13 Abbreviated Approval Pathway for Biosimilars
and Patent Policy:
Balancing the Incentives of Innovation and Price Competition（*）
Invited Researcher: Dong Tao（**）
Recently, there is a rallying cry for applying the ANDA to the biosimilars. Biologics are distinguishable inmajor technical ways from conventional drugs, which makes the provisions of the Hatch-Waxman
legislation governing drugs simply cannot be incorporated into a regulatory scheme simply allowing for
approval of follow-on protein products. IP is a critical intangible asset for biotech and pharmaceutical firms.
But the distinction between biologics and small molecule drugs lead to substantive differences in how
patent system operates in the condition of abbreviated approval pathway to provide market exclusivity forinnovator biological products. To determine what kind of patent protection infrastructure is appropriate forregulating these “follow-on biologics”, a thorough patent policy assessment, from the viewpoint ofbiotechnology environment, is necessary. With these points in mind, this research focuses on the legal andpolicy issues of patents in implementing an abbreviated approval pathway for follow-on biologics fromdifferent perspectives. At last, this research gives some recommended suggestions to these patent issues
from the author’s opinion.

Ⅰ Introduction
Due to the success of Hatch-Waxman Act inpushing forward the market entry of genericdrugs, with several “blockbuster” biotechnology
patents have reached, or are reaching the end of
their patent protection, recently many people callfor applying the Abbreviated New Drug
Application (“ANDA”) pathway, which was set upby the Hatch-Waxman Act, to the biosimilars.
Biologics are distinguishable in major technicalways from conventional drugs, which makes theprovisions of the Hatch-Waxman legislation
governing conventional drugs cannot simply beincorporated into a regulatory scheme allowing
for approval of follow-on protein products.(*1)
The patent issues are open policy questions
that need to be resolved before any new
regulatory approval system is set up.(*2) With
these points in mind, this research focuses on thelegal and policy issues of patents in implementing
an abbreviated approval pathway for follow-on
biologics.(*3) Chapter II offers a brief overview on
the ANDA of Hatch-Waxman Act and why itshould be applied to biological drugs; Chapter III
explores the sticky patent issues arising when
applying abbreviated approval pathway tobiosimilars; Chapter IV explores how the patent
system and regulatory approval scheme shouldinterplay with each other optimally under thebiosimilar pathway compared to how they operate
today under the Hatch-Waxman framework forgeneric small molecule drugs; Chapter V explores
these patent issues from Asian perspective, from
China and Japan; Finally, some conclusions.

Ⅱ The
Regulatory
Approval
Pathway in the Hatch-Waxman
Act
1

The Approval Pathway for Generic
Drugs Pursuant to the Hatch-Waxman
Act

Prior to the enactment of the Hatch-Waxman
Act, a generic manufacturer had to conduct thesame clinical trials as the firm that was awarded
marketing approval for the innovator drug, which(*)

This is a summary of the report published under the Industrial Property Research Promotion Project FY2009 entrusted
by the Japan Patent Office.
(**) Assistant Professor, The Research Center of SIPO (State Intellectual Property Office), China(*1) Bruce S. Manheim, Jr., Patricia Granahan and Kenneth J. Dow, ‘Follow-on Biologics’: Ensuring Continued Innovation in
the Biotechnology Industry, Health Affairs, 25, no.2 (2006): 394-404.
(*2) Henry Grabowski, Iain Cockburn and Genial Long, The Market For Follow-on Biologics: How Will It Evolve? Health
Affairs, 25, no.5 (2006): 1291-1301.
(*3) The present paper will only examine the patent policy issues presented in crafting of the abbreviated regulatory
pathway for follow-on biologics. Not to touch the other related issues, such as safety, efficacy and immunogenicity,although the others are too important.
IIP Bulletin 2010

