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Beijing︱Hong Kong︱Shanghai︱Shenzhen︱Osaka︱New York www.lungtin.com | Copyright © Lung Tin 2015

Established since 1994

www.lungtin.com | Copyright © Lung Tin 2015

Utility Models:

Chinese Practice

Life Sciences Patent:

Chinese Practice

Patentability

Patent Law, Article 25.1 For any of the following, no patent right shall be granted:

• scientific discoveries

• rules and methods for mental activities

• methods for the diagnosis or for the treatment of

diseases

• animal and plant varieties

• …


Patentability

Guidelines for Patent Examination

• natural substances

• medical-use of substances

Swiss-type use claim

• use of substance X in the manufacture of a medication

for the treatment of condition Y


Swiss-type Claim


Patent : CN99812498 (WO00/18419, EP1115417B)

Filing Date: September 24, 1999

Granted: May 19, 2004

Patentee: Cubist Pharmaceuticals Inc.

Title: Methods for Administration of Antibiotics

Claim 1: Use of a daptomycin for the manufacture of a medicament for

treating a bacterial infection in a human patient in need thereof without

skeletal muscle toxicity, wherein a dose for said treating is 3~75 mg/kg

of daptomycin, wherein said dose is repeatedly administered in a dosage

interval of once every 24 hours to once every 48 hours.

Supreme People’s Court Case (November 19, 2013)

Swiss-type Claim


whether the recited treating

bacterial infection without

skeletal muscle toxicity is a new

indication which differs from

the prior art

whether the recited dose and

administration intervals are

limiting

Prior art:

Use of a daptomycin for

treating a bacterial

infection in a human

patient is known

Issues

Swiss-type Claim

Whether the recited treating bacterial infection without

skeletal muscle toxicity is a new indication which differs from

the prior art

• bacterial infection: no further limitation with respect to

any bacterial type or infection level

• without skeletal muscle toxicity: a post-administration

result, which does not affect the use of a medication


No

Swiss-type Claim

whether the recited dose and administration interval are

limiting

• specifications on administration (such as dose and

interval) have no impact on manufacture, and thus are not

limiting

• the information on medicament labeling, insert, and

packaging does not constitute as a part of manufacture

• the invention relies on the medicament dose and

interval, which does not change any anti-bacterial

mechanism, anti-bacterial spectrum, and anti-bacterial

activity, and thus, the invention does not change the

known use of daptomycin


No

Post-Filling Data

Sufficiency

• no

• prior art or common knowledge

Support

• no

Inventiveness

• conditional


Inventiveness


Patent : 96111063

Filing Date: 1996-06-19

Patentee: Takeda Chemical Industries Ltd.

Title: Pharmaceutical composition for use in treatment of

diabetes

Claim 1: A pharmaceutical composition for preventing or treating

diabetes, diabetic syndrome, sugar metabolic disorder or lipid disorders

of the metabolism disorder, comprising pioglitazone or a

pharmacologically acceptable salt thereof as an insulin sensitivity

enhancer, and a sulfonylurea as an insulin secretion enhancer

Supreme People’s Court Case (September 17, 2012)

Inventiveness


whether the submitted data can

be used to determine

inventiveness

etcArguments:

submitted data

(pioglitazone +

glimepride) to show

unexpected synergism

Issues

Prior art:

troglitazone and use of

insulin sensitivity and

secretion enhancers

Inventiveness

whether the submitted data can be used to determine

inventiveness

• the specification only discloses pioglitazone + voglibose

but fails to discuss the other combos and comparison

among them

• the submitted technical effect has not sufficiently

disclosed in the specification, and thus cannot be used


no

Sufficient Disclosure


Patent : CN96195564.3

Filing Date: July 8, 1996

Patentee: Warner-Lambert Co

Title: Crystalline [R-(R+,R+)]-2-(4-fluorophenyl)-beta,

delta-dihydroxy-5-(5-methylethyl)-3-phenyl-4-

(phenylamino) carbonyl]-1H-pyrole-1-heptanoic acid

hemi-calcium salt (atorvastatin)

Claim 1: Containing 1-8 mole water I-type crystalline atorvastatin

hydrate, characterized in that with the following grinding 2 minutes

measured according to the 2 the, d-surface distance and greater than 20%

of the relative intensity of the X-ray powder diffraction patterns, using

CuKα-ray measuring: […… peaks]

