Drug Regulation & Regulatory Authorities

Dept. Of Quality Assurance & Regulatory Affairs L. J. Institute of Pharmacy, Ahmedabad.

EXPERIMENT NO.: DATE:

AIM: Nation Patenting and Legal Aspects in India and its comparison with Europe

& US system and procedure.

REFERENCES:

1) http://www.aidic.it/IBIC2008/webpapers/116singh.pdf

THEORY:

India

US

Europe

General issues

Patent law is national (subject to certain regional treaties, but the

Agreement on Trade Related Aspects of Intellectual Property Rights

(TRIPS) has harmonized the law at the general level.

Generally, patents are available (with some specified exceptions) for

inventive products or processes in all fields of technology so long as the

invention is new, involves an inventive step and is useful (or, equivalently,

is capable of industrial application).

The TRIPS agreement requires that patents shall be enjoyable without

discrimination as to the place of making the invention, the field of

technology and whether products are imported or locally produced (TRIPS,

Article 27).

Patentees will normally wish to patent an important invention in more than

one country. International treaties such as Patent Co operation Treaty will

facilitate this. A single filing of an international application is made with a

Receiving Office (RO) in one language. It then results in a search

performed by an International Searching Authority (ISA), accompanied by

a written opinion regarding the patentability of the invention, which is the

subject of the application. It is optionally followed by a preliminary

examination, performed by an International Preliminary Examining

Authority (IPEA). Finally, the relevant national or regional authorities

administer matters related to the examination of application (if provided by

national law) and issuance of

Drug Regulation & Regulatory Authorities

Dept. Of Quality Assurance & Regulatory Affairs L. J. Institute of Pharmacy, Ahmedabad.

Legislation

The provisions of the

Patent Act, 1970 govern

the procurement and

grant of patents in India

(Non substantive

procedural issues

relating to the

procurement & granting

of patents are governed

by the Patent Rules and

not the 1970 Act).

Section 159 of the Act,

requires the Central

Government to frame

rules to administer and

carry out the intent of

the Act.

The Act was kept in

abeyance till the

formulation of rules.

The rules came into

force on April 20, 1972.

Thus, the 1970 Act

came into force on

April 20, 1972. The

remaining sections of

the Act came into force

on April 1, 1978. Since

its enactment, the Act

has been amended on

five occasions by:

The Repealing

and Amending

Act, 1974 (Act

56 of 1974)

The Delegated

Legislation

Provisions

(Amendment)

Act, 1985 (Act 4

US law is found

primarily in title 35 of

the US Code, as

interpreted by the

courts.

The America Invents

Act (AIA) significantly

amends the 35 USC.

The AIA was signed

into law on September

16, 2011.

One of the major

changes implemented

by the AIA was to

move from a first-to-

invent to a first-

inventor-to-file system

(see below). While not

all of the provisions of

the AIA have yet come

into effect, this

comparison will focus

on US law as amended

by the AIA, as that

reflects current US

thinking and will soon

reflect US law.

European law is a

hybrid system based

on the European

Patent Convention

(EPC). The EPC sets

out substantive law,

similar to our Patent

Act, and also sets up

the framework for the

administration of the

EPC.

Under the EPC

system, patents are

examined and granted

centrally, by the

European Patent

Office (EPO),

according to the law

set out in the EPC.

Patents granted by the

EPO are commonly

referred to as

European patents;

though it should be

noted that

membership of the

EPC is not co-

extensive with the

European Union.

All members of the

European Union are

also members of the

EPC, but there are

several countries that

are members of the

EPC but which are not

members of the EU.

Once granted, a

European patent is

only enforceable

Drug Regulation & Regulatory Authorities

Dept. Of Quality Assurance & Regulatory Affairs L. J. Institute of Pharmacy, Ahmedabad.

of 1985)

The Patents

(Amendment)

Act, 1999 (17 of

1999)

The Patents

(Amendment)

Act, 2002 (38 of

2002)

The Patents

(Amendment)

Act, 2005 (15 of

2005)

according to national

law of an EPC country

in which the patent

has been validated.

For example, if a

patentee believes

someone is infringing

its patent in both the

UK and Germany, it

will have to sue in

both countries.

While national patent

law of all EPC

countries has been

harmonized with the

EPC, the courts in

different countries

may interpret that law

differently. Courts

may also come to

different conclusions

based on the different

evidence that happens

to be presented in

litigation in different

countries. It therefore

may happen that the

same European patent

will be declared valid

in one EPC country

and invalid in another

country.

