In this period when everyone is talking about viruses, but also about vaccines, medicaments and so on we have addressed a few (simple) questions to Cherry Zhou, patent attorney at HFG, in relation to patents and viruses.
Can genetic sequence of a new virus be patented in China?
CZ: The gene of a new virus itself, defined by its nucleotide sequence, cannot be patented in China, since the gene merely is found in the nature and existing in its natural state without providing any industrial utilization, so that it will fall into the unallowable category as recited in Article 25, i.e., “scientific discovery”.
However, a gene and the process to obtain it thereof, can be the subject matter of patent protection if it is isolated or extracted from the nature for the first time, and its sequence can be definitely characterized, and it can be exploited industrially.
For example, a DNA fragment that is designed by use of virus gene, synthetized and isolated, and aims for detecting the cases of the disease, can be patented.
Can the test to discover if a certain human being has been infected be patented?
CZ: The test method to detect whether a certain person is infected, cannot be patented in China, because the test method falls into “methods for the diagnosis or for the treatment of disease” as recited in Article 25, which is directly practiced on living human or animal body with immediate purpose to obtain the diagnostic result of a disease or health condition.
However, the method to obtain information form the living human or animal body as an intermediate result does not belong to diagnostic methods and can be patented.
In connection with 2019-nCov, the CT diagnostic method for detecting the cases, cannot be granted a patent right, while a diagnostic kit along with method for nucleotide detection that can provide the existing or non-existing result (below the threshold value) of virus gene by use of the sample form the patients, such as blood and saliva, can be grant a patent right.
Can the drug to cure the virus be patented?
CZ: The drug to cure the virus can be patented, and the subject matter of patents related to the drug, usually directs to a chemical compound or antibody, a composition, a formulation and a usage of existing compound.
Can be done a "second-use" patent for an existing drug which is proved to be very efficient on the new virus?
An existing drug that is proved to have excellent efficacy on the new virus, can be patented, and the subject matter of the patent directs to the new usage of the existing drug.
For example, the novel usage of compound of Remdesivir of Gilead Sciences (a US pharmaceutical company), that is proved to exhibit excellent therapeutic efficacy on this novel coronavirus, is patenting by a Chinese famous virus research institution.
The patent can be granted, if the novel usage is not obvious and cannot be anticipated by the ordinary person of the skill.
Can a patent be obtained on the cocktail of existing drugs to cure the new virus?
CZ: The cocktail of existing drugs to cure the new virus can be patented, which directs to a combination of two, three or more drugs.
The specification of the patent for the cocktail should record the improved therapy efficacy of the combination relative to the single drug.
The beginning of famous cocktail treatment firstly used against HIV is tracked back to 1990s, and it can be reasonably expected that the cocktail treatment can be successful to cure the disease of the new virus, because of same therapeutic mechanism.
Can a patent be transferred/licensed to another company if it is related to a drug that need to be produced in a moment like this (outbreak of new virus)?
CZ: There is a compulsory license system of medicine patents in Chinese patent law. As prescribed in Article 50 of Chinese Patent Law, for purposes of public health, the patent administration department under the State Council may grant a compulsory license to manufacture a pharmaceutical product which has been granted patent right, but the decision made by the patent administration department should be notified to the patentee, and shall be registered and announced.
In this moment (outbreak of new virus), the government appears to be capable of adopt a compulsory license, but two sides of the compulsory license system, particularly the disadvantage(s) should be also considered.
The system is helpful to relax the crisis of public health in short term, while on the other hand, it may be bad for the medicine development and social benefit in the long term.
By way of examples, the compulsory license might reduce the incentive to develop the novel drug, and then be averse to the long-term development of pharmaceuticals industry.
Because of the non-establishment of the strict legal procedure, the system might be possibly abused, amplifying the patentee’s loss.
Additionally, the system might negatively influence the investment and research, and attraction of foreign capital.
At present, most of countries around the world remain very cautious about the compulsory license, though they proposed implement of the compulsory license in treatment of HIV and malaria.