Rule 27ter of
the Implementing Regulations to Patent Act provides the condition for
Furnishing of Samples.
Rule 27ter (internal citation omitted and emphasis added)
(1) A person who wishes to carry out the invention involving the deposited
microorganisms for the purpose of
examination or research may be furnished the sample of microorganisms
under the following circumstances:
i) the invention involving
the deposited microorganisms is patented,
ii) the person is given a
warning that the person is carrying out the invention involving the deposited
microorganisms which falls in the scope of claims of a published patent
application, or
iii) it is necessary for the
person to obtain the sample of microorganisms in order to draft a Written
Opinion in response to the Notice of Reasons of Refusal.
(2) The person who obtained the sample of microorganisms from the depositary
authority shall not allow a third party uses the sample.
In this context, the term “examination or research” means “examination or
research for i) assessing the patentability of or ii) the effect of the
invention involving the deposited microorganisms, or iii) improving the
invention involving the deposited microorganisms.” Examination or research in
university or institution that utilizes the invention as a tool is not included. In other words, the deposited microorganisms
itself must be the object of such an examination or research.
Of course, the depositary authority shall furnish a sample of any deposited
microorganism:
(i) to the depositor, on his
request; or
(ii) to the authorized
party, on the request of such party, provided that the request is accompanied
by a declaration of the depositor authorizing the requested furnishing of a
sample.
With regard to the scope of claims supported by deposit, it is possible to
obtain claims directed to a genus of cells that are broader than just the
deposited cell line, if the applicant has deposited “enough” number of cell
lines and disclosed them in the specification. If you have only one cell line
deposited and disclosed in the specification, the examiner would pose a
question of reproducibility and you will need a strong argument that a person
skilled in the art would have been able to obtain additional cell lines that
should fall in the claims with the guidance of the specification and the common
knowledge in the art. If you have more than two cell lines deposited and
disclosed in the specification, you should not have reproducibility problems,
but the examiner might say that the two or more cell lines do not represent the
entire scope of the broad genus claims. This argument is not specific to the
deposited microorganisms but is universal to the issue of enablement in
general. Attached please find schema explaining the relationship between the
number of examples and enablement (filename: Requirement of enablement
figure.pdf). Traditionally, the Japanese courts and the JPO have required that
the applicant show, by way of examples or scientifically sound theories, that
every single invention which is encompassed in the claims actually works or is
reasonably expected to work. Consequently, the scope of claims allowed in Japan
has been narrower than EPO and USPTO.
March 20, 2012
Differences between a simple method and a method of producing a product
An abbreviated translation of Art.2(3) of Patent Act is as follows:
“Working” of an invention in this Act means the following acts:
(i) in the case of an invention of a product, making, using, selling, leasing, exporting, importing, or offering for sale or lease thereof;
(ii) in the case of an invention of a process, the use thereof; and
(iii) in the case of an invention of a process for producing a product, in addition to the action as provided in item (ii), acts of using, selling, leasing, exporting, importing, or offering for sale or lease the product produced by the process.
It is characteristic of Japanese Patent Act that an invention of a (simple) process and an invention of a process for producing a product are explicitly distinguished from each other. As you can see, an invention of a process for producing a product can enjoy a higher degree of protection.
A famous case concerning this issue is the Supreme Court decision of 16 July 1999 (H10 (O) No.604). This case involves a patent for an assay for physiologically active substance. This assay is used for the quality control of pharmaceuticals. The defendant used this patented assay during the manufacture of their product, but outside Japan territory. Therefore, the use of the assay by the defendant did not infringe the Japanese patent of the patentee. The patentee still tried to enforce the patent against the imported pharmaceutical products. They argued that their assay method is essentially a method of producing pharmaceuticals because the assay is indispensable for the method of producing pharmaceuticals. The Tokyo High Court agreed and found infringement.
However, the Supreme Court disagreed. The Court said that the Patent Act explicitly distinguishes a (simple) process from a process of producing a product, and provides different protection to them. Whether an invention is a (simple) process or a process of producing a product should primarily be determined by the description of the claims. The patentee’s assay is clearly a (simple) process.
