By Sameekshya Naik, NLUO
Editor’s Note: The possibility of the discovery of drugs and cures based on genetic studies that may have the potential to treat diseases hereto considered incurable, has meant an investment of huge amounts in research and development of bioinformatics tools of a more sophisticated, nature which would aid in the field of comparative genomics and such.
In this scenario, there has already been a copious amount of funding into research and development of bioinformatics tools and applications, by both public and private institutions. It is only natural to expect some form of a legal framework of protection for the innovations in terms of new bioinformatics tools, which would ensure a return on the investments secured from marauding interests. This is the argument for the application of IPR to the field of bioinformatics, at the most basic level.
This paper analyses and makes a case for the protection of this research and investment that would have been pumped into the very wide and extensive areas of research that are associated with bioinformatics.
Bioinformatics is a scientific discipline that as emerged in response of the excessive demand for a flexible and intelligent means of storing, managing, querying large and complex biological data sets. Over the past few years rapid developments in genomic and other molecular research technologies and developments in information technologies have combined to produce a tremendous amount of information related to molecular biology.
At the onset of genomic revolution, the main concern of bioinformatics was the creation and maintenance of a database to store biological information such as nucleotide and amino acid sequences[i]. Development of this type of database involved not only design issues but the development of an interface whereby researchers could access both existing data as well as submit new or revised data.
Over the century ago, bioinformatics history started with an Austrian monk named Gregor Mendel. He is known as “Father of Genomics”. He cross-fertilized different colors of the same species of flowers[ii]. He kept careful records of the colors of the flowers that he cross-fertilized and color of the flowers they produced. After this discovery of Mendel, bioinformatics and genetic record keeping have come a long way. The understanding of genetics has developed remarkably since the last thirty years[iii].
In 1981, 579 human genes had been mapped and mapping by in situ hybridization had become a standard method. In 1988, The Human Genome Organization (HUGO) was founded. This is an international organization of scientists involved in the Human Genome Project. In 1989, the first complete genome map was published of the bacteria Haemophilus influenza[iv].
Bioinformatics was created by the need to create huge databases such as Gene Bank and DNA Database and compare the DNA sequence data erupting from the human genome and other genome sequencing projects. Today, bioinformatics constitutes protein structure analysis, gene and protein functional information, data from patients and the metabolic pathways of numerous species[v].
The main objective of Bioinformatics is mainly threefold. Firstly it organizes the data in a way that helps the researches to access existing information and put it new entries as they produce. Secondly, it helps in developing the tools for the analysis of data. Thirdly, to use these tools to analyze the data and interpret the results in a biologically meaningful manner[vi].
The ability to use bioinformatics to organize and analyze from data collected by researchers had a major impact on biological research by reducing the time required to find solutions to certain biological questions[vii]. With this potential to dramatically reduce the time and money wastage a great deal of intellectual and financial resources, both in public and private sector, have been poured into the development of bioinformatics tools, particularly in the area of genomics.[viii] With the influx of money and intellectual effort into the study of bioinformatics, the issue of intellectual property protection for new technologies an important issue to consider.
In the current information technology era, bioinformatics is growing and developing rapidly due to vast database systems available and an increasing amount of biological data being published. Due to the perceived importance of bioinformatics databases, many countries including United States, Japan, India have been expending a lot of effort to study and construct bioinformatics databases and the government providing financial support[ix].
Bioinformatics has emerged as an important factor in the realm of biomedical sciences and pharmaceuticals[x]. It is often argued that the continued advancement of the field of bioinformatics movement is highly dependent on the ability to obtain intellectual property protection and mainly patent protection in particular fields. Therefore, without the possibility of intellectual property protection, it has been argued that people are less likely to invest a large amount of money and time into new technologies[xi].
Classification of Bioinformatics Databases
Keeping in mind the characteristics and contents of bioinformatics databases can be classified as Primary and Secondary Databases. Primary database constitutes of gene-related data including nucleic acid[xii], protein sequences with information about features of nucleic acid, amino acid sequences, and biochemical reactions. Secondary databases, on the other hand, are created based on primary databases and the information derived from the primary databases. Primary and secondary databases have some differences or the other[xiii].
Mainly the primary database includes the experimental results like the contents of DNA and protein sequence and protein structure derived from genomic mapping, X-ray diffractometry, and Nuclear Magnetic Resonance Measurements. Secondary databases are completely derived from the primary database only[xiv]. At present, a majority of bioinformatics databases are sequence databases, including DNA, RNA and protein sequence. There are also a lot of databases on gene mapping and protein structure.
