Priority

医療分野の知的財産について

今回は、最近、環太平洋戦略経済連携協定(TPP)絡みで話題になることが多い医療分野の知的財産について少々お話致します。TPPが日本の知的財産に与える影響については未だ明確なことは分かりませんので、ここでは議論致しませんが、話題を理解する上で役に立つかも知れない情報についてお話します。

医療行為について:

Trips第27条には、加盟国は「人又は動物の治療のための診断方法、治療方法及び外科的方法」を特許の対象から除外することができると定められています。

人間に対する医療行為(手術、治療又は診断する方法)については、米国やオーストラリアなどのごく少数の国を除いて、特許保護の対象として認められていません。日本、欧州、中国、韓国などにおいては、現在のところ、人間に対する医療行為に関する特許は取れません。

一方、TPP案(2012年5月)の8.2条には、以下のように規定されています。

「各当事国は、以下の発明について特許の対象とする事を認めなければならない:
a. 植物及び動物、並びに
b.  人又は動物の治療のための診断方法、治療方法及び外科的方法。」

因みに、米国では医療行為に関する特許を取得することは可能ですが、医師に対しては特許権を行使することは出来ません。しかし、全く権利行使が不可能という訳ではなく、以下のような場合に権利行使出来る可能性があります:

- 医薬の投与方法の特許を侵害する行為は、医師であっても免責されない可能性がある。

- 製薬企業が医師に医薬を提供する行為も間接侵害(寄与侵害)に該当する可能性がある。

- バイオテクノロジー特許を侵害する行為は、医師であっても免責されない。

日本でも医療行為を特許保護の対象に含めるべきかという点は以前から議論されておりますが、ごく限られた例外を除いて今までのところ実現には至っておりません。

韓国においても米国とのFTA締結に伴い、2012年特許法が改正され、特許出願に関する所謂「グレース・ピリオド」が米国と同様に1年間に変更されましたが、医療行為は特許の対象外のままです。日本も、医療行為を特許の対象と認めることに同意することはないように思われますが、はたしてどうなるでしょうか。

動物に対する医療行為について:

人間に対する医療行為(手術、治療又は診断する方法)だけでなく、動物に対する医療行為についても、特許保護が認められていない国があります。

参考までに、各国における「医療分野における方法」(医療行為や準医療行為)の特許保護可能性の概要を下記表に示します。

 

各国における「医療分野における方法」(医療行為や準医療行為)の特許保護可能性の概要

 

手術方法

治療方法

診断方法

測定方法

動物に対する 医療行為

米国1)

O

O

O

O

O

オーストラリア2)

O

O

O

O

O

日本

×

×

×

3)

O

EP

×

×

4-1)

4-2)

ヒトについてと同様

カナダ

×

×

5)

5)

ヒトについてと同様

ニュージーランド

×

×

6)

6)

O

韓国

×

×

×

7)

O

中国

×

×

×

8)

ヒトについてと同様

台湾

×

×

9-1)

9-2)

ヒトについてと同様

マレーシア

×

×

10-1)

10-2)

ヒトについてと同様

インド

×

×

11-1)

11-2)

ヒトについてと同様

インドネシア

×

×

×

×

×

注1)(米国) 医師・医療機関の特許侵害に対して部分的な免責規定がある。即ち、米国特許法第287条の第(c)項(いわゆる「免責規定」)により、(1)医師が侵害に該当する医療行為を実施した場合は、差止請求権・損害賠償請求権などの規定は該医師又は該医療行為に関与する関連医療機関には適用されない。(2)ただし、該「医療行為」とは、身体に対する医療的又は外科的処置を施すことをいうが、次に挙げる行為は含まないものとする。(i) 特許された装置、製造物または組成物の侵害的使用、(ii) 組成物の使用に関する特許の侵害的実施、及び (iii) バイオテクノロジー特許を侵害するプロセスの実施。

注2)(オーストラリア) 医師・医療機関の特許侵害に対して免責規定は無い。

注3)(日本) 手術工程・治療工程を含まず、また医療目的で判断する工程を含まない、人体に対する測定方法は、特許対象である。また、検体の分析・測定方法は特許対象である。(審査基準 第Ⅱ部 第1章 産業上利用することができる発明、2.1.1参照)

