Data Exclusivity

 For the pharmaceutical industry to invest the billions of dollars, Euros, yen, etc. in these
highly risky health care solutions, Intellectual property protection is essential. However,
patent and trademark protections are not the entire story.
 An innovator company enjoys a period of "data exclusivity" during which their pre-
clinical and clinical trials data may not be referenced in the regulatory filings of
another company(typically a generic company) for the same drug substance.
 The rationale for granting data and market exclusivity is to compensate the innovator
company for the investment it has put in to developing the new medicinal product and to
generating the data required to obtain a marketing authorisation. It was designed to
promote a balance between new drug innovation and generic drug competition.
 Regulatory approval for medicinal products requires applicants to provide information
about the efficacy and safety of their product to regulatory authorities. The first applicant
for approval of a new medicinal product must provide a substantial body of data relating
to the product (including the results of pre-clinical tests and clinical trials).
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WHAT IS DATA EXCLUSIVITY

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 The regulatory regime permits generic companies, who subsequently wish to gain their own
approval for the same drug substance, to rely on information filed by the innovator company that
made the first application. In order to be able to benefit from the data provided by the innovator in
their regulatory filings for that medicinal product - the "reference medicinal product" - a generic
company must show that their product has the same qualitative and quantitative composition as that
product and that it is bioequivalent.
 The Agreement on Trade-Related Intellectual Property Rights (the “TRIPs Agreement”/ also known
as Doha Declaration) specifically recognizes the “protection of undisclosed information” as being a
category of Intellectual property subject to protection.
 Article 39.3 of the TRIPs Agreement provides that:
“Members, when requiring, as a condition of approving the marketing of
pharmaceutical or of agricultural chemical entities, the submission of undisclosed
test or other data, the origination of which involves a considerable effort, shall
protect such data against unfair commercial use.
In addition, Members shall protect such data against disclosure, except where
necessary to protect the public, or unless steps are taken to ensure that the data are
protected against unfair commercial use.”

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 The Intellectual property right reference in Article 39.3 is commonly referred to as
“data exclusivity” in the U. S. and “data protection” or “regulatory data protection” in the
European Union.
SECTION 7 : PROTECTION OF UNDISCLOSED INFORMATION (TRIPS)
Article 39
1. In the course of ensuring effective protection against unfair competition as provided in Article 10bis of the Paris Convention
(1967), Members shall protect undisclosed information in accordance with paragraph 2 below and data submitted to governments or
governmental agencies in accordance with paragraph 3 below.
2. Natural and legal persons shall have the possibility of preventing information lawfully within their control from being disclosed to,
acquired by, or used by others without their consent in a manner contrary to honest commercial practices* so long as such
information :
 is secret in the sense that it is not, as a body or in the precise configuration of its components, generally known among or readily
accessible to persons within the circles that normally deal with the kind of information in question ;
 has commercial value because it is secret ; and
 has been subject to reasonable steps under the circumstances, by the person lawfully in control of the information, to keep it
secret.
3. Members, when requiring, as a condition of approving the marketing of a pharmaceutical or of agricultural or chemical products
which utilize new chemical entities, the submission of undisclosed test or other data, the origination of which involves a considerable
effort, shall protect such data against unfair commercial use. In addition, Members shall protect such data against disclosure, except
when necessary to protect the public, or unless steps are taken to ensure that the data are protected against unfair commercial use.

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 In short article 39.3 requires countries to protect undisclosed registration data, against disclosure and
unfair commercial use.
 The data exclusivity (DE) is independent of IP laws
 DE determines the length of time during which;
 the generic/biosimilar application cannot cross-refer to the originators’ data and
 the regulatory authorities cannot rely on originator’s data to approve a generic/biosimilar
version of relevant originator product
DE period becomes Market Exclusivity (ME) when;
 There is no patent or when weak patents are invalidated
 Country has no patent law
 DE exclusivity period goes beyond patent/SPC expiry
Exclusivity is granted upon approval of a drug product if the statutory requirements are met. The length
of time that FDA grants new drug
exclusivity depends on the type of exclusivity. Note that exclusivity is not added to the patent life.