It is not surprising that nowadays an invention which is essentially a simple process is often drafted in a claim of a process for producing a product as follows:
A process of producing a medicament, comprising
(i).....
(ii) detecting the presence of substance X, and
(iii)..........
This type of claims can be allowed. But, we do not know yet how this type of claim should be interpreted in an infringement suit.
Recent decision of Intellectual Property High Court of 10 May 2010 (2009(Gyo-ke)No.10170) also involves the issue of simple vs. produce methods.
A very simplified representation of the claim at issue is as follows.
A process for manufacturing a pharmaceutical composition for the treatment of condition X, comprising the steps of:
- screening a compound for the treatment of condition X; and
- preparing a medicament.
In this case, the method of screening a compound for the treatment of condition X was patentable. Moreover, the step of preparing a medicament is considered to be a routine procedure for a person skilled in the art.
The IP High Court held that the specification does not meet the requirement of enablement. The court’s reasoning is as follows.
From the description of the application itself, a person skilled in the art should be able to identify the active ingredient of the pharmaceutical composition, which is a product to be produced by the method, as the chemical compounds per se. In other words, a person skilled in the art should be able to know from the description of the application whether a composition comprising a compound of certain structure falls within the scope of the patent claims or not. The number or availability of candidate compounds, the time required for screening, and whether the process is routine or not is irrelevant in this case.
Restriction on Assertions in Retrial of a Court Judgment in Patent Infringement Lawsuit
There is no system for post-grant opposition under Japan’s current effective patent law, but after a patent is granted, a trial may be demanded for the invalidation of the patent by anyone (Article 123(1)(2) of the Patent Act).
Invalidation trial may be requested soon after the grant and even after the expiration of patent (but there are some statutes of limitations).
There is no threshold for initiating the invalidation trial as long as the formalities are met. The grounds for requesting invalidation trial are not limited to questions of novelty and/or inventive steps. The exceptions are that only a person who has a right to obtain a patent may request an invalidation trial with the grounds that the patent has been granted to a person who does not have a right to obtain a patent and that only a person who should have been listed as a co-applicant may request an invalidation trial with the grounds that the patent has been granted to a patent application that does not meet the requirement of co-applicant.
The evidence is not limited to patents or printed publications. The trial board may also examine necessary evidence upon request or ex officio.
Typical scenario of invalidation trial and infringement suit is as follows.
A patentee finds a potential infringer and sends a “love letter” requesting that he stop making the patented product. The potential infringer answers that his product is outside the scope of patent claims and/or the patent is invalid. The patentee then brings a law suit at the Tokyo District Court or Osaka District Court. The potential infringer in tern files an invalidation trial at the JPO. In the law suit, the defendant may argue that the patent should be judged as invalid in an invalidation trial. The court may judge the validity of the claims by themselves (the Tokyo District Court and Osaka District Court have special fulltime staffs that help judges. They are mostly patent attorneys and ex-JPO examiners). In the invalidation trial, the patentee may request correction of patent in order to remove deficiencies. Then, the JPO trial board and the Court reach to their decisions independently. It is not rare that the JPO and the Court reach different conclusions. Let us assume that the patentee won at the JPO invalidation trial and the defendant won in the infringement law suit at the Tokyo District Court. The both parties will appeal to the Intellectual Property High Court. The IP High Court will join the two proceedings ((i) Litigation Rescinding the Trial Decision; and (ii) Infringement Court of Second Instance) as much as possible.
Let us assume that IP High Court holds that the claims are invalid and therefore there is no infringement. The patentee can file a final appeal to the Supreme Court. But, the Supreme Court will dismiss the case unless it involves a very important matter of law. The patentee has finally lost the infringement case. The case of invalidation trial is remanded to the JPO, and the JPO appeal board who is bound by the court decision will decide that the claims are invalid. Then, the patentee may request a Correction Trial at the JPO in order to remove the defects of the patent. In most cases, the patentee amends the claims to narrow the scope. Under current Japanese Patent Act, with these valid claims, the patentee may request a retrial of the infringement case which the patentee has lost a few years before. The battle continues.