注4-1)(EP) 検体を用いた診断方法は特許対象である(EPO Guidelines for Examination, G-II, 4.2.1参照)。

注4-2)(EP) 手術工程を含まない、診断プロセスに至らない人体に対する測定方法は特許対象である(EPO Guidelines for Examination, G-II, 4.2.1参照)。

注5)(カナダ) 手術又は治療の工程を含まない人体に対する診断方法は特許対象である(カナダ国知財庁の特許審査ガイドラインによる)。

注6)(ニュージーランド) 手術工程を含まない人体に対する診断方法は特許対象である(ニュージーランド国知財庁の特許審査ガイドラインによる)。

注7)(韓国) 人体に直接的でかつ一時的でない影響を与える工程を含まない限り、人体に対する測定方法(臨床的判断を含まない)は特許対象である(韓国知財庁の特許審査ガイドラインによる)。

注8)(中国) 手術工程を含まない、診断プロセスに至らない人体に対する測定方法は特許対象である。また、診断プロセスに至らない検体の分析・測定方法は特許対象である。(中国知財庁の特許審査ガイドラインによる)

注9-1)(台湾) 検体を用いた診断方法は特許対象である(台湾国知財庁の特許審査ガイドラインによる)。

注9-2)(台湾) 手術工程を含まない、診断プロセスに至らない人体に対する測定方法は特許対象である(台湾知財庁の特許審査ガイドラインによる)。

注10-1)(マレーシア) 検体を用いた診断方法は特許対象である(マレーシア国知財庁の特許審査ガイドラインによる)。

注10-2)(マレーシア) 手術工程を含まない、診断プロセスに至らない人体に対する測定方法は特許対象である(マレーシア国知財庁の特許審査ガイドラインによる)。

注11-1)(インド) 検体を用いた診断方法は特許対象である(インド国知財庁の特許審査ガイドラインによる)。

注11-2)(インド) 手術工程を含まない、診断プロセスに至らない人体に対する測定方法は特許対象である(インド国知財庁の特許審査ガイドラインによる)。

医薬品の特許期間とジェネリック医薬品:

現在、日本において特許の存続期間は出願から20年であり、医薬品の場合、最大で5年間の延長が認められます。特許が有効に存在している間は、第三者は特許権者の許可なく発明を実施することは出来ません。即ち、第三者は、許可無く、特許された医薬品を製造・販売することは出来ません。

しかし特許期間が満了すると、第三者が、特許権者の許可無く発明を実施できるようになります。医薬品の場合、先発医薬品が認可を受けていれば、簡単な審査で特許製品と同様の医薬品の認可が下ります。研究開発費などはかかっていないわけですので通常、先発医薬品よりも安価に提供され、そのような医薬品を通常「ジェネリック医薬品」と称します。

更に、TRIPS(知的所有権の貿易関連の側面に関する協定)においては、ジェネリック医薬品製薬会社が既存の医薬品の臨床データを、薬剤認可を受ける際に利用することを許容しています。臨床データの取得は、時間と費用がかかるため、臨床データが不要であることはジェネリック医薬品の価格低下に大きく寄与しています。

また、近年、2010~2012年頃にかけて、大型医薬品(ブロックバスター)の特許が一斉に切れるという所謂「2010年問題」が話題になっています。ジェネリック大国である中国・インドなどが、この機を大きなビジネスチャンスと考えています。

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National Patent Application in Japan

Q. Is it possible to file a patent application in Japan with an English specification?

A.  A valid filing date in Japan can be obtained by filing English versions of a specification (including claims and description), an abstract and drawings (if any) together with a duly filled-out application form (in Japanese language).  However, Japanese translations of the English specification etc. must be filed within 1 year and 2 months from the filing date or, if the Japanese application claims the convention priority, from the priority date.  Failure to do so results in the application being deemed to be abandoned.

PCT National Phase in Japan

Q1. What are the time limits for entering Japanese national phase under PCT Chapters I and II?

A1.  The time limit is 30 months from the earliest priority date (if any) or the international filing date of the PCT application for both Chapters I and II.

Q2. Are Japanese translations of the PCT specification, abstract and drawings necessary for entering the Japanese national phase?

A2.  Yes.  Japanese translations of the PCT specification, abstract and drawings must be filed with the Japan Patent Office.  Further, Japanese translations of amendments under PCT Article 19 and 34 (if any) should be filed with the Japanese translations of the specification, abstract and drawings.

