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Stem cells: Global research policies and patent laws

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While harmonization of stem cell research policies and patent laws worldwide is desirable, given the cultural and religious differences among the countries, it may not be possible. This is increasingly evident in the field of stem cells, where there is no international consensus with respect to the morality of working with human embryonic stem cells (hESCs) and where the corresponding policies for patenting vary among the national patent offices worldwide.

Many believe that patents should be available for isolated human embryonic stem cells and methods of production or use of hESCs, as long as they meet the general patent criteria in a particular country (e.g., novelty, utility, non-obviousness, industrial applicability, inventive step and/or sufficiency of disclosure), while exclusions to patentability due to the principles of "public order" or morality should be limited if possible. Today, technical solutions to these moral dilemmas are being reported often, including recently described techniques such as parthenogenetically derived blastocysts or reprogramming of adult cells to generate embryonic stem cells.

In Europe, ethical regulations bar the patenting of the human embryo or uses of human embryos for industrial or commercial purposes. This regulation originates from a law that prohibits patenting inventions contrary to morality or "ordre public." Similar to Europe, many other countries have a "morality" clause that affects patentability of certain biotechnological inventions. In many countries, this prohibition or effect on patentability includes human embryonic stem cells, the process of extracting human embryonic stem cells from a human blastocyst, and patents covering human embryonic stem cell lines. For example, the United States looks at "public policy"; China, "public interest"; Japan, "morality"; Singapore, "offensive, immoral or anti-social behavior"; and Australia, technologies that are "against the law." In some European countries, such as Germany, hESCs may not be extracted from embryos and research on imported pluripotent hESCs is permitted only if the cells originate from culture lines established before Jan. 1, 2002. Europe generally prevents any financial gain from use of cells or tissues of the human body, however, some argue that embryonic stem cell lines are not "body parts" since they are "artifacts" of a culture system. In Asia, including China, India, Japan, Singapore and South Korea, where there are positive views on stem cell research, private and public entities are developing hES cell lines. Interestingly, while India and China appear to be moving forward quickly with successes in stem cell research, these countries have much less experience in terms of a well-developed patent system.

In the Asian culture, the human embryo is highly respected; however, it is the financial exploitation of human embryos that is rejected. In other words, the "sin" in the use of human embryos for research is in patent protection and subsequent financial exploitation as a result of patents.

A look at the global collection of stem cell patent families consisted of 47,467 documents in November 2007. The greatest percentage of patents and patent applications were filed in the United States Patent & Trademark office (USPTO); the PCT (Patent Cooperation Treaty application) or the European Patent Office (EPO), followed by Australia, Canada and Japan. More than 50 percent of inventors on stem cell patents and applications are from the United States and more than 57 percent of assignees or owners of these patents and applications are from the United States.

Patents granted in the United States to the Wisconsin Alumni Research Foundation (WARF) for work done at the University of Wisconsin on embryonic stem cells have created concerns that access to even basic research tools for studying human embryonic stem cells will be more and more difficult over time. Although more than 400 research and 20 commercial licenses have been made available by WARF for hESC production and use, it is believed that with the increase in the number of patent application filings in the stem cell area, other patents may be required for freedom to operate in the field, thus imposing increasing transaction costs and stacking royalty obligations on those companies entering into this area of research and development. Regardless of the technology area, the need for licenses to multiple patents in any field slows the investment of capital into new ventures, and the overall development and commercialization of new technologies is likewise delayed.

The three WARF patents, claiming all primate and human embryonic stem cell lines, were challenged in 2006 and one was upheld in part in February and two in March. While it was previously believed that these patents were the biggest hurdles to overcome with respect to freedom to operate in the stem cell field, certain claims in the patents were narrowed to the point that they may only include certain technologies known at the time of the filing of the original patent applications (e.g., 1998 and 2001).

For example, recent technologies, including parthenogenesis or reprogramming of adult cells, which allow for preparation of hESCs through methods that do not require generation of a "pre-implantation" embryo, may fall outside of the scope of the re-examined WARF patent claims for hESCs. While this may be a positive result for the advancement of the stem cell field, there are other technology areas where overlapping patent claims for nuclear transfer methods, specific markers unique to stem cells or products of stem cells, or other complementary technologies for example, may be required for freedom to operate toward development of commercial and therapeutic applications of stem cells.

Regardless of ethical or moral regulations that affect patentability of hESCs in various countries, new methodologies in stem cell research may aid in avoiding various restrictions in patent laws and may lead to increased research in the United States and other countries.

Haile, J.D., Ph.D., is a partner and the co-chair of the Global Life Sciences practice at the global law firm DLA Piper in San Diego.

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