Korean Patent PracticeKorean Patent Practice- Pharmaceutical field -- Pharmaceutical field -

Jonghyeok ParkJonghyeok Park MS., Ph.D.courseMS., Ph.D.coursePartnerPharmacistPatent Attorney

Y. S. CHANG & ASSOCIATESY. S. CHANG & ASSOCIATES

May 2009May 2009

Mr. Jong-Hyeok Park

Partner, Pharmacist, Patent Attorney

- B.S., Pharmacy

- M.S., Pharmacy

- Ph.D. Course, Pharmacy

PresenterPresenter

ContentsContents

Ⅰ Ⅰ Basic InformationBasic Information

ⅰ ⅰ Patentable Subject MattersPatentable Subject Matters

ⅱ ⅱ Claim DescriptionClaim Description

ⅲ ⅲ Support requirementSupport requirement

(Pharmacological data)(Pharmacological data)

Ⅱ Ⅱ PTE applicationPTE application

ⅰ ⅰ Outline of the PTE systemOutline of the PTE system

ⅱ ⅱ Extension periodExtension period

ⅲ ⅲ ProblemsProblems

Ⅲ Ⅲ Issues regarding FTAIssues regarding FTA

ⅰ ⅰ Patent-approval linkagePatent-approval linkage

ⅱ ⅱ Data exclusivityData exclusivity

ⅲ ⅲ Patent Term ExtensionPatent Term Extension

ⅳ ⅳ Bolar exceptionBolar exception

ⅣⅣ Litigation - Case studiesLitigation - Case studies

ⅰ ⅰ PLAVIXPLAVIX®® (clopidogrel bisulfate) (clopidogrel bisulfate)

ⅱ ⅱ NORVASCNORVASC®® (amlodipine (amlodipine

besylate)besylate)

ⅲ ⅲ Lipitor Lipitor ®®(atorvastatin)(atorvastatin)

ⅳ ⅳ ULTRACETULTRACET®® (tramadol/AAP) (tramadol/AAP)

Patentable Subject Patentable Subject MattersMatters

Surgical and diagnostic methods practiced on the human Surgical and diagnostic methods practiced on the human

are not allowedare not allowed

– A method of surgeryA method of surgery

– Treating method of a human beings including DNA therapyTreating method of a human beings including DNA therapy

– Method of diagnosis for human beingsMethod of diagnosis for human beings

ExceptionException

– Medical treatment is allowed if a human beings is expressly excludedMedical treatment is allowed if a human beings is expressly excluded

Diagnosis method may be patentable if claimDiagnosis method may be patentable if claim

– does not contain the clinical decision step(i.e., deductive decision does not contain the clinical decision step(i.e., deductive decision

phase).phase).

– does not contain the surgical step which is practiced on human in order does not contain the surgical step which is practiced on human in order

to collect datato collect data

New System(From 2008)

Claim DescriptionClaim Description

““Use of compound for the use of treating ~Use of compound for the use of treating ~”” claim is not claim is not

allowedallowed

– Instead, Instead, ““Pharmaceutical composition comprising the compound for Pharmaceutical composition comprising the compound for

treating ~treating ~”” should be used. should be used.

Medical use of a pharmaceutical composition must be recited Medical use of a pharmaceutical composition must be recited

in claims when claiming a pharmaceutical compositionin claims when claiming a pharmaceutical composition

– Medical use should be specified by the specific diseases, e.g., treating Medical use should be specified by the specific diseases, e.g., treating

pulmonary cancer, etc.pulmonary cancer, etc.

– No functional expression, no reach through claim can be used in claims No functional expression, no reach through claim can be used in claims

when specifying the medical use.when specifying the medical use.

– Contrary to the KIPOContrary to the KIPO’’s guideline, s guideline, ““angiogenesis inhibitorangiogenesis inhibitor”” has been has been

exceptionally allowed by Supreme Court, but not normal practice.exceptionally allowed by Supreme Court, but not normal practice.

Support RequirementSupport Requirement(Data Requirement)(Data Requirement)

Specific pharmacological data are strictly requiredSpecific pharmacological data are strictly required

– Actual data such as ICActual data such as IC5050 values of individual compounds should be values of individual compounds should be

contained in originally filed specificationcontained in originally filed specification

– Simple description on pharmacological activity is not sufficientSimple description on pharmacological activity is not sufficient