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 "Market exclusivity" refers to the period in which the recipient of the first regulatory
approval for a product is granted an exclusive right to market the product.
 “Data exclusivity” refers to the period in which certain information that has been
provided to a regulatory authority for the purposes of obtaining regulatory approval,
remains confidential, or cannot be relied upon by the regulatory authority or a third party
in order to obtain regulatory approval of a follow-on product.
 The data protected by data exclusivity regimes typically include the results of extensive
and costly clinical trials. As such, data exclusivity can effectively block or significantly
delay the launch of equivalent competitor products during the data exclusivity period,
even in the absence of patent protection.
 Data exclusivity is separate from other forms of intellectual property protection, such as
the protection provided by patents. In some instances, the period of data exclusivity may
extend beyond the term of any patent which protects the same product.

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 Normally, the DE application must be submitted within 18 months from the date the product is ﬁrst
registered or granted market authorization in the country of origin, or any other country, and is
referred to as the ‘access window.’
 For pharmaceutical products with a new indication, the DE period of three years is calculated from
the date the additional indication is approved in any country. Application for DE must be made
within 12 months from the date the second indication is approved.

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US EXCLUSIVITIES
 In the US, “exclusivity” provided by the Food and Drug Administration (FDA) generally refers to
market exclusivity only, but may also have the effect of providing a period of data exclusivity.
 On September 24, 1984 the President signed into law the Drug Price Competition and Patent Term
Restoration Act of 1984 (Hatch/Waxman Amendments).
 Title 1 of the Hatch/Waxman Amendments amended the Federal Food, Drug, and Cosmetic Act (the
Act) to expand the universe of drugs for which FDA would accept ANDAs.
 The Hatch/Waxman Amendments also provided for New Drug Product Exclusivity and are often
referred to as Hatch/Waxman exclusivity since Senator Hatch and Congressman Waxman sponsored
the amendments.
 New Drug Product Exclusivity is provided by the Federal Food, Drug, and Cosmetic Act under
section 505(c)(3)(E) and 505(j)(5)(F).
 If a product is approved in combination and if a product is approved as single entity (NCE) from that
combination then the exclusivity will be calculated from the approval date of combination of that
entity (called as Umbrella Exclusivity i.e. exclusivity applied under same drug combination for
individual entities). (this rule applies for calculating combination exclusivity in Europe as well)

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Exclusivity Period Notes
New Chemical
Entity
(NCE)
5 years  Commences on the date of the NDA approval
 prohibits the FDA from accepting for review during the period of exclusivity, any
ANDA or application under s 505(b)(2) for a drug containing the same active
moiety.
- 5 years if an ANDA or 505(b)(2) does not contain a paragraph IV certification to a
listed patent
- 4 years if an ANDA or 505(b)(2) is submitted containing a paragraph IV certification
to a listed patent
(Described in 21 CFR 314.108)
Orphan Drug
Exclusivity
(ODE)
7 years  commences on the date of approval of the NDA or BLA.
(Covered under the Orphan Drug Act and 21 CFR 316.31)
Paediatric
Exclusivity
(PED)
6 months  provided when the sponsor of a drug conducted and submitted paediatric studies
on the active moiety in response to a Written Request from the FDA
 Paediatric exclusivity can attach to any of the NCE, ODE or “Other” exclusivity
periods
(Described in Section 505(A) of the FDA Modernization Act of 1997)
Exclusivities Table

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New Clinical
Investigation
(NCI)
3 years  granted in respect of a pharmaceutical product for which regulatory approval
was obtained, where the FDA had previously provided regulatory approval of
another pharmaceutical product containing the same active moiety.
 exclusivity period is granted by the FDA when an application or supplement
contains reports of new clinical investigations (other than bioavailability)
conducted or sponsored by the applicant.
(Described in 21 CFR 314.108)
First generic
exclusivity
180 days  first company to submit an ANDA to the FDA has the exclusive right to
market the generic drug for 180 days.
 exclusivity provisions provides an incentive of 180 market exclusivity for
the first generic applicant who challenges a listed patent.
 The 180 day period of exclusivity commences on the day that the
commercial marketing of the first generic product begins, or from the date
that a court find a relevant patent invalid, unenforceable or not infringed
(whichever date is earliest).

