An Australian court gets through the BRCA1 gene patent application of Genetic Technologies of Melbourne Co., Ltd recently. The U.S. Supreme Court sentenced that Myriad's holding of BRCA1 and BRCA2 DNA sequence test patent were invalid in 2013. The reason is that naturally occurring DNA fragments are products of nature, and it could not have a patent application just because of being separated out .
Which invention can be granted a patent right in biomedical fields? The provisions of each country is different, and the cognizance of the Patent Office also different with the courts' ruling.
Guangzhou University of Chinese Medicine professor Zeng Qingping told the reporter that whether to apply the biological patent is also a problem.
People engaged in high-end scientific research (basic research) never consider the practical application of scientific research. Limited to the current industrialization level, the advanced achievements are difficult to apply. If the applicants turn them into
patent, in addition to pay the patent annual fee each year, they will not bring any economic benefit to the applicants.
The complicated biological patents
Biological patents which can apply and whether it should apply, make the relevant personage confused and often argue. This problem is associated with the uniqueness of biological patents.
Xu Xinming, Chinese Intellectual Property Lawyers Net chief lawyer and Beijing Ming Tai Law Firm senior partner, said to the China Science Daily reporter that the uniqueness of biological patents was the fuzzy boundaries between "scientific discovery" and the "invention".
Chief Lawyer Xu Xinming thinks the U.S. Courts and Australian courts having different ideas on the thing looks like playing word games. The fundamental reason of the difference is that the the judgment standard between "discovery" and "invention" is subjective and difficult to define accurately.
Not only the gene patents, but also the stem-cell field has a lot of fuzzy applying for patents.
In Shenzhen International Biotech Summit 2014, a foreign patent agent pointed out that cell therapy can't apply for a patent in some situations, such as stem cells derived from forming embryos could not apply for patents. These fields were limited by ethics, no matter in China or abroad.
Beike Biotechnology Co., Ltd. project department manager Ding Changcai thinks the related patent review policies and review standards of human embryonic stem cells are quite different. But the truth that stem cells derived from forming embryos could not apply for patents because of the ethic limitation have reached a consensus. According to the different embryonic stem cells types, there are different patent regulations in some countries. Human embryonic universal cells that may develop into a complete human can not be granted patents; otherwise, they can be granted patents without the means of destroying human embryos.
Biological patents are limited by the Principle of Public Order and Good Custom. Patent Law of the People's Republic of China article 5 regulates: “No patent right shall be granted for any invention-creation that is contrary to the laws of the State or social morality or that is detrimental to public interest.”
There is no clear regulation on the Principle of Public Order and Good Custom in U.S. Patent Law. But this does not mean that the United States court in patent cases, especially the gene patent disputes, are regardless of the public order and public interests.
Chief lawyer Xu Xinming said the debate between "the scientific discovery" and "invented" is the patent holder interests and social public interests opposition and balance. When the judge tries the biotechnology patent cases, he should grasp the balance of interests between the two in condition with their urban situation. Besides the interests balance, biological patents also are limited by religious, ethical, moral in many times and the situation will become more complex.
Biological technology protection should be considered comprehensively
Ding Caichang told the reporter that enterprise or researchers also were experiencing complex applications process for biological patents.
The product applying for patents should be the first time invented in the worldwide with uniqueness and individuality according to patent laws. We should carefully exam and verify before the start of research, research process, and applying for patent.
Ding Changcai said we should further search the similar results obtained by others in the process of research and after the achievements.
The careful verification is to ensure that the products can be applied successfully. The time to apply for a patent needs to learn.
“Some people immediately apply for a patent after they get part products, then fill the formal application after the whole product. Owing to the application time calculating according to the first time, the laws also allow this method.” Ding Changcai said.
If it is not the secret patent or reaches the condition of secret patent, according to the openness principle, the name, structure, and concentration are open.
In the interview, many experts thinks, for reasons of not wanting to open technology or technology cycle too short (3 years) or too long (more than 20 years), some technology holders will give up the patent and take the business secret protection form.
“Commercial secrets to protect the interests of the biological technology holders is a good way, but for the biological field, whether to apply for the patent and how to protect is a problem need to measure because most new technologies need to summarize and reform the old technologies, and hold biological patents bringing benefits. ”Ding Changcai summarized.