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Protection Status of Medical-Use Invention in Various Countries

06

JAN

2020

In the patent field, discovering new therapeutic uses of drugs is known as invention for medical use. In the current patent system, an invention that uses known substance or composition that has not been used to treat a disease is considered as First Medical-use Invention. An invention that uses known substance or composition that has been used to treat a disease is considered as Second Medical-use Invention. In the medicine field, the subject of patent right varies from country to country. This article discusses the composition and the scope of protection of invention in Medical-use application with reference to the relevant reference of the subject of non-patentability in China, Europe, America, Japan, Korea, Russia, Ukraine, Australia, Canada, Brazil, Mexico, South Africa, Egypt, India, Indonesia and Vietnam.

China

In China, the Claim of Right in Medical-use application is usually written as “Use of substance X in the preparation of a medicament” and “Use of substance X in the preparation of a medicament for the treatment of disease Y”, that forms the pharmaceutical method types of Usage Claim of Rights. This kind of Claim of Right is known as both Second Invention in Medical Application and Swiss-type Claim in Europe.

According to Chinese Patent Law, Claim of Rights that subjects on usage belongs to Method Claim of Rights. The patentability of a use claim needs to be examined according to the characteristics of the method invention, that is, the pharmaceutical use claim is understood as a pharmaceutical method claim. Reviewing the practice, the subject "Use of substance X in the preparation of a medicament for the treatment of disease Y" is generally equivalent to " Use of substance X in the preparation of a medicament ". When determining the scope of protection of the claims, only those technical features that can have a limiting effect on the process of preparing the drug needed to be considered, such as the choice of raw materials, the choice of preparation steps and conditions, and the composition and content of the product. However, due to the intricate relationship between the use methods, treatment mechanisms, and indications of the drugs, it is often difficult for the examiner to evaluate the relevance, so in most cases, the drug administration object in the claims for pharmaceutical use will not be easily recognized. The characteristics of the drug, such as the dosage regimen, dosage, and the like, have a substantial limiting effect on the claims for pharmaceutical use.

Europe

On February 19, 2010, the EPO's Expanded Appeal Board made decision on G02 / 08: The new European Patent Convention Art 54 (5) would not only recognize the novelty of known medicinal compound and combination of "for use in new disease indications", but also the novelty of known medicinal compound and combination of “for use in new treatment of known disease indications”, wherein the “new treatment” includes “dosing regimen”. Meanwhile, EPO recognizes the novelty and inventiveness of medicine that are given by new major function, dosage, dosing regimen and etc. In G02/08, EPO also decides that from now on, EPO would not recognize the rationality of claim right for pharmaceutical usage (Swiss-type).

In Europe, the acceptable forms of Claim are: (a product Claim the subject matter title of which contains definition by use.)

Product A being used as medicine.

Product A for the treatment of cancer.

• Product A for the treatment of cancer by means of external application.

• Product A for the treatment of cancer, wherein said product A is applied before meal, three times a day.

• Product A for the treatment of cancer, wherein said product A is administered at a dose of 1 mg / Kg,

• Product A for the treatment of cancer of mice or human.

America

In the practice of patent examination in the United States, the scope of new use application that can be granted is very wide, that is, there are new-use inventions together with medical devices, medicines, etc., as well as new-use inventions together with drug administration methods, objects of administration, etc.

In the United States, the acceptable forms of Claim are:

• A method for the treatment of cancer, including apply an effective amount of product A for treatment to subjects who are in need of it.

• A method for the treatment of cancer, including apply an effective amount of product A for treatment to subjects who are in need of it by means of external administration.

• A method for the treatment of cancer, including apply product A three times a day before meal to subjects who are in need of it.

• A method for the treatment of cancer, including apply product A at a dose of 1 mg / Kg to subjects who are in need of it.

• A method for the treatment of cancer, including apply an effective amount of product A to mice or human.

Japan

In Japan, the diagnosis and treatment of diseases are not granted as a patent right. The treatment of diseases is classified as a medical act in Japan due to the fact that medical acts generally must be completed under the supervision of a doctor or under its supervision. It does not belong to industry, so it does not have industrial applicability.

