7 An Empirical Study ofPharmaceutical Patent Harmonization (*)
Invited Researcher: Benjamin Piwei LIU (**)
How harmonized is patent protection today? Despite the long history of the harmonization process andthe central role of pharmaceutical patent protection within the debate, we currently face a paucity of empiricalstudies measuring the degree of convergence or divergence among the actual patents issued by major patentoffices and nothing on the subject of pharmaceutical patents. This empirical study begins filling this gap bycomparing the patents issued by the United States Patent and Trademark Office (USPTO), the Japanese
Patent Office (JPO), and the State Intellectual Property Office of China (SIPO) to the same pharmaceuticalinvention. Thus this is the first study that examines the de facto level of harmonization among the three
countries that boast the three largest pharmaceutical markets as well as the three largest patent offices.
Surprisingly, considerable differences exist between the USPTO and JPO despite ongoing harmonization
efforts. In contrast, the JPO grants slightly more patents and claim than SIPO but the results are generallycomparable in the absence of extensive harmonization effort. This suggests that the current harmonization
effort may have overestimated the extent of difference in some instances while overlooking conditions that
contribute to significant divergence in other instances.

Ϩ Introduction

boast the three largest pharmaceutical markets aswell as the three largest patent offices.

Technology knows no borders, but patent
protection does. The latest iPhone is available in
115 countries, the asthma medicine Symbicort in
70. But the patents protecting them remain
territorial, issued by national patent offices
thousands of miles apart pursuant to the patentlaws of each state. This patchwork of legal
protections has been criticized for being archaic
and inconsistent with modern business practices.
How harmonized is patent protection today?
Despite the long history of the harmonization
process and the central role of pharmaceuticalpatent protection within the debate, we currently
face a paucity of empirical studies measuring thedegree of convergence or divergence among theactual pharmaceutical patents issued by major
patent offices and nothing on the subject ofpharmaceutical patents. This empirical study
begins filling this gap by comparing the patents
issued by the United States Patent andTrademark Office (USPTO), the Japanese Patent
Office (JPO), and the State Intellectual Property
Office of China (SIPO) to the same
pharmaceutical invention. Thus this is the firststudy that examines the de facto level ofharmonization among the three countries that

ϩ The Harmonization
ExaminationofPatentAlthough further harmonization is stalled in
WTO and WIPO, countries may still harmonize
substantive patent law outside the context ofinternational treaties. This section summarizes
the current harmonization at the national andadministrative level as well as highlighting
significant harmonization developments within
the pharmaceutical area.
1

National Patent Law Amendments
The US, Japan and China have all amended
their national patent law in recent years. On
March 16, 2013, the United States moved awayfrom its first-to-invent system of determining
patent priority when the American Invents Act(AIA) came into effect, resolving one of the
sticking points that doomed the Patent Law
Treaty 20 years earlier. China and Japan haveboth amended their respective patent laws tobring their law closer to each other.

(*) This is a summary of the report published under the Industrial Property Research Promotion Project FY2014
entrusted by the Japan Patent Office.
(**) Assistant Professor, The John Marshall Law School, at our institute over a period of approximately 2.5 months fromMay 19, 2014 through August 9, 2014, as an Invited Researcher for the Fiscal Year 2014.

