Intellectual Property

Herdegen M. Patents on parts of the human body: salient issues under EC and WTO law. The Journal of World Intellectual Property. 2002 Mar;5(2): 145-55.
The author examines the EC’s new intellectual property regime for biotechnological inventions. He concludes that the EC proposes no undue restrictions on the patentability of human genes. The only restrictions that exist are in cases where the commercial exploitation would be contrary to ordre public or morality. He argues that the erosion of intellectual property may easily destroy incentive for medical and technological innovation. The real challenge is for legislators to strike a balance of interests within the research community.

Gold ER. Biotechnology patents: strategies for meeting economic and ethical concerns. Nature – Genetics. 2002 Apr;30(4): 359.
The review presents the tools that patent law offers to alleviate the socio-ethical issues arising from biotechnology patenting. These tools include determination of the scope of the patent, the morality clause and others.

Crespi RS. Patenting and ethics–a dubious connection. Journal of the Patent and Trademark Office Society. 2003 Jan;85(1): 31-47
The author argues that genes are unique in that they cannot be considered “property,” the way that holding a patent might suggest. This is because there is a strong case for considering genes as discoveries, and not inventions. In addition, there are strong objections for the use of DNA materials because of the imperfections in experimentation as therapy. European patent law currently regulates ethically questionable patents in a way that U.S. and international patents do not. Based on the problems discussed in the paper, the author concludes by suggesting that the European model opens doors for discussions on ethics and patenting.

Crespi RS. Ethico-legal issues in biomedicine patenting: a patent professional viewpoint. Science and Engineering Ethics. 2005 Jan;11(1): 117-36.
The author addresses criticism leveled against the legal protection of invention in the Life Sciences by multiple public organizations. From the perspective of a patent attorney, he argues that making ethical judgments against gene patents based on how they might misuse their control is outside the realm of a patent office. Furthermore, there are anti-competitive laws that attempt to restrict such behavior. Therefore, such arguments should not negatively influence legislators to prevent patent protection for biological inventions. The primary concern lies in being able to prove that the invention is in fact novel, inventive (non-obvious), useful, and that it can be reasonably used to develop a product.

*Nicol D. Balancing innovation and access to healthcare through the patent system–an Australian perspective. Community Genetics. 2005;8(4): 228-34.
The author examines the enforcement of scientific patents, particularly related to genetics, in Australia. Specifically, the author reviews proposals made by the Australian Law Reform Commission to change the balance between protection of intellectual property rights and access to healthcare by introducing some patenting restrictions assisting healthcare providers in using patented inventions.

Pressman L, Burgess R, Cook-Deegan RM, McCormack SJ, Nami-Wolk I, Soucy M, Walters L. The licensing of DNA patents by US academic institutions: an empirical survey. Nature – Biotechnology. 2006 Jan;24(1): 31-9.
The authors conducted an empirical survey of technology transfer of DNA inventions at 19 top US research universities. The authors found that simple reports on licensing often neglect to mention relevant nuances of licensing practice. Large universities however, were found to be mostly consistent in their licensing practices with NIH guidelines for research tools and genomic inventions. A third important observation in the study was that of market sensitivity in both patenting and licensing behavior. This suggests the importance of interesting future investigation of how the timing of licensing is influenced relative to publication of the inventions. In sum, the authors argue that licensing practices are evolving in light of experience and appear to be designed pragmatically to accommodate both economic and social goals.

Eisenberg RS. Biotech patents: looking backward while moving forward. Nature. 2006. 24(3): 317-319.
“Although the patent system is designed to promote the progress of science and the useful arts, it is slow to adapt to technological change.” The author highlights several flaws in the patent legal system, including the use of precedent in decision-making rather than anticipating change in the future; having the same set of rule for all fields of technology, while some observers argued that they are being applied differently; the court’s inability to fine tune laws according to new technologies; the delay in resolving legal issues, often occurring years after a technology is introduced; and the lack of clear definition of the boundaries of patent eligibility.

Gold ER, Bubela T, Miller FA, Nicol D, Piper T. Gene patents–more evidence needed, but policymakers must act. Nature Biotechnology. 2007 Apr;25(4): 388-9.
The authors provide feedback to Caulfield et al.’s article on the Myriad controversy, while specifically mentioning that more research needs to be conducted to determine the role of the patent system in the area of biotechnology.

Simon J. Biotechnology and law: biotechnology patents. Special considerations on the inventions with human material. Law and the Human Genome Review. 2006 Jul-Dec;(25): 139-59.
The author examines the differences between patent laws and regulations between Europe and the US in relation to biotechnological inventions. Both WTO members agree that human beings are not patentable. When it comes to the human body, however, opinions are different—they may be patented if they are produced artificially or are separated from the human body. In the US, this applies to all components with the exception of totipotent stem cells.