– Reasonable correlation between the pharmacological activity and Reasonable correlation between the pharmacological activity and

the claimed medical use should be substantiated by data described the claimed medical use should be substantiated by data described

in specificationin specification

Later submission of data is not allowedLater submission of data is not allowed

– Before 2000, supreme court allowed the applicant to submit such Before 2000, supreme court allowed the applicant to submit such

data during prosecutiondata during prosecution

Outline of the PTE systemOutline of the PTE system

Type of Inventions eligible for Type of Inventions eligible for

PTEPTE

– only permitted for inventions

pertaining to pharmaceutical

products and agricultural

chemicals

– Cosmetics, food additives, Cosmetics, food additives,

pigments, and medical pigments, and medical

instruments may not be instruments may not be

entitled to PTEentitled to PTE

Deadline for filing PTEDeadline for filing PTE

– Within 3 months from the Within 3 months from the

approval date except for the approval date except for the

last six months from the last six months from the

expiry date of the original expiry date of the original

patent termpatent term

Number of times of PTENumber of times of PTE

– One(1) extension is allowed One(1) extension is allowed

per one patentper one patent

– A divisional application A divisional application

should be preferably filed should be preferably filed

during examination stage if during examination stage if

two or more approval can be two or more approval can be

obtainedobtained

– If three patents for one If three patents for one

approval, each of the approval, each of the

patents is entitled to PTEpatents is entitled to PTE

Maximum amount of time Maximum amount of time

that the patent can be that the patent can be

extended extended

– 5 years5 years

Restoration PeriodRestoration Period

Calculated from the sum of “Period required to conduct

clinical trial” and “period required to conduct regulatory

review”

Can be reduced when the applicant fails to act with due

diligence

ProblemsProblems

Period required to

conduct clinical trial in

foreign country is not

added to the restoration

period.

Restoration periods

which global

pharmaceutical

companies has actually

obtained are not that

long, a few months.

US-Bahrain FTA 15.9(6)

Patent LinkagePatent Linkage

US requests Korean government to introduce patent linkage, but in progress

– Generic companies have to inform HIRA on when they will begin to

sell the generic drugs, in case there is patent right covering the

drug.

– If an innovator company raises a legal measure against generic

companies, 12 months stay will be obtained

Points at issue

– Whether of not a confirmation trial should be included in the legal

measure

– Whether of not 12 months stay should be appropriate, too short?,

too long?

Data exclusivityData exclusivity

There is no explicit provision regarding data exclusivity

in Korean pharmaceutical affair act

However, as a practical matter, the KFDA has a

reexamination system based on data exclusivity by

which a pharmaceutical company that first obtains

regulatory approval, can block a second company from

obtaining a second, subsequent approval, for a certain

product for a given period

– 6 years for new drugs

– 4 years for drugs having new medical use

Patent Term ExtensionPatent Term Extension

No issue

– Korea has already PTE system which can meet US’s request

Clinical Trial conducted in Foreign countries

– Maybe not easy

Bolar ExceptionBolar Exception

Article 96 (Limitations on Patent Right)– (1) The effects of the patent right shall not extend to the following:

» Working of the patented invention for the purpose of research or

experiment;

» Vessels, aircraft or vehicles merely passing through the Republic of

Korea or machinery, instruments, equipment or other accessories

used therein; or

» Articles existing in the Republic of Korea at the time the patent

application was filed.

Therefore, generics manufacturers are allowed to

manufacture the patented drug for the purpose of obtaining

marketing approval before the patent protection expires. – Storage after obtaining approval does not constitute patent

infringement(Patent Court, now pending before supreme court)

PLAVIXPLAVIX®® (clopidogrel bisulfate) (clopidogrel bisulfate)

Blood Clot inhibitor

Patent has been invalidated due to lack of an inventive step by PatentCourt

– Enatiomer : selection invention

– No unexpected effect is achieved by adapting one enantiomer from racemate

Point at issue– Of opinion that it does have an

unexpected effect by adapting the salt of “bisulfate”

– Now, pending before supreme court

Sanofi-Aventis vs.

17 Korean generic manufacturers

NORVASCNORVASC®® (amlodipine besylate) (amlodipine besylate)

LEVOTENSION (S-

amlodipine besylate

dihyrate)– Falls within the scope of the

patent right relating

NORVASC® (amlodipine

besylate) because S-

amlodipine besylate dihyrate is

only one specific embodiments

of amlodipine besylate.

– Patent right relating a

compound can cover both

anhydride and hydrate thereof

But, later, this patent has

been invalidated, same as

United States

Pfizer Inc. vs.

Ahn-Gook Pharm. Co.,Ltd.

ULTRACETULTRACET®® (tramadol/AAP) (tramadol/AAP)

Patent covering Ultracet

duly exists.– A generic manufacture has filed

an invalidation trial against the

patent.

– More than 100 generic

companies have applied for

marketing approval for generic

version of Ultracet®® and obtained

marketing approval.

– Now many kinds of generic

version of Ultracet®® are being sold.

– Waiting for the 1st instance

decision

If they are not successful in

the invalidation trial, then?

Ortho-McNeil-Janssen Pharmaceuticals vs.

15 Korean generic manufacturers

Any Questions?Any Questions?

Thank you very muchThank you very much