ニュース

Supreme Court of Japan overturn ‘Product-by-Process’ claims

Published on: 25 November 2015 by Kazuya Sekiguchi, Patent Attorney (JP) and European Patent Attorney at Dennemyer & Associates

In June, the Supreme Court overturned a decision by the IPHC in regards to the interpretation of the Product-by-Process claims. Today, Kazuya Sekiguchi of Dennemyer & Associates, gives insight to the case and explains what this means for the future.

On 5 June 2015, the Supreme Court overturned the decision by the Grand Panel of the Intellectual Property High Court (IPHC) with respect to the interpretation of the Product-by-Process (PBP) claims. According to the decision, PBP claims can be used only when it is impossible or unrealistic to define the product itself without using the process to obtain it at the time of application. In this case, the scope of the claims should be interpreted to include products produced, not only by the process recited in the PBP claims, but also products obtained by any other process.

PBP Claim History

Interpretation of PBP claims

A PBP claim is a claim which includes a statement defining a product by its manufacturing process, such as “Product A which is obtained by a process X”. In Japanese practice, the applicant can choose to use PBP claims when he believes it is inappropriate to define the product without using the process, even when the product can be defined without doing so.

When interpreting the scope of the PBP claims, there have been two types of interpretation. One is that the scope of a PBP claim (Product A which is obtained by a process X) covers any products irrelevant to the process to obtain it; this is called Product-based-interpretation. The other one is that a PBP claim covers only the product A which is produced by exactly the recited process X; this is called Process-based-interpretation.

At the examination stage, the PBP claims are interpreted based on Product-based-interpretation. That is, if the product (A) itself is not novel, the claimed product (A) is not patentable even if the process defined in PBP claims it is new and inventive.

On the other hand, when judging the infringement of the PBP claims, there are case laws that adopt both Product-based-interpretation and Process-based-interpretation to define the scope of the PBP claims. In order to unify the interpretation of the PBP claims, the Grand Panel of the IPHC issued an important decision in January, 2012.

Grand Panel of the IPHC Decision

Case Outline

 

  • Plaintiff; TEVA Gyogyszergyar (hereinafter “TEVA”)
  • The defendant; Kyowa Hakko Kirin (hereinafter “Kyowa”)
  • Patent No. JP 3737801 B (TEVA’s patent)
  • Title: “Pravastatin sodium substantially free of pravastatin lactone and epi-pravastatin, and compositions containing same”
  • Claim 1: “Pravastatin sodium containing less than 0.5 wt.% of pravastatin lactone and less than 0.2 wt.%of epiprava, wherein the pravastatin sodium is obtained by the following steps:

 

 

  1. Preparing a concentrated organic solution of pravastatin,
  2. Precipitating the pravastatin as its ammonium salt,
  3. Purifying the pravastatin by recrystallization of the ammonium salt,
  4. Transposing the ammonium salt to pravastatin sodium salt, and
  5. Isolating pravastatin sodium.”

 

Kyowa manufactures and distributes “Pravastatin sodium containing less than 0.2 wt.% of paravastatin lactone and less than 0.1 wt.% of epiprava”. TEVA filed a suit against Kyowa at the Tokyo District Court (2007(Wa)35324), requesting injunction of the manufacturing and distributing of Kyowa’s product. Kyowa replied that its product is not manufactured by the same process as claimed in TEVA’s patent (Kyowa’s process does not include the step A of the TEVA’s patent).

The Decision

In the decision, the Grand Panel of the IPHC ruled the criterion how to interpret PBP claims as follows:

“The scope of PBP claims, in principle, should be interpreted by using the entire wording in the claims, and thus it should be limited to the product obtained by the recited process X.

However, for some new products, it might be difficult or impossible to define the product itself without using the process to obtain the product at the time of application. Only in such cases, the scope of the PBP claim may be interpreted to include the product independently of the process to obtain it.”

The patentee must prove the fact that it was difficult or impossible to define the claimed product (A) without using the process (X) to obtain it at the time of application if he wants broader protection (without the limitation of the process to obtain the claimed product).

The Grand Panel also ruled that this criterion should also be applied to the examination procedure.