Why is Bioinformatics needed?
As more and more DNA, RNA and protein sequences are reported, scientists are developing biological databases to catalog and store the sequence information. These databases are important if the stored information can be readily searched and analyzed. For example, scientists can use these databases to compare and assign biological functions to particular and characteristics functions[xv].
Then, when a scientist obtains a sequence from an unknown DNA, RNA or protein molecule, the scientists can use these databases to identify the unknown molecule and determine its function. Although several databases are available to the general public, private companies are not required to make their databases freely available. For instance, one company working on sequencing the human genome[xvi], Celera, generally charges for its access to the database, although it provides free access to “qualified academic users”.
Intellectual Property Protection for Bioinformatics Databases: Transnational Perspectives
At present, laws which protect bioinformatics databases are the one which protects other databases also. The European Union takes sui generis route to protect bioinformatics databases, whereas in most countries the copyright law is used. On one hand, there was the copyright to protect databases, whereas, on the other was the sui generis right which could be used to protect the maker’s investment on some special but non – original databases.
A balance was worked out as a result of which, copyright protection for databases was available to countries and parties under the Berne Convention or Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement[xvii]. And sui generis right was available only to the makers of European Union.
In U.S. copyright law is used to protect databases. In 1991, it was accessed whether databases can be protected through copyright or the standards of ‘industrious collection’ or ‘sweat of the brow’ can be applied to them[xviii]. The fact that laws in the European Union and the U.S.A. are so different, they have a significant impact and the possibility of a collaborative effort between the EU and the U.S. seems remote. Therefore, the system of I.P rights can result in unintentional consequences. Because of these contradictions, complex databases such as the bioinformatics databases are not well covered under Database Law[xix].
Patentable Technologies in Bioinformatics
While databases are not themselves patentable, patent protection may be given for the database – related inventions. In the U.S. a software invention is patentable if it satisfies all the ingredients of software patents[xx]. Previously, I.P. protection alone for the software was not available as they were not considered within the patentable subject matter.
But, the U.S. Federal Circuit Court of Appeal in State Street Bank & Trust Co. vs Signature Financial Group Inc.[xxi]., changed the law in this software patent area drastically and may have a substantial impact in the bioinformatics industry[xxii]. In the State Street Case, the Court ruled that mathematic algorithms are patentable if they produce a “useful, concrete and tangible result”, and that the mere fact that claimed invention involves inputting numbers, calculating and storing numbers[xxiii], would not render it non statutory subject matter unless it does not produce a tangible result. Based on this case law, software and algorithms that meet the criteria are patentable in the U.S.
In Canada, the leading court decision was Schlumberger Canada Ltd. v. Canada[xxiv] (Commissioner of Patents), where algorithms used in software applications to calculate protein sequences, shapes, locations, and functions may also be applicable. Therefore, it may be seen that the current patent law is amenable to bioinformatics patents[xxv].
Bioinformatics Software and Hardware
To analyze the information contained in these databases, software developers have developed bioinformatics tools. BLAST (Basic Local Alignment Search Tool), compares sequences for similarity by first aligning the two sequences at areas of local identity or similarity and then calculating a ‘similarity score’.
Such algorithms can be designed to incorporate scientific principles based on the molecular biology of DNA, RNA and protein sequences. For instance, an algorithm may be created to compare two nucleotides or amino acids that are not identical but function similarly based on their molecular biology. Such programs are useful in predicting the function of an unknown gene or protein or to draw evolutionary relationships.
Patent Protection: Eligible Subject Matter must be a Process, Machine, Apparatus or Composition of Matter[xxvi]
Patent Protection for DNA, RNA, and Protein Sequences:
Erstwhile biological molecules are themselves patentable as compositions, the information within the composition, i.e. the abstract biological sequence itself, is not the patentable subject matter. In Diamond vs. Diehr, it was stated that to qualify as patentable subject matter the biological sequence has to be categorized as process, machine or apparatus.
An idea of itself is not patentable and neither the principle in the abstract[xxvii]. Thus, patent protection for DNA, RNA, Protein Sequence extends only to biological and physical compositions and not to the abstract biological sequence information that describes the composition. Therefore, a patentee could only prevent from using the composition itself and not the information within the molecule[xxviii].
