India – Product By Process Claims: A Different Aspect For Patentability And Infringement.

Claims define the boundary of a patent specification or in other words claims define the protection conferred by a patent. There are various types of claims; product by process claim is one of them used to make the product/product of a specific method. For example polypeptides, recombinant or genetically modified product etc. obtained/produced by process/method of claim. The claim typically uses the words such as a product "obtained by", "obtainable by", "produced by", and "A product of a process comprising the steps of". Product by process claims are generally drafted to define a novel and non-obvious product which could not be defined by its physical attributes. Moreover the product may have the novel and non-obvious characteristics linked to the process from which it is obtained.

 

Patentability Criteria:

 

In Indian Jurisdiction:

 

Patentability criteria of product by process claims are not defined in the Indian patent statute. However the guidelines for examination of patent applications in the field of pharmaceuticals issued in Oct 2014, defines specifically by referring to the IPAB case held in ORDER No. 200/2012 which states "even though product by process claims are limited by and defined by the process, determination of patentability is based on the product itself".

 

In order to distinguish the product claimed in terms of product by process from the prior art, one must be able to establish the novelty and inventive step of the product regardless of the process from which the product is obtained.

 

Therefore in Indian jurisdiction patentability of the product by process claims depends only on the patentability of product irrespective of the process from which it is obtained.

 

In European jurisdiction

 

With regard to the patentability of product by process claims, EPO has well defined guidelines which states that product defined in terms of process is allowable only if the claimed product full fills the requirement of patentability i.e. the product per se should be novel and inventive regardless of the fact that it is produced from a new process.

 

If the product is defined by the process than the burden of proof lies on the applicant to prove that the product defined by process is different from the known product and to provide evidence that the modification of the process has resulted in a modified product.

 

US Jurisdiction:

 

Alike European jurisdiction, Product by process claims are allowed only if the product per se full fills the patentability requirement in US jurisdiction as well.

 

Patentability criteria in all major jurisdictions are determined by the patentability of the product alone not by the process from which it is obtained. Reason for the same might be that an Applicant should not acquire exclusive rights to the product already in the prior art. Therefore there is a need of doing full analytical check-up of a product defined by a process such that it can be distinguished with the prior art products of the same category.

 

Infringement Criteria:

 

It is well established that product claim confers the protection to the product irrespective of the process from which it is obtained and process claims gives protection to the claimed process only.

With regard to product by process claims, infringement law is unclear whether the product by process claims gives protection to the product irrespective of the process from which it is obtained (similar to the patentability aspect) or only encompasses the product which are obtained by the claimed process.

 

In Indian Jurisdiction:

 

The Indian Patent Act defines the scope conferred by the product claims and process claims but is silent over the scope conferred by the product by process claims.

 

In European jurisdiction:

 

According to board of appeal of T 0020/94 (Amorphous TPM/ENICHEM) of 4.11.1998, point 4.4 gave some clarification with regard to the protection conferred by the product by process claim. It states that the product by process claims gives protection to the particular product regardless of the process by which it is obtained. Particular product herein referred as a product having the characteristic features of process from which it is obtained. Therefore the product by process claims extends the protection conferred by the process claims.

 

UK court in Hospira UK Ltd v Genetech Inc [2014] EWHC 3857 (Pat)(Ch D(Patent Ct)) reviewed the decision of EPO and gave the clarification w.r.t. the product by process claims. This case defines the patentability and infringement aspect of product by process claims in UK. The court infers that "by process" language limits the scope of claim for the purpose of infringement. This judgement also throws some light on the product by process claim construction where the term "obtainable by" is much broader to the term "obtained by". The term obtained by restricts the product to the single claimed process whereas the term obtainable by means the product may beobtained by the claimed process and does not mean that it must be.

In view of the decision it seems that the term "obtainable by" would confer more protection to the product. Particularly in case of the product by process claims where the process defined characteristics of a product are specifically disclosed.

 

In U.S. jurisdiction:

 

The infringement aspect of product by process claims in US jurisdiction varies from case to case.

 

In the Scripps Case (Fed. Cir. 1991), three benched judge panel has held that the product by process claims should confer the protection to the product irrespective of the process from which it is obtained i.e. the product by process claims shall be interpreted as the product claims. The reasoning behind the decision is: firstly the Scripp has established the novelty and non-obviousness of the product over the cited prior arts based on the product characteristics. Secondly the product by process claims should be considered in similar way for both patentability and infringement.

 

Next, the Atlantic Thermoplastics (Fed. Cir. 1992), which has turned the aspect of infringement of product by process claims laid in Scipps Case. The panel of Antlantic Thermoplastics states "An accused infringer can avoid infringement by showing that the accused device lacks even a single claim limitation." Since the product by process claims has a limitation of process therefore the scope of the product by process claims is also linked to the process limitation.

 

The judgement of the two cases is contrary to each other and therefore request for rehearing was made but the court disagreed. The Judge Newman then differentiated the decision of two cases. He characterised that the product by process claims in the two cases is entirely different. Claims in Atlantic case are product of process claims and their patentability also defined the novelty and non-obviousness of the process, therefore process limitation rules the infringement of product by process claims.

 

On the other hand Sripps claims relate to a new and non-obvious product which cannot be defined independent of process. Therefore the inventions which cannot be structurally defined but their patentability depends on the novelty and non-obviousness of product only should be infringed by the product irrespective of the process by which it is made.

 

According to judge Newman the infringement of the product by process claims depends on the invention in light of specification, prosecution history, prior arts cited.

 

Conclusion:

 

It is well established in each jurisdiction that patentability of the product defined by a process is determined by product alone irrespective of the novel process from which it is obtained. The burden of proof lies on the Applicant to establish the non-obvious difference of the product obtained by a process in view of the similar product disclosed in the prior arts. But the infringement aspect of the product by process claims somehow depends on the way the claims are drafted, need of drafting product by process claims, prosecution history, and the prior arts. According to the case laws defined above, it seems that product by process claims majorly provide protection to the product which is obtained by the claimed process. Hence it is advisable to avoid drafting product by process claims when the product can be defined by its physical attributes or file a provisional first to save the priority date and then draft the product claims with characteristic features of the product to enjoy the full scope of product protection.