Let us now assume that IP High Court holds that the claims are valid and there is an infringement. The defendant files a final appeal to the Supreme Court but the appeal is dismissed. The defendant has finally lost the case. Then, the defendant newly finds a publication that negates the inventive steps of the patented invention. The defendant requests a new invalidation trial, and finally invalidates the relevant claims of the patent. Under current Japanese Patent Act, the defendant may request a retrial of the infringement case which the defendant has lost several years before. The battle continues.
Under new Japanese Patent Act, effective on April 1, 2012, neither the patentee nor defendant may request a retrial of the infringement case on the grounds that the patent has been corrected or invalidated afterwards. Ratio legis of this amendment is that if the patentee or defendant may correct or invalidate the patent now, they should have so argued in the infringement law suit years before.
I suppose that ratio legis of the “substantial new question of patentability” threshold standard in the U.S. is that the requester of the inter partes review should not abuse the system in order to delay the settlement of dispute. It is interesting to note that the U.S. and Japan take quite different approaches to the same problem of the rapidness of the proceedings.
Pre-grant submission in Japan
Rule 13bis(1) of the Implementing Regulation to the Japan Patent Act provides that any person may submit for consideration of a patent application any documents such as patent publication and other printed publication, if such submission is made during the pendency of the patent application.
Such submission will be included in the record and any person may review it via internet or request photocopies at the JPO.
Items (i) to (iv) of Rule 13bis(1) requires that the submission should be related to the following issues:
(i) The application does not meet the requirements of Art.17bis(3) (amendment: introducing new matter that exceeds the original disclosure).
(ii) The application does not meet the requirement of Art.29(1) (novelty: the invention was publicly known, publicly worked, described in a distributed publication or made available to the public through telecommunication line in Japan or a foreign country before filing the application).
The application does not meet the requirement of Art.29bis (the invention was described in a previously-filed and later-published Japanese patent application: similar to current 35U.S.C. § 102(e) and new § 102(a)(2)). If the previously-filed and later-published application is a PCT application filed in a language other than Japanese, Japanese translations of application documents must have been filed within 30 months (2 months extension available) from the priority date in order to be eligible as an Art.29bis prior art.
The application does not meet the requirement of Art.39(1) to (4) (double patenting: claimed invention is the same as that of an application filed on or before the filing date of the present application).
(iii) The application does not meet the requirement of Art.36(4) or items (i) to (iii) of Art.36(6) (enablement, IDS, support, clarity, and conciseness).
(iv) The content of Japanese translations of application documents exceeds the disclosure of the original foreign language application documents.
Rule 13bis(2) provides that the submission must be in writing with the form 20.
Rule 13bis(3) provides that a seal (corresponds to signature) is not required.
Rule 13bis(4) provides that the submission may be done anonymously.
Rule 13ter provides similar provisions for a patent after grant.
Consequently, you may file the submission any time after publication of a patent application. But, please note that the examiner is not at all obliged to consider the submission. If the submission helps the examiner, he or she will use it. Moreover, no deference will be given to JPO examination in a later proceeding even in an invalidation trial at the JPO (not to mention in the court).
Such submission will be included in the record and any person may review it via internet or request photocopies at the JPO.
Items (i) to (iv) of Rule 13bis(1) requires that the submission should be related to the following issues:
(i) The application does not meet the requirements of Art.17bis(3) (amendment: introducing new matter that exceeds the original disclosure).
(ii) The application does not meet the requirement of Art.29(1) (novelty: the invention was publicly known, publicly worked, described in a distributed publication or made available to the public through telecommunication line in Japan or a foreign country before filing the application).
The application does not meet the requirement of Art.29bis (the invention was described in a previously-filed and later-published Japanese patent application: similar to current 35U.S.C. § 102(e) and new § 102(a)(2)). If the previously-filed and later-published application is a PCT application filed in a language other than Japanese, Japanese translations of application documents must have been filed within 30 months (2 months extension available) from the priority date in order to be eligible as an Art.29bis prior art.
The application does not meet the requirement of Art.39(1) to (4) (double patenting: claimed invention is the same as that of an application filed on or before the filing date of the present application).
(iii) The application does not meet the requirement of Art.36(4) or items (i) to (iii) of Art.36(6) (enablement, IDS, support, clarity, and conciseness).
(iv) The content of Japanese translations of application documents exceeds the disclosure of the original foreign language application documents.
