Comparative Study on Patenting of Human Embryonic Stem Cells

By Huan Zhu --

With recent developments in biotechnology, the legal issues surrounding its patent law since the 1980's have been a growing concern.  Among all the subcategories of biotechnology, hESCs (human embryonic stem cells), one of the most controversial categories, is receiving different patent system treatments in different countries.  The rules and regulations regarding patents, their applications, issuance, and litigations are studied and compared in the United States, the European Patent Organization (EPO), and China.  The analysis is based on the general theory and principles of patents along with the existing patent laws.

The essence of patent law is to reward inventors, through legal intellectual property protection, in order to both stimulate and promote innovation.  The main task of patent law is to protect a legal monopoly while maintaining a fair competition market.  With regard to hESCs, this task is more complicated than with other subjects.  There are obvious issues due to the close relation to human embryonic stem cells and human beings along with a symbolic component of human dignity.  People question both the legitimacy of human embryonic stem cell research and the state granted monopoly on related research findings.  In addition, it is questionable whether patent law, in its current form, can keep the perfect balance between stimulating hESC innovation in industry and ensuring that patients can benefit from inventions derived from hESC research.  Due to this collection of considerations, different countries have developed various, and sometimes competing, viewpoints on hESC patentability and patent protocol.

For instance, China explicitly opposes the patentablity of hESCs in its agency manual for morality consideration under the Chinese Patent Law because patenting hESCs is contrary to morality and public interest.

Similarly, the EPO, based on ambiguous language in the European Patent Convention (EPC), excludes hESCs' patentability during patent examination by broadly interpreting the morality clause under the EPC, as long as hESCs used in inventions are derived from human embryos.  A similar interpretation is issued in a recent case Brüstle v Greenpeace e.V before the Court of Justice of European Union, stating that any stem cells derived from human embryos are considered "human embryos," and therefore not patentable, regardless of whether the purpose is for business and industry or therapy and treatment.  Nevertheless, whether this interpretation will be adopted by the European Patent Office is still in question, the same as how national patent offices will respond to the decision.

In contrast to both China and the EPO, the United States has become the main progenitor of hESC patents, although debates on the validity of those patents have begun and continue to be of interest.  Instead of taking morality into account as in China and the EPO, people have questioned the validity of hESC patents on the grounds of their novelty and non-obviousness.  The novelty and non-obviousness clauses are believed by some to be an alternative method to exclude hESCs from patenting due to the lack of morality considerations in US patent law.

According to a survey on hESCs-related patents issued and patent applications filed before the US Patent and Trademark Office, the European Patent Office, and the State of Intellectual Property Office of the PRC, two elements may constitute the law and policy differences, especially between the US and China.  One factor is the development of hESC research.  The US owns more than half of the hESC-related patents issued in the three patent offices, which gives the US more motivation to protect the results and findings than other countries.  The other possibly influential element is the ownership types of patent holders.  In the US, individuals and companies are the primary owners of hESC-related inventions, while government-affiliated research institutes and public universities are the main owner types in China.  Whether inventions are circulated in the free market determines whether patent rights are needed to function as an innovation stimulus, which may ultimately affect the patentability policy adopted by these governments.

Huan Zhu is a policy research assistant with DB Capitol Strategies PLLC in Washington, D.C.  Prior to joining DB Capitol Strategies, she earned a Doctorate in Juridical Science from the University of Kansas School of Law in 2011 after completing her dissertation entitled "A Comparative Study on Human Embryonic Stem Cell Patent Law in the United States, the European Patent Organization, and China."  This article is based in part on a presentation Dr. Zhu gave at the Biolaw 5.0: Law at the Frontiers of Biology conference at the University of Kansas School of Law on October 21, 2011.

Comments

[EG]

Dr. Zhu,

Thanks for comparing the patent law situation on hESCs in China/the EPO v. the US. The "morality/ethical/public interest" basis for denying patent-eligibility of such subject matter is a very slippery slope. There have been many attempts to preclude patenting in the US of various biotech subject matters (e.g., human nucleotides in the various Becerra bills) and only the recent prescription against patenting "human organisms" in the America Invents Act (AIA) has succeeded (and is frankly redundant as such patenting is proscribed by USPTO policy, as well as the US Constitution). That shows the reluctance of the US to follow the path of China/the EPO.

More significant, if the research underlying the subject matter for which patenting is sought is not itself deemed illegal/unlawful as being against "morality/ethical/public interest," then how can patenting such subject matter be deemed against "morality/ethical/public interest"? Does China/the EPO consider the underlying research on hESCs a "morality/ethical/public interest" problem? If not, I see a double standard being applied here by China/the EPO.

[Tech transfer voice]

And further to EG's comment, when therapies are developed from hESCs, will it be legal to sell them in these countries? Will it be morally suspect to accept treatment which was derived by killing a blastocyst?

[HZ]

Thank you for your questions. It does seem like a paradox that some countries allow hESC research but not patents. My understanding is that to these countries who support hESC research only under restricted conditions but deny its patentability, it is immoral or against the public interest to industrialize, commercialize or monopolize the research results. In Contrast, hESC research that falls out of the legitimate research field is not patentable due to the immorality of violating human dignity while the lawful research results are not patentable because a monopoly on such results is against the public interest.

The same rule applies to imported tools or treatments that are patented in other countries. They may or may not be allowed to enter into the market of these countries.

[maroussia levesque]

Hello,
I would be interested in reading your dissertation for research purposes, please get in touch with me.