Patent Protection for Biological Databases:
Biological databases are compilations of biological sequences. And if biological sequences are unpatentable, then biological databases are also unpatentable. To make it patentable, they have to be related to a statutory subject matter. Even if the database itself, does not constitute patentable subject matter, the manner of creating the database may constitute a patentable process.
In the State Street case[xxix], it was said that even if information per se is not patentable as a tangible product, a process of producing the information may be patentable. Secondly, patent protection would extend only to the process for creating the database and not the database itself. It would limit the value of the patent because a competitor wanting to infringe the patented product can simply make the product in a non-infringing way[xxx].
Patent Protection for Bioinformatic Software and Hardware:
Unlike biological sequences and databases, computer software constitutes patentable subject matter if the software produces a useful and tangible matter. The results produced by bioinformatic software have a biological application and are therefore most definitely tangible subject matter. Since bioinformatic software can be used to make medical drugs and diagnoses, it would be difficult to hold bioinformatic software as unpatentable.
Similarly, bioinformatics hardware is also patentable. Since a patent will only protect the patentee from an infringer who uses the machine or apparatus that contains all the elements of the claimed invention, the patentee could not protect a biological sequence or a database that is only a component of a protected the machine or apparatus.
Trade Secret and Trademark Law
For the protection of secondary databases, trade secret law is also available. The database can be protected by the trade secret because the maker makes all the efforts not to make it public. But in the present era, it is a difficult task to make the database a secret. Trademark law will only protect the content of the database. The makers of the database can also gain protection from copyright law. They can prevent the third parties, from copying or accessing contents, using contract law. For the non–original database, the contract law is the only mode of protection. In the contract law, the maker of the database can prevent a breach of faith and infringement.
Presently, Shrinkwrap and Clickwrap are the most used contracts for the protection of databases. Shrinkwrap license is used for the databases in CDs and is the license, which is put down in writing during the packaging. Once he uses the products, he agrees to all the terms and conditions of the product. Clickwrap licenses are on the other hand for internet users. When the buyers want to access the content in the database, they should enter “agree” online which means that they have agreed to the contract. Generally, the contract determines the kind of information that can be accessed.
The Use of Gene Sequences[xxxi]
How the function of the intellectual property system may be compromised by life chances will have direct relevance to the fulfillment of the contract with the public when it comes to crucial technology such as medicinal products. With respect to this question of use, the development of patent protection for gene sequences arguably emphasizes the role of the public in the manifestation of the invention. It is useful to trace this greater participation in the patent system by the figure of the consumer through the controversial territory of gene patents.
In this area, technology itself introduces a potential alienation of the consumer in ways not really at play in pharmaceutical use patents, at least in terms of the contributing research. That is, research into medicines benefits from an ethical priority that is not really straightforward in the context of gene-related technologies. In other words, developments in patent protection for gene-related inventions and the concept of use as a feature of the invention indicate the way in which the very nature of the intellectual bargain with the public is the core of economic analyses of innovation.
Most recently, this bargain is such that the relationship with the consumer underpins the legitimacy of the law – this is not only in terms of access to medicines and the rejection of market-driven prices for drugs around the world but also in terms of the scope of inventions in biotechnology.
When it comes to gene-related inventions, the controversy attached to patents on these inventions includes not only the suspicion of the creation of ‘inventorship’ with respect to the units of evolution, but also the restriction of innovation through expansive monopolies over the basic starting material for the genetic research into other uses and applications of a particular sequence.
Therefore, apart from the suspicion of commercial monopolies over the material considered to be natural building blocks of humanity, as it were, the very nature of genetic research appears to be confounded by the way in which patent protection and the scope of the subsequent monopolies are conferred[xxxii].
The basic nature of the industry itself is relevant to these questions, particularly in terms of the ‘access’ and ‘use’ of that starting material by other inventive actors in the field. Indeed, the interpretation of the monopoly with respect to gene-related inventions will be critical to the cultural and knowledge exchange within that scientific community.[xxxiii]
Genetic Sequencing is in a way an incomplete exercise without subsequent analysis to identify protein – coding sequences, and the nature and function of those proteins. Genes and genetic sequences are indeed mere portfolios of information. Patent protection must surely coincide with some kind of technical solution to a problem – deciphering/decoding of that information. In other words, the mere location and identification of a particular sequence does not provide the technical information for any useful application.