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greatly delayed the launch of more affordable
generic drugs.(*4) Enacted in 1984, Hatch-Waxman
Act amended the Federal Food, Drug, andCosmetic Act (FDC Act), and established a kind of
abbreviated new drug application (ANDA) topermit generic producers to rely on theinnovator’s clinical data.(*5) Any drugs approved
under ANDA pathway are referred to as genericdrugs.(*6)
2

The Patent Protection Provision in the
Hatch-Waxman Scheme

In light of the ease with which genericmanufacturers could free ride on the research anddevelopment conducted by innovator firms,
there’re also several additional provisions relatingtopatentprotection
includedintheHatch-Waxman Act.(*7)
The first one is the requirement of the active
ingredient in any product approved through the
ANDA process is the “same” as that in theinnovator drug.(*8) “To be the “same” active
ingredient, the generic product invariably must
fall within the scope of the patent that theinnovator holds for that compound. Thus, ageneric drug manufacturer cannot have it bothways--it cannot gain FDA approval of its productby arguing “sameness” of the two products in an
ANDA and then claim in the patent context thatits product is different from the innovator’s
drug.”(*9)
The second one is that the Hatch-Waxman
Amendments established a kind of early patent

resolution mechanism as an integral part of the
ANDA, what is commonly known as “Patent
Linkage”.
The third one is that the Hatch-Waxman Act
recognized that there would be no generic market
without the products developed by innovators,
and created a mechanism allowing for“patent-term extensions”.
Even with the three kinds of patentbolstering protections mentioned above, thenormal patent protection alone is still not
sufficient to provide protection to innovators.
Hatch-WaxmanActsestablishedanothermechanism called “data exclusivity” forinnovators.(*10)
Under the Hatch-Waxman Act, generic firms
also enjoy two enhanced patent related rights.(*11)(i) The Hatch-Waxman Act provides a special kindof patent infringement law, a statutory exemption
called “Bolar exemption” provision; (ii) A180-day
generic exclusivity for the first generic applicant
to successfully challenge the patent for any
approved drug.(*12)
3

The Statutory and Regulatory Regime
for Biological Drugs

There are important differences between theregulation of biologics and that of non-biologic
drugs. Due to the physical difference between the
biologic and non-biologic drugs, presently, the
ANDA is not applicable to the biosimilars.

(*4) See George Fox, Integra v. Merck: Limiting the Scope of the §271(e)(1) Exception to Patent Infringement, 19 Berkeley
Tech. L. J. 193, 195 n.16(2004).
(*5) David M. Dudzinski, Reflections On Historical Scientific, And Legal Issues Relevant To Designing Approval Pathways
For Generic Versions Of Recombinant Protein-Based Therapeutics And Monoclonal Antibodies, 60 Food and Drug Law
Journal (2005), 143.
(*6) Donna M. Gitter, Innovators And Imitators: An Analysis Of Proposed Legislation Implementing An AbbreviatedApproval Pathway For Follow-On Biologics In The United States, Florida State University Law Review (Spring, 2008).
(*7) Bruce N Kuhlik, The Assault on Pharmaceutical Intellectual Property, 71 U.Chi.L. Rev. 93, 96-97(2004).
(*8) Additional kinds of information, designed to show that the drug covered by the ANDA is the same in its indications andits effects as a previously approved drug (a “listed drug”) or is so similar that use of the data on the previously
approved drug is appropriate, must be included in the ANDA application documents. See FDCA Section 2.02505(j)(2)(A), 21 U.S.C. 355(j)(2)(A). If the listed drug has only one active ingredient, the ANDA must show that theactive ingredient of the product it covers is the same as that of the listed drug. See FDCA Section 2.02505(j)(2)(A)(ii)(I), 21 U.S.C. 355(j)(2)(A)(ii)(I). If, however, the listed drug has more than one active ingredient, theinformation in the ANDA may show either that all of the active ingredients are the same as those of the listed drug orthat FDA has approved an ANDA suitability petition to allow substitution of one such ingredient. See FDCA Section
2.02 505(j)(2)(A)(ii)(I), (II),21 U.S.C. 355(j)(2)(A)(ii)(I),(II).
(*9) Bruce S. Manheim, Jr., Patricia Granahan and Kenneth J. Dow, ‘Follow-on Biologics’: Ensuring Continued Innovation in
the Biotechnology Industry, Health Affairs, 25, no.2 (2006): 394-404.
(*10) See BIO: A Follow-on Biologics Regime without Strong Data Exclusivity Will Stifle the Development of New
Medicines, available at http://www.bio.org, (accessed Oct 20, 2009).
(*11) Bryan A. Liang, Regulating Follow-On Biologics, Harvard Journal on Legislation (Summer, 2007).
(*12) 21 U.S.C.A. §355(j)(5)(B)(iv)(I)(2009).
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Ⅲ The Patent Issues Arising When
Applying Abbreviated Approval
Pathway to Biosimilars
The application of the patent protection
provisions of the Hatch-Waxman Act to thebiosimilars may present complex issues. The
followings are some major ones:
1

