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Introduction In the chemical field, it is difficult to seek invalidation of a patent claiming to have achieved unexpected technical effect. This case provides a strategy for success...
Currently, many countries and regions do not provide patent protection for methods of treating and diagnosing diseases, but inventions of medical uses including new uses of known compounds or compositions are protected in some forms.
The subject matter of medical use claims can be classified into the following categories: product claim, Swiss-type claim and medicament manufacturing method claim. A product claim appears as “Compound (composition) X for the manufacture of a medicament” or “Compound (composition) X for the manufacture of a medicament for the treatment of disease Y.” A Swiss type claim assumes the form of “Use of compound (composition) X for the manufacture of a medicament” or “Use of compound (composition) X for the manufacture of a medicament for the treatment of disease Y.” A medicament manufacturing method claim may be written as “a method of manufacturing a medicament, wherein compound (composition) X is used” or “a method of manufacturing a medicament for the treatment of disease Y, wherein compound (composition) X is used.”
Patent protection provided by different countries and regions is different in degree, scope, condition and format. This difference is embodied in the appraisal of novelty, support determination and claim type. A brief comparison among Europe, Japan and China is presented below.
I. Europe
1. Novelty
In the European Patent Office, a new medical use may render a compound or composition novel. To be specific, if the prior art does not disclose any use of a compound or composition, the compound or composition defined by a use is considered novel, even if the compound or composition has already been known. If the prior art discloses medical use of a compound or composition but does not disclose a specific use, the compound or composition defined by the specific use is considered novel.
According to the case law of the EPO, the treatment object (patient), administration route, dosage regimen, and other aspects can identify a medical use as a new one, provided these aspects are not part of the prior art, and a new medical use is not limited to a new indication (therapy of a new disease).
2. Support
According to the case law of the EPO Boards of Appeal, the EPO does not require the claim to be limited to a specific therapeutic use mentioned in the description even though the description does not teach that the compound or composition can treat all diseases or a specific disease. In other words, even though the description discloses only a specific medical use while the claim covers all medical uses, the claim is not deemed to lack support in the description. It is for the delimitation of novelty that Article 54(5) of EPC 2000 narrows a second or a further medical use to a “specific use.”
3. Claim type
In February 2010, the EPO Enlarged Board of Appeal made a decision on medical use (G 0002/08). As recited in the decision, where the subject matter of a claim is rendered novel only by a new therapeutic use of a medicament, such claim may no longer have the format of a Swiss-type claim. As a result, product claims of compounds or compositions defined by medical uses will become the primary form of subject matters of inventions of medical uses.
II. Japan Patent Office
1. Novelty
Under the Examination Guidelines for Patent and Utility Model in Japan, a known compound defined by a new medical use is not rendered novel by the medical use.
A medical invention referred to in the Examination Guidelines means an invention of a product (a composition or a medicament preparation) based on discovering unknown attributes of compounds and finding that compounds are suitable for a new medical use due to the presence of such attributes. Its novelty is judged from two points of view: (i) compounds and (ii) a medical use based on the attribute. In other words, a medical invention is considered novel if the medical use is new, even if the active substance or the composition has a known constitution.
Like the EPO, a different indication (disease) or way of administration (such as administration route and dosage regimen) is also regarded in Japan as a different medical use and can render a medical invention novel.
2. Support
The Examination Guidelines in Japan prescribe that, in cases where the statement in a claim of a medical use does not express a specific medical use but a general medical use (for example, the statement expresses not a “pharmaceutical agent for disease Y consisting of ...” but a “pharmaceutical agent consisting of …”), it should not be deemed a violation of Article 36(6)(ii) merely because the statement expresses a general use (i.e., merely because the scope of the claim is relatively broad) unless the expression makes unclear the invention for which a patent is sought.
3. Claim type
In Japan, the subject matter of a medical use claim is not particularly restricted, so long as it is not written as a method for the treatment and diagnosis of a disease.
III. SIPO
1. Novelty
In China, no special principle is applied to determine the novelty of a compound or composition defined by means of a medical use. In other words, a new medical use cannot render a known compound or composition novel.
In the case of a Swiss-type claim (e.g., Use of compound or composition X for the manufacture of a medicament for the treatment of disease Y), where “the method of manufacturing the medicament with the compound or composition X” is no different from “the prior art methods,” a “new indication” (i.e. a therapy for a new disease) can render the use claim novel. However, where “the method of manufacturing the medicament with the compound or composition X” and “the indication” are no different from the prior art, the way of administration (such as administration route and dosage regimen) alone cannot render the use claim novel. If the way of administration, e.g. the administration route, causes “the method of manufacturing the medicament with the compound or composition X” to vary so as to be distinct from the prior art, the use claim will certainly be rendered novel.
2. Support
In China, the medical use in a claim is not allowed to be expressed in a general way. In other words, if a claim is written as “Use of compound or composition X for the manufacture of a medicament,” the Examiner generally points out that the claim is not supported by the description, on the ground that the “medicament” covers a rather broad scope.
3. Claim type
Despite the fact that no specific limitation is imposed on the type of subject matter of medical use claims in China, neither a product claim of compound (composition) nor a claim of medicament manufacturing method is practical for an invention of a new medical use whose compound, composition or medicament manufacturing method has no difference from the prior art., because a general principle is applied to the determination of novelty of the compound (composition) and the medicament manufacturing method, that is, neither of these claims is rendered novel by the new medical use. Swiss-type use claims are adopted in practice.
As shown above, patent protection provided by different countries for medical uses is different in degree, scope, condition and applicable claim type. Thus, it is necessary to select appropriate protection strategies for specific inventions in order to adapt to the patent systems of different countries and regions.
Hopefully, the above introduction is helpful in understanding similarities and differences among different countries’ patent systems and dealing with patent cases.