A gene sequence is simply the ordering of amino acids or nucleotides – it is simply identifying the information, a product of nature. It is the analysis and identification of the function and the ‘inventive’ skill and research subsists. Identification of the gene sequence’s function and application in the body will be the relevant contribution to knowledge and, in the context of the intellectual property paradigm, the justification for the recognition of the inventor and the declaration of the invention.
The problem is that patent law is currently interpreted in Europe, the identification of one function may normally result in the protection of all possible and potential functions or uses of the product. This is because there is absolute protection for the product– that is, the original function or use. Where used for another function will inevitably affect the original function or use, infringement will occur.
In other words, this function would, therefore, be infringed whenever the substance is used, regardless of whether that use is for an entirely new purpose. There is infringement because of the ‘side effect’, as it were, of the original function. A restricted purpose– bound approach to patent protection of gene sequences has been advocated to define the scope of the invention when it comes to gene-related technology.
This is the general approach towards which the European Parliament is proceeding, having adopted a resolution at the end of 2005 calling on the Commission to examine whether an amendment to the Biotechnology Directive will be necessary to achieve the objectives in the 2005 implementation report in which scope of protection was considered. The report considered that Article 5.3 of the Biotechnology Directive, together with Recitals 23 and 25, might allow for a more limited scope of protection restricted to the disclosure of a specific industrial application.
While it might be suggested that the proliferation of function and uses that attend one particular gene sequence is not comparable to the few functions identified with other patentable products, including chemical substances, this does not necessarily recommend against comparable approaches to use[xxxiv].
A concern may be raised that in that biological materials contain an enormous quantity of known and unknown information, a distinct from chemical and mechanical inventions, this could result in a large number of patents relating to one gene sequence.
However, the obstacle to research and access posed by the protection of all uses by one would arguably become, in effect, protection for mere information, which can never be the subject matter for intellectual property protection. As Recital 23 of the Biotechnology Directive explicitly states, a mere DNA sequence without indication of a function does not contain any technical information and is therefore not a patentable invention.
The European Patent Convention (EPC) and the Biotechnology Directive both require that use or industrial application of the invention is disclosed in the patent application. That might include the function performed by that sequence or the protein produced, which would then be relevant to understanding potential therapeutic or diagnostic uses.
In other words, that patent relates to the function rather than the structure of the sequence – the identification of an application and use rather the mere information. The human effort or intervention in an otherwise natural substance is deemed to be found in the technical change that is brought about by the otherwise discovery of the gene sequence and its function. Change is thus invention. Investment can thus be inventive.
Therefore, in the case of a gene patent, what has emerged from the previous discussion in which way in which ‘inventiveness’, as it were, is achieved by use for the purposes of patentability. What is sometimes criticized as a patent for discovery, is ‘inventive’ by virtue of the identification of the application or function. In other words, there is a kind of critical nexus between use and inventiveness, in this respect. Indeed, back in 1994, efforts to patent gene sequences in the United States were defeated by lack of utility.
As we have seen previously, it is not the isolation and identification of the sequence that is critical to the technological development, but rather, it is the identification of the function and application of the protein coded by that sequence that is the useful and industrious aspect. In other words, in the case of gene patents, it is the identification of use or application for the gene sequence that renders the sequence patentable and defines that invention through what we are known as ‘functional claims’. The question of ‘inventiveness’ might be understood as being linked to the ‘discovery’ of that use.
The controversy characterizing the patentability of gene sequences is largely incorporated within the application of classical interpretation of patent protection, having developed from more traditional technologies, is not necessarily compatible with the nature of technological innovation in genetic research. As the law is currently applied, identification of a use for a gene sequence will be sufficient to render the subject matter patentable, but the patent will grant control over all uses of the patented sequence as a product, resulting in de facto patentability of the sequence itself.
With classical protection of gene sequences, and thus protection of future and unknown use, there is a problematic patenting of information as such and, in effect, the patenting of a discovery. The classical interpretation of the subject matter could inadvertently lead to a monopoly over all subsequent examination and analysis of the functions of the coded protein, potentially limiting follow on the investigation for the life of the patent.
Whatever conceptualization of the actor in which the original rights must vest, the effort that is expended is that which leads to the identification of the function and application identified in the claim. This is the bargain, as it were. Therefore, control over all uses might suggest that this kind of interpretation of patent protection would arguably limit the interest in pursuing research into subsequent and significant identification of future applications for a particular sequence through the limitation of access to gene sequences and the limitation of use in terms of the subsequent benefit. In this way, it would be contrary to the cultural and technical specificity of genetic research[xxxv].