Q3. The time limit for entering Japanese national phase is drawing near but it seems unlikely that a Japanese translation of the PCT specification can be timely prepared.  Does the JPO allow postponement of the filing of the Japanese translation? 

A3.  We can first file a “formal notice of entry into Japanese national phase” by the 30-month deadline for entry into Japanese national phase and, then, file Japanese translations of the PCT specification, abstract and drawings.  The formal notice can be prepared at our end based on the information shown in the cover page of the international publication.  The Japanese translations may be validly filed within 2 months from the date of the filing of the above-mentioned formal notice of entry.  No extra charge is necessary for such delayed filing of the Japanese translations.

Exceptions to Lack of Novelty of Invention

Q1. We understand that Japan has a grace period for avoiding certain public disclosures from constituting prior art against a Japanese application.  How long is this grace period?

A1.  The grace period defined under Article 30 of the Japanese patent law (Exceptions to Lack of Novelty of Invention) is 6 months from the date of public disclosure.

Q2. What type of disclosures is capable of taking advantage of the Exceptions to Lack of Novelty of Invention in Japan?

A2.  According to current Article 30 of the Japanese patent law (effective as of April 1, 2012), virtually any disclosure, including “inventions made public at meetings and seminars, which are not academic conference designated by the Commissioner of the Patent Office, inventions made public on TV and radio, and inventions made public through sales”, are covered by the Exceptions to Lack of Novelty of Invention.  However, a patent publication is not a non-prejudicial disclosure.

Q3. Is the grace period applicable to scientific articles published on the web? 

A3.  The 6-month grace period is also applicable to electronic publications of scientific articles.  When a scientific article is published in the form of an electronic publication in advance to the publication in print, the 6-month grace period will start from the date of the electronic publication.  This rule applies not only to a free electronic publication, but also to an electronic publication which requires registered membership and/or purchase of the publication for accessing the electronic publication.

Q4. An invention has been published as a scientific article and a basic patent application has been filed in the US within 6 months from the publication of the scientific article.  Already 10 months have passed from the publication of the scientific article, but is it still possible to enjoy the benefit of the Japanese 6-month grace period by filing a Japanese patent application claiming the Paris convention priority from the basic US application filed within 6 months from the publication date? 

A4.  No.  Claiming of the Paris convention priority does not allow the filing date in Japan to date back for the purpose of grace period.  In other words, when a basic application is filed in other country within 6 months from the date of public disclosure, and a Japanese patent application claiming the convention priority from the basic application is filed after the expiration of the 6-months grace period, the Japanese patent application cannot enjoy the benefit of the grace period.

For receiving the benefit of the 6-month grace period in Japan, the Applicant must file within the 6-month grace period either one of the following applications:

   (1) Japanese national patent application*, or

   (2) PCT application designating Japan as one of the designated states. 

* Either a Japanese patent application or a PCT application claiming the convention priority from this Japanese patent application can be filed after the expiration of the grace period and still enjoy the benefit of the grace period.

Q5. What are the steps necessary for obtaining the benefit of the Japanese 6-month grace period?  

A5.  Necessary steps are explained separately for Japanese national patent application and PCT application.

Japanese national patent application:

A patent application is filed simultaneously with a Request for Grace Period within 6 months from the date of public disclosure.  Alternatively, the Request may be omitted by stating such effect in the patent application.

Next, a Document Verifying the Request, which is signed by all applicants, is filed within 30 days from the filing date of the patent application.  Filing of a specific evidence material (such as a copy of the scientific article disclosing the invention) is not required, but it is most advisable to file the evidence material with the Document.

PCT application designating Japan:

When a PCT application designating Japan as one of the designated states is filed within the 6 month grace period, such a PCT application will obtain the benefit of the grace period even when the PCT application enters the Japanese national phase after the expiration of the grace period (i.e., within non-extensible 30 month deadline).  In this case, both the Request for Grace Period and the Document Verifying the Request are filed within 30 days from the entry into the Japanese national phase. 

[Filing of the Request for Grace Period can be omitted when “Declaration as to Non-Prejudicial Disclosures or Exceptions to Lack of Novelty” (PCT Rule 4.17(v), 26ter.1) is made at the international stage.]

The Document Verifying the Request can be prepared at our end and forwarded for execution by the applicant(s). 

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Design Registration

Q1. If a design application is to be filed in Japan claiming Convention Priority based on a non-Japanese application, is the priority period one year as in patent applications? 