Based on this criterion, the Grand Panel concluded that the TEVA did not prove that it was difficult or impossible to define the claimed product (A) without using the process (X) at the time of the application. Therefore, the scope of TEVA’s patent should be interpreted based on “Process-based-interpretation”.

Since the Kyowa’s process to obtain the product does not include step a) of TEVA’s patent claim, listed above, the Grand Panel ruled that Kyowa’s product is not within the scope of the TEVA’s patent and thus no infringement in this case.

In summary, the Grand Panel of the IPHC ruled that the scope of the PBP claims is limited to the product obtained by the claimed process in principle. Exceptionally, the scope can be broadened to the claimed product, irrelevant to the process to obtain it, when it is difficult or impossible to define the claimed product without using the process at the time of the application.

Supreme Court Decision

The Supreme Court overturned the decision by the Grand Panel of the IPHC and decided to send back this case to the IPHC.

In the decision, the Supreme Court states:

“A patent may be granted to the invention of a product, a process and a process to produce a product. The scope of the patent of a product claim should cover all the products which have the same structure, physical properties, etc. as those of the claimed product. PBP claim defines an invention of a product itself, though the product is defined by a process to obtain it. Therefore, the scope of the PBP claims should be interpreted in the same way as for the other claims relating to a product, namely to cover products which have same structure, physical properties, etc. as those of the claimed product, irrelevant to the process to obtain it.”

That is, the Supreme Court clearly showed a criterion that the scope of the PBP claims should always be interpreted based on the “Product-based-interpretation”.

On the other hand, it is necessary that the structure, physical properties, etc. of the claimed product should be clearly read from the claims. Otherwise, a third party cannot properly judge the scope of the claimed invention and thus they may suffer unpredictable prejudice. If it is difficult or impossible for the skilled person to understand the scope of the claimed product, such a claim should be regarded as unclear. In this regard, when a product is defined by the process to obtain it, it is usually difficult for the skilled person to understand what structure, physical properties, etc. the claimed product has.

Consequently, the Supreme Court ruled:

“A claim defined by the process to obtain it (a PBP claim) is in principle unclear because it is usually difficult for the skilled person to understand what structure, physical properties, etc. the claimed product has. Therefore, PBP claims will be rejected since they are not clear. However, there is a case where it is impossible or unrealistic to define the product itself without using the process to obtain it at the time of application. In such a case, defining the product by the process to obtain it should be admitted, i.e. the requirements of clarity should be regarded as met.”

Given the sentences of the Supreme Court, the decision of the IPHC Grand Panel is not appropriate as it mentions that the PBP claims can be interpreted by “Process-based-interpretation” under certain circumstances. Therefore, the case has been sentenced to be sent back to the IPHC for further examination. Based on the Supreme Court decision, it will be re-examined whether the product manufactured by Kyowa has the same structure, physical properties, etc. as those of TEVA’s patent in the IPHC. If it is concluded that the product produced by Kyowa is the same as the TEVA’s claimed product, the IPHC will conclude that Kyowa infringes TEVA’s patent.

On the other hand, the clarity of TEVA’s patent will be an issue. In the previous IPHC’s decision, the Grand Panel stated that it cannot be said that it was impossible or unrealistic to define the product itself without using the process to obtain it, at the time of application. Therefore, if TEVA cannot prove that it was impossible or unrealistic to define the product without using the process to obtain it at the time of application, this patent may be revoked due to lack of clarity.

Conclusion

Following this Supreme Court decision, the Japan Patent Office (JPO) has started to revise the Guidelines for the patent and utility model examination. In order for the PBP claims to be kept in the examination procedure, the JPO examiner will, in principle, raise an objection for clarity and the applicant will need to prove that it was impossible or unrealistic to define the product itself without using the process to obtain it at the time of application.

The JPO announced that the Examination under the new Guideline starts from October 2015. Until then, the examiner will issue an office action for all the applications, including PBP claims, in order for the applicant to have an opportunity to amend claims or to argue the validity of using PBP claims.

Due to the Supreme Court decision, using PBP claims will be more difficult in the future. Now, in order for the PBP claims to be maintained, it is necessary for the applicant to prove that it was impossible or unrealistic to define the product itself without using the process to obtain it at the time of application.

This article originally appeared in Patent Lawyer Magazine, published in November 2015. Click here to read the full article.