There have long been

attempts to create a

true European patent

which would be

unitary after being

granted. Agreement

on important points

was reached in the

past few months at the

Drug Regulation & Regulatory Authorities

Dept. Of Quality Assurance & Regulatory Affairs L. J. Institute of Pharmacy, Ahmedabad.

European Council

level, and it is possible

that a true unitary

patent system will be

implemented in

Europe within the next

few years.

Role of Patent

Office

The Patent Office in each jurisdiction examines patent applications with the

goal of ensuring that the application discloses and claims an invention for

which the applicant is entitled to receive a patent under the laws of that

jurisdiction. If the relevant Patent Office is so satisfied, the patent is

granted.

An Indian Patent

Examiner is mandated to

search for prior art and

for objections under any

other ground as

provided in the Patent's

Act, then to report to the

Controller, who has the

power to either accept or

reject Examiners'

reports.

Unlike the system at the

USPTO /EPO,

Examiners at IPO have

only recommending

power and the

controllers are

empowered by statute

either to accept or refuse

their recommendations

Intellectual Property

Appellate Board is

empowered to receive,

hear and dispose of all

appeals from any order

In US, a decision by

the Patent Office to

refuse a patent may be

appealed to the courts,

ultimately to the

Supreme Court of

Canada or the United

States.

Guidance document;

Manual of Patent

Examining Procedure

(MPEP) in the US

In Europe, the EPO

has its own internal

appeal system, and

decisions of the EPO

Boards of Appeal

cannot be appealed to

the national courts

Guidance document;

Guidelines for

Examination in the

European Patent

Office

Drug Regulation & Regulatory Authorities

Dept. Of Quality Assurance & Regulatory Affairs L. J. Institute of Pharmacy, Ahmedabad.

or

decision of the

Controller and he

jurisdiction to hear

patent infringement

cases continues with the

High Courts

Guidance document;

Manual of Patent Office

Practice and Procedure

Novelty, Utility

and Non-

obviousness/

Inventive step

To be patentable, an invention must be new.

In all jurisdictions this is a strict requirement. The invention will be

considered new unless the very same invention has been previously

publically disclosed.

Novelty is assessed as of a particular date in time, more generally, the

“priority date.” This is normally the date on which the first application is

filed. Disclosure of the invention after the priority date does not matter;

disclosure before the priority date will invalidate the patent (the patent will

be “anticipated.”).

For example, an inventor can create a novelty bar to a patent on their own

invention, by giving a paper at a conference in which the invention is

discussed, or by publically installing an experimental version of the

invention. Normally, therefore, an inventor or applicant should keep their

invention confidential until they have filed a first patent application. To

“anticipate” a claimed invention (i.e. to render it “not new” or not novel),

the prior disclosure must be non-confidential.

The inventor can raise money by disclosing its invention to investors, for

example, so long as the disclosure is strictly confidential. Most countries

enforce an “absolute novelty” requirement, and in these countries a non-

confidential disclosure creates an automatic and immediate bar to

patentability.

In United States have a qualified absolute novelty system wherein an

inventor can validly file an application up to one year after their first non-

confidential disclosure of the invention. In the case of conflicting

applications for the same invention, the first filed application will act as a

novelty bar to the later application.

Drug Regulation & Regulatory Authorities

Dept. Of Quality Assurance & Regulatory Affairs L. J. Institute of Pharmacy, Ahmedabad.

EU and in India are that,

to be patentable, an

invention must be novel

and involve an inventive

step

(Article 52 EPC).

In US requirement

invention must be

novel, industrially

applicable and must

not be obvious (35 US

Code sections 102 and

103)

Same as India

Non-patentable

inventions

Section 3 and Section 4

of the Patents

Amendment Act, 2005

In US, the statute

indicates only the

inventions that are

patentable under

Section 101 of the

U.S.C.

Articles 52 (2) and 53

of the EPC provides

for what is not

regarded as invention

and cannot be

patented.

Best mode

requirement

In India, Section 10

(4)(b) of the Patents

(amendment) Act, 2005

requires an applicant

to disclose the best

method of performing

the invention which is

known to the applicant

and for which he is

entitled to claim

protection.

The specification should

disclose the

best mode of carrying

out the invention and if

there is more than one

best mode of carrying

out the invention, should

describe all of them.

US patent law requires

the inventor to include

the best way to

practice the invention

in the patent

application (35 US

Code Section 112).