However, patentability of the invention in new medical-use application is allowable in Japan. It is stipulated that the claim would be written as:

• A composition for treating disease Y, which includes substance X.

• A formulation for the treatment of disease Y including substance X.

• Use of substance X in the preparation of a medicament for the treatment of disease Y.

It can be seen that there is also a Swiss-type claim in Japan, but in fact, there is no need to use a Swiss-type claim in Japan. By writing the claim as a claim for a pharmaceutical product with a wider scope of protection, the patent right can be granted on dosing regimen, such as:

• An oral immune booster, characterized in that it is formulated to contain 100-2000 mg of compound Z in a unit.

• An anti-cancer drug comprising compound A and B, in which compound A is administered intravenously or subcutaneously, and Compound B is administered orally at a dose of 10-50 mg / kg and 1-30 mg / kg, respectively, daily or 3 times a week.

It is considered in Japanese Examination Guide that when a drug claim relates to characteristics of therapeutic method, such as interval of drug administration, dosage of administration and so on, as long as those skilled in the art can clearly distinguish between this application and the prior art, the method to be protected is novel.

Korea

In Korea, patents are not granted for the diagnosis and treatment of diseases. At the same time, the use claim as the subject matter does not belong to the product and method claims, that is, the Swiss-type claim and the German-type claim (German-type claim: the use of substance X for the treatment of disease Y).

However, patentability of the invention in new medical-use application is allowable in Korea. It is stipulated that the claim would be written as:

A composition for treating disease Y, comprising substance X.

Generally, this form does not protect new dosing regimens, doses, routes of administration, subjects, etc. for treating the same disease.

Russia and Ukraine

In Russia and Ukraine, patents can be granted for the diagnosis and treatment of diseases, and the following claims are also allowable:

• Swiss-type claim;

German-type claim;

MedicamentRussia-type claim: A medicament for treating disease X, said medicament comprising compound Y as an active ingredient

Those forms mentioned above can coexist in Claim. However, product-for-use is not allowable in Russia and Ukraine.

In Russia and Ukraine, the acceptable forms of claim are:

• The use of product A in the preparation of anti-cancer medicine.

• The use of product A in treating cancer.

• A medicine for the treatment of cancer, including compound A as active ingredient.

• A method for the treatment of cancer, including apply an effective amount product A to subjects who are in need of it.

Australia

In Australia, the patent for the diagnosis and treatment of diseases can be granted. The following claims are also allowable:

• Swiss-type claim

Substance X when used as a medicament for the treatment of disease Y.

Those forms mentioned above can coexist in Claim.

Canada

In Canada, the patent for the diagnosis and treatment of diseases cannot be granted. Those claims may be written as follows:

• Swiss-type claim, but not to protect new dosing regimen, dosage, route of administration, subject, etc. for treating same disease.

German-type claim

Product-for-use

Those forms mentioned above can coexist in Claim.

Brazil, Mexico and South Africa

In Brazil, Mexico and South Africa, the patent for the diagnosis and treatment of diseases cannot be granted. Those following claims are allowable:

• Swiss-type claim

Product-for-use

Those forms mentioned above can coexist in Claim.

Egypt, India, Indonesia and Vietnam

In Egypt, India, Indonesia, and Vietnam, inventions in medical application are the subject of non-patentability, that is, claims for any form of medicinal use are not accepted, including:

• The diagnosis and treatment of diseases

• Swiss-type claim

German-type claim

Product-for-use

Composition for treatment use (Korean and Japan type)

To sum up, the writing form and scope of protection of inventions for pharmaceutical use varies from country to country. Understanding this difference will help to deepen the understanding of inventions for medical-use, and enhance the use of inventions for medical purposes so as to protect the results of drug development and make them deliver more value.

About the Firm

Ge Cheng & Co Ltd.
Address Level 19, Tower E3, The Towers, Oriental Plaza, No 1 East Chang An Avenue, Beijing 100073, China.
Tel 86-10-8518 8598
Fax 86-10-8518 3600
Email davidcheng@gechengip.com , info@gechengip.com
Link www.gechengip.com

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