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The US and China take very different approaches to the patentability of a range of inventions in the life sciences field, as Yu Guo of China Patent Agent reports.
Regarding patentable subject matter, the TRIPS Agreement specifies in article 27.1 that patents shall be available “for any inventions, whether products or processes, in all technical fields”. In the US, the Supreme Court established the principle in the decision of Diamond v Chakrabarty in 1981 that “patentable subject matter should include anything under the sun that is made by man”.
However, according to patent laws in each country, not everything made by man is patentable—there are excluded subject matters in most countries. Particularly regarding inventions in the field of life sciences, some countries stipulate the exceptions in their domestic laws according to the provision of article 27.2 and 27.3 of TRIPS.
Pharma inventions in China
ii. The novel medicinal use of a known compound can be drafted in the manner of a Swiss-type claim in order to obtain patent protection of the use. For instance, the drafting manner of “use of compound A in the manufacture of therapeutic agent Q for the treatment of disease X” should be adapted; and
iii. A pharmaceutical composition which is characterised by the administration method, such as the dosage, interval between dosing and/or route of administration, etc, cannot be patented. This means that only the pharmaceutical composition characterised by the composition features such as the components and the amounts is patentable.
The US picture
In the US, inventions related to pharmaceutical products are all patentable. In particular, inventions related to pharmaceutical compounds or pharmaceutical compositions and the preparation methods are patentable. Moreover, the protection is absolute.
The novel medicinal use of a known compound can be drafted in the manner of the method for the treatment of diseases in order to obtain patent protection. In addition, a pharmaceutical composition characterised by the administration method, such as the dosage, interval between dosing and/or route of administration, etc, is also patentable.
Diagnosis/treatment patents in China
Methods for the diagnosis or treatment of diseases are not patentable. However, (i) the method of acquiring information from a living human or animal body as the intermediate result only; (ii) the method of acquiring information by processing or detecting the tissues, body fluid or waste isolated from the human or animal body as the intermediate result only; and (iii) the method of processing the acquired information, are not considered to be methods for the diagnosis of diseases if the immediate purpose is not to obtain the diagnostic result of a disease or health condition.
“Regarding genes and gene sequences (excluding human genes), the USPTO deems that an isolated gene as a compound or manufactured product meets the requirement of patent protection.”
For instance, regarding inventions related to the method of measuring blood pressure, if the core of the invention lies in how to measure blood pressure in a more accurate way instead of determining the blood pressure value, and the invention per se does not draw a conclusion of hypertension, the method of measuring blood pressure is not a method for the diagnosis of diseases, and it is therefore patentable.
Outlook in the US
In the US, any invention for medical treatment is patentable. That means surgical procedures, methods for the treatment of diseases, methods for the diagnosis of diseases, medical instruments and the method of operation are all patentable. However, Congress provides exemption for doctors by enacting special clauses of the Patent Law in order to prevent medical workers from confronting the dilemma of infringement risk when they are saving patients.
In addition, the Supreme Court raised the bar for granting method patents in the decision of Mayo v Prometheus in 2012. The decision pointed out that the patents of Prometheus merely describe the law of nature as “relationships between metabolites in [the] human body”. The steps of “providing” [the dose of thiopurine] and “determining” [the optimal dosage of thiopurine for treating autoimmune disease] in the case, either individually or in combination, are insufficient to transform the identified natural law into a patentable process.
Animal/plant patents in China
In China, inventions related to animals and plants are hard to patent. Animal species and plant varieties are not patentable. An “animal” includes an animal individual, a transgenic animal individual, an embryonic stem cell of an animal, a germ cell, an oosperm, an embryo, etc. A somatic cell of an animal, a tissue and an organ of an animal are excluded. A “plant” includes a plant, a transgenic plant, a seed, etc. A cell, a tissue and an organ of a plant are excluded.
Patent rights may be granted for processes used in producing animal and plant varieties. The processes of production refer to non-biological processes (such as cell engineering technology, genetic engineering technology, etc), and do not include those through essentially biological processes (such as hybridisation or selective breeding, etc).
The preparation methods of microbial strains, microorganisms and microbial products are all patentable. However, a microorganism is patentable only when it is isolated into pure culture and has particular industrial use. Moreover, when an invention involves a new biological material, the applicant should deposit a sample of the biological material.
Regarding experimental animal models:
ii. “Methods of obtaining an animal model through surgery” are not patentable since they are practised on a living animal and are not applicable for industrial use. “Methods of obtaining an animal model not through surgery” are patentable.
iii. “Use of animal models in the evaluation and selection of diagnostic or therapeutic methods” refers to practice on a living animal, which directly results in the diagnosis or treatment of diseases and it is therefore not patentable. “Use of animal models in drug screening” is patentable if the direct purpose is screening drugs or measuring the activity of compounds only.
Ex Parte Allen
Biological inventions in China
Rules relating to nventions in the biological field
i. Embryonic stem cells, germ cells, oosperms, and embryos of human beings shall not be granted patent rights.
ii. A gene or a DNA fragment per se and the process to obtain it can be patented if the gene or DNA fragment is unknown in the prior art and can be accurately characterised and exploited industrially.
iii. A vector, a recombinant vector, a transformant, a polypeptide or a protein, a fusion cell, a monoclonal antibody, the preparation method and its use are all patentable.
What the US says
Regarding genes and gene sequences (excluding human genes), the USPTO deems that an isolated gene as a compound or manufactured product meets the requirement of patent protection, as the purified state of the DNA molecule is different from the compound present in nature.
However, according to the Supreme Court in Association for Molecular Pathology v Myriad Genetics in 2013, isolated DNA is not patent-eligible under section 101. On the contrary, cDNA is not a ‘product of nature’ and is patent-eligible under section 101 as it is absolutely different from the original DNA, even though it maintains natural DNA exons. But cDNA is patent-ineligible if no intron is eliminated during the generation of cDNA.
Non-biological methods which can produce living organisms or other components or modify animals, plants, microorganisms or even part of the tissues of living organisms by technical means such as extracting, changing, storing, carrying and reproducing genes are all
anything under the sun that is made by man is
Yu Guo is a patent attorney at China Patent Agent. He can be contacted at: firstname.lastname@example.org
Yu Guo, China Patent Agent, life sciences, patent, Supreme Court, pharmaceutical, TRIPS,