The Similarity Standard plus the Current
Patent Practices in Biotechnology
Causing a Large “Loophole” in PatentProtection(1) The Similarity Standard Causing the
Leeway to design around the patent
scope
The No.1 measure in Hatch-Waxman scheme
to effective protect of innovator’s patents is the“sameness” standard for generic drugs. Due tothe physical differences between small molecules
and biological, it is virtually impossible for afollow-on company to show that its product is
identical to an innovator’s product. Under various
statutory frameworks being considered forfollow-on biologics, a biosimilar will not be
required to be the “same” as the innovator
product. Instead, the follow-on product will only
have to be similar or highly similar to theinnovator product. This similarity standard forfollow-on biologics created a significant risk that afollow-on competitor will circumvent or “design
around” the innovator’s biotech patents. As aresult, a biosimilar product may be sufficiently
similar to the innovator biologic to rely on thesafety and efficacy data of the innovator productand thus received abbreviated regulatory approval.
Yet, it may be different enough from the innovator
product to avoid a patent infringement claim and,thus, reach the market well in advance ofinnovator patent expiration.
(2) This Loophole Problem Exacerbated byCurrent
PatentPracticesin
Biotechnology
Recently, there’re a trend to heighten
patentability of biotechnology patents andconstraint of the scope of patent. This trend will
create a wider gap that may enable a biosimilar to

exploit more benefits of innovator’s patents thanprevious generic chemical drugs.
2

Is There Any Necessity to Establish
Hatch-Waxman Early Patent Resolution
Mechanism for Biosimilar, and How?

(1) The necessity to Apply Hatch-Waxman
Early Patent Resolution Mechanism to
Biosimilar
Some believe in the context of biologics
competition, the special early patent resolution
mechanism, that is, the “Patent Linkage”, isunnecessary. But the representatives of biologics
hold the opposite. So, the need to apply
Hatch-Waxman
Earlypatentresolution
mechanism to biosimilars is a big question should
be solved firstly before extending the similar
legislation to biologics.
(2) How to Apply Hatch-Waxman Early
PatentResolution
Mechanism
toBiosimilar
Usually, an early patent resolution
mechanism should include two parts: (1)notification requirements, including when
notification begins; and (2) identification ofpatents to be litigated in the pre-approval period,
which could include only “necessary” patents.(*13)
And, in addition, there is a problem of how to set
up enforcement provision to deter abuse by theparticipants that seek to use the process to obtaincompetitive advantage.(*14) Most of the problems
arise in the three aspects.
3

The Patent Term Extension and Safe
Harbor Provision
There’re a few limitations on the applicationof patent term extension provision, which prove
to be too narrow for follow-on proteins. Whether abiosimilar product that differs from the innovator
product, or is not even characterized, should be
subject to the innovator’s patent term extension?
Whether a biosimilar product that does not show
any analytical difference between the innovator
drugs, but demonstrates a clinical difference,
should be subject to the innovator’s patent term
extension?(*15) If the answer is no, such a scenario
would severely undercut the purpose of patent
restoration.

