Availability of the deposited cell line to the public

Rule 27^ter of the Implementing Regulations to Patent Act provides the condition for Furnishing of Samples.

Rule 27^ter (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.

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).