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Competitive
Generic
Therapy
(CGT)
180
days
 Granted when there is not more than one approved drug in the active section of the
Orange Book/ Inadequate generic competition
 This may either be the reference listed drug (RLD) or a drug approved in an ANDA
referencing the same RLD as the drug for which designation as a CGT is sought
e.g. Sildenafil Citrate oral suspension (no OB listed patents and not more than 1 RLD listed
in Orange book)
(Described in FDA Reauthorization Act of 2017, or FDARA)
Generating
Antibiotic
Incentives
Now
(GAIN)
5 years  On July 9, 2012, GAIN was signed into law as Title VIII of FDASIA to stimulate
development of new antibacterial and antifungal drugs
 GAIN created incentives for sponsors to bring to market antibacterial and antifungal
drugs intended to treat serious or life-threatening infections.
 GAIN provides for the designation by FDA of certain antimicrobial drugs as QIDPs
(QUALIFIED INFECTIOUS DISEASE PRODUCTS).
 A QIDP is defined in GAIN as “an antibacterial or antifungal drug for human use
intended to treat serious or life-threatening infections, including those caused by ─
1. an antibacterial or antifungal resistant pathogen, including novel or emerging
infectious pathogens; or
2. qualifying pathogens listed by the Secretary under subsection (f) [of section 505E
of the Food, Drug, and Cosmetic Act (FD&C Act)].”

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Biologics
License
Application
(BLA) –
Reference
Product
Exclusivity
12 years  period of time during which a biosimilar applicant (i.e. a sponsor submitting a
351(k) application) is not permitted to submit and the FDA is not permitted to
license a 351(k) application that refers to a reference product.
 period of exclusivity extends from the date of first licensure of the reference
product
 Approval of a 351(k) application may not be made by the FDA until 12 years
from the first licensure of the reference product (plus any additional 6 month
period for pediatric indication).
 A 351(k) application may not be submitted to the FDA for review until 4 years
after the date of first licensure.

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EUROPE DATA EXCLUSIVITIES
 For marketing authorisation applications made from November 2005 onwards, the
period of data exclusivity in Europe has been harmonised as 8 years from the date of first
authorisation in Europe.
 For marketing authorisation applications made before November 2005, the period of
data exclusivity varies from EU member state to EU member state, and is either 6 years or
10 years.
 For marketing authorisation applications made from November 2005 onwards, there is
an additional period of 2 years of "market exclusivity". This is the period of time during
which a generic company may not market an equivalent generic version of the originator's
pharmaceutical product (although their application for authorisation may be processed
during this period, such that they are in a position to market their product on the expiry of
this additional 2 year period).

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 The rules determining exclusivity changed in 2005. Under the "old rules" data exclusivity
lasted either 6 or 10 years. The "new rules" follow an "8 + 2 + 1" year approach:
 During the first 8 years from the grant of the innovator company's marketing
authorisation, data exclusivity applies.
 After the 8 years have expired a generic company can make use of the pre-clinical and
clinical trial data of the originator in their regulatory applications, but still cannot
market their product.
 After a period of 10 years from the grant of the innovator company's marketing authorisation,
the generic company can also market their product, unless the innovator product qualifies for a
further one year of exclusivity.
 This additional 1 year may be obtained in a number of circumstances, such as where the
innovator company is granted a marketing authorisation for a significant new indication for
the relevant medicinal product. In such a situation the generic company can only market
their product after 11 years from the grant of the innovator company's marketing
authorisation.

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Regulatory evolution for DE in Europe,
1990’s
DE: 6 or 10 yrs
CAP: 10 yrs
2000
Orphans Market
exclusivity
Revision 2004-5
DE/ME
8+2/(+1)
2006
Paediatrics:
 Supplementary Protection
certificate extension
 10+2 yrs ME (orphans)
 DE: 8 years (DE) + 2 years (ME) + 1 year (market protection if new indication is registered in first 8
years with significant benefits over existing therapies)
Generic launchGeneric application can be filed
 Orphan Drug Exclusivity: 10 years
Exclusivities in Europe
 Paediatric Exclusivity (PIP): 10 years + 2years (ME)
 Supplementary protection certificate (SPC): Max 5 years
(provides additional monopoly to compensate the time to get a MA. SPC application need to be lodged within 6
months of the grant of MA. SPC enters into force after expiry of basic patent)
 SPC extension for Paediatric trials: 6 months