(*13) Emerging Health Care Issues: Follow-on Biologic Drug Competition, Federal Trade Commission Report, June 2009,
available at http://www.ftc.gov (accessed Oct 20, 2009).
(*14) Ibid.
(*15) The Difference with Biologics: The Scientific, Legal, and Regulatory Challenges of Any Follow-On Biologics Scheme,
BIO White Paper, April 25, 2007, available at http://www.bio.org, (accessed Oct 20, 2009).

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“Although the legislative history show that
Congress (the Bolar exception rule) wasconcerned with a very narrow class of infringers
and range of activities, the language ultimately
enacted is broader than necessary to allow
pre-expiration studies of a patent product toobtain approval for generic version of the
drug.”(*16) In the context of abbreviated approvalof biosimilar, there is an urgent need forclarification of the §271(e)(1) safe harbor toaddress these problems.
4

The Necessity of 180-day Exclusivity to
Encourage
Follow-On
Biologic
Applicants to Challenge Patents

Many people believe the competitive
dynamics that justified the 180-day exclusivity
period for small-molecule generic drugs are nolonger present in the context of biosimilar
drug.(*17) So, it is highly questionable whether the
180-day exclusivity still be necessary to
encourage the biosimilar drug development ornot.
5OthersWith the entry of biosimilars, those tactics
proven successful for entry-deterring forinnovator under the Hatch-Waxman Act will occur
again. The much more and varied patents
scattered in the biologic drugs field, and thecomplexity of biotechnology, especially thesimilarity standard, will make these tactics muchharder to discern.

Ⅳ Recommended Solutions to the
Patent Issues Might Rose in the
Abbreviated Approval Processof Biosimilar
1

The Present Biosimilar Legislation
Development All Over the World

Biosimilars guidelines and regulations arebeing developed all over the world nowadays,
including EU, Japan, and so on. WHO developed

two draft versions in 2008. Presently, there’re
two bills pending before the House of U.S.A., H.R.
1548 and H.R.1427, reflecting highly divergent
perspectives on data protection and procedures
for addressing patent conflicts.
2

The Recommended Solutions to the
Patent Issues(1) To the patent protection loophole issue
brought by the similarity standard
There’re two ways to solve this loophole
problem. One way is to provide a substantial
period of data exclusivity for the innovators, who
conduct the necessary clinical testing to bring a
new biological product to market; the other one isto harmonize the standard of equivalents between
FDA approval procedure and Court patent
infringement decision.
(2) To the pre-approval patent dispute
resolution issue
The recently issued FTC Report(*18) has
expressed many competition-related concerns
over pre-approval patent litigation procedure andstaked out a propose that a special procedures toresolve patent issues between pioneer andbiosimilar drug manufacturers prior to FDA
approval is unnecessary anymore. But the
representatives of innovator drug believe this
propose is based on flawed assumptions about
patent litigation, and is totally unacceptable. In
the author’s opinion, though the proposal in
FTC’s Report is fair and rational in some degree,
it is too radical to be acceptable. The patent
resolution provisions should be retained, but itshould be re-tailored in consistence with theinherent difference between small-mole drugs
and biological drugs.
The pre-approval regulatory process used to
be used repeatedly as a strategy to delay ofgeneric entry by the innovator manufacturers. To
solve these problems, the H.R.1427(*19) designs aprocess with no regulatory linkage for theassertion of a patent against a biosimilar applicant
and some administrative sanctions on patent
owners, which are attacked strongly by theinnovator manufacturers.(*20) In contrast to(*16) William S. Feiler & Paula L. Wittmayer, The Section 271(E) “Safe Harbor”—A Proposal for Legislative Change, 25
Biotechnology Law Report, No 2, April 2006.
(*17) Emerging Health Care Issues: Follow-on Biologic Drug Competition, Federal Trade Commission Report, June 2009,
available at http://www.ftc.gov (accessed Oct 20, 2009).
(*18) See FTC Report supra note 17.
(*19) See 111th US Congress, H.R.1427.
(*20) See Don Ware and Nick Littlefield, Follow-on Biologics and Patent Reform: Will They Discourage Venture Capital
Investment in the Biotechnology Industry? 2009, Foley Hoag LLP.
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IIP Bulletin 2010