Rule 13bis(2) provides that the submission must be in writing with the form 20.
Rule 13bis(3) provides that a seal (corresponds to signature) is not required.
Rule 13bis(4) provides that the submission may be done anonymously.
Rule 13ter provides similar provisions for a patent after grant.
Consequently, you may file the submission any time after publication of a patent application. But, please note that the examiner is not at all obliged to consider the submission. If the submission helps the examiner, he or she will use it. Moreover, no deference will be given to JPO examination in a later proceeding even in an invalidation trial at the JPO (not to mention in the court).
July 3, 2011
Timing of divisional application before the Japan Patent Office (JPO)
Divisional application. When to file? The deadline.
So, you've got an office action from the JPO. And, you are going to cancel claims which you've not given up entirely. Then, file a divisional now. If your claims shall cover everything you want, or if it was filed on or after April 1, 2007, then, you can wait until the decision of rejection or the decision of patent is issued. But, never forget that once you get the decision of rejection, it will be the last chance to file a divisional application. And if your application was filed before April 1, 2007, then, it will not be possible to file a divisional application after decision of patent.
For more details, please see the following site.
http://www.jpaa.or.jp/english/patent/unique_jpo_practices.html#subcontents2
However, please note that the information provided in the site above is not up to date at this moment and you must read the text as follows.
(2) In an application filed before April 1, 2007, ..........
i. .............
ii. ..............
iii. After a Decision of Rejection is made, an applicant can file a divisional application
(3) In an application filed on or after April 1, 2007, .............
iv. After a Decision of Rejection is issued, an applicant can file a divisional application within
v. ....................
May 7, 2011
Comparison of novelty/inventive steps judgment among Patent Offices
Color key 色分け | Novelty questioned 新規性が問題となる | |||||
Inventive steps questioned 進歩性が問題となる | ||||||
Novel and Inventive 新規かつ進歩性あり | ||||||
Depends on the nature of factor F 因子Fの性質に依存する | ||||||
| Assume the followings as common knowledge in the relevant art: - Treatment of cancer may involve various mechanisms such as inhibition of cell proliferation, angiogenesis and metastasis. - It is not known at this very moment whether the intracellular target, factor F, is involved in any of the cancer cell physiology. 以下を当業者常識として仮定する: - 癌の治療には細胞増殖、血管新生、及び転移の阻害などの様々な機構に関与しうる。 - 今この瞬間、細胞内の標的である因子Fが癌細胞の何らかの生理に関与していることは一切知られていない。 | ||||||
| Japan日本 | ||||||
Known facts (assuming that there is no other prior art other than that shown at the top of the column which the cell belongs to) 公知の事実（セルが属する列の一番上に示された事項以外の先行技術は全く存在しないと仮定する） | ||||||
Compound X 化合物X | Compound X may be used for treating cancer. 化合物Xは癌の処置に使用できる。 | Compound X may be used for inhibiting cell proliferation. 化合物Xは細胞増殖を阻害するために使用できる。 | Compound X may be used for inhibiting the intracellular target, factor F. 化合物Xは細胞内因子Fを阻害するために使用できる。 | Compound X may be used for treating CJD. 化合物XはCJDの処置に使用できる。 | ||
| Claimed Invention 請求に係る発明 | Compound X 化合物X | |||||
| A medicament for treating a disease, comprising compound X (disease not specified) 化合物Xを含む、疾患を処置するための医薬（疾患は特定されていない） | So-called "first medical use claim" is not allowed unless the requirement of enablement is met for wide range of diseases. 広範な疾患について実施可能要件が満たされない限り、いわゆる「第一医療用途クレーム」は許可されない。 | |||||