IIP Bulletin 2015 Vol.24● 46 ●

2

Patent Office Collaborations
While changes to national law are highly
visible,the
lessnoticedadministration
harmonization at the patent office level is more
far-reaching. The harmonization of administrative
procedures ostensibly promotes the time-honored
virtue of consistency, and patent administrators
are motivated to pursue harmonization to cut
expense, reduce backlog and improve applicant
service. Administrative harmonization is lessvisible to critics and sidesteps legislative politics.
It is also easier to initiate, so long as two
likeminded patent offices decide to converge theirpractices. For these reasons, coalitions of the top
patent offices now spearhead sundry initiatives tobring their operations closer together.
For example, two patent offices cancoordinate the examination of related applications.
Under the Patent Prosecution Highway (PPH)
program, an applicant with applications pending in
two or more offices may use the patent grant in
one country to expedite the examination process
in another.
Multiple patent offices may also establish
regular collaborations. The oldest of thesearrangements is the Trilateral Co-operation
project between the USPTO, JPO and EPO in
1983. Similarly, patent administrators of China,
Japan and South Korea began the Trilateral Policy
Dialogue Meeting in 2000. This Asia-based
trilateral arrangement also conducts comparative
studies of different practices between these threepatent offices. By 2007, the top five patent offices
came together in the IP5 working group. The IP5
office currently operates three Working Groups
to standardize technology classification, develop a
global dossier portal for users, and to enhancework-sharing through the Patent Corporation
Treaty and the Patent Prosecution Highway.
Other broad initiatives include the B+ working
group and the Tegernsee Expert group in
response to the stalled WIPO substantive patentlaw treaty negotiation. These concerted efforts
create a positive feedback loop, whereby themore patent offices standardize their processes
and standards, the easier it is to standardize
further.
Lastly, the harmonization of patent
protection can take place through the integrationofunwritten
customs
andinterpretive
communities. To this end, the Trilateral and IP5
projects include eLearning and examiner
exchange programs. JPO examiners andadministrators often attend U.S. law schools as
visiting scholars. Similarly, many examiners fromthe State Intellectual Property Office of China
have attended U.S. law schools for patent law
training. These training and exchange programs
have the effect of reducing the differences
between states.
3

Pharmaceutical Patent Harmonization
Pharmaceuticalinventions
provideaparticularly rich context for examining global
patent harmonization. On the one hand, drug
companies are keen on promoting standards ofheightened patent and quasi-patent protections tosafeguard the worldwide market their products
command. Professor Susan Sall expanded thistheme in the seminal book “Private Power, Public
Law: The Globalization of Intellectual Property
Rights.” On the other hand, the adoption of the2001 Doha Declaration on the TRIPS Agreement
and Public Health marked a watershed event
highlighting the flexibilities in the patent systemthat pushes back harmonization. Throughout allthesemaneuvers,
pharmaceuticalpatentsprotection remains the lightning rod subject of
harmonization.

Ϫ Data Selection and Gathering
1

Technology Selection
This study focuses on patented technologies
enumerated in the list of Approved Drug Productswith Therapeutic Equivalence Evaluations, a.k.a.
the “Orange Book”, for pharmaceuticals approvedby the U.S. Food and Drug Administration (FDA)
in 2010. More specifically, the list includes only
pharmaceuticals based on a new molecular entity,
andtherefore
excludesgeneric
drugs,
over-the-counter products, diagnostics, medical
devices, new dosages or administration form ofpreviously approved compounds.1 For this study,a single invention is defined as a single disclosure,and all claims based on the identical disclosure
are considered the same invention regardless ofwhether they belong to a single or multiple
patents.
2

Country Selection
The patents issued by three patent offices
are chosen for analysis: the United States Patent
and Trademark Office (USPTO), the Japanese
Patent Office (JPO), and the State Intellectual
Property Office of China (SIPO).
3

Patent Selection
A Derwent World Patent Index search is
conducted for each Orange Book patent using● 47 ●IIP Bulletin 2015 Vol.24

Westlaw. This search generates the prior art
history, family, and title of the patent searched.
The “Patent Family” heading generates thepatent family for the US patent searched. To
ensure the correct family was selected, the US
Patent that was originally entered into the searchshould be one of the US patents listed within thefamily. After selecting the family, all the US,
Chinese and Japanese patent publications listed inthis family were recorded. A subsequent search is
conducted at the patent database at each of thethree patent offices. The actual patent documents
are downloaded during this step. Only patents
granted as of January 1, 2014 are included in theanalysis.
4