H.R.1427, the H.R.1548,(*21) Pathway for
Biosimilars Act (Eshoo), which is applauded by
the innovator manufacturers, designs a procedurethat enables that the BLA holder and third-party
patent owners to identify relevant patents basedon information provided by the biosimilar
applicant under appropriate conditions ofconfidentiality is established. So, the H.R.1548, in
the author’s opinion, not as radical as H.R.1427,
provides a more lenient and acceptable scheme tosolve the above mentioned problems, may will bemuch easier to strike compromise between the
opposite parties.

producers are of “ordinary skill” in the art.
Alternatively,
patentclaimsmay
moreproductively be directed toward the biologic agent
per se rather than to pharmaceutical compositions,avoiding any negative implications between claim
scope and sufficiency of disclosure.”(*23)
To the innovator’s patent-blocking tactics, thegovernment should consider more aggressive
legal action against the violations of antitrustlaw.(*24) But any antitrust intervention needs tounderstand fully the risks to biotechnology
innovation and intellectual property protection ofan ill considered attack on the patent system.(*25)(3) To the patent term extension provisionand safe harbor
The present method that the statute limits
the scope of rights granted in a patent term
restoration to a product’s active ingredient will
not applicable to the biologics due to the nature ofprotein products. That means the patent
restoration statute needs making someadjustment to biologic to guarantee the same
degree of effective protection as that forsmall-molecule drugs under the Hatch-Waxman.
The solution to this problem once again comes tothe similarity standard as above mentioned when
deciding the scope of right granted in the patentterm restoration for the innovator products.
In the context biosimilars, it is necessary to
clarify the scope of article§271(e)(1), the safe
harbor clause.

Ⅴ Asian Perspective(4) To the 180-day exclusivity
Both H.R.1548 and H.R.1427 restrict thiskindofexclusivity
incentive
only
to“interchangeable” follow-on biologics, not otherbiosimilars, from coming to the market duringthat period of time.(*22) Maybe it’s a better
solution to this problem.
(5) Other suggestions
It’s necessary to put more stringent
enforcement of the disclosure requirement on
biologic patent application. “It may be appropriate
to focus on whether follow-on biologic drug

1

China: Where are we heading?

In China, as for the generic drugs, there hasan abbreviated approval pathway to get market
approval without submission of clinical data,(*26)
but as for the biosimilars, they can not apply for
approval through the abbreviated approval
pathway.(*27) In fact, when the safety and efficacy
can be established, the SFDA will not refuse to
apply the abbreviated approval pathway to thebiosimilars.
(1) The present patent policy environment
in the context of biosimilar
In China, there isn’t special patent protection
provision as those in Hatch-Waxman Act, but wedo pay attention to the patent issues in theprocess of approval of generic drug. We do havethe same active ingredient requirement for
generic drugs and 6 years data exclusivity forinnovator drugs. We don’t have the patent
extension provision, but the SFDA provides 5
years market exclusivity in a degree similar tothat. We don’t have patent linkage provision, but
in the process of regulatory approval for genericdrug, the SFDA indeed take heed of the existenceof patent officially. We don’t have the statutory
provision in patent law about doctrine ofequivalents, but the courts in various levels have
tried cases involving the doctrine of equivalents.