Supreme People’s Court Case (April 16, 2015)



whether the to-be-solved

technical problem shall be

considered in view of the

sufficiency requirement

what disclosure is needed for a

chemical invention

Specification:

Two examples on type-I

crystalline form, without

characterization of

water contents

Issues


whether the to-be-solved technical problem shall be

considered in view of the sufficiency requirement

• the sufficiency requirement shall consider technical

problem-solution-effect, but first shall consider the

reproducibility

• claims define the invention by (i) composition—type I

atorvastatin hydrate containing 1-8 mole water, (ii)

structure—crystalline with XPRD and 13NMR peaks



what disclosure is needed for a chemical invention

• identification, preparation, use/effect

• identification: chemical/physical property parameters

relating to the technical problem to be solved

• preparation: at least one preparation method disclosing

raw materials, procedures, conditions

• one skilled in the art would not (i) identify containing 1-8 mole

water type I atorvastatin having the same XPRD; and (ii) assure

hydrate (tirhydrate) form actually has been prepared. Thus,

characterization of the water content is a must for the claimed

invention.



Utility Models:

Chinese PracticeSoftware/Business Methods:

Chinese Practice


Related regulations

Law and Regulations

Chinese Patent Law (effective 2009), Article 25

For any of the following, no right shall be granted,

(2) Rules and methods for mental activities.

Article 2

Invention means any new technical a product, a

process or improvement thereof.


Law and Regulations

Chinese examination Guidelines, Part Ⅱ chapter 1 4.2

Computer program shall not be granted

Part Ⅱ chapter 9

Some provisions on examination of invention application

Relating to computer programs


Examples

Software

Example 1 and 2

1 A method to solve the radio of the circumference of a circle

to its diameter using computer programs.

2 A general translation method for global language characters

Mental activities as provided for in article 25.1(2) are not the

subject matter of patent protection


Examples

Software

Example 3 and 4

3 A method for controlling a die forming process of rubber

4 A method of removing image noise

The solution of Example 3 or 4 solves a technical problem,

obtains a technical effect, and thus is patentable.


Software patent claim drafting

Software

A software patent claim can be drafted as a process claim

or product claim.

The step of a process claim shall be drafted according to

each step in the said computer program flow.

The apparatus claim shall be drafted with some

components and each component in the claim completely

corresponds to each step in the said computer program

flow or each step in the said process claim.



Software

Example 5

A process claim

step A

step B

An apparatus claim

a controller for step A

an inputting means for step B



Software

Example 6

A process claim

step A

step B

An apparatus claim

a controller for step A

an inputting means for step B

Another apparatus claim

a display device,

a receiver,

and a CPU executes the follow step,

step A and step B.


Data structure patent

Software

Example 7

Data structure claim can be drafted like following

A transmission data frame,

data head,

data information,

data end.

But applicant can draft a process claim to describe the data

structure, which will be accepted by SIPO.

A method for transmitting the data,

step to transmit the data head,

step to transmit the data information,

step to transmit the data end.


Business method patent in China

Business Methods

SIPO tended to use unpatentable subject matter or mental

activities to refuse the business method patent.

But now the examiners are encouraged to determine the

patentability of business methods by inventiveness.


Utility Models:

Chinese Practice

Utility Models:

Chinese Practice


Applications Filed Patents granted

Number Percentage Number Percentage

Invention

Total 928,177 100.0% 233,228 100.0%

Chinese Applicants 801,135 86.3% 162,680 69.8%

Foreign Applicants 127,042 13.7% 70,548 30.1%

Utility

Model

Total 868,511 100.0% 707,883 100.0%



Design

Total 564,555 100% 361,576 100%



Applications Filed with SIPO in 2014

(Data from SIPO)

Chinese Applications


Applications Filed with SIPO in 2014

0.0%

20.0%

40.0%

60.0%

80.0%

100.0%86.3%

99.1% 97.1%

13.7%

0.9% 2.9%

Chinese Applicants

Foreign Applicants

Invention Utility Model Design

Chinese Applications


Statistics-UM

203802

344472408110

571175692845 707883

310771

409836

585467

740290

892362 868511

2009 2010 2011 2012 2013 2014

Granted Filed


Statistics-UM

16892214

3024

4425

6637

7912

19102598

4164

5853

7136

7458

2009 2010 2011 2012 2013 2014

Granted (foreign) Filed (foreign)


Statistics-UM

Utility Models: in force by the end of 2014 (2,291,326)

Corporation81%

Individual19%

Domestic99%

Foreign1%

Utility Models

Chinese Patent Law (effective 2009), Article 2

"utility model" indicates any new technical solution

relating to the shape, the structure, or their

combination, of a product, which is fit for practical

use.