Claim Analysis
The claims of the patents within thecorresponding disclosure families are extracted
for quantitative and qualitative analysis. A humancoder manually reviewed the independent claimsof all the patents belonging to the same invention(same disclosure) and identify corresponding
independent claims between national applications.
It should be noted that corresponding
independent claims need not be identical—they
may contain meaningful but limited differencesthat are not so encompassing as to elude
comparison. It is expected that some independentclaims will be unique to a jurisdiction (where one
claim embodies a fundamental change from theclaims of another jurisdiction), while others areshared among a subset of the three jurisdictions.
The degree of overlap provides a rough overview
of the equivalence between corresponding
national patents.
5

Patent Scope Coding
To assess the degree of difference between
the scope of patents in the U.S. and elsewhere,
the claims of the U.S. patent are compared to thecorresponding claims of the Japanese and Chinese
patents. For each pair of the US-others
comparison, the exact differences are recorded asa “difference event.”

ϫ Results and Analysis
1

Patent Counts
Overall, most countries offer some patent
protection to these products but the protection
offered in the United States outstrips theprotection offered in Japan or China. While China
offers the least extensive protection of the three,the differences between China and Japan are
muted. Of the drugs approved by the US Food andDrug Administration in 2010, 33 new drugs
contained patents listed in the Orange Book.
Some of these patents are divisional orcontinuation applications of each other and sharethe same specification. These patents fall into 83
sets of distinct specifications. These 83
disclosures issued into 177 US patents. The
number of patents issued from a specification isgreater than the number of patents listed in the
Orange Book. This is because that a specification
can generate multiple patents and only some ofthose patents are listed in the Orange Book. On
average two patents are issued for every
invention disclosure.
In the case of Japan, JPO granted 47 patents
based on 41 distinct disclosures. This is about halfof the distinct disclosures and a quarter of thepatents issued in the United States. However,these patents still cover about two-third of the
drug targets, or  out of 33 drugs. In the case of
China, SIPO granted 38 patents based on 31
disclosures and provided coverage for 20 drugs.
That China offers the fewest number of patentrights may not be surprising. China offered patent
protection to 1 drug that was not protected inJapan, while Japan offered patent protection to 5
drugs that were not protected in China. Overall,
25 drugs are protected in either Japan or China,
which corresponds to a distinct 47 disclosures. In
the United States, these 47 matched disclosuresresulted in 131 US patents. Table 1 summarizes
these results.

Table 1
Drugs

Disclosure

Patents

US (Total)

33

83

177

US (Matched Disclosure)

27

47

131

JP (Matched Disclosure)

24

41

47

CN (Matched Disclosure)

20

31

38

IIP Bulletin 2015 Vol.24● 48 ●

While most drugs studied have at least one
patent issued by each of the trilateral patentoffices, the United States stands out for thenumber of patents it grants for a given set ofpharmaceutical products and the innovative ideas
embodied in these product—twice as many
distinct disclosures received patent protection in
the United States.
A disclosure that leads to patents outside of
the U.S. generates more patents within the
United States. The protection of disclosure in the
United States is deeper as it is broader. For the 47
disclosures that were patented in both the UnitedStates and either Japan or China, they receive on
average three US patents each and one patent inJapan or China. In contrast, the 36 disclosuresthat did not result in a Japanese or Chinese patent
generated only 46 US patents altogether. Silenor
again illustrates this trend: Five disclosures led toa single US patent each and no Japanese or
Chinese patents. A sixth disclosure generated
Table 2Claim Count

seven US patents but only one Japanese patent.
The patent protection of pharmaceuticalknowledge in the United States is thick as it isbroad.
2

Claim Counts
The 177 US patents correspond to 3623
claims, of which 522 are independent claims.
However, only 47 of the 83 disclosure families
have a counterpart patent in Japan or China andthese matched invention disclosures offer abettercomparison.
These
47
matching
disclosures correspond to 131 US patents andaccounts for 2726 claims and 402 independents
clams. In contrast, Japan grants 47 patents that
accounts for 727 total claims and 126 independentclaims—far fewer claims and independent claims
for the corresponding patent disclosures.
Similarly, China grants 571 total claims and 117
independent claims. Table 2 summarizes thisresult.