Editors, Patenting the parts. Nature – Biotechnology. 2007 Aug;25(8): 822.
This editorial addresses recent patent issues in the area of synthetic biology, such as the creation of genetically modified organisms. “On the one hand, aggressive patenting and licensing could put many of the DNA parts off limits to researchers. On the other, patents are needed to stimulate private sector investment in the development of practical applications of the technology.” The editors suggest that “it makes little sense for companies or other institutions to patent individual genes, or DNA parts, especially in a not-so-distant world where a 10-megabase stretch of DNA may be printed in under 24 hours.” Instead, encouraging open access to DNA parts can reduce time and resources expended on R&D.

*Gold ER, Kaplan W, Orbinski J, Harland-Logan S, N-Marandi S. Are Patents Impeding Medical Care and Innovation? Public Library of Science Medicine. 2009 January; 7(1): 1-5
The authors debate how and whether patents are an impediment to accessible health care and innovation—each author providing their own perspective. Gold argues that we could increase the productivity of biomedical innovation systems by rethinking how we use patents. Kaplan argues that the evidence on whether patents impede medical innovation is ambiguous. Obrinski, Harland Logan, and N-Marandi argue that patents skew biomedical research toward problems of the rich world.

Bentwich M. Changing the rules of the game: addressing the conflict between free access to scientific discovery and intellectual property rights. Nature – Biotechnology. 2010; 28: 137-140.
Bentwich discusses the barriers to information exchange and sharing under the current patent system, and proposes a revised mandatory version of the existing US provisional patent application (PPA), the provisional patented paper application (PPPA). PPPA combines the patent protection of the traditional PPAs with the ease and information exchange advantages of academic journal peer review process, which will administer the PPPAs to grantees instead of the USPTO. If implemented as an obligatory step in the process of filing a full patent application, this model can limit “the negative effects of the tragedy of the anticommons.”

Wu G. Patenting biotech beyond the central dogma. Nature – Biotechnology. 2010; 28: 230-233.
The author reviews several key cases that established new standards of patentability in biotechnology. Among the cases discussed are In re: Gleave on the novelty criterion, In re: Kubin on non-obviousness criterion, and In re Bilski on patentable subject areas for method or process claims. These precedents are also discussed in the context of the Myriad Genetics lawsuit filed by the ACLU. These cases illustrate the shift in the standards for biotech patents, where “patentability will depend less on biology and more on technology.”

Chan S, Sulston J. Patents in synthetic biology. British Medical Journal. 2010 Jun 14;340: 2984.
The authors highlight the implications of the patent system in relation to synthetic biology, particularly focusing on how patenting may affect the sharing of information and collaboration in the new field. They argue that part of the difficulty is that it is hard to measure the impact patents have on hindering future research. They highlight the broad scope of patents as a potential issue, as well as exclusive rights granted to patent holders to exploit the technology. Lastly, they argue that patents have the ability to restrict access to the innovations derived from research.

Kepler BT, Crossman C, Cook-Deegan R. Metastasizing patent claims on BRCA1. Genomics. 2010 May; 95(5): 312-314.
Bioinformatics was used to quantify the scope of the claim under patent 4,747,282 on BRCA1. The authors found that the patent claim covers a significant portion of cDNA and mRNA sequences contributed to GenBank, and that “Any “isolated” DNA molecules that include such 15 bp nucleotide sequences would fall under the claim as granted by the US Patent and Trademark Office.” The authors argue that the patent is broad because if it were enforced, many medical practices and research projects would be affected and will be in danger of patent infringement.

Carbone J, Gold ER, Sampat B, Chandrasekharan S, Knowles L, Angrist M, Cook-Deegan R. DNA patents and diagnostics: not a pretty picture. Nature – Biotechnology. 2010 Aug;28(8): 784-91.
The authors highlight the problems that patenting and licensing practices produce for DNA diagnostics. The authors particularly focus on the difficulties that broad patent claims and ambiguities about patent deployment cause for DNA diagnostics. Additionally, they unite on the claim that TTOs need to be adequately funded to promote permissive clinical data dissemination policies and transparency in the industry.

Cook-Deegan R, Heaney C. Patents in genomics and human genetics. Annual Review of Genomics and Human Genetics. 2010 Sep 22;11: 383-425.
Genomics and human genetics came to prominence via government and non-profit funding and, even more so, privately funded research in biotechnology and pharmaceuticals. Existing patents on DNA technologies seem to harm the relevant fields due to the exclusivity of university licensing practices. However, whole-genome sequencing will confront uncertainties regarding existing patents with broad and generic patent claims.

*Note: entries are presented in chronological order within each category. Entries marked with an asterisk are those that we found to be particularly helpful as we developed materials for this project.