A1.  No. For filing design applications in Japan claiming Convention priority, the priority period is for six (6) months, instead of one year, from the filing of the priority application.  Even if you have a design "patent" application filed at the USPTO, the priority period is 6 months for filing a Japanese patent application with a valid priority claim based on the degisn "patent" application filed in the US.  

You also have to be careful when filing a patent application in Japan claiming priority from both a patent application and a design application.  That is, for example, if you filed in your country a patent application on May 1, 2012 and a design application on October 30, 2012 and are now considering filing a patent application on May 1, 2013 in Japan claiming priority from both of the above-mentioned patent application and design application filed in your country, this date “May 1, 2013” is within one-year priority period based on the patent application but is after the expiration of six-month priority period (October 30, 2012 + 6 months = April 40, 2013) based on the design application.  Therefore, the priority claim based on the design application is not valid.  

Q2. I am planning to file a design patent application in Japan claiming priority from a US design patent application.  What are the major differences in practice between the United States and Japan that require particular attention?

A2.  Firstly, unlike the “design patent” in the United States which is one type of patents and is basically dealt with under the patent law, Japan has a design law separate from a patent law. 

Therefore, in Japan, an application for registration of a design is referred to as “design application”, not “design patent application” as in the United States.  

More importantly, this difference in legal system leads to some significant differences in design registration practice between the US and Japan representative examples of which are enumerated below.

Difference 1)  “Single design per application” system in Japan

It is understood that the US system allows an applicant to pursue two or more designs (embodiments) of a single inventive concept in a single design patent application.  This, however, is not the case in Japan.  According to the Japanese practice, each design application may include only a single design of single shape.

Therefore, in Japan, when a single priority application includes multiple designs, it is necessary to either:

-  file separate design applications with respect to the different designs, or

-  file an application including different designs and later file a divisional application(s).

In this connection, however, it should be noted that it is not allowed to file a divisional application on a “partial” design from a “whole” design application and vice versa.  Concerning the “partial” and “whole” designs, explanations are made below.

Further, there is an exception to the "single design per application" system, and the Japan's Design Law provides "related design" system for covering a plurality of similar designs.

1-1) Exception to the “single design per application” rule

The Japan’s Design Law exceptionally allows for discrete objects to be claimed in a single application if common sense indicates that such discrete objects are usually sold as a “set”, as in the case of, for example, a 3-piece set including a knife, fork and spoon. 

1-2) Related design applications

In the case where the priority US application contains a plurality of different but similar designs (e.g., minor variations of a certain design), such similar designs may be covered by utilizing the related design system in Japan.  Specifically, the similar designs can be covered by filing a principal design application and filing a related design application(s) by one day prior to the publication of the principal design. 

The design registered as the related design can be enforced independently of the registered principal design and other registered related design(s).  That is, a related design right can cover even a design similar to that related design, which, however, is not similar to the principal design. 

For covering such similar designs under the related design regime, it is possible to either:

-  file a principal design application and also file a related design application(s) simultaneously with the principal application or later (by one day prior to the publication of the principal design at the latest), or

-  file general design applications on the similar designs, and later amend the general applications into a principal design application and a related design application(s).

The JPO may find that the designs are not similar enough to be eligible for registration under the related design regime but there is no need to be so nervous about this point.  If the JPO denies the similarity, the JPO will issue an office action requesting the applicant to stop relying on the related design system and change the applications to normal applications.

 

Finally, the right of a registered related design is independent from the right of a registered principal design but there are the following exceptions.

1.   Synchronized protection term: 

The protection term for both of a registered principal design and a registered related design is 20 years from the registration date of the principal design.  This point, however, is substantially immaterial in the present case because the two applications will probably be registered almost simultaneously.  Further, the registered related design can be maintained even if the principal design is allowed to lapse due to non-payment of maintenance fee, and vice versa.   

 2.   Restriction of transfer of rights and licensing: 

The right of a registered related design cannot be transferred or licensed independently from the registered principal design.  That is, for transfer of design rights to a third party by assignment etc., the principal and related designs must be simultaneously transferred together to the same entity.  Further, also for licensing, the principal and related designs must be licensed simultaneously to the same entity.

 

Difference 2)  Partial Design System

The Japan’s Design Law has a “partial design system” which allows registration of parts of shapes or forms with distinct characteristics.  