Disclosure

Patents

Total C.

Ind. C.

US (Total)

83

177

3623

522

US (Matched Disclosure)

47

131

2726

402

JP (Matched Disclosure)

41

47

727

126

CN (Matched Disclosure)

31

38

571

117

With respect to the comparison between US,
Japan and China, both Japan and China grantfewer claims per disclosure and per patent.
However, the numbers of independent claims
remain similar between the jurisdictions. The
Table 3Claim Ratios

claim ratios between Japan and China are very
similar, especially when viewed in light of the US
ratios, while Chinese patents contain slightly
more independent claims than in Japan. Table 3
summarizes these results.

US (Total)

All Claim/
Disclosure
43.65

All Claim/
Patents
20.47

Ind. Claim/
Disclosure
6.28

Ind. Claim/
Patent
2.95

US (Matched Disclosure)

58.00

20.81

8.55

3.07

JP (Matched Disclosure)

17.73

15.47

3.07

2.68

CN (Matched Disclosure)

18.42

15.03

3.77

3.08

The 126 matched Japanese independentclaims and 117 matched Chinese independentclaims are translated for further comparison. Of
these 402 independent claims in the US, 127
match either a Japanese or Chinese independentclaim (or both). A great majority (95) of theJapanese independent claims (126) can bematched to a US independent claim. In contrast,
only about half (65) of the Chinese independentclaims (117) has a match in the US. 25 Japanese

claims and 22 Chinese claims are practically
identical to US independent claims (41). On
average there are 2.32 matched independentclaims per disclosure between Japan and the US,
and 2.10 matched independent claims perdisclosure between China and the US. Less than
one independent claim per disclosure ispractically identical among the jurisdictions.
Table 4 summarizes the finding.

● 49 ●IIP Bulletin 2015 Vol.24

Table 4
Matched Claims

Disclosure

US (Matched Disclosure)

47

Ind.
C.
402

Matched127

PracticallyIdentical
41

Matched/Disclosure
2.70

Identical/
Disclosure
0.87

JP (Matched Disclosure)

41

126

95

25

2.32

0.61

CN (Matched Disclosure)

31

117

65

22

2.10

0.71

3

Claim Difference
The 95 matching Japanese independentclaims and 65 matching Chinese independentclaims are compared to their US counterpart todetermine the exact claim level difference
between US-Japan and US-China. A comparison of
US and Japanese matching independent claims
show a good number of changes relating toformulations and compounds, with slightly morenarrowing events than broadening events. In thecase of US and China, the number of narrowing
events out number broadening events two to one.

Ϭ Implication for Harmonization
The varying breadth of protection and thedifferent coverage among the three jurisdictions
reveals important clues to the level ofharmonization among these patent offices. The
data shows considerable differences between thescope of patents granted in the United States,
Japan and China for the same pharmaceuticalinvention. The United States protects more
distinct disclosures, more patents, and more
dependent and independent claims per drug. The
number in each category is multiples of theprotection in Japan or China. With respect toindividual claim elements, the US-Japan
comparison shows the notable a number ofdifferences with the Chinese claim elements,
where claim elements are narrowed slightly more
often than expanded. The narrowing tendency ismuch more pronounced for Chinese patents. In
summary, considerable differences exist between
what the United States offer versus what Japanand China offers to the same pharmaceuticalinventions.
As between the two Asian patent offices,Japan grants slightly more patents and claims
than its China but the difference is muted. In fact,by most of the measures used in the analysis thefigures for China are close to Japan. This finding
is consistent with recent research noting that
China’s patent system is now close to parity with
developed countries. On the other hand, it calls
into question the perceived alliance of Japan andthe US on the issue of patent harmonization.