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Examples for 8+2(+1) year market protection
Medicinal Product Therapeutic Indication Grounds for acceptance/ refusal
Torisel (temsirolimus)
(+ 1 year granted)
Treatment of adult patients with relapsed and/or
refractory mantle cell lymphoma (MCL)
(New target disease)
There is no approved treatments
for relapsed MCL in EU
Zytiga (Abiraterone)
(+ 1 year granted)
Tretament of men with mCRPC after failure of
androgen deprivation therapy
(different stages or severity of a disease)
There is no available treatment
options in EU for patients with
mCRPC who are asymptomatic or
mildly symptomatic
Isentress
(Raltegravir)
(+ 1 year refused)
ART-naïve patients Lack of proof of superior efficacy
results and safety profile
Prezista (darunavir)
(+ 1 year refused)
Co-administered with low dose ritonavir in
combination with other antiretroviral medicinal
products for the treatment of HIV-1 infection in
ARV treatment-naïve adults
Lack of proof of superior efficacy
and safety profile not significantly
better

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Centralised Process in Europe
The following states are currently members of the European Patent Organization: 31
Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Germany, Denmark, Estonia, Spain, Finland,
France, United Kingdom, Greece, Croatia, Hungary, Ireland,, Italy,, Lithuania, Luxembourg, Latvia,
Malta, Netherlands,, Poland, Portugal, Romania, Sweden, Slovenia, Slovakia, Iceland, Norway,
Liechtenstein
 There are two ways of obtaining a marketing authorisation:
1. Centralised Procedure
2. National Authorisation Procedures

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 Marketing authorisations granted under the "centralised procedure" allow the marketing-
authorisation holder to market the medicine and make it available to patients and healthcare
professionals throughout the EU on the basis of a single marketing authorisation.
 One application leads to one evaluation leading to one authorisation valid in the 28 Member States
of the European Union as well as Iceland, Norway and Lichtenstein
 Importantly it also results in a single set of product information for healthcare professionals and
patients in the all the European Union official languages.
 Such authorisation is granted by the European Commission following the scientific assessment of
the application by the European Medicines Agency.
The centralised procedure is laid down in Regulation (EC) No 726/2004 compulsory for:
 Products derived from biotechnology
 Orphan medicinal products
 Medicinal products for human use which contain an active substance authorised in the Union after
20 May 2004 and which are intended for the treatment of AIDS, cancer, neurodegenerative disorders
or diabetes.

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It can also apply to all medicinal products:
 That contain an active substance not authorised before 20 May 2004,
 Constituting a significant therapeutic scientific or technical innovation, or
 For which an EU authorisation would be in the interest of patients.
 Under the centralised procedure, a company may only obtain one marketing authorisation per
medicinal product.
 However, in specific cases a company may apply for a duplicate marketing authorisation. Requests
to submit an application for a duplicate should be sent to the Commission.
The review process:
 Companies wishing to market a medicinal product that is eligible for the centralised authorisation
procedure, submit their application directly to the European Medicines Agency (EMA). The EMA is
responsible for the validation and scientific evaluation of the application.
 The EMA's Committee for Medicinal products for Human Use (CHMP) carries out a scientific
assessment of the application and give a recommendation on whether the medicine should be
authorised or not.

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 A favourable opinion is accompanied by a draft summary of the product's characteristics, the package
leaflet, and the proposed text for the packaging.
 The time limit for the evaluation procedure is 210 days, subject to extensions if additional
questions need to be addressed. Within 15 days of the adoption, the EMA will forward its opinion to
the European Commission to start the decision-making phase.
Authorisation:
 Within 15 days a draft implementing decision is sent by the Commission to the Standing Committee
on Medicinal Products for Human Use, allowing for its scrutiny by EU countries.
 They have 15 days to return their linguistic comments, and 22 days for substantial ones. Once a
favourable opinion is reached, the draft decision is adopted via an empowerment procedure.
 The adoption of the decision should take place within 67 days of the opinion of the EMA.
 The Commission's Secretariat-General then notifies the decision to the marketing authorisation holder.
The decision is subsequently published in the Union Register.
 Marketing authorisations are initially valid for 5 years. Applications for renewal must be made to the
EMA at least six months before this five-year period expires.