| A medicament for treating cancer, comprising compound X 化合物Xを含む、癌を処置するための医薬 | ||||||
| An agent for inhibiting cell proliferation, comprising compound X (Nobody knows the real utility of this type of claims in litigation) 化合物Xを含む、細胞増殖の阻害剤（この手の請求項が訴訟で実際に役に立つかは不明） | ||||||
| An agent for inhibiting the intracellular factor F, comprising compound X (Same as above) 化合物Xを含む、細胞内因子Fの阻害剤（同上） | ||||||
| EP 欧州 | ||||||
Known facts (assuming that there is no other prior art other than that shown at the top of the column which the cell belongs to) 公知の事実（セルが属する列の一番上に示された事項以外の先行技術は全く存在しないと仮定する） | ||||||
Compound X 化合物X | Compound X may be used for treating cancer. 化合物Xは癌の処置に使用できる。 | Compound X may be used for inhibiting cell proliferation. 化合物Xは細胞増殖を阻害するために使用できる。 | Compound X may be used for inhibiting the intracellular target, factor F. 化合物Xは細胞内因子Fを阻害するために使用できる。 | Compound X may be used for treating CJD. 化合物XはCJDの処置に使用できる。 | ||
| Claimed Invention 請求に係る発明 | Compound X 化合物X | |||||
| A medicament for treating a disease, comprising compound X (disease not specified) 化合物Xを含む、疾患を処置するための医薬（疾患は特定されていない） | Not a "first medical use" (EPC Art.54(4) does not apply) 「第一医療用途」でない（EPC第54条（4）は適用されない） | Not a "first medical use" (EPC Art.54(4) does not apply) 「第一医療用途」でない（EPC第54条（4）は適用されない） | ||||
| A medicament for treating cancer, comprising compound X 化合物Xを含む、癌を処置するための医薬 | ||||||
| An agent for inhibiting cell proliferation, comprising compound X 化合物Xを含む、細胞増殖の阻害剤 | Judged as compound X per se (EPC Art.54(4)(5) do not apply）. Non-therapeutic method claim might be drafted (e.g. for research or cosmetic purpose). 化合物Xそれ自体として判断される（EPC第54条（4）（5）は適用されない）。 非治療方法の請求項は立てられるかもしれない （即ち、研究又は美容目的の方法） | |||||
| An agent for inhibiting the intracellular factor F, comprising compound X 化合物Xを含む、細胞内因子Fの阻害剤 | ||||||
| US 米国 | ||||||
Known facts (assuming that there is no other prior art other than that shown at the top of the column which the cell belongs to) 公知の事実（セルが属する列の一番上に示された事項以外の先行技術は全く存在しないと仮定する） | ||||||
Compound X 化合物X | Compound X may be used for treating cancer. 化合物Xは癌の処置に使用できる。 | Compound X may be used for inhibiting cell proliferation. 化合物Xは細胞増殖を阻害するために使用できる。 | Compound X may be used for inhibiting the intracellular target, factor F. 化合物Xは細胞内因子Fを阻害するために使用できる。 | Compound X may be used for treating CJD. 化合物XはCJDの処置に使用できる。 | ||
| Claimed Invention 請求に係る発明 | Compound X 化合物X | |||||
| A method for treating a disease, comprising administering compound X to humans (disease not specified) 化合物Xをヒトに投与する工程を含む、疾患の処置方法（疾患は特定されていない） | No substantial utilities (35 U.S.C §101, MPEP 2107.01) 実質的な有用性がない（米国特許法第101条、審査基準2107.01） | |||||
| A method for treating cancer, comprising administering compound X to humans with cancer 癌に罹患したヒトに化合物Xを投与する工程を含む、癌の処置方法 | ||||||
| A method for inhibiting cell proliferation, comprising administering compound X to humans with cell proliferation related disease 細胞増殖関連の疾患に罹患したヒトに化合物Xを投与する工程を含む、細胞増殖を阻害する方法 | inherency 必然性 | |||||
| A method for inhibiting the intracellular factor F, comprising administering compound X to humans with facter F related disease 細胞内因子F関連の疾患に罹患したヒトに化合物Xを投与する工程を含む、当該因子Fを阻害する方法 | ||||||
July 9, 2009
Medicament characterized by novel dose and usage shall be patentable.
The following subcategories of inventions are already patentable subject matter under current practice.
- A medicament characterized by a novel component.
- A medicament characterized by a novel composition.
- A medicament characterized by a novel use.
The expert committee recommends that the following category of invention become a patentable subject matter as well.
- A medicament characterized by a novel dose (amount per administration) and a novel usage (dosage interval).