Under the US patent

system a specification

shall contain a written

description of the

invention, and of the

manner and process of

making and using it, in

such full, clear,

concise, and exact

terms as to enable any

person skilled in the art

to which it pertains, or

with which it is most

nearly connected, to

make and use the

same, and shall set

forth the best mode

In contrast, in EU

there is no such

requirement. At least

one way of practicing

the invention must be

included in the

application but there is

nothing that states this

way must be the best

way

Drug Regulation & Regulatory Authorities

Dept. Of Quality Assurance & Regulatory Affairs L. J. Institute of Pharmacy, Ahmedabad.

contemplated by the

inventor of carrying

out his invention.

Publication of

patent

applications

India (Section 11, rule

24), where all patent

applications are

published

18 months after their

filing date, unless they

have been withdrawn.

Non-Publication

request cannot be made

US patents were only

published after grant.

This has been changed

as on November 29,

2000, and now in the

US patent applications

are published 18

months after their

filing date [U.S.C

Section 122(b)], unless

they have been

withdrawn or they are

filed with a non-

publication request.

EU (Article 93)where

all patent applications

are published 18

months after their

filing date, unless they

have been withdrawn.

Non-Publication

request cannot be

made

Grace period

India has 12 month

grace period for filling

patent application after

public display at an

exhibition which is

specially approved by

the government

An inventor is granted

a one year grace period

from the first non-

confidential disclosure

of the invention to file

a patent application in

the United States.

The disclosure by the

inventor will not count

as prior art if the

inventor subsequently

files within the grace

period. However, the

new America Invents

Act (AIA) provides

that any disclosure of

the subject matter of

that invention during

the grace period will

not count as prior art,

There is no general

grace period for

disclosures by the

inventor, and a non-

confidential disclosure

normally raises an

immediate and

automatic bar to

patentability. There

are some very limited

grace periods

provided, for example,

where there is a

breach of

confidentiality, but

these will be relevant

only in unusual

circumstances.

Drug Regulation & Regulatory Authorities

Dept. Of Quality Assurance & Regulatory Affairs L. J. Institute of Pharmacy, Ahmedabad.

including disclosure by

independent parties.

First-to-

file/first-to-

invent

In a first-to-file patent system, if two individuals invent the same invention,

the first to file their patent application will be entitled to the patent. In a

first-to-invent system, the patent will be awarded to the individual who first

invented the invention, after a special proceeding is held to make that

determination. Almost all countries like India, Europe except the US now

use a first-to-file rule, and the US will be adopting the first-to-file rule in

March of 2013.

Patent term

extension

The patent term in India

is twenty years from the

date of filing the

application [Section

53(2) of the Act]

In US the patent term

for utility patents and

plant patents is twenty

years[35U.S.C.154(A)]

whereas for design

patents it is 14 years.

The US patent system

also includes provisions

for patent term

extension.

The patent term in EU

is twenty years from

the date of filing the

application [Article 63

of the EPC]

Challenging

patent

applicability

Within 1 year after the

grant of a patent in

India

The US has a system of

“reexamination

proceeding”. The re-

examination procedure

does not work the same

as an opposition.

Prosecution of the

patent has been

characterized as a

“give-and-take affair,”

with negotiation and

renegotiation between

the patentee and the

examiner that ordinarily

continues up to 2-3

years.

Within 9 months after

the grant of a patent in

EU

Drug Regulation & Regulatory Authorities

Dept. Of Quality Assurance & Regulatory Affairs L. J. Institute of Pharmacy, Ahmedabad.

Two part

claims

US and Indian Patent applications will almost

always have one part claims

Contains two-part

claims. The first part

of claims is the former

features that are found

in the prior art. And

the second part of

claims is what

constitutes the

invention, often called

the characterizing

features.

Language

The US and Indian Patent Office deals only with

the English language.

The official languages

of European Patent

Office are English,

French and German.

Patent applications

may be filed in any

language provided

that a translation into

one of the official

language is submitted

within two months.

Opposition

after grant

The Indian Patent law

deals only with the

opposition to the patent

where the application

for patent has been

published but before a

patent has been granted.

USA has a re-

examination procedure

which is not same as an

opposition. In re-

examination, anyone

can present reasons and

evidence to USPTO to

challenge the validity of

a granted Patent.

Anyone has the right

to oppose it within

nine months after

grant.

After nine months, the

Patent can only be

revoked separately for

each Country in which

it was granted. This is

substantially more

expensive and time

consuming.

If the Patent is found

to be invalid, it is

revoked in all

countries

simultaneously.

Drug Regulation & Regulatory Authorities

Dept. Of Quality Assurance & Regulatory Affairs L. J. Institute of Pharmacy, Ahmedabad.

An appeal may be

preferred against the

decision in the

opposition

proceedings.