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Type of Approvals
1. Standard: Comprehensive data is required to enable full evaluation
2. Conditional Approval:
 Can be granted, when although comprehensive clinical data have not been supplied, and are unlikely
to be able to be provided (to be provided after approval)
 Must fulfil scope for approval (orphan drugs, emergency threats, serious and life-threatening diseases)
 These approvals are valid for a renewable 1 year period.
3. Exceptional Circumstances:
 Medicines are approved where the applicant is unable to provide data on the efficacy and safety of the
medicine.
 This is usually where the indication is so rare that the applicant cannot reasonably be expected to
provide comprehensive evidence or it is contrary to medical ethics to collect such information.
After Approval/Authorization:
The EMA monitors the safety of medicines for as long as they are on the market and if necessary takes
regulatory actions to protect public health in the EU.

Exclusivities in other countries
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1. Australia
2. Canada
3. China
4. Hong Kong
5. India
6. Japan
7. Korea (South)
8. Malaysia
9. New Zealand
10. Russia
11. Saudi Arabia
12. Singapore
13. Thailand
14. Vietnam

AUSTRALIA
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In Australia, the Therapeutic Goods Amendment Act 1998 established a 5 year data exclusivity
period for new products containing pharmaceutical actives approved after 17 April 1998.
The data exclusivity period begins on the date of marketing approval.
The Act provides data exclusivity in relation to therapeutic goods which contain a "new active
component". This is defined as a substance having a therapeutic effect.
The Explanatory Memorandum to the Act states that "substance" may include "a biological product or
compound".
Data exclusivity is only provided in relation to new active components which have never been
included in the Australian Register of Therapeutic Goods. Therefore, data exclusivity is not provided
for new uses/indications or new formulations of existing compounds.
Australia provides for patent term extensions of up to 5 years. To obtain an extension of the term
the first regulatory approval for goods that contain, or consist of the pharmaceutical substance(s)
which is “in substance disclosed” in the patent, and falls within the scope of at least one claim of the
granted patent, must have occurred more than 5 years after the filing date of the patent application.
An application for an extension of term must be made within 6 months after the latest of:
a) the date the patent was granted; b) the date of the first regulatory approval.

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CANADA
 Data exclusivity is not legally defined term in Canadian law
 DE is not a Canadian conception but was instead forced upon Canada in the course of trade
negotiations. The Food and Drugs Act is the enabling statute of the Food and Drug Regulations,
which contain Canada’s data exclusivity provisions.
 The Register of Innovative Drugs is maintained pursuant to C.08.004.1 of the Food and Drug
Regulations. The register indicates the drugs that are eligible for data protection.
 Under the October 5, 2006 data protection provisions, companies introducing a drug containing a
new chemical entity (i.e. an “innovative drug”) are entitled to an 8 year period of market
exclusivity.
 In addition, a subsequent-entry manufacturer is prevented from filing a submission for a copy of that
innovative drug for the first 6 years of the eight-year period.
 The data protection period may be extended a further 6 months if, within the first 5 years of the 8-
year period, the results of pediatric clinical trials, designed and conducted for the purpose of
increasing knowledge of the use of the drug in pediatric populations, are also submitted and found
acceptable.
 There is also no market exclusivity for the first approved generic drug or biologic drug against
subsequent drugs.

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CHINA
 Under Article 35 of the Implementing Regulations of the Drug Administration Law of 4 August
2002, China provides 6 years of data exclusivity as from the date of marketing approval.
 Patent term extensions are not available in China.
 The data exclusivity period is up to 6 years for innovative new drugs approved in China and up
to 12 years for innovative therapeutic biologics.
 For innovative drugs that have been approved for marketing, a six-year data exclusivity period will
be granted. However, data exclusivity of 10 years will be granted if the innovative drug is for rare or
paediatric diseases.
 For improved new drugs for rare or paediatric diseases, a three-year data exclusivity period will be
issued. Innovative and improved new drugs belong to Classes 1 and 2 respectively under the current
classification of new drugs.

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New Draft Policy in Chinese Government:
 As per the new updates, Chinese national government extended the period of exclusivity on
pharmaceutical patents from 20 years up to 25 years.
 The draft policy also proposed a 10-year data exclusivity period for therapeutically innovative
biologics.
 In particular, the draft guideline limits the types of exclusivity-eligible data to those pre-clinical
and clinical trial data related to drug efficacy, and explicitly excludes data related to drug safety. In
addition, the following requirements must be met:
1. the data submitted to the agency as a part of the drug application are for the purpose of obtaining
a marketing authorization;
2. the data are not otherwise publicly disclosed prior to the drug application submission;
3. the data are independently developed without reliance on any experimental data by others or
published research results.
 Data exclusivity will also be granted to a new drug which is first approved by other authorities and
later enters China within a certain period.