A medicament sold with indications for the dose and usage will infringe the corresponding patent. A medicament without indication will not.
The committee suggests that such a medicament characterized by novel dose and usage be considered to involve inventive steps only when it should dramatically reduce the side effect or improve patients' quality of life (QOL).
July 5, 2009
The expert committee recommends expansion of patentable subject matter by rewriting the examination manual
The expert committee recommends that each of the following category of the invention be a patentable subject matter.
- A medicament characterized by a novel dose (amount per administration) and a novel usage (dosage interval).
- A method of gathering data from human body in order to assist physicians provide diagnosis.
Note that this policy change is brought by rewriting of the examination manual, and hence, perhaps it will be applied to all the pending applications retrospectively. Several interested parties express concern about legal instability of the grant based on the new examination manual. Examination manual is just a internal standard of the Japanese Patent Office provided for the convenience of examiners and applicants. The court is not at all bound by the manual. They argue that such policy change for the patentable subject matter should be firmly legislated in the Patent Act.
July 4, 2009
Patentable invention with difficulties in specifying cells
Novel use of known human- or animal-derived materials, such as cells or cell-derived materials, is patentable as described before. However, it might be practically impossible to define or specify the material per se because of its complexity. Consequently, a product claim for such not-well-defined material is likely to be rejected for being unclear in Japanese practice.
When the material is not well defined, such novel use should NOT be claimed in the form of product claims, such as:
A cultured cell sheet derived from oral mucosa epithelial cells for regenerating cornea.
This claim is likely to be rejected for being unclear because the cultured cell sheet is not so well defined as to clearly outline the scope of the claim, and thus, appropriately warn the third parties.
Instead, such novel use should be claimed in the form of method of manufacturing claims, for example:
A method of manufacturing cultured cell sheet for regenerating cornea comprising a step of: treating oral mucosa epithelial cells with procedure X.
Please note that none of the oral mucosa epithelial cells, the procedure X and the cultured cell sheet has to be novel. In other words, patentability of the claim is recognized within novel use of a known product.
When the material is not well defined, such novel use should NOT be claimed in the form of product claims, such as:
A cultured cell sheet derived from oral mucosa epithelial cells for regenerating cornea.
This claim is likely to be rejected for being unclear because the cultured cell sheet is not so well defined as to clearly outline the scope of the claim, and thus, appropriately warn the third parties.
Instead, such novel use should be claimed in the form of method of manufacturing claims, for example:
A method of manufacturing cultured cell sheet for regenerating cornea comprising a step of: treating oral mucosa epithelial cells with procedure X.
Please note that none of the oral mucosa epithelial cells, the procedure X and the cultured cell sheet has to be novel. In other words, patentability of the claim is recognized within novel use of a known product.
June 27, 2009
Patentable invention characterized by use of human- or animal-derived materials, such as cells
The following subcategories of inventions are patentable subject matter under current Japanese practice.
i) a human- or animal-derived materials such as cells or cell-derived materials.
ii) novel use of known human- or animal-derived materials such as cells or cell-derived materials.
Such novel use should be claimed in the form of product claims, for example:
A cultured cell sheet derived from oral mucosa epithelial cells for regenerating cornea.
Such novel use should NOT be claimed in the form of simple method claims, for example:
Use of a cultured cell sheet derived from oral mucosa epithelial cells for regenerating cornea.
A method of regenerating cornea by using a cultured cell sheet derived from oral mucosa epithelial cells.
The distinction between the product claims and the method claims is, again, whether the practice of physicians and medical doctors should fall within the scope of the claim or not.
i) a human- or animal-derived materials such as cells or cell-derived materials.
ii) novel use of known human- or animal-derived materials such as cells or cell-derived materials.
Such novel use should be claimed in the form of product claims, for example:
A cultured cell sheet derived from oral mucosa epithelial cells for regenerating cornea.
Such novel use should NOT be claimed in the form of simple method claims, for example:
Use of a cultured cell sheet derived from oral mucosa epithelial cells for regenerating cornea.
A method of regenerating cornea by using a cultured cell sheet derived from oral mucosa epithelial cells.
The distinction between the product claims and the method claims is, again, whether the practice of physicians and medical doctors should fall within the scope of the claim or not.
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