By Irina Pomestchenko and Aurelia Mitchell Durant | www.amdlawgroup.com
The global biotechnology sector is rapidly expanding. This expansion is leading to more discoveries and innovations than ever before. The field of biotechnology is based upon the controlled and deliberate manipulation of biological systems for the manufacture or processing of useful products. Biological systems are living cells and their cellular and molecular components. Genetic splicing was modernized in 1971 by Paul Berg, a professor at Stanford University in California. The study of biotechnology wad further enhanced by Herbert W. Boyer from the University of California and Stanley N. Cohen from Stanford. Boyer and Cohen advanced a way to transfer genetic material by encasing it in bacterium. The ability to transfer genetic material is crucial to the ability to reproduce the material making the process of manipulating genetic material commercially viable.
On June 16, 1980, the United States Supreme Court in the case of Diamond v. Chakrabarty ruled that genetically modified microorganisms could be patented. Patentability is critical to the commercial success of the biotechnological processes. The current state of the biotechnological space is able to sequence genes, identify their functions, and mutations create systems to selectively express regulate or silence genes. There is also a capability to predict protein structures, map the influence of genetic makeup on metabolism. Biotechnology allows researchers to analyze vast amounts of genetic data pushing the limits of what is possible and uncovering new horizons in healthcare discovery.
Because of its critical importance and commercial viability, genetic research has been the subject of extensive investment by both the public and private sectors by way of the promotion development of new products, processes, technologies, therapeutics and diagnostic tools. At the forefront of genetic research is the study of human genomes. A genome is the complete set of genetic information in an organism. Genomes provide all of the information the organism requires to function. In living organisms, the genome is stored in long molecules of DNA called chromosomes. Small sections of DNA, called genes, code for the RNA and protein molecules required by the organism. Intellectual property protection is central to the growth in the study of genomes. For example, one may debate whether extracted strands of human deoxyribonucleic acid (“DNA” or “biological code”) are sufficiently “man-made” to avoid 35 U.S.C. § 101’s prohibition of patents on “naturally occurring phenomena.” The United States Supreme Court formally addressed this issue in Association for Molecular Pathology v. Myriad Genetics wherein the Court held that merely isolating genes that are naturally found in nature does not make them patentable.
Recently, some governments, in particular of countries members of The Organization for Economic Co-operation and Development including the United States, as well as patient groups and healthcare providers have become concerned about how certain genetic discoveries have been licensed and exploited, particularly for diagnostic genetic services in the human healthcare field. The highly dynamic pharmaceutical industry and public and private biotechnology sectors often tend to misuse the intellectual property protection system in the mere hope that their inventions might find commercial applications in the future.
The number of patents granted in biotechnology filed with United States Patent and Trademark Office (USPTO) and European Patent Office (EPO) has been steadily escalating with 3,223 biotech patents being granted by USPTO in 2014 (https://www.nature.com/articles/nbt.3288) A large subset of these patents relate to the “genetic inventions” i.e. have claims that cover DNA and/or RNA sequences that may encode gene or fragment of gene.
Genetic inventions more broadly understood also include agricultural, environmental and industrial uses such as genetically modified produce, bioremediation, production of chemicals, textiles, and biofuels produced in part by genetically altered organisms. Patent claims in a gene patent application may pertain among other things to processes used for the production of a genetically modified product and use of genetic sequences of proteins. Genetic tests for specific genetic diseases and drugs are developed on the basis of the knowledge of the proteins and their biological activity and industrial applications of protein functions. In 2001, the USPTO published the “Revised Guidelines on the Examination of Patent Applications”, which clarified that patent applications must disclose “a specific, substantial and credible utility”. Utility in this instance is important to rebut the presumption that the grant of patent protection would be deemed premature.
In 2014, in response to decisions from the U.S. Supreme Court regarding claims reciting judicial exceptions including abstract ideas, laws of nature, and natural phenomena, the USPTO issued Interim Guidance on Subject Matter Eligibility (15 Dec 2014) explaining how patent examiners should evaluate claims for patent subject matter eligibility under 35 U.S.C. 101. The steady rise of innovations in biotechnology offer hope for humanity.
The major challenge is to strike a balance between the need to keep information and access to genetic data open in order to promote the diffusion of research results with the commercial need to protect inventions in order to create revenue from investments in research and design. Some of the issues include: dependency problems, restrictive patent licenses, the reluctance of researchers to enter fields where genes have already been patented or where multiple groups are competing to patent the same gene
For example, Myriad’s patents covering BRCA1 and BRCA2 began to issue in 1997 and 1998, and company obtained a total of nine patents covering different aspects of the two cancer susceptibility genes. At the same time the UK group led by Stratton, another U.S.-based company, OncorMed, Inc., obtained licenses to some of the early BRCA markers and succeeded in patenting a slightly different set of BRCA sequences than Myriad. OncorMed also obtained a license from the UK Cancer Research Campaign, which owned the rights to the discoveries made by the Stratton group. Like Myriad, OncorMed’s principal U.S. patent on BRCA1 issued in 1997, and the two companies promptly sued each other for patent infringement. The litigation was eventually settled with Myriad’s acquisition of OncorMed’s BRCA patents in 1998, thus consolidating in Myriad’s hands substantially all U.S. patent rights relating to the BRCA1/2 genes.