Arguably, this is also contrary to the principles of patent law, in that the claimed invention is not sufficiently disclosed in the patent specification. In other words, the patentee is obtaining protection for uses that are not disclosed in the patent specification[xxxvi]. In other words, the patentee is obtaining protection for uses that are not disclosed in the description and claims of the patent, thus defying the basic bargain of patent protection – a monopoly in return for the disclosure of the invention for others to experiment upon and use for the purposes of further innovation and technological progress.
Currently, the scope of the biotechnological invention should be limited to the disclosure of the ‘invention’. Such scope should be limited to the purposes in the patent document. Purpose – limited protection or purpose claims limits protection to the industrial application or function that is disclosed in the patent. Thus, the patent recognizes and protects the technical contribution of the inventor, rather than providing what is arguably an indirect monopoly over the natural substance and all its future uses This is the sort of the principle that has been used expressly recognized in the European Patent Convention, 2000, but they existed back in the 1980s in case laws.
Liability for infringement is, as I have said, absolute. It depends upon whether the act in question falls within the claims and pays no attention to the alleged infringer’s state of mind. But this doctrine may be difficult to apply to a patent for the use of a known substance in a known way for a new purpose. How does one tell whether the person putting the additive into his engine is legitimately using it to inhibit rust or infringing by using it to reduce friction”.
Although the U.K. does not yet follow a purpose – bound approach to the interpretation of gene patents, it may well be that since the decision of the House of Lords in Kirin Amgen Inc vs Hoechst Mariam Roussel, a patent for a gene sequence will now be interpreted as limited to those uses which a person skilled in the art would have reasonably considered to have been disclosed in the application.
That is, the uses anticipated by a so-called gene patent might be limited by the state of the art at the time of application. The scope of the patent would be limited to what would be reasonable to expect of a person skilled in the art at that time. In other words, patentability, in this case, relates to the inventor’s knowledge at the time, not the state of the starting material and the function that always inhered in that material.
Bioinformatics in India
Studies have found that India will be a great potential star in biotechnology keeping in mind the factors like bio-diversity, human resources, infrastructure facilities, and government initiatives.
Bioinformatics has emerged out of the inputs from several different areas such as biology, biochemistry, molecular biology, biostatics, and information technology. Specially designed algorithms and organized databases are the core of all informatics system.
The requirements for such an activity make heavy and high demands on both the hardware and software capabilities. This sector is the quickest growing field in the country. The vertical growth is because of the linkages between IT and biotechnology, spurred by the Human Genome Project. There have already been many startups in Hyderabad, Bangalore, Pune etc.
Challenges to Bioinformatics
Bioinformatics patents present some unique challenges – some obvious, some not so obvious. The obvious challenges relate to the multidisciplinary nature of the technology involved. The less obvious challenges relate to the diversity in bioinformatics business models and the corresponding diversity of patent claim types that may be necessary to ensure maximum patent protection.
For many bioinformatics inventions, the obvious challenge is finding a patent attorney that understands both the IT and biotechnology aspects of the invention. Many have suggested using a pair of patent attorneys – an IT patent attorney and a biotech patent attorney – to ensure that the technical aspects of a bioinformatics patent are covered.
This ‘tag team’ approach parallels how the US Patent and Trademark Office examines bioinformatics patents. The Patent and Trademark Office has created a separate group of examiners with multidisciplinary backgrounds to examine bioinformatics patents. These examiners have backgrounds in biotechnology, computer science, physics, mathematics, and other disciplines.
Although the ‘tag team’ approach may help tackle the technical challenges, it is not sufficient by itself to realize maximum value from a bioinformatics patent. Another critical challenge is the need to understand the various business models relating to bioinformatics and the various types of patent claims potentially applicable to those models.
Patent protection poses significant challenges for companies that sell data. Data itself is not patentable, but data structures are. An important aspect of bioinformatics is handling the incredibly large amount – terabytes and more – of data generated from genetic and proteomic research. Some of the inventions that relate to the technology for handling this data include unique ways of storing data. ‘Data structure’ claims can be used to cover the way in which data is stored.
ASP models and other clients/server inventions pose some unique international issues. If an ASP system claim includes interaction between a client terminal and a server, territoriality issues may preclude a finding of infringement. If a competitor operates the server outside the United States and it is accessed by a client terminal in the United States (or vice versa), a system claim may not cover this activity.
