Product-by-Process Claims: A Jurisdictional Overview

Saul Ewing LLP
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Summary

The Supreme Court of Japan has issued a decision which made significant changes to how product-by-process claims are handled by the Japanese Patent Office. The decision makes Japanese law on product-by-process claims similar to European law. United States law, however, significantly differs from its Japanese and European counterparts in how validity and coverage of a product-by-process claim are determined. In particular, in the United States, a product-by-process claim offers limited protection to the claimed product compared to Japan and Europe. However, product-by-process claims may be more difficult to obtain in Japan and Europe because of additional patentability requirements for such claims in these jurisdictions.

A “product-by-process” claim claims a product by defining or reciting the process of making the product, rather than by defining the structure or properties of the product. On June 5, 2015, in Case Nos. 2012(ju)1204 and 2012(ju) 2658,  the Supreme Court of Japan ruled that to be patentable, a product-by-process claim must be considered to have been “impossible” or “utterly impractical” to define the claimed product directly by its structure or properties on the filing date of the application. Further, the court ruled that a product-by-process claim covers any product identical to the claimed product in its structure or properties. Thus, under Japanese law, (1) a product-by-process claim is patentable if the product made by the process meets patentability criteria and the requirement that the product was otherwise “impossible” to define by its structure or properties on the filing date, and (2) a product-by-process claim covers any product identical to the claimed product, regardless of the process by which the product was made.

The European Patent Office treats product-by-process claims similarly. A product-by-process claim is patentable in Europe only when the product of the product-by-process claim meets patentability criteria (e.g., novelty and inventiveness) and “no other information [is] available in the application which could enable the applicant to define the product satisfactorily by reference to its composition, structure or some other testable parameter” (see Guidelines for Examination in the EPO Chapter IV- 4.12; T 0150/82). In addition, like Japanese law, a product-by-process claim is “to be construed as a claim to the product as such.” A product-by-process claim in Europe covers the “product per se” and “confers absolute protection upon the product.” 

United States law differs from Japanese and European law in its requirements for patentability and infringement of product-by-process claims. In determining patentability of a product-by-process claim against prior art, similar to the Japanese and European Patent Office, the U.S. Patent Office considers the product made by the process recited in the claim (see MPEP § 2113 and § 2173.05(p)). However, unlike Japanese or European law, U.S. law does not pose an additional requirement that the product must be otherwise impossible or difficult to define by reference to its structure or properties.

Further, in contrast to Japanese and European law, a product-by-process claim in the United States is construed to cover only the product made by the steps recited in the claim. In Abbott Labs. v. Sandoz, 566 F.3d 1282 (Fed. Cir.  2009), the Court of Appeals for the Federal Circuit held that process terms of a product-by-process claim served as claim limitations so that similar products made by a different process did not infringe on the claim. The limited protection for products defined in product-by-process claims in the United States is similar to the protection offered for products of manufacturing method or process claims in Europe and Japan, where a method or process claim extends protection to the product directly obtained from the claimed method or process, but not to similar products made by different methods (see e.g., European Art. 64(2)).

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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