Section 2(j) of the Patents Act, 1970 (the Act) defines an invention as a new product or a process involving an inventive step and capable of industrial application. The legal protection to an invention is based on the claims of the granted patent. Typically, a product patent consists of claims defining a structure, apparatus, or a composition. A process patent on the other hand has claims directed towards a method/ process of manufacture of the product. In some cases, the product may not be defined or distinguished from the prior art except by reference to a process by which the product is made. In such cases, the claims define a product in terms of how the product is made; and claims directed to such products are ‘product-by-process’ claims. For instance, consider a glue stick composition ‘X’ that is well known in the art. Suppose, a glue stick composition X’, with enhanced gluing properties was obtained through a novel and inventive method ‘Y’, wherein the distinguishing feature between X and X’ is not characterizable by any testing parameter. In such cases, a patent for X’ obtained through the method ‘Y’, would be an example of a product-by-process claim. Two important questions that arise in this context are -
- On application for grant of a patent, how does the patent office evaluate the patentability of an invention for a product defined by process claim; and
- On grant, what determines the fence of such a claim – In other words, under what conditions is a third party considered to have infringed the subject matter disclosed in the product-by-process claim.
This article examines the first question.
Patentability criteria for product by process claims in India
The Indian Patents Act, 1970, and the Manual of Patent Office Practice and Procedure (MPPP) 2011 are rather silent on determining the patentability of inventions covered by a product-by-process claim. However, the Guidelines for Examination of Patent Applications in the Field of Pharmaceuticals, issued by the Office of the Controller General of Patents, Designs and Trademarks on 29th Oct, 2014 throw some light on the patentability criteria for examination of a product by process claim, with specific reference to the case of The Research Foundation of State University of New York v. Asst. Controller General of Patents (IPAB Order No. 200 of 2012). A brief summary of the case is as follows:
The Research Foundation of State University of New York v. Asst. Controller General of Patents
In this case, the applicant, The Research Foundation of State University of New York filed a patent application (3219/DELNP/2005) before the Patent Office seeking a patent on ceramic based nanoparticles for entrapping therapeutic agents for photodynamic therapy. The claims of the instant application are directed towards a composite prepared by a novel and an inventive process (product-by-process claims), among other claims. Following the prosecution conducted at the Patent Office, the Controller refused the grant of the patent application under Section 15 of the Act on the ground of lack of an inventive step in light of a prior art document – US 2002/0127224. Aggrieved by the decision of the Controller, the applicant approached the Intellectual Property Appellate Board (IPAB) in appeal against the Controller’s decision.
Before the IPAB, the Applicant argued that since the Controller had acknowledged the process for preparation of the composite as being novel and inventive, the composite prepared by the process was also entitled to be novel and inventive. The IPAB dismissed the applicant’s arguments and pointed out that the product-by-process claims must also define a novel and non-obvious product, and that its patentability cannot depend on the novelty and non-obviousness of the process limitations alone. Therefore, the IPAB held that the patentability of a product by process claim is based on the product itself; and this cannot be conferred by the patentability of the process of preparation of the product in a product by process claim’ [see end note 1].
In the present case, the IPAB observed that the difference between the composite of the instant invention and that of the prior art was with respect to a carrier used for drug delivery, both of which are non-biodegradable. The IPAB further noted that the composite of the instant application does not have any enhanced effect over that of the cited prior art. In the absence of any comparative advantages, the IPAB upheld the Controller’s decision for refusal of the claims directed to the composite.
Umicore AG & Co.KG v. Controller General of Patents
In another case pertaining to product by process claims, the applicant, Umicore AG & Co.KG, filed a patent application (1476/KOLNP/2009) before the Patent Office seeking a patent for a Vanadium free catalyst obtained by a process of impregnating Ce-Zr mixed oxide with an aqueous solution of a compound of Cr, Mo, W, or a mixture thereof, whereby the vanadium free catalyst obtained by this process has better catalytic properties. During examination of the patent application, the controller objected to the claims of the instant application for lack of novelty in light of a prior art (EP1736232) that discloses a vanadium free catalyst prepared by a different process. In light of the cited prior art, the Controller pointed out that the product cannot be rendered novel merely by the fact that it is obtained by a different process. To overcome this objection, the applicant submitted that the claimed process is different leading to a novel product not known in the art. The applicant submitted that the different process employed by the applicant resulted in a catalyst having W inside the pores of the Ce-Zr mixed oxide, unlike that of the prior art, where the W is not located inside the pores; but is incorporated into the oxide structure as Ce-W-Zr oxide. The applicant further compared the catalytic properties of the product of the instant application with that of the prior art, by way of examples, to prove its enhanced catalytic activity, and free flowing properties. The applicant further contented that the different properties are a clear hint that both the products are not the same, but are different; and that the difference lies in the mode of preparation of two catalysts. In light of this argument, the Controller proceeded to grant the patent.
The key take away from the above decisions is that when a product is defined by its method of manufacture; the question to be answered is whether the product under consideration is identical to the known products. The burden of proof for allegedly distinguishing the product in a ‘product-by-process’ claim from that of the prior art product lies with the applicant. The applicant has to provide experimental evidence that the modification of the process parameters results in an altogether new product, for example, by showing the distinct differences in the structural properties of the claimed product versus the known product.
Patentability criteria for product by process claims in US & EU
The jurisprudence with regard to product by process claims are well established in other jurisdictions such as the Europe and the US. The EPO allows claims for products defined in terms of a process of manufacture only if the products as such fulfil the requirements for patentability, i.e. inter alia that they are new and inventive and if there is no other way of clearly defining the product. A product is not rendered novel merely by the fact that it is produced by means of a new process. [T 0081/14, Kennametal Inc. v. Mitsubishi Materials Corporation.]
Similarly, the position of law in the US with respect to product by process claims is that 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 in light of a product in the prior art, the claim is not patentable even though the prior product was made by a different process. [In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985)]
The two Indian cases discussed above seem to echo similar positions as in the US & EU.
[The authors are Senior Patent Analysts, IPR Practice, Lakshmikumaran & Sridharan, New Delhi]
- IPAB order 200/2012