Korean Patent Practice - Pharmaceutical field - Jonghyeok Park MS., Ph.D.course Jonghyeok Park MS.,...
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Transcript of Korean Patent Practice - Pharmaceutical field - Jonghyeok Park MS., Ph.D.course Jonghyeok Park MS.,...
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