Keywords
Patents Patent claims Product-by-process claim Patent drafting
Headlines
Product-by-process claims are patent claims in which a product is defined, at least partly, in terms of the process used to create it. From a patent drafting and a patent enforcement perspective, this can be very appealing. However, different countries have distinctly different views on product-by-process claims. The legal protection provided by this type of claim can vary significantly depending on the country in question. In this article, we provide a global perspective on product-by-process claims, with particular focus on protection in the US, China, Japan, India, UK, France, Germany, European Patent Office (EPO) and Unified Patent Court (UPC).
Introduction
Inventions relating to complex products, such as polymers, can resist being defined in terms of their physical characteristics in a typical patent ‘product’ claim. For example, the microstructure of the product may not be known. Even if an attempt is made to do so, assuming that it is even possible at all, a scope of protection could result that is too narrow and does not justly reward the inventive contribution. While protection can be obtained for a process used to prepare such a product, protecting an invention in this way can leave a gap in protection in relation to the product itself.
To address this issue, product-by-process claims (e.g., “a product X obtainable by a process Y”) can be employed to protect such products by the process in which they are made. In the right circumstances, this type of claim can offer valuable protection. However, how product-by-process claims are treated in various jurisdictions around the world varies significantly, with this type of claim being helpful is some jurisdictions, but less so in others, as we will explore in more detail in this article.
Allowability – is it even possible to have a product-by-process claim?
The European patent office (EPO) only allows this type of claim where it is impossible to define a product other than in terms of a process of manufacture1. The position in the UK, Germany, China and Japan is similar to the EPO’s position, whereas France, India and the USA appear to take a more relaxed approach and allow this type of claim even if it is possible to define a product without reference to the process in which it is made.
Patentability
UK and EPO case law is clear in that product-by-process claims are to be interpreted as protecting products per se and not the processes by which the products are made. In other words, a product-by-process claim is interpreted, for the purposes of assessing patentability (i.e., novelty and inventive step), as a claim to a product itself, with any process steps being limiting only in the sense of any characteristics that the process imparts on the product. Therefore, a product-by-process claim cannot be rendered novel by virtue of making a known product using a different process. For the purposes of assessing patentability, there is no difference between the formulations “obtained by”, “obtainable by” or “directly obtained by”.
These properties of product-by-process claims appear to apply in France, Germany, China, Japan, India and the USA too, subject to the following notable differences: (i) the Japanese patent office do not appear to allow the “obtainable by” formulation and (ii) in India, the formulation “obtained by” is more limiting in that the process limitations are taken into account for the purposes of patentability (whereas they are not if the “obtainable by” formulation is used).
Turning to the Unified Patent Court (UPC), a decision2 of the Düsseldorf Local Division confirmed that the above properties of product-by-process claims also apply in this forum, with this type of claim protecting the product and there being no difference between the formulations “obtained by” and “obtainable by”.
Infringement
The situation regarding infringement of product-by-process claims is more nuanced. A leading decision on this point in the UK is Hospira UK Limited v Genentech Inc.3, where Mr Justice Birss (as he then was) clarified that, to infringe a product-by-process claim in the “obtained by” formulation, a product must be obtained by the process defined in the claim. Therefore, a product obtained via a different process would not infringe a product-by-process claim in this form, even where the product so obtained is identical to the product referred to in the claim.
The judge went on to clarify that a product-by-process claim in the “obtainable by” formulation could be infringed by both (i) a product obtained from the process defined in the claim and (ii) a product obtained by a different process so long as the product has “every single characteristic which is the inevitable consequence of that process”. Therefore, the use of “obtainable by” can potentially offer a broader scope of protection, whereby a product obtained via a different process could infringe a product-by-process claim.
The positions in China and India are similar to the UK in that the “obtained by” formulation is limited to the process defined in the claim, whereas the “obtainable by” formulation offers a broader scope of protection which is not limited to the process recited in the claim.
In France, there appears to be no case law addressing this point specifically, though it is recommended to use the “obtainable by” formulation.
To infringe a product-by-process claim in Germany or via the UPC, the process used to obtain a product does not need to be the process defined in the claim, irrespective of whether the “obtained by” or “obtainable by” formulations are used.
In the USA, product-by-process claims are interpreted narrowly for infringement purposes, such that a product needs to be obtained using the process steps defined in the claim to infringe, irrespective of which formulation is used.
In Japan, product-by-process claims are interpreted broadly in that the scope of protection is not limited to the particular process recited in the claim.
Burden of proof
In proceedings before the EPO, the burden of proof for an allegedly novel feature of a product-by-process claim lies with the applicant, who is required to provide evidence that the product obtained using the process defined in the claim differs to prior art products. A similar position appears to be adopted in the other jurisdictions referred to in this article.
In practice, this can present applicants with a difficult hurdle to surpass, as this can require obtaining experimental data showing how the product as claimed and any prior art products differ. In some cases, obtaining this sort of evidence is simply not possible, in view of the expense and time investment required to do so.
Summary and recommendations
In general, it is advisable to use the “obtainable by” formulation to maximise the potential scope of protection, as infringement of a claim in this form does not necessarily require a product to be produced by the specific process recited in the claim, though this depends on the jurisdiction in question and how the claim is construed by the courts. In addition, this can avoid the potentially challenging requirement to prove during litigation that a product has been produced using a specific method, as this can require deep access to a potentially infringing party’s manufacturing processes, which will most likely be confidential or even protected via trade secrets.
It is recommended that a patent application discloses in detail the process steps referred to in the claim, which identifiable and unambiguous technical features these steps impart to the product referred to in the claim and, where appropriate, how this results in a product which is distinguished from the prior art, for example by including experimental data.
It is also recommended to include process claims directed to the method of producing a product, in case the product-by-process claim is deemed unallowable (e.g., in view of potential difficulties in establishing or proving patentability of the product per se or in view of clarity issues), particularly as the process steps may involve novel and inventive features that may not have been taken into account during the assessment of patentability of the product-by-process claim.
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References
[1] https://www.epo.org/en/legal/guidelines-epc/2025/f_iv_4_12.html
[3] https://www.bailii.org/ew/cases/EWHC/Patents/2014/3857.html
