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By Yungjoon Kwon
In his second Expert View piece, Yungjoon Kwon,
patent/trademark attorney and managing director at law firm Kwon & Kim,
considers a South Korean court’s
view on one of pharma's hottest topics – dosage regime drugs’ patentability.
New dosage regime
Recently introduced new drugs over the globe are not
simply to cure life-depending disease and illness, but also to improve quality
of human regular life, such as in erectile
dysfunction drugs and health supplements, diet pills and others.
With this new trend and changed circumstances, in one
aspect, the new application and use of pharmaceutical compounds have added
more value than the traditional stability and
safety of drugs, especially new drugs, while in another aspect, medical use
claims and the new use of drugs are more in the spotlight in the
pharmaceutical market.
Previously, the Korean Supreme Court ruled that claim
limitations related to the dosage regime (ie, the dosing interval and unit
dosage) must be ignored when
considering the patentability of a pharmaceutical composition invention,
thereby such dosage regime is not considered as patentable feature in
Korea.
The Korean Supreme Court ruled that claim limitations
related to a dosage regime, such as the dosing interval and unit dosage, must
be ignored when considering the patentability of a
pharmaceutical composition invention. This ruling had been followed by a number
of subsequent Patent Court decisions where a new dosage regime is not
recognized as a typical medical use that can be protected by Korean patent law.
However, this was controversial and several cases disputing the principle
above were pending at the Intellectual Property Tribunal and Patent Court as
well as Supreme Court.
Dosing interval and dosage amount
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MERCK & CO, INC., Korean Supreme Court 2007 Hu 2926, issued on May
28, 2009 :
The subject invention is directed to a pharmaceutical composition for
inhibiting bone resorption characterized by a dosing interval and dosage
amount of bisphosphonate.
The claim of subject invention is as follows:
A pharmaceutical composition for inhibiting bone resorption in a mammal,
comprising an effective amount of bisphosphonate and pharmaceutically
acceptable carrier, wherein, unit dosage of said bisphosphonate is
orally administered to said human and said unit dosage comprising from about
8.75mg to about 140mg, on an alendronic acid basis, of a bisphosphonate
according to a continuous schedule having a dosing interval having a dosing
periodicity ranging from about once every three days to about once every 16
days.
The Supreme Court noted that the characterization of “dosing interval”
and “unit dosage” were not elements constituting the presently claimed
pharmaceutical composition but rather correspond to that in a method of
administering the pharmaceutical composition to a human being. It was
recognized that since the technical features of dosing interval and dosage amount of medicament related to administering
method which cannot be patented and did not contribute to the obtained final
product per se, they cannot be considered in assessing the inventiveness
of the claim. The Supreme Court held that the pharmaceutical composition
according to subject invention lacked inventiveness as compared with the
cited prior art.
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For reference, the claim drafting of US and EU
corresponding patents to the above Korean patent was as follows:
※ Comparison of claim drafting among Korean, US, and European corresponding
patents
Korea Pharmaceutical
composition including an effective amount of bisphosphonate and
pharmaceutically acceptable carrier, …
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USA Method for inhibiting bone
resorption, ...
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EU
Use of alendronic acid for the manufacture of a medicament…
Dosing time
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DAIICHI PHARMACEUTICAL CO., LTD., Korean Intellectual Property Tribunal
2007 Won 7860, issued on June 15, 2007 :
The subject invention is directed to a pharmaceutical composition for
treating neurodegeneration, characterized by a dosing time of “within the
first six months after the stroke”.
The claim is as follows:
A pharmaceutical composition for treating neurodegeneration within the
first six months after the strokecomprising an effective amount of
nefiracetam and pharmaceutically acceptable carrier.
The Korean Intellectual Property Tribunal noted that the technical
feature of “treating neurodegeneration within the first six months after the
stroke” was not an element constituting the claimed pharmaceutical
composition but rather corresponds to a method of administering the
pharmaceutical composition to a human being. It was also recognized that the
dosage regime was not considered as new medical use since it does not
affect a constitution of final product, ie a pharmaceutical composition. The
Korean Intellectual Property Tribunal held that a patent lacked
inventiveness since the nefiracetam was known for use of nerodegeneration in
the prior art.
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Mode of administration
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The Regents of Hanyang University, Korean Intellectual Property Tribunal
2011 Won 5999, issued on November 16, 2012 :
The subject invention is directed to a composition for directly applying
to microfractured site for regenerating hyaline cartilage and treating
cartilage injuries consisting of hyaluronic acid and physiological
solution, and DEME media.
The Korean Intellectual Property Tribunal noted that the technical
feature of “for directly applying to microfractured site” was not an element
constituting the claimed composition but rather corresponds to a method
of preparation prior to directly administering the composition.
It was noted that the technical feature of “for regenerating hyaline
cartilage” was a pharmacological mechanism for treating cartilage injuries.