(*21) See 111th US Congress, H.R.1548(*22) See 111th US Congress, H.R.1548, Sec.101(k)(7) and H.R.1427, Sec.3(a)(k)(11).
(*23) Kevin E. Noonan, Follow-on Biologic Drugs and Patent Law: A Potential Disconnect? SINPPETS Review ofDevelopments in Intellectual Property Law, May 2008, Volume 6, Issue 1.
(*24) Arman H. Nadershahi & Joseph M. Reisman, Generic Biotech Products: Provisions in Patent and Drug Development
Law, BioProcess Int’l, Oct 2003, at 26.
(*25) Bill Batchelor, Patent Attack—The EC Sector Inquiry’s Interim Findings, E.C.L.R., issue 5, 2009.
(*26) See Chemical Products Registration Classification and Materials Required for Application, Annex II of the Regulationof Drug Registration of SFDA, 2007.
(*27) Art.17, the Regulation of Drug Registration of SFDA, 2007.

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Recently, the newly issued Draft Version of
Several Regulations on Handling the Applicable
Legal Questions on Patent Disputes by theSupreme Court of China adopted expressly thedoctrine of equivalents. In fact, compared to thecontinuum of patent provision embodied in
Hatch-Waxman Act, what is really missed in
China, besides the patent linkage mechanism, isthe 180-day exclusivity provision for the first
generic drug applicant who challenges the patent.
(2) The future patent policy trend in thecontext of biosimilar products
In China, there’s no possibility to establish
the 180-day exclusivity in the context ofbiosimliar in the future, and there’s a slim chance
to extend the 6 years data exclusivity in thecontext of biosimiars too. But that doesn’t mean
China will not pay attention to the patent issues
arising in the process of drug approval. Especiallyafter the promulgation of Intellectual Property
Strategy Outline and Third Amendment of Patent
Law, China has stressed on the importance ofpatent protection.
Currently, the related authorities in China
have different attitudes toward the Patent
Linkage and Patent Term Extension provisions.
To the patent linkage, they believe that it’s anecessary process to protect the patent right andwill not enhance the patent right inappropriately.
But to the patent term extension, they believethat China has fulfilled the obligations specified in
the TRIPs agreement, that is, 20 years patent
protection for inventors, and no need to provide
higher standard protection more than what isrequired by this treaty. In fact, presently, theSFDA is considering establishing the patent
linkage mechanism, but not the patent term
extension, in the near future, in China.
To China, some suggestions follow as: (1) In
establishing the patent linkage institute, theissues debated in the Biosimilar Bill of USA
should be taken into consideration; (2) In order toprotect the benefit of patentee in the context ofbiosimilar, the complexity of the technology may
necessitate a more sophisticated and specificguidance to the application of doctrine ofequivalency other than present tripartite test, i.e.
the FWR test adopted by the Draft Version; (3)It’s necessary to make some adjustment of theprovision
Art.35ofRegulations
for
Implementation of the Drug Administration Law
of PRC and the Art.18 of Regulation of Drug

Registration 2007, which stipulate expressly the 6
years data exclusivity just apply to the drugs inquestion which contain new chemical entities; and(4) The actual scope of Bolar exception rule
which was set up by the third amendment ofPatent Law, also need clarifying by the case law
as soon as possible.
2

Japan: Which way should Japan follow?

Japan issued a new guideline for the
regulation of follow-on biologics in March 2009,
which paved the way for a national biosimilars
regulatory approval. The newly issued Guideline
follows the European route, and takes acase-by-case approach based on the comparabilityof similar biological products.(*28) It is difficult to
reduce the total development cost of biosimilar
producers by a huge amount.
(1) The present patent policy environment
for the biosimilar in Japan
In Japan, there’s no special patent protection
provision, such as patent linkage provision as thatin Hatch-Waxman Act, but the authorities takeheed of the existence of patents in unofficial
manner in the process of drug approval. There area same active ingredient requirement for genericdrugs and a 8 years re-examination period acting
as data exclusivity. Japan also provides for patent
extension up to 5 years for regulatory delay. After
1998, the doctrine of equivalents became a basic
legal principle applies in Courts of various levels
subject to requirements issued by Supreme Court.
Like China, compared to the continuum of patentprovision embodied in Hatch-Waxman Act, what isreally missed in Japan, besides patent linkage
mechanism, is the 180-day exclusivity provision
for the first generic drug ANDA filer who
challenges the patent.
(2) The patent policy suggestions for Japanin the context of biosimilar
The present Japanese Guideline followed theEuropean route, which was not a reallyabbreviated approval pathway for the biosimilar. If
the Japanese Government does want to push thegeneric sector forward, the abbreviated approval
pathway for biosimilar undergoing in USA should
be followed. Anyway, proper patent policy should
be set up in the context of biosimliar to keep thebalance of innovation incentives and pricecompetition.