The reason is that not all of the activity covered by the claim occurred in the United States. A technique to overcome this is to draft separate server-side claims and separate client-side claims. This way, if either the client or the server is in the United States, the patent may cover the activity[xxxvii].
A number of bioinformatics business models involve licensing data or tools used in research and collecting, as part of the license fee, a royalty on any products developed as a result of the use of the research tool. A product-by-process claim can be used to facilitate this type of patent license. A product-by-process claim covers a product made according to a particular process. If the patent adequately describes and claims how to make a product using the data or research tool, protection for this revenue source may be obtained[xxxviii].
These are just some examples of claim types that can be used to enhance the value of bioinformatics patents. When to use each and what combinations to use requires an understanding of the various potential business model of the patent owner and its potential competitors or licensees.
Formatted on March 15th, 2019.
[i] Benson, D.A., Karsch , I. Lipman, Gen Bank, Nucleic Acids Research, 33, D34-D38.
[ii] Crick F, (1970). Central Dogma of Molecular Biology. Nature, 227, 561-563
[iii] Indigenous knowledge, Bioinformatics and Rural Agriculture. (2005). 9th ICABR International Conference on Agricultural Biotechnology: ten years later, Ravello, (Italy), July 6-10.
[v] Jayaram D. And Priyanka D, Bioinformatics for the better tomorrow, Department of Chemistry & Supercoding facility for bioinformatics & computational biology, Indian Institute of Technology.
[vi] Mcentyre J.and Ostell J. (2005), The NCBI Handbook, Bethseda (MD): National Library of Medicine.
[vii] Ronald M.A. , Knegtel, Irwin D., Kuntz and Oshrio C.M (1997) Molecular Docking to Ensembles of Protein Structures, Journal of Molecular Biology, 266, 424-440
[viii] McEntryreJo Jim, National Center for Biotechnology Information Bethesda,the NCBI Handbook, Medicine, U.S. , NCBI
[ix] Tom Meyers, “Patenting and Financing Bioinformatics Inventions” (Symposium on Bioinformatics and Intellectual Property Law, April 27, 2001) (2002) 8:1 B.U. J. Sci. & Tech. L. 157, online: available at Boston University School of Law <http://www.bu.edu/law/scitech/volume8/Panel1.pdf>.
[x] University of Buffalo Center of Excellence in Bioinformatics, “Introduction to Bioinformatics”, online: University of Buffalo Centre of Excellence in Bioinformatics <http://www.bioinformatics.buffalo. edu/current_buffalo/primer.html>
[xi] M. Chow & D. Fernandez, “Intellectual Property Strategy in Bioinformatics” (Paper presented to the First Virtual Conference on Genomics and Bioinformatics, North Dakota State University, October 15-16, 2001), online: First Virtual Conference on Genomics and Bioinformatics <http://midas-10.cs.ndsu.nodak.edu/bio/papers.html>.
[xii] J.R. Rudolph, “Patentable Invention in Biotechnology” (1996) 14:1 Biotechnology Advances 17 at 28
[xiii] Rebecca Eisenberg, “Molecules v. Information: Should Patents Protect Both?” (Symposium on Bioinformatics and Intellectual Property Law, April 27, 2001) (2002) 8:1 B.U. J. Sci. & Tech. L. 190, online: Boston University School of Law <http://www.bu.edu/law/scitech/volume8/Panel3.pdf>
[xiv] Dennis S. Karjala, “Data Protection Statutes and Bioinformatic Databases” (Symposium on Bioinformatics and Intellectual Property Law, April 27, 2001) (2002) 8:1 B.U. J. Sci. & Tech. L. 171, online: Boston University School of Law <http://www.bu.edu/law/scitech/volume8/Panel2.pdf>. See also James G. Silva, “Copyright Protection of Biotechnology Works: Into the Dustbin of History?” (2000) B.C. Intell. Prop. & Tech. F. 012801, online: Boston College Law School <http://www.bc.edu/bc_org/avp/law/st_org/iptf/articles/