The US system also provides a similar practice where dotted lines can be used to indicate non-claimed parts.  There is, however, one important difference.  That is, the Japan’s system requires that a partial design application should be filed with a clear indication that the application claims a partial design.  In the absence of such indication, the application will be recognized as claiming a whole design. 

Once filed with the indication of a partial design application, it is in principle not allowed to amend the application into a whole design application and vice versa.  Similarly, a divisional application on a partial design cannot be filed from a whole design application and vice versa. 

Therefore, if it is important to cover both of whole and partial designs, it is recommended to file both a whole design application and a partial design application.

 

Of course, there are many other differences between US and Japanese practices; however, the above differences are believed to be the main differences which require particular attention when filing a design application in Japan claiminig priority from a US design patent application.

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Trademarks

Q1. If a trademark application is to be filed in Japan claiming Convention Priority based on a non-Japanese application, is the priority period one year as in patent applications? 

A1.  No. For filing a trademark application in Japan claiming Convention priority, the priority period is six (6) months, instead of one year, from the filing of the priority application. 

Q2. Are there any specific points to be noted for registering a trademark in Japan?

A2.  Some of the points to be noted for registering a trademark in Japan are as follows.

(1)  Goods and services acceptable in Japan:  In the case of trademark registration in Japan via Madrid protocol, the JPO may object to the indications of goods/services in the International Register as being too vague even if they should be acceptable under the NICE Agreement.  This is because the JPO relies on its own list of goods and services as prescribed in the examination standards.  For example, “Apparatus for locomotion by land, air or water” found in the NICE Classifications is not found acceptable by the JPO, and it should be amended to “Aircraft; automobiles; bicycles; motorcycles; rolling stock for railways; ships”.  The amendment of indications is possible as long as it is within the scope of the original Madrid protocol application. 

(2)  Requirement for use of trademark:  A registrable trademark in Japan is a trademark which is being used or which is intended to be used in the near future.  When the range of the goods and services listed in one class is too broad, the trademark will be rejected because the veracity of use or intention of use of the trademark becomes doubtful.

(3)  Registrable subject matter:  Currently, sounds, smells, colors, textures, tastes and movements are not registerable as trademarks in Japan.  (However, the JPO is planning to submit a bill to revise the trademark law to the Japanese Diet in 2013.  So, registration of the mentioned subjects as trademarks may become possible in the near future.)

Q3. Are there any means to accelerate examination of a trademark application in Japan?

A3. Yes.  A request for accelerated examination can be filed anytime after the filing of your trademark application, and the request should be granted as long as the following condition 1 or 2 is met .

Condition 1 : Actual use of trademark and need for quick registration 

You or your licensee is already using your trademark for the goods or services designated in your application, or are preparing to use the trademark, AND

The trademark rights need to be granted urgently due to any one or more of the following reasons:

   1) A third party is using a trademark which is the same or similar to your trademark without authorization from you or your licensee, in connection with designated goods or services that are the same or similar to the goods and services for which you or your licensee has been using the trademark, or for which you or your licensee has prepared to a considerable degree to use the trademark.

   2) A third party has given a warning with respect to the use of your trademark.

   3) A third party is demanding an agreement to their use of your trademark.

   4) You have also applied for the trademark registration at a Patent Office other than the Japan Patent Office (JPO), or to an intergovernmental organization.

Condition 2:  Use of trademark only for designated goods or services

Your application designates only the goods and services for which you or your licensee is already using the trademark or you or your licensee is preparing to use the trademark.

Q4. What are the documents necessary for filing a request for accelerated examination for a trademark application in Japan? 

A4.  A document entitled "Explanation of the Circumstances Concerning Accelerated Examination” should be filed together with evidence(s) showing that the above-mentioned Condition 1 or 2 is fulfilled by the trademark application. 

Q5. What are the specifics of the individual fee system for a trademark registration via Madrid Protocol designating Japan. 

A5.  The JPO has adopted an individual fee consisting of two parts in accordance with Rule 34(3)(a) of the Common Regulations under the Madrid Protocol.

First part of the individual fee:  This corresponds to an application fee, and is paid at the time of international registration or the subsequent designation. 

Second part of the individual fee:  This corresponds to a registration fee, and is paid within the prescribed period mentioned in the notification issued with the Notice of Grant.  Failure of payment results in cancellation of the designation of Japan in the international registration.

Both fees are to be paid directly to the International Bureau of the WIPO.

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