(*28) See Guideline on Follow-on Biologics: Quality, Safety and Efficacy Issues, Art.8, March 4, 2009.
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In Japan, the requirements for application of
the doctrine of equivalence have been developedby case law. These requirements, especially the
non-essential requirement, will come acrossproblems when applying to biotechnology patent
infringement dispute. This approach needs more
specific guidance from the Supreme Court in thecontext of biosimilars.
Compared to USA, what Japanese Guideline
adopted is not a really abbreviated approval
pathway which free-ride a lot of safety andefficacy data of innovator drugs. In the context ofbiosimilar, extending data protection period inJapan, as long as, that in Europe or US, may not
too persuasive.
Although the Japanese authorities appear toheed of the existence of patens in the process of
new drug approval, it is still not enough toprovide patent certainty to the biosimilar
producers. Maybe it’s right time for Japanauthorities to set up the patent linkage
mechanism in the context of biosimilars.
In order to fit the biologics context, someadjustments to the present Japanese patent term
extension provision and precisely clarifying thedefinition of “testing and research” for Article 69
Paragraph 1 are needed.
It’s unnecessary to introduce 180-day
exclusivity into Japan. But the reverse payment
should subject to stringent scrutiny by theanti-monopoly law.
Many Japanese companies engaged indeveloping biosimilars complained that it isdifficult to obtain the original protein as standards
and references for product evaluation. Maybe, it’stime to the patent examination practice taking
some actions, such as putting more stringent
enforcement of deposit requirement, accepting
the follow-on biologic drug producers as the“ordinary skill” in the art, and requiring patentclaims directed toward the biologic agent per serather than to pharmaceutical compositions.

Conclusion 3: The Court, Drug Agency andPatent office should keep an eye on each other’ssimilarity standard from time to time. The
doctrine of equivalents should play a larger role inoffsetting the loophole problem of patent
protection caused by the similarity standard.
Conclusion 4: The patent linkage mechanism
is important not only for the innovator, but also
for the biosimilars applicants, and should be
retained. However, it should be re-tailored inconsistence with the inherent difference between
small-mole drugs and biological drugs. To thecountry like Japan, maybe it’s right time to set up
this mechanism in the context of biosimilars;
Conclusion 5: The data exclusivity is very
important to protect the incentives of biologic
manufacturers to innovate, but it not means thelonger, the better.
Conclusion 6: The Patent Office should lookclosely at its own examination practices and makean adjustment timely. It could play a more positiverole in the development of biosimilars industry;
Conclusion 7: The biopharmaceutical firms
should use ‘Patent life management’ strategy,
wisely and pro-competitively. They should not
distort the research priority to patents labeled as“evergreen” patent, and use the patenting
practices as deterring tactics with the sole
purpose to delay the entry of biosimilars.
Conclusion 8: The Government Antitrust
Agency should try to provide a clear guidance on
the distinctions between the pro- andanti-competitive patent-blocking tactics. But any
antitrust intervention needs to understand fully
the risks to biotechnology innovation and patent
protection of an ill considered attack on the patent
system.

Ⅵ Conclusion
The conclusions as follows:
Conclusion 1: In order to promot thebiosimilars industry, when the safety andeffectiveness can be established, the ANDA
should be applied to the biosimilars application;
Conclusion 2: The Drug Agency should befully aware the difference between similarity
standards when approving a biosimilars
application and when determining the scope of
exclusivity;
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