academics for additional information, data, or materials regarding published research reported that at least one of their requests had been denied in the preceding three years.^[70]

14.50 Patent law and practice may significantly contribute to publication delays and reluctance to share information. In particular, since patent law depends on novelty, publication before a patent application has been filed may prevent a patent being granted (see Chapter 6). For this reason it is said that:

delays in publication may arise where preliminary findings need more work before patent filing is possible or desirable, or to permit the aggregation of incremental advances over a period of time (none of which on their own would be patentable) into a patentable invention.^[71]

14.51 Another United States survey conducted in 1994–95 of 2,167 scientists in universities receiving NIH funding revealed that nearly 20% had delayed publication for more than six months at least once in the preceding three years in order to allow for a patent application, protect their scientific lead, slow the dissemination of undesired results, allow time to negotiate a patent, or resolve disputes over the ownership of intellectual property.^[72] The study concluded that while withholding of research results was not a widespread phenomenon, it was more common among the ‘most productive and entrepreneurial faculty’.^[73]

14.52 Restraints on publication may also affect the free exchange of new technology. As Nicol and Nielsen comment, ‘Where, in the past, researchers often freely exchanged newly developed research reagents and other research tools, public sector institutes now often require recipients to enter into contractual arrangements in the form of material transfer agreements’.^[74]

14.53 On the other hand, patents may sometimes aid research because, without patent protection, some results might be kept as trade secrets, and potentially never revealed. Information that is the subject of a patent application is available in the public domain 18 months after the application is filed, through publication in the Official Journal of Patents.^[75] This can be a valuable source of technical information for use in further research and development.

14.54 In the United States, the NIH has taken steps to help researchers gain access to information for research through the promulgation of the NIH’s Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources (NIH Principles and Guidelines).^[76] The principles include that institutions should:

• Ensure academic freedom and publication. ‘Recipients are expected to avoid signing agreements that unduly limit the freedom of investigators to collaborate and publish’ and ‘excessive publication delays or requirements for editorial control, approval of publications, or withholding of data all undermine the credibility of research results and are unacceptable’.

• Ensure appropriate implementation of the Bayh–Dole Act.^[77] Recipients of NIH funds ‘are expected to maximize the use of their research findings by making them available to the research community and the public, and through their timely transfer to industry for commercialization’.^[78]

• The NIH Principles and Guidelines provide that agreements to acquire materials for use in NIH funded research should address the timely dissemination of research results: ‘Recipients should not agree to significant publication delays, any interference with the full disclosure of research findings, or any undue influence on the objective reporting of research results.^[79]

14.55 In the United States, the Genomic Research and Diagnostic Accessibility Bill of 2002 would have required faster disclosure of genomic sequence information in a patent application when federal funds were used in the development of the invention. The Bill required information to be released within 30 days of the patent application rather than the current 18 months.^[80] The Bill’s sponsor cited the example of research for autism being delayed due to some researchers hoarding tissue samples in order to be the first to find the relevant gene and thus get commercial benefits.^[81]

Submissions and consultations

14.56 A variety of opinions about the effect of patenting on openness in research were expressed in submissions. Some suggested that the necessity of keeping new research secret until a patent application had been filed reduced the free exchange of information between researchers.^[82]

14.57 The Department of Health Western Australia submitted that the need to apply for patents may result in publication delays, slow dissemination of undesired results or suppression or selectivity in publishing results.^[83]

14.58 Others were more positive about the effects of patenting requirements on research culture. AusBiotech Ltd suggested that delays in publication due to the need to maintain confidentiality until a patent application has been filed will be minimal because submitted manuscripts are still regarded as confidential, and because scientific publication lead times are already long.^[84] In addition, GlaxoSmithKline pointed out that ‘confidential information can be shared with others without jeopardising the subsequent filing of a patent application if the disclosure takes place under an appropriate agreement’.^[85]

14.59 Some submissions also recognised that strong patent protection can promote, rather than impede, knowledge sharing by removing the need to protect innovations through commercial secrecy.^[86]