Filing

Indispensable documents for getting the filing date

and determining the protection scope of invention

and utility model


Request

Abstract

Description

Claims

Invention Utility Model

Request

Abstract

Description

Claims

Drawing(s)

Filing


► It is necessary to acquire the patent right as soon as possible

► The life span of the product is relatively short

► Inventive step of the product innovation is lower

► Defensive rights for peripheral technologies are required

► It is for cost-effectiveness concern

► Patent licensing and patent transfer are considered

► Later invalidation based on lack of inventiveness is difficult

► … …

Patentability

Product

• reproducible

• may recite methods/processes, materials/compositions

Improvement relating to shapes and/or structures

• shapes

• structures: mechanical structures, electrical circuits, layers

of materials

Technical solution to solve a technical problem


Patentability


Patent : CN202068578U

Filing

Date:

2010-06-21

Granted: 2011-12-07

Title: Wireless transmitting/receiving

unit, network entity and base

station

Intel Digital utility models

Patentability


Claim 1: A wireless transmitting/receiving unit, characterized in that the wireless

transmitting/receiving unit comprises:

Receiver; A transmitter; Coupled to the receiver and the transmitter and with the

receiver and the transmitter communication with the processor; The receiver and

the processor is configured to, on the basis of the feature information to detect the

wireless transmitting/receiving unit has entered its closed user group identification

on the wireless transmitting/receiving unit in the white list of the home node-B or

family evolved node-B the vicinity of the small area and is configured to receive a

measurement configuration message; and Said transmitter and the processor is

configured to provide the network entity transmits the wireless

transmitting/receiving unit has entered the home node-B or family evolved node-B

instructions in the vicinity of the small area and is configured to perform the

measurement. .

Intel Digital utility models

Patentability

Inventiveness

• Guideline: has [prominent] substantive features and

represents [notable] progress

• Teachings in the art: an explicit description to motivate

one skilled person in the art to look for technical means in

the same or similar technical field

• Teachings in the art: one or two prior art reference may

be cited to assess the inventiveness


Invalidation-Research

Database used：database for proceeding opinions (SIPO)

Analyzed targets：748 (2009) for utility models and 251

(2009) for inventions




All claims

invalid

Some claims

invalid

Valid after

amendments

All claims

valid

Inventions 103（41%） 45（18%） 4（2%） 99（39%）

Utility Models 343（46%） 89（12%） 41（5%） 275（37%）

all invalid46%

some invalid

12%

valid after amend'

5%

all valid37%

all invalid41%

some valid

18%

valid after

amend'2%

all valid39%



Inventions Utility Models

Claims

valid

Claims

invalid

Invalid

%

Claims

valid

Claims

invalid

Invalid

%

Novelty +

Inventiveness

99 121 55 311 418 56.6

Sufficiency 50 4 7.4 80 7 8

Support 42 10 19.2 57 6 9.5

Clarity 54 9 14.3 86 17 16.5

Essential

Elements

24 4 14.3 54 4 6.9

New Matter 21 17 44.7 0 0 0



Inventions Utility Models

Subject Matter Product or process or

improvement thereof

Improvements relating to

shapes and structures

Term 20 years 10 years

Time (filing to

granting)

Ave. 25.8 months Ave. 5.8 months

Cost high low

Examination Substantive examination Formality and preliminary

examination

Inventiveness high low

Enforcement No pre-request Some request evaluation

report



All claims

invalid

Some claims

invalid

All claims

valid

Others

Inventions 33（47.1%） 10（14.3%） 15（21.4%） 12（17.1%）

Utility Models 38（45.8%） 9.6（12%） 21（25.3%） 16（19.3%）

(2012) Beijing High People’s Court Decisions originated

from PRB decisions

391 cases (80 reexamination and 311 invalidation)

See China Patents & Trademarks (2014) No. 1, pp38-45


Examination

Order No. 67

(effective from October 15, 2013)

Preliminary examination of utility model/design application

In the preliminary examination, the examiner may examine whether the

patent application for a utility model/design is obviously lack of novelty

according to the information of prior art or conflicting applications he

obtained.

The examiner may determine whether the application is obviously lack of

novelty based on the reference documents the examiner retrieves by search or

the information the examiner obtains in other ways.

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