[xv] These include U.S., Bill H.R. 3531, Database Investment and Intellectual Property Antipiracy Act of 1996, 104th Cong., 1996 (Moorhead) and U.S., Bill H.R. 2652, 105th Cong., Collections of Information Antipiracy Act, 1997 (Coble), among others. The bills and their status are available online: U.S. House of Representatives
[xvi] Tom Meyers, “Patenting and Financing Bioinformatics Inventions” (Symposium on Bioinformatics and Intellectual Property Law, April 27, 2001) (2002) 8:1 B.U.J. Sci. & Tech. L. 157, online: available at Boston University School of Law <http://www.bu.edu/law/scitech/volume8/Panel1.pdf>
[xvii] University of Buffalo Center of Excellence in Bioinformatics, “Introduction to Bioinformatics”, online: University of Buffalo Centre of Excellence in Bioinformatics <http://www.bioinformatics.buffalo.edu/current_buffalo/primer.html
[xviii] M. Chow & D. Fernandez, “Intellectual Property Strategy in Bioinformatics” (Paper presented to the First Virtual Conference on Genomics and Bioinformatics,North Dakota State University, October 15-16, 2001), online: First Virtual Conference on Genomics and Bioinformatics <http://midas 10.cs.ndsu.nodak.edu/bio/papers.html>
[xix]Kate H. Murashige, “Genome Research and Traditional Intellectual Property Protection–A Bad Fit?” (1996) 7 Risk: Health, Safety & Environment 231, online: Franklin Pierce Law Centre <http://www.piercelaw.edu/risk/vol7/summer/murashig.htm>
[xx] . Dennis S. Karjala, “Data Protection Statutes and Bioinformatic Databases” (Symposium on Bioinformatics and Intellectual Property Law, April 27, 2001) (2002) 8:1 B.U. J. Sci. & Tech. L. 171, online: Boston University School of Law <http://www.bu.edu/law/scitech/volume8/Panel2.pdf>. See also James G. Silva, “Copyright Protection of Biotechnology Works: Into the Dustbin of History?” (2000) B.C. Intell. Prop. & Tech. F. 012801, online: Boston College Law School <http://www.bc.edu/bc_org/avp/law/st_org/iptf/articles/index.html>
[xxi] 149 F.3d 1368 (Fed. Cir. 1998)
[xxii] Stephen M. Maurer, “Appendix C: Raw Knowledge: Protecting Technical Databases for Science and Industry” in Proceedings of the Workshop on Promoting Access to Scientific and Technical Data for the Public Interest: An Assessment of Policy Options, National Academy of Sciences (National Academy of Sciences. 1999), online: National Academies Press <http://www.nap.edu/html/proceedings_sci_tech/appC.html>
[xxiv] (1981), 56 C.P.R. (2d) 204 (F.C. T.D.)
[xxv] National Research Council, A Question of Balance: Private Rights and the Public Interest in Scientific and Technical Databases (Washington, D.C.: National Academies Press, 1999), online: National Academies Press <http://books.nap.edu/html/question_balance/index.html>.
[xxvi] Berkely Technology Law Journal, Vol 14, Issue 4, Bioinformatics and Intellectual Property Protection, M. Scott McBride, Feb 2014.
[xxvii] BENJAMIN LEWIN, GENES VI (6th ed. 1997) (noting that the study of lipids and carbohydrates are largely reserved to biochemists) [hereinafter LEWIN].
[xxviii] Christopher Van Barr, “Decoding software patentability in Canada” (Paper presented at Infonex Conference “Patent Practice Update” Toronto, June 18, 2001) online: Gowlings <http://www.gowlings.com/resources/publications.
[xxx] Ken Howard, “The Bioinformatics Gold Rush” (2000) 282:1 Scientific American 58 at 63. See also Teresa K. Attwood, “The Babel of Bioinformatics” (2000) 290:5491 Science 471.
[xxxi] Intellectual Property Rights and theLife Science Industries, by Graham Duttfield, a 20th century History.
[xxxii] Supra, 32
[xxxiii] Supra 33
[xxxiv] 450 U.S. 175, 185 (1981);
[xxxv] Intellectual Property, Medicine and Health. Current Debates, by Johanna Gibson
[xxxvi] Epstein on Intellectual Property, 5th Edition, by Michael A. Epstein, Wolters Kluwer.
[xxxvii] Paul A. David, “Will Building ‘Good Fences’ Really Make ‘Good Neighbors’ in Science?” (2001), online: Stanford University Economics Department
[xxxviii] National Research Council, A Question of Balance: Private Rights and the Public Interest in Scientific and Technical Databases (Washington, D.C.: National Academies Press, 1999), online: National Academies Press.