Product-by-Process Claims

19 September 2012

Claims define the scope of legal protection for an invention and are crafted in such a manner that they cover all aspects of the protection being sought. For different kinds of inventions different forms of claims are formulated. One such type of claims is “product-by-process” claims. Such claims are drawn to protect a product made by a process.

Such claims may be necessary in situations where a novel product could not be described other than by a reference to the process of its production or where the characteristic of the product depends upon the process it is made by. This type of claim may be in the form of “Product X, obtained by a process comprising steps of……..” or “Product X, obtained by a process of claim …”. The patentability criteria for such claims, even if essentially similar, the scope of protection conferred is construed differently in different jurisdictions and even within the same jurisdiction.

The patentability criteria of productby-process claims in Europe are provided in Guidelines for Examination in the European Patent Office in Part C.III.4.12, which states that a product is not rendered novel merely by the fact that it is produced by means of a new process; the product must fulfill the requirements for patentability for such claims to be allowed. The same guidelines also clarify that the scope of such claims extends to the product per se and confers absolute protection upon the product.

In the United States, where such types of claims actually originated, for such claims to be granted, the product must meet the patentability criteria. The US Patent & Trademark Office has defined the patentability criteria of product-by-process claims in Chapter 2113 of the Manual of Patent Examining Procedure, which states that “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.”

However, in terms of the protection offered, there is a divide. Under Scripps Clinic & Research Found. v. Genentech, it was noted that the product is protected per se, regardless of how the accused product is made. On the other hand, Atlantic Thermoplastics v. Faytex held that for infringement, a product may only infringe if it was made by the same or a substantially similar process as defined in the specific claim under question. In some other cases, the scope of the claims was considered on the basis of the specification and prosecution history estoppels.

In India, the patentability and metes and bounds of such claims cannot be determined outright. Unlike Europe and the US, where the patent offices provide guidelines for the patentability and scope of such claims, the Indian Patents Act, 1970 and the Manual of Patent Practice are silent on such category of claims. Yet, based on the Indian patent practice followed with regard to prosecution of such claims, the product is supposed to meet the criteria of patentability, i.e. the product should be new and inventive for it to be patentable. The objection which is generally raised during the examination for product-by-process claims includes that the product must be characterized by its composition and not by the process by which it is made. It is therefore prudent to define the product by its novel and inventive features in addition to process steps by which it is made.

With regard to the protection conferred by product by process claims in India, absence of guidelines and lack of significant precedence by pertinent case laws, the determination of scope of protection of these claims appears to be in state of quandary. Nonetheless, it may be pertinent to reproduce the provision in the Patents Act which hints of product-by-process claims, Section 64(2)(b), which relates to what would not be considered as anticipation or obviousness for revocation of patents: “Where the patent is for a process or for a product as made by a process described or claimed, the importation into India of the product made abroad by that process shall constitute knowledge or use in India of the invention on the date of the importation, except where such importation has been for the purpose of reasonable trial or experiment only.” One may extend this section to protection of productby-process claims, and make out that the protection conferred by such claims could be restricted to a product obtained by the specified process.

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