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Message from the President Rebecca M. McNeill

Message from the Editor

Minutes of the Annual Meeting

Annual Symposium

BIPLA Annual Writing Competition

MTAS and the Common Law of Bailment

2023 BIPLA Comment on Expanding Criteria for Admission to Practice

2023 BIPLA Comment on Patent System Robustness and Reliability

Members on the Move

A Look At The Legal Intersection Of AI And Life Sciences

Optimising prosecution strategy for patent term extensions in Europe

What is the current threshold for support of a patent claim in New Zealand?

The Top Ten TTAB Decisions of 2022

List of Officers and Board of Governors

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2023 Ⓒ Boston Intellectual Property Law Association

NEWSLETTER ARCHIVE

Volume 54, Issue 1

Optimising prosecution strategy for patent term extensions in Europe

By Natalia Wegner and Daniel Wise, Carpmaels & Ransford LLP

Patent term extensions, also known as ‘Supplementary Protection Certificates’ (SPCs) in Europe, are valuable rights but are often considered late in the timeline. Keeping in mind the requirements for SPCs as early as drafting and during prosecution can reduce problems later on. Here we briefly discuss three scenarios and provide guidance which we hope our US colleagues will find useful in their practice.

1) The picture claim that adds matter

One of the requirements for an SPC is that the authorised product is protected by a basic patent in force. The meaning of “protected by” has been the subject of much debate at the Court of Justice of the European Union (CJEU) over the years. In its most recent judgment on the topic (C-650/17 Royalty Pharma), the CJEU confirmed that the authorised product must be “specifically identifiable” to the skilled person from the patent, the common general knowledge, and the prior art.

Following this judgment, we have seen many enquiries from clients and colleagues asking whether they should now try to obtain a narrow “picture claim” to the commercial product, to ensure that the product is deemed “specifically identifiable” for SPC purposes. While the presence of a picture claim might smooth the way to an SPC, it is arguably not a requirement given that Royalty Pharma refers to the patent as whole (including the description) and not just the claims. Furthermore, the authorised product may be “specifically identifiable” from multiple claims (e.g. claim x as dependent on claim y as dependent on claim 1).

The benefits and risks of introducing a picture claim should therefore be carefully evaluated on a case-by-case basis. The EPO is infamously strict in its assessment of added subject matter: the claimed subject matter must be “directly and unambiguously derivable” by the skilled person from the application as filed (and any priority application), using their common general knowledge. For example, if all the features of the picture claim are not disclosed in combination in the application as filed but need to be assembled from various parts of the description, then introducing the picture claim comes with the risk that the EPO or later an opponent objects that the picture claim adds matter. The question then arises whether the authorised product, i.e. the subject matter of the picture claim, can be “specifically identifiable” for SPC purposes when it is arguably not “directly and unambiguously derivable” from the application.

2) The description that leaves out ‘well-known’ features

Another scenario that we sometimes encounter is that the patent description does not specify all of the aspects of the authorised product, in particular those aspects that may have been considered well-known at the priority date. Examples are specific salt forms, Fc region sequences of antibodies, known drugs conjugated to antibodies or known virus strains in vaccines.

The absence of that detail in the description generally means that it will be necessary to explain, for SPC purposes, why the skilled person was able to “specifically identify” those aspects from their common general knowledge and/or the prior art at the priority date, which can create challenges. For example, prior art documents that do describe the missing aspects might be rejected on the basis that other documents describe alternatives, and so the skilled person was allegedly not in a position to pick the specific embodiment of the authorised product over other options that are described in the prior art.

When drafting a new application, and in light of the current case law, it is therefore advisable to briefly describe even known aspects of the future commercial product, to the extent that this is feasible at such an early stage.

3) The description that lists too many alternatives

A similar problem to that described above arises where the description does include the necessary detail for the authorised product, but it also lists many alternative embodiments without an indication of preference.

As a consequence, SPC examiners may object that the skilled person was unable to “specifically identify” the specific embodiment of the authorised product, given the many alternative embodiments that are additionally proposed in the description. Rebutting this objection is difficult and often requires evidence to show why the skilled person would have picked the commercial embodiment in particular.

The problem may be avoided during drafting by characterising as preferred (ideally with a reason) those embodiments that will likely be used in the commercial product, even if they relate to well-known features.