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 According to the draft, corresponding data exclusivity will be granted for new drugs with an
application for marketing and data protection submitted in China within one year of being approved
in the United States, Japan and Europe.
 If the application is submitted in China after the one-year period, any excess time will be deducted
from the corresponding data exclusivity.
 Data exclusivity of one-and-a-half years will be granted if less than one-and-a-half years after
deduction.
 Data exclusivity of one-and-a-half years will also be granted to the first generic drug launched under
a successful challenge to the patents.

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The exclusivity period may be reduced or revoked under any of the following scenarios:
a. When a drug application uses data from an international multicenter clinical trial in China and the
drug application filed in China is later than those outside of China, the exclusivity period is 1 to 5 years
depending on the delay. When the delay is more than six years, there is no data exclusivity.
b. If the drug application uses data from clinical trials conducted outside of China with no Chinese
patients, the data exclusivity period is 25 percent of the above.
c. If the drug application is supplemented with clinical trial data in China, the data exclusivity
period is 50 percent of the above.
d. The data exclusivity is revoked if a company fails to bring a drug to market within one year after
obtaining regulatory approval.
For orphan drugs and pediatric drugs, the data exclusivity periods are six years, regardless of the source
of the data and the timing of the drug application filing.

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China plans to increase market exclusivity term for pharmaceuticals based on improved pharmaceutical trial
data protection (August 26, 2018 article)
 The proposed draft involves in a variety of protection terms for different conditions as shown in Table below.
Drugs/Products Conditions Protection Term
Innovative drugs Use the clinical trial data or Multi-regional Clinical
Trial (MRCT) data carried out in China to apply for
marketing domestically or apply for marketing
domestically and overseas simultaneously
6 years from the date of
approval for marketing in China
Innovative biological products for therapy 12 years from the date of
Innovative drugs Use the Multi-regional Clinical Trial (MRCT) data
carried out in China to apply for marketing
domestically after first applying overseas
1 to 5 years from the date of
Innovative biological products for therapy
Innovative drugs Only use the clinical trial data carried out overseas to
apply for marketing domestically
1.5 years from the date of
Innovative drugs Use the clinical trial data carried out overseas and
supplement clinical trial data on Chinese subjects to
apply for marketing domestically
3 years from the date of
Orphan drugs None 6 years from the date of the first
approval of the indication of a
newly-recognized disease in
China
Pediatric drugs
Generic drugs Invalidate relevant patents of original drugs
successfully
No official information yet

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INDIA
 There are currently no provisions in India for obtaining an extension of term of a patent or for the
protection of data submitted to a regulatory authority.
HONG KONG
 There are currently no provisions in Hong Kong for obtaining an extension of term of a patent or for
the protection of data submitted to a regulatory authority.

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JAPAN
 There are no data or marketing exclusivity provisions for pharmaceutical products in Japan.
However, the effect of post market pharmacovigilance provisions is to ostensibly act as a data
exclusivity provision and prevent any generic from coming onto the market during the Post
Marketing Surveillance period.
 Post Market Surveillance is a process whereby the Japanese regulatory authority (Pharmaceuticals
and Medical Devices Agency) re-examines the safety and efficacy of new chemical entities and
previously approved pharmaceuticals later approved for new indications.
 The re-examination period lasts for between 4 to 10 years, during which time any data submitted to
the regulatory authority by the drug sponsor which relates to the safety of the drug cannot be
obtained by generic companies. It is not until after the conclusion of this period that a generic
company is able to commence marketing of their product.
 The data exclusivity period varies from 4 years (for medicinal products with new indications,
formulations, dosages, or compositions with related prescriptions) to
6-8 years (for drugs containing a new chemical entity or medicinal composition, or requiring a new
route of administration) to
10 years (for orphan drugs or new drugs requiring pharmaco-epidemiological study).

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 In Japan, patent term extensions of up to 5 years are available for pharmaceuticals and
agrochemicals.
 An application for an extension of term must be filed within three months of the first regulatory
approval of the product. An early patent grant is also advantageous for maximising the term of the
extension because time lost in the regulatory process while the patent application is still pending does
not count towards the extension of term.
 Notably, in Japan subsequent approval for the same active ingredient for a second indication may
serve as a basis for an additional extension.
 The Japanese regulatory authority re-examines the safety and efficacy of new chemical entities and
drugs approved for new indications. The re-examination period lasts from 4 to 10 years during which
time data is protected.