In the statutory language, the patent holder has “the right to exclude others from making, using, offering for sale, or selling” the invention in the United States or “importing” the invention into the United States. What is granted is not the right to make, use, offer for sale, sell or import, but the right to exclude others from making, using, offering for sale, selling or importing the invention.” (www.uspto.gov) Thus, the inventing party being entitled to the patent is often limited in its rights to practice the invention as it can be a subject to the prior invention. In the field of biotechnology, being subject to a prior invention is not uncommon.
In February 2006, Organization for Economic Co-operation and Development (OECD), which includes 35 member countries from the Americas, Europe, and the Asia-Pacific, adopted the Guidelines for the Licensing of Genetic Inventions (https://www.oecd.org/sti/biotech/36198812.pdf). These Guidelines comprise principles and recommended practices for those in business, R&D and health systems who enter into license agreements for genetic inventions. Following, in October 2008 the OECD Council adopted Guidelines on Human Genetic Research Databases that provide principles and best practices on the numerous issues that arise with respect to human genetic research databases including, among others, funding mechanisms, governance structure, privacy, and confidentiality policies. (http://www.oecd.org)
Additionally, the European Society of Human Genetics supports the OECD guidelines that licenses should be non-exclusive and easily obtainable, practically and financially. In order to promote the alternative models for licensing patent pools and clearinghouses shall be explored. It has been proposed that in order to better track development in the field, the establishment of a voluntary reporting system whereby genetics could report any issues related to new and/or old patents or licenses. The patent pools or clearinghouses have previously been successfully employed within other areas, such as information technology and the Australian Law Reform Commission, the Canadian Expert Working Party on Human Genetic Materials, Intellectual Property and the Health Sector (Canadian Biotechnology Advisory Committee).
In the United States, the National Institute of Health (NIH) agrees on the following practices that and recommends to adhere the following recommendations: (https://www.ott.nih.gov/sites/default/files/documents/pdfs/70fr18413.pdf)
- Patent protection shall be only sought on a genomic invention if significant research and development by the private sector is further required to bring the invention to a practical and commercial application and if capital investments are necessary to develop and make the invention widely available. Otherwise, IP protection shall be deemed premature and not to be pursued.
- Once protection is granted and definite commercial pathways unfold, the distinction shall be made which embodiments of the invention that require exclusive licensing as an incentive for the commercial development of products and which would be best-disseminated non-exclusively in the market and available for wide use.
- Whenever possible, a non-exclusive license should be pursued as it would favor broader technological and research uses of the invention and enables access to the knowledge by the scientific community.
- When a genomic invention represents a component part or background to a commercial development, a non-exclusive freedom-to-operate licensing may provide an appropriate solution.
- If exclusive licensing has to be pursued, the licenses should be tailored to ensure efficient development of multiple aspects of the technology. Specific indications, the field of use and territories should be limited commensurate with the abilities and commitments of the licensees to bring the innovation/technology to the market swiftly.
- It is recommended that license agreements be written with preset and enforceable milestones marks to ensure that the technology is fully developed by the licensee. The NIH Best practices provide a room for modification and termination of the licenses when the commercialization progress is deemed inadequate.
A healthy and commercially vibrant society demands a licensing system capable of undergoing rapid development and metamorphoses to adapt to the modern pace of the progress. Companies, governments, research institution and the public are reacting rapidly to deal with the increasing complexity of the intellectual property system in the biotechnology sector. However, there is a need for a policy-based solution to current problems. The continued monitoring of patenting and licensing of genetic inventions is necessary along with the collection and analysis of robust economic data as a basis for action to ensure that access does not become more problematic.
Federal Register, Vol.70, No.68, 2005, p. 18413-18415
Genetic Inventions, Intellectual Property Rights and Licensing practices, http://www.oecd.org/sti/sci-tech/2491084.pdf
Hawkins, N.; International Review of Intellectual property and competition Law, 2012, Issue 6. “An exception to infringement for genetic testing- addressing patient access and divergence between law and practice”.
Matthijs S. A., Soini, S.; European Journal of Human Genetics, 2008, 16, s3-s9. “Patenting and licensing in genetic testing”.