It was recognized that such technical features are not considered as new
medical use since they do not affect a final product, ie a constitution of
composition per se. The Korean Intellectual Property Tribunal held that a
patent lacked inventiveness since the hyaluronic acid was known for use
of cartilage injuries in the prior art.
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Mode/time of administration
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SIGMA-TAU INDUSTRIE FARMACEUTICHE RIUNITE S.p.A, Korean Patent Court
2013 Heo 686, issued on September 27, 2013 :
The subject invention is directed to a medicament for the two-step
perioperative therapy of solid tumors, wherein the first agentendowed with
tumor tropism is administered intraoperatively via a locoregional route
to said patient, wherein said first agent is selected from the group
consisting of avidin, streptavidin, their polymeric derivatives and
their derivatives with polyethylene glycol capable of concentrating
locally on the tumor or in the vicinity of it and then the second anticancer
agent is administered within four to 24 hours postoperatively via a
systemic route with a nity for said first agent.
The Patent Court noted that the technical feature of
administration timing and administration method of medicament was not the
element constituting the medicament. The Korean patent court assessed
inventiveness of combination comprising the first agent and second agent. The
Korean patent court held that a patent lacked inventiveness since the
combination of the first agent endowed with tumor tropism and second
anticancer was known for using in the treatment of solid tumor.
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Mode of administration
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SCHERING CORPORATION, Korean Supreme Court 2012 Hu 153/191, issued on
May 24, 2012 :
The subject invention is directed to a medicament comprising an aqueous
suspension of mometasone furoate for the intranasal once-a-day treatment of
allergic or seasonal allergic rhinitis in the substantial absence of
absorption systemically into the bloodstream of said mometasone furoate. The
Supreme Court held that the patent lacked inventiveness since
the technical feature of “once-a-day treatment of an aqueous suspension
of mometasone furoate” did not have technical signi¸cance as compared with cited
prior art.
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The SCHERING CORPORATION case would be significant in
that the “the administration interval - once-a-day treatment” was considered
in assessing inventiveness of the invention.
This can be construed that the concentration of mometasone furoate in an
aqueous suspension should be adjusted to achieve once-a-day administration
in effective dose amount, that affects constitution of an aqueous suspension,
thus this technical feature would be considered in the assessment of
inventiveness.
Considering the above Supreme Court’s decision, it was
expected that new dosage regime could be patentable second medical use if
such dosage regime brings a change in the
constitution of the medicament/composition.
Finally, the Korean Supreme Court (en banc decision) in
May 2015 ruled that a second medical use defined by a different dosage regimen
can be patentable feature, and at the same time
overruled its previous decisions as above.
In the en banc decision, the Supreme Court concluded that
if an invention defined by a new medical use, such as a dosage regime and a
dose, satisfies the requirements for
patentability, such invention will be granted a patent, as set forth below.
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Bristol-Myers Squibb Company (US) Vs. Jeil Pharmaceutical Co. Ltd. (KR),
Korean Supreme Court 2014Hu768, en banc, issued on May 21, 2015 :
If a medical invention de¸ned by a dosage regimen and a dose together
with the identi¸cation of a target disease or an e cacy, such dosage regimen
and dose should be considered as elements of an invention. Accordingly, an
invention having novelty and an inventive step by de¸ning a new medical use
with the help of such a dosage regimen and a dose can be granted a patent.
Under such a legal principle, the administration intervals and dosage –
for 1.065 mg of entecavir monohydrate to be taken once daily – constitute an
element of invention.
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Subsequently, the Korean Manual of Patent Examining
Procedure (K-MPEP) newly stipulates as follows:
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A ‘medical use invention’ indicates an invention that de¸nes
pharmaceutical e cacy by combining speci¸c ingredients or substances, such as
(i) an application to the speci¸c disease (for example, pharmaceutical
composition comprising an active ingredient A for disease B) or (ii)
an application to the speci c disease in which dosage and administration such
as dosing time, dosing order, dosing amount or administration areas
(hereinafter referred to as “dosage and administration”) are speci ed.
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Summary
The Korean Supreme Court (en banc decision) in May 2015
ruled that a second medical use defined by a different dosage regimen can
be patentable feature, and at the same time
overruled its previous decisions which held that “a dosage regimen and a dose” as
defined in the claims of a pharmaceutical composition do not constitute a
medical substance, and hence, cannot be considered as elements of an invention
when determining the novelty and inventive step of the invention.
As a result, the dosage regime invention is now
patentable in Korea as well as in other major jurisdictions.
※ The information provided on this website is for informational purposes only for our clients and colleagues and is not intended as legal advice. Although we endeavor to keep the information correct, the information may not address all the issues in sufficient detail for your particular needs and may change without notice due to changes in Korean laws, regulations, rules and policies. Visitors to this site agree that KWON & KIM Patent & Trademark Attorneys is not liable for errors or omissions of any of the information provided. Any other reproduction, transmission, distribution, republication or retransmission of such newsletters without the express written permission of KWON & KIM Patent & Trademark Attorneys is prohibited.
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