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MALAYSIA
 Malaysia grants a DE period for new pharmaceutical products for at least 5 years, while 3 years
protection is given if new indication, new formulation, or new method of administration is
approved for a previously approved pharmaceutical product.
 In the case of a new biologic product, Malaysia currently does not provide DE for biologic product
but is taking the second option of a minimum standard of 5 years DE instead of 8 years to ensure
that less expensive biosimilar products reach the market more quickly.

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 New Zealand implemented Article 39.3 of TRIPS via the Medicines Amendment Act 1994 (NZ),
effective as from 1 January 1995.
 Generally, the protection period is 5 years. There is no data exclusivity period for data relating to
new uses/indications or formulations of old active ingredients.
 Patent term extensions are not available in New Zealand.
NEW ZEALAND

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RUSSIA
 The right of data exclusivity became effective on August 22, 2012, the official date of Russian
Federation accession to the WTO.
 The concept was later introduced into the article 18 of Federal law № 61-FZ “On the Turnover of
Medicines”, a central law for pharmaceutical industry in Russia.
 Russian Federal law № 429-FZ [December 22, 2014] – [Amendments to Federal law № 61-FZ on
“Circulation of Medicines”]
Effective from January 01, 2016, Data exclusivity was defined as follows:
 It is not permitted to use for the commercial purposes the results of pre-clinical trials of medicinal
products and clinical trials of medicines, provided by the applicant for state registration of the
medicine without his consent for the period of 6 YEARS from the date of state registration of the
Reference Medicine in the Russian Federation.
 Division of the 6 year term
[4 Year registration Exclusivity + 2 Year Market Exclusivity for generic drugs]
[ 3 year registration exclusivity + 3 year Market exclusivity for biosimilars]
Registration exclusivity is determined from the date of registration of a reference medicine

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SAUDI ARABIA
 Under Saudi Arabian law, official authorities are required to protect the confidential commercial data
disclosed to them for a minimum period of 5 years from the date of obtaining the approval (Article 5,
Regulations for the Protection of Confidential Commercial Information).
(Case: Gilead Sciences was granted marketing approval by the SFDA in 2014 for its product Sofosbuvir. The SFDA
has subsequently granted marketing approval for generic versions of this product made by a Saudi and Egyptian
company within the 5-year data exclusivity window. This was the breach of Saudi data exclusivity regulations).
OMAN
 In Oman, a person who has first obtained marketing approval for a new pharmaceutical or agricultural
chemical product in Oman can expect data disclosed to the governmental agency during the approval
process to not be relied for a period of at least:
5 years for pharmaceutical products and 10 years for agricultural chemical products.
 It also provides protection for new clinical data that is required to be submitted as a condition of granting
marketing approval for a pharmaceutical product that includes a chemical entity that has been previously
approved for marketing.
 The authorising body must not authorise another person to market the same or a similar product based on
the new clinical data submitted in support of the marketing approval, for at least 3 years from the date of
marketing approval in Oman.

37
SINGAPORE
 Singapore provides a 5 year data exclusivity period which commences on the date that
a product licence is granted.
 The deadline for making an application for an extension of patent term is the later of six
months from the grant of the patent or six months from obtaining marketing approval for
the pharmaceutical product by Singapore’s Health Services Authority.
 In order to be eligible to make an application, the time between filing for marketing
approval and the date marketing approval was obtained must be at least two years.
 Of all the countries in Southeast Asia, only Singapore and Brunei provide for patent
term extensions, in each case of up to 5 years.

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SOUTH KOREA
 South Korea provides patent term extensions of up to 5 years for pharmaceuticals and
agrochemicals. An application for an extension of term must be filed within three months of the first
regulatory approval of a product comprising a new chemical entity and within six months of the
expiry date of the patent.
 South Korea provides a 5 year data exclusivity period for new chemical entities which commences
from the date on which a product licence is granted.

39
THAILAND
 Patent term extensions are not available in Thailand.
 Thailand provides a 5 year protection period that ensures the data provided in respect of a new
drug application remains confidential.
VIETNAM
 Patent term extensions are not available in Vietnam.
 Vietnam provides a 5 year data exclusivity period which commences from the date on which a
product licence is granted.

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