IIP Bulletin 2015 Vol.24

Although Japan and the US often take similar
positions in international negotiations and theirpatent offices have been in collaboration for thelast 30 years, this study shows that considerable
differences persist, which in turn highlights thedifficulty of genuine harmonization even among
countries that occupies similar runes of thedevelopment ladder. On the other hand, it also
showcases a degree of convergence between
Japanese and Chinese patent regimes thatsuggests a patent norm in the region different
from that espoused by the United States. The
remainder of this section considers theimplication of these similarities and differences
for the stakeholders of the pharmaceutical patentharmonization process—the trade negotiators,
the pharmaceutical companies, and public healthadvocates.
1

Trade Negotiators
This empirical study questions the goal of
harmonizing the level of patent protection upward
through the harmonization project. This study
shows that China is already offering the numberof patents and claims near the level of Japan. To
the extent differences exist, the study suggeststhat it is of a type not easily remedied throughinternational treaties or free trade agreements.
Instead of the all-or-nothing choices ofpharmaceutical product or secondary use patenteligibility that were the subject of the debate
during TRIPs negotiation, it is the subtle
judgment calls to narrow a claim that separates a
Chinese claim from its counterpart in US or Japan.
These decisions flow from internal policies
nestled deep within customary practices there are
difficult to reach through international lawmaking.
Moreover, it is through the exercise of thesejudgments that patent administrations ofindividual countries maintain their relevanceduring the era of harmonization. Therefore it isunlikely that patent offices will relinquish its
discretion.
2

Pharmaceutical Companies
Companies are primarily concerned with theextent of protection for the drugs they sell.

● 50 ●

Although this study focused on disclosures, theterm “invention” can refer to innovative products
and services. This is also consistent with theconventional wisdom that the patent system
incentivizes the development of tangible
inventions that are welfare enhancing.
The analysis here indicates considerable
differences among patent protection between
China, Japan and the US. We see that the majorityof “invention as a drug product” received patent
protection outside the US while only half of the“invention as disclosed information” received
patent protection outside the US. Generic drug
manufacturers in Japan and China can begin
producing a third of the pharmaceutical products
studied (unless there are patents granted in Japanor China that do not have a US counterpart in the
Orange Book).
As for the majority of drugs where at least
one patents exist in Japan or China, the overall
patenting pattern there fosters greater directcompetition than in the United States for two
reasons. First, a drug in the US is likely coveredby a portfolio of patents directed to multiple
disclosures while the same drug is likely
protected under a single patent family in Japan or
China. This means that the US patents are likely
to expire on different dates and protect the drug
over a longer period of time—a phenomenonlabeled “evergreening.” In contrast, the practiceof evergreening does not appear prevalent in
China or Japan.
Lastly, substitute competition is likely
greater in China and Japan. Again, it is mucheasier to design a competing product around asingle patent than a portfolio of patents. Second,in the instances where the patent claims scope
appears narrower than that in the US,
competitors may design a substitute productaround the patent protection. Overall, narrower
patents permit the development of more me-too
and me-better drugs.

copying. This strategy is a departure from theIndian paradigm of issuing compulsory license or
denying patent protection all together. This
flexibility within the patent system may provide
new levers for balancing public health concern
and innovation in a more precise, surgical mannerin contrast with India’s all-or-nothing approach topharmaceutical patenting.

ϫ Conclusion
This study delivers the first empirical look at
the level of harmonization among the top threepatent offices and shows that similarities anddifferences between patent systems may not be
what we may have expected. But more
importantly the methodology here offers a path tobroader and richer studies that will ultimately
connect legal doctrines with actual results. We
now have more tools to develop evidence- andoutcome-based patent harmonization policy.

1

The definitions are established by the Tufts Center for
the Study of Drug Development and the FDA's
definitions of a new drug approval or a new molecular
entity.

3

Health Advocates
The number of pharmaceutical patents
differs greatly and patent offices are granting
patents of varying scopes that permit the
emergence of substitute products. This meansthat countries with some R&D capacity andpatent examination expertise may adopt thestrategy of developing “me-too” solutions tomeet local healthcare demand. Moreover thisstrategy has the added benefit of incentivizing a
local
pharmaceuticalindustry
basedonderivations and improvement instead of slavish● 51 ●IIP Bulletin 2015 Vol.24